-CITE-
    21 USC CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

-HEAD-
             CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT         

-MISC1-
                        SUBCHAPTER I - SHORT TITLE                    
    Sec.                                                     
    301.        Short title.                                          

                        SUBCHAPTER II - DEFINITIONS                    
    321.        Definitions; generally.                               
    321a.       "Butter" defined.                                     
    321b.       "Package" defined.                                    
    321c.       Nonfat dry milk; "milk" defined.                      
    321d.       Market names for catfish and ginseng.                 

              SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES          
    331.        Prohibited acts.                                      
    332.        Injunction proceedings.                               
    333.        Penalties.                                            
    333a.       Repealed.                                             
    334.        Seizure.                                              
    335.        Hearing before report of criminal violation.          
    335a.       Debarment, temporary denial of approval, and
                 suspension.                                          
    335b.       Civil penalties.                                      
    335c.       Authority to withdraw approval of abbreviated drug
                 applications.                                        
    336.        Report of minor violations.                           
    337.        Proceedings in name of United States; provision as to
                 subpoenas.                                           

                           SUBCHAPTER IV - FOOD                       
    341.        Definitions and standards for food.                   
    342.        Adulterated food.                                     
    343.        Misbranded food.                                      
    343-1.      National uniform nutrition labeling.                  
    343-2.      Dietary supplement labeling exemptions.               
    343-3.      Disclosure.                                           
    343a.       Repealed.                                             
    344.        Emergency permit control.                             
    345.        Regulations making exemptions.                        
    346.        Tolerances for poisonous or deleterious substances in
                 food; regulations.                                   
    346a.       Tolerances and exemptions for pesticide chemical
                 residues.                                            
    346b.       Authorization of appropriations.                      
    347.        Intrastate sales of colored oleomargarine.            
    347a.       Congressional declaration of policy regarding
                 oleomargarine sales.                                 
    347b.       Contravention of State laws.                          
    348.        Food additives.                                       
    349.        Bottled drinking water standards; publication in
                 Federal Register.                                    
    350.        Vitamins and minerals.                                
    350a.       Infant formulas.                                      
    350b.       New dietary ingredients.                              
    350c.       Maintenance and inspection of records.                
    350d.       Registration of food facilities.                      
    350e.       Sanitary transportation practices.                    

                     SUBCHAPTER V - DRUGS AND DEVICES                 

                        PART A - DRUGS AND DEVICES                    
    351.        Adulterated drugs and devices.                        
    352.        Misbranded drugs and devices.                         
    353.        Exemptions and consideration for certain drugs,
                 devices, and biological products.                    
    353a.       Pharmacy compounding.                                 
    354.        Veterinary feed directive drugs.                      
    355.        New drugs.                                            
    355a.       Pediatric studies of drugs.                           
    355b.       Adverse-event reporting.                              
    355c.       Research into pediatric uses for drugs and biological
                 products.                                            
    356.        Fast track products.                                  
    356-1.      Accelerated approval of priority countermeasures.     
    356a.       Manufacturing changes.                                
    356b.       Reports of postmarketing studies.                     
    356c.       Discontinuance of life saving product.                
    357.        Repealed.                                             
    358.        Authority to designate official names.                
    359.        Nonapplicability of subchapter to cosmetics.          
    360.        Registration of producers of drugs or devices.        
    360a.       Repealed.                                             
    360b.       New animal drugs.                                     
    360c.       Classification of devices intended for human use.     
    360d.       Performance standards.                                
    360e.       Premarket approval.                                   
    360f.       Banned devices.                                       
    360g.       Judicial review.                                      
    360h.       Notification and other remedies.                      
    360i.       Records and reports on devices.                       
    360j.       General provisions respecting control of devices
                 intended for human use.                              
    360k.       State and local requirements respecting devices.      
    360l.       Postmarket surveillance.                              
    360m.       Accredited persons.                                   

              PART B - DRUGS FOR RARE DISEASES OR CONDITIONS          
    360aa.      Recommendations for investigations of drugs for rare
                 diseases or conditions.                              
    360bb.      Designation of drugs for rare diseases or conditions. 
    360cc.      Protection for drugs for rare diseases or conditions. 
    360dd.      Open protocols for investigations of drugs for rare
                 diseases or conditions.                              
    360ee.      Grants and contracts for development of drugs for rare
                 diseases and conditions.                             

               PART C - ELECTRONIC PRODUCT RADIATION CONTROL           
    360hh.      Definitions.                                          
    360ii.      Program of control.                                   
    360jj.      Studies by Secretary.                                 
    360kk.      Performance standards for electronic products.        
    360ll.      Notification of defects in and repair or replacement
                 of electronic products.                              
    360mm.      Imports.                                              
    360nn.      Inspection, records, and reports.                     
    360oo.      Prohibited acts.                                      
    360pp.      Enforcement.                                          
    360qq.      Repealed.                                             
    360rr.      Federal-State cooperation.                            
    360ss.      State standards.                                      

              PART D - DISSEMINATION OF TREATMENT INFORMATION          
    360aaa.     Requirements for dissemination of treatment
                 information on drugs or devices.                     
    360aaa-1.   Information authorized to be disseminated.            
    360aaa-2.   Establishment of list of articles and publications
                 disseminated and list of providers that received
                 articles and reference publications.                 
    360aaa-3.   Requirement regarding submission of supplemental
                 application for new use; exemption from requirement. 
    360aaa-4.   Corrective actions; cessation of dissemination.       
    360aaa-5.   Definitions.                                          
    360aaa-6.   Rules of construction.                                

         PART E - GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES     
    360bbb.     Expanded access to unapproved therapies and
                 diagnostics.                                         
    360bbb-1.   Dispute resolution.                                   
    360bbb-2.   Classification of products.                           
    360bbb-3.   Authorization for medical products for use in
                 emergencies.                                         
    360bbb-4.   Technical assistance.                                 

         PART F - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES     
    360ccc.     Conditional approval of new animal drugs for minor use
                 and minor species.                                   
    360ccc-1.   Index of legally marketed unapproved new animal drugs
                 for minor species.                                   
    360ccc-2.   Designated new animal drugs for minor use or minor
                 species.                                             

                         SUBCHAPTER VI - COSMETICS                     
    361.        Adulterated cosmetics.                                
    362.        Misbranded cosmetics.                                 
    363.        Regulations making exemptions.                        
    364.        Repealed.                                             

                    SUBCHAPTER VII - GENERAL AUTHORITY                

                PART A - GENERAL ADMINISTRATIVE PROVISIONS            
    371.        Regulations and hearings.                             
    372.        Examinations and investigations.                      
    372a.       Transferred.                                          
    373.        Records.                                              
    374.        Inspection.                                           
    374a.       Inspections relating to food allergens.               
    375.        Publicity.                                            
    376.        Examination of sea food on request of packer; marking
                 food with results; fees; penalties.                  
    377.        Revision of United States Pharmacopoeia; development
                 of analysis and mechanical and physical tests.       
    378.        Advertising of foods.                                 
    379.        Confidential information.                             
    379a.       Presumption of existence of jurisdiction.             
    379b.       Consolidated administrative and laboratory facility.  
    379c.       Transferred.                                          
    379d.       Automation of Food and Drug Administration.           

                              PART B - COLORS                          
    379e.       Listing and certification of color additives for
                 foods, drugs, devices, and cosmetics.                

                               PART C - FEES                           

                  SUBPART 1 - FREEDOM OF INFORMATION FEES              
    379f.       Recovery and retention of fees for freedom of
                 information requests.                                

                    SUBPART 2 - FEES RELATING TO DRUGS                
    379g.       Definitions.                                          
    379h.       Authority to assess and use drug fees.                

                   SUBPART 3 - FEES RELATING TO DEVICES               
    379i.       Definitions.                                          
    379j.       Authority to assess and use device fees.              

                 SUBPART 4 - FEES RELATING TO ANIMAL DRUGS             
    379j-11.    Definitions.                                          
    379j-12.    Authority to assess and use animal drug fees.         

                    PART D - INFORMATION AND EDUCATION                
    379k.       Information system.                                   
    379l.       Education.                                            

                   PART E - ENVIRONMENTAL IMPACT REVIEW               
    379o.       Environmental impact.                                 

        PART F - NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
             PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS
    379r.       National uniformity for nonprescription drugs.        
    379s.       Preemption for labeling or packaging of cosmetics.    

                          PART G - SAFETY REPORTS                      
    379v.       Safety report disclaimers.                            

                  PART H - SERIOUS ADVERSE EVENT REPORTS              
    379aa.      Serious adverse event reporting for nonprescription
                 drugs.                                               
    379aa-1.    Serious adverse event reporting for dietary
                 supplements.                                         

                   SUBCHAPTER VIII - IMPORTS AND EXPORTS               
    381.        Imports and exports.                                  
    382.        Exports of certain unapproved products.               
    383.        Office of International Relations.                    
    384.        Importation of prescription drugs.                    

                       SUBCHAPTER IX - MISCELLANEOUS                   
    391.        Separability clause.                                  
    392.        Exemption of meats and meat food products.            
    393.        Food and Drug Administration.                         
    393a.       Office of Pediatric Therapeutics.                     
    394.        Scientific review groups.                             
    395.        Loan repayment program.                               
    396.        Practice of medicine.                                 
    397.        Contracts for expert review.                          
    398.        Notices to States regarding imported food.            
    399.        Grants to States for inspections.                     

-End-


-CITE-
    21 USC SUBCHAPTER I - SHORT TITLE                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER I - SHORT TITLE

-HEAD-
                        SUBCHAPTER I - SHORT TITLE                    

-End-



-CITE-
    21 USC Sec. 301                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER I - SHORT TITLE

-HEAD-
    Sec. 301. Short title

-STATUTE-
      This chapter may be cited as the Federal Food, Drug, and Cosmetic
    Act.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 1, 52 Stat. 1040.)


-MISC1-
               EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES           
      Act June 23, 1939, ch. 242, Secs. 1, 2, 53 Stat. 853, 854,
    provided that:
      "[Sec. 1] (a) The effective date of the following provisions of
    the Federal Food, Drug, and Cosmetic Act is hereby postponed until
    January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1)
    [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
    to (k) of this title]; 501(a), (4) [351(a)(4) of this title];
    502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this
    title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this
    title].
      "(b) The Secretary of Agriculture shall promulgate regulations
    further postponing to July 1, 1940 the effective date of the
    provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g),
    (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g),
    and (h) [352(b), (d) to (h) of this title]; and 602(b) [362(b) of
    this title] of such Act with respect to lithographed labeling which
    was manufactured prior to February 1, 1939, and to containers
    bearing labeling which, prior to February 1, 1939, was
    lithographed, etched, stamped, pressed, printed, fused or blown on
    or in such containers, where compliance with such provisions would
    be unduly burdensome by reason of causing the loss of valuable
    stocks of such labeling or containers, and where such postponement
    would not prevent the public interest being adequately served:
    Provided, That in no case shall such regulations apply to labeling
    which would not have complied with the requirements of the Food and
    Drugs Act of June 30, 1906, as amended.
      "Sec. 2. (a) The provisions of section 8 [section 10 of this
    title], paragraph fifth, under the heading 'In the case of food:',
    of the Food and Drugs Act of June 30, 1906, as amended, and
    regulations promulgated thereunder, and all other provisions of
    such Act to the extent that they may relate to the enforcement of
    such section 8 [section 10 of this title] and of such regulations,
    shall remain in force until January 1, 1940.
      "(b) The provisions of such Act of June 30, 1906, as amended,
    [sections 1 to 5, 7 to 15, and 372a of this title] to the extent
    that they impose, or authorize the imposition of, any requirement
    imposed by section 403(k) of the Federal Food, Drug, and Cosmetic
    Act [section 343(k) of this title], shall remain in force until
    January 1, 1940.
      "(c) Notwithstanding the provisions of section 1 of this Act,
    such section shall not apply - 
        "(1) to the provisions of section 502(d) and (e) of the Federal
      Food, Drug, and Cosmetic Act [352(d), (e) of this title], insofar
      as such provisions relate to any substance named in section 8
      [section 10 of this title], paragraph second, under the heading
      'In the case of drugs:', of the Food and Drugs Act of June 30,
      1906, as amended, or a derivative of any such substance; or
        "(2) to the provisions of section 502(b), (d), (e), (f), (g),
      and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d)
      to (h) of this title], insofar as such provisions relate to drugs
      to which section 505 [355 of this title] of such Act applies."

                              EFFECTIVE DATE                          
      Section 902(a) of act June 25, 1938, provided that: "This Act
    [enacting this chapter and repealing sections 1 to 5 and 7 to 15 of
    this title], shall take effect twelve months after the date of its
    enactment [June 25, 1938]. The Federal Food and Drugs Act of June
    30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1-15),
    shall remain in force until such effective date, and, except as
    otherwise provided in this subsection, is hereby repealed effective
    upon such date: Provided, That the provisions of section 701
    [section 371 of this title] shall become effective on the enactment
    of this Act, and thereafter the Secretary is authorized hereby to
    (1) conduct hearings and to promulgate regulations which shall
    become effective on or after the effective date of this Act as the
    Secretary shall direct, and (2) designate prior to the effective
    date of this Act food having common or usual names and exempt such
    food from the requirements of clause (2) of section 403(i) [section
    343(i) of this title] for a reasonable time to permit the
    formulation, promulgation, and effective application of definitions
    and standards of identity therefor as provided by section 401
    [section 341 of this title]: Provided further, That sections
    502(j), 505, and 601(a) [sections 352(j), 355, 361(a), respectively
    of this title], and all other provisions of this Act to the extent
    that they may relate to the enforcement of such sections, shall
    take effect on the date of the enactment of this Act, except that
    in the case of a cosmetic to which the proviso of section 601(a)
    [section 361(a) of this title], relates, such cosmetic shall not,
    prior to the ninetieth day after such date of enactment, be deemed
    adulterated by reason of the failure of its label to bear the
    legend prescribed in such proviso: Provided further, That the Act
    of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 [section 321a
    of this title]; 42 Stat. 1500, ch. 268), defining butter and
    providing a standard therefor; the Act of July 24, 1919 (U.S.C.,
    1934 ed., title 21, sec. 10 [section 321b of this title]; 41 Stat.
    271, ch. 26], defining wrapped meats as in package form; and the
    amendment to the Food and Drugs Act, section 10A, approved August
    27, 1935 (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a [section
    372a of this title]) shall remain in force and effect and be
    applicable to the provisions of this Act."

                       SHORT TITLE OF 2006 AMENDMENT                   
      Pub. L. 109-462, Sec. 1, Dec. 22, 2006, 120 Stat. 3469, provided
    that: "This Act [enacting sections 379aa and 379aa-1 of this title,
    amending sections 331, 343, 352, and 381 of this title, and
    enacting provisions set out as notes under sections 331, 343, 352,
    379aa, and 381 of this title] may be cited as the 'Dietary
    Supplement and Nonprescription Drug Consumer Protection Act'."

                      SHORT TITLE OF 2005 AMENDMENTS                  
      Pub. L. 109-59, title VII, Sec. 7201, Aug. 10, 2005, 119 Stat.
    1911, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
    of title VII of Pub. L. 109-59, enacting section 350e of this
    title, amending sections 331, 342, and 373 of this title and
    section 5701 of Title 49, Transportation, omitting sections 5702 to
    5714 of Title 49, and enacting provisions set out as a note under
    section 331 of this title] may be cited as the 'Sanitary Food
    Transportation Act of 2005'."
      Pub. L. 109-43, Sec. 1, Aug. 1, 2005, 119 Stat. 439, provided
    that: "This Act [amending sections 352 and 379j of this title,
    enacting provisions set out as a note under section 352 of this
    title, and amending provisions set out as notes under sections 352
    and 379i of this title] may be cited as the 'Medical Device User
    Fee Stabilization Act of 2005'."

                      SHORT TITLE OF 2004 AMENDMENTS                  
      Pub. L. 108-282, title I, Sec. 101, Aug. 2, 2004, 118 Stat. 891,
    provided that: "This title [enacting sections 360ccc to 360ccc-2 of
    this title, amending sections 321, 331, 352, 353, 354, and 360b of
    this title, enacting provisions set out as notes under sections
    360ccc and 393 of this title, and amending provisions set out as a
    note under section 360b of this title] may be cited as the 'Minor
    Use and Minor Species Animal Health Act of 2004'."
      Pub. L. 108-282, title II, Sec. 201, Aug. 2, 2004, 118 Stat. 905,
    provided that: "This title [enacting section 374a of this title and
    section 242r of Title 42, The Public Health and Welfare, amending
    sections 321, 343, and 343-1 of this title, and enacting provisions
    set out as notes under sections 321 and 343 of this title and
    sections 243 and 300d-2 of Title 42] may be cited as the 'Food
    Allergen Labeling and Consumer Protection Act of 2004'."
      Pub. L. 108-214, Sec. 1, Apr. 1, 2004, 118 Stat. 572, provided
    that: "This Act [amending sections 331, 352, 360, 360e, 374, 379i,
    and 379j of this title and provisions set out as notes under
    sections 352, 360l, and 379j of this title] may be cited as the
    'Medical Devices Technical Corrections Act'."

                      SHORT TITLE OF 2003 AMENDMENTS                  
      Pub. L. 108-155, Sec. 1, Dec. 3, 2003, 117 Stat. 1936, provided
    that: "This Act [enacting section 355c of this title, amending
    sections 355, 355a, and 355b of this title and sections 262 and
    284m of Title 42, The Public Health and Welfare, enacting
    provisions set out as a note under section 355c of this title, and
    amending provisions set out as notes under section 355a of this
    title and section 284m of Title 42] may be cited as the 'Pediatric
    Research Equity Act of 2003'."
      Pub. L. 108-130, Sec. 1, Nov. 18, 2003, 117 Stat. 1361, provided
    that: "This Act [enacting sections 379j-11 and 379j-12 of this
    title and provisions set out as notes under section 379j-11 of this
    title] may be cited as the 'Animal Drug User Fee Act of 2003'."

                      SHORT TITLE OF 2002 AMENDMENTS                  
      Pub. L. 107-281, Sec. 1, Nov. 6, 2002, 116 Stat. 1992, provided
    that: "This Act [amending sections 360cc and 360ee of this title
    and enacting provisions set out as a note under section 360ee of
    this title] may be cited as the 'Rare Diseases Orphan Product
    Development Act of 2002'."
      Pub. L. 107-250, Sec. 1(a), Oct. 26, 2002, 116 Stat. 1588,
    provided that: "This Act [enacting sections 379i and 379j of this
    title and section 289g-3 of Title 42, The Public Health and
    Welfare, amending sections 321, 331, 333, 335a, 352, 353, 360,
    360c, 360e, 360m, and 374 of this title, and enacting provisions
    set out as notes under sections 352, 360e, 360j, 360l, 379i, and
    379j of this title and section 289g-3 of Title 42] may be cited as
    the 'Medical Device User Fee and Modernization Act of 2002'."
      Pub. L. 107-188, title V, Sec. 501, June 12, 2002, 116 Stat. 687,
    provided that: "This subtitle [subtitle A (Secs. 501-509) of title
    V of Pub. L. 107-188, amending sections 356b, 379g, and 379h of
    this title and enacting provisions set out as notes under sections
    356b and 379g of this title] may be cited as the 'Prescription Drug
    User Fee Amendments of 2002'."
      Pub. L. 107-109, Sec. 1, Jan. 4, 2002, 115 Stat. 1408, provided
    that: "This Act [enacting sections 355b and 393a of this title and
    section 284m of Title 42, The Public Health and Welfare, amending
    sections 321, 355, 355a, and 379h of this title and sections 282,
    284k, 284l, 285a-2, and 290b of Title 42, and enacting provisions
    set out as notes under sections 355 and 355a of this title and
    sections 284m and 289 of Title 42] may be cited as the 'Best
    Pharmaceuticals for Children Act'."

                       SHORT TITLE OF 2000 AMENDMENT                   
      Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(a)], Oct. 28,
    2000, 114 Stat. 1549, 1549A-35, provided that: "This section
    [enacting section 384 of this title, amending sections 331, 333,
    and 381 of this title, and enacting provisions set out as a note
    under section 384 of this title] may be cited as the 'Medicine
    Equity and Drug Safety Act of 2000'."
      Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(a)], Oct. 28,
    2000, 114 Stat. 1549, 1549A-40, provided that: "This section
    [amending section 381 of this title and enacting provisions set out
    as a note under section 381 of this title] may be cited as the
    'Prescription Drug Import Fairness Act of 2000'."

                       SHORT TITLE OF 1998 AMENDMENT                   
      Pub. L. 105-324, Sec. 1, Oct. 30, 1998, 112 Stat. 3035, provided
    that: "This Act [amending sections 321 and 346a of this title] may
    be cited as the 'Antimicrobial Regulation Technical Corrections Act
    of 1998'."

                       SHORT TITLE OF 1997 AMENDMENT                   
      Pub. L. 105-115, Sec. 1(a), Nov. 21, 1997, 111 Stat. 2296,
    provided that: "This Act [enacting sections 343-3, 353a, 355a, 356
    to 356c, 360m, 360aaa to 360aaa-6, 360bbb to 360bbb-2, 379k, 379l,
    379o, 379r, 379s, 379v, 396, and 397 of this title and sections
    247b-8 and 299a-3 of Title 42, The Public Health and Welfare,
    amending sections 321, 331, 334, 335a, 343, 348, 351 to 353, 355,
    360, 360b to 360e, 360g, 360i, 360j, 360l, 360aa to 360cc, 360ee,
    371, 374, 379a, 379g, 379h, 381 to 383, 393, and 802 of this title,
    section 45C of Title 26, Internal Revenue Code, section 156 of
    Title 35, Patents, section 8126 of Title 38, Veterans' Benefits,
    and sections 262, 263a, and 282 of Title 42, repealing sections 356
    and 357 of this title, and enacting provisions set out as notes
    under sections 321, 348, 351, 352, 353a, 355 to 356b, 360i, 360l,
    360m, 360aaa, 371, 379g, 379h, 379k, and 393 of this title and
    sections 247b-8 and 282 of Title 42] may be cited as the 'Food and
    Drug Administration Modernization Act of 1997'."

                      SHORT TITLE OF 1996 AMENDMENTS                  
      Pub. L. 104-250, Sec. 1(a), Oct. 9, 1996, 110 Stat. 3151,
    provided that: "This Act [enacting section 354 of this title,
    amending sections 331, 353, and 360b of this title, and enacting
    provisions set out as notes under section 360b of this title] may
    be cited as the 'Animal Drug Availability Act of 1996'."
      Pub. L. 104-170, title IV, Sec. 401(a), Aug. 3, 1996, 110 Stat.
    1513, provided that: "This title [amending sections 321, 331, 333,
    342, and 346a of this title] may be cited as the 'Food Quality
    Protection Act of 1996'."
      [Another "Food Quality Protection Act of 1996", was enacted by
    Pub. L. 104-170, Sec. 1, 110 Stat. 1489, which is set out as a note
    under section 136 of Title 7, Agriculture.]
      Pub. L. 104-134, title II, Sec. 2101(a), Apr. 26, 1996, 110 Stat.
    1321-313, provided that: "This chapter [chapter 1A (Secs. 2101-
    2105) of title II of Pub. L. 104-134, enacting section 382 of this
    title and amending sections 331 and 381 of this title and section
    262 of Title 42, The Public Health and Welfare] may be cited as the
    'FDA Export Reform and Enhancement Act of 1996'."

                      SHORT TITLE OF 1994 AMENDMENTS                  
      Pub. L. 103-417, Sec. 1(a), Oct. 25, 1994, 108 Stat. 4325,
    provided that: "This Act [enacting sections 343-2 and 350b of this
    title and section 287c-11 of Title 42, The Public Health and
    Welfare, amending sections 321, 331, 342, 343, and 350 of this
    title and section 281 of Title 42, and enacting provisions set out
    as notes under sections 321 and 343 of this title] may be cited as
    the 'Dietary Supplement Health and Education Act of 1994'."
      Pub. L. 103-396, Sec. 1, Oct. 22, 1994, 108 Stat. 4153, provided
    that: "This Act [amending sections 331, 343-1, 360b, and 371 of
    this title and enacting provisions set out as notes under section
    360b of this title] may be cited as the 'Animal Medicinal Drug Use
    Clarification Act of 1994'."

                       SHORT TITLE OF 1993 AMENDMENT                   
      Pub. L. 103-80, Sec. 1, Aug. 13, 1993, 107 Stat. 773, provided
    that: "This Act [amending sections 321, 331 to 333, 334, 335b, 341
    to 343, 346a, 350a, 352, 355 to 358, 360b to 360e, 360i, 360cc,
    360hh to 360ss, 361, 371, 372, 373, 374, 376, 379e, and 381 of this
    title and section 263b of Title 42, The Public Health and Welfare,
    and enacting provisions set out as a note under section 343 of this
    title] may be cited as the 'Nutrition Labeling and Education Act
    Amendments of 1993'."

                      SHORT TITLE OF 1992 AMENDMENTS                  
      Pub. L. 102-571, title I, Sec. 101(a), Oct. 29, 1992, 106 Stat.
    4491, provided that: "This title [enacting sections 379g and 379h
    of this title, transferring sections 372a, 376, and 379c of this
    title to sections 376, 379e and 379f, respectively, of this title,
    amending sections 321, 331, 342, 343, 346a, 351, 352, 360j, 361,
    362, 453, 601, and 1033 of this title, enacting provisions set out
    as notes under section 379g of this title, and amending provisions
    set out as notes under sections 343 and 343-1 of this title] may be
    cited as the 'Prescription Drug User Fee Act of 1992'."
      Pub. L. 102-571, title II, Sec. 201, Oct. 29, 1992, 106 Stat.
    4500, provided that: "This title [enacting provisions set out as
    notes under sections 343 and 393 of this title and amending
    provisions set out as notes under sections 343 and 343-1 of this
    title] may be cited as the 'Dietary Supplement Act of 1992'."
      Pub. L. 102-353, Sec. 1(a), Aug. 26, 1992, 106 Stat. 941,
    provided that: "This Act [amending sections 333, 353, and 381 of
    this title and enacting provisions set out as a note under section
    353 of this title] may be cited as the 'Prescription Drug
    Amendments of 1992'."
      Pub. L. 102-300, Sec. 1(a), June 16, 1992, 106 Stat. 238,
    provided that: "This Act [amending sections 321, 331, 334, 346a,
    352, 353, 356, 357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to
    372a, 376, and 381 of this title and section 262 of Title 42, The
    Public Health and Welfare and enacting and amending provisions set
    out as notes under section 360i of this title] may be cited as the
    'Medical Device Amendments of 1992'."
      Pub. L. 102-282, Sec. 1(a), May 13, 1992, 106 Stat. 149, provided
    that: "This Act [enacting sections 335a to 335c of this title,
    amending sections 321, 336, 337, and 355 of this title, and
    enacting provisions set out as notes under section 335a of this
    title] may be cited as the 'Generic Drug Enforcement Act of 1992'."

                      SHORT TITLE OF 1990 AMENDMENTS                  
      Pub. L. 101-635, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4583,
    provided that: "This Act [enacting sections 379b to 379d and 394 of
    this title] may be cited as the 'Food and Drug Administration
    Revitalization Act'."
      Pub. L. 101-629, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4511,
    provided that: "This Act [enacting sections 360l and 383 of this
    title, amending sections 321, 333, 351, 353, and 360c to 360j of
    this title and sections 263b to 263n of Title 42, The Public Health
    and Welfare, redesignating sections 263b to 263n of Title 42 as
    sections 360gg to 360ss of this title, repealing section 263b of
    Title 42, and enacting provisions set out as notes under sections
    333, 360c, 360i, 360j, 360hh and 383 of this title] may be cited as
    the 'Safe Medical Devices Act of 1990'."
      Pub. L. 101-535, Sec. 1(a), Nov. 8, 1990, 104 Stat. 2353,
    provided that: "This Act [enacting section 343-1 of this title,
    amending sections 321, 337, 343, 345, and 371 of this title, and
    enacting provisions set out as notes under sections 343 and 343-1
    of this title] may be cited as the 'Nutrition Labeling and
    Education Act of 1990'."

                      SHORT TITLE OF 1988 AMENDMENTS                  
      Pub. L. 100-670, Sec. 1(a), Nov. 16, 1988, 102 Stat. 3971,
    provided that: "This Act [amending sections 321, 353, and 360b of
    this title, section 2201 of Title 28, Judiciary and Judicial
    Procedure, and sections 156 and 271 of Title 35, Patents, and
    enacting provisions set out as notes under section 360b of this
    title] may be cited as the 'Generic Animal Drug and Patent Term
    Restoration Act'."
      Pub. L. 100-607, title V, Sec. 501, Nov. 4, 1988, 102 Stat. 3120,
    provided that: "This title [enacting section 393 of this title,
    amending sections 5315 and 5316 of Title 5, Government Organization
    and Employees, and enacting provisions set out as notes under
    section 393 of this title] may be cited as the 'Food and Drug
    Administration Act of 1988'."
      Pub. L. 100-293, Sec. 1(a), Apr. 22, 1988, 102 Stat. 95, provided
    that: "This Act [amending sections 331, 333, 353, and 381 of this
    title and enacting provisions set out as notes under section 353 of
    this title] may be cited as the 'Prescription Drug Marketing Act of
    1987'."
      Pub. L. 100-290, Sec. 1, Apr. 18, 1988, 102 Stat. 90, provided
    that: "This Act [amending sections 360bb and 360ee of this title,
    enacting provisions set out as a note under section 360aa of this
    title, and amending provisions set out as a note under section 236
    of Title 42, The Public Health and Welfare] may be cited as the
    'Orphan Drug Amendments of 1988'."

                       SHORT TITLE OF 1986 AMENDMENT                   
      Pub. L. 99-660, title I, Sec. 101(a), Nov. 14, 1986, 100 Stat.
    3743, provided that: "This title [enacting section 382 of this
    title, amending sections 241 and 262 of Title 42, The Public Health
    and Welfare, and enacting provisions set out as notes under section
    333 of this title and section 262 of Title 42] may be cited as the
    'Drug Export Amendments Act of 1986'."

                       SHORT TITLE OF 1985 AMENDMENT                   
      Pub. L. 99-91, Sec. 1, Aug. 15, 1985, 99 Stat. 387, provided
    that: "This Act [amending sections 360aa to 360cc, and 360ee of
    this title, and sections 295g-1 and 6022 of Title 42, The Public
    Health and Welfare, and enacting provisions set out as notes under
    section 360aa of this title and section 236 of Title 42] may be
    cited as the 'Orphan Drug Amendments of 1985'."

                       SHORT TITLE OF 1984 AMENDMENT                   
      Pub. L. 98-417, Sec. 1, Sept. 24, 1984, 98 Stat. 1585, provided:
    "That this Act [enacting section 156 of Title 35, Patents, amending
    sections 355 and 360cc of this title, sections 68b, 68c, and 70b of
    Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary
    and Judicial Procedure, and sections 271 and 282 of Title 35, and
    enacting provisions set out as notes under section 355 of this
    title and section 68b of Title 15] may be cited as the 'Drug Price
    Competition and Patent Term Restoration Act of 1984'."

                      SHORT TITLE OF 1983 AMENDMENTS                  
      Pub. L. 98-22, Sec. 1, Apr. 22, 1983, 97 Stat. 173, provided:
    "That this Act [amending provisions set out as a note under section
    348 of this title] may be cited as the 'Saccharin Study and
    Labeling Act Amendment of 1983'."
      Pub. L. 97-414, Sec. 1(a), Jan. 4, 1983, 96 Stat. 2049, provided
    that: "This Act [enacting part B of subchapter V of chapter 9 of
    this title, section 44H of Title 26, Internal Revenue Code, section
    155 of Title 35, Patents, and sections 236, 255, and 298b-4 of
    Title 42, The Public Health and Welfare, amending sections 1274,
    1472, 2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and
    Trade, section 904 of this title, sections 280C and 6096 of Title
    26, and sections 209, 231, 242k, 242m, 243, 254c, 254j, 254m, 254o,
    254p, 256, 294j, 295g-1, 295g-4, 295h, 295h-1a, 297-1, 300, 300a-1,
    300a-3, 300b, 300e-1, 300m, 300n-5, 300q-2, 300u-5, 300w-3, 300x-1,
    300x-4, 300y-11, 4577, and 4588 of Title 42, enacting provisions
    set out as notes under section 360aa of this title, section 44H of
    Title 26, and sections 241, 255, 287i, and 300x-1 of Title 42, and
    repealing provisions set out as a note under section 300t-11 of
    Title 42] may be cited as the 'Orphan Drug Act'."

                       SHORT TITLE OF 1981 AMENDMENT                   
      Pub. L. 97-42, Sec. 1, Aug. 14, 1981, 95 Stat. 946, provided:
    "That this Act [amending provisions set out as a note under section
    348 of this title] may be cited as the 'Saccharin Study and
    Labeling Act Amendment of 1981'."

                       SHORT TITLE OF 1980 AMENDMENT                   
      Pub. L. 96-359, Sec. 1, Sept. 26, 1980, 94 Stat. 1190, provided:
    "That this Act [enacting section 350a of this title, amending
    sections 321, 331, 374, 830, 841 to 843, and 873 of this title, and
    enacting a provision set out as a note under section 350a of this
    title] may be cited as the 'Infant Formula Act of 1980'."

                       SHORT TITLE OF 1977 AMENDMENT                   
      Pub. L. 95-203, Sec. 1, Nov. 23, 1977, 91 Stat. 1451, provided
    that: "This Act [enacting section 343a of this title, amending
    sections 321 and 343 of this title, enacting provisions set out as
    notes under sections 343 and 348 of this title, and amending
    provisions set out as notes under sections 218 and 289l-1 of Title
    42, The Public Health and Welfare] may be cited as the 'Saccharin
    Study and Labeling Act'."

                       SHORT TITLE OF 1976 AMENDMENT                   
      Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided
    that: "This Act [enacting sections 360c to 360k, 379, and 379a of
    this title and section 3512 of Title 42, The Public Health and
    Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360,
    374, 379e, and 381 of this title and section 55 of Title 15,
    Commerce and Trade] may be cited as the 'Medical Device Amendments
    of 1976'."

                       SHORT TITLE OF 1972 AMENDMENT                   
      Pub. L. 92-387, Sec. 1, Aug. 16, 1972, 86 Stat. 559, provided
    that: "This Act [amending sections 331, 335, and 360 of this title
    and enacting provisions set out as notes under section 360 of this
    title] may be cited as the 'Drug Listing Act of 1972'."

                      SHORT TITLE OF 1968 AMENDMENTS                  
      Pub. L. 90-602, Sec. 1, Oct. 18, 1968, 82 Stat. 1173, provided
    that: "This Act [enacting provisions now comprising part C (Secs.
    360hh-360ss) of subchapter III of this chapter and provisions set
    out as notes under section 360hh of this title] may be cited as the
    'Radiation Control for Health and Safety Act of 1968'."
      Pub. L. 90-399, Sec. 1, July 13, 1968, 82 Stat. 342, provided:
    "That this Act [enacting section 360b of this title, amending
    sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title,
    and enacting provisions set out as a note under section 360b of
    this title] may be cited as the 'Animal Drug Amendments of 1968'."

                       SHORT TITLE OF 1965 AMENDMENT                   
      Pub. L. 89-74, Sec. 1, July 15, 1965, 79 Stat. 226, provided:
    "That this Act [amending sections 321, 331, 333, 334, 360, and 372
    of this title and section 1114 of Title 18, Crimes and Criminal
    Procedure, and enacting provisions set out as notes under sections
    321 and 352 of this title] may be cited as the 'Drug Abuse Control
    Amendments of 1965'."

                       SHORT TITLE OF 1962 AMENDMENT                   
      Pub. L. 87-781, Sec. 1, Oct. 10, 1962, 76 Stat. 780, provided in
    part that such Act [enacting sections 358 to 360 of this title,
    amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,
    374, 379e, and 381 of this title, and enacting provisions set out
    as notes under sections 321, 331, 332, 352, 355, 358, 360, and 374
    of this title] may be cited as the 'Drug Amendments of 1962'."

                       SHORT TITLE OF 1960 AMENDMENT                   
      Pub. L. 86-618, Sec. 1, July 12, 1960, 74 Stat. 397, provided:
    "That this Act [amending sections 321, 331, 333, 342, 346, 351,
    352, 361, 362, 371, and 379e of this title, repealing sections 354
    and 364 of this title, and enacting notes set out under this
    section] may be cited as the 'Color Additive Amendments of 1960'."

                       SHORT TITLE OF 1958 AMENDMENT                   
      Pub. L. 85-929, Sec. 1, Sept. 6, 1958, 72 Stat. 1784, provided:
    "That this Act [amending sections 321, 331, 342, 346, 348 of this
    title and section 210 of Title 42, The Public Health and Welfare,
    and enacting provisions set out as notes under sections 321, 342,
    and 451 of this title] may be cited as the 'Food Additives
    Amendment of 1958'."

                           HAZARDOUS SUBSTANCES                       
      Federal Hazardous Substances Act as not modifying this chapter,
    see Pub. L. 86-613, Sec. 18, July 12, 1960, 74 Stat. 380, set out
    as an Effect Upon Federal and State Laws note under section 1261 of
    Title 15, Commerce and Trade.

-End-


-CITE-
    21 USC SUBCHAPTER II - DEFINITIONS                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
                        SUBCHAPTER II - DEFINITIONS                    

-End-



-CITE-
    21 USC Sec. 321                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321. Definitions; generally

-STATUTE-
      For the purposes of this chapter - 
      (a)(1) The term "State", except as used in the last sentence of
    section 372(a) of this title, means any State or Territory of the
    United States, the District of Columbia, and the Commonwealth of
    Puerto Rico.
      (2) The term "Territory" means any Territory or possession of the
    United States, including the District of Columbia, and excluding
    the Commonwealth of Puerto Rico and the Canal Zone.
      (b) The term "interstate commerce" means (1) commerce between any
    State or Territory and any place outside thereof, and (2) commerce
    within the District of Columbia or within any other Territory not
    organized with a legislative body.
      (c) The term "Department" means Department of Health and Human
    Services.
      (d) The term "Secretary" means the Secretary of Health and Human
    Services.
      (e) The term "person" includes individual, partnership,
    corporation, and association.
      (f) The term "food" means (1) articles used for food or drink for
    man or other animals, (2) chewing gum, and (3) articles used for
    components of any such article.
      (g)(1) The term "drug" means (A) articles recognized in the
    official United States Pharmacopoeia, official Homoeopathic
    Pharmacopoeia of the United States, or official National Formulary,
    or any supplement to any of them; and (B) articles intended for use
    in the diagnosis, cure, mitigation, treatment, or prevention of
    disease in man or other animals; and (C) articles (other than food)
    intended to affect the structure or any function of the body of man
    or other animals; and (D) articles intended for use as a component
    of any article specified in clause (A), (B), or (C). A food or
    dietary supplement for which a claim, subject to sections
    343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
    and 343(r)(5)(D) of this title, is made in accordance with the
    requirements of section 343(r) of this title is not a drug solely
    because the label or the labeling contains such a claim. A food,
    dietary ingredient, or dietary supplement for which a truthful and
    not misleading statement is made in accordance with section
    343(r)(6) of this title is not a drug under clause (C) solely
    because the label or the labeling contains such a statement.
      (2) The term "counterfeit drug" means a drug which, or the
    container or labeling of which, without authorization, bears the
    trademark, trade name, or other identifying mark, imprint, or
    device, or any likeness thereof, of a drug manufacturer, processor,
    packer, or distributor other than the person or persons who in fact
    manufactured, processed, packed, or distributed such drug and which
    thereby falsely purports or is represented to be the product of, or
    to have been packed or distributed by, such other drug
    manufacturer, processor, packer, or distributor.
      (h) The term "device" (except when used in paragraph (n) of this
    section and in sections 331(i), 343(f), 352(c), and 362(c) of this
    title) means an instrument, apparatus, implement, machine,
    contrivance, implant, in vitro reagent, or other similar or related
    article, including any component, part, or accessory, which is - 
        (1) recognized in the official National Formulary, or the
      United States Pharmacopeia, or any supplement to them,
        (2) intended for use in the diagnosis of disease or other
      conditions, or in the cure, mitigation, treatment, or prevention
      of disease, in man or other animals, or
        (3) intended to affect the structure or any function of the
      body of man or other animals, and

    which does not achieve its primary intended purposes through
    chemical action within or on the body of man or other animals and
    which is not dependent upon being metabolized for the achievement
    of its primary intended purposes.
      (i) The term "cosmetic" means (1) articles intended to be rubbed,
    poured, sprinkled, or sprayed on, introduced into, or otherwise
    applied to the human body or any part thereof for cleansing,
    beautifying, promoting attractiveness, or altering the appearance,
    and (2) articles intended for use as a component of any such
    articles; except that such term shall not include soap.
      (j) The term "official compendium" means the official United
    States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
    United States, official National Formulary, or any supplement to
    any of them.
      (k) The term "label" means a display of written, printed, or
    graphic matter upon the immediate container of any article; and a
    requirement made by or under authority of this chapter that any
    word, statement, or other information appear on the label shall not
    be considered to be complied with unless such word, statement, or
    other information also appears on the outside container or wrapper,
    if any there be, of the retail package of such article, or is
    easily legible through the outside container or wrapper.
      (l) The term "immediate container" does not include package
    liners.
      (m) The term "labeling" means all labels and other written,
    printed, or graphic matter (1) upon any article or any of its
    containers or wrappers, or (2) accompanying such article.
      (n) If an article is alleged to be misbranded because the
    labeling or advertising is misleading, then in determining whether
    the labeling or advertising is misleading there shall be taken into
    account (among other things) not only representations made or
    suggested by statement, word, design, device, or any combination
    thereof, but also the extent to which the labeling or advertising
    fails to reveal facts material in the light of such representations
    or material with respect to consequences which may result from the
    use of the article to which the labeling or advertising relates
    under the conditions of use prescribed in the labeling or
    advertising thereof or under such conditions of use as are
    customary or usual.
      (o) The representation of a drug, in its labeling, as an
    antiseptic shall be considered to be a representation that it is a
    germicide, except in the case of a drug purporting to be, or
    represented as, an antiseptic for inhibitory use as a wet dressing,
    ointment, dusting powder, or such other use as involves prolonged
    contact with the body.
      (p) The term "new drug" means - 
        (1) Any drug (except a new animal drug or an animal feed
      bearing or containing a new animal drug) the composition of which
      is such that such drug is not generally recognized, among experts
      qualified by scientific training and experience to evaluate the
      safety and effectiveness of drugs, as safe and effective for use
      under the conditions prescribed, recommended, or suggested in the
      labeling thereof, except that such a drug not so recognized shall
      not be deemed to be a "new drug" if at any time prior to June 25,
      1938, it was subject to the Food and Drugs Act of June 30, 1906,
      as amended, and if at such time its labeling contained the same
      representations concerning the conditions of its use; or
        (2) Any drug (except a new animal drug or an animal feed
      bearing or containing a new animal drug) the composition of which
      is such that such drug, as a result of investigations to
      determine its safety and effectiveness for use under such
      conditions, has become so recognized, but which has not,
      otherwise than in such investigations, been used to a material
      extent or for a material time under such conditions.

      (q)(1)(A) Except as provided in clause (B), the term "pesticide
    chemical" means any substance that is a pesticide within the
    meaning of the Federal Insecticide, Fungicide, and Rodenticide Act
    [7 U.S.C. 136 et seq.], including all active and inert ingredients
    of such pesticide. Notwithstanding any other provision of law, the
    term "pesticide" within such meaning includes ethylene oxide and
    propylene oxide when such substances are applied on food.
      (B) In the case of the use, with respect to food, of a substance
    described in clause (A) to prevent, destroy, repel, or mitigate
    microorganisms (including bacteria, viruses, fungi, protozoa,
    algae, and slime), the following applies for purposes of clause
    (A):
        (i) The definition in such clause for the term "pesticide
      chemical" does not include the substance if the substance is
      applied for such use on food, or the substance is included for
      such use in water that comes into contact with the food, in the
      preparing, packing, or holding of the food for commercial
      purposes. The substance is not excluded under this subclause from
      such definition if the substance is ethylene oxide or propylene
      oxide, and is applied for such use on food. The substance is not
      so excluded if the substance is applied for such use on a raw
      agricultural commodity, or the substance is included for such use
      in water that comes into contact with the commodity, as follows:
          (I) The substance is applied in the field.
          (II) The substance is applied at a treatment facility where
        raw agricultural commodities are the only food treated, and the
        treatment is in a manner that does not change the status of the
        food as a raw agricultural commodity (including treatment
        through washing, waxing, fumigating, and packing such
        commodities in such manner).
          (III) The substance is applied during the transportation of
        such commodity between the field and such a treatment facility.

        (ii) The definition in such clause for the term "pesticide
      chemical" does not include the substance if the substance is a
      food contact substance as defined in section 348(h)(6) of this
      title, and any of the following circumstances exist: The
      substance is included for such use in an object that has a food
      contact surface but is not intended to have an ongoing effect on
      any portion of the object; the substance is included for such use
      in an object that has a food contact surface and is intended to
      have an ongoing effect on a portion of the object but not on the
      food contact surface; or the substance is included for such use
      in or is applied for such use on food packaging (without regard
      to whether the substance is intended to have an ongoing effect on
      any portion of the packaging). The food contact substance is not
      excluded under this subclause from such definition if any of the
      following circumstances exist: The substance is applied for such
      use on a semipermanent or permanent food contact surface (other
      than being applied on food packaging); or the substance is
      included for such use in an object that has a semipermanent or
      permanent food contact surface (other than being included in food
      packaging) and the substance is intended to have an ongoing
      effect on the food contact surface.

    With respect to the definition of the term "pesticide" that is
    applicable to the Federal Insecticide, Fungicide, and Rodenticide
    Act [7 U.S.C. 136 et seq.], this clause does not exclude any
    substance from such definition.
      (2) The term "pesticide chemical residue" means a residue in or
    on raw agricultural commodity or processed food of - 
        (A) a pesticide chemical; or
        (B) any other added substance that is present on or in the
      commodity or food primarily as a result of the metabolism or
      other degradation of a pesticide chemical.

      (3) Notwithstanding subparagraphs (1) and (2), the Administrator
    may by regulation except a substance from the definition of
    "pesticide chemical" or "pesticide chemical residue" if - 
        (A) its occurrence as a residue on or in a raw agricultural
      commodity or processed food is attributable primarily to natural
      causes or to human activities not involving the use of any
      substances for a pesticidal purpose in the production, storage,
      processing, or transportation of any raw agricultural commodity
      or processed food; and
        (B) the Administrator, after consultation with the Secretary,
      determines that the substance more appropriately should be
      regulated under one or more provisions of this chapter other than
      sections 342(a)(2)(B) and 346a of this title.

      (r) The term "raw agricultural commodity" means any food in its
    raw or natural state, including all fruits that are washed,
    colored, or otherwise treated in their unpeeled natural form prior
    to marketing.
      (s) The term "food additive" means any substance the intended use
    of which results or may reasonably be expected to result, directly
    or indirectly, in its becoming a component or otherwise affecting
    the characteristics of any food (including any substance intended
    for use in producing, manufacturing, packing, processing,
    preparing, treating, packaging, transporting, or holding food; and
    including any source of radiation intended for any such use), if
    such substance is not generally recognized, among experts qualified
    by scientific training and experience to evaluate its safety, as
    having been adequately shown through scientific procedures (or, in
    the case of a substance used in food prior to January 1, 1958,
    through either scientific procedures or experience based on common
    use in food) to be safe under the conditions of its intended use;
    except that such term does not include - 
        (1) a pesticide chemical residue in or on a raw agricultural
      commodity or processed food; or
        (2) a pesticide chemical; or
        (3) a color additive; or
        (4) any substance used in accordance with a sanction or
      approval granted prior to September 6, 1958, pursuant to this
      chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et
      seq.] or the Meat Inspection Act of March 4, 1907, as amended and
      extended [21 U.S.C. 601 et seq.];
        (5) a new animal drug; or
        (6) an ingredient described in paragraph (ff) in, or intended
      for use in, a dietary supplement.

      (t)(1) The term "color additive" means a material which - 
        (A) is a dye, pigment, or other substance made by a process of
      synthesis or similar artifice, or extracted, isolated, or
      otherwise derived, with or without intermediate or final change
      of identity, from a vegetable, animal, mineral, or other source,
      and
        (B) when added or applied to a food, drug, or cosmetic, or to
      the human body or any part thereof, is capable (alone or through
      reaction with other substance) of imparting color thereto;

    except that such term does not include any material which the
    Secretary, by regulation, determines is used (or intended to be
    used) solely for a purpose or purposes other than coloring.
      (2) The term "color" includes black, white, and intermediate
    grays.
      (3) Nothing in subparagraph (1) of this paragraph shall be
    construed to apply to any pesticide chemical, soil or plant
    nutrient, or other agricultural chemical solely because of its
    effect in aiding, retarding, or otherwise affecting, directly or
    indirectly, the growth or other natural physiological processes of
    produce of the soil and thereby affecting its color, whether before
    or after harvest.
      (u) The term "safe" as used in paragraph (s) of this section and
    in sections 348, 360b, 360ccc, and 379e of this title, has
    reference to the health of man or animal.
      (v) The term "new animal drug" means any drug intended for use
    for animals other than man, including any drug intended for use in
    animal feed but not including such animal feed, - 
        (1) the composition of which is such that such drug is not
      generally recognized, among experts qualified by scientific
      training and experience to evaluate the safety and effectiveness
      of animal drugs, as safe and effective for use under the
      conditions prescribed, recommended, or suggested in the labeling
      thereof; except that such a drug not so recognized shall not be
      deemed to be a "new animal drug" if at any time prior to June 25,
      1938, it was subject to the Food and Drug Act of June 30, 1906,
      as amended, and if at such time its labeling contained the same
      representations concerning the conditions of its use; or
        (2) the composition of which is such that such drug, as a
      result of investigations to determine its safety and
      effectiveness for use under such conditions, has become so
      recognized but which has not, otherwise than in such
      investigations, been used to a material extent or for a material
      time under such conditions.

    Provided that any drug intended for minor use or use in a minor
    species that is not the subject of a final regulation published by
    the Secretary through notice and comment rulemaking finding that
    the criteria of paragraphs (1) and (2) have not been met (or that
    the exception to the criterion in paragraph (1) has been met) is a
    new animal drug.
      (w) The term "animal feed", as used in paragraph (w) (!1) of this
    section, in section 360b of this title, and in provisions of this
    chapter referring to such paragraph or section, means an article
    which is intended for use for food for animals other than man and
    which is intended for use as a substantial source of nutrients in
    the diet of the animal, and is not limited to a mixture intended to
    be the sole ration of the animal.

      (x) The term "informal hearing" means a hearing which is not
    subject to section 554, 556, or 557 of title 5 and which provides
    for the following:
        (1) The presiding officer in the hearing shall be designated by
      the Secretary from officers and employees of the Department who
      have not participated in any action of the Secretary which is the
      subject of the hearing and who are not directly responsible to an
      officer or employee of the Department who has participated in any
      such action.
        (2) Each party to the hearing shall have the right at all times
      to be advised and accompanied by an attorney.
        (3) Before the hearing, each party to the hearing shall be
      given reasonable notice of the matters to be considered at the
      hearing, including a comprehensive statement of the basis for the
      action taken or proposed by the Secretary which is the subject of
      the hearing and a general summary of the information which will
      be presented by the Secretary at the hearing in support of such
      action.
        (4) At the hearing the parties to the hearing shall have the
      right to hear a full and complete statement of the action of the
      Secretary which is the subject of the hearing together with the
      information and reasons supporting such action, to conduct
      reasonable questioning, and to present any oral or written
      information relevant to such action.
        (5) The presiding officer in such hearing shall prepare a
      written report of the hearing to which shall be attached all
      written material presented at the hearing. The participants in
      the hearing shall be given the opportunity to review and correct
      or supplement the presiding officer's report of the hearing.
        (6) The Secretary may require the hearing to be transcribed. A
      party to the hearing shall have the right to have the hearing
      transcribed at his expense. Any transcription of a hearing shall
      be included in the presiding officer's report of the hearing.

      (y) The term "saccharin" includes calcium saccharin, sodium
    saccharin, and ammonium saccharin.
      (z) The term "infant formula" means a food which purports to be
    or is represented for special dietary use solely as a food for
    infants by reason of its simulation of human milk or its
    suitability as a complete or partial substitute for human milk.
      (aa) The term "abbreviated drug application" means an application
    submitted under section 355(j) of this title for the approval of a
    drug that relies on the approved application of another drug with
    the same active ingredient to establish safety and efficacy, and - 
        (1) in the case of section 335a of this title, includes a
      supplement to such an application for a different or additional
      use of the drug but does not include a supplement to such an
      application for other than a different or additional use of the
      drug, and
        (2) in the case of sections 335b and 335c of this title,
      includes any supplement to such an application.

      (bb) The term "knowingly" or "knew" means that a person, with
    respect to information - 
        (1) has actual knowledge of the information, or
        (2) acts in deliberate ignorance or reckless disregard of the
      truth or falsity of the information.

      (cc) For purposes of section 335a of this title, the term "high
    managerial agent" - 
        (1) means - 
          (A) an officer or director of a corporation or an
        association,
          (B) a partner of a partnership, or
          (C) any employee or other agent of a corporation,
        association, or partnership,

      having duties such that the conduct of such officer, director,
      partner, employee, or agent may fairly be assumed to represent
      the policy of the corporation, association, or partnership, and
        (2) includes persons having management responsibility for - 
          (A) submissions to the Food and Drug Administration regarding
        the development or approval of any drug product,
          (B) production, quality assurance, or quality control of any
        drug product, or
          (C) research and development of any drug product.

      (dd) For purposes of sections 335a and 335b of this title, the
    term "drug product" means a drug subject to regulation under
    section 355, 360b, or 382 of this title or under section 262 of
    title 42.
      (ee) The term "Commissioner" means the Commissioner of Food and
    Drugs.
      (ff) The term "dietary supplement" - 
        (1) means a product (other than tobacco) intended to supplement
      the diet that bears or contains one or more of the following
      dietary ingredients:
          (A) a vitamin;
          (B) a mineral;
          (C) an herb or other botanical;
          (D) an amino acid;
          (E) a dietary substance for use by man to supplement the diet
        by increasing the total dietary intake; or
          (F) a concentrate, metabolite, constituent, extract, or
        combination of any ingredient described in clause (A), (B),
        (C), (D), or (E);

        (2) means a product that - 
          (A)(i) is intended for ingestion in a form described in
        section 350(c)(1)(B)(i) of this title; or
          (ii) complies with section 350(c)(1)(B)(ii) of this title;
          (B) is not represented for use as a conventional food or as a
        sole item of a meal or the diet; and
          (C) is labeled as a dietary supplement; and

        (3) does - 
          (A) include an article that is approved as a new drug under
        section 355 of this title or licensed as a biologic under
        section 262 of title 42 and was, prior to such approval,
        certification, or license, marketed as a dietary supplement or
        as a food unless the Secretary has issued a regulation, after
        notice and comment, finding that the article, when used as or
        in a dietary supplement under the conditions of use and dosages
        set forth in the labeling for such dietary supplement, is
        unlawful under section 342(f) of this title; and
          (B) not include - 
            (i) an article that is approved as a new drug under section
          355 of this title, certified as an antibiotic under section
          357 of this title, or licensed as a biologic under section
          262 of title 42, or
            (ii) an article authorized for investigation as a new drug,
          antibiotic, or biological for which substantial clinical
          investigations have been instituted and for which the
          existence of such investigations has been made public,

      which was not before such approval, certification, licensing, or
      authorization marketed as a dietary supplement or as a food
      unless the Secretary, in the Secretary's discretion, has issued a
      regulation, after notice and comment, finding that the article
      would be lawful under this chapter.

    Except for purposes of paragraph (g), a dietary supplement shall be
    deemed to be a food within the meaning of this chapter.
      (gg) The term "processed food" means any food other than a raw
    agricultural commodity and includes any raw agricultural commodity
    that has been subject to processing, such as canning, cooking,
    freezing, dehydration, or milling.
      (hh) The term "Administrator" means the Administrator of the
    United States Environmental Protection Agency.
      (ii) The term "compounded positron emission tomography drug" - 
        (1) means a drug that - 
          (A) exhibits spontaneous disintegration of unstable nuclei by
        the emission of positrons and is used for the purpose of
        providing dual photon positron emission tomographic diagnostic
        images; and
          (B) has been compounded by or on the order of a practitioner
        who is licensed by a State to compound or order compounding for
        a drug described in subparagraph (A), and is compounded in
        accordance with that State's law, for a patient or for
        research, teaching, or quality control; and

        (2) includes any nonradioactive reagent, reagent kit,
      ingredient, nuclide generator, accelerator, target material,
      electronic synthesizer, or other apparatus or computer program to
      be used in the preparation of such a drug.

      (jj) The term "antibiotic drug" means any drug (except drugs for
    use in animals other than humans) composed wholly or partly of any
    kind of penicillin, streptomycin, chlortetracycline,
    chloramphenicol, bacitracin, or any other drug intended for human
    use containing any quantity of any chemical substance which is
    produced by a micro-organism and which has the capacity to inhibit
    or destroy micro-organisms in dilute solution (including a
    chemically synthesized equivalent of any such substance) or any
    derivative thereof.
      (kk) Priority supplement. - The term "priority supplement" means
    a drug application referred to in section 101(4) of the Food and
    Drug Administration Modernization Act of 1997 (111 Stat. 2298).
      (ll)(1) The term "single-use device" means a device that is
    intended for one use, or on a single patient during a single
    procedure.
      (2)(A) The term "reprocessed", with respect to a single-use
    device, means an original device that has previously been used on a
    patient and has been subjected to additional processing and
    manufacturing for the purpose of an additional single use on a
    patient. The subsequent processing and manufacture of a reprocessed
    single-use device shall result in a device that is reprocessed
    within the meaning of this definition.
      (B) A single-use device that meets the definition under clause
    (A) shall be considered a reprocessed device without regard to any
    description of the device used by the manufacturer of the device or
    other persons, including a description that uses the term
    "recycled" rather than the term "reprocessed".
      (3) The term "original device" means a new, unused single-use
    device.
      (mm)(1) The term "critical reprocessed single-use device" means a
    reprocessed single-use device that is intended to contact normally
    sterile tissue or body spaces during use.
      (2) The term "semi-critical reprocessed single-use device" means
    a reprocessed single-use device that is intended to contact intact
    mucous membranes and not penetrate normally sterile areas of the
    body.
      (nn) The term "major species" means cattle, horses, swine,
    chickens, turkeys, dogs, and cats, except that the Secretary may
    add species to this definition by regulation.
      (oo) The term "minor species" means animals other than humans
    that are not major species.
      (pp) The term "minor use" means the intended use of a drug in a
    major species for an indication that occurs infrequently and in
    only a small number of animals or in limited geographical areas and
    in only a small number of animals annually.
      (qq) The term "major food allergen" means any of the following:
        (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean
      shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g.,
      almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
        (2) A food ingredient that contains protein derived from a food
      specified in paragraph (1), except the following:
          (A) Any highly refined oil derived from a food specified in
        paragraph (1) and any ingredient derived from such highly
        refined oil.
          (B) A food ingredient that is exempt under paragraph (6) or
        (7) of section 343(w) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 201, 52 Stat. 1040; July 22, 1954,
    ch. 559, Sec. 1, 68 Stat. 511; Pub. L. 85-929, Sec. 2, Sept. 6,
    1958, 72 Stat. 1784; Pub. L. 86-618, title I, Sec. 101, July 12,
    1960, 74 Stat. 397; Pub. L. 87-781, title I, Sec. 102(a), title
    III, Sec. 307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74,
    Secs. 3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399,
    Sec. 102, July 13, 1968, 82 Stat. 351; Pub. L. 90-639, Secs. 1,
    4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513, title II,
    Sec. 701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92-
    516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278, title
    V, Sec. 502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-295,
    Sec. 3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95-203,
    Sec. 4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96-359, Sec. 3,
    Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100-670, title I, Sec.
    107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101-535, Sec.
    5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101-629, Sec. 16(b),
    Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-282, Sec. 6, May 13,
    1992, 106 Stat. 161; Pub. L. 102-300, Sec. 6(a), (b), June 16,
    1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(1), Oct.
    29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 3(b), (dd)(1),
    4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103-417, Secs.
    3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104-
    170, title IV, Sec. 402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105-
    115, title I, Secs. 121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111
    Stat. 2320, 2325, 2327; Pub. L. 105-324, Sec. 2(a), (c), Oct. 30,
    1998, 112 Stat. 3035, 3037; Pub. L. 107-109, Sec. 5(b)(1), Jan. 4,
    2002, 115 Stat. 1413; Pub. L. 107-250, title III, Sec. 302(d), Oct.
    26, 2002, 116 Stat. 1619; Pub. L. 108-282, title I, Sec. 102(b)(1),
    (5)(A), (B), title II, Sec. 203(c)(1), Aug. 2, 2004, 118 Stat. 891,
    902, 908.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Food and Drugs Act of June 30, 1906, as amended, referred to
    in par. (p)(1), and the Food and Drug Act of June 30, 1906, as
    amended, referred to in par. (v)(1), is act June 30, 1906, ch.
    3915, 34 Stat. 768, as amended, which was classified to subchapter
    I (Sec. 1 et seq.) of chapter 1 of this title, was repealed (except
    for section 14a which was transferred to section 372a of this
    title) by act June 25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059,
    and is covered by this chapter.
      The Federal Insecticide, Fungicide, and Rodenticide Act, referred
    to in par. (q)(1), is act June 25, 1947, ch. 125, as amended
    generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is
    classified generally to subchapter II (Sec. 136 et seq.) of chapter
    6 of Title 7, Agriculture. For complete classification of this Act
    to the Code, see Short Title note set out under section 136 of
    Title 7 and Tables.
      The Poultry Products Inspection Act, referred to in par. (s)(4),
    is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which
    is classified generally to chapter 10 (Sec. 451 et seq.) of this
    title. For complete classification of this Act to the Code, see
    Short Title note set out under section 451 of this title and
    Tables.
      The Meat Inspection Act of March 4, 1907, as amended and
    extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch.
    2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81
    Stat. 584, which are classified generally to subchapters I to IV
    (Sec. 601 et seq.) of chapter 12 of this title. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 601 of this title and Tables.
      Section 101(4) of the Food and Drug Administration Modernization
    Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L.
    105-115, which is set out as a note under section 379g of this
    title.


-MISC1-
                                AMENDMENTS                            
      2004-Par. (u). Pub. L. 108-282, Sec. 102(b)(5)(A), substituted
    "360b, 360ccc" for "360b".
      Par. (v). Pub. L. 108-282, Sec. 102(b)(5)(B), inserted concluding
    provisions.
      Pars. (nn) to (pp). Pub. L. 108-282, Sec. 102(b)(1), added pars.
    (nn) to (pp).
      Par. (qq). Pub. L. 108-282, Sec. 203(c)(1), added par. (qq).
      2002 - Par. (kk). Pub. L. 107-109 added par. (kk).
      Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and (mm).
      1998 - Par. (q)(1). Pub. L. 105-324, Sec. 2(a), added subpar. (1)
    and struck out former subpar. (1) which read as follows: "The term
    'pesticide chemical' means any substance that is a pesticide within
    the meaning of the Federal Insecticide, Fungicide, and Rodenticide
    Act, including all active and inert ingredients of such pesticide."
      Par. (q)(3). Pub. L. 105-324, Sec. 2(c), substituted
    "subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in
    introductory provisions.
      1997 - Par. (aa). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
    "or 357" after "section 355(j)".
      Par. (dd). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out "357,"
    after "section 355,".
      Par. (ff)(3)(A). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
    ", certified as an antibiotic under section 357 of this title,"
    before "or licensed as a biologic".
      Par. (ii). Pub. L. 105-115, Sec. 121(a), added par. (ii).
      Par. (jj). Pub. L. 105-115, Sec. 125(e), added par. (jj).
      1996 - Par. (q). Pub. L. 104-170, Sec. 402(a), amended par. (q)
    generally. Prior to amendment, par. (q) read as follows: "The term
    'pesticide chemical' means any substance which, alone, in chemical
    combination or in formulation with one or more other substances, is
    'a pesticide' within the meaning of the Federal Insecticide,
    Fungicide, and Rodenticide Act as now in force or as hereafter
    amended, and which is used in the production, storage, or
    transportation of raw agricultural commodities."
      Par. (s)(1), (2). Pub. L. 104-170, Sec. 402(b), amended subpars.
    (1) and (2) generally. Prior to amendment, subpars. (1) and (2)
    read as follows:
      "(1) a pesticide chemical in or on a raw agricultural commodity;
    or
      "(2) a pesticide chemical to the extent that it is intended for
    use or is used in the production, storage, or transportation of any
    raw agricultural commodity; or".
      Pars. (gg), (hh). Pub. L. 104-170, Sec. 402(c), added pars. (gg)
    and (hh).
      1994 - Par. (g)(1). Pub. L. 103-417, Sec. 10(a), amended last
    sentence generally. Prior to amendment, last sentence read as
    follows: "A food for which a claim, subject to sections
    343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
    and 343(r)(5)(D) of this title, is made in accordance with the
    requirements of section 343(r) of this title is not a drug under
    clause (B) solely because the label or labeling contains such a
    claim."
      Par. (s)(6). Pub. L. 103-417, Sec. 3(b), added subpar. (6).
      Par. (ff). Pub. L. 103-417, Sec. 3(a), added par. (ff).
      1993 - Pars. (c), (d). Pub. L. 103-80, Sec. 3(dd)(1), substituted
    "Health and Human Services" for "Agriculture".
      Par. (h). Pub. L. 103-80, Sec. 4(b), amended directory language
    of Pub. L. 102-300, Sec. 6(a)(1). See 1992 amendment note below.
      Pars. (v) to (ff). Pub. L. 103-80, Sec. 3(b), redesignated pars.
    (w) to (ff) as (v) to (ee), respectively.
      1992 - Pars. (c), (d). Pub. L. 102-300, Sec. 6(b)(1), which
    directed the substitution of "Health and Human Services" for
    "Health, Education, and Welfare", could not be executed because
    such words did not appear in the original statutory text. See 1993
    Amendment note above and Transfer of Functions notes below.
      Par. (h). Pub. L. 102-300, Sec. 6(a)(1), as amended by Pub. L.
    103-80, Sec. 4(b), substituted "its primary" for "any of its
    principal" in two places in concluding provisions.
      Par. (u). Pub. L. 102-571 substituted "379e" for "376".
      Par. (y)(1). Pub. L. 102-300, Sec. 6(b)(2), struck out "of
    Health, Education, and Welfare" after "employees of the
    Department".
      Pars. (bb) to (ee). Pub. L. 102-282 added pars. (bb) to (ee).
      Par. (ff). Pub. L. 102-300, Sec. 6(a)(2), added par. (ff).
      1990 - Par. (g)(1). Pub. L. 101-629, Sec. 16(b)(1), struck out ";
    but does not include devices or their components, parts, or
    accessories" after "clause (A), (B), or (C)".
      Pub. L. 101-535 inserted at end "A food for which a claim,
    subject to sections 343(r)(1)(B) and 343(r)(3) of this title or
    sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in
    accordance with the requirements of section 343(r) of this title is
    not a drug under clause (B) solely because the label or labeling
    contains such a claim."
      Par. (h)(3). Pub. L. 101-629, Sec. 16(b)(2), which directed the
    amendment of subpar. (3) by substituting "its primary" for "any of
    its principal", could not be executed because "any of its
    principal" did not appear in subpar. (3).
      1988 - Par. (w)(3). Pub. L. 100-670 struck out subpar. (3) which
    read as follows: "which drug is composed wholly or partly of any
    kind of penicillin, streptomycin, chlortetracycline,
    chloramphenicol, or bacitracin, or any derivative thereof, except
    when there is in effect a published order of the Secretary
    declaring such drug not to be a new animal drug on the grounds that
    (A) the requirement of certification of batches of such drug, as
    provided for in section 360b(n) of this title, is not necessary to
    insure that the objectives specified in paragraph (3) thereof are
    achieved and (B) that neither subparagraph (1) nor (2) of this
    paragraph (w) applies to such drug."
      1980 - Par. (aa). Pub. L. 96-359 added par. (aa).
      1977 - Par. (z). Pub. L. 95-203 added par. (z).
      1976 - Par. (h). Pub. L. 94-295, Sec. 3(a)(1)(A), expanded
    definition of "device" to include implements, machines, implants,
    in vitro reagents, and other similar or related articles, added
    recognition in the National Formulary or the United States
    Pharmacopeia, or any supplement to the Formulary or Pharmacopeia,
    to the enumeration of conditions under which a device may qualify
    for inclusion under this chapter, and inserted requirements that a
    device be one which does not achieve any of its principal intended
    purposes through chemical action within or on the body of man or
    other animals and which is not dependent upon being metabolized for
    the achievement of any of its principal intended purposes.
      Par. (n). Pub. L. 94-278 inserted "or advertising" after
    "labeling" wherever appearing.
      Par. (y). Pub. L. 94-295, Sec. 3(a)(2), added par. (y).
      1972 - Par. (q). Pub. L. 92-516 substituted reference to
    pesticide for reference to economic poison.
      1970 - Par. (a)(2). Pub. L. 91-513, Sec. 701(g), struck out
    reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334,
    337, 360, 360a, 372, 373, 374, and 375 of this title as they apply
    to depressant or stimulant drugs.
      Par. (v). Pub. L. 91-513, Sec. 701(a), struck out par. (v) which
    defined "depressant or stimulant drug".
      1968 - Par. (a)(2). Pub. L. 90-639, Sec. 4(a), extended
    provisions to cover depressant and stimulant drugs, the containers
    thereof, and equipment used in manufacturing, compounding, or
    processing such drugs, to the Canal Zone.
      Par. (p). Pub. L. 90-399, Sec. 102(a), (b), inserted "(except a
    new animal drug or an animal feed bearing or containing a new
    animal drug)" after "Any drug" in subpars. (1) and (2),
    respectively.
      Par. (s)(5). Pub. L. 90-399, Sec. 102(c), added subpar. (5).
      Par. (u). Pub. L. 90-399, Sec. 102(d), inserted reference to
    section 360b of this title.
      Par. (v)(3). Pub. L. 90-639, Sec. 1, inserted reference to
    lysergic acid diethylamide.
      Pars. (w), (x). Pub. L. 90-399, Sec. 102(e), added pars. (w) and
    (x).
      1965 - Par. (g). Pub. L. 89-74, Sec. 9(b), designated existing
    provisions as subpar. (1), redesignated cls. (1) to (4) thereof as
    (A) to (D), substituted "(A), (B), or (C)" for "(1), (2), or (3)"
    and added subpar. (2).
      Par. (v). Pub. L. 89-74, Sec. 3(a), added par. (v).
      1962 - Par. (a). Pub. L. 87-781, Sec. 307(a), designated existing
    provisions as subpar. (2), inserted "Commonwealth of Puerto Rico
    and the", and added subpar. (1).
      Par. (p)(1). Pub. L. 87-781, Sec. 102(a)(1), inserted "and
    effectiveness" after "to evaluate the safety", and "and effective"
    after "as safe".
      Par. (p)(2). Pub. L. 87-781, Sec. 102(a)(2), inserted "and
    effectiveness" after "safety".
      1960 - Par. (s). Pub. L. 86-618, Sec. 101(a), excluded color
    additives from definition of "food additive".
      Par. (t). Pub. L. 86-618, Sec. 101(c), added par. (t). Former
    par. (t) redesignated (u).
      Par. (u). Pub. L. 86-618, Sec. 101(b), redesignated par. (t) as
    (u) and inserted reference to section 376 of this title.
      1958 - Pars. (s), (t). Pub. L. 85-929 added pars. (s) and (t).
      1954 - Pars. (q), (r). Act July 22, 1954, added pars. (q) and
    (r).

                     EFFECTIVE DATE OF 2004 AMENDMENT                 
      Pub. L. 108-282, title II, Sec. 203(d), Aug. 2, 2004, 118 Stat.
    908, provided that: "The amendments made by this section [amending
    this section and sections 343 and 343-1 of this title] shall apply
    to any food that is labeled on or after January 1, 2006."

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Section 501 of Pub. L. 105-115 provided that: "Except as
    otherwise provided in this Act [see Short Title of 1997 Amendment
    note set out under section 301 of this title], this Act and the
    amendments made by this Act, other than the provisions of and the
    amendments made by sections 111, 121, 125, and 307 [enacting
    section 355a of this title, amending this section and sections 331,
    335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381,
    and 382 of this title, section 45C of Title 26, Internal Revenue
    Code, section 156 of Title 35, Patents, and section 8126 of Title
    38, Veterans' Benefits, repealing sections 356 and 357 of this
    title, and enacting provisions set out as notes under sections 351
    and 355 of this title], shall take effect 90 days after the date of
    enactment of this Act [Nov. 21, 1997]."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Amendment by Pub. L. 101-535 effective six months after the date
    of the promulgation of final regulations to implement section
    343(r) of this title, or if such regulations are not promulgated,
    the date proposed regulations are to be considered as such final
    regulations (Nov. 8, 1992), with exception for persons marketing
    food the brand name of which contains a term defined by the
    Secretary under section 343(r)(2)(A)(i) of this title, see section
    10(a) of Pub. L. 101-535, set out as a note under section 343 of
    this title.

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
    1976, see section 502(c) of Pub. L. 94-278, set out as a note under
    section 334 of this title.

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Amendment by Pub. L. 92-516 effective at the close of Oct. 21,
    1972, except if regulations are necessary for the implementation of
    any provision that becomes effective on Oct. 21, 1972, and
    continuation in effect of subchapter I of chapter 6 of Title 7, and
    regulations thereunder, relating to the control of economic
    poisons, as in existence prior to Oct. 21, 1972, until superseded
    by provisions of Pub. L. 92-516, and regulations thereunder, see
    section 4 of Pub. L. 92-516, set out as an Effective Date note
    under section 136 of Title 7, Agriculture.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

        EFFECTIVE DATE OF 1968 AMENDMENTS; TRANSITIONAL PROVISIONS    
      Section 6 of Pub. L. 90-639 provided that: "The amendments made
    by this Act [amending this section, sections 331, 333, 334, and
    360a of this title, and provisions set out as a note under section
    289a of Title 42, The Public Health and Welfare] shall apply only
    with respect to violations of the Federal Food, Drug, and Cosmetic
    Act [this chapter] committed after the date of the enactment of
    this Act [Oct. 24, 1968]."
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, except that in the case of a
    drug (other than one subject to section 360b(n) of this title)
    intended for use in animals other than man which, on Oct. 9, 1962,
    was commercially used or sold in the United States, was not a new
    drug as defined in par. (p) of this section then in force, and was
    not covered by an effective application under section 355 of this
    title, the words "effectiveness" and "effective" contained in par.
    (v) of this section not applicable to such drug when intended
    solely for use under conditions prescribed, recommended, or
    suggested in labeling with respect to such drug on that day, see
    section 108(a), (b)(3) of Pub. L. 90-399, as amended, set out as an
    Effective Date and Transitional Provisions note under section 360b
    of this title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Section 11 of Pub. L. 89-74 provided that: "The foregoing
    provisions of this Act [see Short Title of 1965 Amendment note set
    out under section 301 of this title] shall take effect on the first
    day of the seventh calendar month [Feb. 1, 1966] following the
    month in which this Act is enacted [July 15, 1965]; except that (1)
    the Secretary shall permit persons, owning or operating any
    establishment engaged in manufacturing, preparing, propagating,
    compounding, processing, wholesaling, jobbing, or distributing any
    depressant or stimulant drug, as referred to in the amendments made
    by section 4 of this Act to section 510 of the Federal Food, Drug,
    and Cosmetic Act [section 360 of this title], to register their
    name, places of business, and establishments, and other information
    prescribed by such amendments, with the Secretary prior to such
    effective date, and (2) sections 201(v) and 511(g) of the Federal
    Food, Drug, and Cosmetic Act, as added by this act [par. (v) of
    this section and par. (g) of section 360a of this title], and the
    provisions of sections 8 [amending section 372 of this title and
    section 1114 of Title 18, Crimes and Criminal Procedure] and 10
    [set out as a note under this section] shall take effect upon the
    date of enactment of this Act [July 15, 1965]."

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Section 107 of Pub. L. 87-781 provided that:
      "(a) Except as otherwise provided in this section, the amendments
    made by the foregoing sections of this part A [amending this
    section and sections 331, 332, 348, 351 to 353, 355, 357, 379e of
    this title, and enacting provisions set out as a note under section
    355 of this title] shall take effect on the date of enactment of
    this Act [Oct. 10, 1962].
      "(b) The amendments made by sections 101, 103, 105, and 106 of
    this part A [amending sections 331, 332, 351, 352, 355, and 357 of
    this title] shall, with respect to any drug, take effect on the
    first day of the seventh calendar month following the month in
    which this Act is enacted [Oct. 1962].
      "(c)(1) As used in this subsection, the term 'enactment date'
    means the date of enactment of this Act; and the term 'basic Act'
    means the Federal Food, Drug, and Cosmetic Act [this chapter].
      "(2) An application filed pursuant to section 505(b) of the basic
    Act [section 355(b) of this title] which was 'effective' within the
    meaning of that Act on the day immediately preceding the enactment
    date shall be deemed as of the enactment date, to be an application
    'approved' by the Secretary within the meaning of the basic Act as
    amended by this Act.
      "(3) In the case of any drug with respect to which an application
    filed under section 505(b) of the basic Act is deemed to be an
    approved application on the enactment date by virtue of paragraph
    (2) of this subsection - 
        "(A) the amendments made by this Act to section 201(p), and to
      subsections (b) and (d) of section 505, of the basic Act [par.
      (p) of this section, and subsecs. (b) and (d) of section 355 of
      this title], insofar as such amendments relate to the
      effectiveness of drugs, shall not, so long as approval of such
      application is not withdrawn or suspended pursuant to section
      505(e) of that Act [section 355(e) of this title], apply to such
      drug when intended solely for use under conditions prescribed,
      recommended, or suggested in labeling covered by such approved
      application, but shall apply to any changed use, or conditions of
      use, prescribed, recommended, or suggested in its labeling,
      including such conditions of use as are the subject of an
      amendment or supplement to such application pending on, or filed
      after, the enactment date; and
        "(B) clause (3) of the first sentence of section 505(e) of the
      basic Act, as amended by this Act [section 355(e) of this title],
      shall not apply to such drug when intended solely for use under
      conditions prescribed, recommended, or suggested in labeling
      covered by such approved application (except with respect to such
      use, or conditions of use, as are the subject of an amendment or
      supplement to such approved application, which amendment or
      supplement has been approved after the enactment date under
      section 505 of the basic Act as amended by this Act [section 355
      of this title]) until whichever of the following first occurs:
      (i) the expiration of the two-year period beginning with the
      enactment date; (ii) the effective date of an order under section
      505(e) of the basic Act [section 355(e) of this title], other
      than clause (3) of the first sentence of such section 505(e)
      [section 355(e) of this title], withdrawing or suspending the
      approval of such application.
      "(4) In the case of any drug which, on the day immediately
    preceding the enactment date, (A) was commercially used or sold in
    the United States, (B) was not a new drug as defined by section
    201(p) of the basic Act as then in force [par. (p) of this
    section], and (C) was not covered by an effective application under
    section 505 of that Act [section 355 of this title], the amendments
    to section 201(p) [par. (p) of this section] made by this Act shall
    not apply to such drug when intended solely for use under
    conditions prescribed, recommended, or suggested in labeling with
    respect to such drug on that day."

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                     EFFECTIVE DATE OF 1958 AMENDMENT                 
      Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
    6(a) of Pub. L. 85-929, set out as a note under section 342 of this
    title.

                     EFFECTIVE DATE OF 1954 AMENDMENT                 
      For effective date of amendment by act July 22, 1954, see section
    5 of that act, set out as a note under section 342 of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282           
      Amendment by Pub. L. 102-282 not to preclude any other civil,
    criminal, or administrative remedy provided under Federal or State
    law, including any private right of action against any person for
    the same action subject to any action or civil penalty under an
    amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
    282, set out as a note under section 335a of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Amendments by Pub. L. 101-535 not to be construed to alter
    authority of Secretary of Health and Human Services and Secretary
    of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
    et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
    seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
    seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.

                             SAVINGS PROVISION                         
      Section 702 of Pub. L. 91-513, as amended by Pub. L. 93-481, Sec.
    2, Oct. 26, 1974, 88 Stat. 1455, provided that:
      "(a) Prosecutions for any violation of law occurring prior to the
    effective date [see Effective Date of 1970 Amendment note above] of
    section 701 [repealing section 360a of this title, and amending
    sections 321, 331, 333, 334, 360, 372, and 381 of this title,
    sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure,
    and section 242 of Title 42, The Public Health and Welfare] shall
    not be affected by the repeals or amendments made by such section,
    or abated by reason thereof.
      "(b) Civil seizures or forfeitures and injunctive proceedings
    commenced prior to the effective date of section 701 shall not be
    affected by the repeals or amendments made by such section, or
    abated by reason thereof.
      "(c) All administrative proceedings pending before the Bureau of
    Narcotics and Dangerous Drugs [now the Drug Enforcement
    Administration] on the date of enactment of this Act [Oct. 27,
    1970] shall be continued and brought to final determination in
    accord with laws and regulations in effect prior to such date of
    enactment. Where a drug is finally determined under such
    proceedings to be a depressant or stimulant drug, as defined in
    section 201(v) of the Federal Food, Drug, and Cosmetic Act [par.
    (v) of this section], such drug shall automatically be controlled
    under this title [subchapter I of chapter 13 of this title] by the
    Attorney General without further proceedings and listed in the
    appropriate schedule after he has obtained the recommendation of
    the Secretary. Any drug with respect to which such a final
    determination has been made prior to the date of enactment of this
    Act which is not listed in section 202 [section 812 of this title]
    within schedules I through V shall automatically be controlled
    under this title [subchapter I of chapter 13 of this title] by the
    Attorney General without further proceedings, and be listed in the
    appropriate schedule, after he has obtained the recommendations of
    the Secretary.
      "(d) Notwithstanding subsection (a) of this section or section
    1103 [of Pub. L. 91-513, set out as a note under sections 171 to
    174 of this title], section 4202 of title 18, United States Code,
    shall apply to any individual convicted under any of the laws
    repealed by this title or title III [subchapter I or subchapter II
    of chapter 13 of this title] without regard to the terms of any
    sentence imposed on such individual under such law."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Secretary and Department of Health, Education, and Welfare
    redesignated Secretary and Department of Health and Human Services
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695, which is classified to section 3508(b) of Title 20, Education.
      Functions of Secretary of Health, Education, and Welfare [now
    Health and Human Services] under Federal Food, Drug, and Cosmetic
    Act, to the extent such functions related to administration and
    enforcement of the Poison Prevention Packaging Act of 1970 (15
    U.S.C. 1471 et seq.), transferred to Consumer Product Safety
    Commission by section 2079 of Title 15, Commerce and Trade.
      Functions of Secretary of Health, Education, and Welfare [now
    Health and Human Services] under Drug Abuse Control Amendments of
    1965 [see Short Title of 1965 Amendment note set out under section
    301 of this title] transferred to Attorney General except function
    of regulating counterfeiting of those drugs which are not
    "depressant or stimulant" drugs, see section 2 of Reorg. Plan No. 1
    of 1968, set out in the Appendix to Title 5, Government
    Organization and Employees.
      Functions of Federal Security Administrator transferred to
    Secretary of Health, Education, and Welfare and all agencies of
    Federal Security Agency transferred to Department of Health,
    Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953,
    set out in the Appendix to Title 5, Government Organization and
    Employees. Federal Security Agency and office of Administrator
    abolished by section 8 of Reorg. Plan No. 1 of 1953.
      Food and Drug Administration in Department of Agriculture and its
    functions, except those functions relating to administration of
    Insecticide Act of 1910 and Naval Stores Act, transferred to
    Federal Security Agency, to be administered under direction and
    supervision of Federal Security Administrator, by Reorg. Plan No.
    IV of 1940, set out in the Appendix to Title 5.


-MISC2-
                           REGULATION OF TOBACCO                       
      Section 422 of Pub. L. 105-115 provided that: "Nothing in this
    Act [see Short Title of 1997 Amendment note set out under section
    301 of this title] or the amendments made by this Act shall be
    construed to affect the question of whether the Secretary of Health
    and Human Services has any authority to regulate any tobacco
    product, tobacco ingredient, or tobacco additive. Such authority,
    if any, shall be exercised under the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 301 et seq.] as in effect on the day before
    the date of the enactment of this Act [Nov. 21, 1997]."

            CONGRESSIONAL FINDINGS RELATING TO PUB. L. 103-417        
      Section 2 of Pub. L. 103-417 provided that: "Congress finds that -
     
        "(1) improving the health status of United States citizens
      ranks at the top of the national priorities of the Federal
      Government;
        "(2) the importance of nutrition and the benefits of dietary
      supplements to health promotion and disease prevention have been
      documented increasingly in scientific studies;
        "(3)(A) there is a link between the ingestion of certain
      nutrients or dietary supplements and the prevention of chronic
      diseases such as cancer, heart disease, and osteoporosis; and
        "(B) clinical research has shown that several chronic diseases
      can be prevented simply with a healthful diet, such as a diet
      that is low in fat, saturated fat, cholesterol, and sodium, with
      a high proportion of plant-based foods;
        "(4) healthful diets may mitigate the need for expensive
      medical procedures, such as coronary bypass surgery or
      angioplasty;
        "(5) preventive health measures, including education, good
      nutrition, and appropriate use of safe nutritional supplements
      will limit the incidence of chronic diseases, and reduce long-
      term health care expenditures;
        "(6)(A) promotion of good health and healthy lifestyles
      improves and extends lives while reducing health care
      expenditures; and
        "(B) reduction in health care expenditures is of paramount
      importance to the future of the country and the economic well-
      being of the country;
        "(7) there is a growing need for emphasis on the dissemination
      of information linking nutrition and long-term good health;
        "(8) consumers should be empowered to make choices about
      preventive health care programs based on data from scientific
      studies of health benefits related to particular dietary
      supplements;
        "(9) national surveys have revealed that almost 50 percent of
      the 260,000,000 Americans regularly consume dietary supplements
      of vitamins, minerals, or herbs as a means of improving their
      nutrition;
        "(10) studies indicate that consumers are placing increased
      reliance on the use of nontraditional health care providers to
      avoid the excessive costs of traditional medical services and to
      obtain more holistic consideration of their needs;
        "(11) the United States will spend over $1,000,000,000,000 on
      health care in 1994, which is about 12 percent of the Gross
      National Product of the United States, and this amount and
      percentage will continue to increase unless significant efforts
      are undertaken to reverse the increase;
        "(12)(A) the nutritional supplement industry is an integral
      part of the economy of the United States;
        "(B) the industry consistently projects a positive trade
      balance; and
        "(C) the estimated 600 dietary supplement manufacturers in the
      United States produce approximately 4,000 products, with total
      annual sales of such products alone reaching at least
      $4,000,000,000;
        "(13) although the Federal Government should take swift action
      against products that are unsafe or adulterated, the Federal
      Government should not take any actions to impose unreasonable
      regulatory barriers limiting or slowing the flow of safe products
      and accurate information to consumers;
        "(14) dietary supplements are safe within a broad range of
      intake, and safety problems with the supplements are relatively
      rare; and
        "(15)(A) legislative action that protects the right of access
      of consumers to safe dietary supplements is necessary in order to
      promote wellness; and
        "(B) a rational Federal framework must be established to
      supersede the current ad hoc, patchwork regulatory policy on
      dietary supplements."

     DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSE 
      Section 5 of Pub. L. 90-639 provided that: "It is the sense of
    the Congress that, because of the inadequate knowledge on the part
    of the people of the United States of the substantial adverse
    effects of misuse of depressant and stimulant drugs, and of other
    drugs liable to abuse, on the individual, his family, and the
    community, the highest priority should be given to Federal programs
    to disseminate information which may be used to educate the public,
    particularly young persons, regarding the dangers of drug abuse."

             CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY         
      Section 2 of Pub. L. 89-74 provided that: "The Congress hereby
    finds and declares that there is a widespread illicit traffic in
    depressant and stimulant drugs moving in or otherwise affecting
    interstate commerce; that the use of such drugs, when not under the
    supervision of a licensed practitioner, often endangers safety on
    the highways (without distinction of interstate and intrastate
    traffic thereon) and otherwise has become a threat to the public
    health and safety, making additional regulation of such drugs
    necessary regardless of the intrastate or interstate origin of such
    drugs; that in order to make regulation and protection of
    interstate commerce in such drugs effective, regulation of
    intrastate commerce is also necessary because, among other things,
    such drugs, when held for illicit sale, often do not bear labeling
    showing their place of origin and because in the form in which they
    are so held or in which they are consumed a determination of their
    place of origin is often extremely difficult or impossible; and
    that regulation of interstate commerce without the regulation of
    intrastate commerce in such drugs, as provided in this Act [see
    Short Title of 1965 Amendment note set out under section 301 of
    this title], would discriminate against and adversely affect
    interstate commerce in such drugs."

       EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS   
      Section 10 of Pub. L. 89-74 provided that:
      "(a) Nothing in this Act [enacting section 360a of this title,
    amending sections 321, 331, 333, 334, 360, and 372 of this title
    and section 1114 of Title 18, Crimes and Criminal Procedure, and
    enacting provisions set out as notes under sections 321, 352, and
    360a of this title] shall be construed as authorizing the
    manufacture, compounding, processing, possession, sale, delivery,
    or other disposal of any drug in any State in contravention of the
    laws of such State.
      "(b) No provision of this Act nor any amendment made by it shall
    be construed as indicating an intent on the part of the Congress to
    occupy the field in which such provision or amendment operates to
    the exclusion of any State law on the same subject matter, unless
    there is a direct and positive conflict between such provision or
    amendment and such State law so that the two cannot be reconciled
    or consistently stand together.
      "(c) No amendment made by this Act shall be construed to prevent
    the enforcement in the courts of any State of any statute of such
    State prescribing any criminal penalty for any act made criminal by
    any such amendment."

              EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS          
      Section 202 of Pub. L. 87-781 provided that: "Nothing in the
    amendments made by this Act [enacting sections 358 to 360, amending
    sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e,
    and 381 of this title, and enacting provisions set out as notes
    under sections 321, 331, 332, 352, 355, 360, and 374 of this title]
    to the Federal Food, Drug, and Cosmetic Act [this chapter] shall be
    construed as invalidating any provision of State law which would be
    valid in the absence of such amendments unless there is a direct
    and positive conflict between such amendments and such provision of
    State law."

-CROSS-
                                DEFINITIONS                            
      Section 2 of Pub. L. 105-115 provided that: "In this Act [see
    Short Title of 1997 Amendment note set out under section 301 of
    this title], the terms 'drug', 'device', 'food', and 'dietary
    supplement' have the meaning given such terms in section 201 of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)."

-FOOTNOTE-
    (!1) So in original. Probably should be paragraph "(v)".


-End-



-CITE-
    21 USC Sec. 321a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321a. "Butter" defined

-STATUTE-
      For the purposes of the Food and Drug Act of June 30, 1906
    (Thirty-fourth Statutes at Large, page 768) "butter" shall be
    understood to mean the food product usually known as butter, and
    which is made exclusively from milk or cream, or both, with or
    without common salt, and with or without additional coloring
    matter, and containing not less than 80 per centum by weight of
    milk fat, all tolerances having been allowed for.

-SOURCE-
    (Mar. 4, 1923, ch. 268, 42 Stat. 1500.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Food and Drug Act of June 30, 1906, referred to in text, is
    act June 30, 1906, ch. 3915, 34 Stat. 768, as amended, which was
    classified to subchapter I (Sec. 1 et seq.) of chapter 1 of this
    title, was repealed (except for section 14a which was transferred
    to section 376 of this title) by act June 25, 1938, ch. 675, Sec.
    902(a), 52 Stat. 1059, and is covered by this chapter.

-COD-
                               CODIFICATION                           
      Section, which was not enacted as part of the Federal Food, Drug,
    and Cosmetic Act which comprises this chapter, was formerly
    classified to section 6 of this title. Section 902(a) of act June
    25, 1938, set out as an Effective Date note under section 301 of
    this title, provided that this section should remain in force and
    effect and be applicable to the provisions of this chapter.

-End-



-CITE-
    21 USC Sec. 321b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321b. "Package" defined

-STATUTE-
      The word "package" where it occurs the second and last time in
    the act entitled "An act to amend section 8 of an act entitled, 'An
    act for preventing the manufacture, sale, or transportation of
    adulterated or misbranded or poisonous deleterious foods, drugs,
    medicines, and liquors, and for regulating traffic therein, and for
    other purposes,' " approved March 3, 1913, shall include and shall
    be construed to include wrapped meats inclosed in papers or other
    materials as prepared by the manufacturers thereof for sale.

-SOURCE-
    (July 24, 1919, ch. 26, 41 Stat. 271.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      An act approved March 3, 1913, referred to in text, is act Mar.
    3, 1913, ch. 117, 37 Stat. 732, which amended section 10 of this
    title. For complete classification of this Act to the Code, see
    Tables.
      "An act for preventing the manufacture, sale, or transportation
    of adulterated or misbranded or poisonous deleterious foods, drugs,
    medicines, and liquors, and for regulating traffic therein, and for
    other purposes,", referred to in text, is act June 30, 1906, ch.
    3915, 34 Stat. 768, which was classified to subchapter I (Sec. 1 et
    seq.) of chapter 1 of this title, was repealed (except for section
    14a which was transferred to section 376 of this title) by act June
    25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059, and is covered by
    this chapter.

-COD-
                               CODIFICATION                           
      Section, which was not enacted as part of the Federal Food, Drug,
    and Cosmetic Act which comprises this chapter, was formerly
    classified to the last sentence of paragraph third of section 10 of
    this title. Section 902(a) of act June 25, 1938, set out as an
    Effective Date note under section 301 of this title, provided that
    this section should remain in force and effect and be applicable to
    the provisions of this chapter.

-End-



-CITE-
    21 USC Sec. 321c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321c. Nonfat dry milk; "milk" defined

-STATUTE-
      For the purposes of the Federal Food, Drug, and Cosmetic Act of
    June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) [21 U.S.C. 301 et
    seq.] nonfat dry milk is the product resulting from the removal of
    fat and water from milk, and contains the lactose, milk proteins,
    and milk minerals in the same relative proportions as in the fresh
    milk from which made. It contains not over 5 per centum by weight
    of moisture. The fat content is not over 1 1/2  per centum by
    weight unless otherwise indicated.
      The term "milk", when used herein, means sweet milk of cows.

-SOURCE-
    (Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70
    Stat. 486.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch.
    675, sec. 1, 52 Stat. 1040), referred to in text, probably means
    act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
    classified generally to this chapter (Sec. 301 et seq.). For
    complete classification of this Act to the Code, see section 301 of
    this title and Tables.

-COD-
                               CODIFICATION                           
      Section was not enacted as a part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter, but was made applicable
    thereto.


-MISC1-
                                AMENDMENTS                            
      1956 - Act July 2, 1956, substituted "nonfat dry milk" for
    "nonfat dry milk solids or defatted milk solids".

-End-



-CITE-
    21 USC Sec. 321d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER II - DEFINITIONS

-HEAD-
    Sec. 321d. Market names for catfish and ginseng

-STATUTE-
    (a) Catfish labeling
      (1) In general
        Notwithstanding any other provision of law, for purposes of the
      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) - 
          (A) the term "catfish" may only be considered to be a common
        or usual name (or part thereof) for fish classified within the
        family Ictaluridae; and
          (B) only labeling or advertising for fish classified within
        that family may include the term "catfish".
      (2) Omitted
    (b) Ginseng labeling
      (1) In general
        Notwithstanding any other provision of law, for purposes of the
      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) - 
          (A) the term "ginseng" may only be considered to be a common
        or usual name (or part thereof) for any herb or herbal
        ingredient derived from a plant classified within the genus
        Panax; and
          (B) only labeling or advertising for herbs or herbal
        ingredients classified within that genus may include the term
        "ginseng".
      (2) Omitted

-SOURCE-
    (Pub. L. 107-171, title X, Sec. 10806, May 13, 2002, 116 Stat.
    526.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
    (a)(1), (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to this chapter. For
    complete classification of this Act to the Code, see section 301 of
    this title and Tables.

-COD-
                               CODIFICATION                           
      Section is comprised of section 10806 of Pub. L. 107-171.
    Subsecs. (a)(2) and (b)(2) of section 10806 of Pub. L. 107-171
    amended section 343 of this title.
      Section was enacted as part of the Farm Security and Rural
    Investment Act of 2002, and not as part of Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.

-End-


-CITE-
    21 USC SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
              SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES          

-End-



-CITE-
    21 USC Sec. 331                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 331. Prohibited acts

-STATUTE-
      The following acts and the causing thereof are prohibited:
      (a) The introduction or delivery for introduction into interstate
    commerce of any food, drug, device, or cosmetic that is adulterated
    or misbranded.
      (b) The adulteration or misbranding of any food, drug, device, or
    cosmetic in interstate commerce.
      (c) The receipt in interstate commerce of any food, drug, device,
    or cosmetic that is adulterated or misbranded, and the delivery or
    proffered delivery thereof for pay or otherwise.
      (d) The introduction or delivery for introduction into interstate
    commerce of any article in violation of section 344, 355, or 360bbb-
    3 of this title.
      (e) The refusal to permit access to or copying of any record as
    required by section 350a, 350c, 350e, 354, 360bbb-3, 373, 374(a),
    379aa, or 379aa-1 of this title; or the failure to establish or
    maintain any record, or make any report, required under section
    350a, 350c(b), 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j),
    (l) or (m), 360ccc-1(i).,(!1) 360e(f), 360i, 360bbb-3, 379aa, or
    379aa-1 of this title, or the refusal to permit access to or
    verification or copying of any such required record.

      (f) The refusal to permit entry or inspection as authorized by
    section 374 of this title.
      (g) The manufacture within any Territory of any food, drug,
    device, or cosmetic that is adulterated or misbranded.
      (h) The giving of a guaranty or undertaking referred to in
    section 333(c)(2) of this title, which guaranty or undertaking is
    false, except by a person who relied upon a guaranty or undertaking
    to the same effect signed by, and containing the name and address
    of, the person residing in the United States from whom he received
    in good faith the food, drug, device, or cosmetic; or the giving of
    a guaranty or undertaking referred to in section 333(c)(3) of this
    title, which guaranty or undertaking is false.
      (i)(1) Forging, counterfeiting, simulating, or falsely
    representing, or without proper authority using any mark, stamp,
    tag, label, or other identification device authorized or required
    by regulations promulgated under the provisions of section 344 or
    379e of this title.
      (2) Making, selling, disposing of, or keeping in possession,
    control, or custody, or concealing any punch, die, plate, stone, or
    other thing designed to print, imprint, or reproduce the trademark,
    trade name, or other identifying mark, imprint, or device of
    another or any likeness of any of the foregoing upon any drug or
    container or labeling thereof so as to render such drug a
    counterfeit drug.
      (3) The doing of any act which causes a drug to be a counterfeit
    drug, or the sale or dispensing, or the holding for sale or
    dispensing, of a counterfeit drug.
      (j) The using by any person to his own advantage, or revealing,
    other than to the Secretary or officers or employees of the
    Department, or to the courts when relevant in any judicial
    proceeding under this chapter, any information acquired under
    authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c,
    360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc-1, 360ccc-
    2.,(!1) 374, 379, or 379e of this title concerning any method or
    process which as a trade secret is entitled to protection; or the
    violating of section 346a(i)(2) of this title or any regulation
    issued under that section..(!1) This paragraph does not authorize
    the withholding of information from either House of Congress or
    from, to the extent of matter within its jurisdiction, any
    committee or subcommittee of such committee or any joint committee
    of Congress or any subcommittee of such joint committee.
      (k) The alteration, mutilation, destruction, obliteration, or
    removal of the whole or any part of the labeling of, or the doing
    of any other act with respect to, a food, drug, device, or
    cosmetic, if such act is done while such article is held for sale
    (whether or not the first sale) after shipment in interstate
    commerce and results in such article being adulterated or
    misbranded.
      (l) Repealed. Pub. L. 105-115, title IV, Sec. 421, Nov. 21, 1997,
    111 Stat. 2380.
      (m) The sale or offering for sale of colored oleomargarine or
    colored margarine, or the possession or serving of colored
    oleomargarine or colored margarine in violation of subsections (b)
    or (c) of section 347 of this title.
      (n) The using, in labeling, advertising or other sales promotion
    of any reference to any report or analysis furnished in compliance
    with section 374 of this title.
      (o) In the case of a prescription drug distributed or offered for
    sale in interstate commerce, the failure of the manufacturer,
    packer, or distributor thereof to maintain for transmittal, or to
    transmit, to any practitioner licensed by applicable State law to
    administer such drug who makes written request for information as
    to such drug, true and correct copies of all printed matter which
    is required to be included in any package in which that drug is
    distributed or sold, or such other printed matter as is approved by
    the Secretary. Nothing in this paragraph shall be construed to
    exempt any person from any labeling requirement imposed by or under
    other provisions of this chapter.
      (p) The failure to register in accordance with section 360 of
    this title, the failure to provide any information required by
    section 360(j) or 360(k) of this title, or the failure to provide a
    notice required by section 360(j)(2) of this title.
      (q)(1) The failure or refusal to (A) comply with any requirement
    prescribed under section 360h or 360j(g) of this title, (B) furnish
    any notification or other material or information required by or
    under section 360i or 360j(g) of this title, or (C) comply with a
    requirement under section 360l of this title.
      (2) With respect to any device, the submission of any report that
    is required by or under this chapter that is false or misleading in
    any material respect.
      (r) The movement of a device in violation of an order under
    section 334(g) of this title or the removal or alteration of any
    mark or label required by the order to identify the device as
    detained.
      (s) The failure to provide the notice required by section 350a(c)
    or 350a(e) of this title, the failure to make the reports required
    by section 350a(f)(1)(B) of this title, the failure to retain the
    records required by section 350a(b)(4) of this title, or the
    failure to meet the requirements prescribed under section
    350a(f)(3) of this title.
      (t) The importation of a drug in violation of section 381(d)(1)
    of this title, the sale, purchase, or trade of a drug or drug
    sample or the offer to sell, purchase, or trade a drug or drug
    sample in violation of section 353(c) of this title, the sale,
    purchase, or trade of a coupon, the offer to sell, purchase, or
    trade such a coupon, or the counterfeiting of such a coupon in
    violation of section 353(c)(2) of this title, the distribution of a
    drug sample in violation of section 353(d) of this title or the
    failure to otherwise comply with the requirements of section 353(d)
    of this title, or the distribution of drugs in violation of section
    353(e) of this title or the failure to otherwise comply with the
    requirements of section 353(e) of this title.
      (u) The failure to comply with any requirements of the provisions
    of, or any regulations or orders of the Secretary, under section
    360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.
      (v) The introduction or delivery for introduction into interstate
    commerce of a dietary supplement that is unsafe under section 350b
    of this title.
      (w) The making of a knowingly false statement in any statement,
    certificate of analysis, record, or report required or requested
    under section 381(d)(3) of this title; the failure to submit a
    certificate of analysis as required under such section; the failure
    to maintain records or to submit records or reports as required by
    such section; the release into interstate commerce of any article
    or portion thereof imported into the United States under such
    section or any finished product made from such article or portion,
    except for export in accordance with section 381(e) or 382 of this
    title, or with section 262(h) of title 42; or the failure to so
    export or to destroy such an article or portions thereof, or such a
    finished product.
      (x) The falsification of a declaration of conformity submitted
    under section 360d(c) of this title or the failure or refusal to
    provide data or information requested by the Secretary under
    paragraph (3) of such section.
      (y) In the case of a drug, device, or food - 
        (1) the submission of a report or recommendation by a person
      accredited under section 360m of this title that is false or
      misleading in any material respect;
        (2) the disclosure by a person accredited under section 360m of
      this title of confidential commercial information or any trade
      secret without the express written consent of the person who
      submitted such information or secret to such person; or
        (3) the receipt by a person accredited under section 360m of
      this title of a bribe in any form or the doing of any corrupt act
      by such person associated with a responsibility delegated to such
      person under this chapter.

      (z) The dissemination of information in violation of section
    360aaa of this title.
      (aa) The importation of a prescription drug in violation of
    section 384 of this title, the falsification of any record required
    to be maintained or provided to the Secretary under such section,
    or any other violation of regulations under such section.
      (bb) The transfer of an article of food in violation of an order
    under section 334(h) of this title, or the removal or alteration of
    any mark or label required by the order to identify the article as
    detained.
      (cc) The importing or offering for import into the United States
    of an article of food by, with the assistance of, or at the
    direction of, a person debarred under section 335a(b)(3) of this
    title.
      (dd) The failure to register in accordance with section 350d of
    this title.
      (ee) The importing or offering for import into the United States
    of an article of food in violation of the requirements under
    section 381(m) of this title.
      (ff) The importing or offering for import into the United States
    of a drug or device with respect to which there is a failure to
    comply with a request of the Secretary to submit to the Secretary a
    statement under section 381(o) of this title.
      (gg) The knowing failure to comply with paragraph (7)(E) of
    section 374(g) of this title; the knowing inclusion by a person
    accredited under paragraph (2) of such section of false information
    in an inspection report under paragraph (7)(A) of such section; or
    the knowing failure of such a person to include material facts in
    such a report.
      (hh) The failure by a shipper, carrier by motor vehicle or rail
    vehicle, receiver, or any other person engaged in the
    transportation of food to comply with the sanitary transportation
    practices prescribed by the Secretary under section 350e of this
    title.
      (ii) The falsification of a report of a serious adverse event
    submitted to a responsible person (as defined under section 379aa
    or 379aa-1 of this title) or the falsification of a serious adverse
    event report (as defined under section 379aa or 379aa-1 of this
    title) submitted to the Secretary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 301, 52 Stat. 1042; Dec. 22, 1941,
    ch. 613, Sec. 1, 55 Stat. 851; July 6, 1945, ch. 281, Sec. 1, 59
    Stat. 463; Mar. 10, 1947, ch. 16, Sec. 1, 61 Stat. 11; June 24,
    1948, ch. 613, Sec. 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, Sec.
    3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, Sec. 2, 67 Stat. 477;
    Pub. L. 85-929, Sec. 5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86-
    618, title I, Secs. 104, 105(a), July 12, 1960, 74 Stat. 403; Pub.
    L. 87-781, title I, Secs. 103(c), 104(e)(1), 106(c), 114(a), title
    III, Sec. 304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795;
    Pub. L. 89-74, Secs. 5, 9(c), July 15, 1965, 79 Stat. 232, 235;
    Pub. L. 90-399, Sec. 103, July 13, 1968, 82 Stat. 352; Pub. L. 90-
    639, Sec. 2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91-513,
    title II, Sec. 701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 92-
    387, Sec. 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94-295, Secs.
    3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582; Pub. L.
    96-359, Sec. 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 99-570,
    title IV, Sec. 4014(b)(2), Oct. 27, 1986, 100 Stat. 3207-120; Pub.
    L. 100-293, Sec. 7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101-
    502, Sec. 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101-508,
    title IV, Sec. 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388-210; Pub.
    L. 102-300, Sec. 3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102-
    571, title I, Sec. 107(2), (3), Oct. 29, 1992, 106 Stat. 4499;
    Pub. L. 103-80, Sec. 3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L.
    103-396, Sec. 2(b)(1), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103-
    417, Sec. 10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L. 104-134,
    title II, Sec. 2103, Apr. 26, 1996, 110 Stat. 1321-319; Pub. L. 104-
    170, title IV, Sec. 403, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 104-
    250, Sec. 5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L. 105-115,
    title I, Sec. 125(a)(2)(A), (C), (b)(2)(B), title II, Secs. 204(b),
    210(c), title IV, Secs. 401(b), 421, Nov. 21, 1997, 111 Stat. 2325,
    2336, 2345, 2364, 2380; Pub. L. 106-387, Sec. 1(a) [title VII, Sec.
    745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 1549A-39; Pub. L. 107-
    188, title III, Secs. 303(b), 304(d), 305(b), 306(c), 307(b),
    321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 668, 670,
    672, 676, 677; Pub. L. 107-250, title II, Sec. 201(d), Oct. 26,
    2002, 116 Stat. 1609; Pub. L. 108-136, div. A, title XVI, Sec.
    1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108-173, title XI,
    Sec. 1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108-214,
    Sec. 2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108-282,
    title I, Sec. 102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub.
    L. 109-59, title VII, Sec. 7202(d), (e), Aug. 10, 2005, 119 Stat.
    1913; Pub. L. 109-462, Secs. 2(c), 3(b), 4(a), Dec. 22, 2006, 120
    Stat. 3472, 3475.)


-STATAMEND-
                           AMENDMENT OF SECTION                       
      For termination of amendment by section 401(e) of Pub. L. 105-
    115, see Effective and Termination Dates of 1997 Amendment note
    below.


-MISC1-
                                AMENDMENTS                            
      2006 - Par. (e). Pub. L. 109-462, Sec. 3(b), substituted "374(a),
    379aa, or 379aa-1" for "374(a), or 379aa" and "360bbb-3, 379aa, or
    379aa-1" for "360bbb-3, or 379aa".
      Pub. L. 109-462, Sec. 2(c), substituted ", 374(a), or 379aa" for
    ", or 374(a)" and ", 360bbb-3, or 379aa" for ", or 360bbb-3".
      Par. (ii). Pub. L. 109-462, Sec. 4(a), added par. (ii).
      2005 - Par. (e). Pub. L. 109-59, Sec. 7202(d), inserted "350e,"
    before "354," in two places.
      Par. (hh). Pub. L. 109-59, Sec. 7202(e), added par. (hh).
      2004 - Par. (e). Pub. L. 108-282, Sec. 102(b)(5)(C), which
    directed the substitution of "360b(a)(4)(C), 360b (j), (l) or (m),
    360ccc-1(i)." for "360b(a)(4)(C), 360b(j), (l) or (m)" was executed
    by making the substitution for "360b(a)(4)(C), 360b(j), (l), or
    (m)", to reflect the probable intent of Congress.
      Par. (j). Pub. L. 108-282, Sec. 102(b)(5)(D), substituted "360j,
    360ccc, 360ccc-1, 360ccc-2." for "360j".
      Par. (gg). Pub. L. 108-214 amended par. (gg) generally. Prior to
    amendment, text read as follows: "The knowing failure of a person
    accredited under paragraph (2) of section 374(g) of this title to
    comply with paragraph (7)(E) of such section; the knowing inclusion
    by such a person of false information in an inspection report under
    paragraph (7)(A) of such section; or the knowing failure of such a
    person to include material facts in such a report."
      2003 - Par. (d). Pub. L. 108-136 substituted "section 344, 355,
    or 360bbb-3" for "section 344 or 355".
      Par. (e). Pub. L. 108-136 inserted "360bbb-3," after "350c, 354,"
    and substituted "360i, or 360bbb-3" for "or 360i".
      Par. (aa). Pub. L. 108-173 substituted "prescription drug in
    violation of section 384" for "covered product in violation of
    section 384".
      2002 - Par. (e). Pub. L. 107-188, Sec. 306(c)(1), substituted "by
    section 350a, 350c, 354, 373, or 374(a) of this title" for "by
    section 350a, 354, or 373 of this title" and "under section 350a,
    350c(b)" for "under section 350a".
      Par. (j). Pub. L. 107-188, Sec. 306(c)(2), inserted "350c," after
    "350a,".
      Par. (w). Pub. L. 107-188, Sec. 322(b), amended par. (w)
    generally. Prior to amendment, par. (w) read as follows: "The
    making of a knowingly false statement in any record or report
    required or requested under subparagraph (A) or (B) of section
    381(d)(3) of this title, the failure to submit or maintain records
    as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this
    title, the release into interstate commerce of any article imported
    into the United States under section 381(d)(3) of this title or any
    finished product made from such article (except for export in
    accordance with section 381(e) or 382 of this title or section
    262(h) of title 42), or the failure to export or destroy any
    component, part or accessory not incorporated into a drug,
    biological product or device that will be exported in accordance
    with section 381(e) or 382 of this title or section 262(h) of title
    42."
      Par. (bb). Pub. L. 107-188, Sec. 303(b), added par. (bb).
      Par. (cc). Pub. L. 107-188, Sec. 304(d), added par. (cc).
      Par. (dd). Pub. L. 107-188, Sec. 305(b), added par. (dd).
      Par. (ee). Pub. L. 107-188, Sec. 307(b), added par. (ee).
      Par. (ff). Pub. L. 107-188, Sec. 321(b)(2), added par. (ff).
      Par. (gg). Pub. L. 107-250 added par. (gg).
      2000 - Par. (aa). Pub. L. 106-387 added par. (aa).
      1997 - Par. (e). Pub. L. 105-115, Sec. 125(b)(2)(B), struck out
    "357(d) or (g)," after "355(i) or (k),".
      Par. (i)(1). Pub. L. 105-115, Sec. 125(a)(2)(C), struck out ",
    356, 357," before "or 379e of this title".
      Par. (j). Pub. L. 105-115, Sec. 125(a)(2)(A), struck out "356,
    357," before "360,".
      Par. (l). Pub. L. 105-115, Sec. 421, struck out par. (l) which
    read as follows: "The using, on the labeling of any drug or device
    or in any advertising relating to such drug or device, of any
    representation or suggestion that approval of an application with
    respect to such drug or device is in effect under section 355,
    360e, or 360j(g) of this title, as the case may be, or that such
    drug or device complies with the provisions of such section."
      Par. (x). Pub. L. 105-115, Sec. 204(b), added par. (x).
      Par. (y). Pub. L. 105-115, Sec. 210(c), added par. (y).
      Par. (z). Pub. L. 105-115, Sec. 401(b), (e), temporarily added
    par. (z). See Effective and Termination Dates of 1997 Amendment
    note below.
      1996 - Par. (e). Pub. L. 104-250 inserted ", 354," before "or 373
    of this title" and "354," before "355(i) or (k)".
      Par. (j). Pub. L. 104-170 inserted before period at end of first
    sentence "; or the violating of section 346a(i)(2) of this title or
    any regulation issued under that section."
      Pars. (u) to (w). Pub. L. 104-134 redesignated par. (u) relating
    to introduction into interstate commerce of unsafe dietary
    supplement as (v) and added par. (w).
      1994 - Par. (e). Pub. L. 103-396, Sec. 2(b)(1)(A), substituted
    "357(d) or (g), 360b(a)(4)(C)," for "357(d) or (g),".
      Par. (u). Pub. L. 103-417 added par. (u) relating to introduction
    into interstate commerce of unsafe dietary supplement.
      Pub. L. 103-396, Sec. 2(b)(1)(B), added par. (u) relating to
    failure to comply with regulations or orders of Secretary.
      1993 - Par. (j). Pub. L. 103-80, Sec. 3(c)(1), substituted "379,
    or 379e" for "379e, or 379".
      Par. (s). Pub. L. 103-80, Sec. 3(c)(2), substituted "350a(e)" for
    "350a(d)".
      1992 - Pars. (i)(1), (j). Pub. L. 102-571 substituted "379e" for
    "376".
      Par. (q)(1)(C). Pub. L. 102-300 added cl. (C).
      1990 - Par. (e). Pub. L. 101-502 substituted "or (k)" for "or
    (j)".
      Par. (j). Pub. L. 101-508 inserted at end "This paragraph does
    not authorize the withholding of information from either House of
    Congress or from, to the extent of matter within its jurisdiction,
    any committee or subcommittee of such committee or any joint
    committee of Congress or any subcommittee of such joint committee."
      1988 - Par. (t). Pub. L. 100-293 added par. (t).
      1986 - Par. (s). Pub. L. 99-570 amended par. (s) generally. Prior
    to amendment, par. (s) read as follows: "The failure to provide the
    notice required by section 350a(b) or 350a(c), the failure to make
    the reports required by section 350a(d)(1)(B), or the failure to
    meet the requirements prescribed under section 350a(d)(2)."
      1980 - Par. (e). Pub. L. 96-359, Sec. 5(b), inserted reference to
    section 350a of this title in two places.
      Par. (j). Pub. L. 96-359, Sec. 5(c), inserted reference to
    section 350a of this title.
      Par. (s). Pub. L. 96-359, Sec. 5(a), added par. (s).
      1976 - Par. (e). Pub. L. 94-295, Sec. 3(b)(2), inserted
    references to sections 360e(f) and 360i of this title.
      Par. (j). Pub. L. 94-295, Sec. 3(b)(3), inserted references to
    sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of
    this title.
      Par. (l). Pub. L. 94-295, Sec. 3(b)(4), substituted "drug or
    device" for "drug" wherever appearing, and inserted references to
    sections 360e and 360j(g) of this title.
      Par. (p). Pub. L. 94-295, Sec. 4(b)(1), substituted "section
    360(j) or 360(k) of this title," for "section 360(j) of this
    title,".
      Par. (q). Pub. L. 94-295, Sec. 3(b)(1), added par. (q).
      Par. (r). Pub. L. 94-295, Sec. 7(b), added par. (r).
      1972 - Par. (p). Pub. L. 92-387 added failure to provide
    information required by section 360(j) of this title, and failure
    to provide notice required by section 360(j)(2) of this title as
    prohibited acts.
      1970 - Par. (q). Pub. L. 91-513 struck out par. (q) which set out
    penalties for illegal manufacture, sale, disposition, possession
    and other traffic in stimulant and depressant drugs. See section
    801 et seq. of this title.
      1968 - Par. (e). Pub. L. 90-399, Sec. 103(1), inserted reference
    to section 360b(j), (l), and (m) of this title.
      Par. (j). Pub. L. 90-399, Sec. 103(2), inserted reference to
    section 360b of this title.
      Par. (q). Pub. L. 90-639 divided cl. (3), which referred simply
    to possession in violation of section 360a(c) of this title, into
    subcls. (A) and (B) which refer, respectively, to possession in
    violation of section 360a(c)(1) of this title and possession in
    violation of section 360a(c)(2) of this title.
      1965 - Par. (i). Pub. L. 89-74, Sec. 9(c), designated existing
    provisions as subpar. (1) and added subpars. (2) and (3).
      Par. (q). Pub. L. 89-74, Sec. 5, added par. (q).
      1962 - Par. (e). Pub. L. 87-781, Secs. 103(c), 106(c), prohibited
    the failure to establish or maintain any record, or make any
    report, required under sections 355(i) or (j) and 507(d) or (g) of
    this title, or the refusal to permit access to, or verification or
    copying of, any such required record.
      Par. (l). Pub. L. 87-781, Sec. 104(e)(1), inserted "approval of"
    before "an application", and substituted "in effect" for
    "effective".
      Par. (o). Pub. L. 87-781, Sec. 114(a), added par. (o).
      Par. (p). Pub. L. 87-781, Sec. 304, added par. (p).
      1960 - Par. (i). Pub. L. 86-618, Sec. 105(a), struck out
    references to sections 346(b), 354, and 364 of this title and
    inserted reference to section 376 of this title.
      Par. (j). Pub. L. 86-618, Sec. 104, inserted reference to section
    376 of this title.
      1958 - Par. (j). Pub. L. 85-929, inserted reference to section
    348 of this title.
      1953 - Par. (n). Act Aug. 7, 1953, added par. (n).
      1950 - Par. (m). Act Mar. 16, 1950, added par. (m).
      1948 - Par. (k). Act June 24, 1948, inserted "(whether or not the
    first sale)" so as to make it clear that this subsection is not
    limited to the case where the act occurs while the article is held
    for the first sale after interstate shipment, and extended coverage
    of subsection to acts which result in adulteration.
      1947 - Par. (j). Act Mar. 10, 1947, inserted reference to
    sections 356 and 357 of this title.
      1945 - Par. (i). Act July 6, 1945, inserted reference to section
    357 of this title.
      1941 - Par. (i). Act Dec. 22, 1941, inserted reference to section
    356 of this title.

                     EFFECTIVE DATE OF 2006 AMENDMENT                 
      Amendment by section 2(c) of Pub. L. 109-462 effective 1 year
    after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109-462, set
    out as a note under section 352 of this title.
      Amendment by section 3(b) of Pub. L. 109-462 effective 1 year
    after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109-462, set
    out as a note under section 343 of this title.
      Pub. L. 109-462, Sec. 4(b), Dec. 22, 2006, 120 Stat. 3475,
    provided that: "The amendment made by this section [amending this
    section] shall take effect 1 year after the date of enactment of
    this Act [Dec. 22, 2006]."

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Pub. L. 109-59, title VII, Sec. 7204, Aug. 10, 2005, 119 Stat.
    1914, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
    of title VII of Pub. L. 109-59, enacting section 350e of this
    title, amending this section, sections 342 and 373 of this title,
    and section 5701 of Title 49, Transportation, omitting sections
    5702 to 5714 of Title 49, and enacting provisions set out as a note
    under section 301 of this title] takes effect on October 1, 2005."

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-188, title III, Sec. 321(c), June 12, 2002, 116 Stat.
    676, provided that: "The amendments made by this section [amending
    this section and sections 360 and 381 of this title] take effect
    upon the expiration of the 180-day period beginning on the date of
    the enactment of this Act [June 12, 2002]."
      Pub. L. 107-188, title III, Sec. 322(c), June 12, 2002, 116 Stat.
    678, provided that: "The amendments made by this section [amending
    this section and section 381 of this title] take effect upon the
    expiration of the 90-day period beginning on the date of the
    enactment of this Act [June 12, 2002]."

             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT         
      Amendment by sections 204, 210, and 421 of Pub. L. 105-115
    effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.
      Amendment by section 401(b) of Pub. L. 105-115 effective 1 year
    after Nov. 21, 1997, or upon Secretary's issuance of final
    regulations pursuant to section 401(c) of Pub. L. 105-115,
    whichever is sooner, and ceases to be effective Sept. 30, 2006, or
    7 years after date Secretary promulgates regulations under section
    401(c) of Pub. L. 105-115, whichever is later, see section 401(d),
    (e) of Pub. L. 105-115, set out as an Effective and Termination
    Dates note under section 360aaa of this title.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Amendment by Pub. L. 103-396 effective upon adoption of final
    regulations under section 2(c) of Pub. L. 103-396, set out as a
    Regulations note under section 360b of this title, see section 2(d)
    of Pub. L. 103-396, set out as a note under section 360b of this
    title.

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 4755(c)(2) of Pub. L. 101-508 provided that the amendment
    made by that section is effective as if included in subtitle D of
    title VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L.
    101-239, title VI, Secs. 6601, 6602, Dec. 19, 1989, 103 Stat. 2285,
    see 42 U.S.C. 300aa-1 note, 300aa-10 note.

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-293 effective upon expiration of 90 days
    after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
    as a note under section 353 of this title.

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Amendment by Pub. L. 92-387 effective on first day of sixth month
    beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
    out as a note under section 360 of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENTS                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.
      Amendment by Pub. L. 90-639 applicable only with respect to
    violations of this chapter committed after Oct. 24, 1968, see
    section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
    Amendments; Transitional Provisions note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
    of Pub. L. 89-74, set out as a note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by sections 103(c) and 106(c) of Pub. L. 87-781
    effective on first day of seventh calendar month following Oct.
    1962, and amendment by section 104(e)(1) of Pub. L. 87-781
    effective Oct. 10, 1962, see section 107 of Pub. L. 87-781, set out
    as a note under section 321 of this title.
      Section 114(b) of Pub. L. 87-781 provided that: "This section
    [amending this section] shall take effect on the first day of the
    seventh calendar month following the month in which this Act is
    enacted [October 1962]."

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                     EFFECTIVE DATE OF 1958 AMENDMENT                 
      Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
    6(a) of Pub. L. 85-929, set out as a note under section 342 of this
    title.

                     EFFECTIVE DATE OF 1950 AMENDMENT                 
      Amendment by act Mar. 16, 1950, effective July 1, 1950, see
    section 7 of that act, set out as an Effective Date note under
    section 347 of this title.

                                REGULATIONS                            
      Secretary of Health and Human Services to promulgate regulations
    to implement amendments made by section 401 of Pub. L. 105-115 not
    later than 1 year after Nov. 21, 1997, see section 401(c) of Pub.
    L. 105-115, set out as a note under section 360aaa of this title.

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
    to be continued and brought to final determination in accord with
    laws and regulations in effect prior to Oct. 27, 1970, see section
    702 of Pub. L. 91-513, set out as a note under section 321 of this
    title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188           
      Pub. L. 107-188, title III, Sec. 315, June 12, 2002, 116 Stat.
    675, provided that: "Nothing in this title [enacting sections 350c,
    350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319,
    and 8320 of Title 7, Agriculture, and section 247b-20 of Title 42,
    The Public Health and Welfare, amending this section, sections 334,
    335a, 342, 343, 360, 372, 374, and 381 of this title, and section
    43 of Title 18, Crimes and Criminal Procedure, and enacting
    provisions set out as notes under this section and sections 341,
    350c, 350d, and 381 of this title], or an amendment made by this
    title, shall be construed to alter the jurisdiction between the
    Secretaries of Agriculture and of Health and Human Services, under
    applicable statutes and regulations."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-FOOTNOTE-
    (!1) So in original.


-End-



-CITE-
    21 USC Sec. 332                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 332. Injunction proceedings

-STATUTE-
    (a) Jurisdiction of courts
      The district courts of the United States and the United States
    courts of the Territories shall have jurisdiction, for cause shown
    (!1) to restrain violations of section 331 of this title, except
    paragraphs (h), (i), and (j).

    (b) Violation of injunction
      In case of violation of an injunction or restraining order issued
    under this section, which also constitutes a violation of this
    chapter, trial shall be by the court, or, upon demand of the
    accused, by a jury.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 302, 52 Stat. 1043; Pub. L. 87-781,
    title I, Sec. 103(d), title II, Sec. 201(c), Oct. 10, 1962, 76
    Stat. 784, 793; Pub. L. 103-80, Sec. 3(d), Aug. 13, 1993, 107 Stat.
    775.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(d)(1), struck out ",
    and subject to the provisions of section 17 (relating to notice to
    opposite party) of the Act entitled 'An Act to supplement existing
    laws against unlawful restraints and monopolies, and for other
    purposes', approved October 15, 1914, as amended (U.S.C., 1934 ed.,
    title 28, sec. 381)," after "for cause shown".
      Subsec. (b). Pub. L. 103-80, Sec. 3(d)(2), struck out at end
    "Such trial shall be conducted in accordance with the practice and
    procedure applicable in the case of proceedings subject to the
    provisions of section 22 of such Act of October 15, 1914, as
    amended (U.S.C., 1934 ed., title 28, sec. 387)."
      1962 - Subsec. (a). Pub. L. 87-781, Sec. 103(d), struck out
    "(e)," after "paragraphs".
      Pub. L. 87-781, Sec. 201(c), struck out "(f)," after
    "paragraphs".

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by section 103(c) of Pub. L. 87-781 effective on first
    day of seventh calendar month following October 1962, see section
    107 of Pub. L. 87-781, set out as a note under section 321 of this
    title.
      Section 203 of title II of Pub. L. 87-781 provided that: "The
    amendments made by this title [amending this section and section
    374 of this title and enacting provisions set out as notes under
    sections 321 and 374 of this title] shall take effect on the date
    of enactment of this Act [Oct. 10, 1962]."

-FOOTNOTE-
    (!1) So in original. Probably should be followed by a comma.


-End-



-CITE-
    21 USC Sec. 333                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 333. Penalties

-STATUTE-
    (a) Violation of section 331 of this title; second violation;
      intent to defraud or mislead
      (1) Any person who violates a provision of section 331 of this
    title shall be imprisoned for not more than one year or fined not
    more than $1,000, or both.
      (2) Notwithstanding the provisions of paragraph (1) of this
    section,(!1) if any person commits such a violation after a
    conviction of him under this section has become final, or commits
    such a violation with the intent to defraud or mislead, such person
    shall be imprisoned for not more than three years or fined not more
    than $10,000, or both.

    (b) Prescription drug marketing violations
      (1) Notwithstanding subsection (a) of this section, any person
    who violates section 331(t) of this title by - 
        (A) knowingly importing a drug in violation of section
      381(d)(1) of this title,
        (B) knowingly selling, purchasing, or trading a drug or drug
      sample or knowingly offering to sell, purchase, or trade a drug
      or drug sample, in violation of section 353(c)(1) of this title,
        (C) knowingly selling, purchasing, or trading a coupon,
      knowingly offering to sell, purchase, or trade such a coupon, or
      knowingly counterfeiting such a coupon, in violation of section
      353(c)(2) of this title, or
        (D) knowingly distributing drugs in violation of section
      353(e)(2)(A) of this title,

    shall be imprisoned for not more than 10 years or fined not more
    than $250,000, or both.
      (2) Any manufacturer or distributor who distributes drug samples
    by means other than the mail or common carrier whose
    representative, during the course of the representative's
    employment or association with that manufacturer or distributor,
    violated section 331(t) of this title because of a violation of
    section 353(c)(1) of this title or violated any State law
    prohibiting the sale, purchase, or trade of a drug sample subject
    to section 353(b) of this title or the offer to sell, purchase, or
    trade such a drug sample shall, upon conviction of the
    representative for such violation, be subject to the following
    civil penalties:
        (A) A civil penalty of not more than $50,000 for each of the
      first two such violations resulting in a conviction of any
      representative of the manufacturer or distributor in any 10-year
      period.
        (B) A civil penalty of not more than $1,000,000 for each
      violation resulting in a conviction of any representative after
      the second conviction in any 10-year period.

    For the purposes of this paragraph, multiple convictions of one or
    more persons arising out of the same event or transaction, or a
    related series of events or transactions, shall be considered as
    one violation.
      (3) Any manufacturer or distributor who violates section 331(t)
    of this title because of a failure to make a report required by
    section 353(d)(3)(E) of this title shall be subject to a civil
    penalty of not more than $100,000.
      (4)(A) If a manufacturer or distributor or any representative of
    such manufacturer or distributor provides information leading to
    the institution of a criminal proceeding against, and conviction
    of, any representative of that manufacturer or distributor for a
    violation of section 331(t) of this title because of a sale,
    purchase, or trade or offer to purchase, sell, or trade a drug
    sample in violation of section 353(c)(1) of this title or for a
    violation of State law prohibiting the sale, purchase, or trade or
    offer to sell, purchase, or trade a drug sample, the conviction of
    such representative shall not be considered as a violation for
    purposes of paragraph (2).
      (B) If, in an action brought under paragraph (2) against a
    manufacturer or distributor relating to the conviction of a
    representative of such manufacturer or distributor for the sale,
    purchase, or trade of a drug or the offer to sell, purchase, or
    trade a drug, it is shown, by clear and convincing evidence - 
        (i) that the manufacturer or distributor conducted, before the
      institution of a criminal proceeding against such representative
      for the violation which resulted in such conviction, an
      investigation of events or transactions which would have led to
      the reporting of information leading to the institution of a
      criminal proceeding against, and conviction of, such
      representative for such purchase, sale, or trade or offer to
      purchase, sell, or trade, or
        (ii) that, except in the case of the conviction of a
      representative employed in a supervisory function, despite
      diligent implementation by the manufacturer or distributor of an
      independent audit and security system designed to detect such a
      violation, the manufacturer or distributor could not reasonably
      have been expected to have detected such violation,

    the conviction of such representative shall not be considered as a
    conviction for purposes of paragraph (2).
      (5) If a person provides information leading to the institution
    of a criminal proceeding against, and conviction of, a person for a
    violation of section 331(t) of this title because of the sale,
    purchase, or trade of a drug sample or the offer to sell, purchase,
    or trade a drug sample in violation of section 353(c)(1) of this
    title, such person shall be entitled to one-half of the criminal
    fine imposed and collected for such violation but not more than
    $125,000.
      (6) Notwithstanding subsection (a) of this section, any person
    who is a manufacturer or importer of a prescription drug under
    section 384(b) of this title and knowingly fails to comply with a
    requirement of section 384(e) of this title that is applicable to
    such manufacturer or importer, respectively, shall be imprisoned
    for not more than 10 years or fined not more than $250,000, or
    both.
    (c) Exceptions in certain cases of good faith, etc.
      No person shall be subject to the penalties of subsection (a)(1)
    of this section, (1) for having received in interstate commerce any
    article and delivered it or proffered delivery of it, if such
    delivery or proffer was made in good faith, unless he refuses to
    furnish on request of an officer or employee duly designated by the
    Secretary the name and address of the person from whom he purchased
    or received such article and copies of all documents, if any there
    be, pertaining to the delivery of the article to him; or (2) for
    having violated section 331(a) or (d) of this title, if he
    establishes a guaranty or undertaking signed by, and containing the
    name and address of, the person residing in the United States from
    whom he received in good faith the article, to the effect, in case
    of an alleged violation of section 331(a) of this title, that such
    article is not adulterated or misbranded, within the meaning of
    this chapter designating this chapter or to the effect, in case of
    an alleged violation of section 331(d) of this title, that such
    article is not an article which may not, under the provisions of
    section 344 or 355 of this title, be introduced into interstate
    commerce; or (3) for having violated section 331(a) of this title,
    where the violation exists because the article is adulterated by
    reason of containing a color additive not from a batch certified in
    accordance with regulations promulgated by the Secretary under this
    chapter, if such person establishes a guaranty or undertaking
    signed by, and containing the name and address of, the manufacturer
    of the color additive, to the effect that such color additive was
    from a batch certified in accordance with the applicable
    regulations promulgated by the Secretary under this chapter; or (4)
    for having violated section 331(b), (c) or (k) of this title by
    failure to comply with section 352(f) of this title in respect to
    an article received in interstate commerce to which neither section
    353(a) nor 353(b)(1) of this title is applicable, if the delivery
    or proffered delivery was made in good faith and the labeling at
    the time thereof contained the same directions for use and warning
    statements as were contained in the labeling at the time of such
    receipt of such article; or (5) for having violated section
    331(i)(2) of this title if such person acted in good faith and had
    no reason to believe that use of the punch, die, plate, stone, or
    other thing involved would result in a drug being a counterfeit
    drug, or for having violated section 331(i)(3) of this title if the
    person doing the act or causing it to be done acted in good faith
    and had no reason to believe that the drug was a counterfeit drug.
    (d) Exceptions involving misbranded food
      No person shall be subject to the penalties of subsection (a)(1)
    of this section for a violation of section 331 of this title
    involving misbranded food if the violation exists solely because
    the food is misbranded under section 343(a)(2) of this title
    because of its advertising.
    (e) Prohibited distribution of human growth hormone
      (1) Except as provided in paragraph (2), whoever knowingly
    distributes, or possesses with intent to distribute, human growth
    hormone for any use in humans other than the treatment of a disease
    or other recognized medical condition, where such use has been
    authorized by the Secretary of Health and Human Services under
    section 355 of this title and pursuant to the order of a physician,
    is guilty of an offense punishable by not more than 5 years in
    prison, such fines as are authorized by title 18, or both.
      (2) Whoever commits any offense set forth in paragraph (1) and
    such offense involves an individual under 18 years of age is
    punishable by not more than 10 years imprisonment, such fines as
    are authorized by title 18, or both.
      (3) Any conviction for a violation of paragraphs (1) and (2) of
    this subsection shall be considered a felony violation of the
    Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes
    of forfeiture under section 413 of such Act [21 U.S.C. 853].
      (4) As used in this subsection the term "human growth hormone"
    means somatrem, somatropin, or an analogue of either of them.
      (5) The Drug Enforcement Administration is authorized to
    investigate offenses punishable by this subsection.
    (f) Redesignated (g)
    (g) Violations related to devices
      (1)(A) Except as provided in subparagraph (B), any person who
    violates a requirement of this chapter which relates to devices
    shall be liable to the United States for a civil penalty in an
    amount not to exceed $15,000 for each such violation, and not to
    exceed $1,000,000 for all such violations adjudicated in a single
    proceeding. For purposes of the preceding sentence, a person
    accredited under paragraph (2) of section 374(g) of this title who
    is substantially not in compliance with the standards of
    accreditation under such section, or who poses a threat to public
    health or fails to act in a manner that is consistent with the
    purposes of such section, shall be considered to have violated a
    requirement of this chapter that relates to devices.
      (B) Subparagraph (A) shall not apply - 
        (i) to any person who violates the requirements of section
      360i(a) or 360j(f) of this title unless such violation
      constitutes (I) a significant or knowing departure from such
      requirements, or (II) a risk to public health,
        (ii) to any person who commits minor violations of section
      360i(e) or 360i(f) of this title (only with respect to correction
      reports) if such person demonstrates substantial compliance with
      such section, or
        (iii) to violations of section 351(a)(2)(A) of this title which
      involve one or more devices which are not defective.

      (2)(A) Any person who introduces into interstate commerce or
    delivers for introduction into interstate commerce an article of
    food that is adulterated within the meaning of section 342(a)(2)(B)
    of this title shall be subject to a civil money penalty of not more
    than $50,000 in the case of an individual and $250,000 in the case
    of any other person for such introduction or delivery, not to
    exceed $500,000 for all such violations adjudicated in a single
    proceeding.
      (B) This paragraph shall not apply to any person who grew the
    article of food that is adulterated. If the Secretary assesses a
    civil penalty against any person under this paragraph, the
    Secretary may not use the criminal authorities under this section
    to sanction such person for the introduction or delivery for
    introduction into interstate commerce of the article of food that
    is adulterated. If the Secretary assesses a civil penalty against
    any person under this paragraph, the Secretary may not use the
    seizure authorities of section 334 of this title or the injunction
    authorities of section 332 of this title with respect to the
    article of food that is adulterated.
      (C) In a hearing to assess a civil penalty under this paragraph,
    the presiding officer shall have the same authority with regard to
    compelling testimony or production of documents as a presiding
    officer has under section 346a(g)(2)(B) of this title. The third
    sentence of paragraph (3)(A) shall not apply to any investigation
    under this paragraph.
      (3)(A) A civil penalty under paragraph (1) or (2) shall be
    assessed by the Secretary by an order made on the record after
    opportunity for a hearing provided in accordance with this
    subparagraph and section 554 of title 5. Before issuing such an
    order, the Secretary shall give written notice to the person to be
    assessed a civil penalty under such order of the Secretary's
    proposal to issue such order and provide such person an opportunity
    for a hearing on the order. In the course of any investigation, the
    Secretary may issue subpoenas requiring the attendance and
    testimony of witnesses and the production of evidence that relates
    to the matter under investigation.
      (B) In determining the amount of a civil penalty, the Secretary
    shall take into account the nature, circumstances, extent, and
    gravity of the violation or violations and, with respect to the
    violator, ability to pay, effect on ability to continue to do
    business, any history of prior such violations, the degree of
    culpability, and such other matters as justice may require.
      (C) The Secretary may compromise, modify, or remit, with or
    without conditions, any civil penalty which may be assessed under
    paragraph (1) or (2). The amount of such penalty, when finally
    determined, or the amount agreed upon in compromise, may be
    deducted from any sums owing by the United States to the person
    charged.
      (4) Any person who requested, in accordance with paragraph
    (3)(A), a hearing respecting the assessment of a civil penalty and
    who is aggrieved by an order assessing a civil penalty may file a
    petition for judicial review of such order with the United States
    Court of Appeals for the District of Columbia Circuit or for any
    other circuit in which such person resides or transacts business.
    Such a petition may only be filed within the 60-day period
    beginning on the date the order making such assessment was issued.
      (5) If any person fails to pay an assessment of a civil penalty -
    
        (A) after the order making the assessment becomes final, and if
      such person does not file a petition for judicial review of the
      order in accordance with paragraph (4), or
        (B) after a court in an action brought under paragraph (4) has
      entered a final judgment in favor of the Secretary,

    the Attorney General shall recover the amount assessed (plus
    interest at currently prevailing rates from the date of the
    expiration of the 60-day period referred to in paragraph (4) or the
    date of such final judgment, as the case may be) in an action
    brought in any appropriate district court of the United States. In
    such an action, the validity, amount, and appropriateness of such
    penalty shall not be subject to review.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 303, 52 Stat. 1043; Oct. 26, 1951,
    ch. 578, Sec. 2, 65 Stat. 649; Pub. L. 86-618, title I, Sec.
    105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89-74, Secs. 7, 9(d),
    July 15, 1965, 79 Stat. 233, 235; Pub. L. 90-639, Sec. 3, Oct. 24,
    1968, 82 Stat. 1361; Pub. L. 91-513, title II, Sec. 701(b), Oct.
    27, 1970, 84 Stat. 1281; Pub. L. 94-278, title V, Sec.
    502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100-293, Sec.
    7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100-690, title II, Sec.
    2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101-629, Sec. 17(a),
    Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101-647, title XIX, Sec.
    1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102-353, Sec. 3, Aug.
    26, 1992, 106 Stat. 941; Pub. L. 103-80, Sec. 3(e), Aug. 13, 1993,
    107 Stat. 775; Pub. L. 103-322, title XXXIII, Sec. 330015, Sept.
    13, 1994, 108 Stat. 2146; Pub. L. 104-170, title IV, Sec. 407, Aug.
    3, 1996, 110 Stat. 1535; Pub. L. 106-387, Sec. 1(a) [title VII,
    Sec. 745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40; Pub. L.
    107-250, title II, Sec. 201(c), Oct. 26, 2002, 116 Stat. 1609; Pub.
    L. 108-173, title XI, Sec. 1121(b)(2), Dec. 8, 2003, 117 Stat.
    2469.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Controlled Substances Act, referred to in subsec. (e)(3), is
    title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as
    amended, which is classified principally to subchapter I (Sec. 801
    et seq.) of chapter 13 of this title. For complete classification
    of this Act to the Code, see Short Title note set out under section
    801 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (b)(6). Pub. L. 108-173, which directed amendment
    of subsec. (a)(6) by substituting "prescription drug under section
    384(b)" for "covered product pursuant to section 384(a)", was
    executed by making the substitution in subsec. (b)(6), to reflect
    the probable intent of Congress.
      2002 - Subsec. (g)(1)(A). Pub. L. 107-250 inserted at end "For
    purposes of the preceding sentence, a person accredited under
    paragraph (2) of section 374(g) of this title who is substantially
    not in compliance with the standards of accreditation under such
    section, or who poses a threat to public health or fails to act in
    a manner that is consistent with the purposes of such section,
    shall be considered to have violated a requirement of this chapter
    that relates to devices."
      2000 - Subsec. (b)(6). Pub. L. 106-387 added par. (6).
      1996 - Subsec. (g)(2). Pub. L. 104-170, Sec. 407(1), (2), added
    par. (2). Former par. (2) redesignated (3).
      Subsec. (g)(3). Pub. L. 104-170, Sec. 407(1), (3), redesignated
    par. (2) as (3) and substituted "paragraph (1) or (2)" for
    "paragraph (1)" in subpars. (A) and (C). Former par. (3)
    redesignated (4).
      Subsec. (g)(4). Pub. L. 104-170, Sec. 407(1), (4), redesignated
    par. (3) as (4) and substituted "paragraph (3)(A)" for "paragraph
    (2)(A)". Former par. (4) redesignated (5).
      Subsec. (g)(5). Pub. L. 104-170, Sec. 407(1), (5), redesignated
    par. (4) as (5) and substituted "paragraph (4)" for "paragraph (3)"
    wherever appearing.
      1994 - Subsec. (e). Pub. L. 103-322 amended directory language of
    Pub. L. 101-647. See 1990 Amendment note below.
      1993 - Subsecs. (e) to (g). Pub. L. 103-80, which directed the
    amendment of this section by redesignating the second subsec. (e)
    and subsec. (f) as subsecs. (f) and (g), respectively, could only
    be executed by designating subsec. (f) as (g) because this section
    did not contain a second subsec. (e) subsequent to amendment of
    Pub. L. 101-647 by Pub. L. 103-322. See 1990 and 1994 amendment
    notes for subsec. (e) under this section.
      1992 - Subsec. (b)(1). Pub. L. 102-353, Sec. 3(a), amended par.
    (1) generally. Prior to amendment, par. (1) read as follows:
    "Notwithstanding subsection (a) of this section, any person who
    violates section 331(t) of this title because of an importation of
    a drug in violation of section 381(d)(1) of this title, because of
    a sale, purchase, or trade of a drug or drug sample or the offer to
    sell, purchase, or trade a drug or drug sample in violation of
    section 353(c) of this title, because of the sale, purchase, or
    trade of a coupon, the offer to sell, purchase, or trade such a
    coupon, or the counterfeiting of such a coupon in violation of
    section 353(c)(2) of this title, or the distribution of drugs in
    violation of section 353(e)(2)(A) of this title shall be imprisoned
    for not more than 10 years or fined not more than $250,000, or
    both."
      Subsec. (b)(4)(A). Pub. L. 102-353, Sec. 3(b)(1), substituted
    "the institution of a criminal proceeding against, and conviction
    of," for "the arrest and conviction of".
      Subsec. (b)(4)(B)(i). Pub. L. 102-353, Sec. 3(b)(1), (2),
    substituted "before the institution of a criminal proceeding
    against" for "before the arrest of" and "the institution of a
    criminal proceeding against, and conviction of," for "the arrest
    and conviction of".
      Subsec. (b)(5). Pub. L. 102-353, Sec. 3(b)(3), substituted "the
    institution of a criminal proceeding against, and conviction of,"
    for "the arrest and conviction of".
      Subsec. (c). Pub. L. 102-353, Sec. 3(b)(4), substituted
    "subsection (a)(1) of this section" for "subsection (a) of this
    section".
      Subsec. (d). Pub. L. 102-353, Sec. 3(b)(4), (5), substituted
    "subsection (a)(1) of this section" for "subsection (a) of this
    section" and struck out ", and no person shall be subject to the
    penalties of subsection (b) of this section for such a violation
    unless the violation is committed with the intent to defraud or
    mislead" after "advertising".
      1990 - Subsec. (e). Pub. L. 101-647, as amended by Pub. L. 103-
    322, amended subsec. (e) generally. Prior to amendment, subsec.
    (e) read as follows:
      "(e)(1) Except as provided in paragraph (2), any person who
    distributes or possesses with the intent to distribute any anabolic
    steroid for any use in humans other than the treatment of disease
    pursuant to the order of a physician shall be imprisoned for not
    more than three years or fined under title 18, or both.
      "(2) Any person who distributes or possesses with the intent to
    distribute to an individual under 18 years of age, any anabolic
    steroid for any use in humans other than the treatment of disease
    pursuant to the order of a physician shall be imprisoned for not
    more than six years or fined under title 18, or both."
      Subsec. (f). Pub. L. 101-629 added subsec. (f).
      1988 - Subsecs. (a), (b). Pub. L. 100-293 designated existing
    subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a),
    substituted "paragraph (1)" for "subsection (a)" in par. (2), and
    added subsec. (b).
      Subsec. (e). Pub. L. 100-690 added subsec. (e).
      1976 - Subsec. (d). Pub. L. 94-278 added subsec. (d).
      1970 - Subsec. (a). Pub. L. 91-513 struck out reference to
    subsec. (b) and transferred to subsec. (b) provisions covering
    second offenses and offenses committed with intent to defraud or
    mislead.
      Subsec. (b). Pub. L. 91-513 inserted provisions covering second
    offenses and offenses committed with intent to defraud or mislead
    formerly set out in subsec. (a) and struck out provisions covering
    violations involving depressant and stimulant drugs. See section
    801 et seq. of this title.
      1968 - Subsecs. (a), (b). Pub. L. 90-639 made a general revision
    in the penalties prescribed for offenses involving depressant or
    stimulant drugs, set a fine of not to exceed $10,000 or
    imprisonment of not more than 5 years for offenses involving the
    unlawful manufacturing of, sale, or disposal of, or possession with
    intent to sell, a depressant or stimulant drug or involving
    counterfeit depressant or stimulant drugs, stiffened the penalties
    for unlawful sales or other disposals by persons over 18 to persons
    under 21, and set new penalties for possession of a depressant or
    stimulant drug for purposes other than sale or other disposal.
      1965 - Subsec. (a). Pub. L. 89-74, Sec. 7(a), inserted proviso
    limiting the penalties for depressant or stimulant drug violations
    to two years imprisonment or $5,000 fine or both for first offense
    and to two years imprisonment or $15,000 fine or both for
    subsequent offenses.
      Subsec. (b). Pub. L. 89-74, Sec. 7(b), inserted parenthetical
    exception provision.
      Subsec. (c)(5). Pub. L. 89-74, Sec. 9(d), added cl. (5).
      1960 - Subsec. (c)(3). Pub. L. 86-618 substituted "a color
    additive" for "a coal-tar color", "the color additive" for "the
    coal-tar color" and "such color additive was" for "such color was".
      1951 - Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Section 330015 of Pub. L. 103-322 provided that the amendment
    made by that section is effective as of the date on which section
    1904 of Pub. L. 101-647, which amended this section, took effect.

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 17(b) of Pub. L. 101-629 provided that:
      "(b) Effective Date of Application to Device User Facilities. - 
        "(1) The Secretary of Health and Human Services shall conduct a
      study to determine whether there has been substantial compliance
      with the requirements of section 519(b) of the Federal Food,
      Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user
      facilities (as defined in section 519(b)(5)(A) of such Act). The
      Secretary shall report the results of the study to the Congress
      after the expiration of 45 months after the date of the enactment
      of this Act [Nov. 28, 1990].
        "(2)(A) If upon the expiration of 48 months after the date of
      the enactment of this Act [Nov. 28, 1990] the Secretary has not
      made the report required by paragraph (1), section 303(f) of the
      Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added
      by the amendment made by subsection (a), shall take effect with
      respect to device user facilities (as defined in section
      519(b)(5)(A) of such Act). [Secretary of Health and Human
      Services had not made the report required by par. (1) on the
      expiration of 48 months after Nov. 28, 1990.]
        "(B) If in the report under paragraph (1) the Secretary reports
      that there has been substantial compliance with the requirements
      of such section 519(b) by a type of device user facility and if
      the Secretary does not make a determination under subparagraph
      (C) with respect to such type of facility, such section 303(f)
      shall not take effect with respect to such type of facility.
        "(C) If the Secretary determines in the report under paragraph
      (1) that there is not substantial compliance with the
      requirements of such section 519(b) by a type of device user
      facility or if the Secretary makes such a determination after
      making the report under paragraph (1), such section 303(f) shall
      take effect with respect to such type of facility upon the
      effective date of the report."

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-293 effective upon expiration of 90 days
    after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
    as a note under section 353 of this title.

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
    1976, see section 502(c) of Pub. L. 94-278, set out as a note under
    section 334 of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-639 applicable only with respect to
    violations of this chapter committed after Oct. 24, 1968, see
    section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
    Amendments; Transitional Provisions note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
    of Pub. L. 89-74, set out as a note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                     EFFECTIVE DATE OF 1951 AMENDMENT                 
      Section 3 of act Oct. 26, 1951, provided that: "The provisions of
    this Act [amending this section and section 353 of this title]
    shall take effect six months after the date of its enactment [Oct.
    26, 1951]."

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
    to be continued and brought to final determination in accord with
    laws and regulations in effect prior to Oct. 27, 1970, see section
    702 of Pub. L. 91-513, set out as a note under section 321 of this
    title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
                                ENFORCEMENT                            
      Pub. L. 99-660, title I, Sec. 103, Nov. 14, 1986, 100 Stat. 3751,
    provided that: "For the fines authorized to be imposed under
    section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    333], see section 3623 of title 18, United States Code, for the
    period ending October 31, 1986 [probably should be October 31,
    1987], and sections 3559 and 3571 of such title for the period
    beginning November 1, 1986 [probably should be November 1, 1987]."

-FOOTNOTE-
    (!1) So in original. Words "of this section" probably should not
         appear.


-End-



-CITE-
    21 USC Sec. 333a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 333a. Repealed.

-MISC1-
    Sec. 333a. Repealed. Pub. L. 101-647, title XIX, Sec. 1905, Nov.
      29, 1990, 104 Stat. 4853.
      Section, Pub. L. 100-690, title II, Sec. 2401, Nov. 18, 1988, 102
    Stat. 4230, related to forfeiture and illegal trafficking in
    steroids or human growth hormones.

-End-



-CITE-
    21 USC Sec. 334                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 334. Seizure

-STATUTE-
    (a) Grounds and jurisdiction
      (1) Any article of food, drug, or cosmetic that is adulterated or
    misbranded when introduced into or while in interstate commerce or
    while held for sale (whether or not the first sale) after shipment
    in interstate commerce, or which may not, under the provisions of
    section 344 or 355 of this title, be introduced into interstate
    commerce, shall be liable to be proceeded against while in
    interstate commerce, or at any time thereafter, on libel of
    information and condemned in any district court of the United
    States or United States court of a Territory within the
    jurisdiction of which the article is found. No libel for
    condemnation shall be instituted under this chapter, for any
    alleged misbranding if there is pending in any court a libel for
    condemnation proceeding under this chapter based upon the same
    alleged misbranding, and not more than one such proceeding shall be
    instituted if no such proceeding is so pending, except that such
    limitations shall not apply (A) when such misbranding has been the
    basis of a prior judgment in favor of the United States, in a
    criminal, injunction, or libel for condemnation proceeding under
    this chapter, or (B) when the Secretary has probable cause to
    believe from facts found, without hearing, by him or any officer or
    employee of the Department that the misbranded article is dangerous
    to health, or that the labeling of the misbranded article is
    fraudulent, or would be in a material respect misleading to the
    injury or damage of the purchaser or consumer. In any case where
    the number of libel for condemnation proceedings is limited as
    above provided the proceeding pending or instituted shall, on
    application of the claimant, seasonably made, be removed for trial
    to any district agreed upon by stipulation between the parties, or,
    in case of failure to so stipulate within a reasonable time, the
    claimant may apply to the court of the district in which the
    seizure has been made, and such court (after giving the United
    States attorney for such district reasonable notice and opportunity
    to be heard) shall by order, unless good cause to the contrary is
    shown, specify a district of reasonable proximity to the claimant's
    principal place of business, to which the case shall be removed for
    trial.
      (2) The following shall be liable to be proceeded against at any
    time on libel of information and condemned in any district court of
    the United States or United States court of a Territory within the
    jurisdiction of which they are found: (A) Any drug that is a
    counterfeit drug, (B) Any container of a counterfeit drug, (C) Any
    punch, die, plate, stone, labeling, container, or other thing used
    or designed for use in making a counterfeit drug or drugs, and (D)
    Any adulterated or misbranded device.
      (3)(A) Except as provided in subparagraph (B), no libel for
    condemnation may be instituted under paragraph (1) or (2) against
    any food which - 
        (i) is misbranded under section 343(a)(2) of this title because
      of its advertising, and
        (ii) is being held for sale to the ultimate consumer in an
      establishment other than an establishment owned or operated by a
      manufacturer, packer, or distributor of the food.

      (B) A libel for condemnation may be instituted under paragraph
    (1) or (2) against a food described in subparagraph (A) if - 
        (i)(I) the food's advertising which resulted in the food being
      misbranded under section 343(a)(2) of this title was disseminated
      in the establishment in which the food is being held for sale to
      the ultimate consumer,
        (II) such advertising was disseminated by, or under the
      direction of, the owner or operator of such establishment, or
        (III) all or part of the cost of such advertising was paid by
      such owner or operator; and
        (ii) the owner or operator of such establishment used such
      advertising in the establishment to promote the sale of the food.
    (b) Procedure; multiplicity of pending proceedings
      The article, equipment, or other thing proceeded against shall be
    liable to seizure by process pursuant to the libel, and the
    procedure in cases under this section shall conform, as nearly as
    may be, to the procedure in admiralty; except that on demand of
    either party any issue of fact joined in any such case shall be
    tried by jury. When libel for condemnation proceedings under this
    section, involving the same claimant and the same issues of
    adulteration or misbranding, are pending in two or more
    jurisdictions, such pending proceedings, upon application of the
    claimant seasonably made to the court of one such jurisdiction,
    shall be consolidated for trial by order of such court, and tried
    in (1) any district selected by the claimant where one of such
    proceedings is pending; or (2) a district agreed upon by
    stipulation between the parties. If no order for consolidation is
    so made within a reasonable time, the claimant may apply to the
    court of one such jurisdiction and such court (after giving the
    United States attorney for such district reasonable notice and
    opportunity to be heard) shall by order, unless good cause to the
    contrary is shown, specify a district of reasonable proximity to
    the claimant's principal place of business, in which all such
    pending proceedings shall be consolidated for trial and tried. Such
    order of consolidation shall not apply so as to require the removal
    of any case the date for trial of which has been fixed. The court
    granting such order shall give prompt notification thereof to the
    other courts having jurisdiction of the cases covered thereby.
    (c) Availability of samples of seized goods prior to trial
      The court at any time after seizure up to a reasonable time
    before trial shall by order allow any party to a condemnation
    proceeding, his attorney or agent, to obtain a representative
    sample of the article seized and a true copy of the analysis, if
    any, on which the proceeding is based and the identifying marks or
    numbers, if any, of the packages from which the samples analyzed
    were obtained.
    (d) Disposition of goods after decree of condemnation; claims for
      remission or mitigation of forfeitures
      (1) Any food, drug, device, or cosmetic condemned under this
    section shall, after entry of the decree, be disposed of by
    destruction or sale as the court may, in accordance with the
    provisions of this section, direct and the proceeds thereof, if
    sold, less the legal costs and charges, shall be paid into the
    Treasury of the United States; but such article shall not be sold
    under such decree contrary to the provisions of this chapter or the
    laws of the jurisdiction in which sold. After entry of the decree
    and upon the payment of the costs of such proceedings and the
    execution of a good and sufficient bond conditioned that such
    article shall not be sold or disposed of contrary to the provisions
    of this chapter or the laws of any State or Territory in which
    sold, the court may by order direct that such article be delivered
    to the owner thereof to be destroyed or brought into compliance
    with the provisions of this chapter, under the supervision of an
    officer or employee duly designated by the Secretary, and the
    expenses of such supervision shall be paid by the person obtaining
    release of the article under bond. If the article was imported into
    the United States and the person seeking its release establishes
    (A) that the adulteration, misbranding, or violation did not occur
    after the article was imported, and (B) that he had no cause for
    believing that it was adulterated, misbranded, or in violation
    before it was released from customs custody, the court may permit
    the article to be delivered to the owner for exportation in lieu of
    destruction upon a showing by the owner that all of the conditions
    of section 381(e) of this title can and will be met. The provisions
    of this sentence shall not apply where condemnation is based upon
    violation of section 342(a)(1), (2), or (6), section 351(a)(3),
    section 352(j), or section 361(a) or (d) of this title. Where such
    exportation is made to the original foreign supplier, then
    subparagraphs (A) and (B) of section 381(e)(1) of this title and
    the preceding sentence shall not be applicable; and in all cases of
    exportation the bond shall be conditioned that the article shall
    not be sold or disposed of until the applicable conditions of
    section 381(e) of this title have been met. Any person seeking to
    export an imported article pursuant to any of the provisions of
    this subsection shall establish that the article was intended for
    export at the time the article entered commerce. Any article
    condemned by reason of its being an article which may not, under
    section 344 or 355 of this title, be introduced into interstate
    commerce, shall be disposed of by destruction.
      (2) The provisions of paragraph (1) of this subsection shall, to
    the extent deemed appropriate by the court, apply to any equipment
    or other thing which is not otherwise within the scope of such
    paragraph and which is referred to in paragraph (2) of subsection
    (a) of this section.
      (3) Whenever in any proceeding under this section, involving
    paragraph (2) of subsection (a) of this section, the condemnation
    of any equipment or thing (other than a drug) is decreed, the court
    shall allow the claim of any claimant, to the extent of such
    claimant's interest, for remission or mitigation of such forfeiture
    if such claimant proves to the satisfaction of the court (i) that
    he has not committed or caused to be committed any prohibited act
    referred to in such paragraph (2) and has no interest in any drug
    referred to therein, (ii) that he has an interest in such equipment
    or other thing as owner or lienor or otherwise, acquired by him in
    good faith, and (iii) that he at no time had any knowledge or
    reason to believe that such equipment or other thing was being or
    would be used in, or to facilitate, the violation of laws of the
    United States relating to counterfeit drugs.
    (e) Costs
      When a decree of condemnation is entered against the article,
    court costs and fees, and storage and other proper expenses, shall
    be awarded against the person, if any, intervening as claimant of
    the article.
    (f) Removal of case for trial
      In the case of removal for trial of any case as provided by
    subsection (a) or (b) of this section - 
        (1) The clerk of the court from which removal is made shall
      promptly transmit to the court in which the case is to be tried
      all records in the case necessary in order that such court may
      exercise jurisdiction.
        (2) The court to which such case was removed shall have the
      powers and be subject to the duties, for purposes of such case,
      which the court from which removal was made would have had, or to
      which such court would have been subject, if such case had not
      been removed.
    (g) Administrative restraint; detention orders
      (1) If during an inspection conducted under section 374 of this
    title of a facility or a vehicle, a device which the officer or
    employee making the inspection has reason to believe is adulterated
    or misbranded is found in such facility or vehicle, such officer or
    employee may order the device detained (in accordance with
    regulations prescribed by the Secretary) for a reasonable period
    which may not exceed twenty days unless the Secretary determines
    that a period of detention greater than twenty days is required to
    institute an action under subsection (a) of this section or section
    332 of this title, in which case he may authorize a detention
    period of not to exceed thirty days. Regulations of the Secretary
    prescribed under this paragraph shall require that before a device
    may be ordered detained under this paragraph the Secretary or an
    officer or employee designated by the Secretary approve such order.
    A detention order under this paragraph may require the labeling or
    marking of a device during the period of its detention for the
    purpose of identifying the device as detained. Any person who would
    be entitled to claim a device if it were seized under subsection
    (a) of this section may appeal to the Secretary a detention of such
    device under this paragraph. Within five days of the date an appeal
    of a detention is filed with the Secretary, the Secretary shall
    after affording opportunity for an informal hearing by order
    confirm the detention or revoke it.
      (2)(A) Except as authorized by subparagraph (B), a device subject
    to a detention order issued under paragraph (1) shall not be moved
    by any person from the place at which it is ordered detained until -
     
        (i) released by the Secretary, or
        (ii) the expiration of the detention period applicable to such
      order,

    whichever occurs first.
      (B) A device subject to a detention order under paragraph (1) may
    be moved - 
        (i) in accordance with regulations prescribed by the Secretary,
      and
        (ii) if not in final form for shipment, at the discretion of
      the manufacturer of the device for the purpose of completing the
      work required to put it in such form.
    (h) Administrative detention of foods
      (1) Detention authority
        (A) In general
          An officer or qualified employee of the Food and Drug
        Administration may order the detention, in accordance with this
        subsection, of any article of food that is found during an
        inspection, examination, or investigation under this chapter
        conducted by such officer or qualified employee, if the officer
        or qualified employee has credible evidence or information
        indicating that such article presents a threat of serious
        adverse health consequences or death to humans or animals.
        (B) Secretary's approval
          An article of food may be ordered detained under subparagraph
        (A) only if the Secretary or an official designated by the
        Secretary approves the order. An official may not be so
        designated unless the official is the director of the district
        under this chapter in which the article involved is located, or
        is an official senior to such director.
      (2) Period of detention
        An article of food may be detained under paragraph (1) for a
      reasonable period, not to exceed 20 days, unless a greater
      period, not to exceed 30 days, is necessary, to enable the
      Secretary to institute an action under subsection (a) of this
      section or section 332 of this title. The Secretary shall by
      regulation provide for procedures for instituting such action on
      an expedited basis with respect to perishable foods.
      (3) Security of detained article
        An order under paragraph (1) with respect to an article of food
      may require that such article be labeled or marked as detained,
      and shall require that the article be removed to a secure
      facility, as appropriate. An article subject to such an order
      shall not be transferred by any person from the place at which
      the article is ordered detained, or from the place to which the
      article is so removed, as the case may be, until released by the
      Secretary or until the expiration of the detention period
      applicable under such order, whichever occurs first. This
      subsection may not be construed as authorizing the delivery of
      the article pursuant to the execution of a bond while the article
      is subject to the order, and section 381(b) of this title does
      not authorize the delivery of the article pursuant to the
      execution of a bond while the article is subject to the order.
      (4) Appeal of detention order
        (A) In general
          With respect to an article of food ordered detained under
        paragraph (1), any person who would be entitled to be a
        claimant for such article if the article were seized under
        subsection (a) of this section may appeal the order to the
        Secretary. Within five days after such an appeal is filed, the
        Secretary, after providing opportunity for an informal hearing,
        shall confirm or terminate the order involved, and such
        confirmation by the Secretary shall be considered a final
        agency action for purposes of section 702 of title 5. If during
        such five-day period the Secretary fails to provide such an
        opportunity, or to confirm or terminate such order, the order
        is deemed to be terminated.
        (B) Effect of instituting court action
          The process under subparagraph (A) for the appeal of an order
        under paragraph (1) terminates if the Secretary institutes an
        action under subsection (a) of this section or section 332 of
        this title regarding the article of food involved.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 304, 52 Stat. 1044; June 24, 1948,
    ch. 613, Sec. 2, 62 Stat. 582; Aug. 7, 1953, ch. 350, Sec. 3, 67
    Stat. 477; Pub. L. 85-250, Aug. 31, 1957, 71 Stat. 567; Pub. L. 89-
    74, Sec. 6, July 15, 1965, 79 Stat. 232; Pub. L. 90-639, Sec.
    4(b), Oct. 24, 1968, 82 Stat. 1362; Pub. L. 91-513, title II, Sec.
    701(c), (d), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 94-278,
    title V, Sec. 502(a)(2)(C), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-
    295, Secs. 3(c), 7(a), May 28, 1976, 90 Stat. 576, 582; Pub. L.
    102-300, Sec. 6(c), June 16, 1992, 106 Stat. 240; Pub. L. 103-80,
    Sec. 3(f), Aug. 13, 1993, 107 Stat. 775; Pub. L. 105-115, title IV,
    Sec. 418, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 107-188, title
    III, Sec. 303(a), June 12, 2002, 116 Stat. 663.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (h). Pub. L. 107-188 added subsec. (h).
      1997 - Subsec. (d)(1). Pub. L. 105-115 substituted "subparagraphs
    (A) and (B) of section 381(e)(1) of this title" for "paragraphs (1)
    and (2) of section 381(e) of this title" and inserted "Any person
    seeking to export an imported article pursuant to any of the
    provisions of this subsection shall establish that the article was
    intended for export at the time the article entered commerce."
    before "Any article condemned by reason".
      1993 - Subsec. (a)(1). Pub. L. 103-80, Sec. 3(f)(1), substituted
    "found. No libel" for "found: Provided, however, That no libel".
      Subsec. (d)(1). Pub. L. 103-80, Sec. 3(f)(2), substituted "sold.
    After entry" for "sold: Provided, That after entry", "met. The
    provisions of this sentence" for "met: Provided, however, That the
    provisions of this sentence", "title. Where such exportation" for
    "title: And provided further, That where such exportation", and
    "the preceding sentence shall not be applicable" for "the foregoing
    proviso shall not be applicable".
      1992 - Subsec. (d)(1). Pub. L. 102-300 substituted "381(e)" for
    "381(d)" in three places and "paragraphs" for "clauses" before "(1)
    and (2) of section 381(e)".
      1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 3(c)(1), struck out
    "device," after "Any article of food, drug,".
      Subsec. (a)(2). Pub. L. 94-295, Sec. 3(c)(2), (3), added cl. (D)
    covering adulterated or misbranded devices.
      Subsec. (a)(3). Pub. L. 94-278 added par. (3).
      Subsec. (g). Pub. L. 94-295, Sec. 7(a), added subsec. (g).
      1970 - Subsec. (a)(2). Pub. L. 91-513, Sec. 701(c), struck out
    cls. (A) and (D) which dealt with depressant or stimulant drugs,
    struck out reference to depressant or stimulant drugs in cl. (C),
    and redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C),
    respectively.
      Subsec. (d)(3)(iii). Pub. L. 91-513, Sec. 701(d), struck out
    reference to depressant or stimulant drugs.
      1968 - Subsec. (a). Pub. L. 90-639 inserted references to the
    United States courts of Territories.
      1965 - Subsec. (a). Pub. L. 89-74, Sec. 6(a), designated existing
    provisions as par. (1), redesignated cls. (1) and (2) of proviso as
    (A) and (B), and added par. (2).
      Subsec. (b). Pub. L. 89-74, Sec. 6(b)(1), inserted "equipment, or
    other thing proceeded against" after "article" in first sentence.
      Subsec. (d). Pub. L. 89-74, Sec. 6(b)(2), designated existing
    provisions as par. (1), redesignated cls. (1) and (2) of the second
    sentence thereof as (A) and (B), and added pars. (2) and (3).
      1957 - Subsec. (d). Pub. L. 85-250 permitted, under certain
    circumstances, reexportation of articles condemned at places other
    than original port of entry.
      1953 - Subsec. (c). Act Aug. 7, 1953, provided that a true copy
    of the analysis in any case shall be furnished the owner.
      1948 - Subsec. (a). Act June 24, 1948, inserted "or while held
    for sale (whether or not the first sale) after shipment in
    interstate commerce" to make this subsection coextensive with
    section 331(k) of this title.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Section 502(c) of Pub. L. 94-278 provided that: "The amendments
    made by subsection (a) [amending this section and sections 321,
    333, and 343 of this title] shall take effect 180 days after the
    date of the enactment of this Act [Apr. 22, 1976]."

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-639 applicable only with respect to
    violations of this chapter committed after Oct. 24, 1968, see
    section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
    Amendments; Transitional Provisions note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
    of Pub. L. 89-74, set out as a note under section 321 of this
    title.

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for any violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
    to be continued and brought to final determination in accord with
    laws and regulations in effect prior to Oct. 27, 1970, see section
    702 of Pub. L. 91-513, set out as a note under section 321 of this
    title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 335                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 335. Hearing before report of criminal violation

-STATUTE-
      Before any violation of this chapter is reported by the Secretary
    to any United States attorney for institution of a criminal
    proceeding, the person against whom such proceeding is contemplated
    shall be given appropriate notice and an opportunity to present his
    views, either orally or in writing, with regard to such
    contemplated proceeding.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 305, 52 Stat. 1045.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 335a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 335a. Debarment, temporary denial of approval, and suspension

-STATUTE-
    (a) Mandatory debarment; certain drug applications
      (1) Corporations, partnerships, and associations
        If the Secretary finds that a person other than an individual
      has been convicted, after May 13, 1992, of a felony under Federal
      law for conduct relating to the development or approval,
      including the process for development or approval, of any
      abbreviated drug application, the Secretary shall debar such
      person from submitting, or assisting in the submission of, any
      such application.
      (2) Individuals
        If the Secretary finds that an individual has been convicted of
      a felony under Federal law for conduct - 
          (A) relating to the development or approval, including the
        process for development or approval, of any drug product, or
          (B) otherwise relating to the regulation of any drug product
        under this chapter,

      the Secretary shall debar such individual from providing services
      in any capacity to a person that has an approved or pending drug
      product application.
    (b) Permissive debarment; certain drug applications; food imports
      (1) In general
        The Secretary, on the Secretary's own initiative or in response
      to a petition, may, in accordance with paragraph (2), debar - 
          (A) a person other than an individual from submitting or
        assisting in the submission of any abbreviated drug
        application,
          (B) an individual from providing services in any capacity to
        a person that has an approved or pending drug product
        application, or
          (C) a person from importing an article of food or offering
        such an article for import into the United States.
      (2) Persons subject to permissive debarment; certain drug
        applications
        The following persons are subject to debarment under
      subparagraph (A) or (B) of paragraph (1):
        (A) Corporations, partnerships, and associations
          Any person other than an individual that the Secretary finds
        has been convicted - 
            (i) for conduct that - 
              (I) relates to the development or approval, including the
            process for the development or approval, of any abbreviated
            drug application; and
              (II) is a felony under Federal law (if the person was
            convicted before May 13, 1992), a misdemeanor under Federal
            law, or a felony under State law, or

            (ii) of a conspiracy to commit, or aiding or abetting, a
          criminal offense described in clause (i) or a felony
          described in subsection (a)(1) of this section,

        if the Secretary finds that the type of conduct which served as
        the basis for such conviction undermines the process for the
        regulation of drugs.
        (B) Individuals
          (i) Any individual whom the Secretary finds has been
        convicted of - 
            (I) a misdemeanor under Federal law or a felony under State
          law for conduct relating to the development or approval,
          including the process for development or approval, of any
          drug product or otherwise relating to the regulation of drug
          products under this chapter, or
            (II) a conspiracy to commit, or aiding or abetting, such
          criminal offense or a felony described in subsection (a)(2)
          of this section,

        if the Secretary finds that the type of conduct which served as
        the basis for such conviction undermines the process for the
        regulation of drugs.
          (ii) Any individual whom the Secretary finds has been
        convicted of - 
            (I) a felony which is not described in subsection (a)(2) of
          this section or clause (i) of this subparagraph and which
          involves bribery, payment of illegal gratuities, fraud,
          perjury, false statement, racketeering, blackmail, extortion,
          falsification or destruction of records, or interference
          with, obstruction of an investigation into, or prosecution
          of, any criminal offense, or
            (II) a conspiracy to commit, or aiding or abetting, such
          felony,

        if the Secretary finds, on the basis of the conviction of such
        individual and other information, that such individual has
        demonstrated a pattern of conduct sufficient to find that there
        is reason to believe that such individual may violate
        requirements under this chapter relating to drug products.
          (iii) Any individual whom the Secretary finds materially
        participated in acts that were the basis for a conviction for
        an offense described in subsection (a) of this section or in
        clause (i) or (ii) for which a conviction was obtained, if the
        Secretary finds, on the basis of such participation and other
        information, that such individual has demonstrated a pattern of
        conduct sufficient to find that there is reason to believe that
        such individual may violate requirements under this chapter
        relating to drug products.
          (iv) Any high managerial agent whom the Secretary finds - 
            (I) worked for, or worked as a consultant for, the same
          person as another individual during the period in which such
          other individual took actions for which a felony conviction
          was obtained and which resulted in the debarment under
          subsection (a)(2) of this section, or clause (i), of such
          other individual,
            (II) had actual knowledge of the actions described in
          subclause (I) of such other individual, or took action to
          avoid such actual knowledge, or failed to take action for the
          purpose of avoiding such actual knowledge,
            (III) knew that the actions described in subclause (I) were
          violative of law, and
            (IV) did not report such actions, or did not cause such
          actions to be reported, to an officer, employee, or agent of
          the Department or to an appropriate law enforcement officer,
          or failed to take other appropriate action that would have
          ensured that the process for the regulation of drugs was not
          undermined, within a reasonable time after such agent first
          knew of such actions,

        if the Secretary finds that the type of conduct which served as
        the basis for such other individual's conviction undermines the
        process for the regulation of drugs.
      (3) Persons subject to permissive debarment; food importation
        A person is subject to debarment under paragraph (1)(C) if - 
          (A) the person has been convicted of a felony for conduct
        relating to the importation into the United States of any food;
        or
          (B) the person has engaged in a pattern of importing or
        offering for import adulterated food that presents a threat of
        serious adverse health consequences or death to humans or
        animals.
      (4) Stay of certain orders
        An order of the Secretary under clause (iii) or (iv) of
      paragraph (2)(B) shall not take effect until 30 days after the
      order has been issued.
    (c) Debarment period and considerations
      (1) Effect of debarment
        The Secretary - 
          (A) shall not accept or review (other than in connection with
        an audit under this section) any abbreviated drug application
        submitted by or with the assistance of a person debarred under
        subsection (a)(1) or (b)(2)(A) of this section during the
        period such person is debarred,
          (B) shall, during the period of a debarment under subsection
        (a)(2) or (b)(2)(B) of this section, debar an individual from
        providing services in any capacity to a person that has an
        approved or pending drug product application and shall not
        accept or review (other than in connection with an audit under
        this section) an abbreviated drug application from such
        individual, and
          (C) shall, if the Secretary makes the finding described in
        paragraph (6) or (7) of section 335b(a) of this title, assess a
        civil penalty in accordance with section 335b of this title.
      (2) Debarment periods
        (A) In general
          The Secretary shall debar a person under subsection (a) or
        (b) of this section for the following periods:
            (i) The period of debarment of a person (other than an
          individual) under subsection (a)(1) of this section shall not
          be less than 1 year or more than 10 years, but if an act
          leading to a subsequent debarment under subsection (a) of
          this section occurs within 10 years after such person has
          been debarred under subsection (a)(1) of this section, the
          period of debarment shall be permanent.
            (ii) The debarment of an individual under subsection (a)(2)
          of this section shall be permanent.
            (iii) The period of debarment of any person under paragraph
          (2) or (3) of subsection (b) of this section shall not be
          more than 5 years.

        The Secretary may determine whether debarment periods shall run
        concurrently or consecutively in the case of a person debarred
        for multiple offenses.
        (B) Notification
          Upon a conviction for an offense described in subsection (a)
        or (b) of this section or upon execution of an agreement with
        the United States to plead guilty to such an offense, the
        person involved may notify the Secretary that the person
        acquiesces to debarment and such person's debarment shall
        commence upon such notification.
      (3) Considerations
        In determining the appropriateness and the period of a
      debarment of a person under subsection (b) of this section and
      any period of debarment beyond the minimum specified in
      subparagraph (A)(i) of paragraph (2), the Secretary shall
      consider where applicable - 
          (A) the nature and seriousness of any offense involved,
          (B) the nature and extent of management participation in any
        offense involved, whether corporate policies and practices
        encouraged the offense, including whether inadequate
        institutional controls contributed to the offense,
          (C) the nature and extent of voluntary steps to mitigate the
        impact on the public of any offense involved, including the
        recall or the discontinuation of the distribution of suspect
        drugs, full cooperation with any investigations (including the
        extent of disclosure to appropriate authorities of all
        wrongdoing), the relinquishing of profits on drug approvals
        fraudulently obtained, and any other actions taken to
        substantially limit potential or actual adverse effects on the
        public health,
          (D) whether the extent to which changes in ownership,
        management, or operations have corrected the causes of any
        offense involved and provide reasonable assurances that the
        offense will not occur in the future,
          (E) whether the person to be debarred is able to present
        adequate evidence that current production of drugs subject to
        abbreviated drug applications and all pending abbreviated drug
        applications are free of fraud or material false statements,
        and
          (F) prior convictions under this chapter or under other Acts
        involving matters within the jurisdiction of the Food and Drug
        Administration.
    (d) Termination of debarment
      (1) Application
        Any person that is debarred under subsection (a) of this
      section (other than a person permanently debarred) or any person
      that is debarred under subsection (b) of this section may apply
      to the Secretary for termination of the debarment under this
      subsection. Any information submitted to the Secretary under this
      paragraph does not constitute an amendment or supplement to
      pending or approved abbreviated drug applications.
      (2) Deadline
        The Secretary shall grant or deny any application respecting a
      debarment which is submitted under paragraph (1) within 180 days
      of the date the application is submitted.
      (3) Action by the Secretary
        (A) Corporations
          (i) Conviction reversal
            If the conviction which served as the basis for the
          debarment of a person under subsection (a)(1) of this section
          or paragraph (2)(A) or (3) of subsection (b) of this section
          is reversed, the Secretary shall withdraw the order of
          debarment.
          (ii) Application
            Upon application submitted under paragraph (1), the
          Secretary shall terminate the debarment of a person if the
          Secretary finds that - 
              (I) changes in ownership, management, or operations have
            fully corrected the causes of the offense involved and
            provide reasonable assurances that the offense will not
            occur in the future, and
              (II) in applicable cases, sufficient audits, conducted by
            the Food and Drug Administration or by independent experts
            acceptable to the Food and Drug Administration, demonstrate
            that pending applications and the development of drugs
            being tested before the submission of an application are
            free of fraud or material false statements.

          In the case of persons debarred under subsection (a)(1) of
          this section, such termination shall take effect no earlier
          than the expiration of one year from the date of the
          debarment.
        (B) Individuals
          (i) Conviction reversal
            If the conviction which served as the basis for the
          debarment of an individual under subsection (a)(2) of this
          section or clause (i), (ii), (iii), or (iv) of subsection
          (b)(2)(B) or subsection (b)(3) of this section is reversed,
          the Secretary shall withdraw the order of debarment.
          (ii) Application
            Upon application submitted under paragraph (1), the
          Secretary shall terminate the debarment of an individual who
          has been debarred under subsection (b)(2)(B) or subsection
          (b)(3) of this section if such termination serves the
          interests of justice and adequately protects the integrity of
          the drug approval process or the food importation process, as
          the case may be.
      (4) Special termination
        (A) Application
          Any person that is debarred under subsection (a)(1) of this
        section (other than a person permanently debarred under
        subsection (c)(2)(A)(i) of this section) or any individual who
        is debarred under subsection (a)(2) of this section may apply
        to the Secretary for special termination of debarment under
        this subsection. Any information submitted to the Secretary
        under this subparagraph does not constitute an amendment or
        supplement to pending or approved abbreviated drug
        applications.
        (B) Corporations
          Upon an application submitted under subparagraph (A), the
        Secretary may take the action described in subparagraph (D) if
        the Secretary, after an informal hearing, finds that - 
            (i) the person making the application under subparagraph
          (A) has demonstrated that the felony conviction which was the
          basis for such person's debarment involved the commission of
          an offense which was not authorized, requested, commanded,
          performed, or recklessly tolerated by the board of directors
          or by a high managerial agent acting on behalf of the person
          within the scope of the board's or agent's office or
          employment,
            (ii) all individuals who were involved in the commission of
          the offense or who knew or should have known of the offense
          have been removed from employment involving the development
          or approval of any drug subject to sections (!1) 355 of this
          title,

            (iii) the person fully cooperated with all investigations
          and promptly disclosed all wrongdoing to the appropriate
          authorities, and
            (iv) the person acted to mitigate any impact on the public
          of any offense involved, including the recall, or the
          discontinuation of the distribution, of any drug with respect
          to which the Secretary requested a recall or discontinuation
          of distribution due to concerns about the safety or efficacy
          of the drug.
        (C) Individuals
          Upon an application submitted under subparagraph (A), the
        Secretary may take the action described in subparagraph (D) if
        the Secretary, after an informal hearing, finds that such
        individual has provided substantial assistance in the
        investigations or prosecutions of offenses which are described
        in subsection (a) or (b) of this section or which relate to any
        matter under the jurisdiction of the Food and Drug
        Administration.
        (D) Secretarial action
          The action referred to in subparagraphs (B) and (C) is - 
            (i) in the case of a person other than an individual - 
              (I) terminating the debarment immediately, or
              (II) limiting the period of debarment to less than one
            year, and

            (ii) in the case of an individual, limiting the period of
          debarment to less than permanent but to no less than 1 year,

        whichever best serves the interest of justice and protects the
        integrity of the drug approval process.
    (e) Publication and list of debarred persons
      The Secretary shall publish in the Federal Register the name of
    any person debarred under subsection (a) or (b) of this section,
    the effective date of the debarment, and the period of the
    debarment. The Secretary shall also maintain and make available to
    the public a list, updated no less often than quarterly, of such
    persons, of the effective dates and minimum periods of such
    debarments, and of the termination of debarments.
    (f) Temporary denial of approval
      (1) In general
        The Secretary, on the Secretary's own initiative or in response
      to a petition, may, in accordance with paragraph (3), refuse by
      order, for the period prescribed by paragraph (2), to approve any
      abbreviated drug application submitted by any person - 
          (A) if such person is under an active Federal criminal
        investigation in connection with an action described in
        subparagraph (B),
          (B) if the Secretary finds that such person - 
            (i) has bribed or attempted to bribe, has paid or attempted
          to pay an illegal gratuity, or has induced or attempted to
          induce another person to bribe or pay an illegal gratuity to
          any officer, employee, or agent of the Department of Health
          and Human Services or to any other Federal, State, or local
          official in connection with any abbreviated drug application,
          or has conspired to commit, or aided or abetted, such
          actions, or
            (ii) has knowingly made or caused to be made a pattern or
          practice of false statements or misrepresentations with
          respect to material facts relating to any abbreviated drug
          application, or the production of any drug subject to an
          abbreviated drug application, to any officer, employee, or
          agent of the Department of Health and Human Services, or has
          conspired to commit, or aided or abetted, such actions, and

          (C) if a significant question has been raised regarding - 
            (i) the integrity of the approval process with respect to
          such abbreviated drug application, or
            (ii) the reliability of data in or concerning such person's
          abbreviated drug application.

      Such an order may be modified or terminated at any time.
      (2) Applicable period
        (A) In general
          Except as provided in subparagraph (B), a denial of approval
        of an application of a person under paragraph (1) shall be in
        effect for a period determined by the Secretary but not to
        exceed 18 months beginning on the date the Secretary finds that
        the conditions described in subparagraphs (A), (B), and (C) of
        paragraph (1) exist. The Secretary shall terminate such denial -
         
            (i) if the investigation with respect to which the finding
          was made does not result in a criminal charge against such
          person, if criminal charges have been brought and the charges
          have been dismissed, or if a judgment of acquittal has been
          entered, or
            (ii) if the Secretary determines that such finding was in
          error.
        (B) Extension
          If, at the end of the period described in subparagraph (A),
        the Secretary determines that a person has been criminally
        charged for an action described in subparagraph (B) of
        paragraph (1), the Secretary may extend the period of denial of
        approval of an application for a period not to exceed 18
        months. The Secretary shall terminate such extension if the
        charges have been dismissed, if a judgment of acquittal has
        been entered, or if the Secretary determines that the finding
        described in subparagraph (A) was in error.
      (3) Informal hearing
        Within 10 days of the date an order is issued under paragraph
      (1), the Secretary shall provide such person with an opportunity
      for an informal hearing, to be held within such 10 days, on the
      decision of the Secretary to refuse approval of an abbreviated
      drug application. Within 60 days of the date on which such
      hearing is held, the Secretary shall notify the person given such
      hearing whether the Secretary's refusal of approval will be
      continued, terminated, or otherwise modified. Such notification
      shall be final agency action.
    (g) Suspension authority
      (1) In general
        If - 
          (A) the Secretary finds - 
            (i) that a person has engaged in conduct described in
          subparagraph (B) of subsection (f)(1) of this section in
          connection with 2 or more drugs under abbreviated drug
          applications, or
            (ii) that a person has engaged in flagrant and repeated,
          material violations of good manufacturing practice or good
          laboratory practice in connection with the development,
          manufacturing, or distribution of one or more drugs approved
          under an abbreviated drug application during a 2-year period,
          and - 
              (I) such violations may undermine the safety and efficacy
            of such drugs, and
              (II) the causes of such violations have not been
            corrected within a reasonable period of time following
            notice of such violations by the Secretary, and

          (B) such person is under an active investigation by a Federal
        authority in connection with a civil or criminal action
        involving conduct described in subparagraph (A),

      the Secretary shall issue an order suspending the distribution of
      all drugs the development or approval of which was related to
      such conduct described in subparagraph (A) or suspending the
      distribution of all drugs approved under abbreviated drug
      applications of such person if the Secretary finds that such
      conduct may have affected the development or approval of a
      significant number of drugs which the Secretary is unable to
      identify. The Secretary shall exclude a drug from such order if
      the Secretary determines that such conduct was not likely to have
      influenced the safety or efficacy of such drug.
      (2) Public health waiver
        The Secretary shall, on the Secretary's own initiative or in
      response to a petition, waive the suspension under paragraph (1)
      (involving an action described in paragraph (1)(A)(i)) with
      respect to any drug if the Secretary finds that such waiver is
      necessary to protect the public health because sufficient
      quantities of the drug would not otherwise be available. The
      Secretary shall act on any petition seeking action under this
      paragraph within 180 days of the date the petition is submitted
      to the Secretary.
    (h) Termination of suspension
      The Secretary shall withdraw an order of suspension of the
    distribution of a drug under subsection (g) of this section if the
    person with respect to whom the order was issued demonstrates in a
    petition to the Secretary - 
        (1)(A) on the basis of an audit by the Food and Drug
      Administration or by experts acceptable to the Food and Drug
      Administration, or on the basis of other information, that the
      development, approval, manufacturing, and distribution of such
      drug is in substantial compliance with the applicable
      requirements of this chapter, and
        (B) changes in ownership, management, or operations - 
          (i) fully remedy the patterns or practices with respect to
        which the order was issued, and
          (ii) provide reasonable assurances that such actions will not
        occur in the future, or

        (2) the initial determination was in error.

    The Secretary shall act on a submission of a petition under this
    subsection within 180 days of the date of its submission and the
    Secretary may consider the petition concurrently with the
    suspension proceeding. Any information submitted to the Secretary
    under this subsection does not constitute an amendment or
    supplement to a pending or approved abbreviated drug application.
    (i) Procedure
      The Secretary may not take any action under subsection (a), (b),
    (c), (d)(3), (g), or (h) of this section with respect to any person
    unless the Secretary has issued an order for such action made on
    the record after opportunity for an agency hearing on disputed
    issues of material fact. In the course of any investigation or
    hearing under this subsection, the Secretary may administer oaths
    and affirmations, examine witnesses, receive evidence, and issue
    subpoenas requiring the attendance and testimony of witnesses and
    the production of evidence that relates to the matter under
    investigation.
    (j) Judicial review
      (1) In general
        Except as provided in paragraph (2), any person that is the
      subject of an adverse decision under subsection (a), (b), (c),
      (d), (f), (g), or (h) of this section may obtain a review of such
      decision by the United States Court of Appeals for the District
      of Columbia or for the circuit in which the person resides, by
      filing in such court (within 60 days following the date the
      person is notified of the Secretary's decision) a petition
      requesting that the decision be modified or set aside.
      (2) Exception
        Any person that is the subject of an adverse decision under
      clause (iii) or (iv) of subsection (b)(2)(B) of this section may
      obtain a review of such decision by the United States District
      Court for the District of Columbia or a district court of the
      United States for the district in which the person resides, by
      filing in such court (within 30 days following the date the
      person is notified of the Secretary's decision) a complaint
      requesting that the decision be modified or set aside. In such an
      action, the court shall determine the matter de novo.
    (k) Certification
      Any application for approval of a drug product shall include - 
        (1) a certification that the applicant did not and will not use
      in any capacity the services of any person debarred under
      subsection (a) or (b) of this section, in connection with such
      application, and
        (2) if such application is an abbreviated drug application, a
      list of all convictions, described in subsections (a) and (b) of
      this section which occurred within the previous 5 years, of the
      applicant and affiliated persons responsible for the development
      or submission of such application.
    (l) Applicability
      (1) Conviction
        For purposes of this section, a person is considered to have
      been convicted of a criminal offense - 
          (A) when a judgment of conviction has been entered against
        the person by a Federal or State court, regardless of whether
        there is an appeal pending,
          (B) when a plea of guilty or nolo contendere by the person
        has been accepted by a Federal or State court, or
          (C) when the person has entered into participation in a first
        offender, deferred adjudication, or other similar arrangement
        or program where judgment of conviction has been withheld.
      (2) Effective dates
        Subsection (a) of this section, subparagraph (A) of subsection
      (b)(2) of this section, clauses (i) and (ii) of subsection
      (b)(2)(B) of this section, and subsection (b)(3)(A) of this
      section shall not apply to a conviction which occurred more than
      5 years before the initiation of an agency action proposed to be
      taken under subsection (a) or (b) of this section. Clauses (iii)
      and (iv) of subsection (b)(2)(B) of this section, subsection
      (b)(3)(B) of this section, and subsections (f) and (g) of this
      section shall not apply to an act or action which occurred more
      than 5 years before the initiation of an agency action proposed
      to be taken under subsection (b), (f), or (g) of this section.
      Clause (iv) of subsection (b)(2)(B) of this section shall not
      apply to an action which occurred before June 1, 1992. Subsection
      (k) of this section shall not apply to applications submitted to
      the Secretary before June 1, 1992.
    (m) Devices; mandatory debarment regarding third-party inspections
      and reviews
      (1) In general
        If the Secretary finds that a person has been convicted of a
      felony under section 331(gg) of this title, the Secretary shall
      debar such person from being accredited under section 360m(b) or
      374(g)(2) of this title and from carrying out activities under an
      agreement described in section 383(b) of this title.
      (2) Debarment period
        The Secretary shall debar a person under paragraph (1) for the
      following periods:
          (A) The period of debarment of a person (other than an
        individual) shall not be less than 1 year or more than 10
        years, but if an act leading to a subsequent debarment under
        such paragraph occurs within 10 years after such person has
        been debarred under such paragraph, the period of debarment
        shall be permanent.
          (B) The debarment of an individual shall be permanent.
      (3) Termination of debarment; judicial review; other matters
        Subsections (c)(3), (d), (e), (i), (j), and (l)(1) of this
      section apply with respect to a person (other than an individual)
      or an individual who is debarred under paragraph (1) to the same
      extent and in the same manner as such subsections apply with
      respect to a person who is debarred under subsection (a)(1) of
      this section, or an individual who is debarred under subsection
      (a)(2) of this section, respectively.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 306, as added Pub. L. 102-282, Sec.
    2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105-115, title I,
    Sec. 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107-188,
    title III, Sec. 304(a)-(c), June 12, 2002, 116 Stat. 665, 666; Pub.
    L. 107-250, title II, Sec. 203, Oct. 26, 2002, 116 Stat. 1610.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 306 of act June 25, 1938, was renumbered section
    309 and is classified to section 336 of this title.

                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-188, Sec. 304(b)(1), substituted
    "Mandatory debarment; certain drug applications" for "Mandatory
    debarment" in heading.
      Subsec. (b). Pub. L. 107-188, Sec. 304(b)(2)(A), substituted
    "Permissive debarment; certain drug applications; food imports" for
    "Permissive debarment" in heading.
      Subsec. (b)(1)(C). Pub. L. 107-188, Sec. 304(a)(1), added subpar.
    (C).
      Subsec. (b)(2). Pub. L. 107-188, Sec. 304(b)(2)(B), substituted
    "permissive debarment; certain drug applications" for "permissive
    debarment" in heading.
      Pub. L. 107-188, Sec. 304(a)(2)(A), inserted "subparagraph (A) or
    (B) of" before "paragraph (1)" in introductory provisions.
      Subsec. (b)(3), (4). Pub. L. 107-188, Sec. 304(a)(2)(B), (C),
    added par. (3) and redesignated former par. (3) as (4).
      Subsec. (c)(2)(A)(iii). Pub. L. 107-188, Sec. 304(b)(3),
    substituted "paragraph (2) or (3) of subsection (b)" for
    "subsection (b)(2)".
      Subsec. (d)(3)(A)(i). Pub. L. 107-188, Sec. 304(b)(4)(A),
    substituted "subsection (a)(1) of this section or paragraph (2)(A)
    or (3) of subsection (b)" for "subsection (a)(1) or (b)(2)(A)".
      Subsec. (d)(3)(A)(ii)(II). Pub. L. 107-188, Sec. 304(b)(4)(B),
    inserted "in applicable cases," before "sufficient audits".
      Subsec. (d)(3)(B)(i). Pub. L. 107-188, Sec. 304(b)(4)(C),
    inserted "or subsection (b)(3)" after "subsection (b)(2)(B)".
      Subsec. (d)(3)(B)(ii). Pub. L. 107-188, Sec. 304(b)(4)(C), (D),
    inserted "or subsection (b)(3)" after "subsection (b)(2)(B)" and
    "or the food importation process, as the case may be" before
    period.
      Subsec. (l)(2). Pub. L. 107-188, Sec. 304(c), in first sentence
    struck out "and" after "subsection (b)(2) of this section," and
    inserted ", and subsection (b)(3)(A) of this section" after
    "subsection (b)(2)(B) of this section" and in second sentence
    inserted ", subsection (b)(3)(B) of this section," after
    "subsection (b)(2)(B) of this section".
      Subsec. (m). Pub. L. 107-250 added subsec. (m).
      1997 - Subsec. (d)(4)(B)(ii). Pub. L. 105-115 struck out "or 357"
    after "355".

                               CONSTRUCTION                           
      Section 7 of Pub. L. 102-282 provided that: "No amendment made by
    this Act [enacting this section and sections 335b and 335c of this
    title and amending sections 321, 336, 337, and 355 of this title]
    shall preclude any other civil, criminal, or administrative remedy
    provided under Federal or State law, including any private right of
    action against any person for the same action subject to any action
    or civil penalty under an amendment made by this Act."

                          CONGRESSIONAL FINDINGS                      
      Section 1(c) of Pub. L. 102-282 provided that: "The Congress
    finds that - 
        "(1) there is substantial evidence that significant corruption
      occurred in the Food and Drug Administration's process of
      approving drugs under abbreviated drug applications,
        "(2) there is a need to establish procedures designed to
      restore and to ensure the integrity of the abbreviated drug
      application approval process and to protect the public health,
      and
        "(3) there is a need to establish procedures to bar individuals
      who have been convicted of crimes pertaining to the regulation of
      drug products from working for companies that manufacture or
      distribute such products."

-FOOTNOTE-
    (!1) So in original. Probably should be "section".


-End-



-CITE-
    21 USC Sec. 335b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 335b. Civil penalties

-STATUTE-
    (a) In general
      Any person that the Secretary finds - 
        (1) knowingly made or caused to be made, to any officer,
      employee, or agent of the Department of Health and Human
      Services, a false statement or misrepresentation of a material
      fact in connection with an abbreviated drug application,
        (2) bribed or attempted to bribe or paid or attempted to pay an
      illegal gratuity to any officer, employee, or agent of the
      Department of Health and Human Services in connection with an
      abbreviated drug application,
        (3) destroyed, altered, removed, or secreted, or procured the
      destruction, alteration, removal, or secretion of, any material
      document or other material evidence which was the property of or
      in the possession of the Department of Health and Human Services
      for the purpose of interfering with that Department's discharge
      of its responsibilities in connection with an abbreviated drug
      application,
        (4) knowingly failed to disclose, to an officer or employee of
      the Department of Health and Human Services, a material fact
      which such person had an obligation to disclose relating to any
      drug subject to an abbreviated drug application,
        (5) knowingly obstructed an investigation of the Department of
      Health and Human Services into any drug subject to an abbreviated
      drug application,
        (6) is a person that has an approved or pending drug product
      application and has knowingly - 
          (A) employed or retained as a consultant or contractor, or
          (B) otherwise used in any capacity the services of,

      a person who was debarred under section 335a of this title, or
        (7) is an individual debarred under section 335a of this title
      and, during the period of debarment, provided services in any
      capacity to a person that had an approved or pending drug product
      application,

    shall be liable to the United States for a civil penalty for each
    such violation in an amount not to exceed $250,000 in the case of
    an individual and $1,000,000 in the case of any other person.
    (b) Procedure
      (1) In general
        (A) Action by the Secretary
          A civil penalty under subsection (a) of this section shall be
        assessed by the Secretary on a person by an order made on the
        record after an opportunity for an agency hearing on disputed
        issues of material fact and the amount of the penalty. In the
        course of any investigation or hearing under this subparagraph,
        the Secretary may administer oaths and affirmations, examine
        witnesses, receive evidence, and issue subpoenas requiring the
        attendance and testimony of witnesses and the production of
        evidence that relates to the matter under investigation.
        (B) Action by the Attorney General
          In lieu of a proceeding under subparagraph (A), the Attorney
        General may, upon request of the Secretary, institute a civil
        action to recover a civil money penalty in the amount and for
        any of the acts set forth in subsection (a) of this section.
        Such an action may be instituted separately from or in
        connection with any other claim, civil or criminal, initiated
        by the Attorney General under this chapter.
      (2) Amount
        In determining the amount of a civil penalty under paragraph
      (1), the Secretary or the court shall take into account the
      nature, circumstances, extent, and gravity of the act subject to
      penalty, the person's ability to pay, the effect on the person's
      ability to continue to do business, any history of prior, similar
      acts, and such other matters as justice may require.
      (3) Limitation on actions
        No action may be initiated under this section - 
          (A) with respect to any act described in subsection (a) of
        this section that occurred before May 13, 1992, or
          (B) more than 6 years after the date when facts material to
        the act are known or reasonably should have been known by the
        Secretary but in no event more than 10 years after the date the
        act took place.
    (c) Judicial review
      Any person that is the subject of an adverse decision under
    subsection (b)(1)(A) of this section may obtain a review of such
    decision by the United States Court of Appeals for the District of
    Columbia or for the circuit in which the person resides, by filing
    in such court (within 60 days following the date the person is
    notified of the Secretary's decision) a petition requesting that
    the decision be modified or set aside.
    (d) Recovery of penalties
      The Attorney General may recover any civil penalty (plus interest
    at the currently prevailing rates from the date the penalty became
    final) assessed under subsection (b)(1)(A) of this section in an
    action brought in the name of the United States. The amount of such
    penalty may be deducted, when the penalty has become final, from
    any sums then or later owing by the United States to the person
    against whom the penalty has been assessed. In an action brought
    under this subsection, the validity, amount, and appropriateness of
    the penalty shall not be subject to judicial review.
    (e) Informants
      The Secretary may award to any individual (other than an officer
    or employee of the Federal Government or a person who materially
    participated in any conduct described in subsection (a) of this
    section) who provides information leading to the imposition of a
    civil penalty under this section an amount not to exceed - 
        (1) $250,000, or
        (2) one-half of the penalty so imposed and collected,

    whichever is less. The decision of the Secretary on such award
    shall not be reviewable.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 307, as added Pub. L. 102-282, Sec.
    3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103-80, Sec. 3(g),
    Aug. 13, 1993, 107 Stat. 776.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 307 of act June 25, 1938, was renumbered section
    310 and is classified to section 337 of this title.

                                AMENDMENTS                            
      1993 - Subsec. (b)(3)(A). Pub. L. 103-80 made technical amendment
    to reference to May 13, 1992, to reflect correction of
    corresponding provision of original act.

                               CONSTRUCTION                           
      This section not to preclude any other civil, criminal, or
    administrative remedy provided under Federal or State law,
    including any private right of action against any person for the
    same action subject to any action or civil penalty under an
    amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
    282, set out as a note under section 335a of this title.

-End-



-CITE-
    21 USC Sec. 335c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 335c. Authority to withdraw approval of abbreviated drug
      applications

-STATUTE-
    (a) In general
      The Secretary - 
        (1) shall withdraw approval of an abbreviated drug application
      if the Secretary finds that the approval was obtained, expedited,
      or otherwise facilitated through bribery, payment of an illegal
      gratuity, or fraud or material false statement, and
        (2) may withdraw approval of an abbreviated drug application if
      the Secretary finds that the applicant has repeatedly
      demonstrated a lack of ability to produce the drug for which the
      application was submitted in accordance with the formulations or
      manufacturing practice set forth in the abbreviated drug
      application and has introduced, or attempted to introduce, such
      adulterated or misbranded drug into commerce.
    (b) Procedure
      The Secretary may not take any action under subsection (a) of
    this section with respect to any person unless the Secretary has
    issued an order for such action made on the record after
    opportunity for an agency hearing on disputed issues of material
    fact. In the course of any investigation or hearing under this
    subsection, the Secretary may administer oaths and affirmations,
    examine witnesses, receive evidence, and issue subpoenas requiring
    the attendance and testimony of witnesses and the production of
    evidence that relates to the matter under investigation.
    (c) Applicability
      Subsection (a) of this section shall apply with respect to
    offenses or acts regardless of when such offenses or acts occurred.
    (d) Judicial review
      Any person that is the subject of an adverse decision under
    subsection (a) of this section may obtain a review of such decision
    by the United States Court of Appeals for the District of Columbia
    or for the circuit in which the person resides, by filing in such
    court (within 60 days following the date the person is notified of
    the Secretary's decision) a petition requesting that the decision
    be modified or set aside.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 308, as added Pub. L. 102-282, Sec.
    4, May 13, 1992, 106 Stat. 160.)


-MISC1-
                               CONSTRUCTION                           
      This section not to preclude any other civil, criminal, or
    administrative remedy provided under Federal or State law,
    including any private right of action against any person for the
    same action subject to any action or civil penalty under an
    amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
    282, set out as a note under section 335a of this title.

-End-



-CITE-
    21 USC Sec. 336                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 336. Report of minor violations

-STATUTE-
      Nothing in this chapter shall be construed as requiring the
    Secretary to report for prosecution, or for the institution of
    libel or injunction proceedings, minor violations of this chapter
    whenever he believes that the public interest will be adequately
    served by a suitable written notice or warning.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 309, formerly Sec. 306, 52 Stat.
    1045; renumbered Sec. 309, Pub. L. 102-282, Sec. 2, May 13, 1992,
    106 Stat. 150.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 337                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-
    Sec. 337. Proceedings in name of United States; provision as to
      subpoenas

-STATUTE-
      (a) Except as provided in subsection (b) of this section, all
    such proceedings for the enforcement, or to restrain violations, of
    this chapter shall be by and in the name of the United States.
    Subpoenas for witnesses who are required to attend a court of the
    United States, in any district, may run into any other district in
    any proceeding under this section.
      (b)(1) A State may bring in its own name and within its
    jurisdiction proceedings for the civil enforcement, or to restrain
    violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f),
    343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if
    the food that is the subject of the proceedings is located in the
    State.
      (2) No proceeding may be commenced by a State under paragraph (1)
    - 
        (A) before 30 days after the State has given notice to the
      Secretary that the State intends to bring such proceeding,
        (B) before 90 days after the State has given notice to the
      Secretary of such intent if the Secretary has, within such 30
      days, commenced an informal or formal enforcement action
      pertaining to the food which would be the subject of such
      proceeding, or
        (C) if the Secretary is diligently prosecuting a proceeding in
      court pertaining to such food, has settled such proceeding, or
      has settled the informal or formal enforcement action pertaining
      to such food.

    In any court proceeding described in subparagraph (C), a State may
    intervene as a matter of right.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 310, formerly Sec. 307, 52 Stat.
    1046; Sept. 3, 1954, ch. 1263, Sec. 37, 68 Stat. 1239; Pub. L. 101-
    535, Sec. 4, Nov. 8, 1990, 104 Stat. 2362; renumbered Sec. 310,
    Pub. L. 102-282, Sec. 2, May 13, 1992, 106 Stat. 150.)


-MISC1-
                                AMENDMENTS                            
      1990 - Pub. L. 101-535 substituted "(a) Except as provided in
    subsection (b) of this section, all" for "All" and "any proceeding
    under this section" for "any such proceeding" and added subsec.
    (b).
      1954 - Act Sept. 3, 1954, struck out reference to section 654 of
    title 28.

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Amendment by Pub. L. 101-535 effective 24 months after Nov. 8,
    1990, except that such amendment effective Dec. 31, 1993, with
    respect to dietary supplements of vitamins, minerals, herbs, or
    other similar nutritional substances, see section 10(a)(1)(C) of
    Pub. L. 101-535, set out as a note under section 343 of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Amendments by Pub. L. 101-535 not to be construed to alter
    authority of Secretary of Health and Human Services and Secretary
    of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
    et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
    seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
    seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.

-End-


-CITE-
    21 USC SUBCHAPTER IV - FOOD                                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
                           SUBCHAPTER IV - FOOD                       

-End-



-CITE-
    21 USC Sec. 341                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 341. Definitions and standards for food

-STATUTE-
      Whenever in the judgment of the Secretary such action will
    promote honesty and fair dealing in the interest of consumers, he
    shall promulgate regulations fixing and establishing for any food,
    under its common or usual name so far as practicable, a reasonable
    definition and standard of identity, a reasonable standard of
    quality, or reasonable standards of fill of container. No
    definition and standard of identity and no standard of quality
    shall be established for fresh or dried fruits, fresh or dried
    vegetables, or butter, except that definitions and standards of
    identity may be established for avocadoes, cantaloupes, citrus
    fruits, and melons. In prescribing any standard of fill of
    container, the Secretary shall give due consideration to the
    natural shrinkage in storage and in transit of fresh natural food
    and to need for the necessary packing and protective material. In
    the prescribing of any standard of quality for any canned fruit or
    canned vegetable, consideration shall be given and due allowance
    made for the differing characteristics of the several varieties of
    such fruit or vegetable. In prescribing a definition and standard
    of identity for any food or class of food in which optional
    ingredients are permitted, the Secretary shall, for the purpose of
    promoting honesty and fair dealing in the interest of consumers,
    designate the optional ingredients which shall be named on the
    label. Any definition and standard of identity prescribed by the
    Secretary for avocadoes, cantaloupes, citrus fruits, or melons
    shall relate only to maturity and to the effects of freezing.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 401, 52 Stat. 1046; Apr. 15, 1954,
    ch. 143, Sec. 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, Sec. 1, 70
    Stat. 919; Pub. L. 103-80, Sec. 3(h), Aug. 13, 1993, 107 Stat.
    776.)


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 substituted "or reasonable standards of
    fill of container. No definition" for "and/or reasonable standards
    of fill of container: Provided, That no definition".
      1956 - Act Aug. 1, 1956, designated provisions constituting
    subsec. (a) as entire section and repealed subsec. (b) which
    provided the procedure for establishment of regulations and is
    covered by section 371(e) of this title.
      1954 - Act Apr. 15, 1954, designated existing provisions as
    subsec. (a) and added subsec. (b).

                             SAVINGS PROVISION                         
      Section 3 of act Aug. 1, 1956, provided that: "In any case in
    which, prior to the enactment of this Act [Aug. 1, 1956], a public
    hearing has been begun in accordance with section 401 of the
    Federal Food, Drug, and Cosmetic Act [341 of this title] upon a
    proposal to issue, amend, or repeal any regulation contemplated by
    such section, or has been begun in accordance with section 701(e)
    of such Act [section 371(e) of this title] upon a proposal to
    issue, amend, or repeal any regulation contemplated by section
    403(j), 404(a), 406(a) or (b), 501(b), 502(d), 502(h), 504 or 604
    of such Act [section 343(j), 344(a), 346(a) or (b), 351(b), 352(d),
    352(h), 354, or 364 of this title], the provisions of such section
    401 or 701(e), as the case may be, as in force immediately prior to
    the date of the enactment of this Act [Aug. 1, 1956], shall be
    applicable as though this Act [amending this section and section
    371(e) of this title] had not been enacted."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
                     FOOD SAFETY AND SECURITY STRATEGY                 
      Pub. L. 107-188, title III, Sec. 301, June 12, 2002, 116 Stat.
    662, provided that:
      "(a) In General. - The President's Council on Food Safety (as
    established by Executive Order No. 13100 [set out below]) shall, in
    consultation with the Secretary of Transportation, the Secretary of
    the Treasury, other relevant Federal agencies, the food industry,
    consumer and producer groups, scientific organizations, and the
    States, develop a crisis communications and education strategy with
    respect to bioterrorist threats to the food supply. Such strategy
    shall address threat assessments; technologies and procedures for
    securing food processing and manufacturing facilities and modes of
    transportation; response and notification procedures; and risk
    communications to the public.
      "(b) Authorization of Appropriations. - For the purpose of
    implementing the strategy developed under subsection (a), there are
    authorized to be appropriated $750,000 for fiscal year 2002, and
    such sums as may be necessary for each subsequent fiscal year."

                          FOOD SAFETY COMMISSION                      
      Pub. L. 107-171, title X, Sec. 10807, May 13, 2002, 116 Stat.
    527, provided that:
      "(a) Establishment. - 
        "(1) In general. - There is established a commission to be
      known as the 'Food Safety Commission' (referred to in this
      section as the 'Commission').
        "(2) Membership. - 
          "(A) Composition. - The Commission shall be composed of 15
        members (including a Chairperson, appointed by the
        President[)].
          "(B) Eligibility. - 
            "(i) In general. - Members of the Commission - 
         "(I) shall have specialized training or significant experience
          in matters under the jurisdiction of the Commission; and
         "(II) shall represent, at a minimum - 
              "(aa) consumers;
              "(bb) food scientists;
              "(cc) the food industry; and
              "(dd) health professionals.
            "(ii) Federal employees. - Not more than 3 members of the
          Commission may be Federal employees.
          "(C) Date of appointments. - The appointment of the members
        of the Commission shall be made as soon as practicable after
        the date on which funds authorized to be appropriated under
        subsection (e)(1) are made available.
          "(D) Vacancies. - A vacancy on the Commission - 
            "(i) shall not affect the powers of the Commission; and
            "(ii) shall be filled - 
         "(I) not later than 60 days after the date on which the
          vacancy occurs; and
         "(II) in the same manner as the original appointment was made.
        "(3) Meetings. - 
          "(A) Initial meeting. - The initial meeting of the Commission
        shall be conducted not later than 30 days after the date of
        appointment of the final member of the Commission.
          "(B) Other meetings. - The Commission shall meet at the call
        of the Chairperson.
        "(4) Quorum; standing rules. - 
          "(A) Quorum. - A majority of the members of the Commission
        shall constitute a quorum to conduct business.
          "(B) Standing rules. - At the first meeting of the
        Commission, the Commission shall adopt standing rules of the
        Commission to guide the conduct of business and decisionmaking
        of the Commission.
      "(b) Duties. - 
        "(1) Recommendations. - The Commission shall make specific
      recommendations to enhance the food safety system of the United
      States, including a description of how each recommendation would
      improve food safety.
        "(2) Components. - Recommendations made by the Commission under
      paragraph (1) shall address all food available commercially in
      the United States.
        "(3) Report. - Not later than 1 year after the date on which
      the Commission first meets, the Commission shall submit to the
      President and Congress - 
          "(A) the findings, conclusions, and recommendations of the
        Commission, including a description of how each recommendation
        would improve food safety;
          "(B) a summary of any other material used by the Commission
        in the preparation of the report under this paragraph; and
          "(C) if requested by 1 or more members of the Commission, a
        statement of the minority views of the Commission.
      "(c) Powers of the Commission. - 
        "(1) Hearings. - The Commission may, for the purpose of
      carrying out this section, hold such hearings, meet and act at
      such times and places, take such testimony, and receive such
      evidence as the Commission considers advisable.
        "(2) Information from federal agencies. - 
          "(A) In general. - The Commission may secure directly, from
        any Federal agency, such information as the Commission
        considers necessary to carry out this section.
          "(B) Provision of information. - 
            "(i) In general. - Subject to subparagraph (C), on the
          request of the Commission, the head of a Federal agency
          described in subparagraph (A) may furnish information
          requested by the Commission to the Commission.
            "(ii) Administration. - The furnishing of information by a
          Federal agency to the Commission shall not be considered a
          waiver of any exemption available to the agency under section
          552 of title 5, United States Code.
          "(C) Information to be kept confidential. - 
            "(i) In general. - For purposes of section 1905 of title
          18, United States Code - 
         "(I) the Commission shall be considered an agency of the
          Federal Government; and
         "(II) any individual employed by an individual, entity, or
          organization that is a party to a contract with the
          Commission under this section shall be considered an employee
          of the Commission.
            "(ii) Prohibition on disclosure. - Information obtained by
          the Commission, other than information that is available to
          the public, shall not be disclosed to any person in any
          manner except to an employee of the Commission as described
          in clause (i), for the purpose of receiving, reviewing, or
          processing the information.
      "(d) Commission Personnel Matters. - 
        "(1) Members. - 
          "(A) Compensation. - A member of the Commission shall serve
        without compensation for the services of the member on the
        Commission.
          "(B) Travel expenses. - A member of the Commission shall be
        allowed travel expenses, including per diem in lieu of
        subsistence, at rates authorized for an employee of an agency
        under subchapter I of chapter 57 of title 5, United States
        Code, while away from the home or regular place of business of
        the member in the performance of the duties of the Commission.
        "(2) Staff. - 
          "(A) In general. - The Chairperson of the Commission may,
        without regard to the civil service laws (including
        regulations), appoint and terminate the appointment of an
        executive director and such other additional personnel as are
        necessary to enable the Commission to perform the duties of the
        Commission.
          "(B) Confirmation of executive director. - The employment of
        an executive director shall be subject to confirmation by the
        Commission.
          "(C) Compensation. - 
            "(i) In general. - Except as provided in clause (ii), the
          Chairperson of the Commission may fix the compensation of the
          executive director and other personnel without regard to the
          provisions of chapter 51 and subchapter III of chapter 53 of
          title 5, United States Code, relating to classification of
          positions and General Schedule pay rates.
            "(ii) Maximum rate of pay. - The rate of pay for the
          executive director and other personnel shall not exceed the
          rate payable for level II of the Executive Schedule under
          section 5316 of title 5, United States Code.
        "(3) Detail of federal government employees. - 
          "(A) In general. - An employee of the Federal Government may
        be detailed to the Commission, without reimbursement, for such
        period of time as is permitted by law.
          "(B) Civil service status. - The detail of the employee shall
        be without interruption or loss of civil service status or
        privilege.
        "(4) Procurement of temporary and intermittent services. - The
      Chairperson of the Commission may procure temporary and
      intermittent services in accordance with section 3109(b) of title
      5, United States Code, at rates for individuals that do not
      exceed the daily equivalent of the annual rate of basic pay
      prescribed for level II of the Executive Schedule under section
      5316 of that title.
      "(e) Authorization of Appropriations. - 
        "(1) In general. - There is authorized to be appropriated such
      sums as are necessary to carry out this section.
        "(2) Limitation. - No payment may be made under subsection (d)
      except to the extent provided for in advance in an appropriations
      Act.
      "(f) Termination. - The Commission shall terminate on the date
    that is 60 days after the date on which the Commission submits the
    recommendations and report under subsection (b)(3)."


-EXEC-
          EX. ORD. NO. 13100. PRESIDENT'S COUNCIL ON FOOD SAFETY      
      Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as amended by
    Ex. Ord. No. 13286, Sec. 16, Feb. 28, 2003, 68 F.R. 10623,
    provided:
      By the authority vested in me as President by the Constitution
    and the laws of the United States of America, and in order to
    improve the safety of the food supply through science-based
    regulation and well-coordinated inspection, enforcement, research,
    and education programs, it is hereby ordered as follows:
      Section 1. Establishment of President's Council on Food Safety.
    (a) There is established the President's Council on Food Safety
    ("Council"). The Council shall comprise the Secretaries of
    Agriculture, Commerce, Health and Human Services, and Homeland
    Security, the Director of the Office of Management and Budget
    (OMB), the Administrator of the Environmental Protection Agency,
    the Assistant to the President for Science and Technology/Director
    of the Office of Science and Technology Policy, the Assistant to
    the President for Domestic Policy, and the Director of the National
    Partnership for Reinventing Government. The Council shall consult
    with other Federal agencies and State, local, and tribal government
    agencies, and consumer, producer, scientific, and industry groups,
    as appropriate.
      (b) The Secretaries of Agriculture and of Health and Human
    Services and the Assistant to the President for Science and
    Technology/Director of the Office of Science and Technology Policy
    shall serve as Joint Chairs of the Council.
      Sec. 2. Purpose. The purpose of the Council shall be to develop a
    comprehensive strategic plan for Federal food safety activities,
    taking into consideration the findings and recommendations of the
    National Academy of Sciences report "Ensuring Safe Food from
    Production to Consumption" and other input from the public on how
    to improve the effectiveness of the current food safety system. The
    Council shall make recommendations to the President on how to
    advance Federal efforts to implement a comprehensive science-based
    strategy to improve the safety of the food supply and to enhance
    coordination among Federal agencies, State, local, and tribal
    governments, and the private sector. The Council shall advise
    Federal agencies in setting priority areas for investment in food
    safety.
      Sec. 3. Specific Activities and Functions. (a) The Council shall
    develop a comprehensive strategic Federal food safety plan that
    contains specific recommendations on needed changes, including
    measurable outcome goals. The principal goal of the plan should be
    the establishment of a seamless, science-based food safety system.
    The plan should address the steps necessary to achieve this goal,
    including the key public health, resource, and management issues
    regarding food safety. The planning process should consider both
    short-term and long-term issues including new and emerging threats
    and the special needs of vulnerable populations such as children
    and the elderly. In developing this plan, the Council shall consult
    with all interested parties, including State and local agencies,
    tribes, consumers, producers, industry, and academia.
      (b) Consistent with the comprehensive strategic Federal food
    safety plan described in section 3(a) of this order, the Council
    shall advise agencies of priority areas for investment in food
    safety and ensure that Federal agencies annually develop
    coordinated food safety budgets for submission to the OMB that
    sustain and strengthen existing capacities, eliminate duplication,
    and ensure the most effective use of resources for improving food
    safety. The Council shall also ensure that Federal agencies
    annually develop a unified budget for submission to the OMB for the
    President's Food Safety Initiative and such other food safety
    issues as the Council determines appropriate.
      (c) The Council shall ensure that the Joint Institute for Food
    Safety Research (JIFSR), in consultation with the National Science
    and Technology Council, establishes mechanisms to guide Federal
    research efforts toward the highest priority food safety needs. The
    JIFSR shall report to the Council on a regular basis on its
    efforts: (i) to develop a strategic plan for conducting food safety
    research activities consistent with the President's Food Safety
    Initiative and such other food safety activities as the JIFSR
    determines appropriate; and (ii) to coordinate efficiently, within
    the executive branch and with the private sector and academia, all
    Federal food safety research.
      Sec. 4. Cooperation. All actions taken by the Council shall, as
    appropriate, promote partnerships and cooperation with States,
    tribes, and other public and private sector efforts wherever
    possible to improve the safety of the food supply.
      Sec. 5. General Provisions. This order is intended only to
    improve the internal management of the executive branch and is not
    intended to, nor does it, create any right or benefit, substantive
    or procedural, enforceable at law by a party against the United
    States, its agencies, its officers or any person. Nothing in this
    order shall affect or alter the statutory responsibilities of any
    Federal agency charged with food safety responsibilities.

-End-



-CITE-
    21 USC Sec. 342                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 342. Adulterated food

-STATUTE-
      A food shall be deemed to be adulterated - 
    (a) Poisonous, insanitary, etc., ingredients
      (1) If it bears or contains any poisonous or deleterious
    substance which may render it injurious to health; but in case the
    substance is not an added substance such food shall not be
    considered adulterated under this clause if the quantity of such
    substance in such food does not ordinarily render it injurious to
    health.(!1) (2)(A) if it bears or contains any added poisonous or
    added deleterious substance (other than a substance that is a
    pesticide chemical residue in or on a raw agricultural commodity or
    processed food, a food additive, a color additive, or a new animal
    drug) that is unsafe within the meaning of section 346 of this
    title; or (B) if it bears or contains a pesticide chemical residue
    that is unsafe within the meaning of section 346a(a) of this title;
    or (C) if it is or if it bears or contains (i) any food additive
    that is unsafe within the meaning of section 348 of this title; or
    (ii) a new animal drug (or conversion product thereof) that is
    unsafe within the meaning of section 360b of this title; or (3) if
    it consists in whole or in part of any filthy, putrid, or
    decomposed substance, or if it is otherwise unfit for food; or (4)
    if it has been prepared, packed, or held under insanitary
    conditions whereby it may have become contaminated with filth, or
    whereby it may have been rendered injurious to health; or (5) if it
    is, in whole or in part, the product of a diseased animal or of an
    animal which has died otherwise than by slaughter; or (6) if its
    container is composed, in whole or in part, of any poisonous or
    deleterious substance which may render the contents injurious to
    health; or (7) if it has been intentionally subjected to radiation,
    unless the use of the radiation was in conformity with a regulation
    or exemption in effect pursuant to section 348 of this title.

    (b) Absence, substitution, or addition of constituents
      (1) If any valuable constituent has been in whole or in part
    omitted or abstracted therefrom; or (2) if any substance has been
    substituted wholly or in part therefor; or (3) if damage or
    inferiority has been concealed in any manner; or (4) if any
    substance has been added thereto or mixed or packed therewith so as
    to increase its bulk or weight, or reduce its quality or strength,
    or make it appear better or of greater value than it is.
    (c) Color additives
      If it is, or it bears or contains, a color additive which is
    unsafe within the meaning of section 379e(a) of this title.
    (d) Confectionery containing alcohol or nonnutritive substance
      If it is confectionery, and - 
        (1) has partially or completely imbedded therein any
      nonnutritive object, except that this subparagraph shall not
      apply in the case of any nonnutritive object if, in the judgment
      of the Secretary as provided by regulations, such object is of
      practical functional value to the confectionery product and would
      not render the product injurious or hazardous to health;
        (2) bears or contains any alcohol other than alcohol not in
      excess of one-half of 1 per centum by volume derived solely from
      the use of flavoring extracts, except that this clause shall not
      apply to confectionery which is introduced or delivered for
      introduction into, or received or held for sale in, interstate
      commerce if the sale of such confectionery is permitted under the
      laws of the State in which such confectionery is intended to be
      offered for sale;
        (3) bears or contains any nonnutritive substance, except that
      this subparagraph shall not apply to a safe nonnutritive
      substance which is in or on confectionery by reason of its use
      for some practical functional purpose in the manufacture,
      packaging, or storage of such confectionery if the use of the
      substance does not promote deception of the consumer or otherwise
      result in adulteration or misbranding in violation of any
      provision of this chapter, except that the Secretary may, for the
      purpose of avoiding or resolving uncertainty as to the
      application of this subparagraph, issue regulations allowing or
      prohibiting the use of particular nonnutritive substances.
    (e) Oleomargarine containing filthy, putrid, etc., matter
      If it is oleomargarine or margarine or butter and any of the raw
    material used therein consisted in whole or in part of any filthy,
    putrid, or decomposed substance, or such oleomargarine or margarine
    or butter is otherwise unfit for food.
    (f) Dietary supplement or ingredient: safety
      (1) If it is a dietary supplement or contains a dietary
    ingredient that - 
        (A) presents a significant or unreasonable risk of illness or
      injury under - 
          (i) conditions of use recommended or suggested in labeling,
        or
          (ii) if no conditions of use are suggested or recommended in
        the labeling, under ordinary conditions of use;

        (B) is a new dietary ingredient for which there is inadequate
      information to provide reasonable assurance that such ingredient
      does not present a significant or unreasonable risk of illness or
      injury;
        (C) the Secretary declares to pose an imminent hazard to public
      health or safety, except that the authority to make such
      declaration shall not be delegated and the Secretary shall
      promptly after such a declaration initiate a proceeding in
      accordance with sections 554 and 556 of title 5 to affirm or
      withdraw the declaration; or
        (D) is or contains a dietary ingredient that renders it
      adulterated under paragraph (a)(1) under the conditions of use
      recommended or suggested in the labeling of such dietary
      supplement.

    In any proceeding under this subparagraph, the United States shall
    bear the burden of proof on each element to show that a dietary
    supplement is adulterated. The court shall decide any issue under
    this paragraph on a de novo basis.
      (2) Before the Secretary may report to a United States attorney a
    violation of paragraph (!2) (1)(A) for a civil proceeding, the
    person against whom such proceeding would be initiated shall be
    given appropriate notice and the opportunity to present views,
    orally and in writing, at least 10 days before such notice, with
    regard to such proceeding.

    (g) Dietary supplement: manufacturing practices
      (1) If it is a dietary supplement and it has been prepared,
    packed, or held under conditions that do not meet current good
    manufacturing practice regulations, including regulations
    requiring, when necessary, expiration date labeling, issued by the
    Secretary under subparagraph (2).
      (2) The Secretary may by regulation prescribe good manufacturing
    practices for dietary supplements. Such regulations shall be
    modeled after current good manufacturing practice regulations for
    food and may not impose standards for which there is no current and
    generally available analytical methodology. No standard of current
    good manufacturing practice may be imposed unless such standard is
    included in a regulation promulgated after notice and opportunity
    for comment in accordance with chapter 5 of title 5.
    (h) Reoffer of food previously denied admission
      If it is an article of food imported or offered for import into
    the United States and the article of food has previously been
    refused admission under section 381(a) of this title, unless the
    person reoffering the article affirmatively establishes, at the
    expense of the owner or consignee of the article, that the article
    complies with the applicable requirements of this chapter, as
    determined by the Secretary.
    (i) Noncompliance with sanitary transportation practices
      If it is transported or offered for transport by a shipper,
    carrier by motor vehicle or rail vehicle, receiver, or any other
    person engaged in the transportation of food under conditions that
    are not in compliance with regulations promulgated under section
    350e of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 402, 52 Stat. 1046; Mar. 16, 1950,
    ch. 61, Sec. 3(d), 64 Stat. 21; July 22, 1954, ch. 559, Sec. 2, 68
    Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85-929,
    Sec. 3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-2, Mar.
    17, 1959, 73 Stat. 3; Pub. L. 86-618, title I, Secs. 102(a)(1),
    (2), 105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89-477,
    June 29, 1966, 80 Stat. 231; Pub. L. 90-399, Sec. 104, July 13,
    1968, 82 Stat. 352; Pub. L. 99-252, Sec. 10, Feb. 27, 1986, 100
    Stat. 35; Pub. L. 102-571, title I, Sec. 107(4), Oct. 29, 1992, 106
    Stat. 4499; Pub. L. 103-80, Sec. 3(i), Aug. 13, 1993, 107 Stat.
    776; Pub. L. 103-417, Secs. 4, 9, Oct. 25, 1994, 108 Stat. 4328,
    4332; Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996, 110 Stat.
    1514; Pub. L. 107-188, title III, Sec. 309, June 12, 2002, 116
    Stat. 673; Pub. L. 109-59, title VII, Sec. 7202(a), Aug. 10, 2005,
    119 Stat. 1911.)


-MISC1-
                                AMENDMENTS                            
      2005 - Par. (i). Pub. L. 109-59 added par. (i).
      2002 - Par. (h). Pub. L. 107-188 added par. (h).
      1996 - Par. (a). Pub. L. 104-170 added subpar. (2) and struck out
    former subpar. (2) which read as follows: "(2)(A) if it bears or
    contains any added poisonous or added deleterious substance (other
    than one which is (i) a pesticide chemical in or on a raw
    agricultural commodity; (ii) a food additive; (iii) a color
    additive; or (iv) a new animal drug) which is unsafe within the
    meaning of section 346 of this title, or (B) if it is a raw
    agricultural commodity and it bears or contains a pesticide
    chemical which is unsafe within the meaning of section 346a(a) of
    this title, or (C) if it is, or if it bears or contains, any food
    additive which is unsafe within the meaning of section 348 of this
    title: Provided, That where a pesticide chemical has been used in
    or on a raw agricultural commodity in conformity with an exemption
    granted or a tolerance prescribed under section 346a of this title
    and such raw agricultural commodity has been subjected to
    processing such as canning, cooking, freezing, dehydrating, or
    milling, the residue of such pesticide chemical remaining in or on
    such processed food shall, notwithstanding the provisions of
    sections 346 and 348 of this title, not be deemed unsafe if such
    residue in or on the raw agricultural commodity has been removed to
    the extent possible in good manufacturing practice and the
    concentration of such residue in the processed food when ready to
    eat is not greater than the tolerance prescribed for the raw
    agricultural commodity, or (D) if it is, or it bears or contains, a
    new animal drug (or conversion product thereof) which is unsafe
    within the meaning of section 360b of this title;". That part of
    Pub. L. 104-170 which directed the substitution of "or (3) if it
    consists" for "(3) if it consists" was executed by making the
    substitution for "(3) If it consists" to reflect the probable
    intent of Congress.
      1994 - Par. (f). Pub. L. 103-417, Sec. 4, added par. (f).
      Par. (g). Pub. L. 103-417, Sec. 9, added par. (g).
      1993 - Par. (a). Pub. L. 103-80, Sec. 3(i)(1), substituted a
    period for "; or" at end of subpar. (1) and "If it" for "if it" at
    beginning of par. (3). That part of Pub. L. 103-80, Sec. 3(i)(1),
    which directed the substitution of a period for "; or" at end of
    subpar. (2) could not be executed because "; or" did not appear.
      Par. (d)(1). Pub. L. 103-80, Sec. 3(i)(2), substituted ", except
    that this subparagraph" for ": Provided, That this clause".
      Par. (d)(3). Pub. L. 103-80, Sec. 3(i)(3), substituted ", except
    that this subparagraph shall not apply" for ": Provided, That this
    clause shall not apply" and ", except that the Secretary may, for
    the purpose of avoiding or resolving uncertainty as to the
    application of this subparagraph" for ": And provided further, That
    the Secretary may, for the purpose of avoiding or resolving
    uncertainty as to the application of this clause".
      1992 - Par. (c). Pub. L. 102-571 substituted "379e(a)" for
    "376(a)".
      1986 - Par. (d)(2). Pub. L. 99-252 inserted provision that this
    clause not apply to confectionery introduced or delivered for
    introduction into or received or held for sale in, interstate
    commerce if the sale is permitted under the laws of the State in
    which the confectionery is intended to be offered for sale.
      1968 - Par. (a)(2). Pub. L. 90-399 added cls. (A)(iv) and (D).
      1966 - Par. (d). Pub. L. 89-477 permitted the imbedding of
    nonnutritive objects in confectionery foods if in the judgment of
    the Secretary of Health, Education, and Welfare, as provided by
    regulation, the imbedding of the object is of practical functional
    value to the confectionery product and would not render it
    injurious or hazardous to health, raised to one-half of 1 per
    centum by volume the upper limit for the allowable use of alcohol
    derived solely from the use of flavoring extracts, allowed the use
    of safe nonnutritive substances in and on confectionery foods by
    reason of their use for some practical and functional purpose in
    the manufacture, packaging, or storage of the confectionery foods
    if the use of the substances does not promote deception of the
    consumer or otherwise result in adulteration or misbranding,
    authorized the Secretary to issue regulations on the use of
    particular nonnutritive substances, and removed reference to
    nonnutritive masticatory substances added to chewing gum and
    harmless flavoring, harmless resinous glaze not in excess of four-
    tenths of 1 per centum, natural gum, authorized coloring, and
    pectin.
      1960 - Par. (a). Pub. L. 86-618, Sec. 102(a)(1), substituted
    "other than one which is (i) a pesticide chemical in or on a raw
    agricultural commodity; (ii) a food additive; or (iii) a color
    additive" for "(except a pesticide chemical in or on a raw
    agricultural commodity and except a food additive)" in cl. (2)(A).
      Par. (c). Pub. L. 86-618, Sec. 102(a)(2), amended par. (c)
    generally, substituting provisions deeming a food adulterated if it
    is, or it bears or contains, a color additive which is unsafe
    within the meaning of section 376 of this title for provisions
    which related to food that bears or contains a coal-tar color other
    than one from a batch that has been certified in accordance with
    regulations as provided by section 346 of this title, and struck
    out provisos which related to the use of color on oranges.
      Par. (d). Pub. L. 86-618, Sec. 105(c), substituted "authorized
    coloring" for "harmless coloring".
      1959 - Par. (c). Pub. L. 86-2 extended from Mar. 1, 1959, to May
    1, 1959, the period during which subsection is inapplicable to
    oranges which have been colored with F.D. & C. Red 32, and inserted
    proviso requiring Secretary to establish regulations prescribing
    the conditions under which Citrus Red No. 2 may be safely used in
    coloring certain mature oranges, and providing for separately
    listing and for certification of batches of such color.
      1958 - Par. (a). Pub. L. 85-929, among other changes, inserted
    cl. (2)(C) relating to food additive unsafe within the meaning of
    section 348 of this title, and to pesticide chemical, and added cl.
    (7) relating to radiated food.
      1956 - Par. (c). Act July 9, 1956, inserted second proviso
    relating to coloring of oranges.
      1954 - Par. (a)(2). Act July 22, 1954, provided in the case of
    any raw agricultural commodity bearing or containing a pesticide
    chemical, that such commodity shall be deemed to be adulterated if
    such pesticide chemical is unsafe within the meaning of section
    346a of this title.
      1950 - Par. (e). Act Mar. 16, 1950, added par. (e).

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-59 effective Oct. 1, 2005, see section
    7204 of Pub. L. 109-59, set out as a note under section 331 of this
    title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

       EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
                        DESICCANT AMENDMENT OF 1959
      Effective date of par. (a)(2) as in force prior to July 22, 1954,
    with respect to particular commercial use of a nematocide, plant
    regulator, defoliant, or desiccant in or on a raw agricultural
    commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
    139, Aug. 7, 1959, 73 Stat. 288.

                     EFFECTIVE DATE OF 1958 AMENDMENT                 
      Section 6 of Pub. L. 85-929, as amended by Pub. L. 87-19, Sec. 2,
    Apr. 7, 1961, 75 Stat. 42; Pub. L. 88-625, Sec. 2, Oct. 3, 1964, 78
    Stat. 1002, provided that:
      "(a) Except as provided in subsections (b) and (c) of this
    section, this Act [amending this section, sections 321, 331, 346,
    and 348 of this title, and section 210 of Title 42, The Public
    Health and Welfare, and enacting provisions set out as notes under
    sections 321 and 451 of this title] shall take effect on the date
    of its enactment [Sept. 6, 1958].
      "(b) Except as provided in subsection (c) of this section,
    section 3 of this Act [amending this section and section 346 of
    this title] shall take effect on the one hundred and eightieth day
    after the date of enactment of this Act [Sept. 6, 1958].
      "(c) With respect to any particular commercial use of a food
    additive, if such use was made of such additive before January 1,
    1958, section 3 of this Act [amending this section and section 346
    of this title] shall take effect - 
        "(1) Either (A) one year after the effective date established
      in subsection (b) of this section, or (B) at the end of such
      additional period (but not later than two years from such
      effective date established in subsection (b)) as the Secretary of
      Health, Education, and Welfare [now Health and Human Services]
      may prescribe on the basis of a finding that such extension
      involves no undue risk to the public health and that conditions
      exist which necessitate the prescribing of such an additional
      period, or
        "(2) on the date on which an order with respect to such use
      under section 409 of the Federal Food, Drug, and Cosmetic Act
      [section 348 of this title] becomes effective,
    whichever date first occurs. Whenever the Secretary has, pursuant
    to clause (1)(B) of this subsection, extended the effective date of
    section 3 of this Act [amending this section] to March 5, 1961, or
    has on that date a request for such extension pending before him,
    with respect to any such particular use of a food additive, he may,
    notwithstanding the parenthetical time limitation in that clause,
    further extend such effective date, not beyond June 30, 1964, under
    the authority of that clause (but subject to clause (2)) with
    respect to such use of the additive (or a more limited specified
    use or uses thereof) if, in addition to making the findings
    required by clause (1)(B), he finds (i) that bona fide action to
    determine the applicability of such section 409 [section 348 of
    this title] to such use or uses, or to develop the scientific data
    necessary for action under such section, was commenced by an
    interested person before March 6, 1960, and was thereafter pursued
    with reasonable diligence, and (ii) that in the Secretary's
    judgment such extension is consistent with the objective of
    carrying to completion in good faith, as soon as reasonably
    practicable, the scientific investigations necessary as a basis for
    action under such section 409 [section 348 of this title]:
    Provided, That if the Secretary has, pursuant to this sentence,
    granted an extension to June 30, 1964, he may, upon making the
    findings required by clause (1)(B) of this subsection and clauses
    (i) and (ii) of this sentence, further extend such effective date,
    but not beyond December 31, 1965. The Secretary may at any time
    terminate an extension so granted if he finds that it should not
    have been granted, or that by reason of a change in circumstances
    the basis for such extension no longer exists, or that there has
    been a failure to comply with a requirement for submission of
    progress reports or with other conditions attached to such
    extension."

                     EFFECTIVE DATE OF 1954 AMENDMENT                 
      Section 5 of act July 22, 1954, provided that: "This Act
    [amending this section and section 321 of this title and enacting
    sections 346a and 346b of this title] shall take effect upon the
    date of its enactment [July 22, 1954], except that with respect to
    pesticide chemicals for which tolerances or exemptions have not
    been established under section 408 of the Federal Food, Drug, and
    Cosmetic Act [section 346a of this title], the amendment to section
    402(a) of such Act [par. (a) of this section] made by section 2 of
    this Act shall not be effective - 
        "(1) for the period of one year following the date of the
      enactment of this Act [July 22, 1954]; or
        "(2) for such additional period following such period of one
      year, but not extending beyond two years after the date of the
      enactment of this Act [July 22, 1954] as the Secretary of Health,
      Education, and Welfare [now Health and Human Services] may
      prescribe on the basis of a finding that conditions exist which
      necessitate the prescribing of such additional period."

                     EFFECTIVE DATE OF 1950 AMENDMENT                 
      Amendment by act Mar. 16, 1950, effective July 1, 1950, see
    section 7 of act Mar. 16, 1950, set out as an Effective Date note
    under section 347 of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
    53 Stat. 853, set out as an Effective Date; Postponement in Certain
    Cases note under section 301 of this title.

                                SHORT TITLE                            
      Pub. L. 88-625, Sec. 1, Oct. 3, 1964, 78 Stat. 1002, provided:
    "That this Act [amending provisions set out as a note under this
    section and section 135 of Title 7, Agriculture] may be cited as
    the 'Food Additives Transitional Provisions Amendment of 1964'."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
    DOMESTIC FISH OR FISH PRODUCT COMPLIANCE WITH FOOD SAFETY STANDARDS
    OR PROCEDURES DEEMED TO HAVE MET REQUIREMENTS FOR FEDERAL COMMODITY
                             PURCHASE PROGRAMS
      Pub. L. 104-180, title VII, Sec. 733, Aug. 6, 1996, 110 Stat.
    1601, provided that: "Hereafter, notwithstanding any other
    provision of law, any domestic fish or fish product produced in
    compliance with food safety standards or procedures accepted by the
    Food and Drug Administration as satisfying the requirements of the
    'Procedures for the Safe and Sanitary Processing and Importing of
    Fish and Fish Products' (published by the Food and Drug
    Administration as a final regulation in the Federal Register of
    December 18, 1995), shall be deemed to have met any inspection
    requirements of the Department of Agriculture or other Federal
    agency for any Federal commodity purchase program, including the
    program authorized under section 32 of the Act of August 24, 1935
    (7 U.S.C. 612c) except that the Department of Agriculture or other
    Federal agency may utilize lot inspection to establish a reasonable
    degree of certainty that fish or fish products purchased under a
    Federal commodity purchase program, including the program
    authorized under section 32 of the Act of August 24, 1935 (7 U.S.C.
    612c), meet Federal product specifications."

-FOOTNOTE-
    (!1) So in original. The period probably should be "; or".

    (!2) So in original. Probably should be "subparagraph".


-End-



-CITE-
    21 USC Sec. 343                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343. Misbranded food

-STATUTE-
      A food shall be deemed to be misbranded - 
    (a) False or misleading label
      If (1) its labeling is false or misleading in any particular, or
    (2) in the case of a food to which section 350 of this title
    applies, its advertising is false or misleading in a material
    respect or its labeling is in violation of section 350(b)(2) of
    this title.
    (b) Offer for sale under another name
      If it is offered for sale under the name of another food.
    (c) Imitation of another food
      If it is an imitation of another food, unless its label bears, in
    type of uniform size and prominence, the word "imitation" and,
    immediately thereafter, the name of the food imitated.
    (d) Misleading container
      If its container is so made, formed, or filled as to be
    misleading.
    (e) Package form
      If in package form unless it bears a label containing (1) the
    name and place of business of the manufacturer, packer, or
    distributor; and (2) an accurate statement of the quantity of the
    contents in terms of weight, measure, or numerical count, except
    that under clause (2) of this paragraph reasonable variations shall
    be permitted, and exemptions as to small packages shall be
    established, by regulations prescribed by the Secretary.
    (f) Prominence of information on label
      If any word, statement, or other information required by or under
    authority of this chapter to appear on the label or labeling is not
    prominently placed thereon with such conspicuousness (as compared
    with other words, statements, designs, or devices, in the labeling)
    and in such terms as to render it likely to be read and understood
    by the ordinary individual under customary conditions of purchase
    and use.
    (g) Representation as to definition and standard of identity
      If it purports to be or is represented as a food for which a
    definition and standard of identity has been prescribed by
    regulations as provided by section 341 of this title, unless (1) it
    conforms to such definition and standard, and (2) its label bears
    the name of the food specified in the definition and standard, and,
    insofar as may be required by such regulations, the common names of
    optional ingredients (other than spices, flavoring, and coloring)
    present in such food.
    (h) Representation as to standards of quality and fill of container
      If it purports to be or is represented as - 
        (1) a food for which a standard of quality has been prescribed
      by regulations as provided by section 341 of this title, and its
      quality falls below such standard, unless its label bears, in
      such manner and form as such regulations specify, a statement
      that it falls below such standard;
        (2) a food for which a standard or standards of fill of
      container have been prescribed by regulations as provided by
      section 341 of this title, and it falls below the standard of
      fill of container applicable thereto, unless its label bears, in
      such manner and form as such regulations specify, a statement
      that it falls below such standard; or
        (3) a food that is pasteurized unless - 
          (A) such food has been subjected to a safe process or
        treatment that is prescribed as pasteurization for such food in
        a regulation promulgated under this chapter; or
          (B)(i) such food has been subjected to a safe process or
        treatment that - 
            (I) is reasonably certain to achieve destruction or
          elimination in the food of the most resistant microorganisms
          of public health significance that are likely to occur in the
          food;
            (II) is at least as protective of the public health as a
          process or treatment described in subparagraph (A);
            (III) is effective for a period that is at least as long as
          the shelf life of the food when stored under normal and
          moderate abuse conditions; and
            (IV) is the subject of a notification to the Secretary,
          including effectiveness data regarding the process or
          treatment; and

          (ii) at least 120 days have passed after the date of receipt
        of such notification by the Secretary without the Secretary
        making a determination that the process or treatment involved
        has not been shown to meet the requirements of subclauses (I)
        through (III) of clause (i).

    For purposes of paragraph (3), a determination by the Secretary
    that a process or treatment has not been shown to meet the
    requirements of subclauses (I) through (III) of subparagraph (B)(i)
    shall constitute final agency action under such subclauses.
    (i) Label where no representation as to definition and standard of
      identity
      Unless its label bears (1) the common or usual name of the food,
    if any there be, and (2) in case it is fabricated from two or more
    ingredients, the common or usual name of each such ingredient and
    if the food purports to be a beverage containing vegetable or fruit
    juice, a statement with appropriate prominence on the information
    panel of the total percentage of such fruit or vegetable juice
    contained in the food; except that spices, flavorings, and colors
    not required to be certified under section 379e(c) of this title
    (!1) unless sold as spices, flavorings, or such colors, may be
    designated as spices, flavorings, and colorings without naming
    each. To the extent that compliance with the requirements of clause
    (2) of this paragraph is impracticable, or results in deception or
    unfair competition, exemptions shall be established by regulations
    promulgated by the Secretary.

    (j) Representation for special dietary use
      If it purports to be or is represented for special dietary uses,
    unless its label bears such information concerning its vitamin,
    mineral, and other dietary properties as the Secretary determines
    to be, and by regulations prescribes as, necessary in order fully
    to inform purchasers as to its value for such uses.
    (k) Artificial flavoring, artificial coloring, or chemical
      preservatives
      If it bears or contains any artificial flavoring, artificial
    coloring, or chemical preservative, unless it bears labeling
    stating that fact, except that to the extent that compliance with
    the requirements of this paragraph is impracticable, exemptions
    shall be established by regulations promulgated by the Secretary.
    The provisions of this paragraph and paragraphs (g) and (i) with
    respect to artificial coloring shall not apply in the case of
    butter, cheese, or ice cream. The provisions of this paragraph with
    respect to chemical preservatives shall not apply to a pesticide
    chemical when used in or on a raw agricultural commodity which is
    the produce of the soil.
    (l) Pesticide chemicals on raw agricultural commodities
      If it is a raw agricultural commodity which is the produce of the
    soil, bearing or containing a pesticide chemical applied after
    harvest, unless the shipping container of such commodity bears
    labeling which declares the presence of such chemical in or on such
    commodity and the common or usual name and the function of such
    chemical, except that no such declaration shall be required while
    such commodity, having been removed from the shipping container, is
    being held or displayed for sale at retail out of such container in
    accordance with the custom of the trade.
    (m) Color additives
      If it is a color additive, unless its packaging and labeling are
    in conformity with such packaging and labeling requirements,
    applicable to such color additive, as may be contained in
    regulations issued under section 379e of this title.
    (n) Packaging or labeling of drugs in violation of regulations
      If its packaging or labeling is in violation of an applicable
    regulation issued pursuant to section 1472 or 1473 of title 15.
    (o) Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec. 517],
      Dec. 21, 2000, 114 Stat. 2763, 2763A-73
    (p) Repealed. Pub. L. 104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882
    (q) Nutrition information
      (1) Except as provided in subparagraphs (3), (4), and (5), if it
    is a food intended for human consumption and is offered for sale,
    unless its label or labeling bears nutrition information that
    provides - 
        (A)(i) the serving size which is an amount customarily consumed
      and which is expressed in a common household measure that is
      appropriate to the food, or
        (ii) if the use of the food is not typically expressed in a
      serving size, the common household unit of measure that expresses
      the serving size of the food,
        (B) the number of servings or other units of measure per
      container,
        (C) the total number of calories - 
          (i) derived from any source, and
          (ii) derived from the total fat,

      in each serving size or other unit of measure of the food,
        (D) the amount of the following nutrients: Total fat, saturated
      fat, cholesterol, sodium, total carbohydrates, complex
      carbohydrates, sugars, dietary fiber, and total protein contained
      in each serving size or other unit of measure,
        (E) any vitamin, mineral, or other nutrient required to be
      placed on the label and labeling of food under this chapter
      before October 1, 1990, if the Secretary determines that such
      information will assist consumers in maintaining healthy dietary
      practices.

    The Secretary may by regulation require any information required to
    be placed on the label or labeling by this subparagraph or
    subparagraph (2)(A) to be highlighted on the label or labeling by
    larger type, bold type, or contrasting color if the Secretary
    determines that such highlighting will assist consumers in
    maintaining healthy dietary practices.
      (2)(A) If the Secretary determines that a nutrient other than a
    nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should
    be included in the label or labeling of food subject to
    subparagraph (1) for purposes of providing information regarding
    the nutritional value of such food that will assist consumers in
    maintaining healthy dietary practices, the Secretary may by
    regulation require that information relating to such additional
    nutrient be included in the label or labeling of such food.
      (B) If the Secretary determines that the information relating to
    a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or
    clause (A) of this subparagraph to be included in the label or
    labeling of food is not necessary to assist consumers in
    maintaining healthy dietary practices, the Secretary may by
    regulation remove information relating to such nutrient from such
    requirement.
      (3) For food that is received in bulk containers at a retail
    establishment, the Secretary may, by regulation, provide that the
    nutrition information required by subparagraphs (1) and (2) be
    displayed at the location in the retail establishment at which the
    food is offered for sale.
      (4)(A) The Secretary shall provide for furnishing the nutrition
    information required by subparagraphs (1) and (2) with respect to
    raw agricultural commodities and raw fish by issuing voluntary
    nutrition guidelines, as provided by clause (B) or by issuing
    regulations that are mandatory as provided by clause (D).
      (B)(i) Upon the expiration of 12 months after November 8, 1990,
    the Secretary, after providing an opportunity for comment, shall
    issue guidelines for food retailers offering raw agricultural
    commodities or raw fish to provide nutrition information specified
    in subparagraphs (1) and (2). Such guidelines shall take into
    account the actions taken by food retailers during such 12-month
    period to provide to consumers nutrition information on raw
    agricultural commodities and raw fish. Such guidelines shall only
    apply - 
        (I) in the case of raw agricultural commodities, to the 20
      varieties of vegetables most frequently consumed during a year
      and the 20 varieties of fruit most frequently consumed during a
      year, and
        (II) to the 20 varieties of raw fish most frequently consumed
      during a year.

    The vegetables, fruits, and raw fish to which such guidelines apply
    shall be determined by the Secretary by regulation and the
    Secretary may apply such guidelines regionally.
      (ii) Upon the expiration of 12 months after November 8, 1990, the
    Secretary shall issue a final regulation defining the circumstances
    that constitute substantial compliance by food retailers with the
    guidelines issued under subclause (i). The regulation shall provide
    that there is not substantial compliance if a significant number of
    retailers have failed to comply with the guidelines. The size of
    the retailers and the portion of the market served by retailers in
    compliance with the guidelines shall be considered in determining
    whether the substantial-compliance standard has been met.
      (C)(i) Upon the expiration of 30 months after November 8, 1990,
    the Secretary shall issue a report on actions taken by food
    retailers to provide consumers with nutrition information for raw
    agricultural commodities and raw fish under the guidelines issued
    under clause (A). Such report shall include a determination of
    whether there is substantial compliance with the guidelines.
      (ii) If the Secretary finds that there is substantial compliance
    with the guidelines, the Secretary shall issue a report and make a
    determination of the type required in subclause (i) every two
    years.
      (D)(i) If the Secretary determines that there is not substantial
    compliance with the guidelines issued under clause (A), the
    Secretary shall at the time such determination is made issue
    proposed regulations requiring that any person who offers raw
    agricultural commodities or raw fish to consumers provide, in a
    manner prescribed by regulations, the nutrition information
    required by subparagraphs (1) and (2). The Secretary shall issue
    final regulations imposing such requirements 6 months after issuing
    the proposed regulations. The final regulations shall become
    effective 6 months after the date of their promulgation.
      (ii) Regulations issued under subclause (i) may require that the
    nutrition information required by subparagraphs (1) and (2) be
    provided for more than 20 varieties of vegetables, 20 varieties of
    fruit, and 20 varieties of fish most frequently consumed during a
    year if the Secretary finds that a larger number of such products
    are frequently consumed. Such regulations shall permit such
    information to be provided in a single location in each area in
    which raw agricultural commodities and raw fish are offered for
    sale. Such regulations may provide that information shall be
    expressed as an average or range per serving of the same type of
    raw agricultural commodity or raw fish. The Secretary shall develop
    and make available to the persons who offer such food to consumers
    the information required by subparagraphs (1) and (2).
      (iii) Regulations issued under subclause (i) shall permit the
    required information to be provided in each area of an
    establishment in which raw agricultural commodities and raw fish
    are offered for sale. The regulations shall permit food retailers
    to display the required information by supplying copies of the
    information provided by the Secretary, by making the information
    available in brochure, notebook or leaflet form, or by posting a
    sign disclosing the information. Such regulations shall also permit
    presentation of the required information to be supplemented by a
    video, live demonstration, or other media which the Secretary
    approves.
      (E) For purposes of this subparagraph, the term "fish" includes
    freshwater or marine fin fish, crustaceans, and mollusks, including
    shellfish, amphibians, and other forms of aquatic animal life.
      (F) No person who offers raw agricultural commodities or raw fish
    to consumers may be prosecuted for minor violations of this
    subparagraph if there has been substantial compliance with the
    requirements of this paragraph.
      (5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to
    food - 
        (i) which is served in restaurants or other establishments in
      which food is served for immediate human consumption or which is
      sold for sale or use in such establishments,
        (ii) which is processed and prepared primarily in a retail
      establishment, which is ready for human consumption, which is of
      the type described in subclause (i), and which is offered for
      sale to consumers but not for immediate human consumption in such
      establishment and which is not offered for sale outside such
      establishment,
        (iii) which is an infant formula subject to section 350a of
      this title,
        (iv) which is a medical food as defined in section 360ee(b) of
      this title, or
        (v) which is described in section 345(2) of this title.

      (B) Subparagraphs (1) and (2) shall not apply to the label of a
    food if the Secretary determines by regulations that compliance
    with such subparagraphs is impracticable because the package of
    such food is too small to comply with the requirements of such
    subparagraphs and if the label of such food does not contain any
    nutrition information.
      (C) If a food contains insignificant amounts, as determined by
    the Secretary, of all the nutrients required by subparagraphs (1)
    and (2) to be listed in the label or labeling of food, the
    requirements of such subparagraphs shall not apply to such food if
    the label, labeling, or advertising of such food does not make any
    claim with respect to the nutritional value of such food. If a food
    contains insignificant amounts, as determined by the Secretary, of
    more than one-half the nutrients required by subparagraphs (1) and
    (2) to be in the label or labeling of the food, the Secretary shall
    require the amounts of such nutrients to be stated in a simplified
    form prescribed by the Secretary.
      (D) If a person offers food for sale and has annual gross sales
    made or business done in sales to consumers which is not more than
    $500,000 or has annual gross sales made or business done in sales
    of food to consumers which is not more than $50,000, the
    requirements of subparagraphs (1), (2), (3), and (4) shall not
    apply with respect to food sold by such person to consumers unless
    the label or labeling of food offered by such person provides
    nutrition information or makes a nutrition claim.
      (E)(i) During the 12-month period for which an exemption from
    subparagraphs (1) and (2) is claimed pursuant to this subclause,
    the requirements of such subparagraphs shall not apply to any food
    product if - 
        (I) the labeling for such product does not provide nutrition
      information or make a claim subject to paragraph (r),
        (II) the person who claims for such product an exemption from
      such subparagraphs employed fewer than an average of 100 full-
      time equivalent employees,
        (III) such person provided the notice described in subclause
      (iii), and
        (IV) in the case of a food product which was sold in the 12-
      month period preceding the period for which an exemption was
      claimed, fewer than 100,000 units of such product were sold in
      the United States during such preceding period, or in the case of
      a food product which was not sold in the 12-month period
      preceding the period for which such exemption is claimed, fewer
      than 100,000 units of such product are reasonably anticipated to
      be sold in the United States during the period for which such
      exemption is claimed.

      (ii) During the 12-month period after the applicable date
    referred to in this sentence, the requirements of subparagraphs (1)
    and (2) shall not apply to any food product which was first
    introduced into interstate commerce before May 8, 1994, if the
    labeling for such product does not provide nutrition information or
    make a claim subject to paragraph (r), if such person provided the
    notice described in subclause (iii), and if - 
        (I) during the 12-month period preceding May 8, 1994, the
      person who claims for such product an exemption from such
      subparagraphs employed fewer than an average of 300 full-time
      equivalent employees and fewer than 600,000 units of such product
      were sold in the United States,
        (II) during the 12-month period preceding May 8, 1995, the
      person who claims for such product an exemption from such
      subparagraphs employed fewer than an average of 300 full-time
      equivalent employees and fewer than 400,000 units of such product
      were sold in the United States, or
        (III) during the 12-month period preceding May 8, 1996, the
      person who claims for such product an exemption from such
      subparagraphs employed fewer than an average of 200 full-time
      equivalent employees and fewer than 200,000 units of such product
      were sold in the United States.

      (iii) The notice referred to in subclauses (i) and (ii) shall be
    given to the Secretary prior to the beginning of the period during
    which the exemption under subclause (i) or (ii) is to be in effect,
    shall state that the person claiming such exemption for a food
    product has complied with the applicable requirements of subclause
    (i) or (ii), and shall - 
        (I) state the average number of full-time equivalent employees
      such person employed during the 12 months preceding the date such
      person claims such exemption,
        (II) state the approximate number of units the person claiming
      the exemption sold in the United States,
        (III) if the exemption is claimed for a food product which was
      sold in the 12-month period preceding the period for which the
      exemption was claimed, state the approximate number of units of
      such product which were sold in the United States during such
      preceding period, and, if the exemption is claimed for a food
      product which was not sold in such preceding period, state the
      number of units of such product which such person reasonably
      anticipates will be sold in the United States during the period
      for which the exemption was claimed, and
        (IV) contain such information as the Secretary may require to
      verify the information required by the preceding provisions of
      this subclause if the Secretary has questioned the validity of
      such information.

    If a person is not an importer, has fewer than 10 full-time
    equivalent employees, and sells fewer than 10,000 units of any food
    product in any year, such person is not required to file a notice
    for such product under this subclause for such year.
      (iv) In the case of a person who claimed an exemption under
    subclause (i) or (ii), if, during the period of such exemption, the
    number of full-time equivalent employees of such person exceeds the
    number in such subclause or if the number of food products sold in
    the United States exceeds the number in such subclause, such
    exemption shall extend to the expiration of 18 months after the
    date the number of full-time equivalent employees or food products
    sold exceeded the applicable number.
      (v) For any food product first introduced into interstate
    commerce after May 8, 2002, the Secretary may by regulation lower
    the employee or units of food products requirement of subclause (i)
    if the Secretary determines that the cost of compliance with such
    lower requirement will not place an undue burden on persons subject
    to such lower requirement.
      (vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v) -
    
        (I) the term "unit" means the packaging or, if there is no
      packaging, the form in which a food product is offered for sale
      to consumers,
        (II) the term "food product" means food in any sized package
      which is manufactured by a single manufacturer or which bears the
      same brand name, which bears the same statement of identity, and
      which has similar preparation methods, and
        (III) the term "person" in the case of a corporation includes
      all domestic and foreign affiliates of the corporation.

      (F) A dietary supplement product (including a food to which
    section 350 of this title applies) shall comply with the
    requirements of subparagraphs (1) and (2) in a manner which is
    appropriate for the product and which is specified in regulations
    of the Secretary which shall provide that - 
        (i) nutrition information shall first list those dietary
      ingredients that are present in the product in a significant
      amount and for which a recommendation for daily consumption has
      been established by the Secretary, except that a dietary
      ingredient shall not be required to be listed if it is not
      present in a significant amount, and shall list any other dietary
      ingredient present and identified as having no such
      recommendation;
        (ii) the listing of dietary ingredients shall include the
      quantity of each such ingredient (or of a proprietary blend of
      such ingredients) per serving;
        (iii) the listing of dietary ingredients may include the source
      of a dietary ingredient; and
        (iv) the nutrition information shall immediately precede the
      ingredient information required under subclause (i), except that
      no ingredient identified pursuant to subclause (i) shall be
      required to be identified a second time.

      (G) Subparagraphs (1), (2), (3), and (4) shall not apply to food
    which is sold by a food distributor if the food distributor
    principally sells food to restaurants or other establishments in
    which food is served for immediate human consumption and does not
    manufacture, process, or repackage the food it sells.
    (r) Nutrition levels and health-related claims
      (1) Except as provided in clauses (A) through (C) of subparagraph
    (5), if it is a food intended for human consumption which is
    offered for sale and for which a claim is made in the label or
    labeling of the food which expressly or by implication - 
        (A) characterizes the level of any nutrient which is of the
      type required by paragraph (q)(1) or (q)(2) to be in the label or
      labeling of the food unless the claim is made in accordance with
      subparagraph (2), or
        (B) characterizes the relationship of any nutrient which is of
      the type required by paragraph (q)(1) or (q)(2) to be in the
      label or labeling of the food to a disease or a health-related
      condition unless the claim is made in accordance with
      subparagraph (3) or (5)(D).

    A statement of the type required by paragraph (q) that appears as
    part of the nutrition information required or permitted by such
    paragraph is not a claim which is subject to this paragraph and a
    claim subject to clause (A) is not subject to clause (B).
      (2)(A) Except as provided in subparagraphs (4)(A)(ii) and
    (4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a
    claim described in subparagraph (1)(A) - 
        (i) may be made only if the characterization of the level made
      in the claim uses terms which are defined in regulations of the
      Secretary,
        (ii) may not state the absence of a nutrient unless - 
          (I) the nutrient is usually present in the food or in a food
        which substitutes for the food as defined by the Secretary by
        regulation, or
          (II) the Secretary by regulation permits such a statement on
        the basis of a finding that such a statement would assist
        consumers in maintaining healthy dietary practices and the
        statement discloses that the nutrient is not usually present in
        the food,

        (iii) may not be made with respect to the level of cholesterol
      in the food if the food contains, as determined by the Secretary
      by regulation, fat or saturated fat in an amount which increases
      to persons in the general population the risk of disease or a
      health related condition which is diet related unless - 
          (I) the Secretary finds by regulation that the level of
        cholesterol is substantially less than the level usually
        present in the food or in a food which substitutes for the food
        and which has a significant market share, or the Secretary by
        regulation permits a statement regarding the absence of
        cholesterol on the basis of a finding that cholesterol is not
        usually present in the food and that such a statement would
        assist consumers in maintaining healthy dietary practices and
        the regulation requires that the statement disclose that
        cholesterol is not usually present in the food, and
          (II) the label or labeling of the food discloses the level of
        such fat or saturated fat in immediate proximity to such claim
        and with appropriate prominence which shall be no less than one-
        half the size of the claim with respect to the level of
        cholesterol,

        (iv) may not be made with respect to the level of saturated fat
      in the food if the food contains cholesterol unless the label or
      labeling of the food discloses the level of cholesterol in the
      food in immediate proximity to such claim and with appropriate
      prominence which shall be no less than one-half the size of the
      claim with respect to the level of saturated fat,
        (v) may not state that a food is high in dietary fiber unless
      the food is low in total fat as defined by the Secretary or the
      label or labeling discloses the level of total fat in the food in
      immediate proximity to such statement and with appropriate
      prominence which shall be no less than one-half the size of the
      claim with respect to the level of dietary fiber, and
        (vi) may not be made if the Secretary by regulation prohibits
      the claim because the claim is misleading in light of the level
      of another nutrient in the food.

      (B) If a claim described in subparagraph (1)(A) is made with
    respect to a nutrient in a food and the Secretary makes a
    determination that the food contains a nutrient at a level that
    increases to persons in the general population the risk of a
    disease or health-related condition that is diet related, the label
    or labeling of such food shall contain, prominently and in
    immediate proximity to such claim, the following statement: "See
    nutrition information for ___ content." The blank shall identify
    the nutrient associated with the increased disease or health-
    related condition risk. In making the determination described in
    this clause, the Secretary shall take into account the significance
    of the food in the total daily diet.
      (C) Subparagraph (2)(A) does not apply to a claim described in
    subparagraph (1)(A) and contained in the label or labeling of a
    food if such claim is contained in the brand name of such food and
    such brand name was in use on such food before October 25, 1989,
    unless the brand name contains a term defined by the Secretary
    under subparagraph (2)(A)(i). Such a claim is subject to paragraph
    (a).
      (D) Subparagraph (2) does not apply to a claim described in
    subparagraph (1)(A) which uses the term "diet" and is contained in
    the label or labeling of a soft drink if (i) such claim is
    contained in the brand name of such soft drink, (ii) such brand
    name was in use on such soft drink before October 25, 1989, and
    (iii) the use of the term "diet" was in conformity with section
    105.66 of title 21 of the Code of Federal Regulations. Such a claim
    is subject to paragraph (a).
      (E) Subclauses (i) through (v) of subparagraph (2)(A) do not
    apply to a statement in the label or labeling of food which
    describes the percentage of vitamins and minerals in the food in
    relation to the amount of such vitamins and minerals recommended
    for daily consumption by the Secretary.
      (F) Subclause (i) clause (A) does not apply to a statement in the
    labeling of a dietary supplement that characterizes the percentage
    level of a dietary ingredient for which the Secretary has not
    established a reference daily intake, daily recommended value, or
    other recommendation for daily consumption.
      (G) A claim of the type described in subparagraph (1)(A) for a
    nutrient, for which the Secretary has not promulgated a regulation
    under clause (A)(i), shall be authorized and may be made with
    respect to a food if - 
        (i) a scientific body of the United States Government with
      official responsibility for public health protection or research
      directly relating to human nutrition (such as the National
      Institutes of Health or the Centers for Disease Control and
      Prevention) or the National Academy of Sciences or any of its
      subdivisions has published an authoritative statement, which is
      currently in effect, which identifies the nutrient level to which
      the claim refers;
        (ii) a person has submitted to the Secretary, at least 120 days
      (during which the Secretary may notify any person who is making a
      claim as authorized by clause (C) that such person has not
      submitted all the information required by such clause) before the
      first introduction into interstate commerce of the food with a
      label containing the claim, (I) a notice of the claim, which
      shall include the exact words used in the claim and shall include
      a concise description of the basis upon which such person relied
      for determining that the requirements of subclause (i) have been
      satisfied, (II) a copy of the statement referred to in subclause
      (i) upon which such person relied in making the claim, and (III)
      a balanced representation of the scientific literature relating
      to the nutrient level to which the claim refers;
        (iii) the claim and the food for which the claim is made are in
      compliance with clauses (A) and (B), and are otherwise in
      compliance with paragraph (a) and section 321(n) of this title;
      and
        (iv) the claim is stated in a manner so that the claim is an
      accurate representation of the authoritative statement referred
      to in subclause (i) and so that the claim enables the public to
      comprehend the information provided in the claim and to
      understand the relative significance of such information in the
      context of a total daily diet.

    For purposes of this clause, a statement shall be regarded as an
    authoritative statement of a scientific body described in subclause
    (i) only if the statement is published by the scientific body and
    shall not include a statement of an employee of the scientific body
    made in the individual capacity of the employee.
      (H) A claim submitted under the requirements of clause (G) may be
    made until - 
        (i) such time as the Secretary issues a regulation - 
          (I) prohibiting or modifying the claim and the regulation has
        become effective, or
          (II) finding that the requirements of clause (G) have not
        been met, including finding that the petitioner had not
        submitted all the information required by such clause; or

        (ii) a district court of the United States in an enforcement
      proceeding under subchapter III of this chapter has determined
      that the requirements of clause (G) have not been met.

      (3)(A) Except as provided in subparagraph (5), a claim described
    in subparagraph (1)(B) may only be made - 
        (i) if the claim meets the requirements of the regulations of
      the Secretary promulgated under clause (B), and
        (ii) if the food for which the claim is made does not contain,
      as determined by the Secretary by regulation, any nutrient in an
      amount which increases to persons in the general population the
      risk of a disease or health-related condition which is diet
      related, taking into account the significance of the food in the
      total daily diet, except that the Secretary may by regulation
      permit such a claim based on a finding that such a claim would
      assist consumers in maintaining healthy dietary practices and
      based on a requirement that the label contain a disclosure of the
      type required by subparagraph (2)(B).

      (B)(i) The Secretary shall promulgate regulations authorizing
    claims of the type described in subparagraph (1)(B) only if the
    Secretary determines, based on the totality of publicly available
    scientific evidence (including evidence from well-designed studies
    conducted in a manner which is consistent with generally recognized
    scientific procedures and principles), that there is significant
    scientific agreement, among experts qualified by scientific
    training and experience to evaluate such claims, that the claim is
    supported by such evidence.
      (ii) A regulation described in subclause (i) shall describe - 
        (I) the relationship between a nutrient of the type required in
      the label or labeling of food by paragraph (q)(1) or (q)(2) and a
      disease or health-related condition, and
        (II) the significance of each such nutrient in affecting such
      disease or health-related condition.

      (iii) A regulation described in subclause (i) shall require such
    claim to be stated in a manner so that the claim is an accurate
    representation of the matters set out in subclause (ii) and so that
    the claim enables the public to comprehend the information provided
    in the claim and to understand the relative significance of such
    information in the context of a total daily diet.
      (C) Notwithstanding the provisions of clauses (A)(i) and (B), a
    claim of the type described in subparagraph (1)(B) which is not
    authorized by the Secretary in a regulation promulgated in
    accordance with clause (B) shall be authorized and may be made with
    respect to a food if - 
        (i) a scientific body of the United States Government with
      official responsibility for public health protection or research
      directly relating to human nutrition (such as the National
      Institutes of Health or the Centers for Disease Control and
      Prevention) or the National Academy of Sciences or any of its
      subdivisions has published an authoritative statement, which is
      currently in effect, about the relationship between a nutrient
      and a disease or health-related condition to which the claim
      refers;
        (ii) a person has submitted to the Secretary, at least 120 days
      (during which the Secretary may notify any person who is making a
      claim as authorized by clause (C) that such person has not
      submitted all the information required by such clause) before the
      first introduction into interstate commerce of the food with a
      label containing the claim, (I) a notice of the claim, which
      shall include the exact words used in the claim and shall include
      a concise description of the basis upon which such person relied
      for determining that the requirements of subclause (i) have been
      satisfied, (II) a copy of the statement referred to in subclause
      (i) upon which such person relied in making the claim, and (III)
      a balanced representation of the scientific literature relating
      to the relationship between a nutrient and a disease or health-
      related condition to which the claim refers;
        (iii) the claim and the food for which the claim is made are in
      compliance with clause (A)(ii) and are otherwise in compliance
      with paragraph (a) and section 321(n) of this title; and
        (iv) the claim is stated in a manner so that the claim is an
      accurate representation of the authoritative statement referred
      to in subclause (i) and so that the claim enables the public to
      comprehend the information provided in the claim and to
      understand the relative significance of such information in the
      context of a total daily diet.

    For purposes of this clause, a statement shall be regarded as an
    authoritative statement of a scientific body described in subclause
    (i) only if the statement is published by the scientific body and
    shall not include a statement of an employee of the scientific body
    made in the individual capacity of the employee.
      (D) A claim submitted under the requirements of clause (C) may be
    made until - 
        (i) such time as the Secretary issues a regulation under the
      standard in clause (B)(i) - 
          (I) prohibiting or modifying the claim and the regulation has
        become effective, or
          (II) finding that the requirements of clause (C) have not
        been met, including finding that the petitioner has not
        submitted all the information required by such clause; or

        (ii) a district court of the United States in an enforcement
      proceeding under subchapter III of this chapter has determined
      that the requirements of clause (C) have not been met.

      (4)(A)(i) Any person may petition the Secretary to issue a
    regulation under subparagraph (2)(A)(i) or (3)(B) relating to a
    claim described in subparagraph (1)(A) or (1)(B). Not later than
    100 days after the petition is received by the Secretary, the
    Secretary shall issue a final decision denying the petition or file
    the petition for further action by the Secretary. If the Secretary
    does not act within such 100 days, the petition shall be deemed to
    be denied unless an extension is mutually agreed upon by the
    Secretary and the petitioner. If the Secretary denies the petition
    or the petition is deemed to be denied, the petition shall not be
    made available to the public. If the Secretary files the petition,
    the Secretary shall deny the petition or issue a proposed
    regulation to take the action requested in the petition not later
    than 90 days after the date of such decision. If the Secretary does
    not act within such 90 days, the petition shall be deemed to be
    denied unless an extension is mutually agreed upon by the Secretary
    and the petitioner. If the Secretary issues a proposed regulation,
    the rulemaking shall be completed within 540 days of the date the
    petition is received by the Secretary. If the Secretary does not
    issue a regulation within such 540 days, the Secretary shall
    provide the Committee on Commerce of the House of Representatives
    and the Committee on Labor and Human Resources of the Senate the
    reasons action on the regulation did not occur within such 540
    days.
      (ii) Any person may petition the Secretary for permission to use
    in a claim described in subparagraph (1)(A) terms that are
    consistent with the terms defined by the Secretary under
    subparagraph (2)(A)(i). Within 90 days of the submission of such a
    petition, the Secretary shall issue a final decision denying the
    petition or granting such permission.
      (iii) Any person may petition the Secretary for permission to use
    an implied claim described in subparagraph (1)(A) in a brand name.
    After publishing notice of an opportunity to comment on the
    petition in the Federal Register and making the petition available
    to the public, the Secretary shall grant the petition if the
    Secretary finds that such claim is not misleading and is consistent
    with terms defined by the Secretary under subparagraph (2)(A)(i).
    The Secretary shall grant or deny the petition within 100 days of
    the date it is submitted to the Secretary and the petition shall be
    considered granted if the Secretary does not act on it within such
    100 days.
      (B) A petition under clause (A)(i) respecting a claim described
    in subparagraph (1)(A) or (1)(B) shall include an explanation of
    the reasons why the claim meets the requirements of this paragraph
    and a summary of the scientific data which supports such reasons.
      (C) If a petition for a regulation under subparagraph (3)(B)
    relies on a report from an authoritative scientific body of the
    United States, the Secretary shall consider such report and shall
    justify any decision rejecting the conclusions of such report.
      (5)(A) This paragraph does not apply to infant formulas subject
    to section 350a(h) of this title and medical foods as defined in
    section 360ee(b) of this title.
      (B) Subclauses (iii) through (v) of subparagraph (2)(A) and
    subparagraph (2)(B) do not apply to food which is served in
    restaurants or other establishments in which food is served for
    immediate human consumption or which is sold for sale or use in
    such establishments.
      (C) A subparagraph (1)(A) claim made with respect to a food which
    claim is required by a standard of identity issued under section
    341 of this title shall not be subject to subparagraph (2)(A)(i) or
    (2)(B).
      (D) A subparagraph (1)(B) claim made with respect to a dietary
    supplement of vitamins, minerals, herbs, or other similar
    nutritional substances shall not be subject to subparagraph (3) but
    shall be subject to a procedure and standard, respecting the
    validity of such claim, established by regulation of the Secretary.
      (6) For purposes of paragraph (r)(1)(B), a statement for a
    dietary supplement may be made if - 
        (A) the statement claims a benefit related to a classical
      nutrient deficiency disease and discloses the prevalence of such
      disease in the United States, describes the role of a nutrient or
      dietary ingredient intended to affect the structure or function
      in humans, characterizes the documented mechanism by which a
      nutrient or dietary ingredient acts to maintain such structure or
      function, or describes general well-being from consumption of a
      nutrient or dietary ingredient,
        (B) the manufacturer of the dietary supplement has
      substantiation that such statement is truthful and not
      misleading, and
        (C) the statement contains, prominently displayed and in
      boldface type, the following: "This statement has not been
      evaluated by the Food and Drug Administration. This product is
      not intended to diagnose, treat, cure, or prevent any disease.".

    A statement under this subparagraph may not claim to diagnose,
    mitigate, treat, cure, or prevent a specific disease or class of
    diseases. If the manufacturer of a dietary supplement proposes to
    make a statement described in the first sentence of this
    subparagraph in the labeling of the dietary supplement, the
    manufacturer shall notify the Secretary no later than 30 days after
    the first marketing of the dietary supplement with such statement
    that such a statement is being made.
      (7) The Secretary may make proposed regulations issued under this
    paragraph effective upon publication pending consideration of
    public comment and publication of a final regulation if the
    Secretary determines that such action is necessary - 
        (A) to enable the Secretary to review and act promptly on
      petitions the Secretary determines provide for information
      necessary to - 
          (i) enable consumers to develop and maintain healthy dietary
        practices;
          (ii) enable consumers to be informed promptly and effectively
        of important new knowledge regarding nutritional and health
        benefits of food; or
          (iii) ensure that scientifically sound nutritional and health
        information is provided to consumers as soon as possible; or

        (B) to enable the Secretary to act promptly to ban or modify a
      claim under this paragraph.

    Such proposed regulations shall be deemed final agency action for
    purposes of judicial review.
    (s) Dietary supplements
      If - 
        (1) it is a dietary supplement; and
        (2)(A) the label or labeling of the supplement fails to list - 
          (i) the name of each ingredient of the supplement that is
        described in section 321(ff) of this title; and
          (ii)(I) the quantity of each such ingredient; or
          (II) with respect to a proprietary blend of such ingredients,
        the total quantity of all ingredients in the blend;

        (B) the label or labeling of the dietary supplement fails to
      identify the product by using the term "dietary supplement",
      which term may be modified with the name of such an ingredient;
        (C) the supplement contains an ingredient described in section
      321(ff)(1)(C) of this title, and the label or labeling of the
      supplement fails to identify any part of the plant from which the
      ingredient is derived;
        (D) the supplement - 
          (i) is covered by the specifications of an official
        compendium;
          (ii) is represented as conforming to the specifications of an
        official compendium; and
          (iii) fails to so conform; or

        (E) the supplement - 
          (i) is not covered by the specifications of an official
        compendium; and
          (ii)(I) fails to have the identity and strength that the
        supplement is represented to have; or
          (II) fails to meet the quality (including tablet or capsule
        disintegration), purity, or compositional specifications, based
        on validated assay or other appropriate methods, that the
        supplement is represented to meet.

    A dietary supplement shall not be deemed misbranded solely because
    its label or labeling contains directions or conditions of use or
    warnings.
    (t) Catfish
      If it purports to be or is represented as catfish, unless it is
    fish classified within the family Ictaluridae.
    (u) Ginseng
      If it purports to be or is represented as ginseng, unless it is
    an herb or herbal ingredient derived from a plant classified within
    the genus Panax.
    (v) Failure to label; health threat
       If - 
        (1) it fails to bear a label required by the Secretary under
      section 381(n)(1) of this title (relating to food refused
      admission into the United States);
        (2) the Secretary finds that the food presents a threat of
      serious adverse health consequences or death to humans or
      animals; and
        (3) upon or after notifying the owner or consignee involved
      that the label is required under section 381 of this title, the
      Secretary informs the owner or consignee that the food presents
      such a threat.
    (w) Major food allergen labeling requirements
      (1) If it is not a raw agricultural commodity and it is, or it
    contains an ingredient that bears or contains, a major food
    allergen, unless either - 
        (A) the word "Contains", followed by the name of the food
      source from which the major food allergen is derived, is printed
      immediately after or is adjacent to the list of ingredients (in a
      type size no smaller than the type size used in the list of
      ingredients) required under subsections (g) and (i) of this
      section; or
        (B) the common or usual name of the major food allergen in the
      list of ingredients required under subsections (g) and (i) of
      this section is followed in parentheses by the name of the food
      source from which the major food allergen is derived, except that
      the name of the food source is not required when - 
          (i) the common or usual name of the ingredient uses the name
        of the food source from which the major food allergen is
        derived; or
          (ii) the name of the food source from which the major food
        allergen is derived appears elsewhere in the ingredient list,
        unless the name of the food source that appears elsewhere in
        the ingredient list appears as part of the name of a food
        ingredient that is not a major food allergen under section
        321(qq)(2)(A) or (B) of this title.

      (2) As used in this subsection, the term "name of the food source
    from which the major food allergen is derived" means the name
    described in section 321(qq)(1) of this title; provided that in the
    case of a tree nut, fish, or Crustacean shellfish, the term "name
    of the food source from which the major food allergen is derived"
    means the name of the specific type of nut or species of fish or
    Crustacean shellfish.
      (3) The information required under this subsection may appear in
    labeling in lieu of appearing on the label only if the Secretary
    finds that such other labeling is sufficient to protect the public
    health. A finding by the Secretary under this paragraph (including
    any change in an earlier finding under this paragraph) is effective
    upon publication in the Federal Register as a notice.
      (4) Notwithstanding subsection (g), (i), or (k) of this section,
    or any other law, a flavoring, coloring, or incidental additive
    that is, or that bears or contains, a major food allergen shall be
    subject to the labeling requirements of this subsection.
      (5) The Secretary may by regulation modify the requirements of
    subparagraph (A) or (B) of paragraph (1), or eliminate either the
    requirement of subparagraph (A) or the requirements of subparagraph
    (B) of paragraph (1), if the Secretary determines that the
    modification or elimination of the requirement of subparagraph (A)
    or the requirements of subparagraph (B) is necessary to protect the
    public health.
      (6)(A) Any person may petition the Secretary to exempt a food
    ingredient described in section 321(qq)(2) of this title from the
    allergen labeling requirements of this subsection.
      (B) The Secretary shall approve or deny such petition within 180
    days of receipt of the petition or the petition shall be deemed
    denied, unless an extension of time is mutually agreed upon by the
    Secretary and the petitioner.
      (C) The burden shall be on the petitioner to provide scientific
    evidence (including the analytical method used to produce the
    evidence) that demonstrates that such food ingredient, as derived
    by the method specified in the petition, does not cause an allergic
    response that poses a risk to human health.
      (D) A determination regarding a petition under this paragraph
    shall constitute final agency action.
      (E) The Secretary shall promptly post to a public site all
    petitions received under this paragraph within 14 days of receipt
    and the Secretary shall promptly post the Secretary's response to
    each.
      (7)(A) A person need not file a petition under paragraph (6) to
    exempt a food ingredient described in section 321(qq)(2) of this
    title from the allergen labeling requirements of this subsection,
    if the person files with the Secretary a notification containing - 
        (i) scientific evidence (including the analytical method used)
      that demonstrates that the food ingredient (as derived by the
      method specified in the notification, where applicable) does not
      contain allergenic protein; or
        (ii) a determination by the Secretary that the ingredient does
      not cause an allergic response that poses a risk to human health
      under a premarket approval or notification program under section
      348 of this title.

      (B) The food ingredient may be introduced or delivered for
    introduction into interstate commerce as a food ingredient that is
    not a major food allergen 90 days after the date of receipt of the
    notification by the Secretary, unless the Secretary determines
    within the 90-day period that the notification does not meet the
    requirements of this paragraph, or there is insufficient scientific
    evidence to determine that the food ingredient does not contain
    allergenic protein or does not cause an allergenic response that
    poses a risk to human health.
      (C) The Secretary shall promptly post to a public site all
    notifications received under this subparagraph within 14 days of
    receipt and promptly post any objections thereto by the Secretary.
    (x) Nonmajor food allergen labeling requirements
      Notwithstanding subsection (g), (i), or (k) of this section, or
    any other law, a spice, flavoring, coloring, or incidental additive
    that is, or that bears or contains, a food allergen (other than a
    major food allergen), as determined by the Secretary by regulation,
    shall be disclosed in a manner specified by the Secretary by
    regulation.
    (y) Dietary supplements
      If it is a dietary supplement that is marketed in the United
    States, unless the label of such dietary supplement includes a
    domestic address or domestic phone number through which the
    responsible person (as described in section 379aa-1 of this title)
    may receive a report of a serious adverse event with such dietary
    supplement.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 403, 52 Stat. 1047; Pub. L. 86-537,
    Sec. 1, June 29, 1960, 74 Stat. 251; Pub. L. 86-618, title I, Sec.
    102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91-601, Sec. 6(c),
    formerly Sec. 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
    L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
    Pub. L. 94-278, title V, Sec. 502(a)(1), Apr. 22, 1976, 90 Stat.
    411; Pub. L. 95-203, Sec. 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat.
    1452, 1453; Pub. L. 101-535, Secs. 2(a), 3(a), 7, Nov. 8, 1990, 104
    Stat. 2353, 2357, 2364; Pub. L. 102-108, Sec. 2(a), (c), Aug. 17,
    1991, 105 Stat. 549; Pub. L. 102-571, title I, Sec. 107(5), (6),
    Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 2(b), 3(j),
    Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103-417, Secs. 6, 7(a)-
    (c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104-
    124, Sec. 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105-115, title
    III, Secs. 301-305, Nov. 21, 1997, 111 Stat. 2350-2353; Pub. L. 106-
    554, Sec. 1(a)(1) [title V, Sec. 517], Dec. 21, 2000, 114 Stat.
    2763, 2763A-73; Pub. L. 107-171, title X, Secs. 10806(a)(2),
    (b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L.
    107-188, title III, Sec. 308(b), June 12, 2002, 116 Stat. 672; Pub.
    L. 108-282, title II, Sec. 203(a), Aug. 2, 2004, 118 Stat. 906;
    Pub. L. 109-462, Sec. 3(c), Dec. 22, 2006, 120 Stat. 3475.)


-MISC1-
                                AMENDMENTS                            
      2006 - Par. (y). Pub. L. 109-462 added par. (y).
      2004 - Pars. (w), (x). Pub. L. 108-282 added pars. (w) and (x).
      2002 - Par. (h). Pub. L. 107-171, Sec. 10808(b), added subpar.
    (3) and concluding provisions.
      Par. (t). Pub. L. 107-171, Sec. 10806(a)(2), added par. (t).
      Par. (u). Pub. L. 107-171, Sec. 10806(b)(2), added par. (u).
      Par. (v). Pub. L. 107-188 added par. (v).
      2000 - Par. (o). Pub. L. 106-554, which directed repeal of
    section 403(o) of the Food, Drug, and Cosmetic Act, was executed by
    repealing par. (o) of this section, which is section 403 of the
    Federal Food, Drug, and Cosmetic Act, to reflect the probable
    intent of Congress. Prior to repeal, par. (o) provided that a food
    containing saccharin was to be deemed misbranded unless a specified
    warning statement was placed in a conspicuous place on its label.
      1997 - Par. (r)(2)(B). Pub. L. 105-115, Sec. 305, amended cl. (B)
    generally. Prior to amendment, cl. (B) read as follows: "If a claim
    described in subparagraph (1)(A) is made with respect to a nutrient
    in a food, the label or labeling of such food shall contain,
    prominently and in immediate proximity to such claim, the following
    statement: 'See _____ for nutrition information.'. In the statement
    - 
        "(i) the blank shall identify the panel on which the
      information described in the statement may be found, and
        "(ii) if the Secretary determines that the food contains a
      nutrient at a level which increases to persons in the general
      population the risk of a disease or health-related condition
      which is diet related, taking into account the significance of
      the food in the total daily diet, the statement shall also
      identify such nutrient."
      Par. (r)(2)(G), (H). Pub. L. 105-115, Sec. 304, added cls. (G)
    and (H).
      Par. (r)(3)(C), (D). Pub. L. 105-115, Sec. 303, added cls. (C)
    and (D).
      Par. (r)(4)(A)(i). Pub. L. 105-115, Sec. 302, inserted after
    second sentence "If the Secretary does not act within such 100
    days, the petition shall be deemed to be denied unless an extension
    is mutually agreed upon by the Secretary and the petitioner.",
    inserted "or the petition is deemed to be denied" after "If the
    Secretary denies the petition", and inserted at end "If the
    Secretary does not act within such 90 days, the petition shall be
    deemed to be denied unless an extension is mutually agreed upon by
    the Secretary and the petitioner. If the Secretary issues a
    proposed regulation, the rulemaking shall be completed within 540
    days of the date the petition is received by the Secretary. If the
    Secretary does not issue a regulation within such 540 days, the
    Secretary shall provide the Committee on Commerce of the House of
    Representatives and the Committee on Labor and Human Resources of
    the Senate the reasons action on the regulation did not occur
    within such 540 days."
      Par. (r)(7). Pub. L. 105-115, Sec. 301, added subpar. (7).
      1996 - Par. (p). Pub. L. 104-124 struck out par. (p), which
    deemed products containing saccharin and offered for sale, but not
    for immediate consumption, by retail establishment, to be
    misbranded, unless notice of information required by subsec. (o)
    was provided by manufacturer and prominently displayed near
    product.
      1994 - Par. (q)(5)(F). Pub. L. 103-417, Sec. 7(b), amended cl.
    (F) generally. Prior to amendment, cl. (F) read as follows: "If a
    food to which section 350 of this title applies (as defined in
    section 350(c) of this title) contains one or more of the nutrients
    required by subparagraph (1) or (2) to be in the label or labeling
    of the food, the label or labeling of such food shall comply with
    the requirements of subparagraphs (1) and (2) in a manner which is
    appropriate for such food and which is specified in regulations of
    the Secretary."
      Par. (r)(2)(F). Pub. L. 103-417, Sec. 7(c), added cl. (F).
      Par. (r)(6). Pub. L. 103-417, Sec. 6, added subpar. (6).
      Par. (s). Pub. L. 103-417, Sec. 10(c), inserted at end: "A
    dietary supplement shall not be deemed misbranded solely because
    its label or labeling contains directions or conditions of use or
    warnings."
      Pub. L. 103-417, Sec. 7(a), added par. (s).
      1993 - Par. (e). Pub. L. 103-80, Sec. 3(j)(1), substituted
    "count, except that" for "count: Provided, That".
      Par. (i). Pub. L. 103-80, Sec. 3(j)(2), substituted "unless sold
    as spices, flavorings, or such colors" for ", other than those sold
    as such" and "naming each. To the extent" for "naming each:
    Provided, That, to the extent".
      Par. (k). Pub. L. 103-80, Sec. 3(j)(3), substituted ", except
    that" for ": Provided, That".
      Par. (l). Pub. L. 103-80, Sec. 3(j)(4), substituted "chemical,
    except that" for "chemical: Provided, however, That".
      Par. (q)(5)(E) to (G). Pub. L. 103-80, Sec. 2(b), added cl. (E)
    and redesignated former cls. (E) and (F) as (F) and (G),
    respectively.
      Par. (r)(1)(B). Pub. L. 103-80, Sec. 3(j)(5), substituted
    "(5)(D)" for "5(D)".
      Par. (r)(4)(B). Pub. L. 103-80, Sec. 3(j)(6), substituted
    "paragraph" for "subsection".
      1992 - Par. (i). Pub. L. 102-571, Sec. 107(5), substituted
    "379e(c)" for "376(c)".
      Par. (m). Pub. L. 102-571, Sec. 107(6), substituted "379e" for
    "376".
      1991 - Par. (i). Pub. L. 102-108, Sec. 2(c), amended directory
    language of Pub. L. 101-535, Sec. 7(1), (3). See 1990 Amendment
    note below.
      Par. (q)(4)(A). Pub. L. 102-108, Sec. 2(a), substituted "(D)" for
    "(C)".
      1990 - Par. (i). Pub. L. 101-535, Sec. 7, as amended by Pub. L.
    102-108, Sec. 2(c), substituted "Unless" for "If it is not subject
    to the provisions of paragraph (g) unless", inserted "and if the
    food purports to be a beverage containing vegetable or fruit juice,
    a statement with appropriate prominence on the information panel of
    the total percentage of such fruit or vegetable juice contained in
    the food", and substituted "colors not required to be certified
    under section 376(c) of this title" for "colorings" the first time
    appearing.
      Par. (q). Pub. L. 101-535, Sec. 2(a), added par. (q).
      Par. (r). Pub. L. 101-535, Sec. 3(a), added par. (r).
      1977 - Par. (o). Pub. L. 95-203, Sec. 4(a)(1), added par. (o).
      Par. (p). Pub. L. 95-203, Sec. 4(b)(1), added par. (p).
      1976 - Par. (a). Pub. L. 94-278 inserted "(1)" after "If" and
    inserted ", or (2) in the case of a food to which section 350 of
    this title applies, its advertising is false or misleading in a
    material respect or its labeling is in violation of section
    350(b)(2) of this title" after "any particular".
      1970 - Par. (n). Pub. L. 91-601 added par. (n).
      1960 - Par. (k). Pub. L. 86-537, Sec. 1(1), exempted pesticide
    chemicals when used in or on a raw agricultural commodity which is
    the produce of the soil.
      Par. (l). Pub. L. 86-537, Sec. 1(2), added par. (l).
      Par. (m). Pub. L. 86-618 added par. (m).

-CHANGE-
                              CHANGE OF NAME                          
      Committee on Commerce of House of Representatives changed to
    Committee on Energy and Commerce of House of Representatives, and
    jurisdiction over matters relating to securities and exchanges and
    insurance generally transferred to Committee on Financial Services
    of House of Representatives by House Resolution No. 5, One Hundred
    Seventh Congress, Jan. 3, 2001.
      Committee on Labor and Human Resources of Senate changed to
    Committee on Health, Education, Labor, and Pensions of Senate by
    Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
    1999.


-MISC2-
                     EFFECTIVE DATE OF 2006 AMENDMENT                 
      Pub. L. 109-462, Sec. 3(d)(1), (2), Dec. 22, 2006, 120 Stat.
    3475, provided that:
      "(1) In general. - Except as provided in paragraph (2), the
    amendments made by this section [enacting section 379aa-1 of this
    title and amending this section and section 331 of this title]
    shall take effect 1 year after the date of enactment of this Act
    [Dec. 22, 2006].
      "(2) Misbranding. - Section 403(y) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 343(y)] (as added by this section) shall
    apply to any dietary supplement labeled on or after the date that
    is 1 year after the date of enactment of this Act [Dec. 22, 2006]."

                     EFFECTIVE DATE OF 2004 AMENDMENT                 
      Amendment by Pub. L. 108-282 applicable to any food that is
    labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
    282, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Section 7(e) of Pub. L. 103-417 provided that: "Dietary
    supplements - 
        "(1) may be labeled after the date of the enactment of this Act
      [Oct. 25, 1994] in accordance with the amendments made by this
      section [amending this section and section 350 of this title],
      and
        "(2) shall be labeled after December 31, 1996, in accordance
      with such amendments."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 10(a) of Pub. L. 101-535, as amended by Pub. L. 102-571,
    title II, Sec. 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided
    that:
      "(1) Except as provided in paragraph (2) - 
        "(A) the amendments made by section 2 [amending this section]
      shall take effect 6 months after - 
          "(i) the date of the promulgation of all final regulations
        required to implement section 403(q) of the Federal Food, Drug,
        and Cosmetic Act [21 U.S.C. 343(q)], or
          "(ii) if such regulations are not promulgated, the date
        proposed regulations are to be considered as such final
        regulations [Nov. 8, 1992, see 57 F.R. 56347],
      except that section 403(q)(4) of such Act shall take effect as
      prescribed by such section,
        "(B) the amendments made by section 3 [amending this section]
      shall take effect 6 months after - 
          "(i) the date of the promulgation of final regulations to
        implement section 403(r) of the Federal Food, Drug, and
        Cosmetic Act, or
          "(ii) if such regulations are not promulgated, the date
        proposed regulations are to be considered as such final
        regulations [Nov. 8, 1992, see 57 F.R. 56347], except that any
        person marketing a food the brand name of which contains a term
        defined by the Secretary under section 403(r)(2)(A)(i) of the
        Federal Food, Drug, and Cosmetic Act shall be given an
        additional 6 months to comply with section 3,
        "(C) the amendments made by section 4 [amending section 337 of
      this title] shall take effect 24 months after the date of the
      enactment of this Act [Nov. 8, 1990], except that such amendments
      shall take effect with respect to such dietary supplements
      [probably means dietary supplements of vitamins, minerals, herbs,
      or other similar nutritional substances, see section 202(a)(1) of
      Pub. L. 102-571, set out below] on December 31, 1993, and
        "(D) the amendments made by section 5 [amending sections 321
      and 345 of this title] shall take effect on the date the
      amendments made by section 3 take effect.
      "(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act
    (as added by section 2) shall not apply with respect to food which
    was labeled before the effective date of the amendments made by
    section 2 and section 403(r) of the Federal Food, Drug, and
    Cosmetic Act (as added by section 3) shall not apply with respect
    to food which was labeled before the effective date of the
    amendments made by section 3.
      "(3)(A) If the Secretary finds that a person who is subject to
    section 403(q)(4) of such Act is unable to comply with the
    requirements of such section upon the effective date of final
    regulations to implement section 403(q) of such Act or of proposed
    regulations to be considered as such final regulations because the
    Secretary has not made available to such person the information
    required by such section, the Secretary shall delay the application
    of such section to such person for such time as the Secretary may
    require to provide such information.
      "(B) If the Secretary finds that compliance with section 403(q)
    or 403(r)(2) of such Act would cause an undue economic hardship,
    the Secretary may delay the application of such sections for no
    more than one year."
      Section 10(c) of Pub. L. 101-535, as amended by Pub. L. 102-108,
    Sec. 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102-571, title I,
    Sec. 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:
      "(1) Except as provided in paragraphs (2) and (3), the amendments
    made by section 7 [amending this section] shall take effect one
    year after the date of the enactment of this Act [Nov. 8, 1990].
      "(2)(A) If a food subject to section 403(g) of the Federal Food,
    Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or
    more colors required to be certified under section 721(c) [of the
    Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a
    label which was printed before July 1, 1991, and which is attached
    to the food before May 8, 1993, such food shall not be subject to
    the amendments made by section 7(1) and section 7(3) [amending this
    section].
      "(B) If a food described in subparagraph (A) - 
        "(i) bears a label which was printed after July 1, 1991, but
      before the date the proposed regulation described in clause (ii)
      takes effect as a final regulation and which was attached to the
      food before May 8, 1993, and
        "(ii) meets the requirements of the proposed regulation of the
      Secretary of Health and Human Services published in 56 Fed. Reg.
      28592-28636 (June 21, 1991) as it pertains to the amendments made
      by this Act [see Short Title of 1990 Amendment note set out under
      section 301 of this title],
    such food shall not be subject to the amendments made by section
    7(1) and section 7(3) [amending this section].
      "(3) A food purported to be a beverage containing a vegetable or
    fruit juice which bears a label attached to the food before May 8,
    1993, shall not be subject to the amendments made by section 7(2)
    [amending this section]."

                     EFFECTIVE DATE OF 1977 AMENDMENT                 
      Section 4(a)(2) of Pub. L. 95-203 provided that: "The amendment
    made by paragraph (1) [amending this section] shall apply only with
    respect to food introduced or delivered for introduction in
    interstate commerce on and after the 90th day after the date of the
    enactment of this Act [Nov. 23, 1977]."
      Section 4(b)(2) of Pub. L. 95-203 provided that: "The amendment
    made by paragraph (1) [amending this section] shall apply with
    respect to food which is sold in retail establishments on or after
    the 90th day after the effective date of the regulations of the
    Secretary of Health, Education, and Welfare [now Secretary of
    Health and Human Services] under paragraph (p)(4) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 343(p)(4)]."

                     EFFECTIVE DATE OF 1976 AMENDMENT                 
      Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
    1976, see section 502(c) of Pub. L. 94-278, set out as a note under
    section 334 of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such
    subsections effective July 1, 1940, as provided by regulations for
    certain lithographed labeling and containers bearing certain
    labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
    an Effective Date; Postponement in Certain Cases note under section
    301 of this title.

               CONSTRUCTION OF AMENDMENT BY PUB. L. 108-282           
      Pub. L. 108-282, title II, Sec. 203(b), Aug. 2, 2004, 118 Stat.
    908, provided that: "The amendments made by this section [amending
    this section and sections 321 and 343-1 of this title] that require
    a label or labeling for major food allergens do not alter the
    authority of the Secretary of Health and Human Services under the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to
    require a label or labeling for other food allergens."

               CONSTRUCTION OF AMENDMENT BY PUB. L. 107-188           
      Nothing in amendment by Pub. L. 107-188 to be construed to limit
    authority of Secretary of Health and Human Services or Secretary of
    the Treasury to require marking of articles of food imported or
    offered for import into the United States which are refused
    admission, see section 308(c) of Pub. L. 107-188, set out as a note
    under section 381 of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Section 9 of Pub. L. 101-535 provided that: "The amendments made
    by this Act [enacting section 343-1 of this title and amending this
    section and sections 321, 337, 345, and 371 of this title] shall
    not be construed to alter the authority of the Secretary of Health
    and Human Services and the Secretary of Agriculture under the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the
    Federal Meat Inspection Act [21 U.S.C. 601 et seq.], the Poultry
    Products Inspection Act [21 U.S.C. 451 et seq.], and the Egg
    Products Inspection Act [21 U.S.C. 1031 et seq.]."

                                 FINDINGS                             
      Pub. L. 108-282, title II, Sec. 202, Aug. 2, 2004, 118 Stat. 905,
    provided that: "Congress finds that - 
        "(1) it is estimated that - 
          "(A) approximately 2 percent of adults and about 5 percent of
        infants and young children in the United States suffer from
        food allergies; and
          "(B) each year, roughly 30,000 individuals require emergency
        room treatment and 150 individuals die because of allergic
        reactions to food;
        "(2)(A) eight major foods or food groups - milk, eggs, fish,
      Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans -
      account for 90 percent of food allergies;
        "(B) at present, there is no cure for food allergies; and
        "(C) a food allergic consumer must avoid the food to which the
      consumer is allergic;
        "(3)(A) in a review of the foods of randomly selected
      manufacturers of baked goods, ice cream, and candy in Minnesota
      and Wisconsin in 1999, the Food and Drug Administration found
      that 25 percent of sampled foods failed to list peanuts or eggs
      as ingredients on the food labels; and
        "(B) nationally, the number of recalls because of unlabeled
      allergens rose to 121 in 2000 from about 35 a decade earlier;
        "(4) a recent study shows that many parents of children with a
      food allergy were unable to correctly identify in each of several
      food labels the ingredients derived from major food allergens;
        "(5)(A) ingredients in foods must be listed by their 'common or
      usual name';
        "(B) in some cases, the common or usual name of an ingredient
      may be unfamiliar to consumers, and many consumers may not
      realize the ingredient is derived from, or contains, a major food
      allergen; and
        "(C) in other cases, the ingredients may be declared as a
      class, including spices, flavorings, and certain colorings, or
      are exempt from the ingredient labeling requirements, such as
      incidental additives; and
        "(6)(A) celiac disease is an immune-mediated disease that
      causes damage to the gastrointestinal tract, central nervous
      system, and other organs;
        "(B) the current recommended treatment is avoidance of glutens
      in foods that are associated with celiac disease; and
        "(C) a multicenter, multiyear study estimated that the
      prevalence of celiac disease in the United States is 0.5 to 1
      percent of the general population."

                                REGULATIONS                            
      Section 2(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
    title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
    4501, provided that:
      "(1) The Secretary of Health and Human Services shall issue
    proposed regulations to implement section 403(q) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)] within 12 months
    after the date of the enactment of this Act [Nov. 8, 1990], except
    that the Secretary shall issue, not later than June 15, 1993,
    proposed regulations that are applicable to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional substances
    to implement such section. Not later than 24 months after the date
    of the enactment of this Act, the Secretary shall issue final
    regulations to implement the requirements of such section, except
    that the Secretary shall issue, not later than December 31, 1993,
    such a final regulation applicable to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional
    substances..[sic] Such regulations shall - 
        "(A) require the required information to be conveyed to the
      public in a manner which enables the public to readily observe
      and comprehend such information and to understand its relative
      significance in the context of a total daily diet,
        "(B) include regulations which establish standards, in
      accordance with paragraph (1)(A), to define serving size or other
      unit of measure for food,
        "(C) permit the label or labeling of food to include nutrition
      information which is in addition to the information required by
      such section 403(q) and which is of the type described in
      subparagraph (1) or (2) of such section, and
        "(D) permit the nutrition information on the label or labeling
      of a food to remain the same or permit the information to be
      stated as a range even though (i) there are minor variations in
      the nutritional value of the food which occur in the normal
      course of the production or processing of the food, or (ii) the
      food is comprised of an assortment of similar foods which have
      variations in nutritional value.
      "(2) If the Secretary of Health and Human Services does not
    promulgate final regulations under paragraph (1) upon the
    expiration of 24 months after the date of the enactment of this
    Act, the proposed regulations issued in accordance with paragraph
    (1) shall be considered as the final regulations upon the
    expiration of such 24 months, except that the proposed regulations
    applicable to dietary supplements of vitamins, minerals, herbs, or
    other similar nutritional substances shall not be considered to be
    final regulations until December 31, 1993. There shall be promptly
    published in the Federal Register notice of new status of the
    proposed regulations [see 57 F.R. 56347].
      "(3) If the Secretary of Health and Human Services does not
    promulgate final regulations under section 403(q)(4) of the Federal
    Food, Drug, and Cosmetic Act upon the expiration of 6 months after
    the date on which the Secretary makes a finding that there has been
    no substantial compliance with section 403(q)(4)(C) of such Act,
    the proposed regulations issued in accordance with such section
    shall be considered as the final regulations upon the expiration of
    such 6 months. There shall be promptly published in the Federal
    Register notice of new status of the proposed regulations."
      [Section 202(a)(2)(C) of Pub. L. 102-571 provided that: "The
    amendments made by subparagraph (B) [amending sections 2(b) and
    3(b) of Pub. L. 101-535, set out above and below] shall not be
    construed to modify the effective date of final regulations under
    sections 2(b) and 3(b) of the Nutrition Labeling and Education Act
    of 1990 [Pub. L. 101-535] (21 U.S.C. 343 note) with respect to
    foods that are not such dietary supplements."]
      Section 3(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
    title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
    4501, provided that:
      "(1)(A) Within 12 months of the date of the enactment of this Act
    [Nov. 8, 1990], the Secretary of Health and Human Services shall
    issue proposed regulations to implement section 403(r) of the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(r)], except
    that the Secretary shall issue, not later than June 15, 1993,
    proposed regulations that are applicable to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional substances
    to implement such section. Such regulations - 
        "(i) shall identify claims described in section 403(r)(1)(A) of
      such Act which comply with section 403(r)(2) of such Act,
        "(ii) shall identify claims described in section 403(r)(1)(B)
      of such Act which comply with section 403(r)(3) of such Act,
        "(iii) shall, in defining terms used to characterize the level
      of any nutrient in food under section 403(r)(2)(A)(i) of such
      Act, define - 
          "(I) free,
          "(II) low,
          "(III) light or lite,
          "(IV) reduced,
          "(V) less, and
          "(VI) high,
      unless the Secretary finds that the use of any such term would be
      misleading,
        "(iv) shall permit statements describing the amount and
      percentage of nutrients in food which are not misleading and are
      consistent with the terms defined in section 403(r)(2)(A)(i) of
      such Act,
        "(v) shall provide that if multiple claims subject to section
      403(r)(1)(A) of such Act are made on a single panel of the food
      label or page of a labeling brochure, a single statement may be
      made to satisfy section 403(r)(2)(B) of such Act,
        "(vi) shall determine whether claims respecting the following
      nutrients and diseases meet the requirements of section 403(r)(3)
      of such Act: Calcium and osteoporosis, dietary fiber and cancer,
      lipids and cardiovascular disease, lipids and cancer, sodium and
      hypertension, and dietary fiber and cardiovascular disease,
        "(vii) shall not require a person who proposes to make a claim
      described in section 403(r)(1)(B) of such Act which is in
      compliance with such regulations to secure the approval of the
      Secretary before making such claim,
        "(viii) may permit a claim described in section 403(r)(1)(A) of
      such Act to be made for butter,
        "(ix) may, in defining terms under section 403(r)(2)(A)(i),
      include similar terms which are commonly understood to have the
      same meaning, and
        "(x) shall establish, as required by section 403(r)(5)(D), the
      procedure and standard respecting the validity of claims made
      with respect to a dietary supplement of vitamins, minerals,
      herbs, or other similar nutritional substances and shall
      determine whether claims respecting the following nutrients and
      diseases meet the requirements of section 403(r)(5)(D) of such
      Act: folic acid and neural tube defects, antioxident [sic]
      vitamins and cancer, zinc and immune function in the elderly, and
      omega-3 fatty acids and heart disease.
      "(B) Not later than 24 months after the date of the enactment of
    this Act, the Secretary shall issue final regulations to implement
    section 403(r) of the Federal Food, Drug, and Cosmetic Act, except
    that the Secretary shall issue, not later than December 31, 1993,
    such a final regulation applicable to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional
    substances..[sic]
      "(2) If the Secretary does not promulgate final regulations under
    paragraph (1)(B) upon the expiration of 24 months after the date of
    the enactment of this Act, the proposed regulations issued in
    accordance with paragraph (1)(A) shall be considered as the final
    regulations upon the expiration of such 24 months, except that the
    proposed regulations applicable to dietary supplements of vitamins,
    minerals, herbs, or other similar nutritional substances shall not
    be considered to be final regulations until December 31, 1993.
    There shall be promptly published in the Federal Register notice of
    the new status of the proposed regulations [see 57 F.R. 56347]."
      [For construction of amendment made by section 202(a)(2)(B) of
    Pub. L. 102-571 to section 3(b) of Pub. L. 101-535 set out above,
    see section 202(a)(2)(C) of Pub. L. 102-571 set out above following
    section 2(b) of Pub. L. 101-535.]


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC3-
                          RULEMAKING ON LABELING                      
      Pub. L. 108-282, title II, Sec. 206, Aug. 2, 2004, 118 Stat. 910,
    provided that: "Not later than 2 years after the date of enactment
    of this Act [Aug. 2, 2004], the Secretary of Health and Human
    Services, in consultation with appropriate experts and
    stakeholders, shall issue a proposed rule to define, and permit use
    of, the term 'gluten-free' on the labeling of foods. Not later than
    4 years after the date of enactment of this Act, the Secretary
    shall issue a final rule to define, and permit use of, the term
    'gluten-free' on the labeling of foods."
      Pub. L. 107-171, title X, Sec. 10809, May 13, 2002, 116 Stat.
    531, provided that: "The Secretary of Health and Human Services
    (referred to in this section as the 'Secretary') shall publish a
    proposed rule and, with due consideration to public comment, a
    final rule to revise, as appropriate, the current regulation
    governing the labeling of foods that have been treated to reduce
    pest infestation or pathogens by treatment by irradiation using
    radioactive isotope, electronic beam, or x-ray. Pending
    promulgation of the final rule required by this subsection
    [probably should be "this section"], any person may petition the
    Secretary for approval of labeling, which is not false or
    misleading in any material respect, of a food which has been
    treated by irradiation using radioactive isotope, electronic beam,
    or x-ray. The Secretary shall approve or deny such a petition
    within 180 days of receipt of the petition, or the petition shall
    be deemed denied, except to the extent additional agency review is
    mutually agreed upon by the Secretary and the petitioner. Any
    denial of a petition under this subsection shall constitute final
    agency action subject to judicial review by the United States Court
    of Appeals for the District of Columbia Circuit. Any labeling
    approved through the foregoing petition process shall be subject to
    the provisions of the final rule referred to in the first sentence
    of the subparagraph on the effective date of such final rule."

                  COMMISSION ON DIETARY SUPPLEMENT LABELS              
      Section 12 of Pub. L. 103-417 provided that:
      "(a) Establishment. - There shall be established as an
    independent agency within the executive branch a commission to be
    known as the Commission on Dietary Supplement Labels (hereafter in
    this section referred to as the 'Commission').
      "(b) Membership. - 
        "(1) Composition. - The Commission shall be composed of 7
      members who shall be appointed by the President.
        "(2) Expertise requirement. - The members of the Commission
      shall consist of individuals with expertise and experience in
      dietary supplements and in the manufacture, regulation,
      distribution, and use of such supplements. At least three of the
      members of the Commission shall be qualified by scientific
      training and experience to evaluate the benefits to health of the
      use of dietary supplements and one of such three members shall
      have experience in pharmacognosy, medical botany, traditional
      herbal medicine, or other related sciences. Members and staff of
      the Commission shall be without bias on the issue of dietary
      supplements.
      "(c) Functions of the Commission. - The Commission shall conduct
    a study on, and provide recommendations for, the regulation of
    label claims and statements for dietary supplements, including the
    use of literature in connection with the sale of dietary
    supplements and procedures for the evaluation of such claims. In
    making such recommendations, the Commission shall evaluate how best
    to provide truthful, scientifically valid, and not misleading
    information to consumers so that such consumers may make informed
    and appropriate health care choices for themselves and their
    families.
      "(d) Administrative Powers of the Commission. - 
        "(1) Hearings. - The Commission may hold hearings, sit and act
      at such times and places, take such testimony, and receive such
      evidence as the Commission considers advisable to carry out the
      purposes of this section.
        "(2) Information from federal agencies. - The Commission may
      secure directly from any Federal department or agency such
      information as the Commission considers necessary to carry out
      the provisions of this section.
        "(3) Authorization of appropriations. - There are authorized to
      be appropriated such sums as may be necessary to carry out this
      section.
      "(e) Reports and Recommendations. - 
        "(1) Final report required. - Not later than 24 months after
      the date of enactment of this Act [Oct. 25, 1994], the Commission
      shall prepare and submit to the President and to the Congress a
      final report on the study required by this section.
        "(2) Recommendations. - The report described in paragraph (1)
      shall contain such recommendations, including recommendations for
      legislation, as the Commission deems appropriate.
        "(3) Action on recommendations. - Within 90 days of the
      issuance of the report under paragraph (1), the Secretary of
      Health and Human Services shall publish in the Federal Register a
      notice of any recommendation of Commission for changes in
      regulations of the Secretary for the regulation of dietary
      supplements and shall include in such notice a notice of proposed
      rulemaking on such changes together with an opportunity to
      present views on such changes. Such rulemaking shall be completed
      not later than 2 years after the date of the issuance of such
      report. If such rulemaking is not completed on or before the
      expiration of such 2 years, regulations of the Secretary
      published in 59 FR 395-426 on January 4, 1994, shall not be in
      effect."

    EXTENSION OF COMPLIANCE DEADLINE FOR CERTAIN FOOD PRODUCTS PACKAGED
                          PRIOR TO AUGUST 8, 1994
      Pub. L. 103-261, May 26, 1994, 108 Stat. 705, provided: "That
    before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the
    provision of section 403(i) of such Act added by section 7(2) of
    the Nutrition Labeling and Education Act of 1990 [Pub. L. 101-535],
    shall not apply with respect to a food product which is contained
    in a package for which the label was printed before May 8, 1994 (or
    before August 8, 1994, in the case of a juice or milk food product
    if the person responsible for the labeling of such food product
    exercised due diligence in obtaining before such date labels which
    are in compliance with such sections 403(q) and 403(r)(2) and such
    provision of section 403(i)), if, before June 15, 1994, the person
    who introduces or delivers for introduction such food product into
    interstate commerce submits to the Secretary of Health and Human
    Services a certification that such person will comply with this
    section and will comply with such sections 403(q) and 403(r)(2) and
    such provision of section 403(i) after August 8, 1994."

          LIMITATIONS ON APPLICATION OF SMALL BUSINESS EXEMPTION      
      Section 2(a) of Pub. L. 103-80 provided that:
      "(1) Before may 8, 1995. - Before May 8, 1995, the exemption
    provided by section 403(q)(5)(D) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 343(q)(5)(D)] shall be available in
    accordance with the regulations of the Secretary of Health and
    Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993).
      "(2) After may 8, 1995. - After May 8, 1995, the exemption
    provided by section 403(q)(5)(D) of the Federal Food, Drug, and
    Cosmetic Act shall only be available with respect to food when it
    is sold to consumers."

     PROHIBITION ON IMPLEMENTATION OF PUB. L. 101-535 WITH RESPECT TO
                            DIETARY SUPPLEMENTS
      Section 202(a)(1) of Pub. L. 102-571 provided that:
    "Notwithstanding any other provision of law and except as provided
    in subsection (b) [set out as a note below] and in the amendment
    made by paragraph (2)(A) [amending provisions set out as notes
    above], the Secretary of Health and Human Services may not
    implement the Nutrition Labeling and Education Act of 1990 (Public
    Law 101-535; 104 Stat. 2353) [see Short Title of 1990 Amendments
    note set out under section 301 of this title], or any amendment
    made by such Act, earlier than December 15, 1993, with respect to
    dietary supplements of vitamins, minerals, herbs, or other similar
    nutritional substances."

          HEALTH CLAIMS MADE WITH RESPECT TO DIETARY SUPPLEMENTS      
      Section 202(b) of Pub. L. 102-571 provided that: "Notwithstanding
    section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions
    set out as notes above and amending provisions set out as notes
    above and under section 343-1 of this title], the Secretary of
    Health and Human Services may, earlier than December 15, 1993,
    approve claims made with respect to dietary supplements of
    vitamins, minerals, herbs, or other similar nutritional substances
    that are claims described in clauses (vi) and (x) of section
    3(b)(1)(A) of the Nutrition Labeling and Education Act of 1990
    [Pub. L. 101-535] (21 U.S.C. 343 note)."

    UNITED STATES RECOMMENDED DAILY ALLOWANCES OF VITAMINS OR MINERALS
      Section 203 of Pub. L. 102-571 provided that: "Notwithstanding
    any other provision of Federal law, no regulations that require the
    use of, or are based upon, recommended daily allowances of vitamins
    or minerals may be promulgated before November 8, 1993 (other than
    regulations establishing the United States recommended daily
    allowances specified at section 101.9(c)(7)(iv) of title 21, Code
    of Federal Regulations, as in effect on October 6, 1992, or
    regulations under section 403(r)(1)(A) of the Federal Food, Drug,
    and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such
    recommended daily allowances)."

                            CONSUMER EDUCATION                        
      Section 2(c) of Pub. L. 101-535 provided that: "The Secretary of
    Health and Human Services shall carry out activities which educate
    consumers about - 
        "(1) the availability of nutrition information in the label or
      labeling of food, and
        "(2) the importance of that information in maintaining healthy
      dietary practices."

    STUDIES CONCERNING CARCINOGENIC AND OTHER TOXIC SUBSTANCES IN FOOD
                AND IMPURITIES IN AND TOXICITY OF SACCHARIN
      Section 2 of Pub. L. 95-203 directed Secretary of Health,
    Education, and Welfare to conduct a study concerning carcinogenic
    and other toxic substances in food and impurities in and toxicity
    of saccharin and make a report respecting the carcinogenic and
    other substances to Committee on Human Resources of the Senate
    within 12 months of Nov. 23, 1977, and a report respecting
    saccharin to such committee within 15 months of Nov. 23, 1977.

    REPORT TO CONGRESSIONAL COMMITTEES RESPECTING ACTION TAKEN PURSUANT
                           TO FORMER PAR. (O)(2)
      Section 4(a)(3) of Pub. L. 95-203 provided that the Secretary was
    to report to specified congressional committees any action taken
    under former par. (o)(2) of this section.

                     STATE OR TERRITORIAL REQUIREMENTS                 
      Section 2 of Pub. L. 86-537 provided that: "Nothing in the
    amendments made by the first section of this Act [amending this
    section] shall affect any requirement of the laws of any State or
    Territory."

-FOOTNOTE-
    (!1) So in original. Probably should be followed by a comma.


-End-



-CITE-
    21 USC Sec. 343-1                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343-1. National uniform nutrition labeling

-STATUTE-
      (a) Except as provided in subsection (b) of this section, no
    State or political subdivision of a State may directly or
    indirectly establish under any authority or continue in effect as
    to any food in interstate commerce - 
        (1) any requirement for a food which is the subject of a
      standard of identity established under section 341 of this title
      that is not identical to such standard of identity or that is not
      identical to the requirement of section 343(g) of this title,
      except that this paragraph does not apply to a standard of
      identity of a State or political subdivision of a State for maple
      syrup that is of the type required by sections 341 and 343(g) of
      this title,
        (2) any requirement for the labeling of food of the type
      required by section 343(c), 343(e), 343(i)(2), 343(w), or 343(x)
      of this title that is not identical to the requirement of such
      section, except that this paragraph does not apply to a
      requirement of a State or political subdivision of a State that
      is of the type required by section 343(c) of this title and that
      is applicable to maple syrup,
        (3) any requirement for the labeling of food of the type
      required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or
      343(k) of this title that is not identical to the requirement of
      such section, except that this paragraph does not apply to a
      requirement of a State or political subdivision of a State that
      is of the type required by section 343(h)(1) of this title and
      that is applicable to maple syrup,
        (4) any requirement for nutrition labeling of food that is not
      identical to the requirement of section 343(q) of this title,
      except a requirement for nutrition labeling of food which is
      exempt under subclause (i) or (ii) of section 343(q)(5)(A) of
      this title, or
        (5) any requirement respecting any claim of the type described
      in section 343(r)(1) of this title made in the label or labeling
      of food that is not identical to the requirement of section
      343(r) of this title, except a requirement respecting a claim
      made in the label or labeling of food which is exempt under
      section 343(r)(5)(B) of this title.

    Paragraph (3) shall take effect in accordance with section 6(b) of
    the Nutrition Labeling and Education Act of 1990.
      (b) Upon petition of a State or a political subdivision of a
    State, the Secretary may exempt from subsection (a) of this
    section, under such conditions as may be prescribed by regulation,
    any State or local requirement that - 
        (1) would not cause any food to be in violation of any
      applicable requirement under Federal law,
        (2) would not unduly burden interstate commerce, and
        (3) is designed to address a particular need for information
      which need is not met by the requirements of the sections
      referred to in subsection (a) of this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 403A, as added Pub. L. 101-535, Sec.
    6(a), Nov. 8, 1990, 104 Stat. 2362; amended Pub. L. 102-108, Sec.
    2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103-396, Sec. 3(a),
    Oct. 22, 1994, 108 Stat. 4154; Pub. L. 108-282, title II, Sec.
    203(c)(2), Aug. 2, 2004, 118 Stat. 908.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 6(b) of the Nutrition Labeling and Education Act of 1990
    [Pub. L. 101-535], referred to in subsec. (a), is set out below.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (a)(2). Pub. L. 108-282 substituted "343(i)(2),
    343(w), or 343(x)" for "or 343(i)(2)".
      1994 - Subsec. (a)(1). Pub. L. 103-396, Sec. 3(a)(1), inserted at
    end "except that this paragraph does not apply to a standard of
    identity of a State or political subdivision of a State for maple
    syrup that is of the type required by sections 341 and 343(g) of
    this title,".
      Subsec. (a)(2). Pub. L. 103-396, Sec. 3(a)(2), inserted at end
    "except that this paragraph does not apply to a requirement of a
    State or political subdivision of a State that is of the type
    required by section 343(c) of this title and that is applicable to
    maple syrup,".
      Subsec. (a)(3). Pub. L. 103-396, Sec. 3(a)(3), inserted at end
    "except that this paragraph does not apply to a requirement of a
    State or political subdivision of a State that is of the type
    required by section 343(h)(1) of this title and that is applicable
    to maple syrup,".
      1991 - Subsec. (a)(5). Pub. L. 102-108 substituted "section
    343(r)(5)(B) of this title" for "clause (B) of such section".

                     EFFECTIVE DATE OF 2004 AMENDMENT                 
      Amendment by Pub. L. 108-282 applicable to any food that is
    labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
    282, set out as a note under section 321 of this title.

                              EFFECTIVE DATE                          
      Section 10(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
    title I, Sec. 107(16), title II, Sec. 202(a)(4), Oct. 29, 1992, 106
    Stat. 4499, 4501, provided that:
      "(1) In general. - Except as provided in paragraph (2), the
    amendments made by section 6 [enacting this section] shall take
    effect - 
        "(A) with respect to a requirement of a State or political
      subdivision described in paragraph (1) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act [subsec. (a)(1) of this
      section], on the date of the enactment of this Act [Nov. 8,
      1990],
        "(B) with respect to a requirement of a State or political
      subdivision described in paragraph (2) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act, one year after the date of
      the enactment of this Act,
        "(C) with respect to a requirement of a State or political
      subdivision described in paragraph (3) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act, as prescribed by section
      6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L.
      101-535, set out below],
        "(D) with respect to a requirement of a State or political
      subdivision described in paragraph (4) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act, on the date regulations to
      implement section 403(q) of such Act [21 U.S.C. 343(q)] take
      effect, and
        "(E) with respect to a requirement of a State or political
      subdivision described in paragraph (5) of section 403A(a) of the
      Federal Food, Drug, and Cosmetic Act, on the date regulations to
      implement section 403(r) of such Act take effect.
      "(2) Exception. - If a State or political subdivision submits a
    petition under section 403A(b) of the Federal Food, Drug, and
    Cosmetic Act for a requirement described in section 403A(a) of such
    Act within 18 months of the date of the enactment of this Act,
    paragraphs (3) through (5) of such section 403A(a) shall not apply
    with respect to such State or political subdivision requirement
    until - 
        "(A) 24 months after the date of the enactment of this Act, or
        "(B) action on the petition,
    whichever occurs later.
      "(3) Requirements pertaining to certain claims. - Notwithstanding
    subparagraphs (D) and (E) of paragraph (1) and except with respect
    to claims approved in accordance with section 202(b) of the Dietary
    Supplement Act of 1992 [Pub. L. 102-571, set out as a note under
    section 343 of this title], the requirements described in
    paragraphs (4) and (5) of section 403A(a) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(4) and (5)) that pertain
    to dietary supplements of vitamins, minerals, herbs, or other
    similar nutritional substances shall not take effect until the date
    final regulations take effect to implement subsection (q) or (r),
    as appropriate, of section 403 of such Act with respect to such
    dietary supplements."
      Section 6(b) of Pub. L. 101-535 provided that:
      "(1) For the purpose of implementing section 403A(a)(3) [21
    U.S.C. 343-1(a)(3)], the Secretary of Health and Human Services
    shall enter into a contract with a public or nonprofit private
    entity to conduct a study of - 
        "(A) State and local laws which require the labeling of food
      that is of the type required by sections 403(b), 403(d), 403(f),
      403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and
      Cosmetic Act [21 U.S.C. 343(b), (d), (f), (h), (i)(1), (k)], and
        "(B) the sections of the Federal Food, Drug, and Cosmetic Act
      referred to in subparagraph (A) and the regulations issued by the
      Secretary to enforce such sections to determine whether such
      sections and regulations adequately implement the purposes of
      such sections.
      "(2) The contract under paragraph (1) shall provide that the
    study required by such paragraph shall be completed within 6 months
    of the date of the enactment of this Act [Nov. 8, 1990].
      "(3)(A) Within 9 months of the date of the enactment of this Act,
    the Secretary shall publish a proposed list of sections which are
    adequately being implemented by regulations as determined under
    paragraph (1)(B) and sections which are not adequately being
    implemented by regulations as so determined. After publication of
    the lists, the Secretary shall provide 60 days for comments on such
    lists.
      "(B) Within 24 months of the date of the enactment of this Act,
    the Secretary shall publish a final list of sections which are
    adequately being implemented by regulations and a list of sections
    which are not adequately being implemented by regulations. With
    respect to a section which is found by the Secretary to be
    adequately implemented, no State or political subdivision of a
    State may establish or continue in effect as to any food in
    interstate commerce any requirement which is not identical to the
    requirement of such section.
      "(C) Within 24 months of the date of the enactment of this Act,
    the Secretary shall publish proposed revisions to the regulations
    found to be inadequate under subparagraph (B) and within 30 months
    of such date shall issue final revisions. Upon the effective date
    of such final revisions, no State or political subdivision may
    establish or continue in effect any requirement which is not
    identical to the requirement of the section which had its
    regulations revised in accordance with this subparagraph.
      "(D)(i) If the Secretary does not issue a final list in
    accordance with subparagraph (B), the proposed list issued under
    subparagraph (A) shall be considered the final list and States and
    political subdivisions shall be preempted with respect to sections
    found to be adequate in such proposed list in accordance with
    subparagraph (B).
      "(ii) If the Secretary does not issue final revisions of
    regulations in accordance with subparagraph (C), the proposed
    revisions issued under such subparagraph shall be considered the
    final revisions and States and political subdivisions shall be
    preempted with respect to sections the regulations of which are
    revised by the proposed revisions.
      "(E) Subsection (b) of section 403A of the Federal Food, Drug,
    and Cosmetic Act shall apply with respect to the prohibition
    prescribed by subparagraphs (B) and (C)."

                      CONSTRUCTION OF PUB. L. 101-535                  
      Section 6(c) of Pub. L. 101-535 provided that:
      "(1) The Nutrition Labeling and Education Act of 1990 [Pub. L.
    101-535, see Short Title of 1990 Amendment note set out under
    section 301 of this title] shall not be construed to preempt any
    provision of State law, unless such provision is expressly
    preempted under section 403A of the Federal Food, Drug, and
    Cosmetic Act [this section].
      "(2) The amendment made by subsection (a) [enacting this section]
    and the provisions of subsection (b) [set out as a note above]
    shall not be construed to apply to any requirement respecting a
    statement in the labeling of food that provides for a warning
    concerning the safety of the food or component of the food.
      "(3) The amendment made by subsection (a), the provisions of
    subsection (b) and paragraphs (1) and (2) of this subsection shall
    not be construed to affect preemption, express or implied, of any
    such requirement of a State or political subdivision, which may
    arise under the Constitution, any provision of the Federal Food,
    Drug, and Cosmetic Act [this chapter] not amended by subsection
    (a), any other Federal law, or any Federal regulation, order, or
    other final agency action reviewable under chapter 7 of title 5,
    United States Code."
      Amendments by Pub. L. 101-535 not to be construed to alter the
    authority of the Secretary of Health and Human Services and the
    Secretary of Agriculture under the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21
    U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.
    451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031
    et seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.

                DELAYED APPLICABILITY OF CERTAIN PROVISIONS            
      Pub. L. 102-408, title III, Sec. 310, Oct. 13, 1992, 106 Stat.
    2090, provided that: "Notwithstanding any other provision of law,
    section 403A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 343-1(a)(1)) shall not apply with respect to any requirement
    of any State or political subdivision regarding maple syrup until
    September 1, 1994."

-End-



-CITE-
    21 USC Sec. 343-2                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343-2. Dietary supplement labeling exemptions

-STATUTE-
    (a) In general
      A publication, including an article, a chapter in a book, or an
    official abstract of a peer-reviewed scientific publication that
    appears in an article and was prepared by the author or the editors
    of the publication, which is reprinted in its entirety, shall not
    be defined as labeling when used in connection with the sale of a
    dietary supplement to consumers when it - 
        (1) is not false or misleading;
        (2) does not promote a particular manufacturer or brand of a
      dietary supplement;
        (3) is displayed or presented, or is displayed or presented
      with other such items on the same subject matter, so as to
      present a balanced view of the available scientific information
      on a dietary supplement;
        (4) if displayed in an establishment, is physically separate
      from the dietary supplements; and
        (5) does not have appended to it any information by sticker or
      any other method.
    (b) Application
      Subsection (a) of this section shall not apply to or restrict a
    retailer or wholesaler of dietary supplements in any way whatsoever
    in the sale of books or other publications as a part of the
    business of such retailer or wholesaler.
    (c) Burden of proof
      In any proceeding brought under subsection (a) of this section,
    the burden of proof shall be on the United States to establish that
    an article or other such matter is false or misleading.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 403B, as added Pub. L. 103-417, Sec.
    5, Oct. 25, 1994, 108 Stat. 4328.)

-End-



-CITE-
    21 USC Sec. 343-3                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343-3. Disclosure

-STATUTE-
      (a) No provision of section 321(n), 343(a), or 348 of this title
    shall be construed to require on the label or labeling of a food a
    separate radiation disclosure statement that is more prominent than
    the declaration of ingredients required by section 343(i)(2) of
    this title.
      (b) In this section, the term "radiation disclosure statement"
    means a written statement that discloses that a food has been
    intentionally subject to radiation.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 403C, as added Pub. L. 105-115, title
    III, Sec. 306, Nov. 21, 1997, 111 Stat. 2353.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 343a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 343a. Repealed.

-MISC1-
    Sec. 343a. Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec.
      517], Dec. 21, 2000, 114 Stat. 2763, 2763A-73.
      Section, Pub. L. 95-203, Sec. 4(c), (d), Nov. 23, 1977, 91 Stat.
    1453, 1454, related to distribution of information on health risks
    of saccharin.

-End-



-CITE-
    21 USC Sec. 344                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 344. Emergency permit control

-STATUTE-
    (a) Conditions on manufacturing, processing, etc., as health
      measure
      Whenever the Secretary finds after investigation that the
    distribution in interstate commerce of any class of food may, by
    reason of contamination with micro-organisms during the
    manufacture, processing, or packing thereof in any locality, be
    injurious to health, and that such injurious nature cannot be
    adequately determined after such articles have entered interstate
    commerce, he then, and in such case only, shall promulgate
    regulations providing for the issuance, to manufacturers,
    processors, or packers of such class of food in such locality, of
    permits to which shall be attached such conditions governing the
    manufacture, processing, or packing of such class of food, for such
    temporary period of time, as may be necessary to protect the public
    health; and after the effective date of such regulations, and
    during such temporary period, no person shall introduce or deliver
    for introduction into interstate commerce any such food
    manufactured, processed, or packed by any such manufacturer,
    processor, or packer unless such manufacturer, processor, or packer
    holds a permit issued by the Secretary as provided by such
    regulations.
    (b) Violation of permit; suspension and reinstatement
      The Secretary is authorized to suspend immediately upon notice
    any permit issued under authority of this section if it is found
    that any of the conditions of the permit have been violated. The
    holder of a permit so suspended shall be privileged at any time to
    apply for the reinstatement of such permit, and the Secretary
    shall, immediately after prompt hearing and an inspection of the
    establishment, reinstate such permit if it is found that adequate
    measures have been taken to comply with and maintain the conditions
    of the permit, as originally issued or as amended.
    (c) Inspection of permit-holding establishments
      Any officer or employee duly designated by the Secretary shall
    have access to any factory or establishment, the operator of which
    holds a permit from the Secretary, for the purpose of ascertaining
    whether or not the conditions of the permit are being complied
    with, and denial of access for such inspection shall be ground for
    suspension of the permit until such access is freely given by the
    operator.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 404, 52 Stat. 1048.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 345                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 345. Regulations making exemptions

-STATUTE-
      The Secretary shall promulgate regulations exempting from any
    labeling requirement of this chapter (1) small open containers of
    fresh fruits and fresh vegetables and (2) food which is, in
    accordance with the practice of the trade, to be processed,
    labeled, or repacked in substantial quantities at establishments
    other than those where originally processed or packed, on condition
    that such food is not adulterated or misbranded under the
    provisions of this chapter upon removal from such processing,
    labeling, or repacking establishment. This section does not apply
    to the labeling requirements of sections 343(q) and 343(r) of this
    title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 405, 52 Stat. 1049; Pub. L. 101-535,
    Sec. 5(a), Nov. 8, 1990, 104 Stat. 2362.)


-MISC1-
                                AMENDMENTS                            
      1990 - Pub. L. 101-535 inserted at end "This section does not
    apply to the labeling requirements of sections 343(q) and 343(r) of
    this title."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Amendment by Pub. L. 101-535 effective six months after the date
    of the promulgation of final regulations to implement section
    343(r) of this title, or if such regulations are not promulgated,
    the date proposed regulations are to be considered as such final
    regulations (Nov. 8, 1992), with exception for persons marketing
    food the brand name of which contains a term defined by the
    Secretary under section 343(r)(2)(A)(i) of this title, see section
    10(a) of Pub. L. 101-535, set out as a note under section 343 of
    this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Amendments by Pub. L. 101-535 not to be construed to alter
    authority of Secretary of Health and Human Services and Secretary
    of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
    et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
    seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
    seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 346                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 346. Tolerances for poisonous or deleterious substances in
      food; regulations

-STATUTE-
      Any poisonous or deleterious substance added to any food, except
    where such substance is required in the production thereof or
    cannot be avoided by good manufacturing practice shall be deemed to
    be unsafe for purposes of the application of clause (2)(A) of
    section 342(a) of this title; but when such substance is so
    required or cannot be so avoided, the Secretary shall promulgate
    regulations limiting the quantity therein or thereon to such extent
    as he finds necessary for the protection of public health, and any
    quantity exceeding the limits so fixed shall also be deemed to be
    unsafe for purposes of the application of clause (2)(A) of section
    342(a) of this title. While such a regulation is in effect limiting
    the quantity of any such substance in the case of any food, such
    food shall not, by reason of bearing or containing any added amount
    of such substance, be considered to be adulterated within the
    meaning of clause (1) of section 342(a) of this title. In
    determining the quantity of such added substance to be tolerated in
    or on different articles of food the Secretary shall take into
    account the extent to which the use of such substance is required
    or cannot be avoided in the production of each such article, and
    the other ways in which the consumer may be affected by the same or
    other poisonous or deleterious substances.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 406, 52 Stat. 1049; Pub. L. 85-929,
    Sec. 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86-618, title I,
    Sec. 103(a)(1), July 12, 1960, 74 Stat. 398.)


-MISC1-
                                AMENDMENTS                            
      1960 - Pub. L. 86-618 repealed subsec. (b) which required
    Secretary to promulgate regulations for listing of coal-tar colors.
      1958 - Subsec. (a). Pub. L. 85-929 substituted "clause (2)(A)"
    for "clause (2)" in first sentence.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

       EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
                        DESICCANT AMENDMENT OF 1959
      Effective date of subsec. (a) as in force prior to July 22, 1954,
    with respect to particular commercial use of a nematocide, plant
    regulator, defoliant, or desiccant in or on a raw agricultural
    commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
    139, Aug. 7, 1959, 73 Stat. 288.

                     EFFECTIVE DATE OF 1958 AMENDMENT                 
      For effective date of amendment by Pub. L. 85-929, see section
    6(b), (c) of Pub. L. 85-929, set out as a note under section 342 of
    this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Functions vested in Secretary of Health, Education, and Welfare
    [now Health and Human Services] in establishing tolerances for
    pesticide chemicals under this section together with authority to
    monitor compliance with tolerances and effectiveness of
    surveillance and enforcement and to provide technical assistance to
    States and conduct research under this chapter and section 201 et
    seq. of Title 42, The Public Health and Welfare, transferred to
    Administrator of Environmental Protection Agency by Reorg. Plan No.
    3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat.
    2086, set out in the Appendix to Title 5, Government Organization
    and Employees.
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration to Federal Security
    Agency, see notes set out under section 321 of this title.

-End-



-CITE-
    21 USC Sec. 346a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 346a. Tolerances and exemptions for pesticide chemical
      residues

-STATUTE-
    (a) Requirement for tolerance or exemption
      (1) General rule
        Except as provided in paragraph (2) or (3), any pesticide
      chemical residue in or on a food shall be deemed unsafe for the
      purpose of section 342(a)(2)(B) of this title unless - 
          (A) a tolerance for such pesticide chemical residue in or on
        such food is in effect under this section and the quantity of
        the residue is within the limits of the tolerance; or
          (B) an exemption from the requirement of a tolerance is in
        effect under this section for the pesticide chemical residue.

      For the purposes of this section, the term "food", when used as a
      noun without modification, shall mean a raw agricultural
      commodity or processed food.
      (2) Processed food
        Notwithstanding paragraph (1) - 
          (A) if a tolerance is in effect under this section for a
        pesticide chemical residue in or on a raw agricultural
        commodity, a pesticide chemical residue that is present in or
        on a processed food because the food is made from that raw
        agricultural commodity shall not be considered unsafe within
        the meaning of section 342(a)(2)(B) of this title despite the
        lack of a tolerance for the pesticide chemical residue in or on
        the processed food if the pesticide chemical has been used in
        or on the raw agricultural commodity in conformity with a
        tolerance under this section, such residue in or on the raw
        agricultural commodity has been removed to the extent possible
        in good manufacturing practice, and the concentration of the
        pesticide chemical residue in the processed food is not greater
        than the tolerance prescribed for the pesticide chemical
        residue in the raw agricultural commodity; or
          (B) if an exemption for the requirement for a tolerance is in
        effect under this section for a pesticide chemical residue in
        or on a raw agricultural commodity, a pesticide chemical
        residue that is present in or on a processed food because the
        food is made from that raw agricultural commodity shall not be
        considered unsafe within the meaning of section 342(a)(2)(B) of
        this title.
      (3) Residues of degradation products
        If a pesticide chemical residue is present in or on a food
      because it is a metabolite or other degradation product of a
      precursor substance that itself is a pesticide chemical or
      pesticide chemical residue, such a residue shall not be
      considered to be unsafe within the meaning of section
      342(a)(2)(B) of this title despite the lack of a tolerance or
      exemption from the need for a tolerance for such residue in or on
      such food if - 
          (A) the Administrator has not determined that the degradation
        product is likely to pose any potential health risk from
        dietary exposure that is of a different type than, or of a
        greater significance than, any risk posed by dietary exposure
        to the precursor substance;
          (B) either - 
            (i) a tolerance is in effect under this section for
          residues of the precursor substance in or on the food, and
          the combined level of residues of the degradation product and
          the precursor substance in or on the food is at or below the
          stoichiometrically equivalent level that would be permitted
          by the tolerance if the residue consisted only of the
          precursor substance rather than the degradation product; or
            (ii) an exemption from the need for a tolerance is in
          effect under this section for residues of the precursor
          substance in or on the food; and

          (C) the tolerance or exemption for residues of the precursor
        substance does not state that it applies only to particular
        named substances and does not state that it does not apply to
        residues of the degradation product.
      (4) Effect of tolerance or exemption
        While a tolerance or exemption from the requirement for a
      tolerance is in effect under this section for a pesticide
      chemical residue with respect to any food, the food shall not by
      reason of bearing or containing any amount of such a residue be
      considered to be adulterated within the meaning of section
      342(a)(1) of this title.
    (b) Authority and standard for tolerance
      (1) Authority
        The Administrator may issue regulations establishing,
      modifying, or revoking a tolerance for a pesticide chemical
      residue in or on a food - 
          (A) in response to a petition filed under subsection (d) of
        this section; or
          (B) on the Administrator's own initiative under subsection
        (e) of this section.

      As used in this section, the term "modify" shall not mean
      expanding the tolerance to cover additional foods.
      (2) Standard
        (A) General rule
          (i) Standard
            The Administrator may establish or leave in effect a
          tolerance for a pesticide chemical residue in or on a food
          only if the Administrator determines that the tolerance is
          safe. The Administrator shall modify or revoke a tolerance if
          the Administrator determines it is not safe.
          (ii) Determination of safety
            As used in this section, the term "safe", with respect to a
          tolerance for a pesticide chemical residue, means that the
          Administrator has determined that there is a reasonable
          certainty that no harm will result from aggregate exposure to
          the pesticide chemical residue, including all anticipated
          dietary exposures and all other exposures for which there is
          reliable information.
          (iii) Rule of construction
            With respect to a tolerance, a pesticide chemical residue
          meeting the standard under clause (i) is not an eligible
          pesticide chemical residue for purposes of subparagraph (B).
        (B) Tolerances for eligible pesticide chemical residues
          (i) Definition
            As used in this subparagraph, the term "eligible pesticide
          chemical residue" means a pesticide chemical residue as to
          which - 
              (I) the Administrator is not able to identify a level of
            exposure to the residue at which the residue will not cause
            or contribute to a known or anticipated harm to human
            health (referred to in this section as a "nonthreshold
            effect");
              (II) the lifetime risk of experiencing the nonthreshold
            effect is appropriately assessed by quantitative risk
            assessment; and
              (III) with regard to any known or anticipated harm to
            human health for which the Administrator is able to
            identify a level at which the residue will not cause such
            harm (referred to in this section as a "threshold effect"),
            the Administrator determines that the level of aggregate
            exposure is safe.
          (ii) Determination of tolerance
            Notwithstanding subparagraph (A)(i), a tolerance for an
          eligible pesticide chemical residue may be left in effect or
          modified under this subparagraph if - 
              (I) at least one of the conditions described in clause
            (iii) is met; and
              (II) both of the conditions described in clause (iv) are
            met.
          (iii) Conditions regarding use
            For purposes of clause (ii), the conditions described in
          this clause with respect to a tolerance for an eligible
          pesticide chemical residue are the following:
              (I) Use of the pesticide chemical that produces the
            residue protects consumers from adverse effects on health
            that would pose a greater risk than the dietary risk from
            the residue.
              (II) Use of the pesticide chemical that produces the
            residue is necessary to avoid a significant disruption in
            domestic production of an adequate, wholesome, and
            economical food supply.
          (iv) Conditions regarding risk
            For purposes of clause (ii), the conditions described in
          this clause with respect to a tolerance for an eligible
          pesticide chemical residue are the following:
              (I) The yearly risk associated with the nonthreshold
            effect from aggregate exposure to the residue does not
            exceed 10 times the yearly risk that would be allowed under
            subparagraph (A) for such effect.
              (II) The tolerance is limited so as to ensure that the
            risk over a lifetime associated with the nonthreshold
            effect from aggregate exposure to the residue is not
            greater than twice the lifetime risk that would be allowed
            under subparagraph (A) for such effect.
          (v) Review
            Five years after the date on which the Administrator makes
          a determination to leave in effect or modify a tolerance
          under this subparagraph, and thereafter as the Administrator
          deems appropriate, the Administrator shall determine, after
          notice and opportunity for comment, whether it has been
          demonstrated to the Administrator that a condition described
          in clause (iii)(I) or clause (iii)(II) continues to exist
          with respect to the tolerance and that the yearly and
          lifetime risks from aggregate exposure to such residue
          continue to comply with the limits specified in clause (iv).
          If the Administrator determines by such date that such
          demonstration has not been made, the Administrator shall, not
          later than 180 days after the date of such determination,
          issue a regulation under subsection (e)(1) of this section to
          modify or revoke the tolerance.
          (vi) Infants and children
            Any tolerance under this subparagraph shall meet the
          requirements of subparagraph (C).
        (C) Exposure of infants and children
          In establishing, modifying, leaving in effect, or revoking a
        tolerance or exemption for a pesticide chemical residue, the
        Administrator - 
            (i) shall assess the risk of the pesticide chemical residue
          based on - 
              (I) available information about consumption patterns
            among infants and children that are likely to result in
            disproportionately high consumption of foods containing or
            bearing such residue among infants and children in
            comparison to the general population;
              (II) available information concerning the special
            susceptibility of infants and children to the pesticide
            chemical residues, including neurological differences
            between infants and children and adults, and effects of in
            utero exposure to pesticide chemicals; and
              (III) available information concerning the cumulative
            effects on infants and children of such residues and other
            substances that have a common mechanism of toxicity; and

            (ii) shall - 
              (I) ensure that there is a reasonable certainty that no
            harm will result to infants and children from aggregate
            exposure to the pesticide chemical residue; and
              (II) publish a specific determination regarding the
            safety of the pesticide chemical residue for infants and
            children.

        The Secretary of Health and Human Services and the Secretary of
        Agriculture, in consultation with the Administrator, shall
        conduct surveys to document dietary exposure to pesticides
        among infants and children. In the case of threshold effects,
        for purposes of clause (ii)(I) an additional tenfold margin of
        safety for the pesticide chemical residue and other sources of
        exposure shall be applied for infants and children to take into
        account potential pre- and post-natal toxicity and completeness
        of the data with respect to exposure and toxicity to infants
        and children. Notwithstanding such requirement for an
        additional margin of safety, the Administrator may use a
        different margin of safety for the pesticide chemical residue
        only if, on the basis of reliable data, such margin will be
        safe for infants and children.
        (D) Factors
          In establishing, modifying, leaving in effect, or revoking a
        tolerance or exemption for a pesticide chemical residue, the
        Administrator shall consider, among other relevant factors - 
            (i) the validity, completeness, and reliability of the
          available data from studies of the pesticide chemical and
          pesticide chemical residue;
            (ii) the nature of any toxic effect shown to be caused by
          the pesticide chemical or pesticide chemical residue in such
          studies;
            (iii) available information concerning the relationship of
          the results of such studies to human risk;
            (iv) available information concerning the dietary
          consumption patterns of consumers (and major identifiable
          subgroups of consumers);
            (v) available information concerning the cumulative effects
          of such residues and other substances that have a common
          mechanism of toxicity;
            (vi) available information concerning the aggregate
          exposure levels of consumers (and major identifiable
          subgroups of consumers) to the pesticide chemical residue and
          to other related substances, including dietary exposure under
          the tolerance and all other tolerances in effect for the
          pesticide chemical residue, and exposure from other non-
          occupational sources;
            (vii) available information concerning the variability of
          the sensitivities of major identifiable subgroups of
          consumers;
            (viii) such information as the Administrator may require on
          whether the pesticide chemical may have an effect in humans
          that is similar to an effect produced by a naturally
          occurring estrogen or other endocrine effects; and
            (ix) safety factors which in the opinion of experts
          qualified by scientific training and experience to evaluate
          the safety of food additives are generally recognized as
          appropriate for the use of animal experimentation data.
        (E) Data and information regarding anticipated and actual
          residue levels
          (i) Authority
            In establishing, modifying, leaving in effect, or revoking
          a tolerance for a pesticide chemical residue, the
          Administrator may consider available data and information on
          the anticipated residue levels of the pesticide chemical in
          or on food and the actual residue levels of the pesticide
          chemical that have been measured in food, including residue
          data collected by the Food and Drug Administration.
          (ii) Requirement
            If the Administrator relies on anticipated or actual
          residue levels in establishing, modifying, or leaving in
          effect a tolerance, the Administrator shall pursuant to
          subsection (f)(1) of this section require that data be
          provided five years after the date on which the tolerance is
          established, modified, or left in effect, and thereafter as
          the Administrator deems appropriate, demonstrating that such
          residue levels are not above the levels so relied on. If such
          data are not so provided, or if the data do not demonstrate
          that the residue levels are not above the levels so relied
          on, the Administrator shall, not later than 180 days after
          the date on which the data were required to be provided,
          issue a regulation under subsection (e)(1) of this section,
          or an order under subsection (f)(2) of this section, as
          appropriate, to modify or revoke the tolerance.
        (F) Percent of food actually treated
          In establishing, modifying, leaving in effect, or revoking a
        tolerance for a pesticide chemical residue, the Administrator
        may, when assessing chronic dietary risk, consider available
        data and information on the percent of food actually treated
        with the pesticide chemical (including aggregate pesticide use
        data collected by the Department of Agriculture) only if the
        Administrator - 
            (i) finds that the data are reliable and provide a valid
          basis to show what percentage of the food derived from such
          crop is likely to contain such pesticide chemical residue;
            (ii) finds that the exposure estimate does not understate
          exposure for any significant subpopulation group;
            (iii) finds that, if data are available on pesticide use
          and consumption of food in a particular area, the population
          in such area is not dietarily exposed to residues above those
          estimated by the Administrator; and
            (iv) provides for the periodic reevaluation of the estimate
          of anticipated dietary exposure.
      (3) Detection methods
        (A) General rule
          A tolerance for a pesticide chemical residue in or on a food
        shall not be established or modified by the Administrator
        unless the Administrator determines, after consultation with
        the Secretary, that there is a practical method for detecting
        and measuring the levels of the pesticide chemical residue in
        or on the food.
        (B) Detection limit
          A tolerance for a pesticide chemical residue in or on a food
        shall not be established at or modified to a level lower than
        the limit of detection of the method for detecting and
        measuring the pesticide chemical residue specified by the
        Administrator under subparagraph (A).
      (4) International standards
        In establishing a tolerance for a pesticide chemical residue in
      or on a food, the Administrator shall determine whether a maximum
      residue level for the pesticide chemical has been established by
      the Codex Alimentarius Commission. If a Codex maximum residue
      level has been established for the pesticide chemical and the
      Administrator does not propose to adopt the Codex level, the
      Administrator shall publish for public comment a notice
      explaining the reasons for departing from the Codex level.
    (c) Authority and standard for exemptions
      (1) Authority
        The Administrator may issue a regulation establishing,
      modifying, or revoking an exemption from the requirement for a
      tolerance for a pesticide chemical residue in or on food - 
          (A) in response to a petition filed under subsection (d) of
        this section; or
          (B) on the Administrator's initiative under subsection (e) of
        this section.
      (2) Standard
        (A) General rule
          (i) Standard
            The Administrator may establish or leave in effect an
          exemption from the requirement for a tolerance for a
          pesticide chemical residue in or on food only if the
          Administrator determines that the exemption is safe. The
          Administrator shall modify or revoke an exemption if the
          Administrator determines it is not safe.
          (ii) Determination of safety
            The term "safe", with respect to an exemption for a
          pesticide chemical residue, means that the Administrator has
          determined that there is a reasonable certainty that no harm
          will result from aggregate exposure to the pesticide chemical
          residue, including all anticipated dietary exposures and all
          other exposures for which there is reliable information.
        (B) Factors
          In making a determination under this paragraph, the
        Administrator shall take into account, among other relevant
        considerations, the considerations set forth in subparagraphs
        (C) and (D) of subsection (b)(2) of this section.
      (3) Limitation
        An exemption from the requirement for a tolerance for a
      pesticide chemical residue in or on food shall not be established
      or modified by the Administrator unless the Administrator
      determines, after consultation with the Secretary - 
          (A) that there is a practical method for detecting and
        measuring the levels of such pesticide chemical residue in or
        on food; or
          (B) that there is no need for such a method, and states the
        reasons for such determination in issuing the regulation
        establishing or modifying the exemption.
    (d) Petition for tolerance or exemption
      (1) Petitions and petitioners
        Any person may file with the Administrator a petition proposing
      the issuance of a regulation - 
          (A) establishing, modifying, or revoking a tolerance for a
        pesticide chemical residue in or on a food; or
          (B) establishing, modifying, or revoking an exemption from
        the requirement of a tolerance for such a residue.
      (2) Petition contents
        (A) Establishment
          A petition under paragraph (1) to establish a tolerance or
        exemption for a pesticide chemical residue shall be supported
        by such data and information as are specified in regulations
        issued by the Administrator, including - 
            (i)(I) an informative summary of the petition and of the
          data, information, and arguments submitted or cited in
          support of the petition; and
            (II) a statement that the petitioner agrees that such
          summary or any information it contains may be published as a
          part of the notice of filing of the petition to be published
          under this subsection and as part of a proposed or final
          regulation issued under this section;
            (ii) the name, chemical identity, and composition of the
          pesticide chemical residue and of the pesticide chemical that
          produces the residue;
            (iii) data showing the recommended amount, frequency,
          method, and time of application of that pesticide chemical;
            (iv) full reports of tests and investigations made with
          respect to the safety of the pesticide chemical, including
          full information as to the methods and controls used in
          conducting those tests and investigations;
            (v) full reports of tests and investigations made with
          respect to the nature and amount of the pesticide chemical
          residue that is likely to remain in or on the food, including
          a description of the analytical methods used;
            (vi) a practical method for detecting and measuring the
          levels of the pesticide chemical residue in or on the food,
          or for exemptions, a statement why such a method is not
          needed;
            (vii) a proposed tolerance for the pesticide chemical
          residue, if a tolerance is proposed;
            (viii) if the petition relates to a tolerance for a
          processed food, reports of investigations conducted using the
          processing method(s) used to produce that food;
            (ix) such information as the Administrator may require to
          make the determination under subsection (b)(2)(C) of this
          section;
            (x) such information as the Administrator may require on
          whether the pesticide chemical may have an effect in humans
          that is similar to an effect produced by a naturally
          occurring estrogen or other endocrine effects;
            (xi) information regarding exposure to the pesticide
          chemical residue due to any tolerance or exemption already
          granted for such residue;
            (xii) practical methods for removing any amount of the
          residue that would exceed any proposed tolerance; and
            (xiii) such other data and information as the Administrator
          requires by regulation to support the petition.

        If information or data required by this subparagraph is
        available to the Administrator, the person submitting the
        petition may cite the availability of the information or data
        in lieu of submitting it. The Administrator may require a
        petition to be accompanied by samples of the pesticide chemical
        with respect to which the petition is filed.
        (B) Modification or revocation
          The Administrator may by regulation establish the
        requirements for information and data to support a petition to
        modify or revoke a tolerance or to modify or revoke an
        exemption from the requirement for a tolerance.
      (3) Notice
        A notice of the filing of a petition that the Administrator
      determines has met the requirements of paragraph (2) shall be
      published by the Administrator within 30 days after such
      determination. The notice shall announce the availability of a
      description of the analytical methods available to the
      Administrator for the detection and measurement of the pesticide
      chemical residue with respect to which the petition is filed or
      shall set forth the petitioner's statement of why such a method
      is not needed. The notice shall include the summary required by
      paragraph (2)(A)(i)(I).
      (4) Actions by the Administrator
        (A) In general
          The Administrator shall, after giving due consideration to a
        petition filed under paragraph (1) and any other information
        available to the Administrator - 
            (i) issue a final regulation (which may vary from that
          sought by the petition) establishing, modifying, or revoking
          a tolerance for the pesticide chemical residue or an
          exemption of the pesticide chemical residue from the
          requirement of a tolerance (which final regulation shall be
          issued without further notice and without further period for
          public comment);
            (ii) issue a proposed regulation under subsection (e) of
          this section, and thereafter issue a final regulation under
          such subsection; or
            (iii) issue an order denying the petition.
        (B) Priorities
          The Administrator shall give priority to petitions for the
        establishment or modification of a tolerance or exemption for a
        pesticide chemical residue that appears to pose a significantly
        lower risk to human health from dietary exposure than pesticide
        chemical residues that have tolerances in effect for the same
        or similar uses.
        (C) Expedited review of certain petitions
          (i) Date certain for review
            If a person files a complete petition with the
          Administrator proposing the issuance of a regulation
          establishing a tolerance or exemption for a pesticide
          chemical residue that presents a lower risk to human health
          than a pesticide chemical residue for which a tolerance has
          been left in effect or modified under subsection (b)(2)(B) of
          this section, the Administrator shall complete action on such
          petition under this paragraph within 1 year.
          (ii) Required determinations
            If the Administrator issues a final regulation establishing
          a tolerance or exemption for a safer pesticide chemical
          residue under clause (i), the Administrator shall, not later
          than 180 days after the date on which the regulation is
          issued, determine whether a condition described in subclause
          (I) or (II) of subsection (b)(2)(B)(iii) of this section
          continues to exist with respect to a tolerance that has been
          left in effect or modified under subsection (b)(2)(B) of this
          section. If such condition does not continue to exist, the
          Administrator shall, not later than 180 days after the date
          on which the determination under the preceding sentence is
          made, issue a regulation under subsection (e)(1) of this
          section to modify or revoke the tolerance.
    (e) Action on Administrator's own initiative
      (1) General rule
        The Administrator may issue a regulation - 
          (A) establishing, modifying, suspending under subsection
        (l)(3) of this section, or revoking a tolerance for a pesticide
        chemical or a pesticide chemical residue;
          (B) establishing, modifying, suspending under subsection
        (l)(3) of this section, or revoking an exemption of a pesticide
        chemical residue from the requirement of a tolerance; or
          (C) establishing general procedures and requirements to
        implement this section.
      (2) Notice
        Before issuing a final regulation under paragraph (1), the
      Administrator shall issue a notice of proposed rulemaking and
      provide a period of not less than 60 days for public comment on
      the proposed regulation, except that a shorter period for comment
      may be provided if the Administrator for good cause finds that it
      would be in the public interest to do so and states the reasons
      for the finding in the notice of proposed rulemaking.
    (f) Special data requirements
      (1) Requiring submission of additional data
        If the Administrator determines that additional data or
      information are reasonably required to support the continuation
      of a tolerance or exemption that is in effect under this section
      for a pesticide chemical residue on a food, the Administrator
      shall - 
          (A) issue a notice requiring the person holding the pesticide
        registrations associated with such tolerance or exemption to
        submit the data or information under section 3(c)(2)(B) of the
        Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.
        136a(c)(2)(B)];
          (B) issue a rule requiring that testing be conducted on a
        substance or mixture under section 4 of the Toxic Substances
        Control Act [15 U.S.C. 2603]; or
          (C) publish in the Federal Register, after first providing
        notice and an opportunity for comment of not less than 60 days'
        duration, an order - 
            (i) requiring the submission to the Administrator by one or
          more interested persons of a notice identifying the person or
          persons who will submit the required data and information;
            (ii) describing the type of data and information required
          to be submitted to the Administrator and stating why the data
          and information could not be obtained under the authority of
          section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and
          Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or section 4 of the
          Toxic Substances Control Act [15 U.S.C. 2603];
            (iii) describing the reports of the Administrator required
          to be prepared during and after the collection of the data
          and information;
            (iv) requiring the submission to the Administrator of the
          data, information, and reports referred to in clauses (ii)
          and (iii); and
            (v) establishing dates by which the submissions described
          in clauses (i) and (iv) must be made.

        The Administrator may under subparagraph (C) revise any such
        order to correct an error. The Administrator may under this
        paragraph require data or information pertaining to whether the
        pesticide chemical may have an effect in humans that is similar
        to an effect produced by a naturally occurring estrogen or
        other endocrine effects.
      (2) Noncompliance
        If a submission required by a notice issued in accordance with
      paragraph (1)(A), a rule issued under paragraph (1)(B), or an
      order issued under paragraph (1)(C) is not made by the time
      specified in such notice, rule, or order, the Administrator may
      by order published in the Federal Register modify or revoke the
      tolerance or exemption in question. In any review of such an
      order under subsection (g)(2) of this section, the only material
      issue shall be whether a submission required under paragraph (1)
      was not made by the time specified.
    (g) Effective date, objections, hearings, and administrative review
      (1) Effective date
        A regulation or order issued under subsection (d)(4), (e)(1),
      or (f)(2) of this section shall take effect upon publication
      unless the regulation or order specifies otherwise. The
      Administrator may stay the effectiveness of the regulation or
      order if, after issuance of such regulation or order, objections
      are filed with respect to such regulation or order pursuant to
      paragraph (2).
      (2) Further proceedings
        (A) Objections
          Within 60 days after a regulation or order is issued under
        subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or
        (n)(5)(C) of this section, any person may file objections
        thereto with the Administrator, specifying with particularity
        the provisions of the regulation or order deemed objectionable
        and stating reasonable grounds therefor. If the regulation or
        order was issued in response to a petition under subsection
        (d)(1) of this section, a copy of each objection filed by a
        person other than the petitioner shall be served by the
        Administrator on the petitioner.
        (B) Hearing
          An objection may include a request for a public evidentiary
        hearing upon the objection. The Administrator shall, upon the
        initiative of the Administrator or upon the request of an
        interested person and after due notice, hold a public
        evidentiary hearing if and to the extent the Administrator
        determines that such a public hearing is necessary to receive
        factual evidence relevant to material issues of fact raised by
        the objections. The presiding officer in such a hearing may
        authorize a party to obtain discovery from other persons and
        may upon a showing of good cause made by a party issue a
        subpoena to compel testimony or production of documents from
        any person. The presiding officer shall be governed by the
        Federal Rules of Civil Procedure in making any order for the
        protection of the witness or the content of documents produced
        and shall order the payment of reasonable fees and expenses as
        a condition to requiring testimony of the witness. On contest,
        such a subpoena may be enforced by a Federal district court.
        (C) Final decision
          As soon as practicable after receiving the arguments of the
        parties, the Administrator shall issue an order stating the
        action taken upon each such objection and setting forth any
        revision to the regulation or prior order that the
        Administrator has found to be warranted. If a hearing was held
        under subparagraph (B), such order and any revision to the
        regulation or prior order shall, with respect to questions of
        fact at issue in the hearing, be based only on substantial
        evidence of record at such hearing, and shall set forth in
        detail the findings of facts and the conclusions of law or
        policy upon which the order or regulation is based.
    (h) Judicial review
      (1) Petition
        In a case of actual controversy as to the validity of any
      regulation issued under subsection (e)(1)(C) of this section, or
      any order issued under subsection (f)(1)(C) or (g)(2)(C) of this
      section, or any regulation that is the subject of such an order,
      any person who will be adversely affected by such order or
      regulation may obtain judicial review by filing in the United
      States Court of Appeals for the circuit wherein that person
      resides or has its principal place of business, or in the United
      States Court of Appeals for the District of Columbia Circuit,
      within 60 days after publication of such order or regulation, a
      petition praying that the order or regulation be set aside in
      whole or in part.
      (2) Record and jurisdiction
        A copy of the petition under paragraph (1) shall be forthwith
      transmitted by the clerk of the court to the Administrator, or
      any officer designated by the Administrator for that purpose, and
      thereupon the Administrator shall file in the court the record of
      the proceedings on which the Administrator based the order or
      regulation, as provided in section 2112 of title 28. Upon the
      filing of such a petition, the court shall have exclusive
      jurisdiction to affirm or set aside the order or regulation
      complained of in whole or in part. As to orders issued following
      a public evidentiary hearing, the findings of the Administrator
      with respect to questions of fact shall be sustained only if
      supported by substantial evidence when considered on the record
      as a whole.
      (3) Additional evidence
        If a party applies to the court for leave to adduce additional
      evidence and shows to the satisfaction of the court that the
      additional evidence is material and that there were reasonable
      grounds for the failure to adduce the evidence in the proceeding
      before the Administrator, the court may order that the additional
      evidence (and evidence in rebuttal thereof) shall be taken before
      the Administrator in the manner and upon the terms and conditions
      the court deems proper. The Administrator may modify prior
      findings as to the facts by reason of the additional evidence so
      taken and may modify the order or regulation accordingly. The
      Administrator shall file with the court any such modified
      finding, order, or regulation.
      (4) Final judgment; Supreme Court review
        The judgment of the court affirming or setting aside, in whole
      or in part, any regulation or any order and any regulation which
      is the subject of such an order shall be final, subject to review
      by the Supreme Court of the United States as provided in section
      1254 of title 28. The commencement of proceedings under this
      subsection shall not, unless specifically ordered by the court to
      the contrary, operate as a stay of a regulation or order.
      (5) Application
        Any issue as to which review is or was obtainable under this
      subsection shall not be the subject of judicial review under any
      other provision of law.
    (i) Confidentiality and use of data
      (1) General rule
        Data and information that are or have been submitted to the
      Administrator under this section or section 348 of this title in
      support of a tolerance or an exemption from a tolerance shall be
      entitled to confidential treatment for reasons of business
      confidentiality and to exclusive use and data compensation to the
      same extent provided by sections 3 and 10 of the Federal
      Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a,
      136h].
      (2) Exceptions
        (A) In general
          Data and information that are entitled to confidential
        treatment under paragraph (1) may be disclosed, under such
        security requirements as the Administrator may provide by
        regulation, to - 
            (i) employees of the United States authorized by the
          Administrator to examine such data and information in the
          carrying out of their official duties under this chapter or
          other Federal statutes intended to protect the public health;
          or
            (ii) contractors with the United States authorized by the
          Administrator to examine such data and information in the
          carrying out of contracts under this chapter or such
          statutes.
        (B) Congress
          This subsection does not authorize the withholding of data or
        information from either House of Congress or from, to the
        extent of matter within its jurisdiction, any committee or
        subcommittee of such committee or any joint committee of
        Congress or any subcommittee of such joint committee.
      (3) Summaries
        Notwithstanding any provision of this subsection or other law,
      the Administrator may publish the informative summary required by
      subsection (d)(2)(A)(i) of this section and may, in issuing a
      proposed or final regulation or order under this section, publish
      an informative summary of the data relating to the regulation or
      order.
    (j) Status of previously issued regulations
      (1) Regulations under section 346
        Regulations affecting pesticide chemical residues in or on raw
      agricultural commodities promulgated, in accordance with section
      371(e) of this title, under the authority of section 346(a) (!1)
      of this title upon the basis of public hearings instituted before
      January 1, 1953, shall be deemed to be regulations issued under
      this section and shall be subject to modification or revocation
      under subsections (d) and (e) of this section, and shall be
      subject to review under subsection (q) of this section.

      (2) Regulations under section 348
        Regulations that established tolerances for substances that are
      pesticide chemical residues in or on processed food, or that
      otherwise stated the conditions under which such pesticide
      chemicals could be safely used, and that were issued under
      section 348 of this title on or before August 3, 1996, shall be
      deemed to be regulations issued under this section and shall be
      subject to modification or revocation under subsection (d) or (e)
      of this section, and shall be subject to review under subsection
      (q) of this section.
      (3) Regulations under section 346a
        Regulations that established tolerances or exemptions under
      this section that were issued on or before August 3, 1996, shall
      remain in effect unless modified or revoked under subsection (d)
      or (e) of this section, and shall be subject to review under
      subsection (q) of this section.
      (4) Certain substances
        With respect to a substance that is not included in the
      definition of the term "pesticide chemical" under section
      321(q)(1) of this title but was so included on the day before
      October 30, 1998, the following applies as of October 30, 1998:
          (A) Notwithstanding paragraph (2), any regulation applying to
        the use of the substance that was in effect on the day before
        October 30, 1998, and was on such day deemed in such paragraph
        to have been issued under this section, shall be considered to
        have been issued under section 348 of this title.
          (B) Notwithstanding paragraph (3), any regulation applying to
        the use of the substance that was in effect on such day and was
        issued under this section (including any such regulation issued
        before August 3, 1996) is deemed to have been issued under
        section 348 of this title.
    (k) Transitional provision
      If, on the day before August 3, 1996, a substance that is a
    pesticide chemical was, with respect to a particular pesticidal use
    of the substance and any resulting pesticide chemical residue in or
    on a particular food - 
        (1) regarded by the Administrator or the Secretary as generally
      recognized as safe for use within the meaning of the provisions
      of subsection (a) of this section or section 321(s) of this title
      as then in effect; or
        (2) regarded by the Secretary as a substance described by
      section 321(s)(4) of this title;

    such a pesticide chemical residue shall be regarded as exempt from
    the requirement for a tolerance, as of August 3, 1996. The
    Administrator shall by regulation indicate which substances are
    described by this subsection. Any exemption under this subsection
    may be modified or revoked as if it had been issued under
    subsection (c) of this section.
    (l) Harmonization with action under other laws
      (1) Coordination with FIFRA
        To the extent practicable and consistent with the review
      deadlines in subsection (q) of this section, in issuing a final
      rule under this subsection that suspends or revokes a tolerance
      or exemption for a pesticide chemical residue in or on food, the
      Administrator shall coordinate such action with any related
      necessary action under the Federal Insecticide, Fungicide, and
      Rodenticide Act [7 U.S.C. 136 et seq.].
      (2) Revocation of tolerance or exemption following cancellation
        of associated registrations
        If the Administrator, acting under the Federal Insecticide,
      Fungicide, and Rodenticide Act, cancels the registration of each
      pesticide that contains a particular pesticide chemical and that
      is labeled for use on a particular food, or requires that the
      registration of each such pesticide be modified to prohibit its
      use in connection with the production, storage, or transportation
      of such food, due in whole or in part to dietary risks to humans
      posed by residues of that pesticide chemical on that food, the
      Administrator shall revoke any tolerance or exemption that allows
      the presence of the pesticide chemical, or any pesticide chemical
      residue that results from its use, in or on that food. Subsection
      (e) of this section shall apply to actions taken under this
      paragraph. A revocation under this paragraph shall become
      effective not later than 180 days after - 
          (A) the date by which each such cancellation of a
        registration has become effective; or
          (B) the date on which the use of the canceled pesticide
        becomes unlawful under the terms of the cancellation, whichever
        is later.
      (3) Suspension of tolerance or exemption following suspension of
        associated registrations
        (A) Suspension
          If the Administrator, acting under the Federal Insecticide,
        Fungicide, and Rodenticide Act, suspends the use of each
        registered pesticide that contains a particular pesticide
        chemical and that is labeled for use on a particular food, due
        in whole or in part to dietary risks to humans posed by
        residues of that pesticide chemical on that food, the
        Administrator shall suspend any tolerance or exemption that
        allows the presence of the pesticide chemical, or any pesticide
        chemical residue that results from its use, in or on that food.
        Subsection (e) of this section shall apply to actions taken
        under this paragraph. A suspension under this paragraph shall
        become effective not later than 60 days after the date by which
        each such suspension of use has become effective.
        (B) Effect of suspension
          The suspension of a tolerance or exemption under subparagraph
        (A) shall be effective as long as the use of each associated
        registration of a pesticide is suspended under the Federal
        Insecticide, Fungicide, and Rodenticide Act. While a suspension
        of a tolerance or exemption is effective the tolerance or
        exemption shall not be considered to be in effect. If the
        suspension of use of the pesticide under that Act is
        terminated, leaving the registration of the pesticide for such
        use in effect under that Act, the Administrator shall rescind
        any associated suspension of tolerance or exemption.
      (4) Tolerances for unavoidable residues
        In connection with action taken under paragraph (2) or (3), or
      with respect to pesticides whose registrations were suspended or
      canceled prior to August 3, 1996, under the Federal Insecticide,
      Fungicide, and Rodenticide Act, if the Administrator determines
      that a residue of the canceled or suspended pesticide chemical
      will unavoidably persist in the environment and thereby be
      present in or on a food, the Administrator may establish a
      tolerance for the pesticide chemical residue. In establishing
      such a tolerance, the Administrator shall take into account both
      the factors set forth in subsection (b)(2) of this section and
      the unavoidability of the residue. Subsection (e) of this section
      shall apply to the establishment of such tolerance. The
      Administrator shall review any such tolerance periodically and
      modify it as necessary so that it allows no greater level of the
      pesticide chemical residue than is unavoidable.
      (5) Pesticide residues resulting from lawful application of
        pesticide
        Notwithstanding any other provision of this chapter, if a
      tolerance or exemption for a pesticide chemical residue in or on
      a food has been revoked, suspended, or modified under this
      section, an article of that food shall not be deemed unsafe
      solely because of the presence of such pesticide chemical residue
      in or on such food if it is shown to the satisfaction of the
      Secretary that - 
          (A) the residue is present as the result of an application or
        use of a pesticide at a time and in a manner that was lawful
        under the Federal Insecticide, Fungicide, and Rodenticide Act;
        and
          (B) the residue does not exceed a level that was authorized
        at the time of that application or use to be present on the
        food under a tolerance, exemption, food additive regulation, or
        other sanction then in effect under this chapter;

      unless, in the case of any tolerance or exemption revoked,
      suspended, or modified under this subsection or subsection (d) or
      (e) of this section, the Administrator has issued a determination
      that consumption of the legally treated food during the period of
      its likely availability in commerce will pose an unreasonable
      dietary risk.
      (6) Tolerance for use of pesticides under an emergency exemption
        If the Administrator grants an exemption under section 18 of
      the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
      136p) for a pesticide chemical, the Administrator shall establish
      a tolerance or exemption from the requirement for a tolerance for
      the pesticide chemical residue. Such a tolerance or exemption
      from a tolerance shall have an expiration date. The Administrator
      may establish such a tolerance or exemption without providing
      notice or a period for comment on the tolerance or exemption. The
      Administrator shall promulgate regulations within 365 days after
      August 3, 1996, governing the establishment of tolerances and
      exemptions under this paragraph. Such regulations shall be
      consistent with the safety standard under subsections (b)(2) and
      (c)(2) of this section and with section 18 of the Federal
      Insecticide, Fungicide, and Rodenticide Act.
    (m) Fees
      (1) Amount
        The Administrator shall by regulation require the payment of
      such fees as will in the aggregate, in the judgment of the
      Administrator, be sufficient over a reasonable term to provide,
      equip, and maintain an adequate service for the performance of
      the Administrator's functions under this section. Under the
      regulations, the performance of the Administrator's services or
      other functions under this section, including - 
          (A) the acceptance for filing of a petition submitted under
        subsection (d) of this section;
          (B) establishing, modifying, leaving in effect, or revoking a
        tolerance or establishing, modifying, leaving in effect, or
        revoking an exemption from the requirement for a tolerance
        under this section;
          (C) the acceptance for filing of objections under subsection
        (g) of this section; or
          (D) the certification and filing in court of a transcript of
        the proceedings and the record under subsection (h) of this
        section;

      may be conditioned upon the payment of such fees. The regulations
      may further provide for waiver or refund of fees in whole or in
      part when in the judgment of the Administrator such a waiver or
      refund is equitable and not contrary to the purposes of this
      subsection.
      (2) Deposit
        All fees collected under paragraph (1) shall be deposited in
      the Reregistration and Expedited Processing Fund created by
      section 4(k) of the Federal Insecticide, Fungicide, and
      Rodenticide Act [7 U.S.C. 136a-1(k)]. Such fees shall be
      available to the Administrator, without fiscal year limitation,
      for the performance of the Administrator's services or functions
      as specified in paragraph (1).
    (n) National uniformity of tolerances
      (1) "Qualifying pesticide chemical residue" defined
        For purposes of this subsection, the term "qualifying pesticide
      chemical residue" means a pesticide chemical residue resulting
      from the use, in production, processing, or storage of a food, of
      a pesticide chemical that is an active ingredient and that - 
          (A) was first approved for such use in a registration of a
        pesticide issued under section 3(c)(5) of the Federal
        Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.
        136a(c)(5)] on or after April 25, 1985, on the basis of data
        determined by the Administrator to meet all applicable
        requirements for data prescribed by regulations in effect under
        that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or
          (B) was approved for such use in a reregistration eligibility
        determination issued under section 4(g) of that Act [7 U.S.C.
        136a-1(g)] on or after August 3, 1996.
      (2) "Qualifying Federal determination" defined
        For purposes of this subsection, the term "qualifying Federal
      determination" means a tolerance or exemption from the
      requirement for a tolerance for a qualifying pesticide chemical
      residue that - 
          (A) is issued under this section after August 3, 1996, and
        determined by the Administrator to meet the standard under
        subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in
        the case of an exemption) of this section; or
          (B)(i) pursuant to subsection (j) of this section is
        remaining in effect or is deemed to have been issued under this
        section, or is regarded under subsection (k) of this section as
        exempt from the requirement for a tolerance; and
          (ii) is determined by the Administrator to meet the standard
        under subsection (b)(2)(A) (in the case of a tolerance) or
        (c)(2) (in the case of an exemption) of this section.
      (3) Limitation
        The Administrator may make the determination described in
      paragraph (2)(B)(ii) only by issuing a rule in accordance with
      the procedure set forth in subsection (d) or (e) of this section
      and only if the Administrator issues a proposed rule and allows a
      period of not less than 30 days for comment on the proposed rule.
      Any such rule shall be reviewable in accordance with subsections
      (g) and (h) of this section.
      (4) State authority
        Except as provided in paragraphs (5), (6), and (8) no State or
      political subdivision may establish or enforce any regulatory
      limit on a qualifying pesticide chemical residue in or on any
      food if a qualifying Federal determination applies to the
      presence of such pesticide chemical residue in or on such food,
      unless such State regulatory limit is identical to such
      qualifying Federal determination. A State or political
      subdivision shall be deemed to establish or enforce a regulatory
      limit on a pesticide chemical residue in or on a food if it
      purports to prohibit or penalize the production, processing,
      shipping, or other handling of a food because it contains a
      pesticide residue (in excess of a prescribed limit).
      (5) Petition procedure
        (A) In general
          Any State may petition the Administrator for authorization to
        establish in such State a regulatory limit on a qualifying
        pesticide chemical residue in or on any food that is not
        identical to the qualifying Federal determination applicable to
        such qualifying pesticide chemical residue.
        (B) Petition requirements
          Any petition under subparagraph (A) shall - 
            (i) satisfy any requirements prescribed, by rule, by the
          Administrator; and
            (ii) be supported by scientific data about the pesticide
          chemical residue that is the subject of the petition or about
          chemically related pesticide chemical residues, data on the
          consumption within such State of food bearing the pesticide
          chemical residue, and data on exposure of humans within such
          State to the pesticide chemical residue.
        (C) Authorization
          The Administrator may, by order, grant the authorization
        described in subparagraph (A) if the Administrator determines
        that the proposed State regulatory limit - 
            (i) is justified by compelling local conditions; and
            (ii) would not cause any food to be a violation of Federal
          law.
        (D) Treatment
          In lieu of any action authorized under subparagraph (C), the
        Administrator may treat a petition under this paragraph as a
        petition under subsection (d) of this section to modify or
        revoke a tolerance or an exemption. If the Administrator
        determines to treat a petition under this paragraph as a
        petition under subsection (d) of this section, the
        Administrator shall thereafter act on the petition pursuant to
        subsection (d) of this section.
        (E) Review
          Any order of the Administrator granting or denying the
        authorization described in subparagraph (A) shall be subject to
        review in the manner described in subsections (g) and (h) of
        this section.
      (6) Urgent petition procedure
        Any State petition to the Administrator pursuant to paragraph
      (5) that demonstrates that consumption of a food containing such
      pesticide residue level during the period of the food's likely
      availability in the State will pose a significant public health
      threat from acute exposure shall be considered an urgent
      petition. If an order by the Administrator to grant or deny the
      requested authorization in an urgent petition is not made within
      30 days of receipt of the petition, the petitioning State may
      establish and enforce a temporary regulatory limit on a
      qualifying pesticide chemical residue in or on the food. The
      temporary regulatory limit shall be validated or terminated by
      the Administrator's final order on the petition.
      (7) Residues from lawful application
        No State or political subdivision may enforce any regulatory
      limit on the level of a pesticide chemical residue that may
      appear in or on any food if, at the time of the application of
      the pesticide that resulted in such residue, the sale of such
      food with such residue level was lawful under this section and
      under the law of such State, unless the State demonstrates that
      consumption of the food containing such pesticide residue level
      during the period of the food's likely availability in the State
      will pose an unreasonable dietary risk to the health of persons
      within such State.
      (8) Savings
        Nothing in this chapter preempts the authority of any State or
      political subdivision to require that a food containing a
      pesticide chemical residue bear or be the subject of a warning or
      other statement relating to the presence of the pesticide
      chemical residue in or on such food.
    (o) Consumer right to know
      Not later than 2 years after August 3, 1996, and annually
    thereafter, the Administrator shall, in consultation with the
    Secretary of Agriculture and the Secretary of Health and Human
    Services, publish in a format understandable to a lay person, and
    distribute to large retail grocers for public display (in a manner
    determined by the grocer), the following information, at a minimum:
        (1) A discussion of the risks and benefits of pesticide
      chemical residues in or on food purchased by consumers.
        (2) A listing of actions taken under subparagraph (B) of
      subsection (b)(2) of this section that may result in pesticide
      chemical residues in or on food that present a yearly or lifetime
      risk above the risk allowed under subparagraph (A) of such
      subsection, and the food on which the pesticide chemicals
      producing the residues are used.
        (3) Recommendations to consumers for reducing dietary exposure
      to pesticide chemical residues in a manner consistent with
      maintaining a healthy diet, including a list of food that may
      reasonably substitute for food listed under paragraph (2).

      Nothing in this subsection shall prevent retail grocers from
    providing additional information.
    (p) Estrogenic substances screening program
      (1) Development
        Not later than 2 years after August 3, 1996, the Administrator
      shall in consultation with the Secretary of Health and Human
      Services develop a screening program, using appropriate validated
      test systems and other scientifically relevant information, to
      determine whether certain substances may have an effect in humans
      that is similar to an effect produced by a naturally occurring
      estrogen, or such other endocrine effect as the Administrator may
      designate.
      (2) Implementation
        Not later than 3 years after August 3, 1996, after obtaining
      public comment and review of the screening program described in
      paragraph (1) by the scientific advisory panel established under
      section 25(d) of the Federal Insecticide, Fungicide, and
      Rodenticide Act [7 U.S.C. 136w(d)] or the science advisory board
      established by section 4365 (!2) of title 42, the Administrator
      shall implement the program.

      (3) Substances
        In carrying out the screening program described in paragraph
      (1), the Administrator - 
          (A) shall provide for the testing of all pesticide chemicals;
        and
          (B) may provide for the testing of any other substance that
        may have an effect that is cumulative to an effect of a
        pesticide chemical if the Administrator determines that a
        substantial population may be exposed to such substance.
      (4) Exemption
        Notwithstanding paragraph (3), the Administrator may, by order,
      exempt from the requirements of this section a biologic substance
      or other substance if the Administrator determines that the
      substance is anticipated not to produce any effect in humans
      similar to an effect produced by a naturally occurring estrogen.
      (5) Collection of information
        (A) In general
          The Administrator shall issue an order to a registrant of a
        substance for which testing is required under this subsection,
        or to a person who manufactures or imports a substance for
        which testing is required under this subsection, to conduct
        testing in accordance with the screening program described in
        paragraph (1), and submit information obtained from the testing
        to the Administrator, within a reasonable time period that the
        Administrator determines is sufficient for the generation of
        the information.
        (B) Procedures
          To the extent practicable the Administrator shall minimize
        duplicative testing of the same substance for the same
        endocrine effect, develop, as appropriate, procedures for fair
        and equitable sharing of test costs, and develop, as necessary,
        procedures for handling of confidential business information.
        (C) Failure of registrants to submit information
          (i) Suspension
            If a registrant of a substance referred to in paragraph
          (3)(A) fails to comply with an order under subparagraph (A)
          of this paragraph, the Administrator shall issue a notice of
          intent to suspend the sale or distribution of the substance
          by the registrant. Any suspension proposed under this
          paragraph shall become final at the end of the 30-day period
          beginning on the date that the registrant receives the notice
          of intent to suspend, unless during that period a person
          adversely affected by the notice requests a hearing or the
          Administrator determines that the registrant has complied
          fully with this paragraph.
          (ii) Hearing
            If a person requests a hearing under clause (i), the
          hearing shall be conducted in accordance with section 554 of
          title 5. The only matter for resolution at the hearing shall
          be whether the registrant has failed to comply with an order
          under subparagraph (A) of this paragraph. A decision by the
          Administrator after completion of a hearing shall be
          considered to be a final agency action.
          (iii) Termination of suspensions
            The Administrator shall terminate a suspension under this
          subparagraph issued with respect to a registrant if the
          Administrator determines that the registrant has complied
          fully with this paragraph.
        (D) Noncompliance by other persons
          Any person (other than a registrant) who fails to comply with
        an order under subparagraph (A) shall be liable for the same
        penalties and sanctions as are provided under section 16 of the
        Toxic Substances Control Act [15 U.S.C. 2615] in the case of a
        violation referred to in that section. Such penalties and
        sanctions shall be assessed and imposed in the same manner as
        provided in such section 16.
      (6) Agency action
        In the case of any substance that is found, as a result of
      testing and evaluation under this section, to have an endocrine
      effect on humans, the Administrator shall, as appropriate, take
      action under such statutory authority as is available to the
      Administrator, including consideration under other sections of
      this chapter, as is necessary to ensure the protection of public
      health.
      (7) Report to Congress
        Not later than 4 years after August 3, 1996, the Administrator
      shall prepare and submit to Congress a report containing - 
          (A) the findings of the Administrator resulting from the
        screening program described in paragraph (1);
          (B) recommendations for further testing needed to evaluate
        the impact on human health of the substances tested under the
        screening program; and
          (C) recommendations for any further actions (including any
        action described in paragraph (6)) that the Administrator
        determines are appropriate based on the findings.
    (q) Schedule for review
      (1) In general
        The Administrator shall review tolerances and exemptions for
      pesticide chemical residues in effect on the day before August 3,
      1996, as expeditiously as practicable, assuring that - 
          (A) 33 percent of such tolerances and exemptions are reviewed
        within 3 years of August 3, 1996;
          (B) 66 percent of such tolerances and exemptions are reviewed
        within 6 years of August 3, 1996; and
          (C) 100 percent of such tolerances and exemptions are
        reviewed within 10 years of August 3, 1996.

      In conducting a review of a tolerance or exemption, the
      Administrator shall determine whether the tolerance or exemption
      meets the requirements of subsections (!3) (b)(2) or (c)(2) of
      this section and shall, by the deadline for the review of the
      tolerance or exemption, issue a regulation under subsection
      (d)(4) or (e)(1) of this section to modify or revoke the
      tolerance or exemption if the tolerance or exemption does not
      meet such requirements.

      (2) Priorities
        In determining priorities for reviewing tolerances and
      exemptions under paragraph (1), the Administrator shall give
      priority to the review of the tolerances or exemptions that
      appear to pose the greatest risk to public health.
      (3) Publication of schedule
        Not later than 12 months after August 3, 1996, the
      Administrator shall publish a schedule for review of tolerances
      and exemptions established prior to August 3, 1996. The
      determination of priorities for the review of tolerances and
      exemptions pursuant to this subsection is not a rulemaking and
      shall not be subject to judicial review, except that failure to
      take final action pursuant to the schedule established by this
      paragraph shall be subject to judicial review.
    (r) Temporary tolerance or exemption
      The Administrator may, upon the request of any person who has
    obtained an experimental permit for a pesticide chemical under the
    Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136
    et seq.] or upon the Administrator's own initiative, establish a
    temporary tolerance or exemption for the pesticide chemical residue
    for the uses covered by the permit. Subsections (b)(2), (c)(2),
    (d), and (e) of this section shall apply to actions taken under
    this subsection.
    (s) Savings clause
      Nothing in this section shall be construed to amend or modify the
    provisions of the Toxic Substances Control Act [15 U.S.C. 2601 et
    seq.] or the Federal Insecticide, Fungicide, and Rodenticide Act [7
    U.S.C. 136 et seq.].

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 408, as added July 22, 1954, ch. 559,
    Sec. 3, 68 Stat. 511; amended Pub. L. 85-791, Sec. 20, Aug. 28,
    1958, 72 Stat. 947; Pub. L. 91-515, title VI, Sec. 601(d)(1), Oct.
    30, 1970, 84 Stat. 1311; Pub. L. 92-157, title III, Sec. 303(a),
    Nov. 18, 1971, 85 Stat. 464; Pub. L. 92-516, Sec. 3(3), Oct. 21,
    1972, 86 Stat. 998; Pub. L. 98-620, title IV, Sec. 402(25)(A), Nov.
    8, 1984, 98 Stat. 3359; Pub. L. 102-300, Sec. 6(b)(1), June 16,
    1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(7), Oct.
    29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(k), Aug. 13, 1993,
    107 Stat. 776; Pub. L. 104-170, title IV, Sec. 405, Aug. 3, 1996,
    110 Stat. 1514; Pub. L. 105-324, Sec. 2(b), Oct. 30, 1998, 112
    Stat. 3036.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Rules of Civil Procedure, referred to in subsec.
    (g)(2)(B), are set out in the Appendix to Title 28, Judiciary and
    Judicial Procedure.
      Section 346 of this title, referred to in subsec. (j)(1),
    originally consisted of subsecs. (a) and (b). Subsec. (a) was
    redesignated as the entire section 346 and subsec. (b) was repealed
    by Pub. L. 86-618, title I, Sec. 103(a)(1), 74 Stat. 398.
      The Federal Insecticide, Fungicide, and Rodenticide Act, referred
    to in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947,
    ch. 125, as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86
    Stat. 973, which is classified generally to subchapter II (Sec. 136
    et seq.) of chapter 6 of Title 7, Agriculture. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 136 of Title 7 and Tables.
      Section 4365 of title 42, referred to in subsec. (p)(2), was in
    the original "section 8 of the Environmental Research, Development,
    and Demonstration Act of 1978", and was translated as meaning
    section 8 of the Environmental Research, Development, and
    Demonstration Authorization Act of 1978, to reflect the probable
    intent of Congress.
      The Toxic Substances Control Act, referred to in subsec. (s), is
    Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is
    classified generally to chapter 53 (Sec. 2601 et seq.) of Title 15,
    Commerce and Trade. For complete classification of this Act to the
    Code, see Short Title note set out under section 2601 of Title 15
    and Tables.

-COD-
                               CODIFICATION                           
      August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A),
    and (p)(1), (2), (7), was in the original references to the date of
    enactment of this subsection and the date of enactment of this
    section, which was translated as meaning the date of enactment of
    Pub. L. 104-170, which amended this section generally, to reflect
    the probable intent of Congress.


-MISC1-
                                AMENDMENTS                            
      1998 - Subsec. (j)(4). Pub. L. 105-324 added par. (4).
      1996 - Pub. L. 104-170 amended section generally, substituting,
    in subsec. (a), provisions relating to requirement for tolerance or
    exemption for provisions relating to conditions for safety; in
    subsec. (b), provisions relating to authority and standard for
    tolerance for provisions relating to establishment of tolerances;
    in subsec. (c), provisions relating to authority and standard for
    exemptions for provisions relating to exemptions; in subsec. (d),
    provisions relating to petition for tolerance or exemption for
    provisions relating to regulations pursuant to petition,
    publication of notice, time for issuance, referral to advisory
    committees, effective date, and hearings; in subsec. (e),
    provisions relating to action on Administrator's own initiative for
    provisions relating to regulations pursuant to Administrator's
    proposals; in subsec. (f), provisions relating to special data
    requirements for provisions relating to data submitted as
    confidential; in subsec. (g), provisions relating to effective
    date, objections, hearings, and administrative review for
    provisions relating to advisory committees and their appointment,
    composition, compensation, and clerical assistance; in subsec. (h),
    provisions relating to judicial review for provisions relating to
    right of consultation; in subsec. (i), provisions relating to
    confidentiality and use of data for provisions relating to judicial
    review; in subsec. (j), provisions relating to status of previously
    issued regulations for provisions relating to temporary tolerances;
    in subsec. (k), provisions relating to transitions for provisions
    relating to regulations based on public hearings before January 1,
    1953; in subsec. (l), provisions relating to harmonization with
    action under other laws for provisions relating to pesticides under
    Federal Insecticide, Fungicide, and Rodenticide Act, functions of
    Administrator of Environmental Protection Agency, certifications,
    hearings, time limitations, opinions, and regulations; in subsec.
    (m), provisions relating to fees for provisions relating to
    amendment of regulations; in subsec. (n), provisions relating to
    national uniformity of tolerances for provisions relating to
    guaranties; in subsec. (o), provisions relating to consumer right
    to know for provisions relating to payment of fees, services or
    functions conditioned on payment, and waiver or refund of fees; and
    adding subsecs. (p) to (s).
      1993 - Pub. L. 103-80, Sec. 3(k)(6), substituted "Administrator"
    for "Secretary" wherever appearing except when followed by "of
    Agriculture".
      Subsec. (a)(1). Pub. L. 103-80, Sec. 3(k)(1), substituted
    "Administrator of the Environmental Protection Agency (hereinafter
    in this section referred to as the 'Administrator')" for "Secretary
    of Health and Human Services".
      Subsec. (d)(5). Pub. L. 103-80, Sec. 3(k)(2), substituted
    "section 556(c) of title 5" for "section 7(c) of the Administrative
    Procedure Act (5 U.S.C., sec. 1006(c))".
      Subsec. (l). Pub. L. 103-80, Sec. 3(k)(3), substituted "In the
    event" for "It the event" before "a hearing is requested".
      Subsec. (n). Pub. L. 103-80, Sec. 3(k)(4), made technical
    amendment to reference to section 333(c) of this title to reflect
    amendment of corresponding provision of original act.
      Subsec. (o). Pub. L. 103-80, Sec. 3(k)(5), which directed the
    substitution of "Administrator" for "Secretary of Health and Human
    Services" wherever appearing in the original text, was executed by
    making the substitution in the first sentence before "shall by
    regulation require", the only place "Secretary of Health and Human
    Services" appeared in the original text.
      1992 - Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102-
    300 substituted "Health and Human Services" for "Health,
    Education, and Welfare" wherever appearing in the original
    statutory text.
      Subsec. (g). Pub. L. 102-571 substituted "379e" for "376".
      1984 - Subsec. (i)(5). Pub. L. 98-620 struck out provision that
    required the court to advance on the docket and expedite the
    disposition of all causes filed therein pursuant to this section.
      1972 - Subsecs. (d)(1), (e), (l). Pub. L. 92-516 substituted
    references to pesticide for references to economic poison wherever
    appearing therein.
      1971 - Subsec. (g). Pub. L. 92-157 struck out ", which the
    Secretary shall by rules and regulations prescribe," after "as
    compensation for their services a reasonable per diem" prior to
    amendment in 1970, by Pub. L. 91-515, which overlooked such
    language when amending subsec. (g) as provided in 1970 Amendment
    note.
      1970 - Subsec. (g). Pub. L. 91-515 substituted provisions
    authorizing members of an advisory committee to receive
    compensation and travel expenses in accordance with section
    376(b)(5)(D) of this title, for provisions authorizing such members
    to receive as compensation a reasonable per diem for time actually
    spent on committee work, and necessary traveling and subsistence
    expenses while serving away from their places of residence.
      1958 - Subsec. (i)(2). Pub. L. 85-791, Sec. 20(a), in first
    sentence, substituted "transmitted by the clerk of the court to the
    Secretary, or" for "served upon the Secretary, or upon",
    substituted "file in the court the record of the proceedings" for
    "certify and file in the court a transcript of the proceedings and
    the record", and inserted "as provided in section 2112 of title
    28", and which, in second sentence, substituted "the filing of such
    petition" for "such filing".
      Subsec. (i)(3). Pub. L. 85-791, Sec. 20(b), in first sentence,
    substituted "transmitted by the clerk of the court to the Secretary
    of Agriculture, or" for "served upon the Secretary of Agriculture,
    or upon", substituted "file in the court the record of the
    proceedings" for "certify and file in the court a transcript of the
    proceedings and the record", and inserted "as provided in section
    2112 of title 28", and, in second sentence, substituted "the filing
    of such petition" for "such filing".

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Amendment by Pub. L. 98-620 not applicable to cases pending on
    Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an
    Effective Date note under section 1657 of Title 28, Judiciary and
    Judicial Procedure.

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Amendment by Pub. L. 92-516 effective at close of Oct. 21, 1972,
    except if regulations are necessary for implementation of any
    provision that becomes effective on Oct. 21, 1972, and continuation
    in effect of subchapter I of chapter 6 of Title 7, Agriculture, and
    regulations thereunder, relating to control of economic poisons, as
    in existence prior to Oct. 21, 1972, until superseded by provisions
    of Pub. L. 92-516 and regulations thereunder, see section 4 of Pub.
    L. 92-516, set out as an Effective Date note under section 136 of
    Title 7.

                              TOLERANCE FEES                          
      Pub. L. 108-199, div. G, title V, Sec. 501(d)(2), Jan. 23, 2004,
    118 Stat. 422, provided that: "Notwithstanding section 408(m)(1) of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)),
    during the period beginning on October 1, 2003, and ending on
    September 30, 2008, the Administrator of the Environmental
    Protection Agency shall not collect any tolerance fees under that
    section."

    DATA COLLECTION ACTIVITIES TO ASSURE HEALTH OF INFANTS AND CHILDREN
      Section 301 of Pub. L. 104-170 provided that:
      "(a) In General. - The Secretary of Agriculture, in consultation
    with the Administrator of the Environmental Protection Agency and
    the Secretary of Health and Human Services, shall coordinate the
    development and implementation of survey procedures to ensure that
    adequate data on food consumption patterns of infants and children
    are collected.
      "(b) Procedures. - To the extent practicable, the procedures
    referred to in subsection (a) shall include the collection of data
    on food consumption patterns of a statistically valid sample of
    infants and children.
      "(c) Residue Data Collection. - The Secretary of Agriculture
    shall ensure that the residue data collection activities conducted
    by the Department of Agriculture in cooperation with the
    Environmental Protection Agency and the Department of Health and
    Human Services, provide for the improved data collection of
    pesticide residues, including guidelines for the use of comparable
    analytical and standardized reporting methods, and the increased
    sampling of foods most likely consumed by infants and children."

-FOOTNOTE-
    (!1) See References in Text note below.

    (!2) See References in Text note below.

    (!3) So in original. Probably should be "subsection".


-End-



-CITE-
    21 USC Sec. 346b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 346b. Authorization of appropriations

-STATUTE-
      There are authorized to be appropriated, out of any moneys in the
    Treasury not otherwise appropriated, such sums as may be necessary
    for the purpose and administration of sections 321(q), (r),
    342(a)(2), and 346a of this title.

-SOURCE-
    (July 22, 1954, ch. 559, Sec. 4, 68 Stat. 517.)

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.

-End-



-CITE-
    21 USC Sec. 347                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 347. Intrastate sales of colored oleomargarine

-STATUTE-
    (a) Law governing
      Colored oleomargarine or colored margarine which is sold in the
    same State or Territory in which it is produced shall be subject in
    the same manner and to the same extent to the provisions of this
    chapter as if it had been introduced in interstate commerce.
    (b) Labeling and packaging requirements
      No person shall sell, or offer for sale, colored oleomargarine or
    colored margarine unless - 
        (1) such oleomargarine or margarine is packaged,
        (2) the net weight of the contents of any package sold in a
      retail establishment is one pound or less,
        (3) there appears on the label of the package (A) the word
      "oleomargarine" or "margarine" in type or lettering at least as
      large as any other type or lettering on such label, and (B) a
      full and accurate statement of all the ingredients contained in
      such oleomargarine or margarine, and
        (4) each part of the contents of the package is contained in a
      wrapper which bears the word "oleomargarine" or "margarine" in
      type or lettering not smaller than 20-point type.

    The requirements of this subsection shall be in addition to and not
    in lieu of any of the other requirements of this chapter.
    (c) Sales in public eating places
      No person shall possess in a form ready for serving colored
    oleomargarine or colored margarine at a public eating place unless
    a notice that oleomargarine or margarine is served is displayed
    prominently and conspicuously in such place and in such manner as
    to render it likely to be read and understood by the ordinary
    individual being served in such eating place or is printed or is
    otherwise set forth on the menu in type or lettering not smaller
    than that normally used to designate the serving of other food
    items. No person shall serve colored oleomargarine or colored
    margarine at a public eating place, whether or not any charge is
    made therefor, unless (1) each separate serving bears or is
    accompanied by labeling identifying it as oleomargarine or
    margarine, or (2) each separate serving thereof is triangular in
    shape.
    (d) Exemption from labeling requirements
      Colored oleomargarine or colored margarine when served with meals
    at a public eating place shall at the time of such service be
    exempt from the labeling requirements of section 343 of this title
    (except paragraphs (a) and (f)) if it complies with the
    requirements of subsection (b) of this section.
    (e) Color content of oleomargarine
      For the purpose of this section colored oleomargarine or colored
    margarine is oleomargarine or margarine having a tint or shade
    containing more than one and six-tenths degrees of yellow, or of
    yellow and red collectively, but with an excess of yellow over red,
    measured in terms of Lovibond tintometer scale or its equivalent.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 407, as added Mar. 16, 1950, ch. 61,
    Sec. 3(c), 64 Stat. 20.)


-MISC1-
                              EFFECTIVE DATE                          
      Section 7 of act Mar. 16, 1950, provided that: "This Act
    [enacting this section and sections 347a and 347b of this title and
    amending sections 331 and 342 of this title and sections 45 and 55
    of Title 15, Commerce and Trade] shall become effective on July 1,
    1950."

                        TRANSFER OF APPROPRIATIONS                    
      Section 5 of act Mar. 16, 1950, provided that: "So much of the
    unexpended balances of appropriations, allocations, or other funds
    (including funds available for the fiscal year ending June 30,
    1950) for the use of the Bureau of Internal Revenue of the Treasury
    Department in the exercise of functions under the Oleomargarine Tax
    Act (26 U.S.C., Sec. 2300, subchapter A) [now section 4591 et seq.
    of Title 26, Internal Revenue Code], as the Director of the Bureau
    of the Budget [now Director of the Office of Management and Budget]
    may determine, shall be transferred to the Federal Security Agency
    (Food and Drug Administration) [now the Department of Health and
    Human Services] for use in the enforcement of this Act [see
    Effective Date note above]."

-End-



-CITE-
    21 USC Sec. 347a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 347a. Congressional declaration of policy regarding
      oleomargarine sales

-STATUTE-
      The Congress finds and declares that the sale, or the serving in
    public eating places, of colored oleomargarine or colored margarine
    without clear identification as such or which is otherwise
    adulterated or misbranded within the meaning of this chapter
    depresses the market in interstate commerce for butter and for
    oleomargarine or margarine clearly identified and neither
    adulterated nor misbranded, and constitutes a burden on interstate
    commerce in such articles. Such burden exists, irrespective of
    whether such oleomargarine or margarine originates from an
    interstate source or from the State in which it is sold.

-SOURCE-
    (Mar. 16, 1950, ch. 61, Sec. 3(a), 64 Stat. 20.)

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective July 1, 1950, see section 7 of act Mar. 16,
    1950, set out as a note under section 347 of this title.

-End-



-CITE-
    21 USC Sec. 347b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 347b. Contravention of State laws

-STATUTE-
      Nothing in this Act shall be construed as authorizing the
    possession, sale, or serving of colored oleomargarine or colored
    margarine in any State or Territory in contravention of the laws of
    such State or Territory.

-SOURCE-
    (Mar. 16, 1950, ch. 61, Sec. 6, 64 Stat. 22.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64
    Stat. 20, which is classified to sections 331, 342, 347 to 347b of
    this title, and sections 45 and 55 of Title 15, Commerce and Trade.
    For complete classification of this Act to the Code, see Tables.

-COD-
                               CODIFICATION                           
      Section was not enacted as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective July 1, 1950, see section 7 of act Mar. 16,
    1950, set out as a note under section 347 of this title.

-End-



-CITE-
    21 USC Sec. 348                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 348. Food additives

-STATUTE-
    (a) Unsafe food additives; exception for conformity with exemption
      or regulation
      A food additive shall, with respect to any particular use or
    intended use of such additives, be deemed to be unsafe for the
    purposes of the application of clause (2)(C) of section 342(a) of
    this title, unless - 
        (1) it and its use or intended use conform to the terms of an
      exemption which is in effect pursuant to subsection (j) of this
      section;
        (2) there is in effect, and it and its use or intended use are
      in conformity with, a regulation issued under this section
      prescribing the conditions under which such additive may be
      safely used; or
        (3) in the case of a food additive as defined in this chapter
      that is a food contact substance, there is - 
          (A) in effect, and such substance and the use of such
        substance are in conformity with, a regulation issued under
        this section prescribing the conditions under which such
        additive may be safely used; or
          (B) a notification submitted under subsection (h) of this
        section that is effective.

    While such a regulation relating to a food additive, or such a
    notification under subsection (h)(1) of this section relating to a
    food additive that is a food contact substance, is in effect, and
    has not been revoked pursuant to subsection (i) of this section, a
    food shall not, by reason of bearing or containing such a food
    additive in accordance with the regulation or notification, be
    considered adulterated under section 342(a)(1) of this title.
    (b) Petition for regulation prescribing conditions of safe use;
      contents; description of production methods and controls;
      samples; notice of regulation
      (1) Any person may, with respect to any intended use of a food
    additive, file with the Secretary a petition proposing the issuance
    of a regulation prescribing the conditions under which such
    additive may be safely used.
      (2) Such petition shall, in addition to any explanatory or
    supporting data, contain - 
        (A) the name and all pertinent information concerning such food
      additive, including, where available, its chemical identity and
      composition;
        (B) a statement of the conditions of the proposed use of such
      additive, including all directions, recommendations, and
      suggestions proposed for the use of such additive, and including
      specimens of its proposed labeling;
        (C) all relevant data bearing on the physical or other
      technical effect such additive is intended to produce, and the
      quantity of such additive required to produce such effect;
        (D) a description of practicable methods for determining the
      quantity of such additive in or on food, and any substance formed
      in or on food, because of its use; and
        (E) full reports of investigations made with respect to the
      safety for use of such additive, including full information as to
      the methods and controls used in conducting such investigations.

      (3) Upon request of the Secretary, the petitioner shall furnish
    (or, if the petitioner is not the manufacturer of such additive,
    the petitioner shall have the manufacturer of such additive
    furnish, without disclosure to the petitioner) a full description
    of the methods used in, and the facilities and controls used for,
    the production of such additive.
      (4) Upon request of the Secretary, the petitioner shall furnish
    samples of the food additive involved, or articles used as
    components thereof, and of the food in or on which the additive is
    proposed to be used.
      (5) Notice of the regulation proposed by the petitioner shall be
    published in general terms by the Secretary within thirty days
    after filing.
    (c) Approval or denial of petition; time for issuance of order;
      evaluation of data; factors
      (1) The Secretary shall - 
        (A) by order establish a regulation (whether or not in accord
      with that proposed by the petitioner) prescribing, with respect
      to one or more proposed uses of the food additive involved, the
      conditions under which such additive may be safely used
      (including, but not limited to, specifications as to the
      particular food or classes of food in or in which such additive
      may be used, the maximum quantity which may be used or permitted
      to remain in or on such food, the manner in which such additive
      may be added to or used in or on such food, and any directions or
      other labeling or packaging requirements for such additive deemed
      necessary by him to assure the safety of such use), and shall
      notify the petitioner of such order and the reasons for such
      action; or
        (B) by order deny the petition, and shall notify the petitioner
      of such order and of the reasons for such action.

      (2) The order required by paragraph (1)(A) or (B) of this
    subsection shall be issued within ninety days after the date of
    filing of the petition, except that the Secretary may (prior to
    such ninetieth day), by written notice to the petitioner, extend
    such ninety-day period to such time (not more than one hundred and
    eighty days after the date of filing of the petition) as the
    Secretary deems necessary to enable him to study and investigate
    the petition.
      (3) No such regulation shall issue if a fair evaluation of the
    data before the Secretary - 
        (A) fails to establish that the proposed use of the food
      additive, under the conditions of use to be specified in the
      regulation, will be safe: Provided, That no additive shall be
      deemed to be safe if it is found to induce cancer when ingested
      by man or animal, or if it is found, after tests which are
      appropriate for the evaluation of the safety of food additives,
      to induce cancer in man or animal, except that this proviso shall
      not apply with respect to the use of a substance as an ingredient
      of feed for animals which are raised for food production, if the
      Secretary finds (i) that, under the conditions of use and feeding
      specified in proposed labeling and reasonably certain to be
      followed in practice, such additive will not adversely affect the
      animals for which such feed is intended, and (ii) that no residue
      of the additive will be found (by methods of examination
      prescribed or approved by the Secretary by regulations, which
      regulations shall not be subject to subsections (f) and (g) of
      this section) in any edible portion of such animal after
      slaughter or in any food yielded by or derived from the living
      animal; or
        (B) shows that the proposed use of the additive would promote
      deception of the consumer in violation of this chapter or would
      otherwise result in adulteration or in misbranding of food within
      the meaning of this chapter.

      (4) If, in the judgment of the Secretary, based upon a fair
    evaluation of the data before him, a tolerance limitation is
    required in order to assure that the proposed use of an additive
    will be safe, the Secretary - 
        (A) shall not fix such tolerance limitation at a level higher
      than he finds to be reasonably required to accomplish the
      physical or other technical effect for which such additive is
      intended; and
        (B) shall not establish a regulation for such proposed use if
      he finds upon a fair evaluation of the data before him that such
      data do not establish that such use would accomplish the intended
      physical or other technical effect.

      (5) In determining, for the purposes of this section, whether a
    proposed use of a food additive is safe, the Secretary shall
    consider among other relevant factors - 
        (A) the probable consumption of the additive and of any
      substance formed in or on food because of the use of the
      additive;
        (B) the cumulative effect of such additive in the diet of man
      or animals, taking into account any chemically or
      pharmacologically related substance or substances in such diet;
      and
        (C) safety factors which in the opinion of experts qualified by
      scientific training and experience to evaluate the safety of food
      additives are generally recognized as appropriate for the use of
      animal experimentation data.
    (d) Regulation issued on Secretary's initiative
      The Secretary may at any time, upon his own initiative, propose
    the issuance of a regulation prescribing, with respect to any
    particular use of a food additive, the conditions under which such
    additive may be safely used, and the reasons therefor. After the
    thirtieth day following publication of such a proposal, the
    Secretary may by order establish a regulation based upon the
    proposal.
    (e) Publication and effective date of orders
      Any order, including any regulation established by such order,
    issued under subsection (c) or (d) of this section, shall be
    published and shall be effective upon publication, but the
    Secretary may stay such effectiveness if, after issuance of such
    order, a hearing is sought with respect to such order pursuant to
    subsection (f) of this section.
    (f) Objections and public hearing; basis and contents of order;
      statement
      (1) Within thirty days after publication of an order made
    pursuant to subsection (c) or (d) of this section, any person
    adversely affected by such an order may file objections thereto
    with the Secretary, specifying with particularity the provisions of
    the order deemed objectionable, stating reasonable grounds
    therefor, and requesting a public hearing upon such objections. The
    Secretary shall, after due notice, as promptly as possible hold
    such public hearing for the purpose of receiving evidence relevant
    and material to the issues raised by such objections. As soon as
    practicable after completion of the hearing, the Secretary shall by
    order act upon such objections and make such order public.
      (2) Such order shall be based upon a fair evaluation of the
    entire record at such hearing, and shall include a statement
    setting forth in detail the findings and conclusions upon which the
    order is based.
      (3) The Secretary shall specify in the order the date on which it
    shall take effect, except that it shall not be made to take effect
    prior to the ninetieth day after its publication, unless the
    Secretary finds that emergency conditions exist necessitating an
    earlier effective date, in which event the Secretary shall specify
    in the order his findings as to such conditions.
    (g) Judicial review
      (1) In a case of actual controversy as to the validity of any
    order issued under subsection (f) of this section, including any
    order thereunder with respect to amendment or repeal of a
    regulation issued under this section, any person who will be
    adversely affected by such order may obtain judicial review by
    filing in the United States Court of Appeals for the circuit
    wherein such person resides or has his principal place of business,
    or in the United States Court of Appeals for the District of
    Columbia Circuit, within sixty days after the entry of such order,
    a petition praying that the order be set aside in whole or in part.
      (2) A copy of such petition shall be forthwith transmitted by the
    clerk of the court to the Secretary, or any officer designated by
    him for that purpose, and thereupon the Secretary shall file in the
    court the record of the proceedings on which he based his order, as
    provided in section 2112 of title 28. Upon the filing of such
    petition the court shall have jurisdiction, which upon the filing
    of the record with it shall be exclusive, to affirm or set aside
    the order complained of in whole or in part. Until the filing of
    the record the Secretary may modify or set aside his order. The
    findings of the Secretary with respect to questions of fact shall
    be sustained if based upon a fair evaluation of the entire record
    at such hearing.
      (3) The court, on such judicial review, shall not sustain the
    order of the Secretary if he failed to comply with any requirement
    imposed on him by subsection (f)(2) of this section.
      (4) If application is made to the court for leave to adduce
    additional evidence, the court may order such additional evidence
    to be taken before the Secretary and to be adduced upon the hearing
    in such manner and upon such terms and conditions as to the court
    may seem proper, if such evidence is material and there were
    reasonable grounds for failure to adduce such evidence in the
    proceedings below. The Secretary may modify his findings as to the
    facts and order by reason of the additional evidence so taken, and
    shall file with the court such modified findings and order.
      (5) The judgment of the court affirming or setting aside, in
    whole or in part, any order under this section shall be final,
    subject to review by the Supreme Court of the United States upon
    certiorari or certification as provided in section 1254 of title
    28. The commencement of proceedings under this section shall not,
    unless specifically ordered by the court to the contrary, operate
    as a stay of an order.
    (h) Notification relating to food contact substance
      (1) Subject to such regulations as may be promulgated under
    paragraph (3), a manufacturer or supplier of a food contact
    substance may, at least 120 days prior to the introduction or
    delivery for introduction into interstate commerce of the food
    contact substance, notify the Secretary of the identity and
    intended use of the food contact substance, and of the
    determination of the manufacturer or supplier that the intended use
    of such food contact substance is safe under the standard described
    in subsection (c)(3)(A) of this section. The notification shall
    contain the information that forms the basis of the determination
    and all information required to be submitted by regulations
    promulgated by the Secretary.
      (2)(A) A notification submitted under paragraph (1) shall become
    effective 120 days after the date of receipt by the Secretary and
    the food contact substance may be introduced or delivered for
    introduction into interstate commerce, unless the Secretary makes a
    determination within the 120-day period that, based on the data and
    information before the Secretary, such use of the food contact
    substance has not been shown to be safe under the standard
    described in subsection (c)(3)(A) of this section, and informs the
    manufacturer or supplier of such determination.
      (B) A decision by the Secretary to object to a notification shall
    constitute final agency action subject to judicial review.
      (C) In this paragraph, the term "food contact substance" means
    the substance that is the subject of a notification submitted under
    paragraph (1), and does not include a similar or identical
    substance manufactured or prepared by a person other than the
    manufacturer identified in the notification.
      (3)(A) The process in this subsection shall be utilized for
    authorizing the marketing of a food contact substance except where
    the Secretary determines that submission and review of a petition
    under subsection (b) of this section is necessary to provide
    adequate assurance of safety, or where the Secretary and any
    manufacturer or supplier agree that such manufacturer or supplier
    may submit a petition under subsection (b) of this section.
      (B) The Secretary is authorized to promulgate regulations to
    identify the circumstances in which a petition shall be filed under
    subsection (b) of this section, and shall consider criteria such as
    the probable consumption of such food contact substance and
    potential toxicity of the food contact substance in determining the
    circumstances in which a petition shall be filed under subsection
    (b) of this section.
      (4) The Secretary shall keep confidential any information
    provided in a notification under paragraph (1) for 120 days after
    receipt by the Secretary of the notification. After the expiration
    of such 120 days, the information shall be available to any
    interested party except for any matter in the notification that is
    a trade secret or confidential commercial information.
      (5)(A)(i) Except as provided in clause (ii), the notification
    program established under this subsection shall not operate in any
    fiscal year unless - 
        (I) an appropriation equal to or exceeding the applicable
      amount under clause (iv) is made for such fiscal year for
      carrying out such program in such fiscal year; and
        (II) the Secretary certifies that the amount appropriated for
      such fiscal year for the Center for Food Safety and Applied
      Nutrition of the Food and Drug Administration (exclusive of the
      appropriation referred to in subclause (I)) equals or exceeds the
      amount appropriated for the Center for fiscal year 1997,
      excluding any amount appropriated for new programs.

      (ii) The Secretary shall, not later than April 1, 1999, begin
    accepting and reviewing notifications submitted under the
    notification program established under this subsection if - 
        (I) an appropriation equal to or exceeding the applicable
      amount under clause (iii) is made for the last six months of
      fiscal year 1999 for carrying out such program during such
      period; and
        (II) the Secretary certifies that the amount appropriated for
      such period for the Center for Food Safety and Applied Nutrition
      of the Food and Drug Administration (exclusive of the
      appropriation referred to in subclause (I)) equals or exceeds an
      amount equivalent to one-half the amount appropriated for the
      Center for fiscal year 1997, excluding any amount appropriated
      for new programs.

      (iii) For the last six months of fiscal year 1999, the applicable
    amount under this clause is $1,500,000, or the amount specified in
    the budget request of the President for the six-month period
    involved for carrying out the notification program in fiscal year
    1999, whichever is less.
      (iv) For fiscal year 2000 and subsequent fiscal years, the
    applicable amount under this clause is $3,000,000, or the amount
    specified in the budget request of the President for the fiscal
    year involved for carrying out the notification program under this
    subsection, whichever is less.
      (B) For purposes of carrying out the notification program under
    this subsection, there are authorized to be appropriated such sums
    as may be necessary for each of the fiscal years 1999 through
    fiscal year 2003, except that such authorization of appropriations
    is not effective for a fiscal year for any amount that is less than
    the applicable amount under clause (iii) or (iv) of subparagraph
    (A), whichever is applicable.
      (C) Not later than April 1 of fiscal year 1998 and February 1 of
    each subsequent fiscal year, the Secretary shall submit a report to
    the Committees on Appropriations of the House of Representatives
    and the Senate, the Committee on Commerce of the House of
    Representatives, and the Committee on Labor and Human Resources of
    the Senate that provides an estimate of the Secretary of the costs
    of carrying out the notification program established under this
    subsection for the next fiscal year.
      (6) In this section, the term "food contact substance" means any
    substance intended for use as a component of materials used in
    manufacturing, packing, packaging, transporting, or holding food if
    such use is not intended to have any technical effect in such food.
    (i) Amendment or repeal of regulations
      The Secretary shall by regulation prescribe the procedure by
    which regulations under the foregoing provisions of this section
    may be amended or repealed, and such procedure shall conform to the
    procedure provided in this section for the promulgation of such
    regulations. The Secretary shall by regulation prescribe the
    procedure by which the Secretary may deem a notification under
    subsection (h) of this section to no longer be effective.
    (j) Exemptions for investigational use
      Without regard to subsections (b) to (i), inclusive, of this
    section, the Secretary shall by regulation provide for exempting
    from the requirements of this section any food additive, and any
    food bearing or containing such additive, intended solely for
    investigational use by qualified experts when in his opinion such
    exemption is consistent with the public health.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 409, as added Pub. L. 85-929, Sec. 4,
    Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86-546, Sec. 2, June
    29, 1960, 74 Stat. 255; Pub. L. 87-781, title I, Sec. 104(f)(1),
    Oct. 10, 1962, 76 Stat. 785; Pub. L. 98-620, title IV, Sec.
    402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105-115, title
    III, Sec. 309, Nov. 21, 1997, 111 Stat. 2354.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 309(a)(4), in closing
    provisions, substituted "While such a regulation relating to a food
    additive, or such a notification under subsection (h)(1) of this
    section relating to a food additive that is a food contact
    substance, is in effect, and has not been revoked pursuant to
    subsection (i) of this section, a food shall not, by reason of
    bearing or containing such a food additive in accordance with the
    regulation or notification, be considered adulterated under section
    342(a)(1) of this title." for "While such a regulation relating to
    a food additive is in effect, a food shall not, by reason of
    bearing or containing such an additive in accordance with the
    regulation, be considered adulterated within the meaning of clause
    (1) of section 342(a) of this title."
      Subsec. (a)(1). Pub. L. 105-115, Sec. 309(a)(1), substituted
    "subsection (j)" for "subsection (i)".
      Subsec. (a)(3). Pub. L. 105-115, Sec. 309(a)(1)(B), (2), (3),
    added par. (3).
      Subsec. (h). Pub. L. 105-115, Sec. 309(b)(2), added subsec. (h).
    Former subsec. (h) redesignated (i).
      Subsec. (i). Pub. L. 105-115, Sec. 309(b)(1), (3), redesignated
    subsec. (h) as (i) and inserted at end "The Secretary shall by
    regulation prescribe the procedure by which the Secretary may deem
    a notification under subsection (h) of this section to no longer be
    effective."
      Subsec. (j). Pub. L. 105-115, Sec. 309(b)(1), (4), redesignated
    subsec. (i) as (j) and substituted "subsections (b) to (i)" for
    "subsections (b) to (h)".
      1984 - Subsec. (g)(2). Pub. L. 98-620 struck out provision that
    required the court to advance on the docket and expedite the
    disposition of all causes filed therein pursuant to this section.
      1962 - Subsec. (c)(3)(A). Pub. L. 87-781 excepted proviso from
    applying to use of a substance as an ingredient of feed for animals
    raised for food production, if under conditions of use specified in
    proposed labeling, and which conditions are reasonably certain to
    be followed in practice, such additive will not adversely affect
    the animals and no residue will be found in any edible portion of
    such animal after slaughter, or in any food from the living animal.
      1960 - Subsec. (g)(2). Pub. L. 86-546 substituted "forthwith
    transmitted by the clerk of the court to the Secretary, or any
    officer" for "served upon the Secretary, or upon any officer",
    "shall file in the court the record of the proceedings on which he
    based his order, as provided in section 2112 of title 28" for
    "shall certify and file in the court a transcript of the
    proceedings and the record on which he based his order", and "Upon
    the filing of such petition the court shall have jurisdiction,
    which upon the filing of the record with it shall be exclusive,"
    for "Upon such filing, the court shall have exclusive
    jurisdiction", and inserted sentence authorizing the Secretary to
    modify or set aside his order until the filing of the record.

-CHANGE-
                              CHANGE OF NAME                          
      Committee on Commerce of House of Representatives changed to
    Committee on Energy and Commerce of House of Representatives, and
    jurisdiction over matters relating to securities and exchanges and
    insurance generally transferred to Committee on Financial Services
    of House of Representatives by House Resolution No. 5, One Hundred
    Seventh Congress, Jan. 3, 2001.
      Committee on Labor and Human Resources of Senate changed to
    Committee on Health, Education, Labor, and Pensions of Senate by
    Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
    1999.


-MISC2-
                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Amendment by Pub. L. 98-620 not applicable to cases pending on
    Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an
    Effective Date note under section 1657 of Title 28, Judiciary and
    Judicial Procedure.

               EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS           
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    107 of Pub. L. 87-781, set out as an Effective Date of 1962
    Amendment note under section 321 of this title.

                              EFFECTIVE DATE                          
      Section effective Sept. 6, 1958, see section 6(a) of Pub. L. 85-
    929, set out as an Effective Date of 1958 Amendment note under
    section 342 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Functions vested in Secretary of Health, Education, and Welfare
    [now Health and Human Services] in establishing tolerances for
    pesticide chemicals under this section together with authority to
    monitor compliance with tolerances and effectiveness of
    surveillance and enforcement and to provide technical assistance to
    States and conduct research under this chapter and section 201 et
    seq. of Title 42, The Public Health and Welfare, transferred to
    Administrator of Environmental Protection Agency by Reorg. Plan No.
    3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat.
    2086, set out in the Appendix to Title 5, Government Organization
    and Employees.


-MISC3-
                          GLASS AND CERAMIC WARE                      
      Section 308 of Pub. L. 105-115 provided that:
      "(a) In General. - The Secretary may not implement any
    requirement which would ban, as an unapproved food additive, lead
    and cadmium based enamel in the lip and rim area of glass and
    ceramic ware before the expiration of one year after the date such
    requirement is published.
      "(b) Lead and Cadmium Based Enamel. - Unless the Secretary
    determines, based on available data, that lead and cadmium based
    enamel on glass and ceramic ware - 
        "(1) which has less than 60 millimeters of decorating area
      below the external rim, and
        "(2) which is not, by design, representation, or custom of
      usage intended for use by children,
    is unsafe, the Secretary shall not take any action before January
    1, 2003, to ban lead and cadmium based enamel on such glass and
    ceramic ware. Any action taken after January 1, 2003, to ban such
    enamel on such glass and ceramic ware as an unapproved food
    additive shall be taken by regulation and such regulation shall
    provide that such products shall not be removed from the market
    before 1 year after publication of the final regulation."

      MORATORIUM ON AUTHORITY OF SECRETARY WITH RESPECT TO SACCHARIN  
      Pub. L. 95-203, Sec. 3, Nov. 23, 1977, 91 Stat. 1452, as amended
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695; Pub. L. 96-273, June 17, 1980, 94 Stat. 536; Pub. L. 97-42,
    Sec. 2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98-22, Sec. 2, Apr.
    22, 1983, 97 Stat. 173; Pub. L. 99-46, May 24, 1985, 99 Stat. 81;
    Pub. L. 100-71, title I, Sec. 101, July 11, 1987, 101 Stat. 431;
    Pub. L. 102-142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L.
    104-180, title VI, Sec. 602, Aug. 6, 1996, 110 Stat. 1594, provided
    that: "During the period ending May 1, 2002, the Secretary - 
        "(1) may not amend or revoke the interim food additive
      regulation of the Food and Drug Administration of the Department
      of Health and Human Services applicable to saccharin and
      published on March 15, 1977 (section 180.37 of part 180,
      subchapter B, chapter 1, title 21, Code of Federal Regulations
      (42 Fed. Reg. 14638)), or
        "(2) may, except as provided in section 4 [enacting section
      343a of this title, amending sections 321 and 343 of this title,
      and enacting provisions set out as notes under section 343 of
      this title] and the amendments made by such section, not take any
      other action under the Federal Food, Drug, and Cosmetic Act [this
      chapter] to prohibit or restrict the sale or distribution of
      saccharin, any food permitted by such interim food additive
      regulation to contain saccharin, or any drug or cosmetic
      containing saccharin,
    solely on the basis of the carcinogenic or other toxic effect of
    saccharin as determined by any study made available to the
    Secretary before the date of the enactment of this Act [Nov. 23,
    1977] which involved human studies or animal testing, or both."
      For definition of "saccharin" as used in this note, see section
    2(d) of Pub. L. 95-203.

-End-



-CITE-
    21 USC Sec. 349                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 349. Bottled drinking water standards; publication in Federal
      Register

-STATUTE-
      (a) Except as provided in subsection (b) of this section,
    whenever the Administrator of the Environmental Protection Agency
    prescribes interim or revised national primary drinking water
    regulations under section 1412 of the Public Health Service Act [42
    U.S.C. 300g-1], the Secretary shall consult with the Administrator
    and within 180 days after the promulgation of such drinking water
    regulations either promulgate amendments to regulations under this
    chapter applicable to bottled drinking water or publish in the
    Federal Register his reasons for not making such amendments.
      (b)(1) Not later than 180 days before the effective date of a
    national primary drinking water regulation promulgated by the
    Administrator of the Environmental Protection Agency for a
    contaminant under section 1412 of the Safe Drinking Water Act (42
    U.S.C. 300g-1), the Secretary shall promulgate a standard of
    quality regulation under this subsection for that contaminant in
    bottled water or make a finding that such a regulation is not
    necessary to protect the public health because the contaminant is
    contained in water in public water systems (as defined under
    section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water
    used for bottled drinking water. The effective date for any such
    standard of quality regulation shall be the same as the effective
    date for such national primary drinking water regulation, except
    for any standard of quality of regulation promulgated by the
    Secretary before August 6, 1996, for which (as of August 6, 1996)
    an effective date had not been established. In the case of a
    standard of quality regulation to which such exception applies, the
    Secretary shall promulgate monitoring requirements for the
    contaminants covered by the regulation not later than 2 years after
    August 6, 1996.
      (2) A regulation issued by the Secretary as provided in this
    subsection shall include any monitoring requirements that the
    Secretary determines appropriate for bottled water.
      (3) A regulation issued by the Secretary as provided in this
    subsection shall require the following:
        (A) In the case of contaminants for which a maximum contaminant
      level is established in a national primary drinking water
      regulation under section 1412 of the Safe Drinking Water Act (42
      U.S.C. 300g-1), the regulation under this subsection shall
      establish a maximum contaminant level for the contaminant in
      bottled water which is no less stringent than the maximum
      contaminant level provided in the national primary drinking water
      regulation.
        (B) In the case of contaminants for which a treatment technique
      is established in a national primary drinking water regulation
      under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g-
      1), the regulation under this subsection shall require that
      bottled water be subject to requirements no less protective of
      the public health than those applicable to water provided by
      public water systems using the treatment technique required by
      the national primary drinking water regulation.

      (4)(A) If the Secretary does not promulgate a regulation under
    this subsection within the period described in paragraph (1), the
    national primary drinking water regulation referred to in paragraph
    (1) shall be considered, as of the date on which the Secretary is
    required to establish a regulation under paragraph (1), as the
    regulation applicable under this subsection to bottled water.
      (B) In the case of a national primary drinking water regulation
    that pursuant to subparagraph (A) is considered to be a standard of
    quality regulation, the Secretary shall, not later than the
    applicable date referred to in such subparagraph, publish in the
    Federal Register a notice - 
        (i) specifying the contents of such regulation, including
      monitoring requirements; and
        (ii) providing that for purposes of this paragraph the
      effective date for such regulation is the same as the effective
      date for the regulation for purposes of the Safe Drinking Water
      Act [42 U.S.C. 300f et seq.] (or, if the exception under
      paragraph (1) applies to the regulation, that the effective date
      for the regulation is not later than 2 years and 180 days after
      August 6, 1996).

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 410, as added Pub. L. 93-523, Sec. 4,
    Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104-182, title III,
    Sec. 305, Aug. 6, 1996, 110 Stat. 1684.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Safe Drinking Water Act, referred to in subsec.
    (b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16,
    1974, Pub. L. 93-523, Sec. 2(a), 88 Stat. 1660, as amended, which
    is classified generally to subchapter XII (Sec. 300f et seq.) of
    chapter 6A of Title 42, The Public Health and Welfare. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 201 of Title 42 and Tables.


-MISC1-
                                AMENDMENTS                            
      1996 - Pub. L. 104-182 substituted "(a) Except as provided in
    subsection (b) of this section, whenever" for "Whenever" and added
    subsec. (b).

                            BOTTLED WATER STUDY                        
      Section 114(b) of Pub. L. 104-182 provided that: "Not later than
    18 months after the date of enactment of this Act [Aug. 6, 1996],
    the Administrator of the Food and Drug Administration, in
    consultation with the Administrator of the Environmental Protection
    Agency, shall publish for public notice and comment a draft study
    on the feasibility of appropriate methods, if any, of informing
    customers of the contents of bottled water. The Administrator of
    the Food and Drug Administration shall publish a final study not
    later than 30 months after the date of enactment of this Act."

-End-



-CITE-
    21 USC Sec. 350                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350. Vitamins and minerals

-STATUTE-
    (a) Authority and limitations of Secretary; applicability
      (1) Except as provided in paragraph (2) - 
        (A) the Secretary may not establish, under section 321(n), 341,
      or 343 of this title, maximum limits on the potency of any
      synthetic or natural vitamin or mineral within a food to which
      this section applies;
        (B) the Secretary may not classify any natural or synthetic
      vitamin or mineral (or combination thereof) as a drug solely
      because it exceeds the level of potency which the Secretary
      determines is nutritionally rational or useful;
        (C) the Secretary may not limit, under section 321(n), 341, or
      343 of this title, the combination or number of any synthetic or
      natural - 
          (i) vitamin,
          (ii) mineral, or
          (iii) other ingredient of food,

      within a food to which this section applies.

      (2) Paragraph (1) shall not apply in the case of a vitamin,
    mineral, other ingredient of food, or food, which is represented
    for use by individuals in the treatment or management of specific
    diseases or disorders, by children, or by pregnant or lactating
    women. For purposes of this subparagraph,(!1) the term "children"
    means individuals who are under the age of twelve years.

    (b) Labeling and advertising requirements for foods
      (1) A food to which this section applies shall not be deemed
    under section 343 of this title to be misbranded solely because its
    label bears, in accordance with section 343(i)(2) of this title,
    all the ingredients in the food or its advertising contains
    references to ingredients in the food which are not vitamins or
    minerals.
      (2) The labeling for any food to which this section applies may
    not list its ingredients which are not dietary supplement
    ingredients described in section 321(ff) of this title (i) except
    as a part of a list of all the ingredients of such food, and (ii)
    unless such ingredients are listed in accordance with applicable
    regulations under section 343 of this title. To the extent that
    compliance with clause (i) of this subparagraph is impracticable or
    results in deception or unfair competition, exemptions shall be
    established by regulations promulgated by the Secretary.
    (c) Definitions
      (1) For purposes of this section, the term "food to which this
    section applies" means a food for humans which is a food for
    special dietary use - 
        (A) which is or contains any natural or synthetic vitamin or
      mineral, and
        (B) which - 
          (i) is intended for ingestion in tablet, capsule, powder,
        softgel, gelcap, or liquid form, or
          (ii) if not intended for ingestion in such a form, is not
        represented as conventional food and is not represented for use
        as a sole item of a meal or of the diet.

      (2) For purposes of paragraph (1)(B)(i), a food shall be
    considered as intended for ingestion in liquid form only if it is
    formulated in a fluid carrier and it is intended for ingestion in
    daily quantities measured in drops or similar small units of
    measure.
      (3) For purposes of paragraph (1) and of section 343(j) of this
    title insofar as that section is applicable to food to which this
    section applies, the term "special dietary use" as applied to food
    used by man means a particular use for which a food purports or is
    represented to be used, including but not limited to the following:
        (A) Supplying a special dietary need that exists by reason of a
      physical, physiological, pathological, or other condition,
      including but not limited to the condition of disease,
      convalescence, pregnancy, lactation, infancy, allergic
      hypersensitivity to food, underweight, overweight, or the need to
      control the intake of sodium.
        (B) Supplying a vitamin, mineral, or other ingredient for use
      by man to supplement his diet by increasing the total dietary
      intake.
        (C) Supplying a special dietary need by reason of being a food
      for use as the sole item of the diet.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 411, as added Pub. L. 94-278, title
    V, Sec. 501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103-
    417, Secs. 3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)


-MISC1-
                                AMENDMENTS                            
      1994 - Subsec. (b)(2). Pub. L. 103-417, Sec. 7(d), redesignated
    subpar. (A) as par. (2), substituted "dietary supplement
    ingredients described in section 321(ff) of this title" for
    "vitamins or minerals", and struck out former subpar. (B), which
    read as follows: "Notwithstanding the provisions of subparagraph
    (A), the labeling and advertising for any food to which this
    section applies may not give prominence to or emphasize ingredients
    which are not - 
        "(i) vitamins,
        "(ii) minerals, or
        "(iii) represented as a source of vitamins or minerals."
      Subsec. (c)(1)(B)(i). Pub. L. 103-417, Sec. 3(c)(1), inserted
    "powder, softgel, gelcap," after "capsule,".
      Subsec. (c)(1)(B)(ii). Pub. L. 103-417, Sec. 3(c)(2), struck out
    "does not simulate and" after "in such a form,".

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      For provision that dietary supplements may be labeled after Oct.
    25, 1994, in accordance with amendments made by section 7(d) of
    Pub. L. 103-417, and shall be so labeled after Dec. 31, 1996, see
    section 7(e) of Pub. L. 103-417, set out as a note under section
    343 of this title.

            AMENDMENT OF INCONSISTENT REGULATIONS BY SECRETARY        
      Section 501(b) of Pub. L. 94-278, as amended by Pub. L. 96-88,
    title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that:
    "The Secretary of Health and Human Services shall amend any
    regulation promulgated under the Federal Food, Drug, and Cosmetic
    Act [this chapter] which is inconsistent with section 411 of such
    Act [section 350 of this title] (as added by subsection (a)) and
    such amendments shall be promulgated in accordance with section 553
    of title 5, United States Code."

-FOOTNOTE-
    (!1) So in original. Probably should be "paragraph".


-End-



-CITE-
    21 USC Sec. 350a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350a. Infant formulas

-STATUTE-
    (a) Adulteration
      An infant formula, including an infant formula powder, shall be
    deemed to be adulterated if - 
        (1) such infant formula does not provide nutrients as required
      by subsection (i) of this section,
        (2) such infant formula does not meet the quality factor
      requirements prescribed by the Secretary under subsection (b)(1)
      of this section, or
        (3) the processing of such infant formula is not in compliance
      with the good manufacturing practices and the quality control
      procedures prescribed by the Secretary under subsection (b)(2) of
      this section.
    (b) Requirements for quality factors, good manufacturing practices,
      and retention of records
      (1) The Secretary shall by regulation establish requirements for
    quality factors for infant formulas to the extent possible
    consistent with current scientific knowledge, including quality
    factor requirements for the nutrients required by subsection (i) of
    this section.
      (2)(A) The Secretary shall by regulation establish good
    manufacturing practices for infant formulas, including quality
    control procedures that the Secretary determines are necessary to
    assure that an infant formula provides nutrients in accordance with
    this subsection and subsection (i) of this section and is
    manufactured in a manner designed to prevent adulteration of the
    infant formula.
      (B) The good manufacturing practices and quality control
    procedures prescribed by the Secretary under subparagraph (A) shall
    include requirements for - 
        (i) the testing, in accordance with paragraph (3) and by the
      manufacturer of an infant formula or an agent of such
      manufacturer, of each batch of infant formula for each nutrient
      required by subsection (i) of this section before the
      distribution of such batch,
        (ii) regularly scheduled testing, by the manufacturer of an
      infant formula or an agent of such manufacturer, of samples of
      infant formulas during the shelf life of such formulas to ensure
      that such formulas are in compliance with this section,
        (iii) in-process controls including, where necessary, testing
      required by good manufacturing practices designed to prevent
      adulteration of each batch of infant formula, and
        (iv) the conduct by the manufacturer of an infant formula or an
      agent of such manufacturer of regularly scheduled audits to
      determine that such manufacturer has complied with the
      regulations prescribed under subparagraph (A).

    In prescribing requirements for audits under clause (iv), the
    Secretary shall provide that such audits be conducted by
    appropriately trained individuals who do not have any direct
    responsibility for the manufacture or production of infant formula.
      (3)(A) At the final product stage, each batch of infant formula
    shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E
    to ensure that such infant formula is in compliance with the
    requirements of this subsection and subsection (i) of this section
    relating to such vitamins.
      (B) Each nutrient premix used in the manufacture of an infant
    formula shall be tested for each relied upon nutrient required by
    subsection (i) of this section which is contained in such premix to
    ensure that such premix is in compliance with its specifications or
    certifications by a premix supplier.
      (C) During the manufacturing process or at the final product
    stage and before distribution of an infant formula, an infant
    formula shall be tested for all nutrients required to be included
    in such formula by subsection (i) of this section for which testing
    has not been conducted pursuant to subparagraph (A) or (B). Testing
    under this subparagraph shall be conducted to - 
        (i) ensure that each batch of such infant formula is in
      compliance with the requirements of subsection (i) of this
      section relating to such nutrients, and
        (ii) confirm that nutrients contained in any nutrient premix
      used in such infant formula are present in each batch of such
      infant formula in the proper concentration.

      (D) If the Secretary adds a nutrient to the list of nutrients in
    the table in subsection (i) of this section, the Secretary shall by
    regulation require that the manufacturer of an infant formula test
    each batch of such formula for such new nutrient in accordance with
    subparagraph (A), (B), or (C).
      (E) For purposes of this paragraph, the term "final product
    stage" means the point in the manufacturing process, before
    distribution of an infant formula, at which an infant formula is
    homogenous and is not subject to further degradation.
      (4)(A) The Secretary shall by regulation establish requirements
    respecting the retention of records. Such requirements shall
    provide for - 
        (i) the retention of all records necessary to demonstrate
      compliance with the good manufacturing practices and quality
      control procedures prescribed by the Secretary under paragraph
      (2), including records containing the results of all testing
      required under paragraph (2)(B),
        (ii) the retention of all certifications or guarantees of
      analysis by premix suppliers,
        (iii) the retention by a premix supplier of all records
      necessary to confirm the accuracy of all premix certifications
      and guarantees of analysis,
        (iv) the retention of - 
          (I) all records pertaining to the microbiological quality and
        purity of raw materials used in infant formula powder and in
        finished infant formula, and
          (II) all records pertaining to food packaging materials which
        show that such materials do not cause an infant formula to be
        adulterated within the meaning of section 342(a)(2)(C) of this
        title,

        (v) the retention of all records of the results of regularly
      scheduled audits conducted pursuant to the requirements
      prescribed by the Secretary under paragraph (2)(B)(iv), and
        (vi) the retention of all complaints and the maintenance of
      files with respect to, and the review of, complaints concerning
      infant formulas which may reveal the possible existence of a
      hazard to health.

      (B)(i) Records required under subparagraph (A) with respect to an
    infant formula shall be retained for at least one year after the
    expiration of the shelf life of such infant formula. Except as
    provided in clause (ii), such records shall be made available to
    the Secretary for review and duplication upon request of the
    Secretary.
      (ii) A manufacturer need only provide written assurances to the
    Secretary that the regularly scheduled audits required by paragraph
    (2)(B)(iv) are being conducted by the manufacturer, and need not
    make available to the Secretary the actual written reports of such
    audits.
    (c) Registration of persons distributing new infant formula
      (1) No person shall introduce or deliver for introduction into
    interstate commerce any new infant formula unless - 
        (A) such person has, before introducing such new infant
      formula, or delivering such new infant formula for introduction,
      into interstate commerce, registered with the Secretary the name
      of such person, the place of business of such person, and all
      establishments at which such person intends to manufacture such
      new infant formula, and
        (B) such person has at least 90 days before marketing such new
      infant formula, made the submission to the Secretary required by
      subsection (c)(1) of this section.

      (2) For purposes of paragraph (1), the term "new infant formula"
    includes - 
        (A) an infant formula manufactured by a person which has not
      previously manufactured an infant formula, and
        (B) an infant formula manufactured by a person which has
      previously manufactured infant formula and in which there is a
      major change, in processing or formulation, from a current or any
      previous formulation produced by such manufacturer.

    For purposes of this paragraph, the term "major change" has the
    meaning given to such term in section 106.30(c)(2) of title 21,
    Code of Federal Regulations (as in effect on August 1, 1986), and
    guidelines issued thereunder.
    (d) Submission of information about new infant formula required
      (1) A person shall, with respect to any infant formula subject to
    subsection (c) of this section, make a submission to the Secretary
    which shall include - 
        (A) the quantitative formulation of the infant formula,
        (B) a description of any reformulation of the formula or change
      in processing of the infant formula,
        (C) assurances that the infant formula will not be marketed
      unless it meets the requirements of subsections (b)(1) and (i) of
      this section, as demonstrated by the testing required under
      subsection (b)(3) of this section, and
        (D) assurances that the processing of the infant formula
      complies with subsection (b)(2) of this section.

      (2) After the first production of an infant formula subject to
    subsection (c) of this section, and before the introduction into
    interstate commerce of such formula, the manufacturer of such
    formula shall submit to the Secretary, in such form as may be
    prescribed by the Secretary, a written verification which
    summarizes test results and records demonstrating that such formula
    complies with the requirements of subsections (b)(1), (b)(2)(A),
    (b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i) of this
    section.
      (3) If the manufacturer of an infant formula for commercial or
    charitable distribution for human consumption determines that a
    change in the formulation of the formula or a change in the
    processing of the formula may affect whether the formula is
    adulterated under subsection (a) of this section, the manufacturer
    shall, before the first processing of such formula, make the
    submission to the Secretary required by paragraph (1).
    (e) Additional notice requirements for manufacturer
      (1) If the manufacturer of an infant formula has knowledge which
    reasonably supports the conclusion that an infant formula which has
    been processed by the manufacturer and which has left an
    establishment subject to the control of the manufacturer - 
        (A) may not provide the nutrients required by subsection (i) of
      this section, or
        (B) may be otherwise adulterated or misbranded,

    the manufacturer shall promptly notify the Secretary of such
    knowledge. If the Secretary determines that the infant formula
    presents a risk to human health, the manufacturer shall immediately
    take all actions necessary to recall shipments of such infant
    formula from all wholesale and retail establishments, consistent
    with recall regulations and guidelines issued by the Secretary.
      (2) For purposes of paragraph (1), the term "knowledge" as
    applied to a manufacturer means (A) the actual knowledge that the
    manufacturer had, or (B) the knowledge which a reasonable person
    would have had under like circumstances or which would have been
    obtained upon the exercise of due care.
    (f) Procedures applicable to recalls by manufacturer; regulatory
      oversight
      (1) If a recall of infant formula is begun by a manufacturer, the
    recall shall be carried out in accordance with such requirements as
    the Secretary shall prescribe under paragraph (2) and - 
        (A) the Secretary shall, not later than the 15th day after the
      beginning of such recall and at least once every 15 days
      thereafter until the recall is terminated, review the actions
      taken under the recall to determine whether the recall meets the
      requirements prescribed under paragraph (2), and
        (B) the manufacturer shall, not later than the 14th day after
      the beginning of such recall and at least once every 14 days
      thereafter until the recall is terminated, report to the
      Secretary the actions taken to implement the recall.

      (2) The Secretary shall by regulation prescribe the scope and
    extent of recalls of infant formulas necessary and appropriate for
    the degree of risks to human health presented by the formula
    subject to the recall.
      (3) The Secretary shall by regulation require each manufacturer
    of an infant formula who begins a recall of such formula because of
    a risk to human health to request each retail establishment at
    which such formula is sold or available for sale to post at the
    point of purchase of such formula a notice of such recall at such
    establishment for such time that the Secretary determines necessary
    to inform the public of such recall.
    (g) Recordkeeping requirements for manufacturer; regulatory
      oversight and enforcement
      (1) Each manufacturer of an infant formula shall make and retain
    such records respecting the distribution of the infant formula
    through any establishment owned or operated by such manufacturer as
    may be necessary to effect and monitor recalls of the formula. Such
    records shall be retained for at least one year after the
    expiration of the shelf life of the infant formula.
      (2) To the extent that the Secretary determines that records are
    not being made or maintained in accordance with paragraph (1), the
    Secretary may by regulation prescribe the records required to be
    made under paragraph (1) and requirements respecting the retention
    of such records under such paragraph. Such regulations shall take
    effect on such date as the Secretary prescribes but not sooner than
    the 180th day after the date such regulations are promulgated. Such
    regulations shall apply only with respect to distributions of
    infant formulas made after such effective date.
    (h) Exemptions; regulatory oversight
      (1) Any infant formula which is represented and labeled for use
    by an infant - 
        (A) who has an inborn error of metabolism or a low birth
      weight, or
        (B) who otherwise has an unusual medical or dietary problem,

    is exempt from the requirements of subsections (a), (b), and (c) of
    this section. The manufacturer of an infant formula exempt under
    this paragraph shall, in the case of the exempt formula, be
    required to provide the notice required by subsection (e)(1) of
    this section only with respect to adulteration or misbranding
    described in subsection (e)(1)(B) of this section and to comply
    with the regulations prescribed by the Secretary under paragraph
    (2).
      (2) The Secretary may by regulation establish terms and
    conditions for the exemption of an infant formula from the
    requirements of subsections (a), (b), and (c) of this section. An
    exemption of an infant formula under paragraph (1) may be withdrawn
    by the Secretary if such formula is not in compliance with
    applicable terms and conditions prescribed under this paragraph.
    (i) Nutrient requirements
      (1) An infant formula shall contain nutrients in accordance with
    the table set out in this subsection or, if revised by the
    Secretary under paragraph (2), as so revised.
      (2) The Secretary may by regulation - 
        (A) revise the list of nutrients in the table in this
      subsection, and
        (B) revise the required level for any nutrient required by the
      table.



                                 NUTRIENTS                             
    --------------------------------------------------------------------
                 Nutrient                          Minimum       Maximum  
                                                   <sup>a         <sup>a  
                                                   </sup>         </sup>  
    --------------------------------------------------------------------
    Protein (gm)                          1.8                  4.5.       
                                          <su                             
                                          p>b                             
                                          </s                             
                                          up>                             
    Fat:                                                                  
      gm                                  3.3                  6.0.       
      percent cal                        30.0                  54.0.      
    Essential fatty acids                                                 
     (linoeate):                                                          
      percent cal                         2.7                             
      mg                                300.0                             
    Vitamins:                                                             
      A (IU)                            250.0  (75             750.0 (225 
                                                &micro;g        &micro    
                                                )<sup>c</sup>   ;g).<s    
                                                                up>c      
                                                                </sup>    
      D (IU)                             40.0                  100.0.     
      K (&micro;g)                        4.0                             
      E (IU)                              0.7  (with 0.7                  
                                                IU/gm                     
                                                linoleic acid)             
      C (ascorbic acid) (mg)              8.0                             
      B<sub>1</sub> (thiamine)           40.0                             
       (&micro;g)                                                         
      B<sub>2</sub> (riboflavin)         60.0                             
       (&micro;g)                                                         
      B<sub>6</sub> (pyridoxine)         35.0  (with 15                   
       (&micro;g)                               &micro;g/gm               
                                                of protein in             
                                                formula)                  
      B<sub>12</sub> (&micro;g)          0.15                             
      Niacin (&micro;g)                 250.0                             
      Folic acid (&micro;g)               4.0                             
      Pantothenic acid (&micro;g)       300.0                             
      Biotin (&micro;g)                   1.5                             
                                          <su                             
                                          p>d                             
                                          </s                             
                                          up>                             
      Choline (mg)                        7.0                             
                                          <su                             
                                          p>d                             
                                          </s                             
                                          up>                             
      Inositol (mg)                       4.0                             
                                          <su                             
                                          p>d                             
                                          </s                             
                                          up>                             
    Minerals:                                                             
      Calcium (mg)                       50.0                             
                                          <su                             
                                          p>e                             
                                          </s                             
                                          up>                             
      Phosphorus (mg)                    25.0                             
                                          <su                             
                                          p>e                             
                                          </s                             
                                          up>                             
      Magnesium (mg)                      6.0                             
      Iron (mg)                          0.15                             
      Iodine (&micro;g)                   5.0                             
      Zinc (mg)                           0.5                             
      Copper (&micro;g)                  60.0                             
      Manganese (&micro;g)                5.0                             
      Sodium (mg)                        20.0                  60.0.      
      Potassium (mg)                     80.0                  200.0.     
      Chloride (mg)                      55.0                  150.0.     

      <sup>a</sup> Stated per 100 kilocalories.
      <sup>b</sup> The source of protein shall be at least
    nutritionally equivalent to casein.
      <sup>c</sup> Retinol equivalents.
      <sup>d</sup> Required to be included in this amount only in
    formulas which are not milk-based.
      <sup>e</sup> Calcium to phosphorus ratio must be no less than 1.1
    nor more than 2.0.
    --------------------------------------------------------------------


-SOURCE-
    (June 25, 1938, ch. 675, Sec. 412, as added Pub. L. 96-359, Sec. 2,
    Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99-570, title IV,
    Sec. 4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207-116, 3207-120;
    Pub. L. 103-80, Sec. 3(l), Aug. 13, 1993, 107 Stat. 777.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (h)(1). Pub. L. 103-80 substituted "(e)(1)(B) of
    this section" for "(c)(1)(B) of this section," in concluding
    provisions.
      1986 - Subsecs. (a) to (d). Pub. L. 99-570, Sec. 4014(a)(7),
    added subsecs. (a) to (d) and struck out former subsecs. (a)
    relating to adulteration and regulatory oversight, (b) relating to
    notice to the Secretary by a manufacturer and requirements and
    scope of that notice, (c) relating to additional notice
    requirements for the manufacturer, and (d) relating to procedures
    applicable to recalls by a manufacturer.
      Subsecs. (e), (f). Pub. L. 99-570, Sec. 4014(a)(1), (7), added
    subsecs. (e) and (f) and redesignated former subsecs. (e) and (f)
    as (g) and (h), respectively.
      Subsec. (g). Pub. L. 99-570, Sec. 4014(a)(1), (2), redesignated
    subsec. (e) as (g) and substituted "Such records shall be retained
    for at least one year after the expiration of the shelf life of the
    infant formula" for "No manufacturer shall be required under this
    subsection to retain any record respecting the distribution of an
    infant formula for a period of longer than 2 years from the date
    the record was made". Former subsec. (g) redesignated (i).
      Subsec. (h). Pub. L. 99-570, Sec. 4014(a)(1), redesignated
    subsec. (f) as (h).
      Subsec. (h)(1). Pub. L. 99-570, Sec. 4014(a)(3), (4), substituted
    "(a), (b), and (c)" for "(a) and (b)" and "(e)(1)" for "(c)(1)".
      Pub. L. 99-570, Sec. 4014(a)(5), which directed that "(d)(1)(B)"
    be substituted for "(e)(1)(B)" in second sentence could not be
    executed because "(e)(1)(B)" did not appear. See 1993 Amendment
    note above.
      Subsec. (h)(2). Pub. L. 99-570, Sec. 4014(a)(6), substituted
    "(a), (b), and (c)" for "(a) and (b)".
      Subsec. (i). Pub. L. 99-570, Sec. 4014(a)(1), (b)(1),
    redesignated subsec. (g) as (i), designated existing provisions as
    par. (1), substituted "paragraph (2)" for "subsection (a)(2) of
    this section", substituted a period for the colon after "as so
    revised", and added par. (2).

                     EFFECTIVE DATE OF 1980 AMENDMENT                 
      Section 6 of Pub. L. 96-359 provided that: "Section 412 of the
    Federal Food, Drug, and Cosmetic Act (added by section 2) [this
    section] shall apply with respect to infant formulas manufactured
    on or after the 90th day after the date of the enactment of this
    Act [Sept. 26, 1980]."

-End-



-CITE-
    21 USC Sec. 350b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350b. New dietary ingredients

-STATUTE-
    (a) In general
      A dietary supplement which contains a new dietary ingredient
    shall be deemed adulterated under section 342(f) of this title
    unless it meets one of the following requirements:
        (1) The dietary supplement contains only dietary ingredients
      which have been present in the food supply as an article used for
      food in a form in which the food has not been chemically altered.
        (2) There is a history of use or other evidence of safety
      establishing that the dietary ingredient when used under the
      conditions recommended or suggested in the labeling of the
      dietary supplement will reasonably be expected to be safe and, at
      least 75 days before being introduced or delivered for
      introduction into interstate commerce, the manufacturer or
      distributor of the dietary ingredient or dietary supplement
      provides the Secretary with information, including any citation
      to published articles, which is the basis on which the
      manufacturer or distributor has concluded that a dietary
      supplement containing such dietary ingredient will reasonably be
      expected to be safe.

    The Secretary shall keep confidential any information provided
    under paragraph (2) for 90 days following its receipt. After the
    expiration of such 90 days, the Secretary shall place such
    information on public display, except matters in the information
    which are trade secrets or otherwise confidential, commercial
    information.
    (b) Petition
      Any person may file with the Secretary a petition proposing the
    issuance of an order prescribing the conditions under which a new
    dietary ingredient under its intended conditions of use will
    reasonably be expected to be safe. The Secretary shall make a
    decision on such petition within 180 days of the date the petition
    is filed with the Secretary. For purposes of chapter 7 of title 5,
    the decision of the Secretary shall be considered final agency
    action.
    (c) "New dietary ingredient" defined
      For purposes of this section, the term "new dietary ingredient"
    means a dietary ingredient that was not marketed in the United
    States before October 15, 1994 and does not include any dietary
    ingredient which was marketed in the United States before October
    15, 1994.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 413, as added Pub. L. 103-417, Sec.
    8, Oct. 25, 1994, 108 Stat. 4331.)

-End-



-CITE-
    21 USC Sec. 350c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350c. Maintenance and inspection of records

-STATUTE-
    (a) Records inspection
      If the Secretary has a reasonable belief that an article of food
    is adulterated and presents a threat of serious adverse health
    consequences or death to humans or animals, each person (excluding
    farms and restaurants) who manufactures, processes, packs,
    distributes, receives, holds, or imports such article shall, at the
    request of an officer or employee duly designated by the Secretary,
    permit such officer or employee, upon presentation of appropriate
    credentials and a written notice to such person, at reasonable
    times and within reasonable limits and in a reasonable manner, to
    have access to and copy all records relating to such article that
    are needed to assist the Secretary in determining whether the food
    is adulterated and presents a threat of serious adverse health
    consequences or death to humans or animals. The requirement under
    the preceding sentence applies to all records relating to the
    manufacture, processing, packing, distribution, receipt, holding,
    or importation of such article maintained by or on behalf of such
    person in any format (including paper and electronic formats) and
    at any location.
    (b) Regulations concerning recordkeeping
      The Secretary, in consultation and coordination, as appropriate,
    with other Federal departments and agencies with responsibilities
    for regulating food safety, may by regulation establish
    requirements regarding the establishment and maintenance, for not
    longer than two years, of records by persons (excluding farms and
    restaurants) who manufacture, process, pack, transport, distribute,
    receive, hold, or import food, which records are needed by the
    Secretary for inspection to allow the Secretary to identify the
    immediate previous sources and the immediate subsequent recipients
    of food, including its packaging, in order to address credible
    threats of serious adverse health consequences or death to humans
    or animals. The Secretary shall take into account the size of a
    business in promulgating regulations under this section.
    (c) Protection of sensitive information
      The Secretary shall take appropriate measures to ensure that
    there are in effect effective procedures to prevent the
    unauthorized disclosure of any trade secret or confidential
    information that is obtained by the Secretary pursuant to this
    section.
    (d) Limitations
      This section shall not be construed - 
        (1) to limit the authority of the Secretary to inspect records
      or to require establishment and maintenance of records under any
      other provision of this chapter;
        (2) to authorize the Secretary to impose any requirements with
      respect to a food to the extent that it is within the exclusive
      jurisdiction of the Secretary of Agriculture pursuant to the
      Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
      Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg
      Products Inspection Act (21 U.S.C. 1031 et seq.);
        (3) to have any legal effect on section 552 of title 5 or
      section 1905 of title 18; or
        (4) to extend to recipes for food, financial data, pricing
      data, personnel data, research data, or sales data (other than
      shipment data regarding sales).

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 414, as added Pub. L. 107-188, title
    III, Sec. 306(a), June 12, 2002, 116 Stat. 669.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Meat Inspection Act, referred to in subsec. (d)(2),
    is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L.
    90-201, Dec. 15, 1967, 81 Stat. 584, and amended, which are
    classified generally to subchapters I to IV (Sec. 601 et seq.) of
    chapter 12 of this title. For complete classification of this Act
    to the Code, see Short Title note set out under section 601 of this
    title and Tables.
      The Poultry Products Inspection Act, referred to in subsec.
    (d)(2), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended,
    which is classified generally to chapter 10 (Sec. 451 et seq.) of
    this title. For complete classification of this Act to the Code,
    see Short Title note set out under section 451 of this title and
    Tables.
      The Egg Products Inspection Act, referred to in subsec. (d)(2),
    is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as amended, which
    is classified generally to chapter 15 (Sec. 1031 et seq.) of this
    title. For complete classification of this Act to the Code, see
    Short Title note set out under section 1031 of this title and
    Tables.


-MISC1-
                           EXPEDITED RULEMAKING                       
      Pub. L. 107-188, title III, Sec. 306(d), June 12, 2002, 116 Stat.
    670, provided that: "Not later than 18 months after the date of the
    enactment of this Act [June 12, 2002], the Secretary shall
    promulgate proposed and final regulations establishing
    recordkeeping requirements under subsection 414(b) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 350c(b)] (as added by
    subsection (a))."

-End-



-CITE-
    21 USC Sec. 350d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350d. Registration of food facilities

-STATUTE-
    (a) Registration
      (1) In general
        The Secretary shall by regulation require that any facility
      engaged in manufacturing, processing, packing, or holding food
      for consumption in the United States be registered with the
      Secretary. To be registered - 
          (A) for a domestic facility, the owner, operator, or agent in
        charge of the facility shall submit a registration to the
        Secretary; and
          (B) for a foreign facility, the owner, operator, or agent in
        charge of the facility shall submit a registration to the
        Secretary and shall include with the registration the name of
        the United States agent for the facility.
      (2) Registration
        An entity (referred to in this section as the "registrant")
      shall submit a registration under paragraph (1) to the Secretary
      containing information necessary to notify the Secretary of the
      name and address of each facility at which, and all trade names
      under which, the registrant conducts business and, when
      determined necessary by the Secretary through guidance, the
      general food category (as identified under section 170.3 of title
      21, Code of Federal Regulations) of any food manufactured,
      processed, packed, or held at such facility. The registrant shall
      notify the Secretary in a timely manner of changes to such
      information.
      (3) Procedure
        Upon receipt of a completed registration described in paragraph
      (1), the Secretary shall notify the registrant of the receipt of
      such registration and assign a registration number to each
      registered facility.
      (4) List
        The Secretary shall compile and maintain an up-to-date list of
      facilities that are registered under this section. Such list and
      any registration documents submitted pursuant to this subsection
      shall not be subject to disclosure under section 552 of title 5.
      Information derived from such list or registration documents
      shall not be subject to disclosure under section 552 of title 5
      to the extent that it discloses the identity or location of a
      specific registered person.
    (b) Facility
      For purposes of this section:
        (1) The term "facility" includes any factory, warehouse, or
      establishment (including a factory, warehouse, or establishment
      of an importer) that manufactures, processes, packs, or holds
      food. Such term does not include farms; restaurants; other retail
      food establishments; nonprofit food establishments in which food
      is prepared for or served directly to the consumer; or fishing
      vessels (except such vessels engaged in processing as defined in
      section 123.3(k) of title 21, Code of Federal Regulations).
        (2) The term "domestic facility" means a facility located in
      any of the States or Territories.
        (3)(A) The term "foreign facility" means a facility that
      manufacturers, processes, packs, or holds food, but only if food
      from such facility is exported to the United States without
      further processing or packaging outside the United States.
        (B) A food may not be considered to have undergone further
      processing or packaging for purposes of subparagraph (A) solely
      on the basis that labeling was added or that any similar activity
      of a de minimis nature was carried out with respect to the food.
    (c) Rule of construction
      Nothing in this section shall be construed to authorize the
    Secretary to require an application, review, or licensing process.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 415, as added Pub. L. 107-188, title
    III, Sec. 305(a), June 12, 2002, 116 Stat. 667.)


-MISC1-
                                REGULATIONS                            
      Pub. L. 107-188, title III, Sec. 305(e), June 12, 2002, 116 Stat.
    669, provided that: "Not later than 18 months after the date of the
    enactment of this Act [June 12, 2002], the Secretary of Health and
    Human Services shall promulgate proposed and final regulations for
    the requirement of registration under section 415 of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as added by
    subsection (a) of this section). Such requirement of registration
    takes effect - 
        "(1) upon the effective date of such final regulations; or
        "(2) upon the expiration of such 18-month period if the final
      regulations have not been made effective as of the expiration of
      such period, subject to compliance with the final regulations
      when the final regulations are made effective."

                             ELECTRONIC FILING                         
      Pub. L. 107-188, title III, Sec. 305(d), June 12, 2002, 116 Stat.
    668, provided that: "For the purpose of reducing paperwork and
    reporting burdens, the Secretary of Health and Human Services may
    provide for, and encourage the use of, electronic methods of
    submitting to the Secretary registrations required pursuant to this
    section [enacting this section, amending sections 331 and 381 of
    this title, and enacting provisions set out as a note under this
    section]. In providing for the electronic submission of such
    registrations, the Secretary shall ensure adequate authentication
    protocols are used to enable identification of the registrant and
    validation of the data as appropriate."

-End-



-CITE-
    21 USC Sec. 350e                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IV - FOOD

-HEAD-
    Sec. 350e. Sanitary transportation practices

-STATUTE-
    (a) Definitions
      In this section:
      (1) Bulk vehicle
        The term "bulk vehicle" includes a tank truck, hopper truck,
      rail tank car, hopper car, cargo tank, portable tank, freight
      container, or hopper bin, and any other vehicle in which food is
      shipped in bulk, with the food coming into direct contact with
      the vehicle.
      (2) Transportation
        The term "transportation" means any movement in commerce by
      motor vehicle or rail vehicle.
    (b) Regulations
      The Secretary shall by regulation require shippers, carriers by
    motor vehicle or rail vehicle, receivers, and other persons engaged
    in the transportation of food to use sanitary transportation
    practices prescribed by the Secretary to ensure that food is not
    transported under conditions that may render the food adulterated.
    (c) Contents
      The regulations under subsection (b) of this section shall - 
        (1) prescribe such practices as the Secretary determines to be
      appropriate relating to - 
          (A) sanitation;
          (B) packaging, isolation, and other protective measures;
          (C) limitations on the use of vehicles;
          (D) information to be disclosed - 
            (i) to a carrier by a person arranging for the transport of
          food; and
            (ii) to a manufacturer or other person that - 
              (I) arranges for the transportation of food by a carrier;
            or
              (II) furnishes a tank vehicle or bulk vehicle for the
            transportation of food; and

          (E) recordkeeping; and

        (2) include - 
          (A) a list of nonfood products that the Secretary determines
        may, if shipped in a bulk vehicle, render adulterated food that
        is subsequently transported in the same vehicle; and
          (B) a list of nonfood products that the Secretary determines
        may, if shipped in a motor vehicle or rail vehicle (other than
        a tank vehicle or bulk vehicle), render adulterated food that
        is simultaneously or subsequently transported in the same
        vehicle.
    (d) Waivers
      (1) In general
        The Secretary may waive any requirement under this section,
      with respect to any class of persons, vehicles, food, or nonfood
      products, if the Secretary determines that the waiver - 
          (A) will not result in the transportation of food under
        conditions that would be unsafe for human or animal health; and
          (B) will not be contrary to the public interest.
      (2) Publication
        The Secretary shall publish in the Federal Register any waiver
      and the reasons for the waiver.
    (e) Preemption
      (1) In general
        A requirement of a State or political subdivision of a State
      that concerns the transportation of food is preempted if - 
          (A) complying with a requirement of the State or political
        subdivision and a requirement of this section, or a regulation
        prescribed under this section, is not possible; or
          (B) the requirement of the State or political subdivision as
        applied or enforced is an obstacle to accomplishing and
        carrying out this section or a regulation prescribed under this
        section.
      (2) Applicability
        This subsection applies to transportation that occurs on or
      after the effective date of the regulations promulgated under
      subsection (b) of this section.
    (f) Assistance of other agencies
      The Secretary of Transportation, the Secretary of Agriculture,
    the Administrator of the Environmental Protection Agency, and the
    heads of other Federal agencies, as appropriate, shall provide
    assistance on request, to the extent resources are available, to
    the Secretary for the purposes of carrying out this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 416, as added Pub. L. 109-59, title
    VII, Sec. 7202(b), Aug. 10, 2005, 119 Stat. 1911.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109-
    59, set out as an Effective Date of 2005 Amendment note under
    section 331 of this title.

-End-


-CITE-
    21 USC SUBCHAPTER V - DRUGS AND DEVICES                     01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES

-HEAD-
                     SUBCHAPTER V - DRUGS AND DEVICES                 

-End-


-CITE-
    21 USC Part A - Drugs and Devices                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
                        PART A - DRUGS AND DEVICES                    

-End-



-CITE-
    21 USC Sec. 351                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 351. Adulterated drugs and devices

-STATUTE-
      A drug or device shall be deemed to be adulterated - 
    (a) Poisonous, insanitary, etc., ingredients; adequate controls in
      manufacture
      (1) If it consists in whole or in part of any filthy, putrid, or
    decomposed substance; or (2)(A) if it has been prepared, packed, or
    held under insanitary conditions whereby it may have been
    contaminated with filth, or whereby it may have been rendered
    injurious to health; or (B) if it is a drug and the methods used
    in, or the facilities or controls used for, its manufacture,
    processing, packing, or holding do not conform to or are not
    operated or administered in conformity with current good
    manufacturing practice to assure that such drug meets the
    requirements of this chapter as to safety and has the identity and
    strength, and meets the quality and purity characteristics, which
    it purports or is represented to possess; or (C) if it is a
    compounded positron emission tomography drug and the methods used
    in, or the facilities and controls used for, its compounding,
    processing, packing, or holding do not conform to or are not
    operated or administered in conformity with the positron emission
    tomography compounding standards and the official monographs of the
    United States Pharmacopoeia to assure that such drug meets the
    requirements of this chapter as to safety and has the identity and
    strength, and meets the quality and purity characteristics, that it
    purports or is represented to possess; or (3) if its container is
    composed, in whole or in part, of any poisonous or deleterious
    substance which may render the contents injurious to health; or (4)
    if (A) it bears or contains, for purposes of coloring only, a color
    additive which is unsafe within the meaning of section 379e(a) of
    this title, or (B) it is a color additive the intended use of which
    in or on drugs or devices is for purposes of coloring only and is
    unsafe within the meaning of section 379e(a) of this title; or (5)
    if it is a new animal drug which is unsafe within the meaning of
    section 360b of this title; or (6) if it is an animal feed bearing
    or containing a new animal drug, and such animal feed is unsafe
    within the meaning of section 360b of this title.
    (b) Strength, quality, or purity differing from official compendium
      If it purports to be or is represented as a drug the name of
    which is recognized in an official compendium, and its strength
    differs from, or its quality or purity falls below, the standard
    set forth in such compendium. Such determination as to strength,
    quality, or purity shall be made in accordance with the tests or
    methods of assay set forth in such compendium, except that whenever
    tests or methods of assay have not been prescribed in such
    compendium, or such tests or methods of assay as are prescribed
    are, in the judgment of the Secretary, insufficient for the making
    of such determination, the Secretary shall bring such fact to the
    attention of the appropriate body charged with the revision of such
    compendium, and if such body fails within a reasonable time to
    prescribe tests or methods of assay which, in the judgment of the
    Secretary, are sufficient for purposes of this paragraph, then the
    Secretary shall promulgate regulations prescribing appropriate
    tests or methods of assay in accordance with which such
    determination as to strength, quality, or purity shall be made. No
    drug defined in an official compendium shall be deemed to be
    adulterated under this paragraph because it differs from the
    standard of strength, quality, or purity therefor set forth in such
    compendium, if its difference in strength, quality, or purity from
    such standard is plainly stated on its label. Whenever a drug is
    recognized in both the United States Pharmacopoeia and the
    Homoeopathic Pharmacopoeia of the United States it shall be subject
    to the requirements of the United States Pharmacopoeia unless it is
    labeled and offered for sale as a homoeopathic drug, in which case
    it shall be subject to the provisions of the Homoeopathic
    Pharmacopoeia of the United States and not to those of the United
    States Pharmacopoeia.
    (c) Misrepresentation of strength, etc., where drug is unrecognized
      in compendium
      If it is not subject to the provisions of paragraph (b) of this
    section and its strength differs from, or its purity or quality
    falls below, that which it purports or is represented to possess.
    (d) Mixture with or substitution of another substance
      If it is a drug and any substance has been (1) mixed or packed
    therewith so as to reduce its quality or strength or (2)
    substituted wholly or in part therefor.
    (e) Devices not in conformity with performance standards
      (1) If it is, or purports to be or is represented as, a device
    which is subject to a performance standard established under
    section 360d of this title unless such device is in all respects in
    conformity with such standard.
      (2) If it is declared to be, purports to be, or is represented
    as, a device that is in conformity with any standard recognized
    under section 360d(c) of this title unless such device is in all
    respects in conformity with such standard.
    (f) Certain class III devices
      (1) If it is a class III device - 
        (A)(i) which is required by a regulation promulgated under
      subsection (b) of section 360e of this title to have an approval
      under such section of an application for premarket approval and
      which is not exempt from section 360e of this title under section
      360j(g) of this title, and
        (ii)(I) for which an application for premarket approval or a
      notice of completion of a product development protocol was not
      filed with the Secretary within the ninety-day period beginning
      on the date of the promulgation of such regulation, or
        (II) for which such an application was filed and approval of
      the application has been denied, suspended, or withdrawn, or such
      a notice was filed and has been declared not completed or the
      approval of the device under the protocol has been withdrawn;
        (B)(i) which was classified under section 360c(f) of this title
      into class III, which under section 360e(a) of this title is
      required to have in effect an approved application for premarket
      approval, and which is not exempt from section 360e of this title
      under section 360j(g) of this title, and
        (ii) which has an application which has been suspended or is
      otherwise not in effect; or
        (C) which was classified under section 360j(l) of this title
      into class III, which under such section is required to have in
      effect an approved application under section 360e of this title,
      and which has an application which has been suspended or is
      otherwise not in effect.

      (2)(A) In the case of a device classified under section 360c(f)
    of this title into class III and intended solely for
    investigational use, paragraph (!1) (1)(B) shall not apply with
    respect to such device during the period ending on the ninetieth
    day after the date of the promulgation of the regulations
    prescribing the procedures and conditions required by section
    360j(g)(2) of this title.

      (B) In the case of a device subject to a regulation promulgated
    under subsection (b) of section 360e of this title, paragraph (!1)
    (1) shall not apply with respect to such device during the period
    ending - 
        (i) on the last day of the thirtieth calendar month beginning
      after the month in which the classification of the device in
      class III became effective under section 360c of this title, or
        (ii) on the ninetieth day after the date of the promulgation of
      such regulation,

    whichever occurs later.
    (g) Banned devices
      If it is a banned device.
    (h) Manufacture, packing, storage, or installation of device not in
      conformity with applicable requirements or conditions
      If it is a device and the methods used in, or the facilities or
    controls used for, its manufacture, packing, storage, or
    installation are not in conformity with applicable requirements
    under section 360j(f)(1) of this title or an applicable condition
    prescribed by an order under section 360j(f)(2) of this title.
    (i) Failure to comply with requirements under which device was
      exempted for investigational use
      If it is a device for which an exemption has been granted under
    section 360j(g) of this title for investigational use and the
    person who was granted such exemption or any investigator who uses
    such device under such exemption fails to comply with a requirement
    prescribed by or under such section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 501, 52 Stat. 1049; Pub. L. 86-618,
    title I, Sec. 102(b)(1), July 12, 1960, 74 Stat. 398; Pub. L. 87-
    781, title I, Sec. 101, Oct. 10, 1962, 76 Stat. 780; Pub. L. 90-
    399, Sec. 101(a), July 13, 1968, 82 Stat. 343; Pub. L. 94-295,
    Secs. 3(d), 9(b)(1), May 28, 1976, 90 Stat. 576, 583; Pub. L. 101-
    629, Sec. 9(b), Nov. 28, 1990, 104 Stat. 4521; Pub. L. 102-571,
    title I, Sec. 107(8), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105-
    115, title I, Sec. 121(b)(1), title II, Sec. 204(c), Nov. 21,
    1997, 111 Stat. 2320, 2336.)


-MISC1-
                                AMENDMENTS                            
      1997 - Par. (a)(2)(C). Pub. L. 105-115, Sec. 121(b)(1), inserted
    "; or (C) if it is a compounded positron emission tomography drug
    and the methods used in, or the facilities and controls used for,
    its compounding, processing, packing, or holding do not conform to
    or are not operated or administered in conformity with the positron
    emission tomography compounding standards and the official
    monographs of the United States Pharmacopoeia to assure that such
    drug meets the requirements of this chapter as to safety and has
    the identity and strength, and meets the quality and purity
    characteristics, that it purports or is represented to possess;"
    before "or (3)".
      Par. (e). Pub. L. 105-115, Sec. 204(c), designated existing
    provisions as subpar. (1) and added subpar. (2).
      1992 - Par. (a)(4). Pub. L. 102-571 substituted "379e(a)" for
    "376(a)" in cls. (A) and (B).
      1990 - Par. (f)(1). Pub. L. 101-629, Sec. 9(b), which directed
    the amendment of subpars. (A) to (C) of par. (f), was executed by
    making the amendments in cls. (A) to (C) of subpar. (1) of par. (f)
    as follows to reflect the probable intent of Congress: in cl.
    (A)(ii)(II), substituted ", suspended, or withdrawn" for "or
    withdrawn"; in cl. (B)(ii), substituted "which has an application
    which has been suspended or is otherwise not in effect" for "which
    does not have such an application in effect"; and in cl. (C),
    substituted "which has an application which has been suspended or
    is otherwise not in effect" for "which does not have such an
    application in effect".
      1976 - Par. (a). Pub. L. 94-295, Sec. 9(b)(1), substituted "(3)
    if its" for "(3) if it is a drug and its" in cl. (3), substituted
    "(4) if (A) it bears or contains" for "(4) if (A) it is a drug
    which bears or contains" in cl. (4)(A), and substituted "drugs or
    devices" for "drugs" in cl. (4)(B).
      Pars. (e) to (i). Pub. L. 94-295, Sec. 3(d), added pars. (e) to
    (i).
      1968 - Par. (a). Pub. L. 90-399 added cls. (5) and (6).
      1962 - Par. (a). Pub. L. 87-781 designated existing provisions of
    cl. (2) as (A) and added (B).
      1960 - Par. (a). Pub. L. 86-618 substituted provisions in cl. (4)
    relating to unsafe color additives for provisions which related to
    a coal-tar color other than one from a batch that has been
    certified in accordance with regulations as provided by section 354
    of this title.

             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT         
      Section 121(b)(2) of Pub. L. 105-115 provided that: "Section
    501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    351(a)(2)(C)) shall not apply 4 years after the date of enactment
    of this Act [Nov. 21, 1997] or 2 years after the date on which the
    Secretary of Health and Human Services establishes the requirements
    described in subsection (c)(1)(B) [section 121(c)(1)(B) of Pub. L.
    105-115, set out as a note under section 355 of this title],
    whichever is later."
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as an Effective Date of 1997 Amendment note under
    section 321 of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.

               EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS           
      Amendment by Pub. L. 87-781 effective on first day of seventh
    calendar month following October 1962, see section 107 of Pub. L.
    87-781, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch.
    242, 53 Stat. 853, set out as an Effective Date; Postponement in
    Certain Cases note under section 301 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-FOOTNOTE-
    (!1) So in original. Probably should be "subparagraph".


-End-



-CITE-
    21 USC Sec. 352                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 352. Misbranded drugs and devices

-STATUTE-
      A drug or device shall be deemed to be misbranded - 
    (a) False or misleading label
      If its labeling is false or misleading in any particular. Health
    care economic information provided to a formulary committee, or
    other similar entity, in the course of the committee or the entity
    carrying out its responsibilities for the selection of drugs for
    managed care or other similar organizations, shall not be
    considered to be false or misleading under this paragraph if the
    health care economic information directly relates to an indication
    approved under section 355 of this title or under section 262(a) of
    title 42 for such drug and is based on competent and reliable
    scientific evidence. The requirements set forth in section 355(a)
    of this title or in section 262(a) of title 42 shall not apply to
    health care economic information provided to such a committee or
    entity in accordance with this paragraph. Information that is
    relevant to the substantiation of the health care economic
    information presented pursuant to this paragraph shall be made
    available to the Secretary upon request. In this paragraph, the
    term "health care economic information" means any analysis that
    identifies, measures, or compares the economic consequences,
    including the costs of the represented health outcomes, of the use
    of a drug to the use of another drug, to another health care
    intervention, or to no intervention.
    (b) Package form; contents of label
      If in package form unless it bears a label containing (1) the
    name and place of business of the manufacturer, packer, or
    distributor; and (2) an accurate statement of the quantity of the
    contents in terms of weight, measure, or numerical count: Provided,
    That under clause (2) of this paragraph reasonable variations shall
    be permitted, and exemptions as to small packages shall be
    established, by regulations prescribed by the Secretary.
    (c) Prominence of information on label
      If any word, statement, or other information required by or under
    authority of this chapter to appear on the label or labeling is not
    prominently placed thereon with such conspicuousness (as compared
    with other words, statements, designs, or devices, in the labeling)
    and in such terms as to render it likely to be read and understood
    by the ordinary individual under customary conditions of purchase
    and use.
    (d) Repealed. Pub. L. 105-115, title I, Sec. 126(b), Nov. 21, 1997,
      111 Stat. 2327
    (e) Designation of drugs or devices by established names
      (1)(A) If it is a drug, unless its label bears, to the exclusion
    of any other nonproprietary name (except the applicable systematic
    chemical name or the chemical formula) - 
        (i) the established name (as defined in subparagraph (3)) of
      the drug, if there is such a name;
        (ii) the established name and quantity or, if determined to be
      appropriate by the Secretary, the proportion of each active
      ingredient, including the quantity, kind, and proportion of any
      alcohol, and also including whether active or not the established
      name and quantity or if determined to be appropriate by the
      Secretary, the proportion of any bromides, ether, chloroform,
      acetanilide, acetophenetidin, amidopyrine, antipyrine, atropine,
      hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,
      mercury, ouabain, strophanthin, strychnine, thyroid, or any
      derivative or preparation of any such substances, contained
      therein, except that the requirement for stating the quantity of
      the active ingredients, other than the quantity of those
      specifically named in this subclause, shall not apply to
      nonprescription drugs not intended for human use; and
        (iii) the established name of each inactive ingredient listed
      in alphabetical order on the outside container of the retail
      package and, if determined to be appropriate by the Secretary, on
      the immediate container, as prescribed in regulation promulgated
      by the Secretary, except that nothing in this subclause shall be
      deemed to require that any trade secret be divulged, and except
      that the requirements of this subclause with respect to
      alphabetical order shall apply only to nonprescription drugs that
      are not also cosmetics and that this subclause shall not apply to
      nonprescription drugs not intended for human use.

      (B) For any prescription drug the established name of such drug
    or ingredient, as the case may be, on such label (and on any
    labeling on which a name for such drug or ingredient is used) shall
    be printed prominently and in type at least half as large as that
    used thereon for any proprietary name or designation for such drug
    or ingredient, except that to the extent that compliance with the
    requirements of subclause (ii) or (iii) of clause (A) or this
    clause is impracticable, exemptions shall be established by
    regulations promulgated by the Secretary.
      (2) If it is a device and it has an established name, unless its
    label bears, to the exclusion of any other nonproprietary name, its
    established name (as defined in subparagraph (4)) prominently
    printed in type at least half as large as that used thereon for any
    proprietary name or designation for such device, except that to the
    extent compliance with the requirements of this subparagraph is
    impracticable, exemptions shall be established by regulations
    promulgated by the Secretary.
      (3) As used in subparagraph (1), the term "established name",
    with respect to a drug or ingredient thereof, means (A) the
    applicable official name designated pursuant to section 358 of this
    title, or (B), if there is no such name and such drug, or such
    ingredient, is an article recognized in an official compendium,
    then the official title thereof in such compendium, or (C) if
    neither clause (A) nor clause (B) of this subparagraph applies,
    then the common or usual name, if any, of such drug or of such
    ingredient, except that where clause (B) of this subparagraph
    applies to an article recognized in the United States Pharmacopeia
    and in the Homoeopathic Pharmacopoeia under different official
    titles, the official title used in the United States Pharmacopeia
    shall apply unless it is labeled and offered for sale as a
    homoeopathic drug, in which case the official title used in the
    Homoeopathic Pharmacopoeia shall apply.
      (4) As used in subparagraph (2), the term "established name" with
    respect to a device means (A) the applicable official name of the
    device designated pursuant to section 358 of this title, (B) if
    there is no such name and such device is an article recognized in
    an official compendium, then the official title thereof in such
    compendium, or (C) if neither clause (A) nor clause (B) of this
    subparagraph applies, then any common or usual name of such device.
    (f) Directions for use and warnings on label
      Unless its labeling bears (1) adequate directions for use; and
    (2) such adequate warnings against use in those pathological
    conditions or by children where its use may be dangerous to health,
    or against unsafe dosage or methods or duration of administration
    or application, in such manner and form, as are necessary for the
    protection of users, except that where any requirement of clause
    (1) of this paragraph, as applied to any drug or device, is not
    necessary for the protection of the public health, the Secretary
    shall promulgate regulations exempting such drug or device from
    such requirement. Required labeling for prescription devices
    intended for use in health care facilities or by a health care
    professional and required labeling for in vitro diagnostic devices
    intended for use by health care professionals or in blood
    establishments may be made available solely by electronic means,
    provided that the labeling complies with all applicable
    requirements of law, and that the manufacturer affords such users
    the opportunity to request the labeling in paper form, and after
    such request, promptly provides the requested information without
    additional cost.
    (g) Representations as recognized drug; packing and labeling;
      inconsistent requirements for designation of drug
      If it purports to be a drug the name of which is recognized in an
    official compendium, unless it is packaged and labeled as
    prescribed therein. The method of packing may be modified with the
    consent of the Secretary. Whenever a drug is recognized in both the
    United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of
    the United States, it shall be subject to the requirements of the
    United States Pharmacopoeia with respect to packaging and labeling
    unless it is labeled and offered for sale as a homoeopathic drug,
    in which case it shall be subject to the provisions of the
    Homoeopathic Pharmacopoeia of the United States, and not those of
    the United States Pharmacopoeia, except that in the event of
    inconsistency between the requirements of this paragraph and those
    of paragraph (e) as to the name by which the drug or its
    ingredients shall be designated, the requirements of paragraph (e)
    shall prevail.
    (h) Deteriorative drugs; packing and labeling
      If it has been found by the Secretary to be a drug liable to
    deterioration, unless it is packaged in such form and manner, and
    its label bears a statement of such precautions, as the Secretary
    shall by regulations require as necessary for the protection of the
    public health. No such regulation shall be established for any drug
    recognized in an official compendium until the Secretary shall have
    informed the appropriate body charged with the revision of such
    compendium of the need for such packaging or labeling requirements
    and such body shall have failed within a reasonable time to
    prescribe such requirements.
    (i) Drug; misleading container; imitation; offer for sale under
      another name
      (1) If it is a drug and its container is so made, formed, or
    filled as to be misleading; or (2) if it is an imitation of another
    drug; or (3) if it is offered for sale under the name of another
    drug.
    (j) Health-endangering when used as prescribed
      If it is dangerous to health when used in the dosage or manner,
    or with the frequency or duration prescribed, recommended, or
    suggested in the labeling thereof.
    (k), (l) Repealed. Pub. L. 105-115, title I, Sec. 125(a)(2)(B),
      (b)(2)(D), Nov. 21, 1997, 111 Stat. 2325
    (m) Color additives; packing and labeling
      If it is a color additive the intended use of which is for the
    purpose of coloring only, unless its packaging and labeling are in
    conformity with such packaging and labeling requirements applicable
    to such color additive, as may be contained in regulations issued
    under section 379e of this title.
    (n) Prescription drug advertisements: established name;
      quantitative formula; side effects, contraindications, and
      effectiveness; prior approval; false advertising; labeling;
      construction of the Convention on Psychotropic Substances
      In the case of any prescription drug distributed or offered for
    sale in any State, unless the manufacturer, packer, or distributor
    thereof includes in all advertisements and other descriptive
    printed matter issued or caused to be issued by the manufacturer,
    packer, or distributor with respect to that drug a true statement
    of (1) the established name as defined in paragraph (e) of this
    section, printed prominently and in type at least half as large as
    that used for any trade or brand name thereof, (2) the formula
    showing quantitatively each ingredient of such drug to the extent
    required for labels under paragraph (e) of this section, and (3)
    such other information in brief summary relating to side effects,
    contraindications, and effectiveness as shall be required in
    regulations which shall be issued by the Secretary in accordance
    with the procedure specified in section 371(e) of this title,
    except that (A) except in extraordinary circumstances, no
    regulation issued under this paragraph shall require prior approval
    by the Secretary of the content of any advertisement, and (B) no
    advertisement of a prescription drug, published after the effective
    date of regulations issued under this paragraph applicable to
    advertisements of prescription drugs, shall with respect to the
    matters specified in this paragraph or covered by such regulations,
    be subject to the provisions of sections 52 to 57 of title 15. This
    paragraph (n) shall not be applicable to any printed matter which
    the Secretary determines to be labeling as defined in section
    321(m) of this title. Nothing in the Convention on Psychotropic
    Substances, signed at Vienna, Austria, on February 21, 1971, shall
    be construed to prevent drug price communications to consumers.
    (o) Drugs or devices from nonregistered establishments
      If it was manufactured, prepared, propagated, compounded, or
    processed in an establishment in any State not duly registered
    under section 360 of this title, if it was not included in a list
    required by section 360(j) of this title, if a notice or other
    information respecting it was not provided as required by such
    section or section 360(k) of this title, or if it does not bear
    such symbols from the uniform system for identification of devices
    prescribed under section 360(e) of this title as the Secretary by
    regulation requires.
    (p) Packaging or labeling of drugs in violation of regulations
      If it is a drug and its packaging or labeling is in violation of
    an applicable regulation issued pursuant to section 1472 or 1473 of
    title 15.
    (q) Restricted devices using false or misleading advertising or
      used in violation of regulations
      In the case of any restricted device distributed or offered for
    sale in any State, if (1) its advertising is false or misleading in
    any particular, or (2) it is sold, distributed, or used in
    violation of regulations prescribed under section 360j(e) of this
    title.
    (r) Restricted devices not carrying requisite accompanying
      statements in advertisements and other descriptive printed matter
      In the case of any restricted device distributed or offered for
    sale in any State, unless the manufacturer, packer, or distributor
    thereof includes in all advertisements and other descriptive
    printed matter issued or caused to be issued by the manufacturer,
    packer, or distributor with respect to that device (1) a true
    statement of the device's established name as defined in subsection
    (e) of this section, printed prominently and in type at least half
    as large as that used for any trade or brand name thereof, and (2)
    a brief statement of the intended uses of the device and relevant
    warnings, precautions, side effects, and contraindications and, in
    the case of specific devices made subject to a finding by the
    Secretary after notice and opportunity for comment that such action
    is necessary to protect the public health, a full description of
    the components of such device or the formula showing quantitatively
    each ingredient of such device to the extent required in
    regulations which shall be issued by the Secretary after an
    opportunity for a hearing. Except in extraordinary circumstances,
    no regulation issued under this paragraph shall require prior
    approval by the Secretary of the content of any advertisement and
    no advertisement of a restricted device, published after the
    effective date of this paragraph shall, with respect to the matters
    specified in this paragraph or covered by regulations issued
    hereunder, be subject to the provisions of sections 52 through 55
    of title 15. This paragraph shall not be applicable to any printed
    matter which the Secretary determines to be labeling as defined in
    section 321(m) of this title.
    (s) Devices subject to performance standards not bearing requisite
      labeling
      If it is a device subject to a performance standard established
    under section 360d of this title, unless it bears such labeling as
    may be prescribed in such performance standard.
    (t) Devices for which there has been a failure or refusal to give
      required notification or to furnish required material or
      information
      If it is a device and there was a failure or refusal (1) to
    comply with any requirement prescribed under section 360h of this
    title respecting the device, (2) to furnish any material or
    information required by or under section 360i of this title
    respecting the device, or (3) to comply with a requirement under
    section 360l of this title.
    (u) Identification of manufacturer
      (1) Subject to paragraph (2), if it is a reprocessed single-use
    device, unless it, or an attachment thereto, prominently and
    conspicuously bears the name of the manufacturer of the reprocessed
    device, a generally recognized abbreviation of such name, or a
    unique and generally recognized symbol identifying such
    manufacturer.
      (2) If the original device or an attachment thereto does not
    prominently and conspicuously bear the name of the manufacturer of
    the original device, a generally recognized abbreviation of such
    name, or a unique and generally recognized symbol identifying such
    manufacturer, a reprocessed device may satisfy the requirements of
    paragraph (1) through the use of a detachable label on the
    packaging that identifies the manufacturer and is intended to be
    affixed to the medical record of a patient.
    (v) Reprocessed single-use devices
      If it is a reprocessed single-use device, unless all labeling of
    the device prominently and conspicuously bears the statement
    "Reprocessed device for single use. Reprocessed by __." The name of
    the manufacturer of the reprocessed device shall be placed in the
    space identifying the person responsible for reprocessing.
    (w) New animal drugs
      If it is a new animal drug - 
        (1) that is conditionally approved under section 360ccc of this
      title and its labeling does not conform with the approved
      application or section 360ccc(f) of this title, or that is not
      conditionally approved under section 360ccc of this title and its
      label bears the statement set forth in section 360ccc(f)(1)(A) of
      this title; or
        (2) that is indexed under section 360ccc-1 of this title and
      its labeling does not conform with the index listing under
      section 360ccc-1(e) of this title or 360ccc-1(h) of this title,
      or that has not been indexed under section 360ccc-1 of this title
      and its label bears the statement set forth in section 360ccc-
      1(h) of this title.
    (x) Nonprescription drugs
      If it is a nonprescription drug (as defined in section 379aa of
    this title) that is marketed in the United States, unless the label
    of such drug includes a domestic address or domestic phone number
    through which the responsible person (as described in section 379aa
    of this title) may receive a report of a serious adverse event (as
    defined in section 379aa of this title) with such drug.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 502, 52 Stat. 1050; June 23, 1939,
    ch. 242, Sec. 3, 53 Stat. 854; Dec. 22, 1941, ch. 613, Sec. 2, 55
    Stat. 851; July 6, 1945, ch. 281, Sec. 2, 59 Stat. 463; Mar. 10,
    1947, ch. 16, Sec. 2, 61 Stat. 11; July 13, 1949, ch. 305, Sec. 1,
    63 Stat. 409; Aug. 5, 1953, ch. 334, Sec. 1, 67 Stat. 389; Pub. L.
    86-618, title I, Sec. 102(b)(2), July 12, 1960, 74 Stat. 398; Pub.
    L. 87-781, title I, Secs. 105(c), 112(a), (b), 131(a), title III,
    Sec. 305, Oct. 10, 1962, 76 Stat. 785, 790, 791, 795; Pub. L. 90-
    399, Sec. 105(a), July 13, 1968, 82 Stat. 352; Pub. L. 91-601,
    Sec. 6(d), formerly Sec. 7(d), Dec. 30, 1970, 84 Stat. 1673,
    renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,
    95 Stat. 716; Pub. L. 94-295, Secs. 3(e), 4(b)(2), 5(a), 9(b)(2),
    May 28, 1976, 90 Stat. 577, 580, 583; Pub. L. 95-633, title I, Sec.
    111, Nov. 10, 1978, 92 Stat. 3773; Pub. L. 102-300, Sec. 3(a)(2),
    June 16, 1992, 106 Stat. 239; Pub. L. 102-571, title I, Sec.
    107(9), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(m),
    Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
    114(a), 125(a)(2)(B), (b)(2)(D), 126(b), title IV, Sec. 412(c),
    Nov. 21, 1997, 111 Stat. 2312, 2325, 2327, 2375; Pub. L. 107-250,
    title II, Sec. 206, title III, Secs. 301(a), 302(a)(1), Oct. 26,
    2002, 116 Stat. 1613, 1616; Pub. L. 108-214, Sec. 2(b)(2)(B), Apr.
    1, 2004, 118 Stat. 575; Pub. L. 108-282, title I, Sec.
    102(b)(5)(E), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109-43, Sec.
    2(c)(1), Aug. 1, 2005, 119 Stat. 441; Pub. L. 109-462, Sec. 2(d),
    Dec. 22, 2006, 120 Stat. 3472.)


-MISC1-
                                AMENDMENTS                            
      2006 - Par. (x). Pub. L. 109-462 added par. (x).
      2005 - Par. (u). Pub. L. 109-43 amended par. (u) generally. Prior
    to amendment, par. (u) read as follows: "If it is a device, unless
    it, or an attachment thereto, prominently and conspicuously bears
    the name of the manufacturer of the device, a generally recognized
    abbreviation of such name, or a unique and generally recognized
    symbol identifying such manufacturer, except that the Secretary may
    waive any requirement under this paragraph for the device if the
    Secretary determines that compliance with the requirement is not
    feasible for the device or would compromise the provision of
    reasonable assurance of the safety or effectiveness of the device."
      2004 - Par. (f). Pub. L. 108-214, in last sentence, inserted "or
    by a health care professional and required labeling for in vitro
    diagnostic devices intended for use by health care professionals or
    in blood establishments" after "in health care facilities",
    inserted comma after "means", substituted "requirements of law, and
    that the manufacturer affords such users the opportunity" for
    "requirements of law and, that the manufacturer affords health care
    facilities the opportunity", and struck out "the health care
    facility" after "promptly provides".
      Par. (w). Pub. L. 108-282 added par. (w).
      2002 - Par. (f). Pub. L. 107-250, Sec. 206, inserted at end
    "Required labeling for prescription devices intended for use in
    health care facilities may be made available solely by electronic
    means provided that the labeling complies with all applicable
    requirements of law and, that the manufacturer affords health care
    facilities the opportunity to request the labeling in paper form,
    and after such request, promptly provides the health care facility
    the requested information without additional cost."
      Par. (u). Pub. L. 107-250, Sec. 301(a), which directed amendment
    of section by adding par. (u) at end, was executed by adding par.
    (u) before par. (v) to reflect the probable intent of Congress.
      Par. (v). Pub. L. 107-250, Sec. 302(a)(1), added par. (v).
      1997 - Par. (a). Pub. L. 105-115, Sec. 114(a), inserted at end
    "Health care economic information provided to a formulary
    committee, or other similar entity, in the course of the committee
    or the entity carrying out its responsibilities for the selection
    of drugs for managed care or other similar organizations, shall not
    be considered to be false or misleading under this paragraph if the
    health care economic information directly relates to an indication
    approved under section 355 of this title or under section 262(a) of
    title 42 for such drug and is based on competent and reliable
    scientific evidence. The requirements set forth in section 355(a)
    of this title or in section 262(a) of title 42 shall not apply to
    health care economic information provided to such a committee or
    entity in accordance with this paragraph. Information that is
    relevant to the substantiation of the health care economic
    information presented pursuant to this paragraph shall be made
    available to the Secretary upon request. In this paragraph, the
    term 'health care economic information' means any analysis that
    identifies, measures, or compares the economic consequences,
    including the costs of the represented health outcomes, of the use
    of a drug to the use of another drug, to another health care
    intervention, or to no intervention."
      Par. (d). Pub. L. 105-115, Sec. 126(b), struck out par. (d) which
    read as follows: "If it is for use by man and contains any quantity
    of the narcotic or hypnotic substance alpha eucaine, barbituric
    acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca,
    cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde,
    peyote, or sulphonmethane; or any chemical derivative of such
    substance, which derivative has been by the Secretary, after
    investigation, found to be, and by regulations designated as, habit
    forming; unless its label bears the name and quantity or proportion
    of such substance or derivative and in juxtaposition therewith the
    statement 'Warning - May be habit forming.' "
      Par. (e)(1). Pub. L. 105-115, Sec. 412(c), amended subpar. (1)
    generally. Prior to amendment, subpar. (1) read as follows: "If it
    is a drug, unless (A) its label bears, to the exclusion of any
    other nonproprietary name (except the applicable systematic
    chemical name or the chemical formula), (i) the established name
    (as defined in subparagraph (3)) of the drug, if such there be, and
    (ii), in case it is fabricated from two or more ingredients, the
    established name and quantity of each active ingredient, including
    the quantity, kind, and proportion of any alcohol, and also
    including, whether active or not, the established name and quantity
    or proportion of any bromides, ether, chloroform, acetanilid,
    acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine,
    hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury
    ouabain strophanthin, strychnine, thyroid, or any derivative or
    preparation of any such substances, contained therein; Provided,
    That the requirement for stating the quantity of the active
    ingredients, other than the quantity of those specifically named in
    this paragraph, shall apply only to prescription drugs; and (B) for
    any prescription drug the established name of such drug or
    ingredient, as the case may be, on such label (and on any labeling
    on which a name for such drug or ingredient is used) is printed
    prominently and in type at least half as large as that used thereon
    for any proprietary name or designation for such drug or
    ingredient: Provided, That to the extent that compliance with the
    requirements of clause (A)(ii) or clause (B) of this subparagraph
    is impracticable, exemptions shall be established by regulations
    promulgated by the Secretary."
      Par. (k). Pub. L. 105-115, Sec. 125(a)(2)(B), struck out par. (k)
    which read as follows: "If it is, or purports to be, or is
    represented as a drug composed wholly or partly of insulin, unless
    (1) it is from a batch with respect to which a certificate or
    release has been issued pursuant to section 356 of this title, and
    (2) such certificate or release is in effect with respect to such
    drug."
      Par. (l). Pub. L. 105-115, Sec. 125(b)(2)(D), struck out par. (l)
    which read as follows: "If it is, or purports to be, or is
    represented as a drug (except a drug for use in animals other than
    man) composed wholly or partly of any kind of penicillin,
    streptomycin, chlortetracycline, chloramphenicol, bacitracin, or
    any other antibiotic drug, or any derivative thereof, unless (1) it
    is from a batch with respect to which a certificate or release has
    been issued pursuant to section 357 of this title, and (2) such
    certificate or release is in effect with respect to such drug:
    Provided, That this paragraph shall not apply to any drug or class
    of drugs exempted by regulations promulgated under section 357(c)
    or (d) of this title."
      1993 - Par. (e)(3). Pub. L. 103-80, Sec. 3(m)(1), substituted "of
    such ingredient, except that" for "of such ingredient: Provided,
    That".
      Par. (f). Pub. L. 103-80, Sec. 3(m)(2), substituted "users,
    except that where" for "users: Provided, That where".
      Par. (g). Pub. L. 103-80, Sec. 3(m)(3), substituted "prescribed
    therein. The method" for "prescribed therein: Provided, That the
    method" and "Pharmacopoeia, except that" for "Pharmacopoeia:
    Provided further, That,".
      Par. (n). Pub. L. 103-80, Sec. 3(m)(4), substituted ", except
    that (A)" for ": Provided, That (A)".
      1992 - Par. (m). Pub. L. 102-571 substituted "379e" for "376".
      Par. (t)(3). Pub. L. 102-300 added cl. (3).
      1978 - Par. (n). Pub. L. 95-633 inserted provision relating to
    the construction of the Convention on Psychotropic Substances.
      1976 - Par. (e). Pub. L. 94-295, Sec. 5(a), substituted
    "subparagraph (3)" for "subparagraph (2)" in subpar. (1), added
    subpar. (2), redesignated former subpar. (2) as (3) and in subpar.
    (3) as so redesignated substituted "subparagraph (1)" for "this
    paragraph (e)", and added subpar. (4).
      Par. (j). Pub. L. 94-295, Sec. 3(e)(2), substituted "dosage or
    manner," for "dosage,".
      Par. (m). Pub. L. 94-295, Sec. 9(b)(2), substituted "the intended
    use of which is for" for "the intended use of which in or on drugs
    is for".
      Par. (o). Pub. L. 94-295, Sec. 4(b)(2), substituted "If it was
    manufactured" for "If it is a drug and was manufactured" and
    inserted ", if it was not included in a list required by section
    360(j) of this title, if a notice or other information respecting
    it was not provided as required by such section or section 360(k)
    of this title, or if it does not bear such symbols from the uniform
    system for identification of devices prescribed under section
    360(e) of this title as the Secretary by regulation requires".
      Pars. (q) to (t). Pub. L. 94-295, Sec. 3(e)(1), added pars. (q)
    to (t).
      1970 - Par. (p). Pub. L. 91-601 added par. (p).
      1968 - Par. (l). Pub. L. 90-399 inserted "(except a drug for use
    in animals other than man)" after "represented as a drug".
      1962 - Par. (e). Pub. L. 87-781, Sec. 112(a), designated existing
    provisions as subpar. (1), substituted ", unless (A) its label
    bears, to the exclusion of any other nonproprietary name (except
    the applicable systematic chemical name or the chemical formula),
    (i) the established name (as defined in subparagraph (2) of this
    subsection) of the drug, if such there be, and (ii), in case it is
    fabricated from two or more ingredients, the established name and
    quantity" for "and is not designated solely by a name recognized in
    an official compendium unless its label bears (1) the common or
    usual name of the drug, if such there be; and (2), in case it is
    fabricated from two or more ingredients, the common or usual name",
    and "the established name" for "the name", provided that the
    requirement for stating the quantity of active ingredients, other
    than those specified in this par., applies only to prescription
    drugs, and that the established name of a drug on a label is to be
    printed prominently and in type at least half as large as used for
    any proprietary designation, and added subpar. (2) defining
    "established name".
      Par. (g). Pub. L. 87-781, Sec. 112(b), provided that if there is
    an inconsistency between the provisions of this par. and those of
    par. (e), as to the name of a drug, the requirements of par. (e)
    should prevail.
      Par. (l). Pub. L. 87-781, Sec. 105(c), substituted "bacitracin,
    or any other antibiotic drug" for "or bacitracin."
      Par. (n). Pub. L. 87-781, Sec. 131(a), added par. (n).
      Par. (o). Pub. L. 87-781, Sec. 305, added par. (o).
      1960 - Par. (m). Pub. L. 86-618 added par. (m).
      1953 - Par. (l). Act Aug. 5, 1953, substituted
    "chlortetracycline" for "aureomycin".
      1949 - Par. (l). Act July 13, 1949, inserted ", aureomycin,
    chloramphenicol, or bacitracin" after "streptomycin".
      1947 - Par. (l). Act Mar. 10, 1947, inserted "or streptomycin"
    after "penicillin".
      1945 - Par. (l). Act July 6, 1945, added par. (l).
      1941 - Par. (k). Act Dec. 22, 1941, added par. (k).
      1939 - Par. (d). Act June 29, 1939, substituted "name, and
    quality or proportion" for "name, quantity, and percentage".

                     EFFECTIVE DATES OF 2006 AMENDMENT                 
      Pub. L. 109-462, Sec. 2(e)(1), (2), Dec. 22, 2006, 120 Stat.
    3472, provided that:
      "(1) In general. - Except as provided in paragraph (2), the
    amendments made by this section [enacting section 379aa of this
    title and amending this section and section 331 of this title]
    shall take effect 1 year after the date of enactment of this Act
    [Dec. 22, 2006].
      "(2) Misbranding. - Section 502(x) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 352(x)] (as added by this section) shall
    apply to any nonprescription drug (as defined in such section
    502(x)) labeled on or after the date that is 1 year after the date
    of enactment of this Act [Dec. 22, 2006]."

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-250, title III, Sec. 301(b), Oct. 26, 2002, 116 Stat.
    1616, as amended by Pub. L. 108-214, Sec. 2(c)(1), Apr. 1, 2004,
    118 Stat. 575; Pub. L. 109-43, Sec. 2(d), Aug. 1, 2005, 119 Stat.
    441, provided that: "Section 502(u) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 352(u)] (as amended by section 2(c) of the
    Medical Device User Fee Stabilization Act of 2005 [Pub. L. 109-43])
    - 
        "(1) shall be effective - 
          "(A) with respect to devices described under paragraph (1) of
        such section, 12 months after the date of enactment of the
        Medical Device User Fee Stabilization Act of 2005 [Aug. 1,
        2005], or the date on which the original device first bears the
        name of the manufacturer of the original device, a generally
        recognized abbreviation of such name, or a unique and generally
        recognized symbol identifying such manufacturer, whichever is
        later; and
          "(B) with respect to devices described under paragraph (2) of
        such section 502(u), 12 months after such date of enactment;
        and
        "(2) shall apply only to devices reprocessed and introduced or
      delivered for introduction in interstate commerce after such
      applicable effective date."
      Pub. L. 107-250, title III, Sec. 302(a)(2), Oct. 26, 2002, 116
    Stat. 1616, provided that: "The amendment made by paragraph (1)
    [amending this section] takes effect 15 months after the date of
    the enactment of this Act [Oct. 26, 2002], and only applies to
    devices introduced or delivered for introduction into interstate
    commerce after such effective date."

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by sections 114(a), 126(b), and 412(c) of Pub. L. 105-
    115 effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.

                     EFFECTIVE DATE OF 1978 AMENDMENT                 
      Amendment by Pub. L. 95-633 effective on date the Convention on
    Psychotropic Substances enters into force in the United States
    [July 15, 1980], see section 112 of Pub. L. 95-633, set out as an
    Effective Date note under section 801a of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Section 112(c) of Pub. L. 87-781 provided that: "This section
    [amending this section] shall take effect on the first day of the
    seventh calendar month following the month in which this Act is
    enacted [October 1962]."
      Section 131(b) of Pub. L. 87-781 provided that: "No drug which
    was being commercially distributed prior to the date of enactment
    of this Act [Oct. 10, 1962] shall be deemed to be misbranded under
    paragraph (n) of section 502 of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 352(n)], as added by this section, until
    the earlier of the following dates: (1) the first day of the
    seventh month following the month in which this Act is enacted; or
    (2) the effective date of regulations first issued under clause (3)
    of such paragraph (n) in accordance with the procedure specified in
    section 701(e) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 371(e)]."
      Amendment by Pub. L. 87-781 effective on first day of seventh
    calendar month following October 1962, see section 107 of Pub. L.
    87-781, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Pars. (b) and (d) to (h) effective Jan. 1, 1940, and such
    paragraphs effective July 1, 1940, as provided by regulations for
    certain lithographed labeling and containers bearing certain
    labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
    an Effective Date: Postponement in Certain Cases note under section
    301 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
                       GUIDANCE; MISBRANDED DEVICES                   
      Pub. L. 109-43, Sec. 2(c)(2), Aug. 1, 2005, 119 Stat. 441,
    provided that: "Not later than 180 days after the date of enactment
    of this Act [Aug. 1, 2005], the Secretary of Health and Human
    Services shall issue guidance to identify circumstances in which
    the name of the manufacturer of the original device, a generally
    recognized abbreviation of such name, or a unique and generally
    recognized symbol identifying such manufacturer, is not 'prominent
    and conspicuous', as used in section 502(u) of Federal Food, Drug,
    and Cosmetic Act [21 U.S.C. 352(u)] (as amended by paragraph (1))."

    STUDY ON MAKING PRESCRIPTION PHARMACEUTICAL INFORMATION ACCESSIBLE
                FOR BLIND AND VISUALLY-IMPAIRED INDIVIDUALS
      Pub. L. 108-173, title I, Sec. 107(f), Dec. 8, 2003, 117 Stat.
    2171, directed the Secretary of Health and Human Services to
    undertake a study of how to make prescription pharmaceutical
    information, including drug labels and usage instructions,
    accessible to blind and visually-impaired individuals, and to
    submit a report to Congress not later than 18 months after Dec. 8,
    2003.

                             STUDY AND REPORT                         
      Section 114(b) of Pub. L. 105-115 provided that: "The Comptroller
    General of the United States shall conduct a study of the
    implementation of the provisions added by the amendment made by
    subsection (a) [amending this section]. Not later than 4 years and
    6 months after the date of enactment of this Act [Nov. 21, 1997],
    the Comptroller General of the United States shall prepare and
    submit to Congress a report containing the findings of the study."

    COUNTERFEITING OF DRUGS; CONGRESSIONAL FINDINGS AND DECLARATION OF
                                  POLICY
      Section 9(a) of Pub. L. 89-74, July 15, 1965, 79 Stat. 234,
    provided that: "The Congress finds and declares that there is a
    substantial traffic in counterfeit drugs simulating the brand or
    other identifying mark or device of the manufacturer of the genuine
    article; that such traffic poses a serious hazard to the health of
    innocent consumers of such drugs because of the lack of proper
    qualifications, facilities, and manufacturing controls on the part
    of the counterfeiter, whose operations are clandestine; that, while
    such drugs are deemed misbranded within the meaning of section
    502(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    352(i)], the controls for the suppression of the traffic in such
    drugs are inadequate because of the difficulty of determining the
    place of interstate origin of such drugs and, if that place is
    discovered, the fact that the implements for counterfeiting are not
    subject to seizure, and that these factors require enactment of
    additional controls with respect to such drugs without regard to
    their interstate or intrastate origins."
      Provisions as effective Feb. 1, 1966, see section 11 of Pub. L.
    89-74, set out as an Effective Date of 1965 Amendment note under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 353                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 353. Exemptions and consideration for certain drugs, devices,
      and biological products

-STATUTE-
    (a) Regulations for goods to be processed, labeled, or repacked
      elsewhere
      The Secretary is directed to promulgate regulations exempting
    from any labeling or packaging requirement of this chapter drugs
    and devices which are, in accordance with the practice of the
    trade, to be processed, labeled, or repacked in substantial
    quantities at establishments other than those where originally
    processed or packed, on condition that such drugs and devices are
    not adulterated or misbranded under the provisions of this chapter
    upon removal from such processing, labeling, or repacking
    establishment.
    (b) Prescription by physician; exemption from labeling and
      prescription requirements; misbranded drugs; compliance with
      narcotic and marihuana laws
      (1) A drug intended for use by man which - 
        (A) because of its toxicity or other potentiality for harmful
      effect, or the method of its use, or the collateral measures
      necessary to its use, is not safe for use except under the
      supervision of a practitioner licensed by law to administer such
      drug; or
        (B) is limited by an approved application under section 355 of
      this title to use under the professional supervision of a
      practitioner licensed by law to administer such drug;

    shall be dispensed only (i) upon a written prescription of a
    practitioner licensed by law to administer such drug, or (ii) upon
    an oral prescription of such practitioner which is reduced promptly
    to writing and filed by the pharmacist, or (iii) by refilling any
    such written or oral prescription if such refilling is authorized
    by the prescriber either in the original prescription or by oral
    order which is reduced promptly to writing and filed by the
    pharmacist. The act of dispensing a drug contrary to the provisions
    of this paragraph shall be deemed to be an act which results in the
    drug being misbranded while held for sale.
      (2) Any drug dispensed by filling or refilling a written or oral
    prescription of a practitioner licensed by law to administer such
    drug shall be exempt from the requirements of section 352 of this
    title, except paragraphs (a), (i)(2) and (3), (k), and (l), and the
    packaging requirements of paragraphs (g), (h), and (p), if the drug
    bears a label containing the name and address of the dispenser, the
    serial number and date of the prescription or of its filling, the
    name of the prescriber, and, if stated in the prescription, the
    name of the patient, and the directions for use and cautionary
    statements, if any, contained in such prescription. This exemption
    shall not apply to any drug dispensed in the course of the conduct
    of a business of dispensing drugs pursuant to diagnosis by mail, or
    to a drug dispensed in violation of paragraph (1) of this
    subsection.
      (3) The Secretary may by regulation remove drugs subject to
    section 355 of this title from the requirements of paragraph (1) of
    this subsection when such requirements are not necessary for the
    protection of the public health.
      (4)(A) A drug that is subject to paragraph (1) shall be deemed to
    be misbranded if at any time prior to dispensing the label of the
    drug fails to bear, at a minimum, the symbol "Rx only".
      (B) A drug to which paragraph (1) does not apply shall be deemed
    to be misbranded if at any time prior to dispensing the label of
    the drug bears the symbol described in subparagraph (A).
      (5) Nothing in this subsection shall be construed to relieve any
    person from any requirement prescribed by or under authority of law
    with respect to drugs now included or which may hereafter be
    included within the classifications stated in sections 4721, 6001,
    and 6151 of title 26, or to marihuana as defined in section 4761 of
    title 26.
    (c) Sales restrictions
      (1) No person may sell, purchase, or trade or offer to sell,
    purchase, or trade any drug sample. For purposes of this paragraph
    and subsection (d) of this section, the term "drug sample" means a
    unit of a drug, subject to subsection (b) of this section, which is
    not intended to be sold and is intended to promote the sale of the
    drug. Nothing in this paragraph shall subject an officer or
    executive of a drug manufacturer or distributor to criminal
    liability solely because of a sale, purchase, trade, or offer to
    sell, purchase, or trade in violation of this paragraph by other
    employees of the manufacturer or distributor.
      (2) No person may sell, purchase, or trade, offer to sell,
    purchase, or trade, or counterfeit any coupon. For purposes of this
    paragraph, the term "coupon" means a form which may be redeemed, at
    no cost or at a reduced cost, for a drug which is prescribed in
    accordance with subsection (b) of this section.
      (3)(A) No person may sell, purchase, or trade, or offer to sell,
    purchase, or trade, any drug - 
        (i) which is subject to subsection (b) of this section, and
        (ii)(I) which was purchased by a public or private hospital or
      other health care entity, or
        (II) which was donated or supplied at a reduced price to a
      charitable organization described in section 501(c)(3) of title
      26.

      (B) Subparagraph (A) does not apply to - 
        (i) the purchase or other acquisition by a hospital or other
      health care entity which is a member of a group purchasing
      organization of a drug for its own use from the group purchasing
      organization or from other hospitals or health care entities
      which are members of such organization,
        (ii) the sale, purchase, or trade of a drug or an offer to
      sell, purchase, or trade a drug by an organization described in
      subparagraph (A)(ii)(II) to a nonprofit affiliate of the
      organization to the extent otherwise permitted by law,
        (iii) a sale, purchase, or trade of a drug or an offer to sell,
      purchase, or trade a drug among hospitals or other health care
      entities which are under common control,
        (iv) a sale, purchase, or trade of a drug or an offer to sell,
      purchase, or trade a drug for emergency medical reasons, or
        (v) a sale, purchase, or trade of a drug, an offer to sell,
      purchase, or trade a drug, or the dispensing of a drug pursuant
      to a prescription executed in accordance with subsection (b) of
      this section.

    For purposes of this paragraph, the term "entity" does not include
    a wholesale distributor of drugs or a retail pharmacy licensed
    under State law and the term "emergency medical reasons" includes
    transfers of a drug between health care entities or from a health
    care entity to a retail pharmacy undertaken to alleviate temporary
    shortages of the drug arising from delays in or interruptions of
    regular distribution schedules.
    (d) Distribution of drug samples
      (1) Except as provided in paragraphs (2) and (3), no person may
    distribute any drug sample. For purposes of this subsection, the
    term "distribute" does not include the providing of a drug sample
    to a patient by a - 
        (A) practitioner licensed to prescribe such drug,
        (B) health care professional acting at the direction and under
      the supervision of such a practitioner, or
        (C) pharmacy of a hospital or of another health care entity
      that is acting at the direction of such a practitioner and that
      received such sample pursuant to paragraph (2) or (3).

      (2)(A) The manufacturer or authorized distributor of record of a
    drug subject to subsection (b) of this section may, in accordance
    with this paragraph, distribute drug samples by mail or common
    carrier to practitioners licensed to prescribe such drugs or, at
    the request of a licensed practitioner, to pharmacies of hospitals
    or other health care entities. Such a distribution of drug samples
    may only be made - 
        (i) in response to a written request for drug samples made on a
      form which meets the requirements of subparagraph (B), and
        (ii) under a system which requires the recipient of the drug
      sample to execute a written receipt for the drug sample upon its
      delivery and the return of the receipt to the manufacturer or
      authorized distributor of record.

      (B) A written request for a drug sample required by subparagraph
    (A)(i) shall contain - 
        (i) the name, address, professional designation, and signature
      of the practitioner making the request,
        (ii) the identity of the drug sample requested and the quantity
      requested,
        (iii) the name of the manufacturer of the drug sample
      requested, and
        (iv) the date of the request.

      (C) Each drug manufacturer or authorized distributor of record
    which makes distributions by mail or common carrier under this
    paragraph shall maintain, for a period of 3 years, the request
    forms submitted for such distributions and the receipts submitted
    for such distributions and shall maintain a record of distributions
    of drug samples which identifies the drugs distributed and the
    recipients of the distributions. Forms, receipts, and records
    required to be maintained under this subparagraph shall be made
    available by the drug manufacturer or authorized distributor of
    record to Federal and State officials engaged in the regulation of
    drugs and in the enforcement of laws applicable to drugs.
      (3) The manufacturer or authorized distributor of record of a
    drug subject to subsection (b) of this section may, by means other
    than mail or common carrier, distribute drug samples only if the
    manufacturer or authorized distributor of record makes the
    distributions in accordance with subparagraph (A) and carries out
    the activities described in subparagraphs (B) through (F) as
    follows:
        (A) Drug samples may only be distributed - 
          (i) to practitioners licensed to prescribe such drugs if they
        make a written request for the drug samples, or
          (ii) at the written request of such a licensed practitioner,
        to pharmacies of hospitals or other health care entities.

      A written request for drug samples shall be made on a form which
      contains the practitioner's name, address, and professional
      designation, the identity of the drug sample requested, the
      quantity of drug samples requested, the name of the manufacturer
      or authorized distributor of record of the drug sample, the date
      of the request and signature of the practitioner making the
      request.
        (B) Drug manufacturers or authorized distributors of record
      shall store drug samples under conditions that will maintain
      their stability, integrity, and effectiveness and will assure
      that the drug samples will be free of contamination,
      deterioration, and adulteration.
        (C) Drug manufacturers or authorized distributors of record
      shall conduct, at least annually, a complete and accurate
      inventory of all drug samples in the possession of
      representatives of the manufacturer or authorized distributor of
      record. Drug manufacturers or authorized distributors of record
      shall maintain lists of the names and address of each of their
      representatives who distribute drug samples and of the sites
      where drug samples are stored. Drug manufacturers or authorized
      distributors of record shall maintain records for at least 3
      years of all drug samples distributed, destroyed, or returned to
      the manufacturer or authorized distributor of record, of all
      inventories maintained under this subparagraph, of all thefts or
      significant losses of drug samples, and of all requests made
      under subparagraph (A) for drug samples. Records and lists
      maintained under this subparagraph shall be made available by the
      drug manufacturer or authorized distributor of record to the
      Secretary upon request.
        (D) Drug manufacturers or authorized distributors of record
      shall notify the Secretary of any significant loss of drug
      samples and any known theft of drug samples.
        (E) Drug manufacturers or authorized distributors of record
      shall report to the Secretary any conviction of their
      representatives for violations of subsection (c)(1) of this
      section or a State law because of the sale, purchase, or trade of
      a drug sample or the offer to sell, purchase, or trade a drug
      sample.
        (F) Drug manufacturers or authorized distributors of record
      shall provide to the Secretary the name and telephone number of
      the individual responsible for responding to a request for
      information respecting drug samples.
    (e) Wholesale distributors; guidelines for licensing; definitions
      (1)(A) Each person who is engaged in the wholesale distribution
    of a drug subject to subsection (b) of this section and who is not
    the manufacturer or an authorized distributor of record of such
    drug shall, before each wholesale distribution of such drug
    (including each distribution to an authorized distributor of record
    or to a retail pharmacy), provide to the person who receives the
    drug a statement (in such form and containing such information as
    the Secretary may require) identifying each prior sale, purchase,
    or trade of such drug (including the date of the transaction and
    the names and addresses of all parties to the transaction).
      (B) Each manufacturer of a drug subject to subsection (b) of this
    section shall maintain at its corporate offices a current list of
    the authorized distributors of record of such drug.
      (2)(A) No person may engage in the wholesale distribution in
    interstate commerce of drugs subject to subsection (b) of this
    section in a State unless such person is licensed by the State in
    accordance with the guidelines issued under subparagraph (B).
      (B) The Secretary shall by regulation issue guidelines
    establishing minimum standards, terms, and conditions for the
    licensing of persons to make wholesale distributions in interstate
    commerce of drugs subject to subsection (b) of this section. Such
    guidelines shall prescribe requirements for the storage and
    handling of such drugs and for the establishment and maintenance of
    records of the distributions of such drugs.
      (3) For the purposes of this subsection and subsection (d) of
    this section - 
        (A) the term "authorized distributors of record" means those
      distributors with whom a manufacturer has established an ongoing
      relationship to distribute such manufacturer's products, and
        (B) the term "wholesale distribution" means distribution of
      drugs subject to subsection (b) of this section to other than the
      consumer or patient but does not include intracompany sales and
      does not include distributions of drugs described in subsection
      (c)(3)(B) of this section.
    (f) Veterinary prescription drugs
      (1)(A) A drug intended for use by animals other than man, other
    than a veterinary feed directive drug intended for use in animal
    feed or an animal feed bearing or containing a veterinary feed
    directive drug, which - 
        (i) because of its toxicity or other potentiality for harmful
      effect, or the method of its use, or the collateral measures
      necessary for its use, is not safe for animal use except under
      the professional supervision of a licensed veterinarian, or
        (ii) is limited by an approved application under subsection (b)
      of section 360b of this title, a conditionally-approved
      application under section 360ccc of this title, or an index
      listing under section 360ccc-1 of this title to use under the
      professional supervision of a licensed veterinarian,

    shall be dispensed only by or upon the lawful written or oral order
    of a licensed veterinarian in the course of the veterinarian's
    professional practice.
      (B) For purposes of subparagraph (A), an order is lawful if the
    order - 
        (i) is a prescription or other order authorized by law,
        (ii) is, if an oral order, promptly reduced to writing by the
      person lawfully filling the order, and filed by that person, and
        (iii) is refilled only if authorized in the original order or
      in a subsequent oral order promptly reduced to writing by the
      person lawfully filling the order, and filed by that person.

      (C) The act of dispensing a drug contrary to the provisions of
    this paragraph shall be deemed to be an act which results in the
    drug being misbranded while held for sale.
      (2) Any drug when dispensed in accordance with paragraph (1) of
    this subsection - 
        (A) shall be exempt from the requirements of section 352 of
      this title, except subsections (a), (g), (h), (i)(2), (i)(3), and
      (p) of such section, and
        (B) shall be exempt from the packaging requirements of
      subsections (g), (h), and (p) of such section, if - 
          (i) when dispensed by a licensed veterinarian, the drug bears
        a label containing the name and address of the practitioner and
        any directions for use and cautionary statements specified by
        the practitioner, or
          (ii) when dispensed by filling the lawful order of a licensed
        veterinarian, the drug bears a label containing the name and
        address of the dispenser, the serial number and date of the
        order or of its filling, the name of the licensed veterinarian,
        and the directions for use and cautionary statements, if any,
        contained in such order.

    The preceding sentence shall not apply to any drug dispensed in the
    course of the conduct of a business of dispensing drugs pursuant to
    diagnosis by mail.
      (3) The Secretary may by regulation exempt drugs for animals
    other than man subject to section 360b, 360ccc, or 360ccc-1 of this
    title from the requirements of paragraph (1) when such requirements
    are not necessary for the protection of the public health.
      (4) A drug which is subject to paragraph (1) shall be deemed to
    be misbranded if at any time prior to dispensing its label fails to
    bear the statement "Caution: Federal law restricts this drug to use
    by or on the order of a licensed veterinarian.". A drug to which
    paragraph (1) does not apply shall be deemed to be misbranded if at
    any time prior to dispensing its label bears the statement
    specified in the preceding sentence.
    (g) Regulation of combination products
      (1) The Secretary shall in accordance with this subsection assign
    an agency center to regulate products that constitute a combination
    of a drug, device, or biological product. The Secretary shall
    determine the primary mode of action of the combination product. If
    the Secretary determines that the primary mode of action is that of
    - 
        (A) a drug (other than a biological product), the agency center
      charged with premarket review of drugs shall have primary
      jurisdiction,
        (B) a device, the agency center charged with premarket review
      of devices shall have primary jurisdiction, or
        (C) a biological product, the agency center charged with
      premarket review of biological products shall have primary
      jurisdiction.

      (2) Nothing in this subsection shall prevent the Secretary from
    using any agency resources of the Food and Drug Administration
    necessary to ensure adequate review of the safety, effectiveness,
    or substantial equivalence of an article.
      (3) The Secretary shall promulgate regulations to implement
    market clearance procedures in accordance with paragraphs (1) and
    (2) not later than 1 year after November 28, 1990.
      (4)(A) Not later than 60 days after October 26, 2002, the
    Secretary shall establish within the Office of the Commissioner of
    Food and Drugs an office to ensure the prompt assignment of
    combination products to agency centers, the timely and effective
    premarket review of such products, and consistent and appropriate
    postmarket regulation of like products subject to the same
    statutory requirements to the extent permitted by law.
    Additionally, the office shall, in determining whether a product is
    to be designated a combination product, consult with the component
    within the Office of the Commissioner of Food and Drugs that is
    responsible for such determinations. Such office (referred to in
    this paragraph as the "Office") shall have appropriate scientific
    and medical expertise, and shall be headed by a director.
      (B) In carrying out this subsection, the Office shall, for each
    combination product, promptly assign an agency center with primary
    jurisdiction in accordance with paragraph (1) for the premarket
    review of such product.
      (C)(i) In carrying out this subsection, the Office shall ensure
    timely and effective premarket reviews by overseeing the timeliness
    of and coordinating reviews involving more than one agency center.
      (ii) In order to ensure the timeliness of the premarket review of
    a combination product, the agency center with primary jurisdiction
    for the product, and the consulting agency center, shall be
    responsible to the Office with respect to the timeliness of the
    premarket review.
      (D) In carrying out this subsection, the Office shall ensure the
    consistency and appropriateness of postmarket regulation of like
    products subject to the same statutory requirements to the extent
    permitted by law.
      (E)(i) Any dispute regarding the timeliness of the premarket
    review of a combination product may be presented to the Office for
    resolution, unless the dispute is clearly premature.
      (ii) During the review process, any dispute regarding the
    substance of the premarket review may be presented to the
    Commissioner of Food and Drugs after first being considered by the
    agency center with primary jurisdiction of the premarket review,
    under the scientific dispute resolution procedures for such center.
    The Commissioner of Food and Drugs shall consult with the Director
    of the Office in resolving the substantive dispute.
      (F) The Secretary, acting through the Office, shall review each
    agreement, guidance, or practice of the Secretary that is specific
    to the assignment of combination products to agency centers and
    shall determine whether the agreement, guidance, or practice is
    consistent with the requirements of this subsection. In carrying
    out such review, the Secretary shall consult with stakeholders and
    the directors of the agency centers. After such consultation, the
    Secretary shall determine whether to continue in effect, modify,
    revise, or eliminate such agreement, guidance, or practice, and
    shall publish in the Federal Register a notice of the availability
    of such modified or revised agreement, guidance or practice.
    Nothing in this paragraph shall be construed as preventing the
    Secretary from following each agreement, guidance, or practice
    until continued, modified, revised, or eliminated.
      (G) Not later than one year after October 26, 2002, and annually
    thereafter, the Secretary shall report to the appropriate
    committees of Congress on the activities and impact of the Office.
    The report shall include provisions - 
        (i) describing the numbers and types of combination products
      under review and the timeliness in days of such assignments,
      reviews, and dispute resolutions;
        (ii) identifying the number of premarket reviews of such
      products that involved a consulting agency center; and
        (iii) describing improvements in the consistency of postmarket
      regulation of combination products.

      (H) Nothing in this paragraph shall be construed to limit the
    regulatory authority of any agency center.
      (5) As used in this subsection:
        (A) The term "agency center" means a center or alternative
      organizational component of the Food and Drug Administration.
        (B) The term "biological product" has the meaning given the
      term in section 262(i) of title 42.
        (C) The term "market clearance" includes - 
          (i) approval of an application under section 355, 357,(!1)
        360e, or 360j(g) of this title,

          (ii) a finding of substantial equivalence under this part,
        and
          (iii) approval of a biologics license application under
        subsection (a) of section 262 of title 42.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 503, 52 Stat. 1051; Oct. 26, 1951,
    ch. 578, Sec. 1, 65 Stat. 648; Pub. L. 87-781, title I, Sec.
    104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91-601, Sec. 6(e),
    formerly Sec. 7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
    L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
    Pub. L. 100-293, Secs. 4-6, Apr. 22, 1988, 102 Stat. 96-98; Pub. L.
    100-670, title I, Sec. 105, Nov. 16, 1988, 102 Stat. 3983; Pub. L.
    101-629, Sec. 16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-
    108, Sec. 2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102-300,
    Sec. 6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102-353, Secs.
    2(a)-(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104-250,
    Sec. 5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105-115, title I,
    Secs. 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324,
    2327, 2328; Pub. L. 107-250, title II, Sec. 204, Oct. 26, 2002, 116
    Stat. 1611; Pub. L. 108-282, title I, Sec. 102(b)(5)(F), Aug. 2,
    2004, 118 Stat. 903.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 357 of this title, referred to in subsec. (g)(5)(C)(i),
    was repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,
    1997, 111 Stat. 2325.

-COD-
                               CODIFICATION                           
      In subsec. (b)(5), "sections 4721, 6001, and 6151 of title 26"
    and "section 4761 of title 26" substituted for "section 3220 of the
    Internal Revenue Code (26 U.S.C. 3220)" and "section 3238(b) of the
    Internal Revenue Code (26 U.S.C. 3238(b))", respectively, on
    authority of section 7852(b) of Title 26, Internal Revenue Code.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (f)(1)(A)(ii). Pub. L. 108-282, Sec.
    102(b)(5)(F)(i), substituted "360b of this title, a conditionally-
    approved application under section 360ccc of this title, or an
    index listing under section 360ccc-1 of this title" for "360b of
    this title".
      Subsec. (f)(3). Pub. L. 108-282, Sec. 102(b)(5)(F)(ii),
    substituted "section 360b, 360ccc, or 360ccc-1" for "section 360b".
      2002 - Subsec. (g)(1). Pub. L. 107-250, Sec. 204(1)(A),
    substituted "shall in accordance with this subsection assign an
    agency center" for "shall designate a component of the Food and
    Drug Administration" in first sentence of introductory provisions.
      Subsec. (g)(1)(A) to (C). Pub. L. 107-250, Sec. 204(1)(B),
    substituted "the agency center charged" for "the persons charged".
      Subsec. (g)(4). Pub. L. 107-250, Sec. 204(3), added par. (4).
    Former par. (4) redesignated (5).
      Subsec. (g)(5). Pub. L. 107-250, Sec. 204(2), (4), redesignated
    par. (4) as (5), added subpar. (A), and redesignated former
    subpars. (A) and (B) as (B) and (C), respectively.
      1997 - Subsec. (b)(1)(A) to (C). Pub. L. 105-115, Sec. 126(c)(1),
    redesignated subpars. (B) and (C) as (A) and (B), respectively, and
    struck out former subpar. (A), which read as follows: "is a habit-
    forming drug to which section 352(d) of this title applies; or".
      Subsec. (b)(3). Pub. L. 105-115, Sec. 126(c)(2), struck out
    reference to section 352(d) of this title before "355".
      Subsec. (b)(4). Pub. L. 105-115, Sec. 126(a), amended par. (4)
    generally. Prior to amendment, par. (4) read as follows: "A drug
    which is subject to paragraph (1) of this subsection shall be
    deemed to be misbranded if at any time prior to dispensing its
    label fails to bear the statement 'Caution: Federal law prohibits
    dispensing without prescription'. A drug to which paragraph (1) of
    this subsection does not apply shall be deemed to be misbranded if
    at any time prior to dispensing its label bears the caution
    statement quoted in the preceding sentence."
      Subsec. (g)(4)(A). Pub. L. 105-115, Sec. 123(e)(1), substituted
    "section 262(i) of title 42" for "section 262(a) of title 42".
      Subsec. (g)(4)(B)(iii). Pub. L. 105-115, Sec. 123(e)(2),
    substituted "biologics license application under subsection (a)"
    for "product or establishment license under subsection (a) or (d)".
      1996 - Subsec. (f)(1)(A). Pub. L. 104-250 inserted ", other than
    a veterinary feed directive drug intended for use in animal feed or
    an animal feed bearing or containing a veterinary feed directive
    drug," after "other than man" in introductory provisions.
      1992 - Subsec. (d)(1). Pub. L. 102-353, Sec. 4(1), amended par.
    (1) generally. Prior to amendment, par. (1) read as follows:
    "Except as provided in paragraphs (2) and (3), no representative of
    a drug manufacturer or distributor may distribute any drug sample."
      Subsec. (d)(2). Pub. L. 102-353, Sec. 4(2), substituted
    "authorized distributor of record" for "distributor" wherever
    appearing.
      Subsec. (d)(3). Pub. L. 102-353, Sec. 4(2), substituted
    "authorized distributor of record" for "distributor" and
    "authorized distributors of record" for "distributors" wherever
    appearing.
      Subsec. (e)(1). Pub. L. 102-353, Sec. 4(3), amended par. (1)
    generally. Prior to amendment, par. (1) read as follows: "Each
    person who is engaged in the wholesale distribution of drugs
    subject to subsection (b) of this section and who is not an
    authorized distributor of record of such drugs shall provide to
    each wholesale distributor of such drugs a statement identifying
    each sale of the drug (including the date of the sale) before the
    sale to such wholesale distributor. Each manufacturer shall
    maintain at its corporate offices a current list of such authorized
    distributors."
      Subsec. (e)(2)(A). Pub. L. 102-353, Sec. 2(a), (d), temporarily
    inserted "or has registered with the Secretary in accordance with
    paragraph (3)". See Termination Date of 1992 Amendment note below.
      Subsec. (e)(3). Pub. L. 102-353, Sec. 2(b), (d), temporarily
    added par. (3). Former par. (3) redesignated (4). See Termination
    Date of 1992 Amendment note below.
      Subsec. (e)(4). Pub. L. 102-353, Sec. 4(4), inserted "and
    subsection (d) of this section" after "For the purposes of this
    subsection".
      Pub. L. 102-353, Sec. 2(b), (d), temporarily redesignated par.
    (3) as (4). See Termination Date of 1992 Amendment note below.
      Subsec. (f)(1)(B). Pub. L. 102-353, Sec. 2(c), which directed the
    substitution of "an order" for "and order", could not be executed
    because "and order" did not appear in subpar. (B).
      Subsec. (g)(3). Pub. L. 102-300 substituted "clearance" for
    "approval".
      1991 - Subsec. (c). Pub. L. 102-108, Sec. 2(d)(3), redesignated
    subsec. (c), relating to veterinary prescription drugs, as (f).
    Former subsec. (f) redesignated (g).
      Subsec. (c)(2), (3)(B)(v). Pub. L. 102-108, Sec. 2(d)(1), made
    technical amendment to reference to subsection (b) of this section
    involving corresponding provision of original act.
      Subsec. (d)(3)(E). Pub. L. 102-108, Sec. 2(d)(2), made technical
    amendment to reference to subsection (c)(1) of this section
    involving corresponding provision of original act.
      Subsec. (f). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
    (f), relating to regulation of combination products, as (g).
      Pub. L. 102-108, Sec. 2(d)(3), redesignated subsec. (c), relating
    to veterinary prescription drugs, as (f).
      Subsec. (g). Pub. L. 102-108, Sec. 2(d)(4), redesignated subsec.
    (f), relating to regulation of combination products, as (g).
      1990 - Pub. L. 101-629, Sec. 16(a)(1), substituted "Exemptions
    and consideration for certain drugs, devices, and biological
    products" for "Exemptions in case of drugs and devices" in section
    catchline.
      Subsec. (f). Pub. L. 101-629, Sec. 16(a)(2), added subsec. (f).
      1988 - Subsec. (c). Pub. L. 100-670 added subsec. (c) relating to
    veterinary prescription drugs.
      Pub. L. 100-293, Sec. 4, added subsec. (c) relating to sales
    restrictions.
      Subsec. (d). Pub. L. 100-293, Sec. 5, added subsec. (d).
      Subsec. (e). Pub. L. 100-293, Sec. 6, added subsec. (e).
      1970 - Subsec. (b)(2). Pub. L. 91-601 included exemption from
    packaging requirements of subsec. (p) of section 352 of this title.
      1962 - Subsec. (b)(1)(C). Pub. L. 87-781 substituted "approved"
    for "effective".
      1951 - Subsec. (b). Act Oct. 26, 1951, amended subsec. (b)
    generally to protect the public from abuses in the sale of potent
    prescription drugs, and to relieve retail pharmacists and the
    public from unnecessary restrictions on the dispensation of drugs
    that are safe to use without supervision of a doctor.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                    TERMINATION DATE OF 1992 AMENDMENT                
      Section 2(d) of Pub. L. 102-353 provided that: "Effective
    September 14, 1994, the amendments made by subsections (a) and (b)
    [amending this section] shall no longer be in effect."

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Section 8 of Pub. L. 100-293 provided that:
      "(a) General Rule. - Except as provided in subsection (b), this
    Act and the amendments made by this Act [amending this section and
    sections 331, 333, and 381 of this title and enacting provisions
    set out as notes under this section and section 301 of this title]
    shall take effect upon the expiration of 90 days after the date of
    the enactment of this Act [Apr. 22, 1988].
      "(b) Exception. - 
        "(1) Section 503(d) of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take
      effect upon the expiration of 180 days after the date of the
      enactment of this Act [Apr. 22, 1988].
        "(2) The Secretary of Health and Human Services shall by
      regulation issue the guidelines required by section 503(e)(2)(B)
      of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
      353(e)(2)(B)] (as added by section 6 of this Act) not later than
      180 days after the date of the enactment of this Act. Section
      503(e)(2)(A) of such Act shall take effect upon the expiration of
      2 years after the date such regulations are promulgated and take
      effect."

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    107 of Pub. L. 87-781, set out as a note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1951 AMENDMENT                 
      Amendment by act Oct. 26, 1951, effective six months after Oct.
    26, 1951, see section 3 of act Oct. 26, 1951, set out as a note
    under section 333 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
                        EFFECTIVE MEDICATION GUIDES                    
      Pub. L. 104-180, title VI, Sec. 601, Aug. 6, 1996, 110 Stat.
    1593, provided that:
      "(a) In General. - Not later than 30 days after the date of
    enactment of this Act [Aug. 6, 1996], the Secretary of the
    Department of Health and Human Services shall request that national
    organizations representing health care professionals, consumer
    organizations, voluntary health agencies, the pharmaceutical
    industry, drug wholesalers, patient drug information database
    companies, and other relevant parties collaborate to develop a long-
    range comprehensive action plan to achieve goals consistent with
    the goals of the proposed rule of the Food and Drug Administration
    on 'Prescription Drug Product Labeling: Medication Guide
    Requirements' (60 Fed. Reg. 44182; relating to the provision of
    oral and written prescription information to consumers).
      "(b) Goals. - Goals consistent with the proposed rule described
    in subsection (a) are the distribution of useful written
    information to 75 percent of individuals receiving new precriptions
    [sic] by the year 2000 and to 95 percent by the year 2006.
      "(c) Plan. - The plan described in subsection (a) shall - 
        "(1) identify the plan goals;
        "(2) assess the effectiveness of the current private-sector
      approaches used to provide oral and written prescription
      information to consumers;
        "(3) develop guidelines for providing effective oral and
      written prescription information consistent with the findings of
      any such assessment;
        "(4) contain elements necessary to ensure the transmittal of
      useful information to the consuming public, including being
      scientifically accurate, non-promotional in tone and content,
      sufficiently specific and comprehensive as to adequately inform
      consumers about the use of the product, and in an understandable,
      legible format that is readily comprehensible and not confusing
      to consumers expected to use the product.[;]
        "(5) develop a mechanism to assess periodically the quality of
      the oral and written prescription information and the frequency
      with which the information is provided to consumers; and
        "(6) provide for compliance with relevant State board
      regulations.
      "(d) Limitation on the Authority of the Secretary. - The
    Secretary of the Department of Health and Human Services shall have
    no authority to implement the proposed rule described in subsection
    (a), or to develop any similar regulation, policy statement, or
    other guideline specifying a uniform content or format for written
    information voluntarily provided to consumers about prescription
    drugs if, (1) not later than 120 days after the date of enactment
    of this Act [Aug. 6, 1996], the national organizations described in
    subsection (a) develop and submit to the Secretary for Health and
    Human Services a comprehensive, long-range action plan (as
    described in subsection (a)) which shall be acceptable to the
    Secretary of Health and Human Services; (2) the aforementioned plan
    is submitted to the Secretary of Health and Human Services for
    review and acceptance: Provided, That the Secretary shall give due
    consideration to the submitted plan and that any such acceptance
    shall not be arbitrarily withheld; and (3) the implementation of
    (a) a plan accepted by the Secretary commences within 30 days of
    the Secretary's acceptance of such plan, or (b) the plan submitted
    to the Secretary commences within 60 days of the submission of such
    plan if the Secretary fails to take any action on the plan within
    30 days of the submission of the plan. The Secretary shall accept,
    reject or suggest modifications to the plan submitted within 30
    days of its submission. The Secretary may confer with and assist
    private parties in the development of the plan described in
    subsections (a) and (b).
      "(e) Secretary Review. - Not later than January 1, 2001, the
    Secretary of the Department of Health and Human Services shall
    review the status of private-sector initiatives designed to achieve
    the goals of the plan described in subsection (a), and if such
    goals are not achieved, the limitation in subsection (d) shall not
    apply, and the Secretary shall seek public comment on other
    initiatives that may be carried out to meet such goals."

                          CONGRESSIONAL FINDINGS                      
      Section 2 of Pub. L. 100-293 provided that: "The Congress finds
    the following:
        "(1) American consumers cannot purchase prescription drugs with
      the certainty that the products are safe and effective.
        "(2) The integrity of the distribution system for prescription
      drugs is insufficient to prevent the introduction and eventual
      retail sale of substandard, ineffective, or even counterfeit
      drugs.
        "(3) The existence and operation of a wholesale submarket,
      commonly known as the 'diversion market', prevents effective
      control over or even routine knowledge of the true sources of
      prescription drugs in a significant number of cases.
        "(4) Large amounts of drugs are being reimported to the United
      States as American goods returned. These imports are a health and
      safety risk to American consumers because they may have become
      subpotent or adulterated during foreign handling and shipping.
        "(5) The ready market for prescription drug reimports has been
      the catalyst for a continuing series of frauds against American
      manufacturers and has provided the cover for the importation of
      foreign counterfeit drugs.
        "(6) The existing system of providing drug samples to
      physicians through manufacturer's representatives has been abused
      for decades and has resulted in the sale to consumers of
      misbranded, expired, and adulterated pharmaceuticals.
        "(7) The bulk resale of below wholesale priced prescription
      drugs by health care entities, for ultimate sale at retail, helps
      fuel the diversion market and is an unfair form of competition to
      wholesalers and retailers that must pay otherwise prevailing
      market prices.
        "(8) The effect of these several practices and conditions is to
      create an unacceptable risk that counterfeit, adulterated,
      misbranded, subpotent, or expired drugs will be sold to American
      consumers."

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 353a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 353a. Pharmacy compounding

-STATUTE-
    (a) In general
      Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not
    apply to a drug product if the drug product is compounded for an
    identified individual patient based on the unsolicited receipt of a
    valid prescription order or a notation, approved by the prescribing
    practitioner, on the prescription order that a compounded product
    is necessary for the identified patient, if the drug product meets
    the requirements of this section, and if the compounding - 
        (1) is by - 
          (A) a licensed pharmacist in a State licensed pharmacy or a
        Federal facility, or
          (B) a licensed physician,

      on the prescription order for such individual patient made by a
      licensed physician or other licensed practitioner authorized by
      State law to prescribe drugs; or
        (2)(A) is by a licensed pharmacist or licensed physician in
      limited quantities before the receipt of a valid prescription
      order for such individual patient; and
        (B) is based on a history of the licensed pharmacist or
      licensed physician receiving valid prescription orders for the
      compounding of the drug product, which orders have been generated
      solely within an established relationship between - 
          (i) the licensed pharmacist or licensed physician; and
          (ii)(I) such individual patient for whom the prescription
        order will be provided; or
          (II) the physician or other licensed practitioner who will
        write such prescription order.
    (b) Compounded drug
      (1) Licensed pharmacist and licensed physician
        A drug product may be compounded under subsection (a) of this
      section if the licensed pharmacist or licensed physician - 
          (A) compounds the drug product using bulk drug substances, as
        defined in regulations of the Secretary published at section
        207.3(a)(4) of title 21 of the Code of Federal Regulations - 
            (i) that - 
              (I) comply with the standards of an applicable United
            States Pharmacopoeia or National Formulary monograph, if a
            monograph exists, and the United States Pharmacopoeia
            chapter on pharmacy compounding;
              (II) if such a monograph does not exist, are drug
            substances that are components of drugs approved by the
            Secretary; or
              (III) if such a monograph does not exist and the drug
            substance is not a component of a drug approved by the
            Secretary, that appear on a list developed by the Secretary
            through regulations issued by the Secretary under
            subsection (d) of this section;

            (ii) that are manufactured by an establishment that is
          registered under section 360 of this title (including a
          foreign establishment that is registered under section 360(i)
          of this title); and
            (iii) that are accompanied by valid certificates of
          analysis for each bulk drug substance;

          (B) compounds the drug product using ingredients (other than
        bulk drug substances) that comply with the standards of an
        applicable United States Pharmacopoeia or National Formulary
        monograph, if a monograph exists, and the United States
        Pharmacopoeia chapter on pharmacy compounding;
          (C) does not compound a drug product that appears on a list
        published by the Secretary in the Federal Register of drug
        products that have been withdrawn or removed from the market
        because such drug products or components of such drug products
        have been found to be unsafe or not effective; and
          (D) does not compound regularly or in inordinate amounts (as
        defined by the Secretary) any drug products that are
        essentially copies of a commercially available drug product.
      (2) Definition
        For purposes of paragraph (1)(D), the term "essentially a copy
      of a commercially available drug product" does not include a drug
      product in which there is a change, made for an identified
      individual patient, which produces for that patient a significant
      difference, as determined by the prescribing practitioner,
      between the compounded drug and the comparable commercially
      available drug product.
      (3) Drug product
        A drug product may be compounded under subsection (a) only if -
      
          (A) such drug product is not a drug product identified by the
        Secretary by regulation as a drug product that presents
        demonstrable difficulties for compounding that reasonably
        demonstrate an adverse effect on the safety or effectiveness of
        that drug product; and
          (B) such drug product is compounded in a State - 
            (i) that has entered into a memorandum of understanding
          with the Secretary which addresses the distribution of
          inordinate amounts of compounded drug products interstate and
          provides for appropriate investigation by a State agency of
          complaints relating to compounded drug products distributed
          outside such State; or
            (ii) that has not entered into the memorandum of
          understanding described in clause (i) and the licensed
          pharmacist, licensed pharmacy, or licensed physician
          distributes (or causes to be distributed) compounded drug
          products out of the State in which they are compounded in
          quantities that do not exceed 5 percent of the total
          prescription orders dispensed or distributed by such pharmacy
          or physician.

      The Secretary shall, in consultation with the National
      Association of Boards of Pharmacy, develop a standard memorandum
      of understanding for use by the States in complying with
      subparagraph (B)(i).
    (c) Advertising and promotion
      A drug may be compounded under subsection (a) of this section
    only if the pharmacy, licensed pharmacist, or licensed physician
    does not advertise or promote the compounding of any particular
    drug, class of drug, or type of drug. The pharmacy, licensed
    pharmacist, or licensed physician may advertise and promote the
    compounding service provided by the licensed pharmacist or licensed
    physician.
    (d) Regulations
      (1) In general
        The Secretary shall issue regulations to implement this
      section. Before issuing regulations to implement subsections
      (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A) of this section, the
      Secretary shall convene and consult an advisory committee on
      compounding unless the Secretary determines that the issuance of
      such regulations before consultation is necessary to protect the
      public health. The advisory committee shall include
      representatives from the National Association of Boards of
      Pharmacy, the United States Pharmacopoeia, pharmacy, physician,
      and consumer organizations, and other experts selected by the
      Secretary.
      (2) Limiting compounding
        The Secretary, in consultation with the United States
      Pharmacopoeia Convention, Incorporated, shall promulgate
      regulations identifying drug substances that may be used in
      compounding under subsection (b)(1)(A)(i)(III) of this section
      for which a monograph does not exist or which are not components
      of drug products approved by the Secretary. The Secretary shall
      include in the regulation the criteria for such substances, which
      shall include historical use, reports in peer reviewed medical
      literature, or other criteria the Secretary may identify.
    (e) Application
      This section shall not apply to - 
        (1) compounded positron emission tomography drugs as defined in
      section 321(ii) of this title; or
        (2) radiopharmaceuticals.
    (f) "Compounding" defined
      As used in this section, the term "compounding" does not include
    mixing, reconstituting, or other such acts that are performed in
    accordance with directions contained in approved labeling provided
    by the product's manufacturer and other manufacturer directions
    consistent with that labeling.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 503A, as added Pub. L. 105-115, title
    I, Sec. 127(a), Nov. 21, 1997, 111 Stat. 2328.)


-MISC1-
                              EFFECTIVE DATE                          
      Section 127(b) of Pub. L. 105-115 provided that: "Section 503A of
    the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by
    subsection (a), shall take effect upon the expiration of the 1-year
    period beginning on the date of the enactment of this Act [Nov. 21,
    1997]."

-End-



-CITE-
    21 USC Sec. 354                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 354. Veterinary feed directive drugs

-STATUTE-
    (a) Lawful veterinary feed directive requirement
      (1) A drug intended for use in or on animal feed which is limited
    by an approved application filed pursuant to section 360b(b) of
    this title, a conditionally-approved application filed pursuant to
    section 360ccc of this title, or an index listing pursuant to
    section 360ccc-1 of this title to use under the professional
    supervision of a licensed veterinarian is a veterinary feed
    directive drug. Any animal feed bearing or containing a veterinary
    feed directive drug shall be fed to animals only by or upon a
    lawful veterinary feed directive issued by a licensed veterinarian
    in the course of the veterinarian's professional practice. When
    labeled, distributed, held, and used in accordance with this
    section, a veterinary feed directive drug and any animal feed
    bearing or containing a veterinary feed directive drug shall be
    exempt from section 352(f) of this title.
      (2) A veterinary feed directive is lawful if it - 
        (A) contains such information as the Secretary may by general
      regulation or by order require; and
        (B) is in compliance with the conditions and indications for
      use of the drug set forth in the notice published pursuant to
      section 360b(i) of this title, or the index listing pursuant to
      section 360ccc-1(e) of this title.

      (3)(A) Any persons involved in the distribution or use of animal
    feed bearing or containing a veterinary feed directive drug and the
    licensed veterinarian issuing the veterinary feed directive shall
    maintain a copy of the veterinary feed directive applicable to each
    such feed, except in the case of a person distributing such feed to
    another person for further distribution. Such person distributing
    the feed shall maintain a written acknowledgment from the person to
    whom the feed is shipped stating that that person shall not ship or
    move such feed to an animal production facility without a
    veterinary feed directive or ship such feed to another person for
    further distribution unless that person has provided the same
    written acknowledgment to its immediate supplier.
      (B) Every person required under subparagraph (A) to maintain
    records, and every person in charge or custody thereof, shall, upon
    request of an officer or employee designated by the Secretary,
    permit such officer or employee at all reasonable times to have
    access to and copy and verify such records.
      (C) Any person who distributes animal feed bearing or containing
    a veterinary feed directive drug shall upon first engaging in such
    distribution notify the Secretary of that person's name and place
    of business. The failure to provide such notification shall be
    deemed to be an act which results in the drug being misbranded.
    (b) Labeling and advertising
      A veterinary feed directive drug and any feed bearing or
    containing a veterinary feed directive drug shall be deemed to be
    misbranded if their labeling fails to bear such cautionary
    statement and such other information as the Secretary may by
    general regulation or by order prescribe, or their advertising
    fails to conform to the conditions and indications for use
    published pursuant to section 360b(i) of this title, or the index
    listing pursuant to section 360ccc-1(e) of this title or fails to
    contain the general cautionary statement prescribed by the
    Secretary.
    (c) Nonprescription status
      Neither a drug subject to this section, nor animal feed bearing
    or containing such a drug, shall be deemed to be a prescription
    article under any Federal or State law.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 504, as added Pub. L. 104-250, Sec.
    5(b), Oct. 9, 1996, 110 Stat. 3155; amended Pub. L. 108-282, title
    I, Sec. 102(b)(5)(G), (H), Aug. 2, 2004, 118 Stat. 903.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 354, act June 25, 1938, ch. 675, Sec. 504, 52
    Stat. 1052, which directed Secretary to promulgate regulations for
    listing of coal-tar colors, was repealed effective July 12, 1960,
    subject to provisions of section 203 of Pub. L. 86-618, by Pub. L.
    86-618, title I, Sec. 103(a)(2), title II, Sec. 202, July 12, 1960,
    74 Stat. 398, 404.

                                AMENDMENTS                            
      2004 - Subsec. (a)(1). Pub. L. 108-282, Sec. 102(b)(5)(G),
    substituted "360b(b) of this title, a conditionally-approved
    application filed pursuant to section 360ccc of this title, or an
    index listing pursuant to section 360ccc-1 of this title" for
    "360b(b) of this title".
      Subsecs. (a)(2)(B), (b). Pub. L. 108-282, Sec. 102(b)(5)(H),
    substituted "360b(i) of this title, or the index listing pursuant
    to section 360ccc-1(e) of this title" for "360b(i) of this title".

-End-



-CITE-
    21 USC Sec. 355                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 355. New drugs

-STATUTE-
    (a) Necessity of effective approval of application
      No person shall introduce or deliver for introduction into
    interstate commerce any new drug, unless an approval of an
    application filed pursuant to subsection (b) or (j) of this section
    is effective with respect to such drug.
    (b) Filing application; contents
      (1) Any person may file with the Secretary an application with
    respect to any drug subject to the provisions of subsection (a) of
    this section. Such person shall submit to the Secretary as a part
    of the application (A) full reports of investigations which have
    been made to show whether or not such drug is safe for use and
    whether such drug is effective in use; (B) a full list of the
    articles used as components of such drug; (C) a full statement of
    the composition of such drug; (D) a full description of the methods
    used in, and the facilities and controls used for, the manufacture,
    processing, and packing of such drug; (E) such samples of such drug
    and of the articles used as components thereof as the Secretary may
    require; (F) specimens of the labeling proposed to be used for such
    drug, and (G) any assessments required under section 355c of this
    title. The applicant shall file with the application the patent
    number and the expiration date of any patent which claims the drug
    for which the applicant submitted the application or which claims a
    method of using such drug and with respect to which a claim of
    patent infringement could reasonably be asserted if a person not
    licensed by the owner engaged in the manufacture, use, or sale of
    the drug. If an application is filed under this subsection for a
    drug and a patent which claims such drug or a method of using such
    drug is issued after the filing date but before approval of the
    application, the applicant shall amend the application to include
    the information required by the preceding sentence. Upon approval
    of the application, the Secretary shall publish information
    submitted under the two preceding sentences. The Secretary shall,
    in consultation with the Director of the National Institutes of
    Health and with representatives of the drug manufacturing industry,
    review and develop guidance, as appropriate, on the inclusion of
    women and minorities in clinical trials required by clause (A).
      (2) An application submitted under paragraph (1) for a drug for
    which the investigations described in clause (A) of such paragraph
    and relied upon by the applicant for approval of the application
    were not conducted by or for the applicant and for which the
    applicant has not obtained a right of reference or use from the
    person by or for whom the investigations were conducted shall also
    include - 
        (A) a certification, in the opinion of the applicant and to the
      best of his knowledge, with respect to each patent which claims
      the drug for which such investigations were conducted or which
      claims a use for such drug for which the applicant is seeking
      approval under this subsection and for which information is
      required to be filed under paragraph (1) or subsection (c) of
      this section - 
          (i) that such patent information has not been filed,
          (ii) that such patent has expired,
          (iii) of the date on which such patent will expire, or
          (iv) that such patent is invalid or will not be infringed by
        the manufacture, use, or sale of the new drug for which the
        application is submitted; and

        (B) if with respect to the drug for which investigations
      described in paragraph (1)(A) were conducted information was
      filed under paragraph (1) or subsection (c) of this section for a
      method of use patent which does not claim a use for which the
      applicant is seeking approval under this subsection, a statement
      that the method of use patent does not claim such a use.

      (3) Notice of opinion that patent is invalid or will not be
    infringed. - 
        (A) Agreement to give notice. - An applicant that makes a
      certification described in paragraph (2)(A)(iv) shall include in
      the application a statement that the applicant will give notice
      as required by this paragraph.
        (B) Timing of notice. - An applicant that makes a certification
      described in paragraph (2)(A)(iv) shall give notice as required
      under this paragraph - 
          (i) if the certification is in the application, not later
        than 20 days after the date of the postmark on the notice with
        which the Secretary informs the applicant that the application
        has been filed; or
          (ii) if the certification is in an amendment or supplement to
        the application, at the time at which the applicant submits the
        amendment or supplement, regardless of whether the applicant
        has already given notice with respect to another such
        certification contained in the application or in an amendment
        or supplement to the application.

        (C) Recipients of notice. - An applicant required under this
      paragraph to give notice shall give notice to - 
          (i) each owner of the patent that is the subject of the
        certification (or a representative of the owner designated to
        receive such a notice); and
          (ii) the holder of the approved application under this
        subsection for the drug that is claimed by the patent or a use
        of which is claimed by the patent (or a representative of the
        holder designated to receive such a notice).

        (D) Contents of notice. - A notice required under this
      paragraph shall - 
          (i) state that an application that contains data from
        bioavailability or bioequivalence studies has been submitted
        under this subsection for the drug with respect to which the
        certification is made to obtain approval to engage in the
        commercial manufacture, use, or sale of the drug before the
        expiration of the patent referred to in the certification; and
          (ii) include a detailed statement of the factual and legal
        basis of the opinion of the applicant that the patent is
        invalid or will not be infringed.

      (4)(A) An applicant may not amend or supplement an application
    referred to in paragraph (2) to seek approval of a drug that is a
    different drug than the drug identified in the application as
    submitted to the Secretary.
      (B) With respect to the drug for which such an application is
    submitted, nothing in this subsection or subsection (c)(3) of this
    section prohibits an applicant from amending or supplementing the
    application to seek approval of a different strength.
      (5)(A) The Secretary shall issue guidance for the individuals who
    review applications submitted under paragraph (1) or under section
    262 of title 42, which shall relate to promptness in conducting the
    review, technical excellence, lack of bias and conflict of
    interest, and knowledge of regulatory and scientific standards, and
    which shall apply equally to all individuals who review such
    applications.
      (B) The Secretary shall meet with a sponsor of an investigation
    or an applicant for approval for a drug under this subsection or
    section 262 of title 42 if the sponsor or applicant makes a
    reasonable written request for a meeting for the purpose of
    reaching agreement on the design and size of clinical trials
    intended to form the primary basis of an effectiveness claim. The
    sponsor or applicant shall provide information necessary for
    discussion and agreement on the design and size of the clinical
    trials. Minutes of any such meeting shall be prepared by the
    Secretary and made available to the sponsor or applicant upon
    request.
      (C) Any agreement regarding the parameters of the design and size
    of clinical trials of a new drug under this paragraph that is
    reached between the Secretary and a sponsor or applicant shall be
    reduced to writing and made part of the administrative record by
    the Secretary. Such agreement shall not be changed after the
    testing begins, except - 
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with
      subparagraph (D) by the director of the reviewing division, that
      a substantial scientific issue essential to determining the
      safety or effectiveness of the drug has been identified after the
      testing has begun.

      (D) A decision under subparagraph (C)(ii) by the director shall
    be in writing and the Secretary shall provide to the sponsor or
    applicant an opportunity for a meeting at which the director and
    the sponsor or applicant will be present and at which the director
    will document the scientific issue involved.
      (E) The written decisions of the reviewing division shall be
    binding upon, and may not directly or indirectly be changed by, the
    field or compliance division personnel unless such field or
    compliance division personnel demonstrate to the reviewing division
    why such decision should be modified.
      (F) No action by the reviewing division may be delayed because of
    the unavailability of information from or action by field personnel
    unless the reviewing division determines that a delay is necessary
    to assure the marketing of a safe and effective drug.
      (G) For purposes of this paragraph, the reviewing division is the
    division responsible for the review of an application for approval
    of a drug under this subsection or section 262 of title 42
    (including all scientific and medical matters, chemistry,
    manufacturing, and controls).
    (c) Period for approval of application; period for, notice, and
      expedition of hearing; period for issuance of order
      (1) Within one hundred and eighty days after the filing of an
    application under subsection (b) of this section, or such
    additional period as may be agreed upon by the Secretary and the
    applicant, the Secretary shall either - 
        (A) approve the application if he then finds that none of the
      grounds for denying approval specified in subsection (d) of this
      section applies, or
        (B) give the applicant notice of an opportunity for a hearing
      before the Secretary under subsection (d) of this section on the
      question whether such application is approvable. If the applicant
      elects to accept the opportunity for hearing by written request
      within thirty days after such notice, such hearing shall commence
      not more than ninety days after the expiration of such thirty
      days unless the Secretary and the applicant otherwise agree. Any
      such hearing shall thereafter be conducted on an expedited basis
      and the Secretary's order thereon shall be issued within ninety
      days after the date fixed by the Secretary for filing final
      briefs.

      (2) If the patent information described in subsection (b) of this
    section could not be filed with the submission of an application
    under subsection (b) of this section because the application was
    filed before the patent information was required under subsection
    (b) of this section or a patent was issued after the application
    was approved under such subsection, the holder of an approved
    application shall file with the Secretary the patent number and the
    expiration date of any patent which claims the drug for which the
    application was submitted or which claims a method of using such
    drug and with respect to which a claim of patent infringement could
    reasonably be asserted if a person not licensed by the owner
    engaged in the manufacture, use, or sale of the drug. If the holder
    of an approved application could not file patent information under
    subsection (b) of this section because it was not required at the
    time the application was approved, the holder shall file such
    information under this subsection not later than thirty days after
    September 24, 1984, and if the holder of an approved application
    could not file patent information under subsection (b) of this
    section because no patent had been issued when an application was
    filed or approved, the holder shall file such information under
    this subsection not later than thirty days after the date the
    patent involved is issued. Upon the submission of patent
    information under this subsection, the Secretary shall publish it.
      (3) The approval of an application filed under subsection (b) of
    this section which contains a certification required by paragraph
    (2) of such subsection shall be made effective on the last
    applicable date determined by applying the following to each
    certification made under subsection (b)(2)(A) of this section:
        (A) If the applicant only made a certification described in
      clause (i) or (ii) of subsection (b)(2)(A) of this section or in
      both such clauses, the approval may be made effective
      immediately.
        (B) If the applicant made a certification described in clause
      (iii) of subsection (b)(2)(A) of this section, the approval may
      be made effective on the date certified under clause (iii).
        (C) If the applicant made a certification described in clause
      (iv) of subsection (b)(2)(A) of this section, the approval shall
      be made effective immediately unless, before the expiration of 45
      days after the date on which the notice described in subsection
      (b)(3) of this section is received, an action is brought for
      infringement of the patent that is the subject of the
      certification and for which information was submitted to the
      Secretary under paragraph (2) or subsection (b)(1) of this
      section before the date on which the application (excluding an
      amendment or supplement to the application) was submitted. If
      such an action is brought before the expiration of such days, the
      approval may be made effective upon the expiration of the thirty-
      month period beginning on the date of the receipt of the notice
      provided under subsection (b)(3) of this section or such shorter
      or longer period as the court may order because either party to
      the action failed to reasonably cooperate in expediting the
      action, except that - 
          (i) if before the expiration of such period the district
        court decides that the patent is invalid or not infringed
        (including any substantive determination that there is no cause
        of action for patent infringement or invalidity), the approval
        shall be made effective on - 
            (I) the date on which the court enters judgment reflecting
          the decision; or
            (II) the date of a settlement order or consent decree
          signed and entered by the court stating that the patent that
          is the subject of the certification is invalid or not
          infringed;

          (ii) if before the expiration of such period the district
        court decides that the patent has been infringed - 
            (I) if the judgment of the district court is appealed, the
          approval shall be made effective on - 
              (aa) the date on which the court of appeals decides that
            the patent is invalid or not infringed (including any
            substantive determination that there is no cause of action
            for patent infringement or invalidity); or
              (bb) the date of a settlement order or consent decree
            signed and entered by the court of appeals stating that the
            patent that is the subject of the certification is invalid
            or not infringed; or

            (II) if the judgment of the district court is not appealed
          or is affirmed, the approval shall be made effective on the
          date specified by the district court in a court order under
          section 271(e)(4)(A) of title 35;

          (iii) if before the expiration of such period the court
        grants a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent is
        invalid or not infringed, the approval shall be made effective
        as provided in clause (i); or
          (iv) if before the expiration of such period the court grants
        a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent has been
        infringed, the approval shall be made effective as provided in
        clause (ii).

      In such an action, each of the parties shall reasonably cooperate
      in expediting the action.
        (D) Civil action to obtain patent certainty. - 
          (i) Declaratory judgment absent infringement action. - 
            (I) In general. - No action may be brought under section
          2201 of title 28 by an applicant referred to in subsection
          (b)(2) of this section for a declaratory judgment with
          respect to a patent which is the subject of the certification
          referred to in subparagraph (C) unless - 
              (aa) the 45-day period referred to in such subparagraph
            has expired;
              (bb) neither the owner of such patent nor the holder of
            the approved application under subsection (b) of this
            section for the drug that is claimed by the patent or a use
            of which is claimed by the patent brought a civil action
            against the applicant for infringement of the patent before
            the expiration of such period; and
              (cc) in any case in which the notice provided under
            paragraph (2)(B) relates to noninfringement, the notice was
            accompanied by a document described in subclause (III).

            (II) Filing of civil action. - If the conditions described
          in items (aa), (bb), and as applicable, (cc) of subclause (I)
          have been met, the applicant referred to in such subclause
          may, in accordance with section 2201 of title 28, bring a
          civil action under such section against the owner or holder
          referred to in such subclause (but not against any owner or
          holder that has brought such a civil action against the
          applicant, unless that civil action was dismissed without
          prejudice) for a declaratory judgment that the patent is
          invalid or will not be infringed by the drug for which the
          applicant seeks approval, except that such civil action may
          be brought for a declaratory judgment that the patent will
          not be infringed only in a case in which the condition
          described in subclause (I)(cc) is applicable. A civil action
          referred to in this subclause shall be brought in the
          judicial district where the defendant has its principal place
          of business or a regular and established place of business.
            (III) Offer of confidential access to application. - For
          purposes of subclause (I)(cc), the document described in this
          subclause is a document providing an offer of confidential
          access to the application that is in the custody of the
          applicant referred to in subsection (b)(2) of this section
          for the purpose of determining whether an action referred to
          in subparagraph (C) should be brought. The document providing
          the offer of confidential access shall contain such
          restrictions as to persons entitled to access, and on the use
          and disposition of any information accessed, as would apply
          had a protective order been entered for the purpose of
          protecting trade secrets and other confidential business
          information. A request for access to an application under an
          offer of confidential access shall be considered acceptance
          of the offer of confidential access with the restrictions as
          to persons entitled to access, and on the use and disposition
          of any information accessed, contained in the offer of
          confidential access, and those restrictions and other terms
          of the offer of confidential access shall be considered terms
          of an enforceable contract. Any person provided an offer of
          confidential access shall review the application for the sole
          and limited purpose of evaluating possible infringement of
          the patent that is the subject of the certification under
          subsection (b)(2)(A)(iv) of this section and for no other
          purpose, and may not disclose information of no relevance to
          any issue of patent infringement to any person other than a
          person provided an offer of confidential access. Further, the
          application may be redacted by the applicant to remove any
          information of no relevance to any issue of patent
          infringement.

          (ii) Counterclaim to infringement action. - 
            (I) In general. - If an owner of the patent or the holder
          of the approved application under subsection (b) of this
          section for the drug that is claimed by the patent or a use
          of which is claimed by the patent brings a patent
          infringement action against the applicant, the applicant may
          assert a counterclaim seeking an order requiring the holder
          to correct or delete the patent information submitted by the
          holder under subsection (b) of this section or this
          subsection on the ground that the patent does not claim
          either - 
              (aa) the drug for which the application was approved; or
              (bb) an approved method of using the drug.

            (II) No independent cause of action. - Subclause (I) does
          not authorize the assertion of a claim described in subclause
          (I) in any civil action or proceeding other than a
          counterclaim described in subclause (I).

          (iii) No damages. - An applicant shall not be entitled to
        damages in a civil action under clause (i) or a counterclaim
        under clause (ii).

        (E)(i) If an application (other than an abbreviated new drug
      application) submitted under subsection (b) of this section for a
      drug, no active ingredient (including any ester or salt of the
      active ingredient) of which has been approved in any other
      application under subsection (b) of this section, was approved
      during the period beginning January 1, 1982, and ending on
      September 24, 1984, the Secretary may not make the approval of
      another application for a drug for which the investigations
      described in clause (A) of subsection (b)(1) of this section and
      relied upon by the applicant for approval of the application were
      not conducted by or for the applicant and for which the applicant
      has not obtained a right of reference or use from the person by
      or for whom the investigations were conducted effective before
      the expiration of ten years from the date of the approval of the
      application previously approved under subsection (b) of this
      section.
        (ii) If an application submitted under subsection (b) of this
      section for a drug, no active ingredient (including any ester or
      salt of the active ingredient) of which has been approved in any
      other application under subsection (b) of this section, is
      approved after September 24, 1984, no application which refers to
      the drug for which the subsection (b) application was submitted
      and for which the investigations described in clause (A) of
      subsection (b)(1) of this section and relied upon by the
      applicant for approval of the application were not conducted by
      or for the applicant and for which the applicant has not obtained
      a right of reference or use from the person by or for whom the
      investigations were conducted may be submitted under subsection
      (b) of this section before the expiration of five years from the
      date of the approval of the application under subsection (b) of
      this section, except that such an application may be submitted
      under subsection (b) of this section after the expiration of four
      years from the date of the approval of the subsection (b)
      application if it contains a certification of patent invalidity
      or noninfringement described in clause (iv) of subsection
      (b)(2)(A) of this section. The approval of such an application
      shall be made effective in accordance with this paragraph except
      that, if an action for patent infringement is commenced during
      the one-year period beginning forty-eight months after the date
      of the approval of the subsection (b) application, the thirty-
      month period referred to in subparagraph (C) shall be extended
      by such amount of time (if any) which is required for seven and
      one-half years to have elapsed from the date of approval of the
      subsection (b) application.
        (iii) If an application submitted under subsection (b) of this
      section for a drug, which includes an active ingredient
      (including any ester or salt of the active ingredient) that has
      been approved in another application approved under subsection
      (b) of this section, is approved after September 24, 1984, and if
      such application contains reports of new clinical investigations
      (other than bioavailability studies) essential to the approval of
      the application and conducted or sponsored by the applicant, the
      Secretary may not make the approval of an application submitted
      under subsection (b) of this section for the conditions of
      approval of such drug in the approved subsection (b) application
      effective before the expiration of three years from the date of
      the approval of the application under subsection (b) of this
      section if the investigations described in clause (A) of
      subsection (b)(1) of this section and relied upon by the
      applicant for approval of the application were not conducted by
      or for the applicant and if the applicant has not obtained a
      right of reference or use from the person by or for whom the
      investigations were conducted.
        (iv) If a supplement to an application approved under
      subsection (b) of this section is approved after September 24,
      1984, and the supplement contains reports of new clinical
      investigations (other than bioavailabilty (!1) studies) essential
      to the approval of the supplement and conducted or sponsored by
      the person submitting the supplement, the Secretary may not make
      the approval of an application submitted under subsection (b) of
      this section for a change approved in the supplement effective
      before the expiration of three years from the date of the
      approval of the supplement under subsection (b) of this section
      if the investigations described in clause (A) of subsection
      (b)(1) of this section and relied upon by the applicant for
      approval of the application were not conducted by or for the
      applicant and if the applicant has not obtained a right of
      reference or use from the person by or for whom the
      investigations were conducted.

        (v) If an application (or supplement to an application)
      submitted under subsection (b) of this section for a drug, which
      includes an active ingredient (including any ester or salt of the
      active ingredient) that has been approved in another application
      under subsection (b) of this section, was approved during the
      period beginning January 1, 1982, and ending on September 24,
      1984, the Secretary may not make the approval of an application
      submitted under this subsection and for which the investigations
      described in clause (A) of subsection (b)(1) of this section and
      relied upon by the applicant for approval of the application were
      not conducted by or for the applicant and for which the applicant
      has not obtained a right of reference or use from the person by
      or for whom the investigations were conducted and which refers to
      the drug for which the subsection (b) application was submitted
      effective before the expiration of two years from September 24,
      1984.

      (4) A drug manufactured in a pilot or other small facility may be
    used to demonstrate the safety and effectiveness of the drug and to
    obtain approval for the drug prior to manufacture of the drug in a
    larger facility, unless the Secretary makes a determination that a
    full scale production facility is necessary to ensure the safety or
    effectiveness of the drug.
    (d) Grounds for refusing application; approval of application;
      "substantial evidence" defined
      If the Secretary finds, after due notice to the applicant in
    accordance with subsection (c) of this section and giving him an
    opportunity for a hearing, in accordance with said subsection, that
    (1) the investigations, reports of which are required to be
    submitted to the Secretary pursuant to subsection (b) of this
    section, do not include adequate tests by all methods reasonably
    applicable to show whether or not such drug is safe for use under
    the conditions prescribed, recommended, or suggested in the
    proposed labeling thereof; (2) the results of such tests show that
    such drug is unsafe for use under such conditions or do not show
    that such drug is safe for use under such conditions; (3) the
    methods used in, and the facilities and controls used for, the
    manufacture, processing, and packing of such drug are inadequate to
    preserve its identity, strength, quality, and purity; (4) upon the
    basis of the information submitted to him as part of the
    application, or upon the basis of any other information before him
    with respect to such drug, he has insufficient information to
    determine whether such drug is safe for use under such conditions;
    or (5) evaluated on the basis of the information submitted to him
    as part of the application and any other information before him
    with respect to such drug, there is a lack of substantial evidence
    that the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the proposed labeling thereof; or (6) the application
    failed to contain the patent information prescribed by subsection
    (b) of this section; or (7) based on a fair evaluation of all
    material facts, such labeling is false or misleading in any
    particular; he shall issue an order refusing to approve the
    application. If, after such notice and opportunity for hearing, the
    Secretary finds that clauses (1) through (6) do not apply, he shall
    issue an order approving the application. As used in this
    subsection and subsection (e) of this section, the term
    "substantial evidence" means evidence consisting of adequate and
    well-controlled investigations, including clinical investigations,
    by experts qualified by scientific training and experience to
    evaluate the effectiveness of the drug involved, on the basis of
    which it could fairly and responsibly be concluded by such experts
    that the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the labeling or proposed labeling thereof. If the
    Secretary determines, based on relevant science, that data from one
    adequate and well-controlled clinical investigation and
    confirmatory evidence (obtained prior to or after such
    investigation) are sufficient to establish effectiveness, the
    Secretary may consider such data and evidence to constitute
    substantial evidence for purposes of the preceding sentence.
    (e) Withdrawal of approval; grounds; immediate suspension upon
      finding imminent hazard to public health
      The Secretary shall, after due notice and opportunity for hearing
    to the applicant, withdraw approval of an application with respect
    to any drug under this section if the Secretary finds (1) that
    clinical or other experience, tests, or other scientific data show
    that such drug is unsafe for use under the conditions of use upon
    the basis of which the application was approved; (2) that new
    evidence of clinical experience, not contained in such application
    or not available to the Secretary until after such application was
    approved, or tests by new methods, or tests by methods not deemed
    reasonably applicable when such application was approved, evaluated
    together with the evidence available to the Secretary when the
    application was approved, shows that such drug is not shown to be
    safe for use under the conditions of use upon the basis of which
    the application was approved; or (3) on the basis of new
    information before him with respect to such drug, evaluated
    together with the evidence available to him when the application
    was approved, that there is a lack of substantial evidence that the
    drug will have the effect it purports or is represented to have
    under the conditions of use prescribed, recommended, or suggested
    in the labeling thereof; or (4) the patent information prescribed
    by subsection (c) of this section was not filed within thirty days
    after the receipt of written notice from the Secretary specifying
    the failure to file such information; or (5) that the application
    contains any untrue statement of a material fact: Provided, That if
    the Secretary (or in his absence the officer acting as Secretary)
    finds that there is an imminent hazard to the public health, he may
    suspend the approval of such application immediately, and give the
    applicant prompt notice of his action and afford the applicant the
    opportunity for an expedited hearing under this subsection; but the
    authority conferred by this proviso to suspend the approval of an
    application shall not be delegated. The Secretary may also, after
    due notice and opportunity for hearing to the applicant, withdraw
    the approval of an application submitted under subsection (b) or
    (j) of this section with respect to any drug under this section if
    the Secretary finds (1) that the applicant has failed to establish
    a system for maintaining required records, or has repeatedly or
    deliberately failed to maintain such records or to make required
    reports, in accordance with a regulation or order under subsection
    (k) of this section or to comply with the notice requirements of
    section 360(k)(2) of this title, or the applicant has refused to
    permit access to, or copying or verification of, such records as
    required by paragraph (2) of such subsection; or (2) that on the
    basis of new information before him, evaluated together with the
    evidence before him when the application was approved, the methods
    used in, or the facilities and controls used for, the manufacture,
    processing, and packing of such drug are inadequate to assure and
    preserve its identity, strength, quality, and purity and were not
    made adequate within a reasonable time after receipt of written
    notice from the Secretary specifying the matter complained of; or
    (3) that on the basis of new information before him, evaluated
    together with the evidence before him when the application was
    approved, the labeling of such drug, based on a fair evaluation of
    all material facts, is false or misleading in any particular and
    was not corrected within a reasonable time after receipt of written
    notice from the Secretary specifying the matter complained of. Any
    order under this subsection shall state the findings upon which it
    is based.
    (f) Revocation of order refusing, withdrawing or suspending
      approval of application
      Whenever the Secretary finds that the facts so require, he shall
    revoke any previous order under subsection (d) or (e) of this
    section refusing, withdrawing, or suspending approval of an
    application and shall approve such application or reinstate such
    approval, as may be appropriate.
    (g) Service of orders
      Orders of the Secretary issued under this section shall be served
    (1) in person by any officer or employee of the department
    designated by the Secretary or (2) by mailing the order by
    registered mail or by certified mail addressed to the applicant or
    respondent at his last-known address in the records of the
    Secretary.
    (h) Appeal from order
      An appeal may be taken by the applicant from an order of the
    Secretary refusing or withdrawing approval of an application under
    this section. Such appeal shall be taken by filing in the United
    States court of appeals for the circuit wherein such applicant
    resides or has his principal place of business, or in the United
    States Court of Appeals for the District of Columbia Circuit,
    within sixty days after the entry of such order, a written petition
    praying that the order of the Secretary be set aside. A copy of
    such petition shall be forthwith transmitted by the clerk of the
    court to the Secretary, or any officer designated by him for that
    purpose, and thereupon the Secretary shall certify and file in the
    court the record upon which the order complained of was entered, as
    provided in section 2112 of title 28. Upon the filing of such
    petition such court shall have exclusive jurisdiction to affirm or
    set aside such order, except that until the filing of the record
    the Secretary may modify or set aside his order. No objection to
    the order of the Secretary shall be considered by the court unless
    such objection shall have been urged before the Secretary or unless
    there were reasonable grounds for failure so to do. The finding of
    the Secretary as to the facts, if supported by substantial
    evidence, shall be conclusive. If any person shall apply to the
    court for leave to adduce additional evidence, and shall show to
    the satisfaction of the court that such additional evidence is
    material and that there were reasonable grounds for failure to
    adduce such evidence in the proceeding before the Secretary, the
    court may order such additional evidence to be taken before the
    Secretary and to be adduced upon the hearing in such manner and
    upon such terms and conditions as to the court may seem proper. The
    Secretary may modify his findings as to the facts by reason of the
    additional evidence so taken, and he shall file with the court such
    modified findings which, if supported by substantial evidence,
    shall be conclusive, and his recommendation, if any, for the
    setting aside of the original order. The judgment of the court
    affirming or setting aside any such order of the Secretary shall be
    final, subject to review by the Supreme Court of the United States
    upon certiorari or certification as provided in section 1254 of
    title 28. The commencement of proceedings under this subsection
    shall not, unless specifically ordered by the court to the
    contrary, operate as a stay of the Secretary's order.
    (i) Exemptions of drugs for research; discretionary and mandatory
      conditions; direct reports to Secretary
      (1) The Secretary shall promulgate regulations for exempting from
    the operation of the foregoing subsections of this section drugs
    intended solely for investigational use by experts qualified by
    scientific training and experience to investigate the safety and
    effectiveness of drugs. Such regulations may, within the discretion
    of the Secretary, among other conditions relating to the protection
    of the public health, provide for conditioning such exemption upon -
     
        (A) the submission to the Secretary, before any clinical
      testing of a new drug is undertaken, of reports, by the
      manufacturer or the sponsor of the investigation of such drug, of
      preclinical tests (including tests on animals) of such drug
      adequate to justify the proposed clinical testing;
        (B) the manufacturer or the sponsor of the investigation of a
      new drug proposed to be distributed to investigators for clinical
      testing obtaining a signed agreement from each of such
      investigators that patients to whom the drug is administered will
      be under his personal supervision, or under the supervision of
      investigators responsible to him, and that he will not supply
      such drug to any other investigator, or to clinics, for
      administration to human beings;
        (C) the establishment and maintenance of such records, and the
      making of such reports to the Secretary, by the manufacturer or
      the sponsor of the investigation of such drug, of data (including
      but not limited to analytical reports by investigators) obtained
      as the result of such investigational use of such drug, as the
      Secretary finds will enable him to evaluate the safety and
      effectiveness of such drug in the event of the filing of an
      application pursuant to subsection (b) of this section; and
        (D) the submission to the Secretary by the manufacturer or the
      sponsor of the investigation of a new drug of a statement of
      intent regarding whether the manufacturer or sponsor has plans
      for assessing pediatric safety and efficacy.

      (2) Subject to paragraph (3), a clinical investigation of a new
    drug may begin 30 days after the Secretary has received from the
    manufacturer or sponsor of the investigation a submission
    containing such information about the drug and the clinical
    investigation, including - 
        (A) information on design of the investigation and adequate
      reports of basic information, certified by the applicant to be
      accurate reports, necessary to assess the safety of the drug for
      use in clinical investigation; and
        (B) adequate information on the chemistry and manufacturing of
      the drug, controls available for the drug, and primary data
      tabulations from animal or human studies.

      (3)(A) At any time, the Secretary may prohibit the sponsor of an
    investigation from conducting the investigation (referred to in
    this paragraph as a "clinical hold") if the Secretary makes a
    determination described in subparagraph (B). The Secretary shall
    specify the basis for the clinical hold, including the specific
    information available to the Secretary which served as the basis
    for such clinical hold, and confirm such determination in writing.
      (B) For purposes of subparagraph (A), a determination described
    in this subparagraph with respect to a clinical hold is that - 
        (i) the drug involved represents an unreasonable risk to the
      safety of the persons who are the subjects of the clinical
      investigation, taking into account the qualifications of the
      clinical investigators, information about the drug, the design of
      the clinical investigation, the condition for which the drug is
      to be investigated, and the health status of the subjects
      involved; or
        (ii) the clinical hold should be issued for such other reasons
      as the Secretary may by regulation establish (including reasons
      established by regulation before November 21, 1997).

      (C) Any written request to the Secretary from the sponsor of an
    investigation that a clinical hold be removed shall receive a
    decision, in writing and specifying the reasons therefor, within 30
    days after receipt of such request. Any such request shall include
    sufficient information to support the removal of such clinical
    hold.
      (4) Regulations under paragraph (1) shall provide that such
    exemption shall be conditioned upon the manufacturer, or the
    sponsor of the investigation, requiring that experts using such
    drugs for investigational purposes certify to such manufacturer or
    sponsor that they will inform any human beings to whom such drugs,
    or any controls used in connection therewith, are being
    administered, or their representatives, that such drugs are being
    used for investigational purposes and will obtain the consent of
    such human beings or their representatives, except where it is not
    feasible or it is contrary to the best interests of such human
    beings. Nothing in this subsection shall be construed to require
    any clinical investigator to submit directly to the Secretary
    reports on the investigational use of drugs.
    (j) Abbreviated new drug applications
      (1) Any person may file with the Secretary an abbreviated
    application for the approval of a new drug.
      (2)(A) An abbreviated application for a new drug shall contain - 
        (i) information to show that the conditions of use prescribed,
      recommended, or suggested in the labeling proposed for the new
      drug have been previously approved for a drug listed under
      paragraph (7) (hereinafter in this subsection referred to as a
      "listed drug");
        (ii)(I) if the listed drug referred to in clause (i) has only
      one active ingredient, information to show that the active
      ingredient of the new drug is the same as that of the listed
      drug;
        (II) if the listed drug referred to in clause (i) has more than
      one active ingredient, information to show that the active
      ingredients of the new drug are the same as those of the listed
      drug, or
        (III) if the listed drug referred to in clause (i) has more
      than one active ingredient and if one of the active ingredients
      of the new drug is different and the application is filed
      pursuant to the approval of a petition filed under subparagraph
      (C), information to show that the other active ingredients of the
      new drug are the same as the active ingredients of the listed
      drug, information to show that the different active ingredient is
      an active ingredient of a listed drug or of a drug which does not
      meet the requirements of section 321(p) of this title, and such
      other information respecting the different active ingredient with
      respect to which the petition was filed as the Secretary may
      require;
        (iii) information to show that the route of administration, the
      dosage form, and the strength of the new drug are the same as
      those of the listed drug referred to in clause (i) or, if the
      route of administration, the dosage form, or the strength of the
      new drug is different and the application is filed pursuant to
      the approval of a petition filed under subparagraph (C), such
      information respecting the route of administration, dosage form,
      or strength with respect to which the petition was filed as the
      Secretary may require;
        (iv) information to show that the new drug is bioequivalent to
      the listed drug referred to in clause (i), except that if the
      application is filed pursuant to the approval of a petition filed
      under subparagraph (C), information to show that the active
      ingredients of the new drug are of the same pharmacological or
      therapeutic class as those of the listed drug referred to in
      clause (i) and the new drug can be expected to have the same
      therapeutic effect as the listed drug when administered to
      patients for a condition of use referred to in clause (i);
        (v) information to show that the labeling proposed for the new
      drug is the same as the labeling approved for the listed drug
      referred to in clause (i) except for changes required because of
      differences approved under a petition filed under subparagraph
      (C) or because the new drug and the listed drug are produced or
      distributed by different manufacturers;
        (vi) the items specified in clauses (B) through (F) of
      subsection (b)(1) of this section;
        (vii) a certification, in the opinion of the applicant and to
      the best of his knowledge, with respect to each patent which
      claims the listed drug referred to in clause (i) or which claims
      a use for such listed drug for which the applicant is seeking
      approval under this subsection and for which information is
      required to be filed under subsection (b) or (c) of this section -
       
          (I) that such patent information has not been filed,
          (II) that such patent has expired,
          (III) of the date on which such patent will expire, or
          (IV) that such patent is invalid or will not be infringed by
        the manufacture, use, or sale of the new drug for which the
        application is submitted; and

        (viii) if with respect to the listed drug referred to in clause
      (i) information was filed under subsection (b) or (c) of this
      section for a method of use patent which does not claim a use for
      which the applicant is seeking approval under this subsection, a
      statement that the method of use patent does not claim such a
      use.

    The Secretary may not require that an abbreviated application
    contain information in addition to that required by clauses (i)
    through (viii).
      (B) Notice of opinion that patent is invalid or will not be
    infringed. - 
        (i) Agreement to give notice. - An applicant that makes a
      certification described in subparagraph (A)(vii)(IV) shall
      include in the application a statement that the applicant will
      give notice as required by this subparagraph.
        (ii) Timing of notice. - An applicant that makes a
      certification described in subparagraph (A)(vii)(IV) shall give
      notice as required under this subparagraph - 
          (I) if the certification is in the application, not later
        than 20 days after the date of the postmark on the notice with
        which the Secretary informs the applicant that the application
        has been filed; or
          (II) if the certification is in an amendment or supplement to
        the application, at the time at which the applicant submits the
        amendment or supplement, regardless of whether the applicant
        has already given notice with respect to another such
        certification contained in the application or in an amendment
        or supplement to the application.

        (iii) Recipients of notice. - An applicant required under this
      subparagraph to give notice shall give notice to - 
          (I) each owner of the patent that is the subject of the
        certification (or a representative of the owner designated to
        receive such a notice); and
          (II) the holder of the approved application under subsection
        (b) of this section for the drug that is claimed by the patent
        or a use of which is claimed by the patent (or a representative
        of the holder designated to receive such a notice).

        (iv) Contents of notice. - A notice required under this
      subparagraph shall - 
          (I) state that an application that contains data from
        bioavailability or bioequivalence studies has been submitted
        under this subsection for the drug with respect to which the
        certification is made to obtain approval to engage in the
        commercial manufacture, use, or sale of the drug before the
        expiration of the patent referred to in the certification; and
          (II) include a detailed statement of the factual and legal
        basis of the opinion of the applicant that the patent is
        invalid or will not be infringed.

      (C) If a person wants to submit an abbreviated application for a
    new drug which has a different active ingredient or whose route of
    administration, dosage form, or strength differ from that of a
    listed drug, such person shall submit a petition to the Secretary
    seeking permission to file such an application. The Secretary shall
    approve or disapprove a petition submitted under this subparagraph
    within ninety days of the date the petition is submitted. The
    Secretary shall approve such a petition unless the Secretary finds -
     
        (i) that investigations must be conducted to show the safety
      and effectiveness of the drug or of any of its active
      ingredients, the route of administration, the dosage form, or
      strength which differ from the listed drug; or
        (ii) that any drug with a different active ingredient may not
      be adequately evaluated for approval as safe and effective on the
      basis of the information required to be submitted in an
      abbreviated application.

      (D)(i) An applicant may not amend or supplement an application to
    seek approval of a drug referring to a different listed drug from
    the listed drug identified in the application as submitted to the
    Secretary.
      (ii) With respect to the drug for which an application is
    submitted, nothing in this subsection prohibits an applicant from
    amending or supplementing the application to seek approval of a
    different strength.
      (iii) Within 60 days after December 8, 2003, the Secretary shall
    issue guidance defining the term "listed drug" for purposes of this
    subparagraph.
      (3)(A) The Secretary shall issue guidance for the individuals who
    review applications submitted under paragraph (1), which shall
    relate to promptness in conducting the review, technical
    excellence, lack of bias and conflict of interest, and knowledge of
    regulatory and scientific standards, and which shall apply equally
    to all individuals who review such applications.
      (B) The Secretary shall meet with a sponsor of an investigation
    or an applicant for approval for a drug under this subsection if
    the sponsor or applicant makes a reasonable written request for a
    meeting for the purpose of reaching agreement on the design and
    size of bioavailability and bioequivalence studies needed for
    approval of such application. The sponsor or applicant shall
    provide information necessary for discussion and agreement on the
    design and size of such studies. Minutes of any such meeting shall
    be prepared by the Secretary and made available to the sponsor or
    applicant.
      (C) Any agreement regarding the parameters of design and size of
    bioavailability and bioequivalence studies of a drug under this
    paragraph that is reached between the Secretary and a sponsor or
    applicant shall be reduced to writing and made part of the
    administrative record by the Secretary. Such agreement shall not be
    changed after the testing begins, except - 
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with
      subparagraph (D) by the director of the reviewing division, that
      a substantial scientific issue essential to determining the
      safety or effectiveness of the drug has been identified after the
      testing has begun.

      (D) A decision under subparagraph (C)(ii) by the director shall
    be in writing and the Secretary shall provide to the sponsor or
    applicant an opportunity for a meeting at which the director and
    the sponsor or applicant will be present and at which the director
    will document the scientific issue involved.
      (E) The written decisions of the reviewing division shall be
    binding upon, and may not directly or indirectly be changed by, the
    field or compliance office personnel unless such field or
    compliance office personnel demonstrate to the reviewing division
    why such decision should be modified.
      (F) No action by the reviewing division may be delayed because of
    the unavailability of information from or action by field personnel
    unless the reviewing division determines that a delay is necessary
    to assure the marketing of a safe and effective drug.
      (G) For purposes of this paragraph, the reviewing division is the
    division responsible for the review of an application for approval
    of a drug under this subsection (including scientific matters,
    chemistry, manufacturing, and controls).
      (4) Subject to paragraph (5), the Secretary shall approve an
    application for a drug unless the Secretary finds - 
        (A) the methods used in, or the facilities and controls used
      for, the manufacture, processing, and packing of the drug are
      inadequate to assure and preserve its identity, strength,
      quality, and purity;
        (B) information submitted with the application is insufficient
      to show that each of the proposed conditions of use have been
      previously approved for the listed drug referred to in the
      application;
        (C)(i) if the listed drug has only one active ingredient,
      information submitted with the application is insufficient to
      show that the active ingredient is the same as that of the listed
      drug;
        (ii) if the listed drug has more than one active ingredient,
      information submitted with the application is insufficient to
      show that the active ingredients are the same as the active
      ingredients of the listed drug, or
        (iii) if the listed drug has more than one active ingredient
      and if the application is for a drug which has an active
      ingredient different from the listed drug, information submitted
      with the application is insufficient to show - 
          (I) that the other active ingredients are the same as the
        active ingredients of the listed drug, or
          (II) that the different active ingredient is an active
        ingredient of a listed drug or a drug which does not meet the
        requirements of section 321(p) of this title,

      or no petition to file an application for the drug with the
      different ingredient was approved under paragraph (2)(C);
        (D)(i) if the application is for a drug whose route of
      administration, dosage form, or strength of the drug is the same
      as the route of administration, dosage form, or strength of the
      listed drug referred to in the application, information submitted
      in the application is insufficient to show that the route of
      administration, dosage form, or strength is the same as that of
      the listed drug, or
        (ii) if the application is for a drug whose route of
      administration, dosage form, or strength of the drug is different
      from that of the listed drug referred to in the application, no
      petition to file an application for the drug with the different
      route of administration, dosage form, or strength was approved
      under paragraph (2)(C);
        (E) if the application was filed pursuant to the approval of a
      petition under paragraph (2)(C), the application did not contain
      the information required by the Secretary respecting the active
      ingredient, route of administration, dosage form, or strength
      which is not the same;
        (F) information submitted in the application is insufficient to
      show that the drug is bioequivalent to the listed drug referred
      to in the application or, if the application was filed pursuant
      to a petition approved under paragraph (2)(C), information
      submitted in the application is insufficient to show that the
      active ingredients of the new drug are of the same
      pharmacological or therapeutic class as those of the listed drug
      referred to in paragraph (2)(A)(i) and that the new drug can be
      expected to have the same therapeutic effect as the listed drug
      when administered to patients for a condition of use referred to
      in such paragraph;
        (G) information submitted in the application is insufficient to
      show that the labeling proposed for the drug is the same as the
      labeling approved for the listed drug referred to in the
      application except for changes required because of differences
      approved under a petition filed under paragraph (2)(C) or because
      the drug and the listed drug are produced or distributed by
      different manufacturers;
        (H) information submitted in the application or any other
      information available to the Secretary shows that (i) the
      inactive ingredients of the drug are unsafe for use under the
      conditions prescribed, recommended, or suggested in the labeling
      proposed for the drug, or (ii) the composition of the drug is
      unsafe under such conditions because of the type or quantity of
      inactive ingredients included or the manner in which the inactive
      ingredients are included;
        (I) the approval under subsection (c) of this section of the
      listed drug referred to in the application under this subsection
      has been withdrawn or suspended for grounds described in the
      first sentence of subsection (e) of this section, the Secretary
      has published a notice of opportunity for hearing to withdraw
      approval of the listed drug under subsection (c) of this section
      for grounds described in the first sentence of subsection (e) of
      this section, the approval under this subsection of the listed
      drug referred to in the application under this subsection has
      been withdrawn or suspended under paragraph (6), or the Secretary
      has determined that the listed drug has been withdrawn from sale
      for safety or effectiveness reasons;
        (J) the application does not meet any other requirement of
      paragraph (2)(A); or
        (K) the application contains an untrue statement of material
      fact.

      (5)(A) Within one hundred and eighty days of the initial receipt
    of an application under paragraph (2) or within such additional
    period as may be agreed upon by the Secretary and the applicant,
    the Secretary shall approve or disapprove the application.
      (B) The approval of an application submitted under paragraph (2)
    shall be made effective on the last applicable date determined by
    applying the following to each certification made under paragraph
    (2)(A)(vii):
        (i) If the applicant only made a certification described in
      subclause (I) or (II) of paragraph (2)(A)(vii) or in both such
      subclauses, the approval may be made effective immediately.
        (ii) If the applicant made a certification described in
      subclause (III) of paragraph (2)(A)(vii), the approval may be
      made effective on the date certified under subclause (III).
        (iii) If the applicant made a certification described in
      subclause (IV) of paragraph (2)(A)(vii), the approval shall be
      made effective immediately unless, before the expiration of 45
      days after the date on which the notice described in paragraph
      (2)(B) is received, an action is brought for infringement of the
      patent that is the subject of the certification and for which
      information was submitted to the Secretary under subsection
      (b)(1) or (c)(2) of this section before the date on which the
      application (excluding an amendment or supplement to the
      application), which the Secretary later determines to be
      substantially complete, was submitted. If such an action is
      brought before the expiration of such days, the approval shall be
      made effective upon the expiration of the thirty-month period
      beginning on the date of the receipt of the notice provided under
      paragraph (2)(B)(i) or such shorter or longer period as the court
      may order because either party to the action failed to reasonably
      cooperate in expediting the action, except that - 
          (I) if before the expiration of such period the district
        court decides that the patent is invalid or not infringed
        (including any substantive determination that there is no cause
        of action for patent infringement or invalidity), the approval
        shall be made effective on - 
            (aa) the date on which the court enters judgment reflecting
          the decision; or
            (bb) the date of a settlement order or consent decree
          signed and entered by the court stating that the patent that
          is the subject of the certification is invalid or not
          infringed;

          (II) if before the expiration of such period the district
        court decides that the patent has been infringed - 
            (aa) if the judgment of the district court is appealed, the
          approval shall be made effective on - 
              (AA) the date on which the court of appeals decides that
            the patent is invalid or not infringed (including any
            substantive determination that there is no cause of action
            for patent infringement or invalidity); or
              (BB) the date of a settlement order or consent decree
            signed and entered by the court of appeals stating that the
            patent that is the subject of the certification is invalid
            or not infringed; or

            (bb) if the judgment of the district court is not appealed
          or is affirmed, the approval shall be made effective on the
          date specified by the district court in a court order under
          section 271(e)(4)(A) of title 35;

          (III) if before the expiration of such period the court
        grants a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent is
        invalid or not infringed, the approval shall be made effective
        as provided in subclause (I); or
          (IV) if before the expiration of such period the court grants
        a preliminary injunction prohibiting the applicant from
        engaging in the commercial manufacture or sale of the drug
        until the court decides the issues of patent validity and
        infringement and if the court decides that such patent has been
        infringed, the approval shall be made effective as provided in
        subclause (II).

      In such an action, each of the parties shall reasonably cooperate
      in expediting the action.
        (iv) 180-day exclusivity period. - 
          (I) Effectiveness of application. - Subject to subparagraph
        (D), if the application contains a certification described in
        paragraph (2)(A)(vii)(IV) and is for a drug for which a first
        applicant has submitted an application containing such a
        certification, the application shall be made effective on the
        date that is 180 days after the date of the first commercial
        marketing of the drug (including the commercial marketing of
        the listed drug) by any first applicant.
          (II) Definitions. - In this paragraph:
            (aa) 180-day exclusivity period. - The term "180-day
          exclusivity period" means the 180-day period ending on the
          day before the date on which an application submitted by an
          applicant other than a first applicant could become effective
          under this clause.
            (bb) First applicant. - As used in this subsection, the
          term "first applicant" means an applicant that, on the first
          day on which a substantially complete application containing
          a certification described in paragraph (2)(A)(vii)(IV) is
          submitted for approval of a drug, submits a substantially
          complete application that contains and lawfully maintains a
          certification described in paragraph (2)(A)(vii)(IV) for the
          drug.
            (cc) Substantially complete application. - As used in this
          subsection, the term "substantially complete application"
          means an application under this subsection that on its face
          is sufficiently complete to permit a substantive review and
          contains all the information required by paragraph (2)(A).
            (dd) Tentative approval. - 
              (AA) In general. - The term "tentative approval" means
            notification to an applicant by the Secretary that an
            application under this subsection meets the requirements of
            paragraph (2)(A), but cannot receive effective approval
            because the application does not meet the requirements of
            this subparagraph, there is a period of exclusivity for the
            listed drug under subparagraph (F) or section 355a of this
            title, or there is a 7-year period of exclusivity for the
            listed drug under section 360cc of this title.
              (BB) Limitation. - A drug that is granted tentative
            approval by the Secretary is not an approved drug and shall
            not have an effective approval until the Secretary issues
            an approval after any necessary additional review of the
            application.

      (C) Civil action to obtain patent certainty. - 
        (i) Declaratory judgment absent infringement action. - 
          (I) In general. - No action may be brought under section 2201
        of title 28 by an applicant under paragraph (2) for a
        declaratory judgment with respect to a patent which is the
        subject of the certification referred to in subparagraph
        (B)(iii) unless - 
            (aa) the 45-day period referred to in such subparagraph has
          expired;
            (bb) neither the owner of such patent nor the holder of the
          approved application under subsection (b) of this section for
          the drug that is claimed by the patent or a use of which is
          claimed by the patent brought a civil action against the
          applicant for infringement of the patent before the
          expiration of such period; and
            (cc) in any case in which the notice provided under
          paragraph (2)(B) relates to noninfringement, the notice was
          accompanied by a document described in subclause (III).

          (II) Filing of civil action. - If the conditions described in
        items (aa), (bb), and as applicable, (cc) of subclause (I) have
        been met, the applicant referred to in such subclause may, in
        accordance with section 2201 of title 28, bring a civil action
        under such section against the owner or holder referred to in
        such subclause (but not against any owner or holder that has
        brought such a civil action against the applicant, unless that
        civil action was dismissed without prejudice) for a declaratory
        judgment that the patent is invalid or will not be infringed by
        the drug for which the applicant seeks approval, except that
        such civil action may be brought for a declaratory judgment
        that the patent will not be infringed only in a case in which
        the condition described in subclause (I)(cc) is applicable. A
        civil action referred to in this subclause shall be brought in
        the judicial district where the defendant has its principal
        place of business or a regular and established place of
        business.
          (III) Offer of confidential access to application. - For
        purposes of subclause (I)(cc), the document described in this
        subclause is a document providing an offer of confidential
        access to the application that is in the custody of the
        applicant under paragraph (2) for the purpose of determining
        whether an action referred to in subparagraph (B)(iii) should
        be brought. The document providing the offer of confidential
        access shall contain such restrictions as to persons entitled
        to access, and on the use and disposition of any information
        accessed, as would apply had a protective order been entered
        for the purpose of protecting trade secrets and other
        confidential business information. A request for access to an
        application under an offer of confidential access shall be
        considered acceptance of the offer of confidential access with
        the restrictions as to persons entitled to access, and on the
        use and disposition of any information accessed, contained in
        the offer of confidential access, and those restrictions and
        other terms of the offer of confidential access shall be
        considered terms of an enforceable contract. Any person
        provided an offer of confidential access shall review the
        application for the sole and limited purpose of evaluating
        possible infringement of the patent that is the subject of the
        certification under paragraph (2)(A)(vii)(IV) and for no other
        purpose, and may not disclose information of no relevance to
        any issue of patent infringement to any person other than a
        person provided an offer of confidential access. Further, the
        application may be redacted by the applicant to remove any
        information of no relevance to any issue of patent
        infringement.

        (ii) Counterclaim to infringement action. - 
          (I) In general. - If an owner of the patent or the holder of
        the approved application under subsection (b) of this section
        for the drug that is claimed by the patent or a use of which is
        claimed by the patent brings a patent infringement action
        against the applicant, the applicant may assert a counterclaim
        seeking an order requiring the holder to correct or delete the
        patent information submitted by the holder under subsection (b)
        or (c) of this section on the ground that the patent does not
        claim either - 
            (aa) the drug for which the application was approved; or
            (bb) an approved method of using the drug.

          (II) No independent cause of action. - Subclause (I) does not
        authorize the assertion of a claim described in subclause (I)
        in any civil action or proceeding other than a counterclaim
        described in subclause (I).

        (iii) No damages. - An applicant shall not be entitled to
      damages in a civil action under clause (i) or a counterclaim
      under clause (ii).

      (D) Forfeiture of 180-day exclusivity period. - 
        (i) Definition of forfeiture event. - In this subparagraph, the
      term "forfeiture event", with respect to an application under
      this subsection, means the occurrence of any of the following:
          (I) Failure to market. - The first applicant fails to market
        the drug by the later of - 
            (aa) the earlier of the date that is - 
              (AA) 75 days after the date on which the approval of the
            application of the first applicant is made effective under
            subparagraph (B)(iii); or
              (BB) 30 months after the date of submission of the
            application of the first applicant; or

            (bb) with respect to the first applicant or any other
          applicant (which other applicant has received tentative
          approval), the date that is 75 days after the date as of
          which, as to each of the patents with respect to which the
          first applicant submitted and lawfully maintained a
          certification qualifying the first applicant for the 180-day
          exclusivity period under subparagraph (B)(iv), at least 1 of
          the following has occurred:
              (AA) In an infringement action brought against that
            applicant with respect to the patent or in a declaratory
            judgment action brought by that applicant with respect to
            the patent, a court enters a final decision from which no
            appeal (other than a petition to the Supreme Court for a
            writ of certiorari) has been or can be taken that the
            patent is invalid or not infringed.
              (BB) In an infringement action or a declaratory judgment
            action described in subitem (AA), a court signs a
            settlement order or consent decree that enters a final
            judgment that includes a finding that the patent is invalid
            or not infringed.
              (CC) The patent information submitted under subsection
            (b) or (c) of this section is withdrawn by the holder of
            the application approved under subsection (b) of this
            section.

          (II) Withdrawal of application. - The first applicant
        withdraws the application or the Secretary considers the
        application to have been withdrawn as a result of a
        determination by the Secretary that the application does not
        meet the requirements for approval under paragraph (4).
          (III) Amendment of certification. - The first applicant
        amends or withdraws the certification for all of the patents
        with respect to which that applicant submitted a certification
        qualifying the applicant for the 180-day exclusivity period.
          (IV) Failure to obtain tentative approval. - The first
        applicant fails to obtain tentative approval of the application
        within 30 months after the date on which the application is
        filed, unless the failure is caused by a change in or a review
        of the requirements for approval of the application imposed
        after the date on which the application is filed.
          (V) Agreement with another applicant, the listed drug
        application holder, or a patent owner. - The first applicant
        enters into an agreement with another applicant under this
        subsection for the drug, the holder of the application for the
        listed drug, or an owner of the patent that is the subject of
        the certification under paragraph (2)(A)(vii)(IV), the Federal
        Trade Commission or the Attorney General files a complaint, and
        there is a final decision of the Federal Trade Commission or
        the court with regard to the complaint from which no appeal
        (other than a petition to the Supreme Court for a writ of
        certiorari) has been or can be taken that the agreement has
        violated the antitrust laws (as defined in section 12 of title
        15, except that the term includes section 45 of title 15 to the
        extent that that section applies to unfair methods of
        competition).
          (VI) Expiration of all patents. - All of the patents as to
        which the applicant submitted a certification qualifying it for
        the 180-day exclusivity period have expired.

        (ii) Forfeiture. - The 180-day exclusivity period described in
      subparagraph (B)(iv) shall be forfeited by a first applicant if a
      forfeiture event occurs with respect to that first applicant.
        (iii) Subsequent applicant. - If all first applicants forfeit
      the 180-day exclusivity period under clause (ii) - 
          (I) approval of any application containing a certification
        described in paragraph (2)(A)(vii)(IV) shall be made effective
        in accordance with subparagraph (B)(iii); and
          (II) no applicant shall be eligible for a 180-day exclusivity
        period.

      (E) If the Secretary decides to disapprove an application, the
    Secretary shall give the applicant notice of an opportunity for a
    hearing before the Secretary on the question of whether such
    application is approvable. If the applicant elects to accept the
    opportunity for hearing by written request within thirty days after
    such notice, such hearing shall commence not more than ninety days
    after the expiration of such thirty days unless the Secretary and
    the applicant otherwise agree. Any such hearing shall thereafter be
    conducted on an expedited basis and the Secretary's order thereon
    shall be issued within ninety days after the date fixed by the
    Secretary for filing final briefs.
      (F)(i) If an application (other than an abbreviated new drug
    application) submitted under subsection (b) of this section for a
    drug, no active ingredient (including any ester or salt of the
    active ingredient) of which has been approved in any other
    application under subsection (b) of this section, was approved
    during the period beginning January 1, 1982, and ending on
    September 24, 1984, the Secretary may not make the approval of an
    application submitted under this subsection which refers to the
    drug for which the subsection (b) application was submitted
    effective before the expiration of ten years from the date of the
    approval of the application under subsection (b) of this section.
      (ii) If an application submitted under subsection (b) of this
    section for a drug, no active ingredient (including any ester or
    salt of the active ingredient) of which has been approved in any
    other application under subsection (b) of this section, is approved
    after September 24, 1984, no application may be submitted under
    this subsection which refers to the drug for which the subsection
    (b) application was submitted before the expiration of five years
    from the date of the approval of the application under subsection
    (b) of this section, except that such an application may be
    submitted under this subsection after the expiration of four years
    from the date of the approval of the subsection (b) application if
    it contains a certification of patent invalidity or noninfringement
    described in subclause (IV) of paragraph (2)(A)(vii). The approval
    of such an application shall be made effective in accordance with
    subparagraph (B) except that, if an action for patent infringement
    is commenced during the one-year period beginning forty-eight
    months after the date of the approval of the subsection (b)
    application, the thirty-month period referred to in subparagraph
    (B)(iii) shall be extended by such amount of time (if any) which is
    required for seven and one-half years to have elapsed from the date
    of approval of the subsection (b) application.
      (iii) If an application submitted under subsection (b) of this
    section for a drug, which includes an active ingredient (including
    any ester or salt of the active ingredient) that has been approved
    in another application approved under subsection (b) of this
    section, is approved after September 24, 1984, and if such
    application contains reports of new clinical investigations (other
    than bioavailability studies) essential to the approval of the
    application and conducted or sponsored by the applicant, the
    Secretary may not make the approval of an application submitted
    under this subsection for the conditions of approval of such drug
    in the subsection (b) application effective before the expiration
    of three years from the date of the approval of the application
    under subsection (b) of this section for such drug.
      (iv) If a supplement to an application approved under subsection
    (b) of this section is approved after September 24, 1984, and the
    supplement contains reports of new clinical investigations (other
    than bioavailability studies) essential to the approval of the
    supplement and conducted or sponsored by the person submitting the
    supplement, the Secretary may not make the approval of an
    application submitted under this subsection for a change approved
    in the supplement effective before the expiration of three years
    from the date of the approval of the supplement under subsection
    (b) of this section.
      (v) If an application (or supplement to an application) submitted
    under subsection (b) of this section for a drug, which includes an
    active ingredient (including any ester or salt of the active
    ingredient) that has been approved in another application under
    subsection (b) of this section, was approved during the period
    beginning January 1, 1982, and ending on September 24, 1984, the
    Secretary may not make the approval of an application submitted
    under this subsection which refers to the drug for which the
    subsection (b) application was submitted or which refers to a
    change approved in a supplement to the subsection (b) application
    effective before the expiration of two years from September 24,
    1984.
      (6) If a drug approved under this subsection refers in its
    approved application to a drug the approval of which was withdrawn
    or suspended for grounds described in the first sentence of
    subsection (e) of this section or was withdrawn or suspended under
    this paragraph or which, as determined by the Secretary, has been
    withdrawn from sale for safety or effectiveness reasons, the
    approval of the drug under this subsection shall be withdrawn or
    suspended - 
        (A) for the same period as the withdrawal or suspension under
      subsection (e) of this section or this paragraph, or
        (B) if the listed drug has been withdrawn from sale, for the
      period of withdrawal from sale or, if earlier, the period ending
      on the date the Secretary determines that the withdrawal from
      sale is not for safety or effectiveness reasons.

      (7)(A)(i) Within sixty days of September 24, 1984, the Secretary
    shall publish and make available to the public - 
        (I) a list in alphabetical order of the official and
      proprietary name of each drug which has been approved for safety
      and effectiveness under subsection (c) of this section before
      September 24, 1984;
        (II) the date of approval if the drug is approved after 1981
      and the number of the application which was approved; and
        (III) whether in vitro or in vivo bioequivalence studies, or
      both such studies, are required for applications filed under this
      subsection which will refer to the drug published.

      (ii) Every thirty days after the publication of the first list
    under clause (i) the Secretary shall revise the list to include
    each drug which has been approved for safety and effectiveness
    under subsection (c) of this section or approved under this
    subsection during the thirty-day period.
      (iii) When patent information submitted under subsection (b) or
    (c) of this section respecting a drug included on the list is to be
    published by the Secretary, the Secretary shall, in revisions made
    under clause (ii), include such information for such drug.
      (B) A drug approved for safety and effectiveness under subsection
    (c) of this section or approved under this subsection shall, for
    purposes of this subsection, be considered to have been published
    under subparagraph (A) on the date of its approval or September 24,
    1984, whichever is later.
      (C) If the approval of a drug was withdrawn or suspended for
    grounds described in the first sentence of subsection (e) of this
    section or was withdrawn or suspended under paragraph (6) or if the
    Secretary determines that a drug has been withdrawn from sale for
    safety or effectiveness reasons, it may not be published in the
    list under subparagraph (A) or, if the withdrawal or suspension
    occurred after its publication in such list, it shall be
    immediately removed from such list - 
        (i) for the same period as the withdrawal or suspension under
      subsection (e) of this section or paragraph (6), or
        (ii) if the listed drug has been withdrawn from sale, for the
      period of withdrawal from sale or, if earlier, the period ending
      on the date the Secretary determines that the withdrawal from
      sale is not for safety or effectiveness reasons.

    A notice of the removal shall be published in the Federal Register.
      (8) For purposes of this subsection:
        (A)(i) The term "bioavailability" means the rate and extent to
      which the active ingredient or therapeutic ingredient is absorbed
      from a drug and becomes available at the site of drug action.
        (ii) For a drug that is not intended to be absorbed into the
      bloodstream, the Secretary may assess bioavailability by
      scientifically valid measurements intended to reflect the rate
      and extent to which the active ingredient or therapeutic
      ingredient becomes available at the site of drug action.
        (B) A drug shall be considered to be bioequivalent to a listed
      drug if - 
          (i) the rate and extent of absorption of the drug do not show
        a significant difference from the rate and extent of absorption
        of the listed drug when administered at the same molar dose of
        the therapeutic ingredient under similar experimental
        conditions in either a single dose or multiple doses; or
          (ii) the extent of absorption of the drug does not show a
        significant difference from the extent of absorption of the
        listed drug when administered at the same molar dose of the
        therapeutic ingredient under similar experimental conditions in
        either a single dose or multiple doses and the difference from
        the listed drug in the rate of absorption of the drug is
        intentional, is reflected in its proposed labeling, is not
        essential to the attainment of effective body drug
        concentrations on chronic use, and is considered medically
        insignificant for the drug.

        (C) For a drug that is not intended to be absorbed into the
      bloodstream, the Secretary may establish alternative,
      scientifically valid methods to show bioequivalence if the
      alternative methods are expected to detect a significant
      difference between the drug and the listed drug in safety and
      therapeutic effect.

      (9) The Secretary shall, with respect to each application
    submitted under this subsection, maintain a record of - 
        (A) the name of the applicant,
        (B) the name of the drug covered by the application,
        (C) the name of each person to whom the review of the chemistry
      of the application was assigned and the date of such assignment,
      and
        (D) the name of each person to whom the bioequivalence review
      for such application was assigned and the date of such
      assignment.

    The information the Secretary is required to maintain under this
    paragraph with respect to an application submitted under this
    subsection shall be made available to the public after the approval
    of such application.
    (k) Records and reports; required information; regulations and
      orders; access to records
      (1) In the case of any drug for which an approval of an
    application filed under subsection (b) or (j) of this section is in
    effect, the applicant shall establish and maintain such records,
    and make such reports to the Secretary, of data relating to
    clinical experience and other data or information, received or
    otherwise obtained by such applicant with respect to such drug, as
    the Secretary may by general regulation, or by order with respect
    to such application, prescribe on the basis of a finding that such
    records and reports are necessary in order to enable the Secretary
    to determine, or facilitate a determination, whether there is or
    may be ground for invoking subsection (e) of this section.
    Regulations and orders issued under this subsection and under
    subsection (i) of this section shall have due regard for the
    professional ethics of the medical profession and the interests of
    patients and shall provide, where the Secretary deems it to be
    appropriate, for the examination, upon request, by the persons to
    whom such regulations or orders are applicable, of similar
    information received or otherwise obtained by the Secretary.
      (2) Every person required under this section to maintain records,
    and every person in charge or custody thereof, shall, upon request
    of an officer or employee designated by the Secretary, permit such
    officer or employee at all reasonable times to have access to and
    copy and verify such records.
    (l) Public disclosure of safety and effectiveness data
      Safety and effectiveness data and information which has been
    submitted in an application under subsection (b) of this section
    for a drug and which has not previously been disclosed to the
    public shall be made available to the public, upon request, unless
    extraordinary circumstances are shown - 
        (1) if no work is being or will be undertaken to have the
      application approved,
        (2) if the Secretary has determined that the application is not
      approvable and all legal appeals have been exhausted,
        (3) if approval of the application under subsection (c) of this
      section is withdrawn and all legal appeals have been exhausted,
        (4) if the Secretary has determined that such drug is not a new
      drug, or
        (5) upon the effective date of the approval of the first
      application under subsection (j) of this section which refers to
      such drug or upon the date upon which the approval of an
      application under subsection (j) of this section which refers to
      such drug could be made effective if such an application had been
      submitted.
    (m) "Patent" defined
      For purposes of this section, the term "patent" means a patent
    issued by the United States Patent and Trademark Office.
    (n) Scientific advisory panels
      (1) For the purpose of providing expert scientific advice and
    recommendations to the Secretary regarding a clinical investigation
    of a drug or the approval for marketing of a drug under this
    section or section 262 of title 42, the Secretary shall establish
    panels of experts or use panels of experts established before
    November 21, 1997, or both.
      (2) The Secretary may delegate the appointment and oversight
    authority granted under section 394 of this title to a director of
    a center or successor entity within the Food and Drug
    Administration.
      (3) The Secretary shall make appointments to each panel
    established under paragraph (1) so that each panel shall consist of
    - 
        (A) members who are qualified by training and experience to
      evaluate the safety and effectiveness of the drugs to be referred
      to the panel and who, to the extent feasible, possess skill and
      experience in the development, manufacture, or utilization of
      such drugs;
        (B) members with diverse expertise in such fields  as  clinical
       and  administrative  medicine, pharmacy, pharmacology,
      pharmacoeconomics, biological and physical sciences, and other
      related professions;
        (C) a representative of consumer interests, and a
      representative of interests of the drug manufacturing industry
      not directly affected by the matter to be brought before the
      panel; and
        (D) two or more members who are specialists or have other
      expertise in the particular disease or condition for which the
      drug under review is proposed to be indicated.

    Scientific, trade, and consumer organizations shall be afforded an
    opportunity to nominate individuals for appointment to the panels.
    No individual who is in the regular full-time employ of the United
    States and engaged in the administration of this chapter may be a
    voting member of any panel. The Secretary shall designate one of
    the members of each panel to serve as chairman thereof.
      (4) Each member of a panel shall publicly disclose all conflicts
    of interest that member may have with the work to be undertaken by
    the panel. No member of a panel may vote on any matter where the
    member or the immediate family of such member could gain
    financially from the advice given to the Secretary. The Secretary
    may grant a waiver of any conflict of interest requirement upon
    public disclosure of such conflict of interest if such waiver is
    necessary to afford the panel essential expertise, except that the
    Secretary may not grant a waiver for a member of a panel when the
    member's own scientific work is involved.
      (5) The Secretary shall, as appropriate, provide education and
    training to each new panel member before such member participates
    in a panel's activities, including education regarding requirements
    under this chapter and related regulations of the Secretary, and
    the administrative processes and procedures related to panel
    meetings.
      (6) Panel members (other than officers or employees of the United
    States), while attending meetings or conferences of a panel or
    otherwise engaged in its business, shall be entitled to receive
    compensation for each day so engaged, including traveltime, at
    rates to be fixed by the Secretary, but not to exceed the daily
    equivalent of the rate in effect for positions classified above
    grade GS-15 of the General Schedule. While serving away from their
    homes or regular places of business, panel members may be allowed
    travel expenses (including per diem in lieu of subsistence) as
    authorized by section 5703 of title 5, for persons in the
    Government service employed intermittently.
      (7) The Secretary shall ensure that scientific advisory panels
    meet regularly and at appropriate intervals so that any matter to
    be reviewed by such a panel can be presented to the panel not more
    than 60 days after the matter is ready for such review. Meetings of
    the panel may be held using electronic communication to convene the
    meetings.
      (8) Within 90 days after a scientific advisory panel makes
    recommendations on any matter under its review, the Food and Drug
    Administration official responsible for the matter shall review the
    conclusions and recommendations of the panel, and notify the
    affected persons of the final decision on the matter, or of the
    reasons that no such decision has been reached. Each such final
    decision shall be documented including the rationale for the
    decision.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 505, 52 Stat. 1052; Pub. L. 86-507,
    Sec. 1(18), June 11, 1960, 74 Stat. 201; Pub. L. 87-781, title I,
    Secs. 102(b)-(d), 103(a), (b), 104(a)-(d)(2), Oct. 10, 1962, 76
    Stat. 781-783, 784, 785; Pub. L. 92-387, Sec. 4(d), Aug. 16, 1972,
    86 Stat. 562; Pub. L. 98-417, title I, Secs. 101, 102(a)-(b)(5),
    103, 104, Sept. 24, 1984, 98 Stat. 1585, 1592, 1593, 1597; Pub. L.
    102-282, Sec. 5, May 13, 1992, 106 Stat. 161; Pub. L. 103-80, Sec.
    3(n), Aug. 13, 1993, 107 Stat. 777; Pub. L. 105-115, title I, Secs.
    115, 117, 119, 120, 124(a), Nov. 21, 1997, 111 Stat. 2313, 2315,
    2316, 2318, 2324; Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title
    IV, Sec. 4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584;
    Pub. L. 107-109, Sec. 15(c)(1), Jan. 4, 2002, 115 Stat. 1420; Pub.
    L. 108-155, Sec. 2(b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-
    173, title XI, Secs. 1101(a), (b), 1102(a), 1103(a), Dec. 8, 2003,
    117 Stat. 2448, 2452, 2457, 2460.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The General Schedule, referred to in subsec. (n)(6), is set out
    under section 5332 of Title 5, Government Organization and
    Employees.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (b)(1). Pub. L. 108-155, in second sentence,
    substituted "(F)" for "and (F)" and inserted ", and (G) any
    assessments required under section 355c of this title" before
    period at end.
      Subsec. (b)(3). Pub. L. 108-173, Sec. 1101(b)(1)(A), added par.
    (3) and struck out former par. (3) which, in subpar. (A), required
    an applicant making a certification under par. (2)(A)(iv) to
    include statement that applicant will give notice to each owner of
    the patent which is the subject of the certification and to the
    holder of the approved application, in subpar. (B), directed that
    notice state that an application has been submitted and include a
    detailed statement of the applicant's opinion that the patent is
    not valid or will not be infringed, and, in subpar. (C), provided
    that if an application is amended, notice shall be given when the
    amended application is submitted.
      Subsec. (b)(4), (5). Pub. L. 108-173, Sec. 1101(b)(1)(B), added
    par. (4) and redesignated former par. (4) as (5).
      Subsec. (c)(3). Pub. L. 108-173, Sec. 1101(b)(2)(A), substituted
    "by applying the following to each certification made under
    subsection (b)(2)(A) of this section" for "under the following" in
    introductory provisions.
      Subsec. (c)(3)(C). Pub. L. 108-173, Sec. 1101(b)(2)(B)(iii),
    which directed the substitution of "subsection (b)(3) of this
    section" for "paragraph (3)(B)" in third sentence, could not be
    executed because such words do not appear. See note below.
      Pub. L. 108-173, Sec. 1101(b)(2)(B)(ii)(VI), in concluding
    provisions, struck out "Until the expiration of forty-five days
    from the date the notice made under paragraph (3)(B) is received,
    no action may be brought under section 2201 of title 28 for a
    declaratory judgment with respect to the patent. Any action brought
    under such section 2201 shall be brought in the judicial district
    where the defendant has its principal place of business or a
    regular and established place of business." after "expediting the
    action."
      Pub. L. 108-173, Sec. 1101(b)(2)(B)(i), (ii)(I), in first
    sentence of introductory provisions, substituted "unless, before
    the expiration of 45 days after the date on which the notice
    described in subsection (b)(3) of this section is received, an
    action is brought for infringement of the patent that is the
    subject of the certification and for which information was
    submitted to the Secretary under paragraph (2) or subsection (b)(1)
    of this section before the date on which the application (excluding
    an amendment or supplement to the application) was submitted" for
    "unless an action is brought for infringement of a patent which is
    the subject of the certification before the expiration of forty-
    five days from the date the notice provided under paragraph (3)(B)
    is received" and, in second sentence of introductory provisions,
    substituted "subsection (b)(3) of this section" for "paragraph
    (3)(B)".
      Subsec. (c)(3)(C)(i). Pub. L. 108-173, Sec.
    1101(b)(2)(B)(ii)(II), added cl. (i) and struck out former cl. (i)
    which read as follows: "if before the expiration of such period the
    court decides that such patent is invalid or not infringed, the
    approval may be made effective on the date of the court decision,".
      Subsec. (c)(3)(C)(ii). Pub. L. 108-173, Sec.
    1101(b)(2)(B)(ii)(III), added cl. (ii) and struck out former cl.
    (ii) which read as follows: "if before the expiration of such
    period the court decides that such patent has been infringed, the
    approval may be made effective on such date as the court orders
    under section 271(e)(4)(A) of title 35, or".
      Subsec. (c)(3)(C)(iii). Pub. L. 108-173, Sec.
    1101(b)(2)(B)(ii)(IV), substituted "as provided in clause (i); or"
    for "on the date of such court decision."
      Subsec. (c)(3)(C)(iv). Pub. L. 108-173, Sec.
    1101(b)(2)(B)(ii)(V), added cl. (iv).
      Subsec. (c)(3)(D), (E). Pub. L. 108-173, Sec. 1101(b)(2)(C), (D),
    added subpar. (D) and redesignated former subpar. (D) as (E).
      Subsec. (j)(2)(B). Pub. L. 108-173, Sec. 1101(a)(1)(A), added
    subpar. (B) and struck out former subpar. (B) which, in cl. (i),
    required that an applicant making a certification under subpar.
    (A)(vii)(IV) include in the application a statement that notice
    would be given to each owner of the patent and the holder of the
    approved application, in cl. (ii), required that notice would state
    that an application had been submitted and that it would include a
    detailed statement of the basis of the applicant's opinion, and, in
    cl. (iii), directed that notice of an amended application be given
    when the amended application had been submitted.
      Subsec. (j)(2)(D). Pub. L. 108-173, Sec. 1101(a)(1)(B), added
    subpar. (D).
      Subsec. (j)(5)(B). Pub. L. 108-173, Sec. 1101(a)(2)(A)(i),
    substituted "by applying the following to each certification made
    under paragraph (2)(A)(vii)" for "under the following" in
    introductory provisions.
      Subsec. (j)(5)(B)(iii). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(ee), which directed amendment of the second
    sentence of subsec. (j)(5)(B)(iii) by striking "Until the
    expiration" and all that follows in the matter after and below
    subclause (IV), was executed by striking "Until the expiration of
    forty-five days from the date the notice made under paragraph
    (2)(B)(i) is received, no action may be brought under section 2201
    of title 28, for a declaratory judgment with respect to the patent.
    Any action brought under section 2201 shall be brought in the
    judicial district where the defendant has its principal place of
    business or a regular and established place of business." after
    "expediting the action." in concluding provisions, to reflect the
    probable intent of Congress.
      Pub. L. 108-173, Sec. 1101(a)(2)(A)(ii)(I), in introductory
    provisions, substituted "unless, before the expiration of 45 days
    after the date on which the notice described in paragraph (2)(B) is
    received, an action is brought for infringement of the patent that
    is the subject of the certification and for which information was
    submitted to the Secretary under subsection (b)(1) or (c)(2) of
    this section before the date on which the application (excluding an
    amendment or supplement to the application), which the Secretary
    later determines to be substantially complete, was submitted" for
    "unless an action is brought for infringement of a patent which is
    the subject of the certification before the expiration of forty-
    five days from the date the notice provided under paragraph
    (2)(B)(i) is received".
      Subsec. (j)(5)(B)(iii)(I). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(aa), added subcl. (I) and struck out former
    subcl. (I) which read as follows: "if before the expiration of such
    period the court decides that such patent is invalid or not
    infringed, the approval shall be made effective on the date of the
    court decision,".
      Subsec. (j)(5)(B)(iii)(II). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(bb), added subcl. (II) and struck out former
    subcl. (II) which read as follows: "if before the expiration of
    such period the court decides that such patent has been infringed,
    the approval shall be made effective on such date as the court
    orders under section 271(e)(4)(A) of title 35, or".
      Subsec. (j)(5)(B)(iii)(III). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(cc), substituted "as provided in subclause
    (I); or" for "on the date of such court decision."
      Subsec. (j)(5)(B)(iii)(IV). Pub. L. 108-173, Sec.
    1101(a)(2)(A)(ii)(II)(dd), added subcl. (IV).
      Subsec. (j)(5)(B)(iv). Pub. L. 108-173, Sec. 1102(a)(1), added
    cl. (iv) and struck out former cl. (iv) which read as follows: "If
    the application contains a certification described in subclause
    (IV) of paragraph (2)(A)(vii) and is for a drug for which a
    previous application has been submitted under this subsection
    continuing such a certification, the application shall be made
    effective not earlier than one hundred and eighty days after - 
        "(I) the date the Secretary receives notice from the applicant
      under the previous application of the first commercial marketing
      of the drug under the previous application, or
        "(II) the date of a decision of a court in an action described
      in clause (iii) holding the patent which is the subject of the
      certification to be invalid or not infringed,
    whichever is earlier."
      Subsec. (j)(5)(C). Pub. L. 108-173, Sec. 1101(a)(2)(B), (C),
    added subpar. (C). Former subpar. (C) redesignated (E).
      Subsec. (j)(5)(D). Pub. L. 108-173, Sec. 1102(a)(2), added
    subpar. (D).
      Pub. L. 108-173, Sec. 1101(a)(2)(B), redesignated subpar. (D) as
    (F).
      Subsec. (j)(5)(E), (F). Pub. L. 108-173, Sec. 1101(a)(2)(B),
    redesignated subpars. (C) and (D) as (E) and (F), respectively.
      Subsec. (j)(8)(A). Pub. L. 108-173, Sec. 1103(a)(1), added
    subpar. (A) and struck out former subpar. (A) which read as
    follows: "The term 'bioavailability' means the rate and extent to
    which the active ingredient or therapeutic ingredient is absorbed
    from a drug and becomes available at the site of drug action."
      Subsec. (j)(8)(C). Pub. L. 108-173, Sec. 1103(a)(2), added
    subpar. (C).
      2002 - Subsec. (i)(1)(D). Pub. L. 107-109 added subpar. (D).
      1999 - Subsec. (m). Pub. L. 106-113 substituted "United States
    Patent and Trademark Office" for "Patent and Trademark Office of
    the Department of Commerce".
      1997 - Subsec. (b)(1). Pub. L. 105-115, Sec. 115(b), inserted at
    end "The Secretary shall, in consultation with the Director of the
    National Institutes of Health and with representatives of the drug
    manufacturing industry, review and develop guidance, as
    appropriate, on the inclusion of women and minorities in clinical
    trials required by clause (A)."
      Subsec. (b)(4). Pub. L. 105-115, Sec. 119(a), added par. (4).
      Subsec. (c)(4). Pub. L. 105-115, Sec. 124(a), added par. (4).
      Subsec. (d). Pub. L. 105-115, Sec. 115(a), inserted at end "If
    the Secretary determines, based on relevant science, that data from
    one adequate and well-controlled clinical investigation and
    confirmatory evidence (obtained prior to or after such
    investigation) are sufficient to establish effectiveness, the
    Secretary may consider such data and evidence to constitute
    substantial evidence for purposes of the preceding sentence."
      Subsec. (i). Pub. L. 105-115, Sec. 117, inserted "(1)" after
    "(i)", redesignated former pars. (1) to (3) as subpars. (A) to (C),
    respectively, of par. (1), added pars. (2) to (4), and struck out
    closing provisions which read as follows: "Such regulations shall
    provide that such exemption shall be conditioned upon the
    manufacturer, or the sponsor of the investigation, requiring that
    experts using such drugs for investigational purposes certify to
    such manufacturer or sponsor that they will inform any human beings
    to whom such drugs, or any controls used in connection therewith,
    are being administered, or their representatives, that such drugs
    are being used for investigational purposes and will obtain the
    consent of such human beings or their representatives, except where
    they deem it not feasible or, in their professional judgment,
    contrary to the best interests of such human beings. Nothing in
    this subsection shall be construed to require any clinical
    investigator to submit directly to the Secretary reports on the
    investigational use of drugs."
      Subsec. (j)(2)(A)(i). Pub. L. 105-115, Sec. 119(b)(2)(A),
    substituted "paragraph (7)" for "paragraph (6)".
      Subsec. (j)(3). Pub. L. 105-115, Sec. 119(b)(1)(B), added par.
    (3). Former par. (3) redesignated (4).
      Subsec. (j)(4). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(B),
    redesignated par. (3) as (4) and in introductory provisions
    substituted "paragraph (5)" for "paragraph (4)". Former par. (4)
    redesignated (5).
      Subsec. (j)(4)(I). Pub. L. 105-115, Sec. 119(b)(2)(C),
    substituted "paragraph (6)" for "paragraph (5)".
      Subsec. (j)(5), (6). Pub. L. 105-115, Sec. 119(b)(1)(A),
    redesignated pars. (4) and (5) as (5) and (6), respectively. Former
    par. (6) redesignated (7).
      Subsec. (j)(7). Pub. L. 105-115, Sec. 119(b)(1)(A), (2)(D),
    redesignated par. (6) as (7) and in subpar. (C) substituted
    "paragraph (6)" for "paragraph (5)" in two places. Former par. (7)
    redesignated (8).
      Subsec. (j)(8), (9). Pub. L. 105-115, Sec. 119(b)(1)(A),
    redesignated pars. (7) and (8) as (8) and (9), respectively.
      Subsec. (n). Pub. L. 105-115, Sec. 120, added subsec. (n).
      1993 - Subsec. (j)(6)(A)(ii). Pub. L. 103-80, Sec. 3(n)(1)(A),
    substituted "Secretary" for "Secretry".
      Subsec. (j)(6)(A)(iii). Pub. L. 103-80, Sec. 3(n)(1)(B), inserted
    comma after "published by the Secretary".
      Subsec. (k)(1). Pub. L. 103-80, Sec. 3(n)(2), substituted
    "section. Regulations" for "section: Provided, however, That
    regulations".
      1992 - Subsec. (j)(8). Pub. L. 102-282 added par. (8).
      1984 - Subsec. (a). Pub. L. 98-417, Sec. 102(b)(1), inserted "or
    (j)" after "subsection (b)".
      Subsec. (b). Pub. L. 98-417, Secs. 102(a)(1), 103(a), designated
    existing provisions of subsec. (b) as par. (1) thereof and
    redesignated existing cls. (1) through (6) of such par. (1) as cls.
    (A) through (F) thereof, respectively, inserted requirement that
    the applicant file with the application the patent number and the
    expiration date of any patent which claims the drug for which the
    applicant submitted the application or which claims a method of
    using such drug and with respect to which a claim of patent
    infringement could reasonably by asserted if a person not licensed
    by the owner engaged in the manufacture, use, or sale of the drug,
    that the applicant amend the application to include such
    information if an application is filed under this subsection for a
    drug and a patent which claims such drug or a method of using such
    drug is issued after the filing date but before approval of the
    application, and that upon approval of the application, the
    Secretary publish the information submitted, and added pars. (2)
    and (3).
      Subsec. (c). Pub. L. 98-417, Secs. 102(a)(2), (b)(2), 103(b),
    designated existing provisions of subsec. (c) as par. (1) thereof
    and in par. (1) as so designated substituted "subsection (b) of
    this section" for "this subsection" and redesignated former pars.
    (1) and (2) as subpars. (A) and (B), respectively, and added pars.
    (2) and (3).
      Subsec. (d)(6), (7). Pub. L. 98-417, Sec. 102(a)(3)(A), added cl.
    (6) relating to the failure of the application to contain the
    patent information prescribed by subsec. (b) of this section, and
    redesignated former cl. (6) as (7).
      Subsec. (e). Pub. L. 98-417, Sec. 102(a)(3)(B), in first
    sentence, added a new cl. (4) relating to the failure to file the
    patent information prescribed by subsec. (c) of this section within
    30 days after the receipt of written notice from the Secretary
    specifying the failure to file such information, and redesignated
    former cl. (4) as (5).
      Pub. L. 98-417, Sec. 102(b)(3), (4), in second sentence, inserted
    in provisions preceding cl. (1) "submitted under subsection (b) or
    (j) of this section" and in cl. (1) substituted "under subsection
    (k) of this section or to comply with the notice requirements of
    section 360(k)(2) of this title" for "under subsection (j) of this
    section or to comply with the notice requirements of section
    360(j)(2) of this title".
      Subsecs. (j), (k). Pub. L. 98-417, Sec. 101, added subsec. (j)
    and redesignated former subsec. (j) as (k).
      Subsec. (k)(1). Pub. L. 98-417, Sec. 102(b)(5), substituted
    "under subsection (b) or (j) of this section" for "pursuant to this
    section".
      Subsecs. (l), (m). Pub. L. 98-417, Sec. 104, added subsecs. (l)
    and (m).
      1972 - Subsec. (e). Pub. L. 92-387 inserted "or to comply with
    the notice requirements of section 360(j)(2) of this title" in cl.
    (1) of second sentence relating to the maintenance of records.
      1962 - Subsec. (a). Pub. L. 87-781, Sec. 104(a), inserted "an
    approval of" before "an application".
      Subsec. (b). Pub. L. 87-781, Sec. 102(b), inserted "and whether
    such drug is effective in use" after "is safe for use".
      Subsec. (c). Pub. L. 87-781, Sec. 104(b), substituted provisions
    requiring the Secretary, within 180 days after filing an
    application, or such additional period as the Secretary and the
    applicant agree upon, to either approve the application, if meeting
    the requirements of subsec. (d) of this section, or give notice of
    opportunity for hearing on question of whether such application is
    approvable, and providing that if applicant requests hearing in
    writing within 30 days, the hearing shall begin within 90 days
    after expiration of said 30 days, unless the Secretary and
    applicant agree otherwise, that such hearing shall be expedited,
    and that the Secretary's order shall be issued within 90 days after
    date for filing final briefs, for provisions which had an
    application become effective on the sixtieth day after filing
    thereof unless prior thereto the Secretary postponed the date by
    written notice to such time, but not more than 180 days after
    filing, as the Secretary deemed necessary to study and investigate
    the application.
      Subsec. (d). Pub. L. 87-781, Sec. 102(c), inserted references to
    subsec. (c), added cls. (5) and (6), provided that if after notice
    and opportunity for hearing, the Secretary finds that cls. (1) to
    (6) do not apply, he shall approve the application, and defined
    "substantial evidence" as used in this subsection and subsec. (e)
    of this section.
      Subsec. (e). Pub. L. 87-781, Sec. 102(d), amended subsec. (e)
    generally, and among other changes, directed the Secretary to
    withdraw approval of an application if by tests, other scientific
    data or experience, or new evidence of clinical experience not
    contained in the application or available at the time of its
    approval, the drug is shown to be unsafe, or on the basis of new
    information, there is shown a lack of substantial evidence that the
    drug has the effect it is represented to have, and provided that if
    the Secretary, or acting Secretary, finds there is an imminent
    hazard to the public health, he may suspend approval immediately,
    notify the applicant, and give him opportunity for an expedited
    hearing, that the Secretary may withdraw approval if the applicant
    fails to establish a system for maintaining required records, or
    has repeatedly or deliberately failed to maintain records and make
    reports, or has refused access to, or copying or verification of
    such records, or if the Secretary finds on new evidence that the
    methods, facilities and controls in the manufacturing, processing,
    and packing are inadequate to assure and preserve the drugs'
    identity, strength, quality and purity, and were not made adequate
    within a reasonable time after receipt of written notice thereof,
    or finds on new evidence, that the labeling is false or misleading
    and was not corrected within a reasonable time after receipt of
    written notice thereof.
      Subsec. (f). Pub. L. 87-781, Sec. 104(c), substituted provisions
    requiring the Secretary to revoke any previous order under subsecs.
    (d) or (e) of this section refusing, withdrawing, or suspending
    approval of an application and to approve such application or
    reinstate such approval, for provisions which required him to
    revoke an order refusing effectiveness to an application.
      Subsec. (h). Pub. L. 87-781, Sec. 104(d)(1), (2), inserted "as
    provided in section 2112 of title 28", and "except that until the
    filing of the record the Secretary may modify or set aside his
    order", substituted "or withdrawing approval of an application
    under this section" for "to permit the application to become
    effective, or suspending the effectiveness of the application",
    "United States court of appeals for the circuit" for "district
    court of the United States within any district", "Court of Appeals
    for the District of Columbia Circuit" for "District Court for the
    District of Columbia", "transmitted by the clerk of the court to"
    for "served upon", and "by the Supreme Court of the United States
    upon certiorari or certification as provided in section 1254 of
    title 28" for "as provided in sections 225, 346, and 347 of title
    28, as amended, and in section 7, as amended, of the Act entitled
    'An Act to establish a Court of Appeals for the District of
    Columbia', approved February 9, 1893", and eliminated "upon" before
    "any officer designated", "a transcript of" before "the record" and
    "and decree" before "of the court affirming".
      Subsec. (i). Pub. L. 87-781, Sec. 103(b), inserted "the foregoing
    subsections of" after "operation of", and "and effectiveness" after
    "safety", and provided that the regulations may condition
    exemptions upon the submission of reports of preclinical tests to
    justify the proposed clinical testing, upon the obtaining by the
    manufacturer or sponsor of the investigation of a new drug of a
    signed agreement from each of the investigators that patients to
    whom the drug is administered will be under his supervision or
    under investigators responsible to him, and that he will not supply
    such drug to any other investigator, or to clinics, for
    administration to human beings, or upon the establishment and
    maintenance of records and reports of data obtained by the
    investigational use of such drug, as the Secretary finds will
    enable him to evaluate the safety and effectiveness of such drug,
    and provided that the regulations shall condition an exemption upon
    the manufacturer or sponsor of the investigation requiring that
    experts using such drugs certify that they will inform humans to
    whom such drugs or any controls connected therewith are
    administered, or their representatives, and will obtain the consent
    of such people where feasible and not contrary to the best
    interests of such people, and that reports on the investigational
    use of drugs are not required to be submitted directly to the
    Secretary.
      Subsec. (j). Pub. L. 87-781, Sec. 103(a), added subsec. (j).
      1960 - Subsec. (g). Pub. L. 86-507 inserted "or by certified
    mail" after "registered mail".

                     EFFECTIVE DATE OF 2003 AMENDMENTS                 
      Pub. L. 108-173, title XI, Sec. 1101(c), Dec. 8, 2003, 117 Stat.
    2456, provided that:
      "(1) In general. - Except as provided in paragraphs (2) and (3),
    the amendments made by subsections (a) and (b) [amending this
    section] apply to any proceeding under section 505 of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 355) that is pending on or
    after the date of the enactment of this Act [Dec. 8, 2003]
    regardless of the date on which the proceeding was commenced or is
    commenced.
      "(2) Notice of opinion that patent is invalid or will not be
    infringed. - The amendments made by subsections (a)(1) and (b)(1)
    apply with respect to any certification under subsection
    (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 355) submitted on or after
    August 18, 2003, in an application filed under subsection (b) or
    (j) of that section or in an amendment or supplement to an
    application filed under subsection (b) or (j) of that section.
      "(3) Effective date of approval. - The amendments made by
    subsections (a)(2)(A)(ii)(I) and (b)(2)(B)(i) apply with respect to
    any patent information submitted under subsection (b)(1) or (c)(2)
    of section 505 of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 355) on or after August 18, 2003."
      Pub. L. 108-173, title XI, Sec. 1102(b), Dec. 8, 2003, 117 Stat.
    2460, provided that:
      "(1) In general. - Except as provided in paragraph (2), the
    amendment made by subsection (a) [amending this section] shall be
    effective only with respect to an application filed under section
    505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
    355(j)) after the date of the enactment of this Act [Dec. 8, 2003]
    for a listed drug for which no certification under section
    505(j)(2)(A)(vii)(IV) of that Act was made before the date of the
    enactment of this Act.
      "(2) Collusive agreements. - If a forfeiture event described in
    section 505(j)(5)(D)(i)(V) of that Act occurs in the case of an
    applicant, the applicant shall forfeit the 180-day period under
    section 505(j)(5)(B)(iv) of that Act without regard to when the
    first certification under section 505(j)(2)(A)(vii)(IV) of that Act
    for the listed drug was made.
      "(3) Decision of a court when the 180-day exclusivity period has
    not been triggered. - With respect to an application filed before,
    on, or after the date of the enactment of this Act [Dec. 8, 2003]
    for a listed drug for which a certification under section
    505(j)(2)(A)(vii)(IV) of that Act was made before the date of the
    enactment of this Act and for which neither of the events described
    in subclause (I) or (II) of section 505(j)(5)(B)(iv) of that Act
    (as in effect on the day before the date of the enactment of this
    Act) has occurred on or before the date of the enactment of this
    Act, the term 'decision of a court' as used in clause (iv) of
    section 505(j)(5)(B) of that Act means a final decision of a court
    from which no appeal (other than a petition to the Supreme Court
    for a writ of certiorari) has been or can be taken."
      Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
    otherwise provided, see section 4 of Pub. L. 108-155, set out as an
    Effective Date note under section 355c of this title.

                     EFFECTIVE DATE OF 1999 AMENDMENT                 
      Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
    1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
    113, set out as a note under section 1 of Title 35, Patents.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1984 AMENDMENT                 
      Section 105 of Pub. L. 98-417 provided that:
      "(a) The Secretary of Health and Human Services shall promulgate,
    in accordance with the notice and comment requirements of section
    553 of title 5, United States Code, such regulations as may be
    necessary for the administration of section 505 of the Federal
    Food, Drug, and Cosmetic Act [this section], as amended by sections
    101, 102, and 103 of this Act, within one year of the date of
    enactment of this Act [Sept. 24, 1984].
      "(b) During the period beginning sixty days after the date of the
    enactment of this Act [Sept. 24, 1984], and ending on the date
    regulations promulgated under subsection (a) take effect,
    abbreviated new drug applications may be submitted in accordance
    with the provisions of section 314.2 of title 21 of the Code of
    Federal Regulations and shall be considered as suitable for any
    drug which has been approved for safety and effectiveness under
    section 505(c) of the Federal Food, Drug, and Cosmetic Act [subsec.
    (c) of this section] before the date of the enactment of this Act.
    If any such provision is inconsistent with the requirements of
    section 505(j) of the Federal Food, Drug, and Cosmetic Act, the
    Secretary shall consider the application under the applicable
    requirements of such section. The Secretary of Health and Human
    Services may not approve such an abbreviated new drug application
    which is filed for a drug which is described in sections
    505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and
    Cosmetic Act, except in accordance with such section."

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Amendment by Pub. L. 92-387 effective on first day of sixth month
    beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
    out as a note under section 360 of this title.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-781 effective on first day of seventh
    calendar month following October 1962, see section 107 of Pub. L.
    87-781, set out as a note under section 321 of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282           
      Amendment by Pub. L. 102-282 not to preclude any other civil,
    criminal, or administrative remedy provided under Federal or State
    law, including any private right of action against any person for
    the same action subject to any action or civil penalty under an
    amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
    282, set out as a note under section 335a of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
      EFFECT OF AMENDMENT BY PUB. L. 108-173 ON ABBREVIATED NEW DRUG
                               APPLICATIONS
      Pub. L. 108-173, title XI, Sec. 1103(b), Dec. 8, 2003, 117 Stat.
    2461, provided that: "The amendment made by subsection (a)
    [amending this section] does not alter the standards for approval
    of drugs under section 505(j) of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 355(j))."

                      FEDERAL TRADE COMMISSION REVIEW                  
      Pub. L. 108-173, title XI, subtitle B, Dec. 8, 2003, 117 Stat.
    2461, provided that:

      "SEC. 1111. DEFINITIONS.
      "In this subtitle:
        "(1) ANDA. - The term 'ANDA' means an abbreviated drug
      application, as defined under section 201(aa) of the Federal
      Food, Drug, and Cosmetic Act [21 U.S.C. 321(aa)].
        "(2) Assistant attorney general. - The term 'Assistant Attorney
      General' means the Assistant Attorney General in charge of the
      Antitrust Division of the Department of Justice.
        "(3) Brand name drug. - The term 'brand name drug' means a drug
      for which an application is approved under section 505(c) of the
      Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(c)],
      including an application referred to in section 505(b)(2) of such
      Act [21 U.S.C. 355(b)(2)].
        "(4) Brand name drug company. - The term 'brand name drug
      company' means the party that holds the approved application
      referred to in paragraph (3) for a brand name drug that is a
      listed drug in an ANDA, or a party that is the owner of a patent
      for which information is submitted for such drug under subsection
      (b) or (c) of section 505 of the Federal Food, Drug, and Cosmetic
      Act [21 U.S.C. 355(b), (c)].
        "(5) Commission. - The term 'Commission' means the Federal
      Trade Commission.
        "(6) Generic drug. - The term 'generic drug' means a drug for
      which an application under section 505(j) of the Federal Food,
      Drug, and Cosmetic Act [21 U.S.C. 355(j)] is approved.
        "(7) Generic drug applicant. - The term 'generic drug
      applicant' means a person who has filed or received approval for
      an ANDA under section 505(j) of the Federal Food, Drug, and
      Cosmetic Act [21 U.S.C. 355(j)].
        "(8) Listed drug. - The term 'listed drug' means a brand name
      drug that is listed under section 505(j)(7) of the Federal Food,
      Drug, and Cosmetic Act [21 U.S.C. 355(j)(7)].

      "SEC. 1112. NOTIFICATION OF AGREEMENTS.
      "(a) Agreement With Brand Name Drug Company. - 
        "(1) Requirement. - A generic drug applicant that has submitted
      an ANDA containing a certification under section
      505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 355(j)(2)(A)(vii)(IV)] and a brand name drug company
      that enter into an agreement described in paragraph (2) shall
      each file the agreement in accordance with subsection (c). The
      agreement shall be filed prior to the date of the first
      commercial marketing of the generic drug that is the subject of
      the ANDA.
        "(2) Subject matter of agreement. - An agreement described in
      this paragraph between a generic drug applicant and a brand name
      drug company is an agreement regarding - 
          "(A) the manufacture, marketing or sale of the brand name
        drug that is the listed drug in the ANDA involved;
          "(B) the manufacture, marketing, or sale of the generic drug
        for which the ANDA was submitted; or
          "(C) the 180-day period referred to in section
        505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act
        [21 U.S.C. 355(j)(5)(B)(iv)] as it applies to such ANDA or to
        any other ANDA based on the same brand name drug.
      "(b) Agreement With Another Generic Drug Applicant. - 
        "(1) Requirement. - A generic drug applicant that has submitted
      an ANDA containing a certification under section
      505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 355(j)(2)(A)(vii)(IV)] with respect to a listed drug
      and another generic drug applicant that has submitted an ANDA
      containing such a certification for the same listed drug shall
      each file the agreement in accordance with subsection (c). The
      agreement shall be filed prior to the date of the first
      commercial marketing of either of the generic drugs for which
      such ANDAs were submitted.
        "(2) Subject matter of agreement. - An agreement described in
      this paragraph between two generic drug applicants is an
      agreement regarding the 180-day period referred to in section
      505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [21
      U.S.C. 355(j)(5)(B)(iv)] as it applies to the ANDAs with which
      the agreement is concerned.
      "(c) Filing. - 
        "(1) Agreement. - The parties that are required in subsection
      (a) or (b) to file an agreement in accordance with this
      subsection shall file with the Assistant Attorney General and the
      Commission the text of any such agreement, except that such
      parties are not required to file an agreement that solely
      concerns - 
          "(A) purchase orders for raw material supplies;
          "(B) equipment and facility contracts;
          "(C) employment or consulting contracts; or
          "(D) packaging and labeling contracts.
        "(2) Other agreements. - The parties that are required in
      subsection (a) or (b) to file an agreement in accordance with
      this subsection shall file with the Assistant Attorney General
      and the Commission the text of any agreements between the parties
      that are not described in such subsections and are contingent
      upon, provide a contingent condition for, or are otherwise
      related to an agreement that is required in subsection (a) or (b)
      to be filed in accordance with this subsection.
        "(3) Description. - In the event that any agreement required in
      subsection (a) or (b) to be filed in accordance with this
      subsection has not been reduced to text, each of the parties
      involved shall file written descriptions of such agreement that
      are sufficient to disclose all the terms and conditions of the
      agreement.

      "SEC. 1113. FILING DEADLINES.
      "Any filing required under section 1112 shall be filed with the
    Assistant Attorney General and the Commission not later than 10
    business days after the date the agreements are executed.

      "SEC. 1114. DISCLOSURE EXEMPTION.
      "Any information or documentary material filed with the Assistant
    Attorney General or the Commission pursuant to this subtitle shall
    be exempt from disclosure under section 552 of title 5, United
    States Code, and no such information or documentary material may be
    made public, except as may be relevant to any administrative or
    judicial action or proceeding. Nothing in this section is intended
    to prevent disclosure to either body of the Congress or to any duly
    authorized committee or subcommittee of the Congress.

      "SEC. 1115. ENFORCEMENT.
      "(a) Civil Penalty. - Any brand name drug company or generic drug
    applicant which fails to comply with any provision of this subtitle
    shall be liable for a civil penalty of not more than $11,000, for
    each day during which such entity is in violation of this subtitle.
    Such penalty may be recovered in a civil action brought by the
    United States, or brought by the Commission in accordance with the
    procedures established in section 16(a)(1) of the Federal Trade
    Commission Act (15 U.S.C. 56(a) [15 U.S.C. 56(a)(1)]).
      "(b) Compliance and Equitable Relief. - If any brand name drug
    company or generic drug applicant fails to comply with any
    provision of this subtitle, the United States district court may
    order compliance, and may grant such other equitable relief as the
    court in its discretion determines necessary or appropriate, upon
    application of the Assistant Attorney General or the Commission.

      "SEC. 1116. RULEMAKING.
      "The Commission, with the concurrence of the Assistant Attorney
    General and by rule in accordance with section 553 of title 5,
    United States Code, consistent with the purposes of this subtitle -
    
        "(1) may define the terms used in this subtitle;
        "(2) may exempt classes of persons or agreements from the
      requirements of this subtitle; and
        "(3) may prescribe such other rules as may be necessary and
      appropriate to carry out the purposes of this subtitle.

      "SEC. 1117. SAVINGS CLAUSE.
      "Any action taken by the Assistant Attorney General or the
    Commission, or any failure of the Assistant Attorney General or the
    Commission to take action, under this subtitle shall not at any
    time bar any proceeding or any action with respect to any agreement
    between a brand name drug company and a generic drug applicant, or
    any agreement between generic drug applicants, under any other
    provision of law, nor shall any filing under this subtitle
    constitute or create a presumption of any violation of any
    competition laws.

      "SEC. 1118. EFFECTIVE DATE.
      "This subtitle shall - 
        "(1) take effect 30 days after the date of the enactment of
      this Act [Dec. 8, 2003]; and
        "(2) shall apply to agreements described in section 1112 that
      are entered into 30 days after the date of the enactment of this
      Act."

     REPORT ON PATIENT ACCESS TO NEW THERAPEUTIC AGENTS FOR PEDIATRIC
                                  CANCER
      Pub. L. 107-109, Sec. 15(d), Jan. 4, 2002, 115 Stat. 1421,
    provided that: "Not later than January 31, 2003, the Secretary of
    Health and Human Services, acting through the Commissioner of Food
    and Drugs and in consultation with the Director of the National
    Institutes of Health, shall submit to the Committee on Health,
    Education, Labor, and Pensions of the Senate and the Committee on
    Energy and Commerce of the House of Representatives a report on
    patient access to new therapeutic agents for pediatric cancer,
    including access to single patient use of new therapeutic agents."

                 DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS             
      Section 118 of Pub. L. 105-115 provided that: "Within 12 months
    after the date of enactment of this Act [Nov. 21, 1997], the
    Secretary of Health and Human Services, acting through the
    Commissioner of Food and Drugs, shall issue guidance that describes
    when abbreviated study reports may be submitted, in lieu of full
    reports, with a new drug application under section 505(b) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and with a
    biologics license application under section 351 of the Public
    Health Service Act (42 U.S.C. 262) for certain types of studies.
    Such guidance shall describe the kinds of studies for which
    abbreviated reports are appropriate and the appropriate abbreviated
    report formats."

      REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND CURRENT GOOD
         MANUFACTURING PRACTICES FOR POSITRON EMISSION TECHNOLOGY
      Section 121(c) of Pub. L. 105-115 provided that:
      "(1) Procedures and requirements. - 
        "(A) In general. - In order to take account of the special
      characteristics of positron emission tomography drugs and the
      special techniques and processes required to produce these drugs,
      not later than 2 years after the date of enactment of this Act
      [Nov. 21, 1997], the Secretary of Health and Human Services shall
      establish - 
          "(i) appropriate procedures for the approval of positron
        emission tomography drugs pursuant to section 505 of the
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
          "(ii) appropriate current good manufacturing practice
        requirements for such drugs.
        "(B) Considerations and consultation. - In establishing the
      procedures and requirements required by subparagraph (A), the
      Secretary of Health and Human Services shall take due account of
      any relevant differences between not-for-profit institutions that
      compound the drugs for their patients and commercial
      manufacturers of the drugs. Prior to establishing the procedures
      and requirements, the Secretary of Health and Human Services
      shall consult with patient advocacy groups, professional
      associations, manufacturers, and physicians and scientists
      licensed to make or use positron emission tomography drugs.
      "(2) Submission of new drug applications and abbreviated new drug
    applications. - 
        "(A) In general. - Except as provided in subparagraph (B), the
      Secretary of Health and Human Services shall not require the
      submission of new drug applications or abbreviated new drug
      applications under subsection (b) or (j) of section 505 (21
      U.S.C. 355), for compounded positron emission tomography drugs
      that are not adulterated drugs described in section 501(a)(2)(C)
      of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
      351(a)(2)(C)) (as amended by subsection (b)), for a period of 4
      years after the date of enactment of this Act [Nov. 21, 1997], or
      for 2 years after the date on which the Secretary establishes
      procedures and requirements under paragraph (1), whichever is
      longer.
        "(B) Exception. - Nothing in this Act [see Short Title of 1997
      Amendment note set out under section 301 of this title] shall
      prohibit the voluntary submission of such applications or the
      review of such applications by the Secretary of Health and Human
      Services. Nothing in this Act shall constitute an exemption for a
      positron emission tomography drug from the requirements of
      regulations issued under section 505(i) of the Federal Food,
      Drug, and Cosmetic Act (21 U.S.C. 355(i))."

          "COMPOUNDED POSITRON EMISSION TOPOGRAPHY DRUG" DEFINED      
      Section 121(e) of Pub. L. 105-115 provided that: "As used in this
    section [amending sections 321 and 351 of this title and enacting
    provisions set out as notes under this section and section 351 of
    this title], the term 'compounded positron emission tomography
    drug' has the meaning given the term in section 201 of the Federal
    Food, Drug, and Cosmetic Act (21 U.S.C. 321)."

                   REQUIREMENTS FOR RADIOPHARMACEUTICALS               
      Section 122 of Pub. L. 105-115 provided that:
      "(a) Requirements. - 
        "(1) Regulations. - 
          "(A) Proposed regulations. - Not later than 180 days after
        the date of enactment of this Act [Nov. 21, 1997], the
        Secretary of Health and Human Services, after consultation with
        patient advocacy groups, associations, physicians licensed to
        use radiopharmaceuticals, and the regulated industry, shall
        issue proposed regulations governing the approval of
        radiopharmaceuticals. The regulations shall provide that the
        determination of the safety and effectiveness of such a
        radiopharmaceutical under section 505 of the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the
        Public Health Service Act (42 U.S.C. 262) shall include
        consideration of the proposed use of the radiopharmaceutical in
        the practice of medicine, the pharmacological and toxicological
        activity of the radiopharmaceutical (including any carrier or
        ligand component of the radiopharmaceutical), and the estimated
        absorbed radiation dose of the radiopharmaceutical.
          "(B) Final regulations. - Not later than 18 months after the
        date of enactment of this Act, the Secretary shall promulgate
        final regulations governing the approval of the
        radiopharmaceuticals.
        "(2) Special rule. - In the case of a radiopharmaceutical, the
      indications for which such radiopharmaceutical is approved for
      marketing may, in appropriate cases, refer to manifestations of
      disease (such as biochemical, physiological, anatomic, or
      pathological processes) common to, or present in, one or more
      disease states.
      "(b) Definition. - In this section, the term
    'radiopharmaceutical' means - 
        "(1) an article - 
          "(A) that is intended for use in the diagnosis or monitoring
        of a disease or a manifestation of a disease in humans; and
          "(B) that exhibits spontaneous disintegration of unstable
        nuclei with the emission of nuclear particles or photons; or
        "(2) any nonradioactive reagent kit or nuclide generator that
      is intended to be used in the preparation of any such article."

                               SPECIAL RULE                           
      Section 123(f) of Pub. L. 105-115 provided that: "The Secretary
    of Health and Human Services shall take measures to minimize
    differences in the review and approval of products required to have
    approved biologics license applications under section 351 of the
    Public Health Service Act (42 U.S.C. 262) and products required to
    have approved new drug applications under section 505(b)(1) of the
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1))."

                                TRANSITION                            
      Section 125(d) of Pub. L. 105-115 provided that:
      "(1) In general. - An application that was approved by the
    Secretary of Health and Human Services before the date of the
    enactment of this Act [Nov. 21, 1997] for the marketing of an
    antibiotic drug under section 507 of the Federal Food, Drug, and
    Cosmetic Act (21 U.S.C. 357), as in effect on the day before the
    date of the enactment of this Act, shall, on and after such date of
    enactment, be considered to be an application that was submitted
    and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and
    approved for safety and effectiveness under section 505(c) of such
    Act (21 U.S.C. 355(c)), except that if such application for
    marketing was in the form of an abbreviated application, the
    application shall be considered to have been filed and approved
    under section 505(j) of such Act (21 U.S.C. 355(j)).
      "(2) Exception. - The following subsections of section 505 (21
    U.S.C. 355) shall not apply to any application for marketing in
    which the drug that is the subject of the application contains an
    antibiotic drug and the antibiotic drug was the subject of any
    application for marketing received by the Secretary of Health and
    Human Services under section 507 of such Act (21 U.S.C. 357) before
    the date of the enactment of this Act [Nov. 21, 1997]:
        "(A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii),
      (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and
        "(ii) The third and fourth sentences of subsection (b)(1)
      (regarding the filing and publication of patent information); and
        "(B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if
      the investigations relied upon by the applicant for approval of
      the application were not conducted by or for the applicant and
      for which the applicant has not obtained a right of reference or
      use from the person by or for whom the investigations were
      conducted.
      "(3) Publication. - For purposes of this section, the Secretary
    is authorized to make available to the public the established name
    of each antibiotic drug that was the subject of any application for
    marketing received by the Secretary for Health and Human Services
    under section 507 of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 357) before the date of enactment of this Act [Nov. 21,
    1997]."

                      TERMINATION OF ADVISORY PANELS                  
      Advisory panels established after Jan. 5, 1973, to terminate not
    later than the expiration of the 2-year period beginning on the
    date of their establishment, unless, in the case of a panel
    established by the President or an officer of the Federal
    Government, such panel is renewed by appropriate action prior to
    the expiration of such 2-year period, or in the case of a panel
    established by Congress, its duration is otherwise provided for by
    law. See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 770, 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

                  APPEALS TAKEN PRIOR TO OCTOBER 10, 1962              
      Section 104(d)(3) of Pub. L. 87-781 made amendments to subsec.
    (h) of this section inapplicable to any appeal taken prior to Oct.
    10, 1962.

-FOOTNOTE-
    (!1) So in original. Probably should be "bioavailability".


-End-



-CITE-
    21 USC Sec. 355a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 355a. Pediatric studies of drugs

-STATUTE-
    (a) Definitions
      As used in this section, the term "pediatric studies" or
    "studies" means at least one clinical investigation (that, at the
    Secretary's discretion, may include pharmacokinetic studies) in
    pediatric age groups (including neonates in appropriate cases) in
    which a drug is anticipated to be used.
    (b) Market exclusivity for new drugs
      If, prior to approval of an application that is submitted under
    section 355(b)(1) of this title, the Secretary determines that
    information relating to the use of a new drug in the pediatric
    population may produce health benefits in that population, the
    Secretary makes a written request for pediatric studies (which
    shall include a timeframe for completing such studies), and such
    studies are completed within any such timeframe and the reports
    thereof submitted in accordance with subsection (d)(2) of this
    section or accepted in accordance with subsection (d)(3) of this
    section - 
        (1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of
      section 355 of this title, and in subsection (j)(5)(F)(ii) of
      such section, is deemed to be five years and six months rather
      than five years, and the references in subsections (c)(3)(D)(ii)
      and (j)(5)(F)(ii) of such section to four years, to forty-eight
      months, and to seven and one-half years are deemed to be four and
      one-half years, fifty-four months, and eight years, respectively;
      or
        (ii) the period referred to in clauses (iii) and (iv) of
      subsection (c)(3)(D) of such section, and in clauses (iii) and
      (iv) of subsection (j)(5)(F) of such section, is deemed to be
      three years and six months rather than three years; and
        (B) if the drug is designated under section 360bb of this title
      for a rare disease or condition, the period referred to in
      section 360cc(a) of this title is deemed to be seven years and
      six months rather than seven years; and
        (2)(A) if the drug is the subject of - 
          (i) a listed patent for which a certification has been
        submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II)
        of section 355 of this title and for which pediatric studies
        were submitted prior to the expiration of the patent (including
        any patent extensions); or
          (ii) a listed patent for which a certification has been
        submitted under subsections (b)(2)(A)(iii) or
        (j)(2)(A)(vii)(III) of section 355 of this title,

      the period during which an application may not be approved under
      section 355(c)(3) of this title or section 355(j)(5)(B) of this
      title shall be extended by a period of six months after the date
      the patent expires (including any patent extensions); or
        (B) if the drug is the subject of a listed patent for which a
      certification has been submitted under subsection (b)(2)(A)(iv)
      or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the
      patent infringement litigation resulting from the certification
      the court determines that the patent is valid and would be
      infringed, the period during which an application may not be
      approved under section 355(c)(3) of this title or section
      355(j)(5)(B) of this title shall be extended by a period of six
      months after the date the patent expires (including any patent
      extensions).
    (c) Market exclusivity for already-marketed drugs
      If the Secretary determines that information relating to the use
    of an approved drug in the pediatric population may produce health
    benefits in that population and makes a written request to the
    holder of an approved application under section 355(b)(1) of this
    title for pediatric studies (which shall include a timeframe for
    completing such studies), the holder agrees to the request, the
    studies are completed within any such timeframe, and the reports
    thereof are submitted in accordance with subsection (d)(2) of this
    section or accepted in accordance with subsection (d)(3) of this
    section - 
        (1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of
      section 355 of this title, and in subsection (j)(5)(F)(ii) of
      such section, is deemed to be five years and six months rather
      than five years, and the references in subsections (c)(3)(D)(ii)
      and (j)(5)(F)(ii) of such section to four years, to forty-eight
      months, and to seven and one-half years are deemed to be four and
      one-half years, fifty-four months, and eight years, respectively;
      or
        (ii) the period referred to in clauses (iii) and (iv) of
      subsection (c)(3)(D) of such section, and in clauses (iii) and
      (iv) of subsection (j)(5)(F) of such section, is deemed to be
      three years and six months rather than three years; and
        (B) if the drug is designated under section 360bb of this title
      for a rare disease or condition, the period referred to in
      section 360cc(a) of this title is deemed to be seven years and
      six months rather than seven years; and
        (2)(A) if the drug is the subject of - 
          (i) a listed patent for which a certification has been
        submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II)
        of section 355 of this title and for which pediatric studies
        were submitted prior to the expiration of the patent (including
        any patent extensions); or
          (ii) a listed patent for which a certification has been
        submitted under subsection (b)(2)(A)(iii) or
        (j)(2)(A)(vii)(III) of section 355 of this title,

      the period during which an application may not be approved under
      section 355(c)(3) of this title or section 355(j)(5)(B) of this
      title shall be extended by a period of six months after the date
      the patent expires (including any patent extensions); or
        (B) if the drug is the subject of a listed patent for which a
      certification has been submitted under subsection (b)(2)(A)(iv)
      or (j)(2)(A)(vii)(IV) of section 355 of this title, and in the
      patent infringement litigation resulting from the certification
      the court determines that the patent is valid and would be
      infringed, the period during which an application may not be
      approved under section 355(c)(3) of this title or section
      355(j)(5)(B) of this title shall be extended by a period of six
      months after the date the patent expires (including any patent
      extensions).
    (d) Conduct of pediatric studies
      (1) Agreement for studies
        The Secretary may, pursuant to a written request from the
      Secretary under subsection (b) or (c) of this section, after
      consultation with - 
          (A) the sponsor of an application for an investigational new
        drug under section 355(i) of this title;
          (B) the sponsor of an application for a new drug under
        section 355(b)(1) of this title; or
          (C) the holder of an approved application for a drug under
        section 355(b)(1) of this title,

      agree with the sponsor or holder for the conduct of pediatric
      studies for such drug. Such agreement shall be in writing and
      shall include a timeframe for such studies.
      (2) Written protocols to meet the studies requirement
        If the sponsor or holder and the Secretary agree upon written
      protocols for the studies, the studies requirement of subsection
      (b) or (c) of this section is satisfied upon the completion of
      the studies and submission of the reports thereof in accordance
      with the original written request and the written agreement
      referred to in paragraph (1). In reaching an agreement regarding
      written protocols, the Secretary shall take into account adequate
      representation of children of ethnic and racial minorities. Not
      later than 60 days after the submission of the report of the
      studies, the Secretary shall determine if such studies were or
      were not conducted in accordance with the original written
      request and the written agreement and reported in accordance with
      the requirements of the Secretary for filing and so notify the
      sponsor or holder.
      (3) Other methods to meet the studies requirement
        If the sponsor or holder and the Secretary have not agreed in
      writing on the protocols for the studies, the studies requirement
      of subsection (b) or (c) of this section is satisfied when such
      studies have been completed and the reports accepted by the
      Secretary. Not later than 90 days after the submission of the
      reports of the studies, the Secretary shall accept or reject such
      reports and so notify the sponsor or holder. The Secretary's only
      responsibility in accepting or rejecting the reports shall be to
      determine, within the 90 days, whether the studies fairly respond
      to the written request, have been conducted in accordance with
      commonly accepted scientific principles and protocols, and have
      been reported in accordance with the requirements of the
      Secretary for filing.
      (4) Written request to holders of approved applications for drugs
        that have market exclusivity
        (A) Request and response
          If the Secretary makes a written request for pediatric
        studies (including neonates, as appropriate) under subsection
        (c) of this section to the holder of an application approved
        under section 355(b)(1) of this title, the holder, not later
        than 180 days after receiving the written request, shall
        respond to the Secretary as to the intention of the holder to
        act on the request by - 
            (i) indicating when the pediatric studies will be
          initiated, if the holder agrees to the request; or
            (ii) indicating that the holder does not agree to the
          request.
        (B) No agreement to request
          (i) Referral
            If the holder does not agree to a written request within
          the time period specified in subparagraph (A), and if the
          Secretary determines that there is a continuing need for
          information relating to the use of the drug in the pediatric
          population (including neonates, as appropriate), the
          Secretary shall refer the drug to the Foundation for the
          National Institutes of Health established under section 290b
          of title 42 (referred to in this paragraph as the
          "Foundation") for the conduct of the pediatric studies
          described in the written request.
          (ii) Public notice
            The Secretary shall give public notice of the name of the
          drug, the name of the manufacturer, and the indications to be
          studied made in a referral under clause (i).
        (C) Lack of funds
          On referral of a drug under subparagraph (B)(i), the
        Foundation shall issue a proposal to award a grant to conduct
        the requested studies unless the Foundation certifies to the
        Secretary, within a timeframe that the Secretary determines is
        appropriate through guidance, that the Foundation does not have
        funds available under section 290b(j)(9)(B)(i) (!1) of title 42
        to conduct the requested studies. If the Foundation so
        certifies, the Secretary shall refer the drug for inclusion on
        the list established under section 284m of title 42 for the
        conduct of the studies.

        (D) Effect of subsection
          Nothing in this subsection (including with respect to
        referrals from the Secretary to the Foundation) alters or
        amends section 331(j) of this title or section 552 of title 5
        or section 1905 of title 18.
        (E) No requirement to refer
          Nothing in this subsection shall be construed to require that
        every declined written request shall be referred to the
        Foundation.
        (F) Written requests under subsection (b)
          For drugs under subsection (b) of this section for which
        written requests have not been accepted, if the Secretary
        determines that there is a continuing need for information
        relating to the use of the drug in the pediatric population
        (including neonates, as appropriate), the Secretary shall issue
        a written request under subsection (c) of this section after
        the date of approval of the drug.
    (e) Delay of effective date for certain application
      If the Secretary determines that the acceptance or approval of an
    application under section 355(b)(2) or 355(j) of this title for a
    new drug may occur after submission of reports of pediatric studies
    under this section, which were submitted prior to the expiration of
    the patent (including any patent extension) or the applicable
    period under clauses (ii) through (iv) of section 355(c)(3)(D) of
    this title or clauses (ii) through (iv) of section 355(j)(5)(F) of
    this title, but before the Secretary has determined whether the
    requirements of subsection (d) of this section have been satisfied,
    the Secretary shall delay the acceptance or approval under section
    355(b)(2) or 355(j) of this title until the determination under
    subsection (d) of this section is made, but any such delay shall
    not exceed 90 days. In the event that requirements of this section
    are satisfied, the applicable six-month period under subsection (b)
    or (c) of this section shall be deemed to have been running during
    the period of delay.
    (f) Notice of determinations on studies requirement
      The Secretary shall publish a notice of any determination that
    the requirements of subsection (d) of this section have been met
    and that submissions and approvals under subsection (b)(2) or (j)
    of section 355 of this title for a drug will be subject to the
    provisions of this section.
    (g) Limitations
      A drug to which the six-month period under subsection (b) or (c)
    of this section has already been applied - 
        (1) may receive an additional six-month period under subsection
      (c)(1)(A)(ii) of this section for a supplemental application if
      all other requirements under this section are satisfied, except
      that such a drug may not receive any additional such period under
      subsection (c)(2) of this section; and
        (2) may not receive any additional such period under subsection
      (c)(1)(B) of this section.
    (h) Relationship to pediatric research requirements
      Notwithstanding any other provision of law, if any pediatric
    study is required by a provision of law (including a regulation)
    other than this section and such study meets the completeness,
    timeliness, and other requirements of this section, such study
    shall be deemed to satisfy the requirement for market exclusivity
    pursuant to this section.
    (i) Labeling supplements
      (1) Priority status for pediatric supplements
        Any supplement to an application under section 355 of this
      title proposing a labeling change pursuant to a report on a
      pediatric study under this section - 
          (A) shall be considered to be a priority supplement; and
          (B) shall be subject to the performance goals established by
        the Commissioner for priority drugs.
      (2) Dispute resolution
        (A) Request for labeling change and failure to agree
          If the Commissioner determines that an application with
        respect to which a pediatric study is conducted under this
        section is approvable and that the only open issue for final
        action on the application is the reaching of an agreement
        between the sponsor of the application and the Commissioner on
        appropriate changes to the labeling for the drug that is the
        subject of the application, not later than 180 days after the
        date of submission of the application - 
            (i) the Commissioner shall request that the sponsor of the
          application make any labeling change that the Commissioner
          determines to be appropriate; and
            (ii) if the sponsor of the application does not agree to
          make a labeling change requested by the Commissioner, the
          Commissioner shall refer the matter to the Pediatric Advisory
          Committee.
        (B) Action by the Pediatric Advisory Committee
          Not later than 90 days after receiving a referral under
        subparagraph (A)(ii), the Pediatric Advisory Committee shall - 
            (i) review the pediatric study reports; and
            (ii) make a recommendation to the Commissioner concerning
          appropriate labeling changes, if any.
        (C) Consideration of recommendations
          The Commissioner shall consider the recommendations of the
        Pediatric Advisory Committee and, if appropriate, not later
        than 30 days after receiving the recommendation, make a request
        to the sponsor of the application to make any labeling change
        that the Commissioner determines to be appropriate.
        (D) Misbranding
          If the sponsor of the application, within 30 days after
        receiving a request under subparagraph (C), does not agree to
        make a labeling change requested by the Commissioner, the
        Commissioner may deem the drug that is the subject of the
        application to be misbranded.
        (E) No effect on authority
          Nothing in this subsection limits the authority of the United
        States to bring an enforcement action under this chapter when a
        drug lacks appropriate pediatric labeling. Neither course of
        action (the Pediatric Advisory Committee process or an
        enforcement action referred to in the preceding sentence) shall
        preclude, delay, or serve as the basis to stay the other course
        of action.
    (j) Dissemination of pediatric information
      (1) In general
        Not later than 180 days after the date of submission of a
      report on a pediatric study under this section, the Commissioner
      shall make available to the public a summary of the medical and
      clinical pharmacology reviews of pediatric studies conducted for
      the supplement, including by publication in the Federal Register.
      (2) Effect of subsection
        Nothing in this subsection alters or amends section 331(j) of
      this title or section 552 of title 5 or section 1905 of title 18.
    (k) Clarification of interaction of market exclusivity under this
      section and market exclusivity awarded to an applicant for
      approval of a drug under section 355(j) of this title
      If a 180-day period under section 355(j)(5)(B)(iv) of this title
    overlaps with a 6-month exclusivity period under this section, so
    that the applicant for approval of a drug under section 355(j) of
    this title entitled to the 180-day period under that section loses
    a portion of the 180-day period to which the applicant is entitled
    for the drug, the 180-day period shall be extended from - 
        (1) the date on which the 180-day period would have expired by
      the number of days of the overlap, if the 180-day period would,
      but for the application of this subsection, expire after the 6-
      month exclusivity period; or
        (2) the date on which the 6-month exclusivity period expires,
      by the number of days of the overlap if the 180-day period would,
      but for the application of this subsection, expire during the six-
      month exclusivity period.
    (l) Prompt approval of drugs under section 355(j) of this title
      when pediatric information is added to labeling
      (1) General rule
        A drug for which an application has been submitted or approved
      under section 355(j) of this title shall not be considered
      ineligible for approval under that section or misbranded under
      section 352 of this title on the basis that the labeling of the
      drug omits a pediatric indication or any other aspect of labeling
      pertaining to pediatric use when the omitted indication or other
      aspect is protected by patent or by exclusivity under clause
      (iii) or (iv) of section 355(j)(5)(F) of this title.
      (2) Labeling
        Notwithstanding clauses (iii) and (iv) of section 355(j)(5)(F)
      of this title, the Secretary may require that the labeling of a
      drug approved under section 355(j) of this title that omits a
      pediatric indication or other aspect of labeling as described in
      paragraph (1) include - 
          (A) a statement that, because of marketing exclusivity for a
        manufacturer - 
            (i) the drug is not labeled for pediatric use; or
            (ii) in the case of a drug for which there is an additional
          pediatric use not referred to in paragraph (1), the drug is
          not labeled for the pediatric use under paragraph (1); and

          (B) a statement of any appropriate pediatric
        contraindications, warnings, or precautions that the Secretary
        considers necessary.
      (3) Preservation of pediatric exclusivity and other provisions
        This subsection does not affect - 
          (A) the availability or scope of exclusivity under this
        section;
          (B) the availability or scope of exclusivity under section
        355 of this title for pediatric formulations;
          (C) the question of the eligibility for approval of any
        application under section 355(j) of this title that omits any
        other conditions of approval entitled to exclusivity under
        clause (iii) or (iv) of section 355(j)(5)(F) of this title; or
          (D) except as expressly provided in paragraphs (1) and (2),
        the operation of section 355 of this title.
    (m) Report
      The Secretary shall conduct a study and report to Congress not
    later than January 1, 2001, based on the experience under the
    program established under this section. The study and report shall
    examine all relevant issues, including - 
        (1) the effectiveness of the program in improving information
      about important pediatric uses for approved drugs;
        (2) the adequacy of the incentive provided under this section;
        (3) the economic impact of the program on taxpayers and
      consumers, including the impact of the lack of lower cost generic
      drugs on patients, including on lower income patients; and
        (4) any suggestions for modification that the Secretary
      determines to be appropriate.
    (n) Sunset
      A drug may not receive any 6-month period under subsection (b) or
    (c) of this section unless - 
        (1) on or before October 1, 2007, the Secretary makes a written
      request for pediatric studies of the drug;
        (2) on or before October 1, 2007, an application for the drug
      is accepted for filing under section 355(b) of this title; and
        (3) all requirements of this section are met.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 505A, as added Pub. L. 105-115, title
    I, Sec. 111, Nov. 21, 1997, 111 Stat. 2305; amended Pub. L. 107-
    109, Secs. 2, 4, 5(b)(2), 7-11(a), 18(a), 19, Jan. 4, 2002, 115
    Stat. 1408, 1411, 1413-1415, 1423, 1424; Pub. L. 108-155, Secs.
    2(b)(2), 3(a), (b)(1), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 108-
    173, title XI, Sec. 1104, Dec. 8, 2003, 117 Stat. 2461.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 290b(j)(9)(B)(i) of title 42, referred to in subsec.
    (d)(4)(C), was in the original "section 499(j)(9)(B)(i)" and was
    translated as meaning section 499(j)(9)(B)(i) of the Public Health
    Service Act to reflect the probable intent of Congress because
    there is no section 499 of the Federal Food, Drug, and Cosmetic Act
    and section 499 of the Public Health Service Act relates to the
    establishment and duties of the National Foundation for Biomedical
    Research.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (b)(1)(A)(i). Pub. L. 108-173, Sec. 1104(1),
    substituted "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places.
      Subsec. (b)(1)(A)(ii). Pub. L. 108-173, Sec. 1104(2), substituted
    "(j)(5)(F)" for "(j)(5)(D)".
      Subsec. (b)(2). Pub. L. 108-155, Sec. 3(a), substituted
    "355(j)(5)(B)" for "355(j)(4)(B)" in two places.
      Subsec. (c)(1)(A)(i). Pub. L. 108-173, Sec. 1104(1), substituted
    "(j)(5)(F)(ii)" for "(j)(5)(D)(ii)" in two places.
      Subsec. (c)(1)(A)(ii). Pub. L. 108-173, Sec. 1104(2), substituted
    "(j)(5)(F)" for "(j)(5)(D)".
      Subsec. (c)(2). Pub. L. 108-155, Sec. 3(a), substituted
    "355(j)(5)(B)" for "355(j)(4)(B)" in two places.
      Subsec. (e). Pub. L. 108-173, Sec. 1104(3), substituted
    "355(j)(5)(F)" for "355(j)(5)(D)".
      Subsec. (h). Pub. L. 108-155, Sec. 2(b)(2), substituted
    "pediatric research requirements" for "regulations" in heading and
    "by a provision of law (including a regulation) other than this
    section" for "pursuant to regulations promulgated by the Secretary"
    in text.
      Subsec. (i)(2). Pub. L. 108-155, Sec. 3(b)(1), struck out
    "Advisory Subcommittee of the Anti-Infective Drugs" before
    "Advisory Committee" wherever appearing.
      Subsec. (l). Pub. L. 108-173, Sec. 1104(3), substituted
    "355(j)(5)(F)" for "355(j)(5)(D)" wherever appearing.
      2002 - Subsec. (a). Pub. L. 107-109, Sec. 19(2), (3),
    redesignated subsec. (g) as (a). Former subsec. (a) redesignated
    (b).
      Subsec. (a)(1)(A). Pub. L. 107-109, Sec. 19(1)(A), (B),
    substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in
    cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii).
      Subsec. (b). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (a) as (b).
      Pub. L. 107-109, Sec. 2(1), struck out heading and text of
    subsec. (b). Text read as follows: "Not later than 180 days after
    November 21, 1997, the Secretary, after consultation with experts
    in pediatric research shall develop, prioritize, and publish an
    initial list of approved drugs for which additional pediatric
    information may produce health benefits in the pediatric
    population. The Secretary shall annually update the list."
      Subsec. (c). Pub. L. 107-109, Sec. 2(2), in introductory
    provisions, inserted "determines that information relating to the
    use of an approved drug in the pediatric population may produce
    health benefits in that population and" after "the Secretary" and
    struck out "concerning a drug identified in the list described in
    subsection (b) of this section" after "such studies)".
      Subsec. (c)(1)(A). Pub. L. 107-109, Sec. 19(1)(A), (B),
    substituted "(j)(5)(D)(ii)" for "(j)(4)(D)(ii)" in two places in
    cl. (i) and "(j)(5)(D)" for "(j)(4)(D)" in cl. (ii).
      Subsec. (d)(1). Pub. L. 107-109, Sec. 19(4), substituted
    "subsection (b) or (c)" for "subsection (a) or (c)" in introductory
    provisions.
      Subsec. (d)(2). Pub. L. 107-109, Secs. 18(a), 19(4), substituted
    "subsection (b) or (c)" for "subsection (a) or (c)" and inserted
    "In reaching an agreement regarding written protocols, the
    Secretary shall take into account adequate representation of
    children of ethnic and racial minorities." after first sentence.
      Subsec. (d)(3). Pub. L. 107-109, Sec. 19(4), substituted
    "subsection (b) or (c)" for "subsection (a) or (c)".
      Subsec. (d)(4). Pub. L. 107-109, Sec. 4, added par. (4).
      Subsec. (e). Pub. L. 107-109, Sec. 19(1)(C), (4), substituted
    "section 355(j)(5)(D)" for "section 355(j)(4)(D)" and "subsection
    (b) or (c)" for "subsection (a) or (c)".
      Subsec. (g). Pub. L. 107-109, Sec. 19(2), (3), (5), redesignated
    subsec. (h) as (g) and substituted "subsection (b) or (c)" for
    "subsection (a) or (b)" in introductory provisions. Former subsec.
    (g) redesignated (a).
      Pub. L. 107-109, Sec. 7, inserted "(including neonates in
    appropriate cases)" after "pediatric age groups".
      Subsec. (h). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (i) as (h). Former subsec. (h) redesignated (g).
      Subsec. (i). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (l) as (i). Former subsec. (i) redesignated (h).
      Subsec. (j). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (m) as (j). Former subsec. (j) redesignated (n).
      Pub. L. 107-109, Sec. 8, added subsec. (j) and struck out heading
    and text of former subsec. (j). Text read as follows: "A drug may
    not receive any six-month period under subsection (a) or (c) of
    this section unless the application for the drug under section
    355(b)(1) of this title is submitted on or before January 1, 2002.
    After January 1, 2002, a drug shall receive a six-month period
    under subsection (c) of this section if - 
        "(1) the drug was in commercial distribution as of November 21,
      1997;
        "(2) the drug was included by the Secretary on the list under
      subsection (b) of this section as of January 1, 2002;
        "(3) the Secretary determines that there is a continuing need
      for information relating to the use of the drug in the pediatric
      population and that the drug may provide health benefits in that
      population; and
        "(4) all requirements of this section are met."
      Subsec. (k). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (n) as (k). Former subsec. (k) redesignated (m).
      Subsec. (l). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (o) as (l). Former subsec. (l) redesignated (i).
      Pub. L. 107-109, Sec. 5(b)(2), added subsec. (l).
      Subsec. (m). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (k) as (m). Former subsec. (m) redesignated (j).
      Pub. L. 107-109, Sec. 9, added subsec. (m).
      Subsec. (n). Pub. L. 107-109, Sec. 19(4), which directed
    substitution of "subsection (b) or (c)" for "subsection (a) or (c)"
    in subsec. (m), was executed by making the substitution in
    introductory provisions of subsec. (n), to reflect the probable
    intent of Congress.
      Pub. L. 107-109, Sec. 19(2), (3), redesignated subsec. (j) as
    (n). Former subsec. (n) redesignated (k).
      Pub. L. 107-109, Sec. 10, added subsec. (n).
      Subsec. (o). Pub. L. 107-109, Sec. 19(2), (3), redesignated
    subsec. (o) as (l).
      Pub. L. 107-109, Sec. 11(a), added subsec. (o).

                     EFFECTIVE DATE OF 2003 AMENDMENT                 
      Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
    otherwise provided, see section 4 of Pub. L. 108-155, set out as an
    Effective Date note under section 355c of this title.

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-109, Sec. 11(b), Jan. 4, 2002, 115 Stat. 1416,
    provided that: "The amendment made by subsection (a) [amending this
    section] takes effect on the date of enactment of this Act [Jan. 4,
    2002], including with respect to applications under section 505(j)
    of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that
    are approved or pending on that date."

                  REPORT ON PEDIATRIC EXCLUSIVITY PROGRAM              
      Pub. L. 107-109, Sec. 16, Jan. 4, 2002, 115 Stat. 1421, as
    amended by Pub. L. 108-155, Sec. 3(b)(4), Dec. 3, 2003, 117 Stat.
    1942, provided that: "Not later than October 1, 2006, the
    Comptroller General of the United States, in consultation with the
    Secretary of Health and Human Services, shall submit to Congress a
    report that addresses the following issues, using publicly
    available data or data otherwise available to the Government that
    may be used and disclosed under applicable law:
        "(1) The effectiveness of section 505A of the Federal Food,
      Drug, and Cosmetic Act [21 U.S.C. 355a] and section 409I of the
      Public Health Service Act [42 U.S.C. 284m] (as added by this Act)
      in ensuring that medicines used by children are tested and
      properly labeled, including - 
          "(A) the number and importance of drugs for children that are
        being tested as a result of this legislation and the importance
        for children, health care providers, parents, and others of
        labeling changes made as a result of such testing;
          "(B) the number and importance of drugs for children that are
        not being tested for their use notwithstanding the provisions
        of this legislation, and possible reasons for the lack of
        testing; and
          "(C) the number of drugs for which testing is being done,
        exclusivity granted, and labeling changes required, including
        the date pediatric exclusivity is granted and the date labeling
        changes are made and which labeling changes required the use of
        the dispute resolution process established pursuant to the
        amendments made by this Act [see Short Title of 2002 Amendment
        note set out under section 301 of this title], together with a
        description of the outcomes of such process, including a
        description of the disputes and the recommendations of the
        Pediatric Advisory Committee.
        "(2) The economic impact of section 505A of the Federal Food,
      Drug, and Cosmetic Act and section 409I of the Public Health
      Service Act (as added by this Act), including an estimate of - 
          "(A) the costs to taxpayers in the form of higher
        expenditures by medicaid and other Government programs;
          "(B) sales for each drug during the 6-month period for which
        exclusivity is granted, as attributable to such exclusivity;
          "(C) costs to consumers and private insurers as a result of
        any delay in the availability of lower cost generic equivalents
        of drugs tested and granted exclusivity under the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and loss of
        revenue by the generic drug industry and retail pharmacies as a
        result of any such delay; and
          "(D) the benefits to the government, to private insurers, and
        to consumers resulting from decreased health care costs,
        including - 
            "(i) decreased hospitalizations and fewer medical errors,
          due to more appropriate and more effective use of medications
          in children as a result of testing and re-labeling because of
          the amendments made by this Act;
            "(ii) direct and indirect benefits associated with fewer
          physician visits not related to hospitalization;
            "(iii) benefits to children from missing less time at
          school and being less affected by chronic illnesses, thereby
          allowing a better quality of life;
            "(iv) benefits to consumers from lower health insurance
          premiums due to lower treatment costs and hospitalization
          rates; and
            "(v) benefits to employers from reduced need for employees
          to care for family members.
        "(3) The nature and type of studies in children for each drug
      granted exclusivity under the Federal Food, Drug, and Cosmetic
      Act (21 U.S.C. 301 et seq.), including - 
          "(A) a description of the complexity of the studies;
          "(B) the number of study sites necessary to obtain
        appropriate data;
          "(C) the number of children involved in any clinical studies;
        and
          "(D) the estimated cost of each of the studies.
        "(4) Any recommendations for modifications to the programs
      established under section 505A of the Federal Food, Drug, and
      Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public
      Health Service Act [42 U.S.C. 284m] (as added by section 3) that
      the Secretary determines to be appropriate, including a detailed
      rationale for each recommendation.
        "(5) The increased private and Government-funded pediatric
      research capability associated with this Act and the amendments
      made by this Act.
        "(6) The number of written requests and additional letters of
      recommendation that the Secretary issues.
        "(7) The prioritized list of off-patent drugs for which the
      Secretary issues written requests.
        "(8)(A) The efforts made by the Secretary to increase the
      number of studies conducted in the neonate population; and
        "(B) the results of those efforts, including efforts made to
      encourage the conduct of appropriate studies in neonates by
      companies with products that have sufficient safety and other
      information to make the conduct of studies ethical and safe."

                    STUDY BY GENERAL ACCOUNTING OFFICE                
      Pub. L. 107-109, Sec. 18(b), Jan. 4, 2002, 115 Stat. 1423,
    required the Comptroller General, not later than Jan. 10, 2003, to
    conduct a study relating to the representation of children of
    ethnic and racial minorities in studies under section 355a of this
    title and to submit a report to Congress describing the findings of
    the study.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 355b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 355b. Adverse-event reporting

-STATUTE-
    (a) Toll-free number in labeling
      Not later than one year after January 4, 2002, the Secretary of
    Health and Human Services shall promulgate a final rule requiring
    that the labeling of each drug for which an application is approved
    under section 505 of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 355] (regardless of the date on which approved) include the
    toll-free number maintained by the Secretary for the purpose of
    receiving reports of adverse events regarding drugs and a statement
    that such number is to be used for reporting purposes only, not to
    receive medical advice. With respect to the final rule:
        (1) The rule shall provide for the implementation of such
      labeling requirement in a manner that the Secretary considers to
      be most likely to reach the broadest consumer audience.
        (2) In promulgating the rule, the Secretary shall seek to
      minimize the cost of the rule on the pharmacy profession.
        (3) The rule shall take effect not later than 60 days after the
      date on which the rule is promulgated.
    (b) Drugs with pediatric market exclusivity
      (1) In general
        During the one year beginning on the date on which a drug
      receives a period of market exclusivity under 505A (!1) of the
      Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], any report
      of an adverse event regarding the drug that the Secretary of
      Health and Human Services receives shall be referred to the
      Office of Pediatric Therapeutics established under section 393a
      of this title. In considering the report, the Director of such
      Office shall provide for the review of the report by the
      Pediatric Advisory Committee, including obtaining any
      recommendations of such subcommittee (!2) regarding whether the
      Secretary should take action under the Federal Food, Drug, and
      Cosmetic Act [21 U.S.C. 301 et seq.] in response to the report.


      (2) Rule of construction
        Paragraph (1) may not be construed as restricting the authority
      of the Secretary of Health and Human Services to continue
      carrying out the activities described in such paragraph regarding
      a drug after the one-year period described in such paragraph
      regarding the drug has expired.

-SOURCE-
    (Pub. L. 107-109, Sec. 17, Jan. 4, 2002, 115 Stat. 1422; Pub. L.
    108-155, Sec. 3(b)(5), Dec. 3, 2003, 117 Stat. 1942.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
    (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
    which is classified generally to this chapter. For complete
    classification of this Act to the Code, see section 301 of this
    title and Tables.

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Best Pharmaceuticals for
    Children Act, and not as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.


-MISC1-
                                AMENDMENTS                            
      2003 - Subsec. (b)(1). Pub. L. 108-155 struck out "Advisory
    Subcommittee of the Anti-Infective Drugs" before "Advisory
    Committee".

                     EFFECTIVE DATE OF 2003 AMENDMENT                 
      Amendment by Pub. L. 108-155 effective Dec. 3, 2003, except as
    otherwise provided, see section 4 of Pub. L. 108-155, set out as an
    Effective Date note under section 355c of this title.

-FOOTNOTE-
    (!1) So in original. Probably should be preceded by "section".

    (!2) So in original. Probably should be "Committee".


-End-



-CITE-
    21 USC Sec. 355c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 355c. Research into pediatric uses for drugs and biological
      products

-STATUTE-
    (a) New drugs and biological products
      (1) In general
        A person that submits an application (or supplement to an
      application) - 
          (A) under section 355 of this title for a new active
        ingredient, new indication, new dosage form, new dosing
        regimen, or new route of administration; or
          (B) under section 262 of title 42 for a new active
        ingredient, new indication, new dosage form, new dosing
        regimen, or new route of administration;

      shall submit with the application the assessments described in
      paragraph (2).
      (2) Assessments
        (A) In general
          The assessments referred to in paragraph (1) shall contain
        data, gathered using appropriate formulations for each age
        group for which the assessment is required, that are adequate -
        
            (i) to assess the safety and effectiveness of the drug or
          the biological product for the claimed indications in all
          relevant pediatric subpopulations; and
            (ii) to support dosing and administration for each
          pediatric subpopulation for which the drug or the biological
          product is safe and effective.
        (B) Similar course of disease or similar effect of drug or
          biological product
          (i) In general
            If the course of the disease and the effects of the drug
          are sufficiently similar in adults and pediatric patients,
          the Secretary may conclude that pediatric effectiveness can
          be extrapolated from adequate and well-controlled studies in
          adults, usually supplemented with other information obtained
          in pediatric patients, such as pharmacokinetic studies.
          (ii) Extrapolation between age groups
            A study may not be needed in each pediatric age group if
          data from one age group can be extrapolated to another age
          group.
      (3) Deferral
        On the initiative of the Secretary or at the request of the
      applicant, the Secretary may defer submission of some or all
      assessments required under paragraph (1) until a specified date
      after approval of the drug or issuance of the license for a
      biological product if - 
          (A) the Secretary finds that - 
            (i) the drug or biological product is ready for approval
          for use in adults before pediatric studies are complete;
            (ii) pediatric studies should be delayed until additional
          safety or effectiveness data have been collected; or
            (iii) there is another appropriate reason for deferral; and

          (B) the applicant submits to the Secretary - 
            (i) certification of the grounds for deferring the
          assessments;
            (ii) a description of the planned or ongoing studies; and
            (iii) evidence that the studies are being conducted or will
          be conducted with due diligence and at the earliest possible
          time.
      (4) Waivers
        (A) Full waiver
          On the initiative of the Secretary or at the request of an
        applicant, the Secretary shall grant a full waiver, as
        appropriate, of the requirement to submit assessments for a
        drug or biological product under this subsection if the
        applicant certifies and the Secretary finds that - 
            (i) necessary studies are impossible or highly
          impracticable (because, for example, the number of patients
          is so small or the patients are geographically dispersed);
            (ii) there is evidence strongly suggesting that the drug or
          biological product would be ineffective or unsafe in all
          pediatric age groups; or
            (iii) the drug or biological product - 
              (I) does not represent a meaningful therapeutic benefit
            over existing therapies for pediatric patients; and
              (II) is not likely to be used in a substantial number of
            pediatric patients.
        (B) Partial waiver
          On the initiative of the Secretary or at the request of an
        applicant, the Secretary shall grant a partial waiver, as
        appropriate, of the requirement to submit assessments for a
        drug or biological product under this subsection with respect
        to a specific pediatric age group if the applicant certifies
        and the Secretary finds that - 
            (i) necessary studies are impossible or highly
          impracticable (because, for example, the number of patients
          in that age group is so small or patients in that age group
          are geographically dispersed);
            (ii) there is evidence strongly suggesting that the drug or
          biological product would be ineffective or unsafe in that age
          group;
            (iii) the drug or biological product - 
              (I) does not represent a meaningful therapeutic benefit
            over existing therapies for pediatric patients in that age
            group; and
              (II) is not likely to be used by a substantial number of
            pediatric patients in that age group; or

            (iv) the applicant can demonstrate that reasonable attempts
          to produce a pediatric formulation necessary for that age
          group have failed.
        (C) Pediatric formulation not possible
          If a waiver is granted on the ground that it is not possible
        to develop a pediatric formulation, the waiver shall cover only
        the pediatric groups requiring that formulation.
        (D) Labeling requirement
          If the Secretary grants a full or partial waiver because
        there is evidence that a drug or biological product would be
        ineffective or unsafe in pediatric populations, the information
        shall be included in the labeling for the drug or biological
        product.
    (b) Marketed drugs and biological products
      (1) In general
        After providing notice in the form of a letter and an
      opportunity for written response and a meeting, which may include
      an advisory committee meeting, the Secretary may (by order in the
      form of a letter) require the holder of an approved application
      for a drug under section 355 of this title or the holder of a
      license for a biological product under section 262 of title 42 to
      submit by a specified date the assessments described in
      subsection (a)(2) of this section if the Secretary finds that - 
          (A)(i) the drug or biological product is used for a
        substantial number of pediatric patients for the labeled
        indications; and
          (ii) the absence of adequate labeling could pose significant
        risks to pediatric patients; or
          (B)(i) there is reason to believe that the drug or biological
        product would represent a meaningful therapeutic benefit over
        existing therapies for pediatric patients for one or more of
        the claimed indications; and
          (ii) the absence of adequate labeling could pose significant
        risks to pediatric patients.
      (2) Waivers
        (A) Full waiver
          At the request of an applicant, the Secretary shall grant a
        full waiver, as appropriate, of the requirement to submit
        assessments under this subsection if the applicant certifies
        and the Secretary finds that - 
            (i) necessary studies are impossible or highly
          impracticable (because, for example, the number of patients
          in that age group is so small or patients in that age group
          are geographically dispersed); or
            (ii) there is evidence strongly suggesting that the drug or
          biological product would be ineffective or unsafe in all
          pediatric age groups.
        (B) Partial waiver
          At the request of an applicant, the Secretary shall grant a
        partial waiver, as appropriate, of the requirement to submit
        assessments under this subsection with respect to a specific
        pediatric age group if the applicant certifies and the
        Secretary finds that - 
            (i) necessary studies are impossible or highly
          impracticable (because, for example, the number of patients
          in that age group is so small or patients in that age group
          are geographically dispersed);
            (ii) there is evidence strongly suggesting that the drug or
          biological product would be ineffective or unsafe in that age
          group;
            (iii)(I) the drug or biological product - 
              (aa) does not represent a meaningful therapeutic benefit
            over existing therapies for pediatric patients in that age
            group; and
              (bb) is not likely to be used in a substantial number of
            pediatric patients in that age group; and

            (II) the absence of adequate labeling could not pose
          significant risks to pediatric patients; or
            (iv) the applicant can demonstrate that reasonable attempts
          to produce a pediatric formulation necessary for that age
          group have failed.
        (C) Pediatric formulation not possible
          If a waiver is granted on the ground that it is not possible
        to develop a pediatric formulation, the waiver shall cover only
        the pediatric groups requiring that formulation.
        (D) Labeling requirement
          If the Secretary grants a full or partial waiver because
        there is evidence that a drug or biological product would be
        ineffective or unsafe in pediatric populations, the information
        shall be included in the labeling for the drug or biological
        product.
      (3) Relationship to other pediatric provisions
        (A) No assessment without written request
          No assessment may be required under paragraph (1) for a drug
        subject to an approved application under section 355 of this
        title unless - 
            (i) the Secretary has issued a written request for a
          related pediatric study under section 355a(c) of this title
          or section 284m of title 42;
            (ii)(I) if the request was made under section 355a(c) of
          this title - 
              (aa) the recipient of the written request does not agree
            to the request; or
              (bb) the Secretary does not receive a response as
            specified under section 355a(d)(4)(A) of this title; or

            (II) if the request was made under section 284m of title 42
          - 
              (aa) the recipient of the written request does not agree
            to the request; or
              (bb) the Secretary does not receive a response as
            specified under section 284m(c)(2) of title 42; and

            (iii)(I) the Secretary certifies under subparagraph (B)
          that there are insufficient funds under sections 284m and
          290b of title 42 to conduct the study; or
            (II) the Secretary publishes in the Federal Register a
          certification that certifies that - 
              (aa) no contract or grant has been awarded under section
            284m or 290b of title 42; and
              (bb) not less than 270 days have passed since the date of
            a certification under subparagraph (B) that there are
            sufficient funds to conduct the study.
        (B) No agreement to request
          Not later than 60 days after determining that no holder will
        agree to the written request (including a determination that
        the Secretary has not received a response specified under
        section 355a(d) of this title or section 284m of title 42,(!1)
        the Secretary shall certify whether the Secretary has
        sufficient funds to conduct the study under section 284m or
        290b of title 42, taking into account the prioritization under
        section 284m of title 42.

    (c) Meaningful therapeutic benefit
      For the purposes of paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I)
    of subsection (a) of this section and paragraphs (1)(B)(i) and
    (2)(B)(iii)(I)(aa) of subsection (b) of this section, a drug or
    biological product shall be considered to represent a meaningful
    therapeutic benefit over existing therapies if the Secretary
    estimates that - 
        (1) if approved, the drug or biological product would represent
      a significant improvement in the treatment, diagnosis, or
      prevention of a disease, compared with marketed products
      adequately labeled for that use in the relevant pediatric
      population; or
        (2) the drug or biological product is in a class of products or
      for an indication for which there is a need for additional
      options.
    (d) Submission of assessments
      If a person fails to submit an assessment described in subsection
    (a)(2) of this section, or a request for approval of a pediatric
    formulation described in subsection (a) or (b) of this section, in
    accordance with applicable provisions of subsections (a) and (b) of
    this section - 
        (1) the drug or biological product that is the subject of the
      assessment or request may be considered misbranded solely because
      of that failure and subject to relevant enforcement action
      (except that the drug or biological product shall not be subject
      to action under section 333 of this title); but
        (2) the failure to submit the assessment or request shall not
      be the basis for a proceeding - 
          (A) to withdraw approval for a drug under section 355(e) of
        this title; or
          (B) to revoke the license for a biological product under
        section 262 of title 42.
    (e) Meetings
      Before and during the investigational process for a new drug or
    biological product, the Secretary shall meet at appropriate times
    with the sponsor of the new drug or biological product to discuss -
    
        (1) information that the sponsor submits on plans and timelines
      for pediatric studies; or
        (2) any planned request by the sponsor for waiver or deferral
      of pediatric studies.
    (f) Scope of authority
      Nothing in this section provides to the Secretary any authority
    to require a pediatric assessment of any drug or biological
    product, or any assessment regarding other populations or uses of a
    drug or biological product, other than the pediatric assessments
    described in this section.
    (g) Orphan drugs
      Unless the Secretary requires otherwise by regulation, this
    section does not apply to any drug for an indication for which
    orphan designation has been granted under section 360bb of this
    title.
    (h) Integration with other pediatric studies
      The authority under this section shall remain in effect so long
    as an application subject to this section may be accepted for
    filing by the Secretary on or before the date specified in section
    355a(n) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 505B, as added Pub. L. 108-155, Sec.
    2(a), Dec. 3, 2003, 117 Stat. 1936.)


-MISC1-
                              EFFECTIVE DATE                          
      Pub. L. 108-155, Sec. 4, Dec. 3, 2003, 117 Stat. 1942, provided
    that:
      "(a) In General. - Subject to subsection (b), this Act [enacting
    this section, amending sections 355, 355a, and 355b of this title
    and sections 262 and 284m of Title 42, The Public Health and
    Welfare, enacting provisions set out as a note under section 301 of
    this title, and amending provisions set out as notes under section
    355a of this title and section 284m of Title 42] and the amendments
    made by this Act take effect on the date of enactment of this Act
    [Dec. 3, 2003].
      "(b) Applicability to New Drugs and Biological Products. - 
        "(1) In general. - Subsection (a) of section 505B of the
      Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355c(a)] (as
      added by section 2) shall apply to an application described in
      paragraph (1) of that subsection submitted to the Secretary of
      Health and Human Services on or after April 1, 1999.
        "(2) Waivers and deferrals. - 
          "(A) Waiver or deferral granted. - If, with respect to an
        application submitted to the Secretary of Health and Human
        Services between April 1, 1999, and the date of enactment of
        this Act [Dec. 3, 2003], a waiver or deferral of pediatric
        assessments was granted under regulations of the Secretary then
        in effect, the waiver or deferral shall be a waiver or deferral
        under subsection (a) of section 505B of the Federal Food, Drug,
        and Cosmetic Act [21 U.S.C. 355c(a)], except that any date
        specified in such a deferral shall be extended by the number of
        days that is equal to the number of days between October 17,
        2002, and the date of enactment of this Act.
          "(B) Waiver and deferral not granted. - If, with respect to
        an application submitted to the Secretary of Health and Human
        Services between April 1, 1999, and the date of enactment of
        this Act [Dec. 3, 2003], neither a waiver nor deferral of
        pediatric assessments was granted under regulations of the
        Secretary then in effect, the person that submitted the
        application shall be required to submit assessments under
        subsection (a)(2) of section 505B of the Federal Food, Drug,
        and Cosmetic Act [21 U.S.C. 355c(a)(2)] on the date that is the
        later of - 
            "(i) the date that is 1 year after the date of enactment of
          this Act; or
            "(ii) such date as the Secretary may specify under
          subsection (a)(3) of that section;
      unless the Secretary grants a waiver under subsection (a)(4) of
      that section.
      "(c) No Limitation of Authority. - Neither the lack of guidance
    or regulations to implement this Act or the amendments made by this
    Act nor the pendency of the process for issuing guidance or
    regulations shall limit the authority of the Secretary of Health
    and Human Services under, or defer any requirement under, this Act
    or those amendments."

-FOOTNOTE-
    (!1) So in original. A closing parenthesis probably should precede
         the comma.


-End-



-CITE-
    21 USC Sec. 356                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356. Fast track products

-STATUTE-
    (a) Designation of drug as fast track product
      (1) In general
        The Secretary shall, at the request of the sponsor of a new
      drug, facilitate the development and expedite the review of such
      drug if it is intended for the treatment of a serious or life-
      threatening condition and it demonstrates the potential to
      address unmet medical needs for such a condition. (In this
      section, such a drug is referred to as a "fast track product".)
      (2) Request for designation
        The sponsor of a new drug may request the Secretary to
      designate the drug as a fast track product. A request for the
      designation may be made concurrently with, or at any time after,
      submission of an application for the investigation of the drug
      under section 355(i) of this title or section 262(a)(3) of title
      42.
      (3) Designation
        Within 60 calendar days after the receipt of a request under
      paragraph (2), the Secretary shall determine whether the drug
      that is the subject of the request meets the criteria described
      in paragraph (1). If the Secretary finds that the drug meets the
      criteria, the Secretary shall designate the drug as a fast track
      product and shall take such actions as are appropriate to
      expedite the development and review of the application for
      approval of such product.
    (b) Approval of application for fast track product
      (1) In general
        The Secretary may approve an application for approval of a fast
      track product under section 355(c) of this title or section 262
      of title 42 upon a determination that the product has an effect
      on a clinical endpoint or on a surrogate endpoint that is
      reasonably likely to predict clinical benefit.
      (2) Limitation
        Approval of a fast track product under this subsection may be
      subject to the requirements - 
          (A) that the sponsor conduct appropriate post-approval
        studies to validate the surrogate endpoint or otherwise confirm
        the effect on the clinical endpoint; and
          (B) that the sponsor submit copies of all promotional
        materials related to the fast track product during the
        preapproval review period and, following approval and for such
        period thereafter as the Secretary determines to be
        appropriate, at least 30 days prior to dissemination of the
        materials.
      (3) Expedited withdrawal of approval
        The Secretary may withdraw approval of a fast track product
      using expedited procedures (as prescribed by the Secretary in
      regulations which shall include an opportunity for an informal
      hearing) if - 
          (A) the sponsor fails to conduct any required post-approval
        study of the fast track drug with due diligence;
          (B) a post-approval study of the fast track product fails to
        verify clinical benefit of the product;
          (C) other evidence demonstrates that the fast track product
        is not safe or effective under the conditions of use; or
          (D) the sponsor disseminates false or misleading promotional
        materials with respect to the product.
    (c) Review of incomplete applications for approval of fast track
      product
      (1) In general
        If the Secretary determines, after preliminary evaluation of
      clinical data submitted by the sponsor, that a fast track product
      may be effective, the Secretary shall evaluate for filing, and
      may commence review of portions of, an application for the
      approval of the product before the sponsor submits a complete
      application. The Secretary shall commence such review only if the
      applicant - 
          (A) provides a schedule for submission of information
        necessary to make the application complete; and
          (B) pays any fee that may be required under section 379h of
        this title.
      (2) Exception
        Any time period for review of human drug applications that has
      been agreed to by the Secretary and that has been set forth in
      goals identified in letters of the Secretary (relating to the use
      of fees collected under section 379h of this title to expedite
      the drug development process and the review of human drug
      applications) shall not apply to an application submitted under
      paragraph (1) until the date on which the application is
      complete.
    (d) Awareness efforts
      The Secretary shall - 
        (1) develop and disseminate to physicians, patient
      organizations, pharmaceutical and biotechnology companies, and
      other appropriate persons a description of the provisions of this
      section applicable to fast track products; and
        (2) establish a program to encourage the development of
      surrogate endpoints that are reasonably likely to predict
      clinical benefit for serious or life-threatening conditions for
      which there exist significant unmet medical needs.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 506, as added Pub. L. 105-115, title
    I, Sec. 112(a), Nov. 21, 1997, 111 Stat. 2309.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 356, act June 25, 1938, ch. 675, Sec. 506, as
    added Dec. 22, 1941, ch. 613, Sec. 3, 55 Stat. 851; amended Pub. L.
    102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103-
    80, Sec. 3(o), Aug. 13, 1993, 107 Stat. 777, related to
    certification of drugs containing insulin, prior to repeal by Pub.
    L. 105-115, title I, Sec. 125(a)(1), Nov. 21, 1997, 111 Stat. 2325.

                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

                                 GUIDANCE                             
      Section 112(b) of Pub. L. 105-115 provided that: "Within 1 year
    after the date of enactment of this Act [Nov. 21, 1997], the
    Secretary of Health and Human Services shall issue guidance for
    fast track products (as defined in section 506(a)(1) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 356(a)(1)]) that describes
    the policies and procedures that pertain to section 506 of such
    Act."

-End-



-CITE-
    21 USC Sec. 356-1                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356-1. Accelerated approval of priority countermeasures

-STATUTE-
    (a) In general
      The Secretary of Health and Human Services may designate a
    priority countermeasure as a fast-track product pursuant to section
    356 of this title or as a device granted review priority pursuant
    to section 360e(d)(5) of this title. Such a designation may be made
    prior to the submission of - 
        (1) a request for designation by the sponsor or applicant; or
        (2) an application for the investigation of the drug under
      section 355(i) of this title or section 262(a)(3) of title 42.

    Nothing in this subsection shall be construed to prohibit a sponsor
    or applicant from declining such a designation.
    (b) Use of animal trials
      A drug for which approval is sought under section 355(b) of this
    title or section 262 of title 42 on the basis of evidence of
    effectiveness that is derived from animal studies pursuant to
    section 123 (!1) may be designated as a fast track product for
    purposes of this section.

    (c) Priority review of drugs and biological products
      A priority countermeasure that is a drug or biological product
    shall be considered a priority drug or biological product for
    purposes of performance goals for priority drugs or biological
    products agreed to by the Commissioner of Food and Drugs.
    (d) Definitions
      For purposes of this title: (!1)
        (1) The term "priority countermeasure" has the meaning given
      such term in section 247d-6(h)(4) of title 42.
        (2) The term "priority drugs or biological products" means a
      drug or biological product that is the subject of a drug or
      biologics application referred to in section 101(4) of the Food
      and Drug Administration Modernization Act of 1997.

-SOURCE-
    (Pub. L. 107-188, title I, Sec. 122, June 12, 2002, 116 Stat. 613.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 123, referred to in subsec. (b), is section 123 of Pub.
    L. 107-188, title I, June 12, 2002, 116 Stat. 613, which is not
    classified to the Code.
      This title, referred to in subsec. (d), is title I of Pub. L. 107-
    188, June 12, 2002, 116 Stat. 596, which enacted this section,
    section 669a of Title 29, Labor, and sections 244, 245, 247d-3a,
    247d-3b, 247d-7a to 247d-7d, 300hh, 300hh-11 to 300hh-13, 1320b-5,
    and 7257d of Title 42, The Public Health and Welfare, amended
    sections 247d to 247d-6, 264, 266, 290hh-1, and 5196b of Title 42,
    and enacted provisions set out as notes preceding section 8101 of
    Title 38, Veterans' Benefits, and under sections 201, 244, 247d,
    247d-6, 300hh, 300hh-12, and 1320b-5 of Title 42. For complete
    classification of this title to the Code, see Tables.
      Section 101(4) of the Food and Drug Administration Modernization
    Act of 1997, referred to in subsec. (d)(2), is section 101(4) of
    Pub. L. 105-115, which is set out as a note under section 379g of
    this title.

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Public Health Security and
    Bioterrorism Preparedness and Response Act of 2002, and not as part
    of the Federal Food, Drug, and Cosmetic Act which comprises this
    chapter.

-FOOTNOTE-
    (!1) See References in Text note below.


-End-



-CITE-
    21 USC Sec. 356a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356a. Manufacturing changes

-STATUTE-
    (a) In general
      With respect to a drug for which there is in effect an approved
    application under section 355 or 360b of this title or a license
    under section 262 of title 42, a change from the manufacturing
    process approved pursuant to such application or license may be
    made, and the drug as made with the change may be distributed, if -
    
        (1) the holder of the approved application or license (referred
      to in this section as a "holder") has validated the effects of
      the change in accordance with subsection (b) of this section; and
        (2)(A) in the case of a major manufacturing change, the holder
      has complied with the requirements of subsection (c) of this
      section; or
        (B) in the case of a change that is not a major manufacturing
      change, the holder complies with the applicable requirements of
      subsection (d) of this section.
    (b) Validation of effects of changes
      For purposes of subsection (a)(1) of this section, a drug made
    with a manufacturing change (whether a major manufacturing change
    or otherwise) may be distributed only if, before distribution of
    the drug as so made, the holder involved validates the effects of
    the change on the identity, strength, quality, purity, and potency
    of the drug as the identity, strength, quality, purity, and potency
    may relate to the safety or effectiveness of the drug.
    (c) Major manufacturing changes
      (1) Requirement of supplemental application
        For purposes of subsection (a)(2)(A) of this section, a drug
      made with a major manufacturing change may be distributed only
      if, before the distribution of the drug as so made, the holder
      involved submits to the Secretary a supplemental application for
      such change and the Secretary approves the application. The
      application shall contain such information as the Secretary
      determines to be appropriate, and shall include the information
      developed under subsection (b) of this section by the holder in
      validating the effects of the change.
      (2) Changes qualifying as major changes
        For purposes of subsection (a)(2)(A) of this section, a major
      manufacturing change is a manufacturing change that is determined
      by the Secretary to have substantial potential to adversely
      affect the identity, strength, quality, purity, or potency of the
      drug as they may relate to the safety or effectiveness of a drug.
      Such a change includes a change that - 
          (A) is made in the qualitative or quantitative formulation of
        the drug involved or in the specifications in the approved
        application or license referred to in subsection (a) of this
        section for the drug (unless exempted by the Secretary by
        regulation or guidance from the requirements of this
        subsection);
          (B) is determined by the Secretary by regulation or guidance
        to require completion of an appropriate clinical study
        demonstrating equivalence of the drug to the drug as
        manufactured without the change; or
          (C) is another type of change determined by the Secretary by
        regulation or guidance to have a substantial potential to
        adversely affect the safety or effectiveness of the drug.
    (d) Other manufacturing changes
      (1) In general
        For purposes of subsection (a)(2)(B) of this section, the
      Secretary may regulate drugs made with manufacturing changes that
      are not major manufacturing changes as follows:
          (A) The Secretary may in accordance with paragraph (2)
        authorize holders to distribute such drugs without submitting a
        supplemental application for such changes.
          (B) The Secretary may in accordance with paragraph (3)
        require that, prior to the distribution of such drugs, holders
        submit to the Secretary supplemental applications for such
        changes.
          (C) The Secretary may establish categories of such changes
        and designate categories to which subparagraph (A) applies and
        categories to which subparagraph (B) applies.
      (2) Changes not requiring supplemental application
        (A) Submission of report
          A holder making a manufacturing change to which paragraph
        (1)(A) applies shall submit to the Secretary a report on the
        change, which shall contain such information as the Secretary
        determines to be appropriate, and which shall include the
        information developed under subsection (b) of this section by
        the holder in validating the effects of the change. The report
        shall be submitted by such date as the Secretary may specify.
        (B) Authority regarding annual reports
          In the case of a holder that during a single year makes more
        than one manufacturing change to which paragraph (1)(A)
        applies, the Secretary may in carrying out subparagraph (A)
        authorize the holder to comply with such subparagraph by
        submitting a single report for the year that provides the
        information required in such subparagraph for all the changes
        made by the holder during the year.
      (3) Changes requiring supplemental application
        (A) Submission of supplemental application
          The supplemental application required under paragraph (1)(B)
        for a manufacturing change shall contain such information as
        the Secretary determines to be appropriate, which shall include
        the information developed under subsection (b) of this section
        by the holder in validating the effects of the change.
        (B) Authority for distribution
          In the case of a manufacturing change to which paragraph
        (1)(B) applies:
            (i) The holder involved may commence distribution of the
          drug involved 30 days after the Secretary receives the
          supplemental application under such paragraph, unless the
          Secretary notifies the holder within such 30-day period that
          prior approval of the application is required before
          distribution may be commenced.
            (ii) The Secretary may designate a category of such changes
          for the purpose of providing that, in the case of a change
          that is in such category, the holder involved may commence
          distribution of the drug involved upon the receipt by the
          Secretary of a supplemental application for the change.
            (iii) If the Secretary disapproves the supplemental
          application, the Secretary may order the manufacturer to
          cease the distribution of the drugs that have been made with
          the manufacturing change.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 506A, as added Pub. L. 105-115, title
    I, Sec. 116(a), Nov. 21, 1997, 111 Stat. 2313.)


-MISC1-
                              EFFECTIVE DATE                          
      Section 116(b) of Pub. L. 105-115 provided that: "The amendment
    made by subsection (a) [enacting this section] takes effect upon
    the effective date of regulations promulgated by the Secretary of
    Health and Human Services to implement such amendment, or upon the
    expiration of the 24-month period beginning on the date of the
    enactment of this Act [Nov. 21, 1997], whichever occurs first."

-End-



-CITE-
    21 USC Sec. 356b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356b. Reports of postmarketing studies

-STATUTE-
    (a) Submission
      (1) In general
        A sponsor of a drug that has entered into an agreement with the
      Secretary to conduct a postmarketing study of a drug shall submit
      to the Secretary, within 1 year after the approval of such drug
      and annually thereafter until the study is completed or
      terminated, a report of the progress of the study or the reasons
      for the failure of the sponsor to conduct the study. The report
      shall be submitted in such form as is prescribed by the Secretary
      in regulations issued by the Secretary.
      (2) Agreements prior to effective date
        Any agreement entered into between the Secretary and a sponsor
      of a drug, prior to November 21, 1997, to conduct a postmarketing
      study of a drug shall be subject to the requirements of paragraph
      (1). An initial report for such an agreement shall be submitted
      within 6 months after the date of the issuance of the regulations
      under paragraph (1).
    (b) Consideration of information as public information
      Any information pertaining to a report described in subsection
    (a) of this section shall be considered to be public information to
    the extent that the information is necessary - 
        (1) to identify the sponsor; and
        (2) to establish the status of a study described in subsection
      (a) of this section and the reasons, if any, for any failure to
      carry out the study.
    (c) Status of studies and reports
      The Secretary shall annually develop and publish in the Federal
    Register a report that provides information on the status of the
    postmarketing studies - 
        (1) that sponsors have entered into agreements to conduct; and
        (2) for which reports have been submitted under subsection
      (a)(1) of this section.
    (d) Disclosure
      If a sponsor fails to complete an agreed upon study required by
    this section by its original or otherwise negotiated deadline, the
    Secretary shall publish a statement on the Internet site of the
    Food and Drug Administration stating that the study was not
    completed and, if the reasons for such failure to complete the
    study were not satisfactory to the Secretary, a statement that such
    reasons were not satisfactory to the Secretary.
    (e) Notification
      With respect to studies of the type required under section
    356(b)(2)(A) of this title or under section 314.510 or 601.41 of
    title 21, Code of Federal Regulations, as each of such sections was
    in effect on the day before the effective date of this subsection,
    the Secretary may require that a sponsor who, for reasons not
    satisfactory to the Secretary, fails to complete by its deadline a
    study under any of such sections of such type for a drug or
    biological product (including such a study conducted after such
    effective date) notify practitioners who prescribe such drug or
    biological product of the failure to complete such study and the
    questions of clinical benefit, and, where appropriate, questions of
    safety, that remain unanswered as a result of the failure to
    complete such study. Nothing in this subsection shall be construed
    as altering the requirements of the types of studies required under
    section 356(b)(2)(A) of this title or under section 314.510 or
    601.41 of title 21, Code of Federal Regulations, as so in effect,
    or as prohibiting the Secretary from modifying such sections of
    title 21 of such Code to provide for studies in addition to those
    of such type.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 506B, as added Pub. L. 105-115, title
    I, Sec. 130(a), Nov. 21, 1997, 111 Stat. 2331; amended Pub. L. 107-
    188, title V, Sec. 506, June 12, 2002, 116 Stat. 693.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The effective date of this subsection, referred to in subsec.
    (e), is Oct. 1, 2002, see Effective Date of 2002 Amendment note set
    out below.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsecs. (d), (e). Pub. L. 107-188 added subsecs. (d) and
    (e).

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Pub. L. 107-188, title V, Sec. 508, June 12, 2002, 116 Stat. 694,
    provided that: "The amendments made by this subtitle [subtitle A
    (Secs. 501-509) of title V of Pub. L. 107-188, amending this
    section and sections 379g and 379h of this title] shall take effect
    October 1, 2002."

                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

                    REPORT TO CONGRESSIONAL COMMITTEES                
      Pub. L. 105-115, title I, Sec. 130(b), Nov. 21, 1997, 111 Stat.
    2331, provided that not later than Oct. 1, 2001, the Secretary was
    to submit to Congress a report containing a summary of the reports
    submitted under section 356b of this title and an evaluation and
    legislative recommendations relating to postmarketing studies of
    drugs.

-End-



-CITE-
    21 USC Sec. 356c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 356c. Discontinuance of life saving product

-STATUTE-
    (a) In general
      A manufacturer that is the sole manufacturer of a drug - 
        (1) that is - 
          (A) life-supporting;
          (B) life-sustaining; or
          (C) intended for use in the prevention of a debilitating
        disease or condition;

        (2) for which an application has been approved under section
      355(b) or 355(j) of this title; and
        (3) that is not a product that was originally derived from
      human tissue and was replaced by a recombinant product,

    shall notify the Secretary of a discontinuance of the manufacture
    of the drug at least 6 months prior to the date of the
    discontinuance.
    (b) Reduction in notification period
      The notification period required under subsection (a) of this
    section for a manufacturer may be reduced if the manufacturer
    certifies to the Secretary that good cause exists for the
    reduction, such as a situation in which - 
        (1) a public health problem may result from continuation of the
      manufacturing for the 6-month period;
        (2) a biomaterials shortage prevents the continuation of the
      manufacturing for the 6-month period;
        (3) a liability problem may exist for the manufacturer if the
      manufacturing is continued for the 6-month period;
        (4) continuation of the manufacturing for the 6-month period
      may cause substantial economic hardship for the manufacturer;
        (5) the manufacturer has filed for bankruptcy under chapter 7
      or 11 of title 11; or
        (6) the manufacturer can continue the distribution of the drug
      involved for 6 months.
    (c) Distribution
      To the maximum extent practicable, the Secretary shall distribute
    information on the discontinuation of the drugs described in
    subsection (a) of this section to appropriate physician and patient
    organizations.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 506C, as added Pub. L. 105-115, title
    I, Sec. 131(a), Nov. 21, 1997, 111 Stat. 2332.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 357                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 357. Repealed.

-MISC1-
    Sec. 357. Repealed. Pub. L. 105-115, title I, Sec. 125(b)(1), Nov.
      21, 1997, 111 Stat. 2325.
      Section, act June 25, 1938, ch. 675, Sec. 507, as added July 6,
    1945, ch. 281, Sec. 3, 59 Stat. 463; amended Mar. 10, 1947, ch. 16,
    Sec. 3, 61 Stat. 12; July 13, 1949, ch. 305, Sec. 2, 63 Stat. 409;
    Aug. 5, 1953, ch. 334, Sec. 2, 67 Stat. 389; Pub. L. 87-781, title
    I, Secs. 105(a), (b), (d)-(f), 106(a), (b), Oct. 10, 1962, 76 Stat.
    785, 786, 787; Pub. L. 90-399, Sec. 105(b), July 13, 1968, 82 Stat.
    352; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
    Pub. L. 103-80, Sec. 3(p), Aug. 13, 1993, 107 Stat. 777, related to
    certification of drugs containing penicillin, streptomycin,
    chlortetracycline, chloramphenicol, bacitracin, or any other
    antibiotic drug.

-End-



-CITE-
    21 USC Sec. 358                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 358. Authority to designate official names

-STATUTE-
    (a) Necessity or desirability; use in official compendiums;
      infringement of trademarks
      The Secretary may designate an official name for any drug or
    device if he determines that such action is necessary or desirable
    in the interest of usefulness and simplicity. Any official name
    designated under this section for any drug or device shall be the
    only official name of that drug or device used in any official
    compendium published after such name has been prescribed or for any
    other purpose of this chapter. In no event, however, shall the
    Secretary establish an official name so as to infringe a valid
    trademark.
    (b) Review of names in official compendiums
      Within a reasonable time after October 10, 1962, and at such
    other times as he may deem necessary, the Secretary shall cause a
    review to be made of the official names by which drugs are
    identified in the official United States Pharmacopoeia, the
    official Homoeopathic Pharmacopoeia of the United States, and the
    official National Formulary, and all supplements thereto, and at
    such times as he may deem necessary shall cause a review to be made
    of the official names by which devices are identified in any
    official compendium (and all supplements thereto) to determine
    whether revision of any of those names is necessary or desirable in
    the interest of usefulness and simplicity.
    (c) Determinations of complexity, usefulness, multiplicity, or lack
      of name; designation by Secretary
      Whenever he determines after any such review that (1) any such
    official name is unduly complex or is not useful for any other
    reason, (2) two or more official names have been applied to a
    single drug or device, or to two or more drugs which are identical
    in chemical structure and pharmacological action and which are
    substantially identical in strength, quality, and purity, or to two
    or more devices which are substantially equivalent in design and
    purpose or (3) no official name has been applied to a medically
    useful drug or device, he shall transmit in writing to the compiler
    of each official compendium in which that drug or drugs or device
    are identified and recognized his request for the recommendation of
    a single official name for such drug or drugs or device which will
    have usefulness and simplicity. Whenever such a single official
    name has not been recommended within one hundred and eighty days
    after such request, or the Secretary determines that any name so
    recommended is not useful for any reason, he shall designate a
    single official name for such drug or drugs or device. Whenever he
    determines that the name so recommended is useful, he shall
    designate that name as the official name of such drug or drugs or
    device. Such designation shall be made as a regulation upon public
    notice and in accordance with the procedure set forth in section
    553 of title 5.
    (d) Revised official names; compilation, publication, and public
      distribution of listings
      After each such review, and at such other times as the Secretary
    may determine to be necessary or desirable, the Secretary shall
    cause to be compiled, published, and publicly distributed a list
    which shall list all revised official names of drugs or devices
    designated under this section and shall contain such descriptive
    and explanatory matter as the Secretary may determine to be
    required for the effective use of those names.
    (e) Request by compiler of official compendium for designation of
      name
      Upon a request in writing by any compiler of an official
    compendium that the Secretary exercise the authority granted to him
    under subsection (a) of this section, he shall upon public notice
    and in accordance with the procedure set forth in section 553 of
    title 5 designate the official name of the drug or device for which
    the request is made.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 508, as added Pub. L. 87-781, title
    I, Sec. 111(a), Oct. 10, 1962, 76 Stat. 789; amended Pub. L. 94-
    295, Sec. 5(b), May 28, 1976, 90 Stat. 581; Pub. L. 103-80, Sec.
    3(q), Aug. 13, 1993, 107 Stat. 777.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsecs. (c), (e). Pub. L. 103-80 substituted reference to
    section 553 of title 5 for "section 4 of the Administrative
    Procedure Act (5 U.S.C. 1003)".
      1976 - Subsec. (a). Pub. L. 94-295 substituted "drug or device"
    for "drug" wherever appearing.
      Subsec. (b). Pub. L. 94-295 substituted "National Formulary, and
    all supplements thereto, and at such times as he may deem necessary
    shall cause a review to be made of the official names by which
    devices are identified in any official compendium (and all
    supplements thereto)" for "National Formulary, and all supplements
    thereto,".
      Subsec. (c)(2). Pub. L. 94-295 inserted "or device" after "single
    drug", and "or to two or more devices which are substantially
    equivalent in design and purpose" after "purity,".
      Subsec. (c)(3). Pub. L. 94-295 inserted "or device" after "useful
    drug" and after "drug or drugs" wherever appearing.
      Subsec. (d). Pub. L. 94-295 inserted "or devices" after "drugs".
      Subsec. (e). Pub. L. 94-295 substituted "drug or device" for
    "drug".

                              EFFECTIVE DATE                          
      Section 111(b) of Pub. L. 87-781 provided that: "This section
    [enacting this section] shall take effect on the date of its
    enactment [Oct. 10, 1962]."

-End-



-CITE-
    21 USC Sec. 359                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 359. Nonapplicability of subchapter to cosmetics

-STATUTE-
      This subchapter, as amended by the Drug Amendments of 1962, shall
    not apply to any cosmetic unless such cosmetic is also a drug or
    device or component thereof.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 509, as added Pub. L. 87-781, title
    I, Sec. 113, Oct. 10, 1962, 76 Stat. 791.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This subchapter, as amended by the Drug Amendments of 1962,
    referred to in text, means the amendment of this subchapter by Pub.
    L. 87-781 which enacted sections 358 to 360 of this title, amended
    sections 351 to 353, 355, and 357 of this title, and enacted
    provisions set out as notes under sections 352, 355, 358, and 360
    of this title.
      The Drug Amendments of 1962, referred to in text, is Pub. L. 87-
    781, Oct. 10, 1962, 76 Stat. 780, as amended. For complete
    classification of this Act to the Code, see Short Title of 1962
    Amendment note set out under section 301 of this title and Tables.

-End-



-CITE-
    21 USC Sec. 360                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360. Registration of producers of drugs or devices

-STATUTE-
    (a) Definitions
      As used in this section - 
        (1) the term "manufacture, preparation, propagation,
      compounding, or processing" shall include repackaging or
      otherwise changing the container, wrapper, or labeling of any
      drug package or device package in furtherance of the distribution
      of the drug or device from the original place of manufacture to
      the person who makes final delivery or sale to the ultimate
      consumer or user; and
        (2) the term "name" shall include in the case of a partnership
      the name of each partner and, in the case of a corporation, the
      name of each corporate officer and director, and the State of
      incorporation.
    (b) Annual registration
      On or before December 31 of each year every person who owns or
    operates any establishment in any State engaged in the manufacture,
    preparation, propagation, compounding, or processing of a drug or
    drugs or a device or devices shall register with the Secretary his
    name, places of business, and all such establishments.
    (c) New producers
      Every person upon first engaging in the manufacture, preparation,
    propagation, compounding, or processing of a drug or drugs or a
    device or devices in any establishment which he owns or operates in
    any State shall immediately register with the Secretary his name,
    place of business, and such establishment.
    (d) Additional establishments
      Every person duly registered in accordance with the foregoing
    subsections of this section shall immediately register with the
    Secretary any additional establishment which he owns or operates in
    any State and in which he begins the manufacture, preparation,
    propagation, compounding, or processing of a drug or drugs or a
    device or devices.
    (e) Registration number; uniform system for identification of
      devices intended for human use
      The Secretary may assign a registration number to any person or
    any establishment registered in accordance with this section. The
    Secretary may also assign a listing number to each drug or class of
    drugs listed under subsection (j) of this section. Any number
    assigned pursuant to the preceding sentence shall be the same as
    that assigned pursuant to the National Drug Code. The Secretary may
    by regulation prescribe a uniform system for the identification of
    devices intended for human use and may require that persons who are
    required to list such devices pursuant to subsection (j) of this
    section shall list such devices in accordance with such system.
    (f) Availability of registrations for inspection
      The Secretary shall make available for inspection, to any person
    so requesting, any registration filed pursuant to this section;
    except that any list submitted pursuant to paragraph (3) of
    subsection (j) of this section and the information accompanying any
    list or notice filed under paragraph (1) or (2) of that subsection
    shall be exempt from such inspection unless the Secretary finds
    that such an exemption would be inconsistent with protection of the
    public health.
    (g) Exclusions from application of section
      The foregoing subsections of this section shall not apply to - 
        (1) pharmacies which maintain establishments in conformance
      with any applicable local laws regulating the practice of
      pharmacy and medicine and which are regularly engaged in
      dispensing prescription drugs or devices, upon prescriptions of
      practitioners licensed to administer such drugs or devices to
      patients under the care of such practitioners in the course of
      their professional practice, and which do not manufacture,
      prepare, propagate, compound, or process drugs or devices for
      sale other than in the regular course of their business of
      dispensing or selling drugs or devices at retail;
        (2) practitioners licensed by law to prescribe or administer
      drugs or devices and who manufacture, prepare, propagate,
      compound, or process drugs or devices solely for use in the
      course of their professional practice;
        (3) persons who manufacture, prepare, propagate, compound, or
      process drugs or devices solely for use in research, teaching, or
      chemical analysis and not for sale;
        (4) any distributor who acts as a wholesale distributor of
      devices, and who does not manufacture, repackage, process, or
      relabel a device; or
        (5) such other classes of persons as the Secretary may by
      regulation exempt from the application of this section upon a
      finding that registration by such classes of persons in
      accordance with this section is not necessary for the protection
      of the public health.

    In this subsection, the term "wholesale distributor" means any
    person (other than the manufacturer or the initial importer) who
    distributes a device from the original place of manufacture to the
    person who makes the final delivery or sale of the device to the
    ultimate consumer or user.
    (h) Inspection of premises
      Every establishment in any State registered with the Secretary
    pursuant to this section shall be subject to inspection pursuant to
    section 374 of this title and every such establishment engaged in
    the manufacture, propagation, compounding, or processing of a drug
    or drugs or of a device or devices classified in class II or III
    shall be so inspected by one or more officers or employees duly
    designated by the Secretary, or by persons accredited to conduct
    inspections under section 374(g) of this title, at least once in
    the two-year period beginning with the date of registration of such
    establishment pursuant to this section and at least once in every
    successive two-year period thereafter.
    (i) Registration of foreign establishments
      (1) On or before December 31 of each year, any establishment
    within any foreign country engaged in the manufacture, preparation,
    propagation, compounding, or processing of a drug or a device that
    is imported or offered for import into the United States shall,
    through electronic means in accordance with the criteria of the
    Secretary, register with the Secretary the name and place of
    business of the establishment, the name of the United States agent
    for the establishment, the name of each importer of such drug or
    device in the United States that is known to the establishment, and
    the name of each person who imports or offers for import such drug
    or device to the United States for purposes of importation.
      (2) The establishment shall also provide the information required
    by subsection (j) of this section.
      (3) The Secretary is authorized to enter into cooperative
    arrangements with officials of foreign countries to ensure that
    adequate and effective means are available for purposes of
    determining, from time to time, whether drugs or devices
    manufactured, prepared, propagated, compounded, or processed by an
    establishment described in paragraph (1), if imported or offered
    for import into the United States, shall be refused admission on
    any of the grounds set forth in section 381(a) of this title.
    (j) Filing of lists of drugs and devices manufactured, prepared,
      propagated and compounded by registrants; statements;
      accompanying disclosures
      (1) Every person who registers with the Secretary under
    subsection (b), (c), (d), or (i) of this section shall, at the time
    of registration under any such subsection, file with the Secretary
    a list of all drugs and a list of all devices and a brief statement
    of the basis for believing that each device included in the list is
    a device rather than a drug (with each drug and device in each list
    listed by its established name (as defined in section 352(e) of
    this title) and by any proprietary name) which are being
    manufactured, prepared, propagated, compounded, or processed by him
    for commercial distribution and which he has not included in any
    list of drugs or devices filed by him with the Secretary under this
    paragraph or paragraph (2) before such time of registration. Such
    list shall be prepared in such form and manner as the Secretary may
    prescribe and shall be accompanied by - 
        (A) in the case of a drug contained in the applicable list and
      subject to section 355 or 360b of this title, or a device
      intended for human use contained in the applicable list with
      respect to which a performance standard has been established
      under section 360d of this title or which is subject to section
      360e of this title, a reference to the authority for the
      marketing of such drug or device and a copy of all labeling for
      such drug or device;
        (B) in the case of any other drug or device contained in an
      applicable list - 
          (i) which drug is subject to section 353(b)(1) of this title,
        or which device is a restricted device, a copy of all labeling
        for such drug or device, a representative sampling of
        advertisements for such drug or device, and, upon request made
        by the Secretary for good cause, a copy of all advertisements
        for a particular drug product or device, or
          (ii) which drug is not subject to section 353(b)(1) of this
        title or which device is not a restricted device, the label and
        package insert for such drug or device and a representative
        sampling of any other labeling for such drug or device;

        (C) in the case of any drug contained in an applicable list
      which is described in subparagraph (B), a quantitative listing of
      its active ingredient or ingredients, except that with respect to
      a particular drug product the Secretary may require the
      submission of a quantitative listing of all ingredients if he
      finds that such submission is necessary to carry out the purposes
      of this chapter; and
        (D) if the registrant filing a list has determined that a
      particular drug product or device contained in such list is not
      subject to section 355 or 360b of this title, or the particular
      device contained in such list is not subject to a performance
      standard established under section 360d of this title or to
      section 360e of this title or is not a restricted device a brief
      statement of the basis upon which the registrant made such
      determination if the Secretary requests such a statement with
      respect to that particular drug product or device.

      (2) Each person who registers with the Secretary under this
    section shall report to the Secretary once during the month of June
    of each year and once during the month of December of each year the
    following information:
        (A) A list of each drug or device introduced by the registrant
      for commercial distribution which has not been included in any
      list previously filed by him with the Secretary under this
      subparagraph or paragraph (1) of this subsection. A list under
      this subparagraph shall list a drug or device by its established
      name (as defined in section 352(e) of this title), and by any
      proprietary name it may have and shall be accompanied by the
      other information required by paragraph (1).
        (B) If since the date the registrant last made a report under
      this paragraph (or if he has not made a report under this
      paragraph, since February 1, 1973) he has discontinued the
      manufacture, preparation, propagation, compounding, or processing
      for commercial distribution of a drug or device included in a
      list filed by him under subparagraph (A) or paragraph (1); notice
      of such discontinuance, the date of such discontinuance, and the
      identity (by established name (as defined in section 352(e) of
      this title) and by any proprietary name) of such drug or device.
        (C) If since the date the registrant reported pursuant to
      subparagraph (B) a notice of discontinuance he has resumed the
      manufacture, preparation, propagation, compounding, or processing
      for commercial distribution of the drug or device with respect to
      which such notice of discontinuance was reported; notice of such
      resumption, the date of such resumption, the identity of such
      drug or device (each by established name (as defined in section
      352(e) of this title) and by any proprietary name), and the other
      information required by paragraph (1), unless the registrant has
      previously reported such resumption to the Secretary pursuant to
      this subparagraph.
        (D) Any material change in any information previously submitted
      pursuant to this paragraph or paragraph (1).

      (3) The Secretary may also require each registrant under this
    section to submit a list of each drug product which (A) the
    registrant is manufacturing, preparing, propagating, compounding,
    or processing for commercial distribution, and (B) contains a
    particular ingredient. The Secretary may not require the submission
    of such a list unless he has made a finding that the submission of
    such a list is necessary to carry out the purposes of this chapter.
    (k) Report preceding introduction of devices into interstate
      commerce
      Each person who is required to register under this section and
    who proposes to begin the introduction or delivery for introduction
    into interstate commerce for commercial distribution of a device
    intended for human use shall, at least ninety days before making
    such introduction or delivery, report to the Secretary or person
    who is accredited under section 360m(a) of this title (in such form
    and manner as the Secretary shall by regulation prescribe) - 
        (1) the class in which the device is classified under section
      360c of this title or if such person determines that the device
      is not classified under such section, a statement of that
      determination and the basis for such person's determination that
      the device is or is not so classified, and
        (2) action taken by such person to comply with requirements
      under section 360d or 360e of this title which are applicable to
      the device.
    (l) Exemption from reporting requirements
      A report under subsection (k) of this section is not required for
    a device intended for human use that is exempted from the
    requirements of this subsection under subsection (m) of this
    section or is within a type that has been classified into class I
    under section 360c of this title. The exception established in the
    preceding sentence does not apply to any class I device that is
    intended for a use which is of substantial importance in preventing
    impairment of human health, or to any class I device that presents
    a potential unreasonable risk of illness or injury.
    (m) List of exempt class II devices; determination by Secretary;
      publication in Federal Register
      (1) Not later than 60 days after November 21, 1997, the Secretary
    shall publish in the Federal Register a list of each type of class
    II device that does not require a report under subsection (k) of
    this section to provide reasonable assurance of safety and
    effectiveness. Each type of class II device identified by the
    Secretary as not requiring the report shall be exempt from the
    requirement to provide a report under subsection (k) of this
    section as of the date of the publication of the list in the
    Federal Register. The Secretary shall publish such list on the
    Internet site of the Food and Drug Administration. The list so
    published shall be updated not later than 30 days after each
    revision of the list by the Secretary.
      (2) Beginning on the date that is 1 day after the date of the
    publication of a list under this subsection, the Secretary may
    exempt a class II device from the requirement to submit a report
    under subsection (k) of this section, upon the Secretary's own
    initiative or a petition of an interested person, if the Secretary
    determines that such report is not necessary to assure the safety
    and effectiveness of the device. The Secretary shall publish in the
    Federal Register notice of the intent of the Secretary to exempt
    the device, or of the petition, and provide a 30-day period for
    public comment. Within 120 days after the issuance of the notice in
    the Federal Register, the Secretary shall publish an order in the
    Federal Register that sets forth the final determination of the
    Secretary regarding the exemption of the device that was the
    subject of the notice. If the Secretary fails to respond to a
    petition within 180 days of receiving it, the petition shall be
    deemed to be granted.
    (n) Review of report; time for determination by Secretary
      The Secretary shall review the report required in subsection (k)
    of this section and make a determination under section 360c(f)(1)
    of this title not later than 90 days after receiving the report.
    (o) Reprocessed single-use devices
      (1) With respect to reprocessed single-use devices for which
    reports are required under subsection (k) of this section:
        (A) The Secretary shall identify such devices or types of
      devices for which reports under such subsection must, in order to
      ensure that the device is substantially equivalent to a predicate
      device, include validation data, the types of which shall be
      specified by the Secretary, regarding cleaning and sterilization,
      and functional performance demonstrating that the single-use
      device will remain substantially equivalent to its predicate
      device after the maximum number of times the device is
      reprocessed as intended by the person submitting the premarket
      notification. Within six months after October 26, 2002, the
      Secretary shall publish in the Federal Register a list of the
      types so identified, and shall revise the list as appropriate.
      Reports under subsection (k) of this section for devices or types
      of devices within a type included on the list are, upon
      publication of the list, required to include such validation
      data.
        (B) In the case of each report under subsection (k) of this
      section that was submitted to the Secretary before the
      publication of the initial list under subparagraph (A), or any
      revision thereof, and was for a device or type of device included
      on such list, the person who submitted the report under
      subsection (k) of this section shall submit validation data as
      described in subparagraph (A) to the Secretary not later than
      nine months after the publication of the list. During such nine-
      month period, the Secretary may not take any action under this
      chapter against such device solely on the basis that the
      validation data for the device have not been submitted to the
      Secretary. After the submission of the validation data to the
      Secretary, the Secretary may not determine that the device is
      misbranded under section 352(o) of this title or adulterated
      under section 351(f)(1)(B) of this title, or take action against
      the device under section 331(p) of this title for failure to
      provide any information required by subsection (k) of this
      section until (i) the review is terminated by withdrawal of the
      submission of the report under subsection (k) of this section;
      (ii) the Secretary finds the data to be acceptable and issues a
      letter; or (iii) the Secretary determines that the device is not
      substantially equivalent to a predicate device. Upon a
      determination that a device is not substantially equivalent to a
      predicate device, or if such submission is withdrawn, the device
      can no longer be legally marketed.
        (C) In the case of a report under subsection (k) of this
      section for a device identified under subparagraph (A) that is of
      a type for which the Secretary has not previously received a
      report under such subsection, the Secretary may, in advance of
      revising the list under subparagraph (A) to include such type,
      require that the report include the validation data specified in
      subparagraph (A).
        (D) Section 352(o) of this title applies with respect to the
      failure of a report under subsection (k) of this section to
      include validation data required under subparagraph (A).

      (2) With respect to critical or semi-critical reprocessed single-
    use devices that, under subsection (l) or (m) of this section, are
    exempt from the requirement of submitting reports under subsection
    (k) of this section:
        (A) The Secretary shall identify such devices or types of
      devices for which such exemptions should be terminated in order
      to provide a reasonable assurance of the safety and effectiveness
      of the devices. The Secretary shall publish in the Federal
      Register a list of the devices or types of devices so identified,
      and shall revise the list as appropriate. The exemption for each
      device or type included on the list is terminated upon the
      publication of the list. For each report under subsection (k) of
      this section submitted pursuant to this subparagraph the
      Secretary shall require the validation data described in
      paragraph (1)(A).
        (B) For each device or type of device included on the list
      under subparagraph (A), a report under subsection (k) of this
      section shall be submitted to the Secretary not later than 15
      months after the publication of the initial list, or a revision
      of the list, whichever terminates the exemption for the device.
      During such 15-month period, the Secretary may not take any
      action under this chapter against such device solely on the basis
      that such report has not been submitted to the Secretary. After
      the submission of the report to the Secretary the Secretary may
      not determine that the device is misbranded under section 352(o)
      of this title or adulterated under section 351(f)(1)(B) of this
      title, or take action against the device under section 331(p) of
      this title for failure to provide any information required by
      subsection (k) of this section until (i) the review is terminated
      by withdrawal of the submission; (ii) the Secretary determines by
      order that the device is substantially equivalent to a predicate
      device; or (iii) the Secretary determines by order that the
      device is not substantially equivalent to a predicate device.
      Upon a determination that a device is not substantially
      equivalent to a predicate device, the device can no longer be
      legally marketed.
        (C) In the case of semi-critical devices, the initial list
      under subparagraph (A) shall be published not later than 18
      months after the effective date of this subsection. In the case
      of critical devices, the initial list under such subparagraph
      shall be published not later than six months after such effective
      date.
        (D) Section 352(o) of this title applies with respect to the
      failure to submit a report under subsection (k) of this section
      that is required pursuant to subparagraph (A), including a
      failure of the report to include validation data required in such
      subparagraph.
        (E) The termination under subparagraph (A) of an exemption
      under subsection (l) or (m) of this section for a critical or
      semi-critical reprocessed single-use device does not terminate
      the exemption under subsection (l) or (m) of this section for the
      original device.
    (p) Electronic registration
      Registrations under subsections (b), (c), (d), and (i) of this
    section (including the submission of updated information) shall be
    submitted to the Secretary by electronic means, upon a finding by
    the Secretary that the electronic receipt of such registrations is
    feasible, unless the Secretary grants a request for waiver of such
    requirement because use of electronic means is not reasonable for
    the person requesting such waiver.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 510, as added Pub. L. 87-781, title
    III, Sec. 302, Oct. 10, 1962, 76 Stat. 794; amended Pub. L. 89-74,
    Sec. 4, July 15, 1965, 79 Stat. 231; Pub. L. 91-513, title II, Sec.
    701(e), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 92-387, Secs. 3, 4(a)-
    (c), Aug. 16, 1972, 86 Stat. 560-562; Pub. L. 94-295, Sec. 4(a),
    May 28, 1976, 90 Stat. 579; Pub. L. 105-115, title I, Sec.
    125(a)(2)(C), title II, Secs. 206(a), 209(a), 213(b), title IV,
    Sec. 417, Nov. 21, 1997, 111 Stat. 2325, 2338, 2341, 2347, 2379;
    Pub. L. 107-188, title III, Sec. 321(a), June 12, 2002, 116 Stat.
    675; Pub. L. 107-250, title II, Secs. 201(e), 207, 211, title III,
    Sec. 302(b), Oct. 26, 2002, 116 Stat. 1609, 1613, 1614, 1616; Pub.
    L. 108-214, Sec. 2(c)(2), Apr. 1, 2004, 118 Stat. 576.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The effective date of this subsection, referred to in subsec.
    (o)(2)(C), probably means the date of the enactment of Pub. L. 107-
    250, which enacted subsec. (o) of this section and was approved
    Oct. 26, 2002.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (o)(1)(B), (2)(B). Pub. L. 108-214, Sec.
    2(c)(2)(A), (B)(i), substituted "or adulterated" for ",
    adulterated".
      Subsec. (o)(2)(E). Pub. L. 108-214, Sec. 2(c)(2)(B)(ii),
    substituted "semi-critical" for "semicritical".
      2002 - Subsec. (h). Pub. L. 107-250, Sec. 201(e), inserted ", or
    by persons accredited to conduct inspections under section 374(g)
    of this title," after "duly designated by the Secretary".
      Subsec. (i)(1). Pub. L. 107-188, Sec. 321(a)(1), substituted "On
    or before December 31 of each year, any establishment" for "Any
    establishment" and "shall, through electronic means in accordance
    with the criteria of the Secretary, register with the Secretary the
    name and place of business of the establishment, the name of the
    United States agent for the establishment, the name of each
    importer of such drug or device in the United States that is known
    to the establishment, and the name of each person who imports or
    offers for import such drug or device to the United States for
    purposes of importation" for "shall register with the Secretary the
    name and place of business of the establishment and the name of the
    United States agent for the establishment".
      Subsec. (j)(1). Pub. L. 107-188, Sec. 321(a)(2), substituted
    "subsection (b), (c), (d), or (i)" for "subsection (b), (c), or
    (d)" in first sentence.
      Subsec. (m)(1). Pub. L. 107-250, Sec. 211, inserted at end "The
    Secretary shall publish such list on the Internet site of the Food
    and Drug Administration. The list so published shall be updated not
    later than 30 days after each revision of the list by the
    Secretary."
      Subsec. (o). Pub. L. 107-250, Sec. 302(b), added subsec. (o).
      Subsec. (p). Pub. L. 107-250, Sec. 207, added subsec. (p).
      1997 - Subsec. (g). Pub. L. 105-115, Sec. 213(b)(3), inserted at
    end "In this subsection, the term 'wholesale distributor' means any
    person (other than the manufacturer or the initial importer) who
    distributes a device from the original place of manufacture to the
    person who makes the final delivery or sale of the device to the
    ultimate consumer or user."
      Subsec. (g)(4), (5). Pub. L. 105-115, Sec. 213(b)(1), (2), added
    par. (4) and redesignated former par. (4) as (5).
      Subsec. (i). Pub. L. 105-115, Sec. 417, amended subsec. (i)
    generally. Prior to amendment, subsec. (i) read as follows: "Any
    establishment within any foreign country engaged in the
    manufacture, preparation, propagation, compounding, or processing
    of a drug or drugs, or a device or devices, shall be permitted to
    register under this section pursuant to regulations promulgated by
    the Secretary. Such regulations shall require such establishment to
    provide the information required by subsection (j) of this section
    and shall require such establishment to provide the information
    required by subsection (j) of this section in the case of a device
    or devices and shall include provisions for registration of any
    such establishment upon condition that adequate and effective means
    are available, by arrangement with the government of such foreign
    country or otherwise, to enable the Secretary to determine from
    time to time whether drugs or devices manufactured, prepared,
    propagated, compounded, or processed in such establishment, if
    imported or offered for import into the United States, shall be
    refused admission on any of the grounds set forth in section 381(a)
    of this title."
      Subsec. (j)(1)(A), (D). Pub. L. 105-115, Sec. 125(a)(2)(C),
    struck out ", 356, 357," before "or 360b of this title".
      Subsec. (k). Pub. L. 105-115, Sec. 206(a)(1), inserted "or person
    who is accredited under section 360m(a) of this title" after
    "report to the Secretary".
      Subsecs. (l), (m). Pub. L. 105-115, Sec. 206(a)(2), added
    subsecs. (l) and (m).
      Subsec. (n). Pub. L. 105-115, Sec. 209(a), added subsec. (n).
      1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 4(a)(2), substituted
    "drug package or device package" for "drug package", "distribution
    of the drug or device" for "distribution of the drug", and
    "ultimate consumer or user" for "ultimate consumer".
      Subsecs. (b) to (d). Pub. L. 94-295, Sec. 4(a)(3), inserted "or a
    device or devices" after "drug or drugs".
      Subsec. (e). Pub. L. 94-295, Sec. 4(a)(4), authorized the
    Secretary to prescribe by regulation a uniform system for the
    identification of devices intended for human use and authorized
    him, in addition, to require that persons who are required to list
    devices pursuant to subsec. (j) also list such devices in
    accordance with the system.
      Subsec. (g)(1) to (3). Pub. L. 94-295, Sec. 4(a)(5), substituted
    "drugs or devices" for "drugs".
      Subsec. (h). Pub. L. 94-295, Sec. 4(a)(6), inserted reference to
    establishments engaged in the manufacture, propagation,
    compounding, or processing of a drug or drugs or of a device or
    devices classified in class II or III.
      Subsec. (i). Pub. L. 94-295, Sec. 4(a)(7), inserted reference to
    devices and inserted requirement that regulations require
    establishments to provide the information required by subsection
    (j) of this section in the case of a device or devices.
      Subsec. (j)(1). Pub. L. 94-295, Sec. 4(a)(8)(A), in introductory
    provisions substituted "a list of all drugs and a list of all
    devices and a brief statement of the basis for believing that each
    device included in the list is a device rather than a drug (with
    each drug and device in each list listed by its established name"
    for "a list of all drugs (by established name" and "drugs or
    devices filed" for "drugs filed".
      Subsec. (j)(1)(A). Pub. L. 94-295, Sec. 4(a)(8)(B), substituted
    "the applicable list" for "such list", inserted "or a device
    intended for human use contained in the applicable list with
    respect to which a performance standard has been established under
    section 360d of this title or which is subject to section 360e of
    this title," after "360b of this title,", and substituted "such
    drug or device" for "such drug" wherever appearing.
      Subsec. (j)(1)(B). Pub. L. 94-295, Sec. 4(a)(8)(C), in
    introductory provisions substituted "drug or device contained in an
    applicable list" for "drug contained in such list".
      Subsec. (j)(1)(B)(i). Pub. L. 94-295, Sec. 4(a)(8)(D),
    substituted "which drug is subject to section 353(b)(1) of this
    title, or which device is a restricted device, a copy of all
    labeling for such drug or device, a representative sampling of
    advertisements for such drug or device, and, upon request made by
    the Secretary for good cause, a copy of all advertisements for a
    particular drug product or device, or" for "which is subject to
    section 353(b)(1) of this title, a copy of all labeling for such
    drug, a representative sampling of advertisements for such drug,
    and, upon request made by the Secretary for good cause, a copy of
    all advertisements for a particular drug product, or".
      Subsec. (j)(1)(B)(ii). Pub. L. 94-295, Sec. 4(a)(8)(E),
    substituted "which drug is not subject to section 353(b)(1) of this
    title or which device is not a restricted device, the label and
    package insert for such drug or device and a representative
    sampling of any other labeling for such drug or device" for "which
    is not subject to section 353(b)(1) of this title, the label and
    package insert for such drug and a representative sampling of any
    other labeling for such drug".
      Subsec. (j)(1)(C). Pub. L. 94-295, Sec. 4(a)(8)(F), substituted
    "an applicable list" for "such list".
      Subsec. (j)(1)(D). Pub. L. 94-295, Sec. 4(a)(8)(G), substituted
    "a list" for "the list", inserted "or the particular device
    contained in such list is not subject to a performance standard
    established under section 360d of this title or to section 360e of
    this title or is not a restricted device" after "or 360b of this
    title,", and substituted "particular drug product or device" for
    "particular drug product" wherever appearing.
      Subsec. (j)(2). Pub. L. 94-295, Sec. 4(a)(8)(H), substituted
    "drug or device" for "drug" in subpars. (A), (B), and (C), and
    substituted "(each by established name" for "(by established name"
    in subpar. (C).
      Subsec. (k). Pub. L. 94-295, Sec. 4(a)(9), added subsec. (k).
      1972 - Subsec. (e). Pub. L. 92-387, Sec. 4(a), inserted provision
    that the Secretary may assign a listing number to each drug or
    class of drugs listed under subsec. (j).
      Subsec. (f). Pub. L. 92-387, Sec. 4(b), inserted exception that
    the list submitted under subsec. (j)(3) and information submitted
    under subsec. (j)(1), (2) shall be exempt from inspection unless
    the Secretary determines otherwise.
      Subsec. (i). Pub. L. 92-387, Sec. 4(c), inserted provision that
    the regulations shall require such establishment to provide the
    information required by subsec. (j).
      Subsec. (j). Pub. L. 92-387, Sec. 3, added subsec. (j).
      1970 - Subsec. (a). Pub. L. 91-513 struck out provisions defining
    the wholesaling, jobbing, or distributing of depressant or
    stimulant drugs.
      Subsec. (b). Pub. L. 91-513 struck out provisions covering
    establishments engaged in the wholesaling, jobbing, or distributing
    of depressant or stimulant drugs and the inclusion of the fact of
    such activity in the annual registration.
      Subsec. (c). Pub. L. 91-513 struck out provisions covering new
    registrations of persons first engaging in the wholesaling,
    jobbing, or distributing of depressant or stimulant drugs and the
    inclusion of the fact of such activity in the registration.
      Subsec. (d). Pub. L. 91-513 struck out number designation "(1)"
    preceding first sentence, struck out portion of such redesignated
    provisions covering the wholesaling, jobbing, or distributing of
    depressant or stimulant drugs, and struck out par. (2) covering the
    filing of supplemental registration whenever a person not
    previously engaged or involved with depressant or stimulant drugs
    goes into the manufacturing, preparation, or processing thereof.
      1965 - Pub. L. 89-74, Sec. 4(e), included certain wholesalers in
    section catchline.
      Subsec. (a)(2), (3). Pub. L. 89-74, Sec. 4(a), added par. (2) and
    redesignated former par. (2) as (3).
      Subsecs. (b), (c). Pub. L. 89-74, Sec. 4(b), (c), inserted "or in
    the wholesaling, jobbing, or distributing of any depressant or
    stimulant drug" after "drug or drugs" and inserted requirement that
    establishment indicate activity in depressant or stimulant drugs at
    time of registration.
      Subsec. (d). Pub. L. 89-74 Sec. 4(d), designated existing
    provisions as par. (1), inserted "or the wholesaling, jobbing, or
    distributing of any depressant or stimulant drug" and the
    requirement that the additional establishment indicate activity in
    depressant or stimulant drugs at time of registration, and added
    par. (2).

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Amendment by Pub. L. 107-188 effective upon the expiration of the
    180-day period beginning June 12, 2002, see section 321(c) of Pub.
    L. 107-188, set out as a note under section 331 of this title.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by sections 206(a), 209(a), 213(b), and 417 of Pub. L.
    105-115 effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.

                     EFFECTIVE DATE OF 1972 AMENDMENT                 
      Section 5 of Pub. L. 92-387 provided that: "The amendments made
    by this Act [amending this section and sections 331 and 335 of this
    title and enacting provisions set out below] shall take effect on
    the first day of the sixth month beginning after the date of
    enactment of this Act [Aug. 16, 1972]."

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective Feb. 1, 1966, subject to
    registration with Secretary of names, places of business,
    establishments, and other prescribed information prior to Feb. 1,
    1966, see section 11 of Pub. L. 89-74, set out as a note under
    section 321 of this title.

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for any violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
    to be continued and brought to final determination in accord with
    laws and regulations in effect prior to Oct. 27, 1970, see section
    702 of Pub. L. 91-513, set out as a note under section 321 of this
    title.

     CONGRESSIONAL DECLARATION OF NEED FOR REGISTRATION AND INSPECTION
                          OF DRUG ESTABLISHMENTS
      Section 301 of Pub. L. 87-781 provided that: "The Congress hereby
    finds and declares that in order to make regulation of interstate
    commerce in drugs effective, it is necessary to provide for
    registration and inspection of all establishments in which drugs
    are manufactured, prepared, propagated, compounded, or processed;
    that the products of all such establishments are likely to enter
    the channels of interstate commerce and directly affect such
    commerce; and that the regulation of interstate commerce in drugs
    without provision for registration and inspection of establishments
    that may be engaged only in intrastate commerce in such drugs would
    discriminate against and depress interstate commerce in such drugs,
    and adversely burden, obstruct, and affect such interstate
    commerce."

             DECLARATION OF POLICY OF DRUG LISTING ACT OF 1972         
      Section 2 of Pub. L. 92-387 provided that: "The Federal
    Government which is responsible for regulating drugs has no ready
    means of determining what drugs are actually being manufactured or
    packed by establishments registered under the Federal Food, Drug,
    and Cosmetic Act [this chapter] except by periodic inspection of
    such registered establishments. Knowledge of which particular drugs
    are being manufactured or packed by each registered establishment
    would substantially assist in the enforcement of Federal laws
    requiring that such drugs be pure, safe, effective, and properly
    labeled. Information on the discontinuance of a particular drug
    could serve to alleviate the burden of reviewing and implementing
    enforcement actions against drugs which, although commercially
    discontinued, remain active for regulatory purposes. Information on
    the type and number of different drugs being manufactured or packed
    by drug establishments could permit more effective and timely
    regulation by the agencies of the Federal Government responsible
    for regulating drugs, including identification of which drugs in
    interstate commerce are subject to section 505 or 507 [section 355
    or 357 of this title], or to other provisions of the Federal Food,
    Drug, and Cosmetic Act."

         REGISTRATION OF CERTAIN PERSONS OWNING OR OPERATING DRUG
                   ESTABLISHMENTS PRIOR TO OCT. 10, 1962
      Section 303 of Pub. L. 87-781 provided that any person who, on
    the day immediately preceding Oct. 10, 1962, owned or operated an
    establishment which manufactured or processed drugs, registered
    before the first day of the seventh month following October, 1962,
    would be deemed to be registered in accordance with subsec. (b) of
    this section for the calendar year 1962 and if registered within
    this period and effected in 1963, be deemed in compliance for that
    calendar year.

-End-



-CITE-
    21 USC Sec. 360a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360a. Repealed.

-MISC1-
    Sec. 360a. Repealed. Pub. L. 91-513, title II, Sec. 701(a), Oct.
      27, 1970, 84 Stat. 1281.
      Section, act June 25, 1938, ch. 675, Sec. 511, as added July 15,
    1965, Pub. L. 89-74, Sec. 3(b), 79 Stat. 227; amended Oct. 24,
    1968, Pub. L. 90-639, Sec. 2(a), 82 Stat. 1361, regulated the
    manufacture, compounding, and processing of depressant and
    stimulant drugs and their sale, delivery, disposal, possession, and
    recordkeeping activities connected therewith. See section 801 et
    seq. of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                             SAVINGS PROVISION                         
      Repeal not to affect or abate any prosecutions for violation of
    law or any civil seizures or forfeitures and injunctive proceedings
    commenced prior to the effective date of such repeal, and all
    administrative proceedings pending before the Bureau of Narcotics
    and Dangerous Drugs [now Drug Enforcement Administration] on Oct.
    27, 1970, to be continued and brought to final determination in
    accord with laws and regulations in effect prior to Oct. 27, 1970,
    see section 702 of Pub. L. 91-513, set out as a note under section
    321 of this title.

-End-



-CITE-
    21 USC Sec. 360b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360b. New animal drugs

-STATUTE-
    (a) Unsafe new animal drugs and animal feed containing such drugs;
      conditions of safety; exemption of drugs for research; import
      tolerances
      (1) A new animal drug shall, with respect to any particular use
    or intended use of such drug, be deemed unsafe for purposes of
    section 351(a)(5) of this title and section 342(a)(2)(C)(ii) of
    this title unless - 
        (A) there is in effect an approval of an application filed
      pursuant to subsection (b) of this section with respect to such
      use or intended use of such drug, and such drug, its labeling,
      and such use conform to such approved application;
        (B) there is in effect a conditional approval of an application
      filed pursuant to section 360ccc of this title with respect to
      such use or intended use of such drug, and such drug, its
      labeling, and such use conform to such conditionally approved
      application; or
        (C) there is in effect an index listing pursuant to section
      360ccc-1 of this title with respect to such use or intended use
      of such drug in a minor species, and such drug, its labeling, and
      such use conform to such index listing.

    A new animal drug shall also be deemed unsafe for such purposes in
    the event of removal from the establishment of a manufacturer,
    packer, or distributor of such drug for use in the manufacture of
    animal feed in any State unless at the time of such removal such
    manufacturer, packer, or distributor has an unrevoked written
    statement from the consignee of such drug, or notice from the
    Secretary, to the effect that, with respect to the use of such drug
    in animal feed, such consignee (i) holds a license issued under
    subsection (m) of this section and has in its possession current
    approved labeling for such drug in animal feed; or (ii) will, if
    the consignee is not a user of the drug, ship such drug only to a
    holder of a license issued under subsection (m) of this section.
      (2) An animal feed bearing or containing a new animal drug shall,
    with respect to any particular use or intended use of such animal
    feed be deemed unsafe for purposes of section 351(a)(6) of this
    title unless - 
        (A) there is in effect - 
          (i) an approval of an application filed pursuant to
        subsection (b) of this section with respect to such drug, as
        used in such animal feed, and such animal feed and its
        labeling, distribution, holding, and use conform to such
        approved application;
          (ii) a conditional approval of an application filed pursuant
        to section 360ccc of this title with respect to such drug, as
        used in such animal feed, and such animal feed and its
        labeling, distribution, holding, and use conform to such
        conditionally approved application; or
          (iii) an index listing pursuant to section 360ccc-1 of this
        title with respect to such drug, as used in such animal feed,
        and such animal feed and its labeling, distribution, holding,
        and use conform to such index listing; and

        (B) such animal feed is manufactured at a site for which there
      is in effect a license issued pursuant to subsection (m)(1) of
      this section to manufacture such animal feed.

      (3) A new animal drug or an animal feed bearing or containing a
    new animal drug shall not be deemed unsafe for the purposes of
    section 351(a)(5) or (6) of this title if such article is for
    investigational use and conforms to the terms of an exemption in
    effect with respect thereto under subsection (j) of this section.
      (4)(A) Except as provided in subparagraph (B), if an approval of
    an application filed under subsection (b) of this section is in
    effect with respect to a particular use or intended use of a new
    animal drug, the drug shall not be deemed unsafe for the purposes
    of paragraph (1) and shall be exempt from the requirements of
    section 352(f) of this title with respect to a different use or
    intended use of the drug, other than a use in or on animal feed, if
    such use or intended use - 
        (i) is by or on the lawful written or oral order of a licensed
      veterinarian within the context of a veterinarian-client-patient
      relationship, as defined by the Secretary; and
        (ii) is in compliance with regulations promulgated by the
      Secretary that establish the conditions for such different use or
      intended use.

    The regulations promulgated by the Secretary under clause (ii) may
    prohibit particular uses of an animal drug and shall not permit
    such different use of an animal drug if the labeling of another
    animal drug that contains the same active ingredient and which is
    in the same dosage form and concentration provides for such
    different use.
      (B) If the Secretary finds that there is a reasonable probability
    that a use of an animal drug authorized under subparagraph (A) may
    present a risk to the public health, the Secretary may - 
        (i) establish a safe level for a residue of an animal drug when
      it is used for such different use authorized by subparagraph (A);
      and
        (ii) require the development of a practical, analytical method
      for the detection of residues of such drug above the safe level
      established under clause (i).

    The use of an animal drug that results in residues exceeding a safe
    level established under clause (i) shall be considered an unsafe
    use of such drug under paragraph (1). Safe levels may be
    established under clause (i) either by regulation or order.
      (C) The Secretary may by general regulation provide access to the
    records of veterinarians to ascertain any use or intended use
    authorized under subparagraph (A) that the Secretary has determined
    may present a risk to the public health.
      (D) If the Secretary finds, after affording an opportunity for
    public comment, that a use of an animal drug authorized under
    subparagraph (A) presents a risk to the public health or that an
    analytical method required under subparagraph (B) has not been
    developed and submitted to the Secretary, the Secretary may, by
    order, prohibit any such use.
      (5) If the approval of an application filed under section 355 of
    this title is in effect, the drug under such application shall not
    be deemed unsafe for purposes of paragraph (1) and shall be exempt
    from the requirements of section 352(f) of this title with respect
    to a use or intended use of the drug in animals if such use or
    intended use - 
        (A) is by or on the lawful written or oral order of a licensed
      veterinarian within the context of a veterinarian-client-patient
      relationship, as defined by the Secretary; and
        (B) is in compliance with regulations promulgated by the
      Secretary that establish the conditions for the use or intended
      use of the drug in animals.
      (6) For purposes of section 342(a)(2)(D) (!1) of this title, a
    use or intended use of a new animal drug shall not be deemed unsafe
    under this section if the Secretary establishes a tolerance for
    such drug and any edible portion of any animal imported into the
    United States does not contain residues exceeding such tolerance.
    In establishing such tolerance, the Secretary shall rely on data
    sufficient to demonstrate that a proposed tolerance is safe based
    on similar food safety criteria used by the Secretary to establish
    tolerances for applications for new animal drugs filed under
    subsection (b)(1) of this section. The Secretary may consider and
    rely on data submitted by the drug manufacturer, including data
    submitted to appropriate regulatory authorities in any country
    where the new animal drug is lawfully used or data available from a
    relevant international organization, to the extent such data are
    not inconsistent with the criteria used by the Secretary to
    establish a tolerance for applications for new animal drugs filed
    under subsection (b)(1) of this section. For purposes of this
    paragraph, "relevant international organization" means the Codex
    Alimenterius (!2) Commission or other international organization
    deemed appropriate by the Secretary. The Secretary may, under
    procedures specified by regulation, revoke a tolerance established
    under this paragraph if information demonstrates that the use of
    the new animal drug under actual use conditions results in food
    being imported into the United States with residues exceeding the
    tolerance or if scientific evidence shows the tolerance to be
    unsafe.


    (b) Filing application for uses of new animal drug; contents;
      patent information; abbreviated application; presubmission
      conference
      (1) Any person may file with the Secretary an application with
    respect to any intended use or uses of a new animal drug. Such
    person shall submit to the Secretary as a part of the application
    (A) full reports of investigations which have been made to show
    whether or not such drug is safe and effective for use; (B) a full
    list of the articles used as components of such drug; (C) a full
    statement of the composition of such drug; (D) a full description
    of the methods used in, and the facilities and controls used for,
    the manufacture, processing, and packing of such drug; (E) such
    samples of such drug and of the articles used as components
    thereof, of any animal feed for use in or on which such drug is
    intended, and of the edible portions or products (before or after
    slaughter) of animals to which such drug (directly or in or on
    animal feed) is intended to be administered, as the Secretary may
    require; (F) specimens of the labeling proposed to be used for such
    drug, or in case such drug is intended for use in animal feed,
    proposed labeling appropriate for such use, and specimens of the
    labeling for the drug to be manufactured, packed, or distributed by
    the applicant; (G) a description of practicable methods for
    determining the quantity, if any, of such drug in or on food, and
    any substance formed in or on food, because of its use; and (H) the
    proposed tolerance or withdrawal period or other use restrictions
    for such drug if any tolerance or withdrawal period or other use
    restrictions are required in order to assure that the proposed use
    of such drug will be safe. The applicant shall file with the
    application the patent number and the expiration date of any patent
    which claims the new animal drug for which the applicant filed the
    application or which claims a method of using such drug and with
    respect to which a claim of patent infringement could reasonably be
    asserted if a person not licensed by the owner engaged in the
    manufacture, use, or sale of the drug. If an application is filed
    under this subsection for a drug and a patent which claims such
    drug or a method of using such drug is issued after the filing date
    but before approval of the application, the applicant shall amend
    the application to include the information required by the
    preceding sentence. Upon approval of the application, the Secretary
    shall publish information submitted under the two preceding
    sentences.
      (2) Any person may file with the Secretary an abbreviated
    application for the approval of a new animal drug. An abbreviated
    application shall contain the information required by subsection
    (n) of this section.
      (3) Any person intending to file an application under paragraph
    (1), section 360ccc of this title, or a request for an
    investigational exemption under subsection (j) of this section
    shall be entitled to one or more conferences prior to such
    submission to reach an agreement acceptable to the Secretary
    establishing a submission or an investigational requirement, which
    may include a requirement for a field investigation. A decision
    establishing a submission or an investigational requirement shall
    bind the Secretary and the applicant or requestor unless (A) the
    Secretary and the applicant or requestor mutually agree to modify
    the requirement, or (B) the Secretary by written order determines
    that a substantiated scientific requirement essential to the
    determination of safety or effectiveness of the animal drug
    involved has appeared after the conference. No later than 25
    calendar days after each such conference, the Secretary shall
    provide a written order setting forth a scientific justification
    specific to the animal drug and intended uses under consideration
    if the agreement referred to in the first sentence requires more
    than one field investigation as being essential to provide
    substantial evidence of effectiveness for the intended uses of the
    drug. Nothing in this paragraph shall be construed as compelling
    the Secretary to require a field investigation.
    (c) Period for submission and approval of application; period for
      notice and expedition of hearing; period for issuance of order;
      abbreviated applications; withdrawal periods; effective date of
      approval; relationship to other applications; withdrawal or
      suspension of approval; bioequivalence; filing of additional
      patent information
      (1) Within one hundred and eighty days after the filing of an
    application pursuant to subsection (b) of this section, or such
    additional period as may be agreed upon by the Secretary and the
    applicant, the Secretary shall either (A) issue an order approving
    the application if he then finds that none of the grounds for
    denying approval specified in subsection (d) of this section
    applies, or (B) give the applicant notice of an opportunity for a
    hearing before the Secretary under subsection (d) of this section
    on the question whether such application is approvable. If the
    applicant elects to accept the opportunity for a hearing by written
    request within thirty days after such notice, such hearing shall
    commence not more than ninety days after the expiration of such
    thirty days unless the Secretary and the applicant otherwise agree.
    Any such hearing shall thereafter be conducted on an expedited
    basis and the Secretary's order thereon shall be issued within
    ninety days after the date fixed by the Secretary for filing final
    briefs.
      (2)(A) Subject to subparagraph (C), the Secretary shall approve
    an abbreviated application for a drug unless the Secretary finds - 
        (i) the methods used in, or the facilities and controls used
      for, the manufacture, processing, and packing of the drug are
      inadequate to assure and preserve its identity, strength,
      quality, and purity;
        (ii) the conditions of use prescribed, recommended, or
      suggested in the proposed labeling are not reasonably certain to
      be followed in practice or, except as provided in subparagraph
      (B), information submitted with the application is insufficient
      to show that each of the proposed conditions of use or similar
      limitations (whether in the labeling or published pursuant to
      subsection (i) of this section) have been previously approved for
      the approved new animal drug referred to in the application;
        (iii) information submitted with the application is
      insufficient to show that the active ingredients are the same as
      those of the approved new animal drug referred to in the
      application;
        (iv)(I) if the application is for a drug whose active
      ingredients, route of administration, dosage form, strength, or
      use with other animal drugs in animal feed is the same as the
      active ingredients, route of administration, dosage form,
      strength, or use with other animal drugs in animal feed of the
      approved new animal drug referred to in the application,
      information submitted in the application is insufficient to show
      that the active ingredients, route of administration, dosage
      form, strength, or use with other animal drugs in animal feed is
      the same as that of the approved new animal drug, or
        (II) if the application is for a drug whose active ingredients,
      route of administration, dosage form, strength, or use with other
      animal drugs in animal feed is different from that of the
      approved new animal drug referred to in the application, no
      petition to file an application for the drug with the different
      active ingredients, route of administration, dosage form,
      strength, or use with other animal drugs in animal feed was
      approved under subsection (n)(3) of this section;
        (v) if the application was filed pursuant to the approval of a
      petition under subsection (n)(3) of this section, the application
      did not contain the information required by the Secretary
      respecting the active ingredients, route of administration,
      dosage form, strength, or use with other animal drugs in animal
      feed which is not the same;
        (vi) information submitted in the application is insufficient
      to show that the drug is bioequivalent to the approved new animal
      drug referred to in the application, or if the application is
      filed under a petition approved pursuant to subsection (n)(3) of
      this section, information submitted in the application is
      insufficient to show that the active ingredients of the new
      animal drug are of the same pharmacological or therapeutic class
      as the pharmacological or therapeutic class of the approved new
      animal drug and that the new animal drug can be expected to have
      the same therapeutic effect as the approved new animal drug when
      used in accordance with the labeling;
        (vii) information submitted in the application is insufficient
      to show that the labeling proposed for the drug is the same as
      the labeling approved for the approved new animal drug referred
      to in the application except for changes required because of
      differences approved under a petition filed under subsection
      (n)(3) of this section, because of a different withdrawal period,
      or because the drug and the approved new animal drug are produced
      or distributed by different manufacturers;
        (viii) information submitted in the application or any other
      information available to the Secretary shows that (I) the
      inactive ingredients of the drug are unsafe for use under the
      conditions prescribed, recommended, or suggested in the labeling
      proposed for the drug, (II) the composition of the drug is unsafe
      under such conditions because of the type or quantity of inactive
      ingredients included or the manner in which the inactive
      ingredients are included, or (III) in the case of a drug for food
      producing animals, the inactive ingredients of the drug or its
      composition may be unsafe with respect to human food safety;
        (ix) the approval under subsection (b)(1) of this section of
      the approved new animal drug referred to in the application filed
      under subsection (b)(2) of this section has been withdrawn or
      suspended for grounds described in paragraph (1) of subsection
      (e) of this section, the Secretary has published a notice of a
      hearing to withdraw approval of the approved new animal drug for
      such grounds, the approval under this paragraph of the new animal
      drug for which the application under subsection (b)(2) of this
      section was filed has been withdrawn or suspended under
      subparagraph (G) for such grounds, or the Secretary has
      determined that the approved new animal drug has been withdrawn
      from sale for safety or effectiveness reasons;
        (x) the application does not meet any other requirement of
      subsection (n) of this section; or
        (xi) the application contains an untrue statement of material
      fact.

      (B) If the Secretary finds that a new animal drug for which an
    application is submitted under subsection (b)(2) of this section is
    bioequivalent to the approved new animal drug referred to in such
    application and that residues of the new animal drug are consistent
    with the tolerances established for such approved new animal drug
    but at a withdrawal period which is different than the withdrawal
    period approved for such approved new animal drug, the Secretary
    may establish, on the basis of information submitted, such
    different withdrawal period as the withdrawal period for the new
    animal drug for purposes of the approval of such application for
    such drug.
      (C) Within 180 days of the initial receipt of an application
    under subsection (b)(2) of this section or within such additional
    period as may be agreed upon by the Secretary and the applicant,
    the Secretary shall approve or disapprove the application.
      (D) The approval of an application filed under subsection (b)(2)
    of this section shall be made effective on the last applicable date
    determined under the following:
        (i) If the applicant only made a certification described in
      clause (i) or (ii) of subsection (n)(1)(G) of this section or in
      both such clauses, the approval may be made effective
      immediately.
        (ii) If the applicant made a certification described in clause
      (iii) of subsection (n)(1)(G) of this section, the approval may
      be made effective on the date certified under clause (iii).
        (iii) If the applicant made a certification described in clause
      (iv) of subsection (n)(1)(G) of this section, the approval shall
      be made effective immediately unless an action is brought for
      infringement of a patent which is the subject of the
      certification before the expiration of 45 days from the date the
      notice provided under subsection (n)(2)(B)(i) of this section is
      received. If such an action is brought before the expiration of
      such days, the approval shall be made effective upon the
      expiration of the 30 month period beginning on the date of the
      receipt of the notice provided under subsection (n)(2)(B) of this
      section or such shorter or longer period as the court may order
      because either party to the action failed to reasonably cooperate
      in expediting the action, except that if before the expiration of
      such period - 
          (I) the court decides that such patent is invalid or not
        infringed, the approval shall be made effective on the date of
        the court decision,
          (II) the court decides that such patent has been infringed,
        the approval shall be made effective on such date as the court
        orders under section 271(e)(4)(A) of title 35, or
          (III) the court grants a preliminary injunction prohibiting
        the applicant from engaging in the commercial manufacture or
        sale of the drug until the court decides the issues of patent
        validity and infringement and if the court decides that such
        patent is invalid or not infringed, the approval shall be made
        effective on the date of such court decision.

      In such an action, each of the parties shall reasonably cooperate
      in expediting the action. Until the expiration of 45 days from
      the date the notice made under subsection (n)(2)(B) of this
      section is received, no action may be brought under section 2201
      of title 28 for a declaratory judgment with respect to the
      patent. Any action brought under section 2201 of title 28 shall
      be brought in the judicial district where the defendant has its
      principal place of business or a regular and established place of
      business.
        (iv) If the application contains a certification described in
      clause (iv) of subsection (n)(1)(G) of this section and is for a
      drug for which a previous application has been filed under this
      subsection containing such a certification, the application shall
      be made effective not earlier than 180 days after - 
          (I) the date the Secretary receives notice from the applicant
        under the previous application of the first commercial
        marketing of the drug under the previous application, or
          (II) the date of a decision of a court in an action described
        in subclause (III) (!3) holding the patent which is the subject
        of the certification to be invalid or not infringed,


      whichever is earlier.

      (E) If the Secretary decides to disapprove an application, the
    Secretary shall give the applicant notice of an opportunity for a
    hearing before the Secretary on the question of whether such
    application is approvable. If the applicant elects to accept the
    opportunity for hearing by written request within 30 days after
    such notice, such hearing shall commence not more than 90 days
    after the expiration of such 30 days unless the Secretary and the
    applicant otherwise agree. Any such hearing shall thereafter be
    conducted on an expedited basis and the Secretary's order thereon
    shall be issued within 90 days after the date fixed by the
    Secretary for filing final briefs.
      (F)(i) If an application submitted under subsection (b)(1) of
    this section for a drug, no active ingredient (including any ester
    or salt of the active ingredient) of which has been approved in any
    other application under subsection (b)(1) of this section, is
    approved after November 16, 1988, no application may be submitted
    under subsection (b)(2) of this section which refers to the drug
    for which the subsection (b)(1) application was submitted before
    the expiration of 5 years from the date of the approval of the
    application under subsection (b)(1) of this section, except that
    such an application may be submitted under subsection (b)(2) of
    this section after the expiration of 4 years from the date of the
    approval of the subsection (b)(1) application if it contains a
    certification of patent invalidity or noninfringement described in
    clause (iv) of subsection (n)(1)(G) of this section. The approval
    of such an application shall be made effective in accordance with
    subparagraph (B) except that, if an action for patent infringement
    is commenced during the one-year period beginning 48 months after
    the date of the approval of the subsection (b) application, the 30
    month period referred to in subparagraph (D)(iii) shall be extended
    by such amount of time (if any) which is required for seven and one-
    half years to have elapsed from the date of approval of the
    subsection (b) application.
      (ii) If an application submitted under subsection (b)(1) of this
    section for a drug, which includes an active ingredient (including
    any ester or salt of the active ingredient) that has been approved
    in another application approved under such subsection, is approved
    after November 16, 1988, and if such application contains
    substantial evidence of the effectiveness of the drug involved, any
    studies of animal safety, or, in the case of food producing
    animals, human food safety studies (other than bioequivalence
    studies or residue depletion studies, except residue depletion
    studies for minor uses or minor species) required for the approval
    of the application and conducted or sponsored by the applicant, the
    Secretary may not make the approval of an application submitted
    under subsection (b)(2) of this section for the conditions of
    approval of such drug in the subsection (b)(1) application
    effective before the expiration of 3 years from the date of the
    approval of the application under subsection (b)(1) of this section
    for such drug.
      (iii) If a supplement to an application approved under subsection
    (b)(1) of this section is approved after November 16, 1988, and the
    supplement contains substantial evidence of the effectiveness of
    the drug involved, any studies of animal safety, or, in the case of
    food producing animals, human food safety studies (other than
    bioequivalence studies or residue depletion studies, except residue
    depletion studies for minor uses or minor species) required for the
    approval of the supplement and conducted or sponsored by the person
    submitting the supplement, the Secretary may not make the approval
    of an application submitted under subsection (b)(2) of this section
    for a change approved in the supplement effective before the
    expiration of 3 years from the date of the approval of the
    supplement.
      (iv) An applicant under subsection (b)(1) of this section who
    comes within the provisions of clause (i) of this subparagraph as a
    result of an application which seeks approval for a use solely in
    non-food producing animals, may elect, within 10 days of receiving
    such approval, to waive clause (i) of this subparagraph, in which
    event the limitation on approval of applications submitted under
    subsection (b)(2) of this section set forth in clause (ii) of this
    subparagraph shall be applicable to the subsection (b)(1)
    application.
      (v) If an application (including any supplement to a new animal
    drug application) submitted under subsection (b)(1) of this section
    for a new animal drug for a food-producing animal use, which
    includes an active ingredient (including any ester or salt of the
    active ingredient) which has been the subject of a waiver under
    clause (iv) is approved after November 16, 1988, and if the
    application contains substantial evidence of the effectiveness of
    the drug involved, any studies of animal safety, or human food
    safety studies (other than bioequivalence studies or residue
    depletion studies, except residue depletion studies for minor uses
    or minor species) required for the new approval of the application
    and conducted or sponsored by the applicant, the Secretary may not
    make the approval of an application (including any supplement to
    such application) submitted under subsection (b)(2) of this section
    for the new conditions of approval of such drug in the subsection
    (b)(1) application effective before the expiration of five years
    from the date of approval of the application under subsection
    (b)(1) of this section for such drug. The provisions of this
    paragraph shall apply only to the first approval for a food-
    producing animal use for the same applicant after the waiver under
    clause (iv).
      (G) If an approved application submitted under subsection (b)(2)
    of this section for a new animal drug refers to a drug the approval
    of which was withdrawn or suspended for grounds described in
    paragraph (1) or (2) of subsection (e) of this section or was
    withdrawn or suspended under this subparagraph or which, as
    determined by the Secretary, has been withdrawn from sale for
    safety or effectiveness reasons, the approval of the drug under
    this paragraph shall be withdrawn or suspended - 
        (i) for the same period as the withdrawal or suspension under
      subsection (e) of this section or this subparagraph, or
        (ii) if the approved new animal drug has been withdrawn from
      sale, for the period of withdrawal from sale or, if earlier, the
      period ending on the date the Secretary determines that the
      withdrawal from sale is not for safety or effectiveness reasons.

      (H) For purposes of this paragraph:
        (i) The term "bioequivalence" means the rate and extent to
      which the active ingredient or therapeutic ingredient is absorbed
      from a new animal drug and becomes available at the site of drug
      action.
        (ii) A new animal drug shall be considered to be bioequivalent
      to the approved new animal drug referred to in its application
      under subsection (n) of this section if - 
          (I) the rate and extent of absorption of the drug do not show
        a significant difference from the rate and extent of absorption
        of the approved new animal drug referred to in the application
        when administered at the same dose of the active ingredient
        under similar experimental conditions in either a single dose
        or multiple doses;
          (II) the extent of absorption of the drug does not show a
        significant difference from the extent of absorption of the
        approved new animal drug referred to in the application when
        administered at the same dose of the active ingredient under
        similar experimental conditions in either a single dose or
        multiple doses and the difference from the approved new animal
        drug in the rate of absorption of the drug is intentional, is
        reflected in its proposed labeling, is not essential to the
        attainment of effective drug concentrations in use, and is
        considered scientifically insignificant for the drug in
        attaining the intended purposes of its use and preserving human
        food safety; or
          (III) in any case in which the Secretary determines that the
        measurement of the rate and extent of absorption or excretion
        of the new animal drug in biological fluids is inappropriate or
        impractical, an appropriate acute pharmacological effects test
        or other test of the new animal drug and, when deemed
        scientifically necessary, of the approved new animal drug
        referred to in the application in the species to be tested or
        in an appropriate animal model does not show a significant
        difference between the new animal drug and such approved new
        animal drug when administered at the same dose under similar
        experimental conditions.

      If the approved new animal drug referred to in the application
      for a new animal drug under subsection (n) of this section is
      approved for use in more than one animal species, the
      bioequivalency information described in subclauses (I), (II), and
      (III) shall be obtained for one species, or if the Secretary
      deems appropriate based on scientific principles, shall be
      obtained for more than one species. The Secretary may prescribe
      the dose to be used in determining bioequivalency under subclause
      (I), (II), or (III). To assure that the residues of the new
      animal drug will be consistent with the established tolerances
      for the approved new animal drug referred to in the application
      under subsection (b)(2) of this section upon the expiration of
      the withdrawal period contained in the application for the new
      animal drug, the Secretary shall require bioequivalency data or
      residue depletion studies of the new animal drug or such other
      data or studies as the Secretary considers appropriate based on
      scientific principles. If the Secretary requires one or more
      residue studies under the preceding sentence, the Secretary may
      not require that the assay methodology used to determine the
      withdrawal period of the new animal drug be more rigorous than
      the methodology used to determine the withdrawal period for the
      approved new animal drug referred to in the application. If such
      studies are required and if the approved new animal drug,
      referred to in the application for the new animal drug for which
      such studies are required, is approved for use in more than one
      animal species, such studies shall be conducted for one species,
      or if the Secretary deems appropriate based on scientific
      principles, shall be conducted for more than one species.

      (3) If the patent information described in subsection (b)(1) of
    this section could not be filed with the submission of an
    application under subsection (b)(1) of this section because the
    application was filed before the patent information was required
    under subsection (b)(1) of this section or a patent was issued
    after the application was approved under such subsection, the
    holder of an approved application shall file with the Secretary the
    patent number and the expiration date of any patent which claims
    the new animal drug for which the application was filed or which
    claims a method of using such drug and with respect to which a
    claim of patent infringement could reasonably be asserted if a
    person not licensed by the owner engaged in the manufacture, use,
    or sale of the drug. If the holder of an approved application could
    not file patent information under subsection (b)(1) of this section
    because it was not required at the time the application was
    approved, the holder shall file such information under this
    subsection not later than 30 days after November 16, 1988, and if
    the holder of an approved application could not file patent
    information under subsection (b)(1) of this section because no
    patent had been issued when an application was filed or approved,
    the holder shall file such information under this subsection not
    later than 30 days after the date the patent involved is issued.
    Upon the submission of patent information under this subsection,
    the Secretary shall publish it.
      (4) A drug manufactured in a pilot or other small facility may be
    used to demonstrate the safety and effectiveness of the drug and to
    obtain approval for the drug prior to manufacture of the drug in a
    larger facility, unless the Secretary makes a determination that a
    full scale production facility is necessary to ensure the safety or
    effectiveness of the drug.
    (d) Grounds for refusing application; approval of application;
      factors; "substantial evidence" defined; combination drugs
      (1) If the Secretary finds, after due notice to the applicant in
    accordance with subsection (c) of this section and giving him an
    opportunity for a hearing, in accordance with said subsection, that
    - 
        (A) the investigations, reports of which are required to be
      submitted to the Secretary pursuant to subsection (b) of this
      section, do not include adequate tests by all methods reasonably
      applicable to show whether or not such drug is safe for use under
      the conditions prescribed, recommended, or suggested in the
      proposed labeling thereof;
        (B) the results of such tests show that such drug is unsafe for
      use under such conditions or do not show that such drug is safe
      for use under such conditions;
        (C) the methods used in, and the facilities and controls used
      for, the manufacture, processing, and packing of such drug are
      inadequate to preserve its identity, strength, quality, and
      purity;
        (D) upon the basis of the information submitted to him as part
      of the application, or upon the basis of any other information
      before him with respect to such drug, he has insufficient
      information to determine whether such drug is safe for use under
      such conditions;
        (E) evaluated on the basis of the information submitted to him
      as part of the application and any other information before him
      with respect to such drug, there is a lack of substantial
      evidence that the drug will have the effect it purports or is
      represented to have under the conditions of use prescribed,
      recommended, or suggested in the proposed labeling thereof;
        (F) upon the basis of information submitted to the Secretary as
      part of the application or any other information before the
      Secretary with respect to such drug, any use prescribed,
      recommended, or suggested in labeling proposed for such drug will
      result in a residue of such drug in excess of a tolerance found
      by the Secretary to be safe for such drug;
        (G) the application failed to contain the patent information
      prescribed by subsection (b)(1) of this section;
        (H) based on a fair evaluation of all material facts, such
      labeling is false or misleading in any particular; or
        (I) such drug induces cancer when ingested by man or animal or,
      after tests which are appropriate for the evaluation of the
      safety of such drug, induces cancer in man or animal, except that
      the foregoing provisions of this subparagraph shall not apply
      with respect to such drug if the Secretary finds that, under the
      conditions of use specified in proposed labeling and reasonably
      certain to be followed in practice (i) such drug will not
      adversely affect the animals for which it is intended, and (ii)
      no residue of such drug will be found (by methods of examination
      prescribed or approved by the Secretary by regulations, which
      regulations shall not be subject to subsections (c), (d), and (h)
      of this section), in any edible portion of such animals after
      slaughter or in any food yielded by or derived from the living
      animals;

    he shall issue an order refusing to approve the application. If,
    after such notice and opportunity for hearings, the Secretary finds
    that subparagraphs (A) through (I) do not apply, he shall issue an
    order approving the application.
      (2) In determining whether such drug is safe for use under the
    conditions prescribed, recommended, or suggested in the proposed
    labeling thereof, the Secretary shall consider, among other
    relevant factors, (A) the probable consumption of such drug and of
    any substance formed in or on food because of the use of such drug,
    (B) the cumulative effect on man or animal of such drug, taking
    into account any chemically or pharmacologically related substance,
    (C) safety factors which in the opinion of experts, qualified by
    scientific training and experience to evaluate the safety of such
    drugs, are appropriate for the use of animal experimentation data,
    and (D) whether the conditions of use prescribed, recommended, or
    suggested in the proposed labeling are reasonably certain to be
    followed in practice. Any order issued under this subsection
    refusing to approve an application shall state the findings upon
    which it is based.
      (3) As used in this section, the term "substantial evidence"
    means evidence consisting of one or more adequate and well
    controlled investigations, such as - 
        (A) a study in a target species;
        (B) a study in laboratory animals;
        (C) any field investigation that may be required under this
      section and that meets the requirements of subsection (b)(3) of
      this section if a presubmission conference is requested by the
      applicant;
        (D) a bioequivalence study; or
        (E) an in vitro study;

    by experts qualified by scientific training and experience to
    evaluate the effectiveness of the drug involved, on the basis of
    which it could fairly and reasonably be concluded by such experts
    that the drug will have the effect it purports or is represented to
    have under the conditions of use prescribed, recommended, or
    suggested in the labeling or proposed labeling thereof.
      (4) In a case in which an animal drug contains more than one
    active ingredient, or the labeling of the drug prescribes,
    recommends, or suggests use of the drug in combination with one or
    more other animal drugs, and the active ingredients or drugs
    intended for use in the combination have previously been separately
    approved pursuant to an application submitted under subsection
    (b)(1) of this section for particular uses and conditions of use
    for which they are intended for use in the combination - 
        (A) the Secretary shall not issue an order under paragraph
      (1)(A), (1)(B), or (1)(D) refusing to approve the application for
      such combination on human food safety grounds unless the
      Secretary finds that the application fails to establish that - 
          (i) none of the active ingredients or drugs intended for use
        in the combination, respectively, at the longest withdrawal
        time of any of the active ingredients or drugs in the
        combination, respectively, exceeds its established tolerance;
        or
          (ii) none of the active ingredients or drugs in the
        combination interferes with the methods of analysis for another
        of the active ingredients or drugs in the combination,
        respectively;

        (B) the Secretary shall not issue an order under paragraph
      (1)(A), (1)(B), or (1)(D) refusing to approve the application for
      such combination on target animal safety grounds unless the
      Secretary finds that - 
          (i)(I) there is a substantiated scientific issue, specific to
        one or more of the active ingredients or animal drugs in the
        combination, that cannot adequately be evaluated based on
        information contained in the application for the combination
        (including any investigations, studies, or tests for which the
        applicant has a right of reference or use from the person by or
        for whom the investigations, studies, or tests were conducted);
        or
          (II) there is a scientific issue raised by target animal
        observations contained in studies submitted to the Secretary as
        part of the application; and
          (ii) based on the Secretary's evaluation of the information
        contained in the application with respect to the issues
        identified in clauses (i)(I) and (II), paragraph (1)(A), (B),
        or (D) apply;

        (C) except in the case of a combination that contains a
      nontopical antibacterial ingredient or animal drug, the Secretary
      shall not issue an order under paragraph (1)(E) refusing to
      approve an application for a combination animal drug intended for
      use other than in animal feed or drinking water unless the
      Secretary finds that the application fails to demonstrate that - 
          (i) there is substantial evidence that any active ingredient
        or animal drug intended only for the same use as another active
        ingredient or animal drug in the combination makes a
        contribution to labeled effectiveness;
          (ii) each active ingredient or animal drug intended for at
        least one use that is different from all other active
        ingredients or animal drugs used in the combination provides
        appropriate concurrent use for the intended target population;
        or
          (iii) where based on scientific information the Secretary has
        reason to believe the active ingredients or animal drugs may be
        physically incompatible or have disparate dosing regimens, such
        active ingredients or animal drugs are physically compatible or
        do not have disparate dosing regimens; and

        (D) the Secretary shall not issue an order under paragraph
      (1)(E) refusing to approve an application for a combination
      animal drug intended for use in animal feed or drinking water
      unless the Secretary finds that the application fails to
      demonstrate that - 
          (i) there is substantial evidence that any active ingredient
        or animal drug intended only for the same use as another active
        ingredient or animal drug in the combination makes a
        contribution to the labeled effectiveness;
          (ii) each of the active ingredients or animal drugs intended
        for at least one use that is different from all other active
        ingredients or animal drugs used in the combination provides
        appropriate concurrent use for the intended target population;
          (iii) where a combination contains more than one nontopical
        antibacterial ingredient or animal drug, there is substantial
        evidence that each of the nontopical antibacterial ingredients
        or animal drugs makes a contribution to the labeled
        effectiveness, except that for purposes of this clause,
        antibacterial ingredient or animal drug does not include the
        ionophore or arsenical classes of animal drugs; or
          (iv) where based on scientific information the Secretary has
        reason to believe the active ingredients or animal drugs
        intended for use in drinking water may be physically
        incompatible, such active ingredients or animal drugs intended
        for use in drinking water are physically compatible.

      (5) In reviewing an application that proposes a change to add an
    intended use for a minor use or a minor species to an approved new
    animal drug application, the Secretary shall reevaluate only the
    relevant information in the approved application to determine
    whether the application for the minor use or minor species can be
    approved. A decision to approve the application for the minor use
    or minor species is not, implicitly or explicitly, a reaffirmation
    of the approval of the original application.
    (e) Withdrawal of approval; grounds; immediate suspension upon
      finding imminent hazard to health of man or animals
      (1) The Secretary shall, after due notice and opportunity for
    hearing to the applicant, issue an order withdrawing approval of an
    application filed pursuant to subsection (b) of this section with
    respect to any new animal drug if the Secretary finds - 
        (A) that experience or scientific data show that such drug is
      unsafe for use under the conditions of use upon the basis of
      which the application was approved or the condition of use
      authorized under subsection (a)(4)(A) of this section;
        (B) that new evidence not contained in such application or not
      available to the Secretary until after such application was
      approved, or tests by new methods, or tests by methods not deemed
      reasonably applicable when such application was approved,
      evaluated together with the evidence available to the Secretary
      when the application was approved, shows that such drug is not
      shown to be safe for use under the conditions of use upon the
      basis of which the application was approved or that subparagraph
      (I) of paragraph (1) of subsection (d) of this section applies to
      such drug;
        (C) on the basis of new information before him with respect to
      such drug, evaluated together with the evidence available to him
      when the application was approved, that there is a lack of
      substantial evidence that such drug will have the effect it
      purports or is represented to have under the conditions of use
      prescribed, recommended, or suggested in the labeling thereof;
        (D) the patent information prescribed by subsection (c)(3) of
      this section was not filed within 30 days after the receipt of
      written notice from the Secretary specifying the failure to file
      such information;
        (E) that the application contains any untrue statement of a
      material fact; or
        (F) that the applicant has made any changes from the standpoint
      of safety or effectiveness beyond the variations provided for in
      the application unless he has supplemented the application by
      filing with the Secretary adequate information respecting all
      such changes and unless there is in effect an approval of the
      supplemental application. The supplemental application shall be
      treated in the same manner as the original application.

    If the Secretary (or in his absence the officer acting as
    Secretary) finds that there is an imminent hazard to the health of
    man or of the animals for which such drug is intended, he may
    suspend the approval of such application immediately, and give the
    applicant prompt notice of his action and afford the applicant the
    opportunity for an expedited hearing under this subsection; but the
    authority conferred by this sentence to suspend the approval of an
    application shall not be delegated.
      (2) The Secretary may also, after due notice and opportunity for
    hearing to the applicant, issue an order withdrawing the approval
    of an application with respect to any new animal drug under this
    section if the Secretary finds - 
        (A) that the applicant has failed to establish a system for
      maintaining required records, or has repeatedly or deliberately
      failed to maintain such records or to make required reports in
      accordance with a regulation or order under subsection (1) of
      this section, or the applicant has refused to permit access to,
      or copying or verification of, such records as required by
      paragraph (2) of such subsection;
        (B) that on the basis of new information before him, evaluated
      together with the evidence before him when the application was
      approved, the methods used in, or the facilities and controls
      used for, the manufacture, processing, and packing of such drug
      are inadequate to assure and preserve its identity, strength,
      quality, and purity and were not made adequate within a
      reasonable time after receipt of written notice from the
      Secretary specifying the matter complained of; or
        (C) that on the basis of new information before him, evaluated
      together with the evidence before him when the application was
      approved, the labeling of such drug, based on a fair evaluation
      of all material facts, is false or misleading in any particular
      and was not corrected within a reasonable time after receipt of
      written notice from the Secretary specifying the matter
      complained of.

      (3) Any order under this subsection shall state the findings upon
    which it is based.
    (f) Revocation of order refusing, withdrawing or suspending
      approval of application
      Whenever the Secretary finds that the facts so require, he shall
    revoke any previous order under subsection (d), (e), or (m) of this
    section, or section 360ccc(c), (d), or (e) of this title refusing,
    withdrawing, or suspending approval of an application and shall
    approve such application or reinstate such approval, as may be
    appropriate.
    (g) Service of orders
      Orders of the Secretary issued under this section, or section
    360ccc of this title (other than orders issuing, amending, or
    repealing regulations) shall be served (1) in person by any officer
    or employee of the department designated by the Secretary or (2) by
    mailing the order by registered mail or by certified mail addressed
    to the applicant or respondent at his last known address in the
    records of the Secretary.
    (h) Appeal from order
      An appeal may be taken by the applicant from an order of the
    Secretary refusing or withdrawing approval of an application filed
    under subsection (b) or (m) of this section. The provisions of
    subsection (h) of section 355 of this title shall govern any such
    appeal.
    (i) Publication in Federal Register; effective date and revocation
      or suspension of regulation
      When a new animal drug application filed pursuant to subsection
    (b) of this section or section 360ccc of this title is approved,
    the Secretary shall by notice, which upon publication shall be
    effective as a regulation, publish in the Federal Register the name
    and address of the applicant and the conditions and indications of
    use of the new animal drug covered by such application, including
    any tolerance and withdrawal period or other use restrictions and,
    if such new animal drug is intended for use in animal feed,
    appropriate purposes and conditions of use (including special
    labeling requirements and any requirement that an animal feed
    bearing or containing the new animal drug be limited to use under
    the professional supervision of a licensed veterinarian) applicable
    to any animal feed for use in which such drug is approved, and such
    other information, upon the basis of which such application was
    approved, as the Secretary deems necessary to assure the safe and
    effective use of such drug. Upon withdrawal of approval of such new
    animal drug application or upon its suspension or upon failure to
    renew a conditional approval under section 360ccc of this title,
    the Secretary shall forthwith revoke or suspend, as the case may
    be, the regulation published pursuant to this subsection (i)
    insofar as it is based on the approval of such application.
    (j) Exemption of drugs for research; discretionary and mandatory
      conditions
      To the extent consistent with the public health, the Secretary
    shall promulgate regulations for exempting from the operation of
    this section new animal drugs, and animal feeds bearing or
    containing new animal drugs, intended solely for investigational
    use by experts qualified by scientific training and experience to
    investigate the safety and effectiveness of animal drugs. Such
    regulations may, in the discretion of the Secretary, among other
    conditions relating to the protection of the public health, provide
    for conditioning such exemption upon the establishment and
    maintenance of such records, and the making of such reports to the
    Secretary, by the manufacturer or the sponsor of the investigation
    of such article, of data (including but not limited to analytical
    reports by investigators) obtained as a result of such
    investigational use of such article, as the Secretary finds will
    enable him to evaluate the safety and effectiveness of such article
    in the event of the filing of an application pursuant to this
    section. Such regulations, among other things, shall set forth the
    conditions (if any) upon which animals treated with such articles,
    and any products of such animals (before or after slaughter), may
    be marketed for food use.
    (k) Food containing new animal drug considered unadulterated while
      approval of application for such drug is effective
      While approval of an application for a new animal drug is
    effective, a food shall not, by reason of bearing or containing
    such drug or any substance formed in or on the food because of its
    use in accordance with such application (including the conditions
    and indications of use prescribed pursuant to subsection (i) of
    this section), be considered adulterated within the meaning of
    clause (1) of section 342(a) of this title.
    (l) Records and reports; required information; regulations and
      orders; examination of data; access to records
      (1) In the case of any new animal drug for which an approval of
    an application filed pursuant to subsection (b) of this section or
    section 360ccc of this title is in effect, the applicant shall
    establish and maintain such records, and make such reports to the
    Secretary, of data relating to experience, including experience
    with uses authorized under subsection (a)(4)(A) of this section,
    and other data or information, received or otherwise obtained by
    such applicant with respect to such drug, or with respect to animal
    feeds bearing or containing such drug, as the Secretary may by
    general regulation, or by order with respect to such application,
    prescribe on the basis of a finding that such records and reports
    are necessary in order to enable the Secretary to determine, or
    facilitate a determination, whether there is or may be ground for
    invoking subsection (e) or subsection (m)(4) of this section. Such
    regulation or order shall provide, where the Secretary deems it to
    be appropriate, for the examination, upon request, by the persons
    to whom such regulation or order is applicable, of similar
    information received or otherwise obtained by the Secretary.
      (2) Every person required under this subsection to maintain
    records, and every person in charge or custody thereof, shall, upon
    request of an officer or employee designated by the Secretary,
    permit such officer or employee at all reasonable times to have
    access to and copy and verify such records.
    (m) Feed mill licenses
      (1) Any person may file with the Secretary an application for a
    license to manufacture animal feeds bearing or containing new
    animal drugs. Such person shall submit to the Secretary as part of
    the application (A) a full statement of the business name and
    address of the specific facility at which the manufacturing is to
    take place and the facility's registration number, (B) the name and
    signature of the responsible individual or individuals for that
    facility, (C) a certification that the animal feeds bearing or
    containing new animal drugs are manufactured and labeled in
    accordance with the applicable regulations published pursuant to
    subsection (i) of this section or for indexed new animal drugs in
    accordance with the index listing published pursuant to section
    360ccc-1(e)(2) of this title and the labeling requirements set
    forth in section 360ccc-1(h) of this title, and (D) a certification
    that the methods used in, and the facilities and controls used for,
    manufacturing, processing, packaging, and holding such animal feeds
    are in conformity with current good manufacturing practice as
    described in section 351(a)(2)(B) of this title.
      (2) Within 90 days after the filing of an application pursuant to
    paragraph (1), or such additional period as may be agreed upon by
    the Secretary and the applicant, the Secretary shall (A) issue an
    order approving the application if the Secretary then finds that
    none of the grounds for denying approval specified in paragraph (3)
    applies, or (B) give the applicant notice of an opportunity for a
    hearing before the Secretary under paragraph (3) on the question
    whether such application is approvable. The procedure governing
    such a hearing shall be the procedure set forth in the last two
    sentences of subsection (c)(1) of this section.
      (3) If the Secretary, after due notice to the applicant in
    accordance with paragraph (2) and giving the applicant an
    opportunity for a hearing in accordance with such paragraph, finds,
    on the basis of information submitted to the Secretary as part of
    the application, on the basis of a preapproval inspection, or on
    the basis of any other information before the Secretary - 
        (A) that the application is incomplete, false, or misleading in
      any particular;
        (B) that the methods used in, and the facilities and controls
      used for, the manufacture, processing, and packing of such animal
      feed are inadequate to preserve the identity, strength, quality,
      and purity of the new animal drug therein; or
        (C) that the facility manufactures animal feeds bearing or
      containing new animal drugs in a manner that does not accord with
      the specifications for manufacture or labels animal feeds bearing
      or containing new animal drugs in a manner that does not accord
      with the conditions or indications of use that are published
      pursuant to subsection (i) of this section or an index listing
      pursuant to section 360ccc-1(e) of this title,

    the Secretary shall issue an order refusing to approve the
    application. If, after such notice and opportunity for hearing, the
    Secretary finds that subparagraphs (A) through (C) do not apply,
    the Secretary shall issue an order approving the application. An
    order under this subsection approving an application for a license
    to manufacture animal feeds bearing or containing new animal drugs
    shall permit a facility to manufacture only those animal feeds
    bearing or containing new animal drugs for which there are in
    effect regulations pursuant to subsection (i) of this section or an
    index listing pursuant to section 360ccc-1(e) of this title
    relating to the use of such drugs in or on such animal feed.
      (4)(A) The Secretary shall, after due notice and opportunity for
    hearing to the applicant, revoke a license to manufacture animal
    feeds bearing or containing new animal drugs under this subsection
    if the Secretary finds - 
        (i) that the application for such license contains any untrue
      statement of a material fact; or
        (ii) that the applicant has made changes that would cause the
      application to contain any untrue statements of material fact or
      that would affect the safety or effectiveness of the animal feeds
      manufactured at the facility unless the applicant has
      supplemented the application by filing with the Secretary
      adequate information respecting all such changes and unless there
      is in effect an approval of the supplemental application.

    If the Secretary (or in the Secretary's absence the officer acting
    as the Secretary) finds that there is an imminent hazard to the
    health of humans or of the animals for which such animal feed is
    intended, the Secretary may suspend the license immediately, and
    give the applicant prompt notice of the action and afford the
    applicant the opportunity for an expedited hearing under this
    subsection; but the authority conferred by this sentence shall not
    be delegated.
      (B) The Secretary may also, after due notice and opportunity for
    hearing to the applicant, revoke a license to manufacture animal
    feed under this subsection if the Secretary finds - 
        (i) that the applicant has failed to establish a system for
      maintaining required records, or has repeatedly or deliberately
      failed to maintain such records or to make required reports in
      accordance with a regulation or order under paragraph (5)(A) of
      this subsection or section 354(a)(3)(A) of this title, or the
      applicant has refused to permit access to, or copying or
      verification of, such records as required by subparagraph (B) of
      such paragraph or section 354(a)(3)(B) of this title;
        (ii) that on the basis of new information before the Secretary,
      evaluated together with the evidence before the Secretary when
      such license was issued, the methods used in, or the facilities
      and controls used for, the manufacture, processing, packing, and
      holding of such animal feed are inadequate to assure and preserve
      the identity, strength, quality, and purity of the new animal
      drug therein, and were not made adequate within a reasonable time
      after receipt of written notice from the Secretary, specifying
      the matter complained of;
        (iii) that on the basis of new information before the
      Secretary, evaluated together with the evidence before the
      Secretary when such license was issued, the labeling of any
      animal feeds, based on a fair evaluation of all material facts,
      is false or misleading in any particular and was not corrected
      within a reasonable time after receipt of written notice from the
      Secretary specifying the matter complained of; or
        (iv) that on the basis of new information before the Secretary,
      evaluated together with the evidence before the Secretary when
      such license was issued, the facility has manufactured,
      processed, packed, or held animal feed bearing or containing a
      new animal drug adulterated under section 351(a)(6) of this title
      and the facility did not discontinue the manufacture, processing,
      packing, or holding of such animal feed within a reasonable time
      after receipt of written notice from the Secretary specifying the
      matter complained of.

      (C) The Secretary may also revoke a license to manufacture animal
    feeds under this subsection if an applicant gives notice to the
    Secretary of intention to discontinue the manufacture of all animal
    feed covered under this subsection and waives an opportunity for a
    hearing on the matter.
      (D) Any order under this paragraph shall state the findings upon
    which it is based.
      (5) When a license to manufacture animal feeds bearing or
    containing new animal drugs has been issued - 
        (A) the applicant shall establish and maintain such records,
      and make such reports to the Secretary, or (at the option of the
      Secretary) to the appropriate person or persons holding an
      approved application filed under subsection (b) of this section,
      as the Secretary may by general regulation, or by order with
      respect to such application, prescribe on the basis of a finding
      that such records and reports are necessary in order to enable
      the Secretary to determine, or facilitate a determination,
      whether there is or may be ground for invoking subsection (e) of
      this section or paragraph (4); and
        (B) every person required under this subsection to maintain
      records, and every person in charge or custody thereof, shall,
      upon request of an officer or employee designated by the
      Secretary, permit such officer or employee at all reasonable
      times to have access to and copy and verify such records.

      (6) To the extent consistent with the public health, the
    Secretary may promulgate regulations for exempting from the
    operation of this subsection facilities that manufacture, process,
    pack, or hold animal feeds bearing or containing new animal drugs.
    (n) Abbreviated applications for new animal drugs; contents,
      filing, etc.; lists of approved drugs
      (1) An abbreviated application for a new animal drug shall
    contain - 
        (A)(i) except as provided in clause (ii), information to show
      that the conditions of use or similar limitations (whether in the
      labeling or published pursuant to subsection (i) of this section)
      prescribed, recommended, or suggested in the labeling proposed
      for the new animal drug have been previously approved for a new
      animal drug listed under paragraph (4) (hereinafter in this
      subsection referred to as an "approved new animal drug"), and
        (ii) information to show that the withdrawal period at which
      residues of the new animal drug will be consistent with the
      tolerances established for the approved new animal drug is the
      same as the withdrawal period previously established for the
      approved new animal drug or, if the withdrawal period is proposed
      to be different, information showing that the residues of the new
      animal drug at the proposed different withdrawal period will be
      consistent with the tolerances established for the approved new
      animal drug;
        (B)(i) information to show that the active ingredients of the
      new animal drug are the same as those of the approved new animal
      drug, and
        (ii) if the approved new animal drug has more than one active
      ingredient, and if one of the active ingredients of the new
      animal drug is different from one of the active ingredients of
      the approved new animal drug and the application is filed
      pursuant to the approval of a petition filed under paragraph (3) -
       
          (I) information to show that the other active ingredients of
        the new animal drug are the same as the active ingredients of
        the approved new animal drug,
          (II) information to show either that the different active
        ingredient is an active ingredient of another approved new
        animal drug or of an animal drug which does not meet the
        requirements of section 321(v) of this title, and
          (III) such other information respecting the different active
        ingredients as the Secretary may require;

        (C)(i) if the approved new animal drug is permitted to be used
      with one or more animal drugs in animal feed, information to show
      that the proposed uses of the new animal drug with other animal
      drugs in animal feed are the same as the uses of the approved new
      animal drug, and
        (ii) if the approved new animal drug is permitted to be used
      with one or more other animal drugs in animal feed, and one of
      the other animal drugs proposed for use with the new animal drug
      in animal feed is different from one of the other animal drugs
      permitted to be used in animal feed with the approved new animal
      drug, and the application is filed pursuant to the approval of a
      petition filed under paragraph (3) - 
          (I) information to show either that the different animal drug
        proposed for use with the approved new animal drug in animal
        feed is an approved new animal drug permitted to be used in
        animal feed or does not meet the requirements of section 321(v)
        of this title when used with another animal drug in animal
        feed,
          (II) information to show that other animal drugs proposed for
        use with the new animal drug in animal feed are the same as the
        other animal drugs permitted to be used with the approved new
        animal drug, and
          (III) such other information respecting the different animal
        drug or combination with respect to which the petition was
        filed as the Secretary may require,

        (D) information to show that the route of administration, the
      dosage form, and the strength of the new animal drug are the same
      as those of the approved new animal drug or, if the route of
      administration, the dosage form, or the strength of the new
      animal drug is different and the application is filed pursuant to
      the approval of a petition filed under paragraph (3), such
      information respecting the route of administration, dosage form,
      or strength with respect to which the petition was filed as the
      Secretary may require;
        (E) information to show that the new animal drug is
      bioequivalent to the approved new animal drug, except that if the
      application is filed pursuant to the approval of a petition filed
      under paragraph (3) for the purposes described in subparagraph
      (B) or (C), information to show that the active ingredients of
      the new animal drug are of the same pharmacological or
      therapeutic class as the pharmacological or therapeutic class of
      the approved new animal drug and that the new animal drug can be
      expected to have the same therapeutic effect as the approved new
      animal drug when used in accordance with the labeling;
        (F) information to show that the labeling proposed for the new
      animal drug is the same as the labeling approved for the approved
      new animal drug except for changes required because of
      differences approved under a petition filed under paragraph (3),
      because of a different withdrawal period, or because the new
      animal drug and the approved new animal drug are produced or
      distributed by different manufacturers;
        (G) the items specified in clauses (B) through (F) of
      subsection (b)(1) of this section;
        (H) a certification, in the opinion of the applicant and to the
      best of his knowledge, with respect to each patent which claims
      the approved new animal drug or which claims a use for such
      approved new animal drug for which the applicant is seeking
      approval under this subsection and for which information is
      required to be filed under subsection (b)(1) or (c)(3) of this
      section - 
          (i) that such patent information has not been filed,
          (ii) that such patent has expired,
          (iii) of the date on which such patent will expire, or
          (iv) that such patent is invalid or will not be infringed by
        the manufacture, use, or sale of the new animal drug for which
        the application is filed; and

        (I) if with respect to the approved new animal drug information
      was filed under subsection (b)(1) or (c)(3) of this section for a
      method of use patent which does not claim a use for which the
      applicant is seeking approval of an application under subsection
      (c)(2) of this section, a statement that the method of use patent
      does not claim such a use.

    The Secretary may not require that an abbreviated application
    contain information in addition to that required by subparagraphs
    (A) through (I).
      (2)(A) An applicant who makes a certification described in
    paragraph (1)(G)(iv) shall include in the application a statement
    that the applicant will give the notice required by subparagraph
    (B) to - 
        (i) each owner of the patent which is the subject of the
      certification or the representative of such owner designated to
      receive such notice, and
        (ii) the holder of the approved application under subsection
      (c)(1) of this section for the drug which is claimed by the
      patent or a use of which is claimed by the patent or the
      representative of such holder designated to receive such notice.

      (B) The notice referred to in subparagraph (A) shall state that
    an application, which contains data from bioequivalence studies,
    has been filed under this subsection for the drug with respect to
    which the certification is made to obtain approval to engage in the
    commercial manufacture, use, or sale of such drug before the
    expiration of the patent referred to in the certification. Such
    notice shall include a detailed statement of the factual and legal
    basis of the applicant's opinion that the patent is not valid or
    will not be infringed.
      (C) If an application is amended to include a certification
    described in paragraph (1)(G)(iv), the notice required by
    subparagraph (B) shall be given when the amended application is
    filed.
      (3) If a person wants to submit an abbreviated application for a
    new animal drug - 
        (A) whose active ingredients, route of administration, dosage
      form, or strength differ from that of an approved new animal
      drug, or
        (B) whose use with other animal drugs in animal feed differs
      from that of an approved new animal drug,

    such person shall submit a petition to the Secretary seeking
    permission to file such an application. The Secretary shall approve
    a petition for a new animal drug unless the Secretary finds that - 
        (C) investigations must be conducted to show the safety and
      effectiveness, in animals to be treated with the drug, of the
      active ingredients, route of administration, dosage form,
      strength, or use with other animal drugs in animal feed which
      differ from the approved new animal drug, or
        (D) investigations must be conducted to show the safety for
      human consumption of any residues in food resulting from the
      proposed active ingredients, route of administration, dosage
      form, strength, or use with other animal drugs in animal feed for
      the new animal drug which is different from the active
      ingredients, route of administration, dosage form, strength, or
      use with other animal drugs in animal feed of the approved new
      animal drug.

    The Secretary shall approve or disapprove a petition submitted
    under this paragraph within 90 days of the date the petition is
    submitted.
      (4)(A)(i) Within 60 days of November 16, 1988, the Secretary
    shall publish and make available to the public a list in
    alphabetical order of the official and proprietary name of each new
    animal drug which has been approved for safety and effectiveness
    before November 16, 1988.
      (ii) Every 30 days after the publication of the first list under
    clause (i) the Secretary shall revise the list to include each new
    animal drug which has been approved for safety and effectiveness
    under subsection (c) of this section during the 30 day period.
      (iii) When patent information submitted under subsection (b)(1)
    or (c)(3) of this section respecting a new animal drug included on
    the list is to be published by the Secretary, the Secretary shall,
    in revisions made under clause (ii), include such information for
    such drug.
      (B) A new animal drug approved for safety and effectiveness
    before November 16, 1988, or approved for safety and effectiveness
    under subsection (c) of this section shall, for purposes of this
    subsection, be considered to have been published under subparagraph
    (A) on the date of its approval or November 16, 1988, whichever is
    later.
      (C) If the approval of a new animal drug was withdrawn or
    suspended under subsection (c)(2)(G) of this section or for grounds
    described in subsection (e) of this section or if the Secretary
    determines that a drug has been withdrawn from sale for safety or
    effectiveness reasons, it may not be published in the list under
    subparagraph (A) or, if the withdrawal or suspension occurred after
    its publication in such list, it shall be immediately removed from
    such list - 
        (i) for the same period as the withdrawal or suspension under
      subsection (c)(2)(G) or (e) of this section, or
        (ii) if the listed drug has been withdrawn from sale, for the
      period of withdrawal from sale or, if earlier, the period ending
      on the date the Secretary determines that the withdrawal from
      sale is not for safety or effectiveness reasons.

    A notice of the removal shall be published in the Federal Register.
      (5) If an application contains the information required by
    clauses (A), (G), and (H) of subsection (b)(1) of this section and
    such information - 
        (A) is relied on by the applicant for the approval of the
      application, and
        (B) is not information derived either from investigations,
      studies, or tests conducted by or for the applicant or for which
      the applicant had obtained a right of reference or use from the
      person by or for whom the investigations, studies, or tests were
      conducted,

    such application shall be considered to be an application filed
    under subsection (b)(2) of this section.
    (o) "Patent" defined
      For purposes of this section, the term "patent" means a patent
    issued by the United States Patent and Trademark Office.
    (p) Safety and effectiveness data
      (1) Safety and effectiveness data and information which has been
    submitted in an application filed under subsection (b)(1) of this
    section or section 360ccc(a) of this title for a drug and which has
    not previously been disclosed to the public shall be made available
    to the public, upon request, unless extraordinary circumstances are
    shown - 
        (A) if no work is being or will be undertaken to have the
      application approved,
        (B) if the Secretary has determined that the application is not
      approvable and all legal appeals have been exhausted,
        (C) if approval of the application under subsection (c) of this
      section is withdrawn and all legal appeals have been exhausted,
        (D) if the Secretary has determined that such drug is not a new
      drug, or
        (E) upon the effective date of the approval of the first
      application filed under subsection (b)(2) of this section which
      refers to such drug or upon the date upon which the approval of
      an application filed under subsection (b)(2) of this section
      which refers to such drug could be made effective if such an
      application had been filed.

      (2) Any request for data and information pursuant to paragraph
    (1) shall include a verified statement by the person making the
    request that any data or information received under such paragraph
    shall not be disclosed by such person to any other person - 
        (A) for the purpose of, or as part of a plan, scheme, or device
      for, obtaining the right to make, use, or market, or making,
      using, or marketing, outside the United States, the drug
      identified in the application filed under subsection (b)(1) of
      this section or section 360ccc(a) of this title, and
        (B) without obtaining from any person to whom the data and
      information are disclosed an identical verified statement, a copy
      of which is to be provided by such person to the Secretary, which
      meets the requirements of this paragraph.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 512, as added Pub. L. 90-399, Sec.
    101(b), July 13, 1968, 82 Stat. 343; amended Pub. L. 100-670, title
    I, Secs. 101, 102, 104, 107(a)(2), Nov. 16, 1988, 102 Stat. 3971,
    3981, 3982, 3984; Pub. L. 102-108, Sec. 2(e), Aug. 17, 1991, 105
    Stat. 550; Pub. L. 103-80, Sec. 3(r), Aug. 13, 1993, 107 Stat. 777;
    Pub. L. 103-396, Sec. 2(a), (b)(2), (3), Oct. 22, 1994, 108 Stat.
    4153, 4154; Pub. L. 104-250, Secs. 2(a)-(d), 3-5(c), 6(a), (b),
    Oct. 9, 1996, 110 Stat. 3151-3153, 3155-3157; Pub. L. 105-115,
    title I, Sec. 124(b), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 105-
    277, div. A, Sec. 101(a) [title VII, Sec. 737], Oct. 21, 1998, 112
    Stat. 2681, 2681-30; Pub. L. 106-113, div. B, Sec. 1000(a)(9)
    [title IV, Sec. 4732(b)(11)], Nov. 29, 1999, 113 Stat. 1536, 1501A-
    584; Pub. L. 108-282, title I, Sec. 102(b)(2), (3), (5)(I)-(S),
    Aug. 2, 2004, 118 Stat. 892, 903, 904.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 342(a)(2) of this title, referred to in subsec. (a)(6),
    was amended by Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996,
    110 Stat. 1514, and, as so amended, no longer contains a subcl.
    (D). See section 342(a)(2)(C)(ii) of this title.


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (a)(1), (2). Pub. L. 108-282, Sec. 102(b)(5)(I),
    added pars. (1) and (2) and struck out former pars. (1) and (2)
    which deemed as unsafe new animal drugs and animal feed bearing or
    containing a new animal drug which did not have in effect certain
    approvals.
      Subsec. (b)(3). Pub. L. 108-282, Sec. 102(b)(5)(J), substituted
    "under paragraph (1), section 360ccc of this title, or a request
    for an investigational exemption under subsection (j)" for "under
    paragraph (1) or a request for an investigational exemption under
    subsection (j)".
      Subsec. (c)(2)(F)(ii), (iii), (v). Pub. L. 108-282, Sec.
    102(b)(2), substituted "(other than bioequivalence studies or
    residue depletion studies, except residue depletion studies for
    minor uses or minor species)" for "(other than bioequivalence or
    residue studies)".
      Subsec. (d)(4). Pub. L. 108-282, Sec. 102(b)(5)(K), substituted
    "have previously been separately approved pursuant to an
    application submitted under subsection (b)(1) of this section" for
    "have previously been separately approved" in introductory
    provisions.
      Subsec. (d)(5). Pub. L. 108-282, Sec. 102(b)(3), added par. (5).
      Subsec. (f). Pub. L. 108-282, Sec. 102(b)(5)(L), substituted
    "subsection (d), (e), or (m) of this section, or section 360ccc(c),
    (d), or (e) of this title" for "subsection (d), (e), or (m) of this
    section".
      Subsec. (g). Pub. L. 108-282, Sec. 102(b)(5)(M), substituted
    "this section, or section 360ccc of this title" for "this section".
      Subsec. (i). Pub. L. 108-282, Sec. 102(b)(5)(N), substituted
    "subsection (b) of this section or section 360ccc of this title"
    for "subsection (b) of this section" and inserted "or upon failure
    to renew a conditional approval under section 360ccc of this title"
    after "or upon its suspension".
      Subsec. (l)(1). Pub. L. 108-282, Sec. 102(b)(5)(O), substituted
    "subsection (b) of this section or section 360ccc of this title"
    for "subsection (b) of this section".
      Subsec. (m)(1)(C). Pub. L. 108-282, Sec. 102(b)(5)(P),
    substituted "applicable regulations published pursuant to
    subsection (i) of this section or for indexed new animal drugs in
    accordance with the index listing published pursuant to section
    360ccc-1(e)(2) of this title and the labeling requirements set
    forth in section 360ccc-1(h) of this title" for "applicable
    regulations published pursuant to subsection (i) of this section".
      Subsec. (m)(3). Pub. L. 108-282, Sec. 102(b)(5)(Q), inserted "or
    an index listing pursuant to section 360ccc-1(e) of this title"
    after "subsection (i) of this section" in subpar. (C) and
    concluding provisions.
      Subsec. (p)(1), (2)(A). Pub. L. 108-282, Sec. 102(b)(5)(R), (S),
    substituted "subsection (b)(1) of this section or section 360ccc(a)
    of this title" for "subsection (b)(1) of this section".
      1999 - Subsec. (o). Pub. L. 106-113 substituted "United States
    Patent and Trademark Office" for "Patent and Trademark Office of
    the Department of Commerce".
      1998 - Subsec. (d)(4)(D)(iii). Pub. L. 105-277 inserted before
    semicolon ", except that for purposes of this clause, antibacterial
    ingredient or animal drug does not include the ionophore or
    arsenical classes of animal drugs".
      1997 - Subsec. (c)(4). Pub. L. 105-115 added par. (4).
      1996 - Subsec. (a)(1). Pub. L. 104-250, Sec. 6(a), amended par.
    (1) generally. Prior to amendment, par. (1) read as follows: "A new
    animal drug shall, with respect to any particular use or intended
    use of such drug, be deemed unsafe for the purposes of section
    351(a)(5) and section 342(a)(2)(D) of this title unless - 
        "(A) there is in effect an approval of an application filed
      pursuant to subsection (b) of this section with respect to such
      use or intended use of such drug, and
        "(B) such drug, its labeling, and such use conform to such
      approved application.
    A new animal drug shall also be deemed unsafe for such purposes in
    the event of removal from the establishment of a manufacturer,
    packer, or distributor of such drug for use in the manufacture of
    animal feed in any State unless at the time of such removal such
    manufacturer, packer, or distributor has an unrevoked written
    statement from the consignee of such drug, or notice from the
    Secretary, to the effect that, with respect to the use of such drug
    in animal feed, such consignee - 
        "(i) is the holder of an approved application under subsection
      (m) of this section; or
        "(ii) will, if the consignee is not a user of the drug, ship
      such drug only to a holder of an approved application under
      subsection (m) of this section."
      Subsec. (a)(2). Pub. L. 104-250, Sec. 6(a), amended par. (2)
    generally. Prior to amendment, par. (2) read as follows: "An animal
    feed bearing or containing a new animal drug shall, with respect to
    any particular use or intended use of such animal feed, be deemed
    unsafe for the purposes of section 351(a)(6) of this title unless -
    
        "(A) there is in effect an approval of an application filed
      pursuant to subsection (b) of this section with respect to such
      drugs, as used in such animal feed,
        "(B) there is in effect an approval of an application pursuant
      to subsection (m)(1) of this section with respect to such animal
      feed, and
        "(C) such animal feed, its labeling, and such use conform to
      the conditions and indications of use published pursuant to
      subsection (i) of this section and to the application with
      respect thereto approved under subsection (m) of this section."
      Subsec. (a)(6). Pub. L. 104-250, Sec. 4, added par. (6).
      Subsec. (b)(3). Pub. L. 104-250, Sec. 2(d), added par. (3).
      Subsec. (c)(2)(F)(ii), (iii). Pub. L. 104-250, Sec. 2(b)(1),
    substituted "substantial evidence of the effectiveness of the drug
    involved, any studies of animal safety, or," for "reports of new
    clinical or field investigations (other than bioequivalence or
    residue studies) and," and "required for the approval" for
    "essential to the approval".
      Subsec. (c)(2)(F)(v). Pub. L. 104-250, Sec. 2(b)(2), substituted
    "clause (iv)" for "subparagraph (B)(iv)" in two places,
    "substantial evidence of the effectiveness of the drug involved,
    any studies of animal safety," for "reports of clinical or field
    investigations" and "required for the new approval" for "essential
    to the new approval".
      Subsec. (d)(1)(F). Pub. L. 104-250, Sec. 3, amended subpar. (F)
    generally. Prior to amendment, subpar. (F) read as follows: "upon
    the basis of the information submitted to him as part of the
    application or any other information before him with respect to
    such drug, the tolerance limitation proposed, if any, exceeds that
    reasonably required to accomplish the physical or other technical
    effect for which the drug is intended;".
      Subsec. (d)(3). Pub. L. 104-250, Sec. 2(a), amended par. (3)
    generally. Prior to amendment, par. (3) read as follows: "As used
    in this subsection and subsection (e) of this section, the term
    'substantial evidence' means evidence consisting of adequate and
    well-controlled investigations, including field investigation, by
    experts qualified by scientific training and experience to evaluate
    the effectiveness of the drug involved, on the basis of which it
    could fairly and reasonably be concluded by such experts that the
    drug will have the effect it purports or is represented to have
    under the conditions of use prescribed, recommended, or suggested
    in the labeling or proposed labeling thereof."
      Subsec. (d)(4). Pub. L. 104-250, Sec. 2(c), added par. (4).
      Subsec. (i). Pub. L. 104-250, Sec. 5(c), inserted "and any
    requirement that an animal feed bearing or containing the new
    animal drug be limited to use under the professional supervision of
    a licensed veterinarian" after "(including special labeling
    requirements".
      Subsec. (m). Pub. L. 104-250, Sec. 6(b), amended subsec. (m)
    generally, substituting provisions relating to application for feed
    mill licenses, including approval, refusal, revocation, and
    suspension of such licenses, and provisions for record and
    reporting requirements for, as well as exemption from, such
    licenses, for provisions relating to application for uses of animal
    feed containing new animal drug, including required contents,
    approval, refusal, and withdrawal of approval or suspension of such
    usage applications, and provisions for record and reporting
    requirements of such usage applications.
      1994 - Subsec. (a)(4), (5). Pub. L. 103-396, Sec. 2(a), added
    pars. (4) and (5).
      Subsec. (e)(1)(A). Pub. L. 103-396, Sec. 2(b)(2), inserted before
    semicolon at end "or the condition of use authorized under
    subsection (a)(4)(A) of this section".
      Subsec. (l)(1). Pub. L. 103-396, Sec. 2(b)(3), substituted
    "relating to experience, including experience with uses authorized
    under subsection (a)(4)(A) of this section," for "relating to
    experience".
      1993 - Subsec. (c)(2)(A)(ii). Pub. L. 103-80, Sec. 3(r)(1),
    inserted "in" after "except as provided".
      Subsec. (c)(2)(F)(i). Pub. L. 103-80, Sec. 3(r)(2), substituted
    "subparagraph (D)(iii)" for "subparagraph (C)(iii)".
      Subsec. (c)(2)(H)(ii). Pub. L. 103-80, Sec. 3(r)(3), substituted
    "subclauses" for "subclause" after "bioequivalency information
    described in" in concluding provisions.
      Subsec. (d)(1). Pub. L. 103-80, Sec. 3(r)(4), substituted
    "subparagraphs (A) through (I)" for "subparagraphs (A) through (G)"
    in concluding provisions.
      Subsec. (n)(1). Pub. L. 103-80, Sec. 3(r)(5), substituted
    "section 321(v) of this title" for "section 321(w) of this title"
    in subpars. (B)(ii)(II) and (C)(ii)(I) and substituted "through
    (I)" for "through (H)" in concluding provisions.
      1991 - Subsec. (e)(1)(B). Pub. L. 102-108 substituted "(I)" for
    "(H)".
      1988 - Subsec. (a)(1)(C). Pub. L. 100-670, Sec. 107(a)(2), struck
    out subpar. (C) which read as follows: "in the case of a new animal
    drug subject to subsection (n) of this section and not exempted
    therefrom by regulations it is from a batch with respect to which a
    certificate or release issued pursuant to subsection (n) of this
    section is in effect with respect to such drug."
      Subsec. (b). Pub. L. 100-670, Secs. 101(a), 102(a), designated
    existing provisions as par. (1), redesignated cls. (1) to (8) as
    cls. (A) to (H), respectively, added par. (2), and inserted
    provisions at end of par. (1) which require applicant to file with
    application, patent number and expiration date of any patent which
    claims new animal drug, to amend application to include such
    information if patent which claims such drug or method of using
    such drug is issued after filing date but before approval of
    application, and to publish such information upon approval.
      Subsec. (c). Pub. L. 100-670, Secs. 101(c), 102(b)(1), designated
    existing provisions as par. (1), redesignated cls. (1) and (2) as
    cls. (A) and (B), respectively, and added pars. (2) and (3).
      Subsec. (d)(1). Pub. L. 100-670, Sec. 102(b)(3), substituted
    "(G)" for "(H)" in last sentence.
      Subsec. (d)(1)(G) to (I). Pub. L. 100-670, Sec. 102(b)(2), added
    subpar. (G) and redesignated former subpars. (G) and (H) as (H) and
    (I), respectively.
      Subsec. (e)(1)(D) to (F). Pub. L. 100-670, Sec. 102(b)(4), added
    subpar. (D) and redesignated former subpars. (D) and (E) as (E) and
    (F), respectively.
      Subsecs. (n) to (p). Pub. L. 100-670, Sec. 101(b), added subsecs.
    (n) to (p) and struck out former subsec. (n) which related to
    certification of new drugs containing penicillin, streptomycin,
    chlortetracycline, chloramphenicol, or bacitracin, and release
    prior to certification.

                     EFFECTIVE DATE OF 1999 AMENDMENT                 
      Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
    1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
    113, set out as a note under section 1 of Title 35, Patents.

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1994 AMENDMENT                 
      Section 2(d) of Pub. L. 103-396 provided that: "The amendments
    made by this section [amending this section and section 331 of this
    title] shall take effect upon the adoption of the final regulations
    under subsection (c) [set out below]." [Final regulations were
    dated Oct. 22, 1996, filed Nov. 6, 1996, published Nov. 7, 1996, 61
    F.R. 57732, and effective Dec. 9, 1996.]

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Section 108 of Pub. L. 100-670 provided that: "The Secretary of
    Health and Human Services may not make an approval of an
    application submitted under section 512(b)(2) of the Federal Food,
    Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before
    January 1, 1991."

                EFFECTIVE DATE AND TRANSITIONAL PROVISIONS            
      Pub. L. 90-399, Sec. 108, July 13, 1968, 82 Stat. 353, as amended
    by Pub. L. 108-282, title I, Sec. 102(b)(5)(T), Aug. 2, 2004, 118
    Stat. 905, provided that:
      "(a) Except as otherwise provided in this section, the amendments
    made by the foregoing sections [see Short Title of 1968 Amendment
    note set out under section 301 of this title] shall take effect on
    the first day of the thirteenth calendar month which begins after
    the date of enactment of this Act [July 13, 1968].
      "(b)(1) As used in this subsection, the term 'effective date'
    means the effective date specified in subsection (a) of this
    section; the term 'basic Act' means the Federal Food, Drug, and
    Cosmetic Act [this chapter]; and other terms used both in this
    section and the basic Act shall have the same meaning as they have,
    or had, at the time referred to in the context, under the basic
    Act.
      "(2) Any approval, prior to the effective date, of a new animal
    drug or of an animal feed bearing or containing a new animal drug,
    whether granted by approval of a new-drug application, master file,
    antibiotic regulation, or food additive regulations, shall continue
    in effect, and shall be subject to change in accordance with the
    provisions of the basic Act as amended by this Act [see Short Title
    of 1968 Amendment note set out under section 301 of this title].
      "(3) In the case of any drug (other than a drug subject to
    section 512(n) of the basic Act as amended by this Act) [subsection
    (n) of this section] intended for use in animals other than man
    which, on October 9, 1962, (A) was commercially used or sold in the
    United States, (B) was not a new drug as defined by section 201(p)
    of the basic Act [section 321(p) of this title] as then in force,
    and (C) was not covered by an effective application under section
    505 of that Act [section 355 of this title], the words
    'effectiveness' and 'effective' contained in section 201(v) to the
    basic Act [sic] [section 321(v) of this title] shall not apply to
    such drug when intended solely for use under conditions prescribed,
    recommended, or suggested in labeling with respect to such drug on
    that day.
      "(4) Regulations providing for fees (and advance deposits to
    cover fees) which on the day preceding the effective date
    applicable under subsection (a) of this section were in effect
    pursuant to section 507 of the basic Act [section 357 of this
    title] shall, except as the Secretary may otherwise prescribe, be
    deemed to apply also under section 512(n) of the basic Act
    [subsection (n) of this section], and appropriations of fees (and
    of advance deposits to cover fees) available for the purposes
    specified in such section 507 [section 357 of this title] as in
    effect prior to the effective date shall also be available for the
    purposes specified in section 512(n) [subsection (n) of this
    section], including preparatory work or proceedings prior to that
    date."

                                REGULATIONS                            
      Section 2(e) of Pub. L. 104-250 provided that:
      "(1) In general. - Not later than 6 months after the date of
    enactment of this Act [Oct. 9, 1996], the Secretary of Health and
    Human Services shall issue proposed regulations implementing the
    amendments made by this Act as described in paragraph (2)(A) of
    this subsection, and not later than 18 months after the date of
    enactment of this Act, the Secretary shall issue final regulations
    implementing such amendments. Not later than 12 months after the
    date of enactment of this Act, the Secretary shall issue proposed
    regulations implementing the other amendments made by this Act as
    described in paragraphs (2)(B) and (2)(C) of this subsection, and
    not later than 24 months after the date of enactment of this Act,
    the Secretary shall issue final regulations implementing such
    amendments.
      "(2) Contents. - In issuing regulations implementing the
    amendments made by this Act [see Short Title of 1996 Amendments
    note set out under section 301 of this title], and in taking an
    action to review an application for approval of a new animal drug
    under section 512 of the Federal Food, Drug, and Cosmetic Act (21
    U.S.C. 360b), or a request for an investigational exemption for a
    new animal drug under subsection (j) of such section, that is
    pending or has been submitted prior to the effective date of the
    regulations, the Secretary shall - 
        "(A) further define the term 'adequate and well controlled', as
      used in subsection (d)(3) of section 512 of such Act, to require
      that field investigations be designed and conducted in a
      scientifically sound manner, taking into account practical
      conditions in the field and differences between field conditions
      and laboratory conditions;
        "(B) further define the term 'substantial evidence', as defined
      in subsection (d)(3) of such section, in a manner that encourages
      the submission of applications and supplemental applications; and
        "(C) take into account the proposals contained in the citizen
      petition (FDA Docket No. 91P-0434/CP) jointly submitted by the
      American Veterinary Medical Association and the Animal Health
      Institute, dated October 21, 1991.
    Until the regulations required by subparagraph (A) are issued,
    nothing in the regulations published at 21 C.F.R. 514.111(a)(5)
    (April 1, 1996) shall be construed to compel the Secretary of
    Health and Human Services to require a field investigation under
    section 512(d)(1)(E) of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 360b(d)(1)(E)) or to apply any of its provisions in a
    manner inconsistent with the considerations for scientifically
    sound field investigations set forth in subparagraph (A)."
      Section 2(c) of Pub. L. 103-396 provided that: "Not later than 2
    years after the date of the enactment of this Act [Oct. 22, 1994],
    the Secretary of Health and Human Services shall promulgate
    regulations to implement paragraphs (4)(A) and (5) of section
    512(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    360b(a)(4)(A), (5)] (as amended by subsection (a))."
      Section 103 of Pub. L. 100-670 provided that:
      "(a) General Rule. - The Secretary of Health and Human Services
    shall promulgate, in accordance with the notice and comment
    requirements of section 553 of title 5, United States Code, such
    regulations as may be necessary for the administration of section
    512 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b],
    as amended by sections 101 through 103 of this title, within one
    year of the date of enactment of this Act [Nov. 16, 1988].
      "(b) Transition. - During the period beginning 60 days after the
    date of enactment of this Act [Nov. 16, 1988] and ending on the
    date regulations promulgated under subsection (a) take effect,
    abbreviated new animal drug applications may be submitted in
    accordance with the provisions of section 314.55 and part 320 of
    title 21 of the Code of Federal Regulations and shall be considered
    as suitable for any drug which has been approved for safety and
    effectiveness under section 512(c) of the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 360b(c)] before the date of enactment of
    this Act. If any such provision of section 314.55 or part 320 is
    inconsistent with the requirements of section 512 of the Federal
    Food, Drug, and Cosmetic Act (as amended by this title), the
    Secretary shall consider the application under the applicable
    requirements of section 512 (as so amended)."

              DRUGS INTENDED FOR MINOR SPECIES AND MINOR USES          
      Section 2(f) of Pub. L. 104-250 provided that: "The Secretary of
    Health and Human Services shall consider legislative and regulatory
    options for facilitating the approval under section 512 of the
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360b] of animal
    drugs intended for minor species and for minor uses and, within 18
    months after the date of enactment of this Act [Oct. 9, 1996],
    announce proposals for legislative or regulatory change to the
    approval process under such section for animal drugs intended for
    use in minor species or for minor uses."

    TRANSITIONAL PROVISION REGARDING IMPLEMENTATION OF PUB. L. 104-250;
            APPROVED MEDICATED FEED APPLICATION DEEMED LICENSE
      Section 6(c) of Pub. L. 104-250 provided that: "A person engaged
    in the manufacture of animal feeds bearing or containing new animal
    drugs who holds at least one approved medicated feed application
    for an animal feed bearing or containing new animal drugs, the
    manufacture of which was not otherwise exempt from the requirement
    for an approved medicated feed application on the date of the
    enactment of this Act [Oct. 9, 1996], shall be deemed to hold a
    license for the manufacturing site identified in the approved
    medicated feed application. The revocation of license provisions of
    section 512(m)(4) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 360b(m)(4)], as amended by this Act, shall apply to such
    licenses. Such license shall expire within 18 months from the date
    of enactment of this Act unless the person submits to the Secretary
    a completed license application for the manufacturing site
    accompanied by a copy of an approved medicated feed application for
    such site, which license application shall be deemed to be approved
    upon receipt by the Secretary."

             DRUGS PRIMARILY MANUFACTURED USING BIOTECHNOLOGY         
      Section 106 of Pub. L. 100-670 provided that: "Notwithstanding
    section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 360b(b)(2)], the Secretary of Health and Human Services may
    not approve an abbreviated application submitted under such section
    for a new animal drug which is primarily manufactured using
    recombinant DNA, recombinant RNA, hybridoma technology, or other
    processes involving site specific genetic manipulation techniques."

-FOOTNOTE-
    (!1) See References in Text note below.

    (!2) So in original. Probably should be "Alimentarius".

    (!3) So in original. Probably should be "clause (iii)(III)".


-End-



-CITE-
    21 USC Sec. 360c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360c. Classification of devices intended for human use

-STATUTE-
    (a) Classes of devices
      (1) There are established the following classes of devices
    intended for human use:
        (A) Class I, General Controls. - 
          (i) A device for which the controls authorized by or under
        section 351, 352, 360, 360f, 360h, 360i, or 360j of this title
        or any combination of such sections are sufficient to provide
        reasonable assurance of the safety and effectiveness of the
        device.
          (ii) A device for which insufficient information exists to
        determine that the controls referred to in clause (i) are
        sufficient to provide reasonable assurance of the safety and
        effectiveness of the device or to establish special controls to
        provide such assurance, but because it - 
            (I) is not purported or represented to be for a use in
          supporting or sustaining human life or for a use which is of
          substantial importance in preventing impairment of human
          health, and
            (II) does not present a potential unreasonable risk of
          illness or injury,

        is to be regulated by the controls referred to in clause (i).

        (B) Class II, Special Controls. - A device which cannot be
      classified as a class I device because the general controls by
      themselves are insufficient to provide reasonable assurance of
      the safety and effectiveness of the device, and for which there
      is sufficient information to establish special controls to
      provide such assurance, including the promulgation of performance
      standards, postmarket surveillance, patient registries,
      development and dissemination of guidelines (including guidelines
      for the submission of clinical data in premarket notification
      submissions in accordance with section 360(k) of this title),
      recommendations, and other appropriate actions as the Secretary
      deems necessary to provide such assurance. For a device that is
      purported or represented to be for a use in supporting or
      sustaining human life, the Secretary shall examine and identify
      the special controls, if any, that are necessary to provide
      adequate assurance of safety and effectiveness and describe how
      such controls provide such assurance.
        (C) Class III, Premarket Approval. - A device which because - 
          (i) it (I) cannot be classified as a class I device because
        insufficient information exists to determine that the
        application of general controls are sufficient to provide
        reasonable assurance of the safety and effectiveness of the
        device, and (II) cannot be classified as a class II device
        because insufficient information exists to determine that the
        special controls described in subparagraph (B) would provide
        reasonable assurance of its safety and effectiveness, and
          (ii)(I) is purported or represented to be for a use in
        supporting or sustaining human life or for a use which is of
        substantial importance in preventing impairment of human
        health, or
          (II) presents a potential unreasonable risk of illness or
        injury,

      is to be subject, in accordance with section 360e of this title,
      to premarket approval to provide reasonable assurance of its
      safety and effectiveness.

    If there is not sufficient information to establish a performance
    standard for a device to provide reasonable assurance of its safety
    and effectiveness, the Secretary may conduct such activities as may
    be necessary to develop or obtain such information.
      (2) For purposes of this section and sections 360d and 360e of
    this title, the safety and effectiveness of a device are to be
    determined - 
        (A) with respect to the persons for whose use the device is
      represented or intended,
        (B) with respect to the conditions of use prescribed,
      recommended, or suggested in the labeling of the device, and
        (C) weighing any probable benefit to health from the use of the
      device against any probable risk of injury or illness from such
      use.

      (3)(A) Except as authorized by subparagraph (B), the
    effectiveness of a device is, for purposes of this section and
    sections 360d and 360e of this title, to be determined, in
    accordance with regulations promulgated by the Secretary, on the
    basis of well-controlled investigations, including 1 or more
    clinical investigations where appropriate, by experts qualified by
    training and experience to evaluate the effectiveness of the
    device, from which investigations it can fairly and responsibly be
    concluded by qualified experts that the device will have the effect
    it purports or is represented to have under the conditions of use
    prescribed, recommended, or suggested in the labeling of the
    device.
      (B) If the Secretary determines that there exists valid
    scientific evidence (other than evidence derived from
    investigations described in subparagraph (A)) - 
        (i) which is sufficient to determine the effectiveness of a
      device, and
        (ii) from which it can fairly and responsibly be concluded by
      qualified experts that the device will have the effect it
      purports or is represented to have under the conditions of use
      prescribed, recommended, or suggested in the labeling of the
      device,

    then, for purposes of this section and sections 360d and 360e of
    this title, the Secretary may authorize the effectiveness of the
    device to be determined on the basis of such evidence.
      (C) In making a determination of a reasonable assurance of the
    effectiveness of a device for which an application under section
    360e of this title has been submitted, the Secretary shall consider
    whether the extent of data that otherwise would be required for
    approval of the application with respect to effectiveness can be
    reduced through reliance on postmarket controls.
      (D)(i) The Secretary, upon the written request of any person
    intending to submit an application under section 360e of this
    title, shall meet with such person to determine the type of valid
    scientific evidence (within the meaning of subparagraphs (A) and
    (B)) that will be necessary to demonstrate for purposes of approval
    of an application the effectiveness of a device for the conditions
    of use proposed by such person. The written request shall include a
    detailed description of the device, a detailed description of the
    proposed conditions of use of the device, a proposed plan for
    determining whether there is a reasonable assurance of
    effectiveness, and, if available, information regarding the
    expected performance from the device. Within 30 days after such
    meeting, the Secretary shall specify in writing the type of valid
    scientific evidence that will provide a reasonable assurance that a
    device is effective under the conditions of use proposed by such
    person.
      (ii) Any clinical data, including one or more well-controlled
    investigations, specified in writing by the Secretary for
    demonstrating a reasonable assurance of device effectiveness shall
    be specified as result of a determination by the Secretary that
    such data are necessary to establish device effectiveness. The
    Secretary shall consider, in consultation with the applicant, the
    least burdensome appropriate means of evaluating device
    effectiveness that would have a reasonable likelihood of resulting
    in approval.
      (iii) The determination of the Secretary with respect to the
    specification of valid scientific evidence under clauses (i) and
    (ii) shall be binding upon the Secretary, unless such determination
    by the Secretary could be contrary to the public health.
    (b) Classification panels
      (1) For purposes of - 
        (A) determining which devices intended for human use should be
      subject to the requirements of general controls, performance
      standards, or premarket approval, and
        (B) providing notice to the manufacturers and importers of such
      devices to enable them to prepare for the application of such
      requirements to devices manufactured or imported by them,

    the Secretary shall classify all such devices (other than devices
    classified by subsection (f) of this section) into the classes
    established by subsection (a) of this section. For the purpose of
    securing recommendations with respect to the classification of
    devices, the Secretary shall establish panels of experts or use
    panels of experts established before May 28, 1976, or both. Section
    14 of the Federal Advisory Committee Act shall not apply to the
    duration of a panel established under this paragraph.
      (2) The Secretary shall appoint to each panel established under
    paragraph (1) persons who are qualified by training and experience
    to evaluate the safety and effectiveness of the devices to be
    referred to the panel and who, to the extent feasible, possess
    skill in the use of, or experience in the development, manufacture,
    or utilization of, such devices. The Secretary shall make
    appointments to each panel so that each panel shall consist of
    members with adequately diversified expertise in such fields as
    clinical and administrative medicine, engineering, biological and
    physical sciences, and other related professions. In addition, each
    panel shall include as nonvoting members a representative of
    consumer interests and a representative of interests of the device
    manufacturing industry. Scientific, trade, and consumer
    organizations shall be afforded an opportunity to nominate
    individuals for appointment to the panels. No individual who is in
    the regular full-time employ of the United States and engaged in
    the administration of this chapter may be a member of any panel.
    The Secretary shall designate one of the members of each panel to
    serve as chairman thereof.
      (3) Panel members (other than officers or employees of the United
    States), while attending meetings or conferences of a panel or
    otherwise engaged in its business, shall be entitled to receive
    compensation at rates to be fixed by the Secretary, but not at
    rates exceeding the daily equivalent of the rate in effect for
    grade GS-18 of the General Schedule, for each day so engaged,
    including traveltime; and while so serving away from their homes or
    regular places of business each member may be allowed travel
    expenses (including per diem in lieu of subsistence) as authorized
    by section 5703 of title 5, for persons in the Government service
    employed intermittently.
      (4) The Secretary shall furnish each panel with adequate clerical
    and other necessary assistance.
      (5) Classification panels covering each type of device shall be
    scheduled to meet at such times as may be appropriate for the
    Secretary to meet applicable statutory deadlines.
      (6)(A) Any person whose device is specifically the subject of
    review by a classification panel shall have - 
        (i) the same access to data and information submitted to a
      classification panel (except for data and information that are
      not available for public disclosure under section 552 of title 5)
      as the Secretary;
        (ii) the opportunity to submit, for review by a classification
      panel, information that is based on the data or information
      provided in the application submitted under section 360e of this
      title by the person, which information shall be submitted to the
      Secretary for prompt transmittal to the classification panel; and
        (iii) the same opportunity as the Secretary to participate in
      meetings of the panel.

      (B) Any meetings of a classification panel shall provide adequate
    time for initial presentations and for response to any differing
    views by persons whose devices are specifically the subject of a
    classification panel review, and shall encourage free and open
    participation by all interested persons.
      (7) After receiving from a classification panel the conclusions
    and recommendations of the panel on a matter that the panel has
    reviewed, the Secretary shall review the conclusions and
    recommendations, shall make a final decision on the matter in
    accordance with section 360e(d)(2) of this title, and shall notify
    the affected persons of the decision in writing and, if the
    decision differs from the conclusions and recommendations of the
    panel, shall include the reasons for the difference.
      (8) A classification panel under this subsection shall not be
    subject to the annual chartering and annual report requirements of
    the Federal Advisory Committee Act.
    (c) Classification panel organization and operation
      (1) The Secretary shall organize the panels according to the
    various fields of clinical medicine and fundamental sciences in
    which devices intended for human use are used. The Secretary shall
    refer a device to be classified under this section to an
    appropriate panel established or authorized to be used under
    subsection (b) of this section for its review and for its
    recommendation respecting the classification of the device. The
    Secretary shall by regulation prescribe the procedure to be
    followed by the panels in making their reviews and recommendations.
    In making their reviews of devices, the panels, to the maximum
    extent practicable, shall provide an opportunity for interested
    persons to submit data and views on the classification of the
    devices.
      (2)(A) Upon completion of a panel's review of a device referred
    to it under paragraph (1), the panel shall, subject to
    subparagraphs (B) and (C), submit to the Secretary its
    recommendation for the classification of the device. Any such
    recommendation shall (i) contain (I) a summary of the reasons for
    the recommendation, (II) a summary of the data upon which the
    recommendation is based, and (III) an identification of the risks
    to health (if any) presented by the device with respect to which
    the recommendation is made, and (ii) to the extent practicable,
    include a recommendation for the assignment of a priority for the
    application of the requirements of section 360d or 360e of this
    title to a device recommended to be classified in class II or class
    III.
      (B) A recommendation of a panel for the classification of a
    device in class I shall include a recommendation as to whether the
    device should be exempted from the requirements of section 360,
    360i, or 360j(f) of this title.
      (C) In the case of a device which has been referred under
    paragraph (1) to a panel, and which - 
        (i) is intended to be implanted in the human body or is
      purported or represented to be for a use in supporting or
      sustaining human life, and
        (ii)(I) has been introduced or delivered for introduction into
      interstate commerce for commercial distribution before May 28,
      1976, or
        (II) is within a type of device which was so introduced or
      delivered before such date and is substantially equivalent to
      another device within that type,

    such panel shall recommend to the Secretary that the device be
    classified in class III unless the panel determines that
    classification of the device in such class is not necessary to
    provide reasonable assurance of its safety and effectiveness. If a
    panel does not recommend that such a device be classified in class
    III, it shall in its recommendation to the Secretary for the
    classification of the device set forth the reasons for not
    recommending classification of the device in such class.
      (3) The panels shall submit to the Secretary within one year of
    the date funds are first appropriated for the implementation of
    this section their recommendations respecting all devices of a type
    introduced or delivered for introduction into interstate commerce
    for commercial distribution before May 28, 1976.
    (d) Panel recommendation; publication; priorities
      (1) Upon receipt of a recommendation from a panel respecting a
    device, the Secretary shall publish in the Federal Register the
    panel's recommendation and a proposed regulation classifying such
    device and shall provide interested persons an opportunity to
    submit comments on such recommendation and the proposed regulation.
    After reviewing such comments, the Secretary shall, subject to
    paragraph (2), by regulation classify such device.
      (2)(A) A regulation under paragraph (1) classifying a device in
    class I shall prescribe which, if any, of the requirements of
    section 360, 360i, or 360j(f) of this title shall not apply to the
    device. A regulation which makes a requirement of section 360,
    360i, or 360j(f) of this title inapplicable to a device shall be
    accompanied by a statement of the reasons of the Secretary for
    making such requirement inapplicable.
      (B) A device described in subsection (c)(2)(C) of this section
    shall be classified in class III unless the Secretary determines
    that classification of the device in such class is not necessary to
    provide reasonable assurance of its safety and effectiveness. A
    proposed regulation under paragraph (1) classifying such a device
    in a class other than class III shall be accompanied by a full
    statement of the reasons of the Secretary (and supporting
    documentation and data) for not classifying such device in such
    class and an identification of the risks to health (if any)
    presented by such device.
      (3) In the case of devices classified in class II and devices
    classified under this subsection in class III and described in
    section 360e(b)(1) of this title the Secretary may establish
    priorities which, in his discretion, shall be used in applying
    sections 360d and 360e of this title, as appropriate, to such
    devices.
    (e) Classification changes
      (1) Based on new information respecting a device, the Secretary
    may, upon his own initiative or upon petition of an interested
    person, by regulation (A) change such device's classification, and
    (B) revoke, because of the change in classification, any regulation
    or requirement in effect under section 360d or 360e of this title
    with respect to such device. In the promulgation of such a
    regulation respecting a device's classification, the Secretary may
    secure from the panel to which the device was last referred
    pursuant to subsection (c) of this section a recommendation
    respecting the proposed change in the device's classification and
    shall publish in the Federal Register any recommendation submitted
    to the Secretary by the panel respecting such change. A regulation
    under this subsection changing the classification of a device from
    class III to class II may provide that such classification shall
    not take effect until the effective date of a performance standard
    established under section 360d of this title for such device.
      (2) By regulation promulgated under paragraph (1), the Secretary
    may change the classification of a device from class III - 
        (A) to class II if the Secretary determines that special
      controls would provide reasonable assurance of the safety and
      effectiveness of the device and that general controls would not
      provide reasonable assurance of the safety and effectiveness of
      the device, or
        (B) to class I if the Secretary determines that general
      controls would provide reasonable assurance of the safety and
      effectiveness of the device.
    (f) Initial classification and reclassification of certain devices
      (1) Any device intended for human use which was not introduced or
    delivered for introduction into interstate commerce for commercial
    distribution before May 28, 1976, is classified in class III unless
    - 
        (A) the device - 
          (i) is within a type of device (I) which was introduced or
        delivered for introduction into interstate commerce for
        commercial distribution before such date and which is to be
        classified pursuant to subsection (b) of this section, or (II)
        which was not so introduced or delivered before such date and
        has been classified in class I or II, and
          (ii) is substantially equivalent to another device within
        such type, or

        (B) the Secretary in response to a petition submitted under
      paragraph (3) has classified such device in class I or II.

    A device classified in class III under this paragraph shall be
    classified in that class until the effective date of an order of
    the Secretary under paragraph (2) or (3) classifying the device in
    class I or II.
      (2)(A) Any person who submits a report under section 360(k) of
    this title for a type of device that has not been previously
    classified under this chapter, and that is classified into class
    III under paragraph (1), may request, within 30 days after
    receiving written notice of such a classification, the Secretary to
    classify the device under the criteria set forth in subparagraphs
    (A) through (C) of subsection (a)(1) of this section. The person
    may, in the request, recommend to the Secretary a classification
    for the device. Any such request shall describe the device and
    provide detailed information and reasons for the recommended
    classification.
      (B)(i) Not later than 60 days after the date of the submission of
    the request under subparagraph (A), the Secretary shall by written
    order classify the device involved. Such classification shall be
    the initial classification of the device for purposes of paragraph
    (1) and any device classified under this paragraph shall be a
    predicate device for determining substantial equivalence under
    paragraph (1).
      (ii) A device that remains in class III under this subparagraph
    shall be deemed to be adulterated within the meaning of section
    351(f)(1)(B) of this title until approved under section 360e of
    this title or exempted from such approval under section 360j(g) of
    this title.
      (C) Within 30 days after the issuance of an order classifying a
    device under this paragraph, the Secretary shall publish a notice
    in the Federal Register announcing such classification.
      (3)(A) The Secretary may initiate the reclassification of a
    device classified into class III under paragraph (1) of this
    subsection or the manufacturer or importer of a device classified
    under paragraph (1) may petition the Secretary (in such form and
    manner as he shall prescribe) for the issuance of an order
    classifying the device in class I or class II. Within thirty days
    of the filing of such a petition, the Secretary shall notify the
    petitioner of any deficiencies in the petition which prevent the
    Secretary from making a decision on the petition.
      (B)(i) Upon determining that a petition does not contain any
    deficiency which prevents the Secretary from making a decision on
    the petition, the Secretary may for good cause shown refer the
    petition to an appropriate panel established or authorized to be
    used under subsection (b) of this section. A panel to which such a
    petition has been referred shall not later than ninety days after
    the referral of the petition make a recommendation to the Secretary
    respecting approval or denial of the petition. Any such
    recommendation shall contain (I) a summary of the reasons for the
    recommendation, (II) a summary of the data upon which the
    recommendation is based, and (III) an identification of the risks
    to health (if any) presented by the device with respect to which
    the petition was filed. In the case of a petition for a device
    which is intended to be implanted in the human body or which is
    purported or represented to be for a use in supporting or
    sustaining human life, the panel shall recommend that the petition
    be denied unless the panel determines that the classification in
    class III of the device is not necessary to provide reasonable
    assurance of its safety and effectiveness. If the panel recommends
    that such petition be approved, it shall in its recommendation to
    the Secretary set forth its reasons for such recommendation.
      (ii) The requirements of paragraphs (1) and (2) of subsection (c)
    of this section (relating to opportunities for submission of data
    and views and recommendations respecting priorities and exemptions
    from sections 360, 360i, and 360j(f) of this title) shall apply
    with respect to consideration by panels of petitions submitted
    under subparagraph (A).
      (C)(i) Within ninety days from the date the Secretary receives
    the recommendation of a panel respecting a petition (but not later
    than 210 days after the filing of such petition) the Secretary
    shall by order deny or approve the petition. If the Secretary
    approves the petition, the Secretary shall order the classification
    of the device into class I or class II in accordance with the
    criteria prescribed by subsection (a)(1)(A) or (a)(1)(B) of this
    section. In the case of a petition for a device which is intended
    to be implanted in the human body or which is purported or
    represented to be for a use in supporting or sustaining human life,
    the Secretary shall deny the petition unless the Secretary
    determines that the classification in class III of the device is
    not necessary to provide reasonable assurance of its safety and
    effectiveness. An order approving such petition shall be
    accompanied by a full statement of the reasons of the Secretary
    (and supporting documentation and data) for approving the petition
    and an identification of the risks to health (if any) presented by
    the device to which such order applies.
      (ii) The requirements of paragraphs (1) and (2)(A) of subsection
    (d) of this section (relating to publication of recommendations,
    opportunity for submission of comments, and exemption from sections
    360, 360i, and 360j(f) of this title) shall apply with respect to
    action by the Secretary on petitions submitted under subparagraph
    (A).
      (4) If a manufacturer reports to the Secretary under section
    360(k) of this title that a device is substantially equivalent to
    another device - 
        (A) which the Secretary has classified as a class III device
      under subsection (b) of this section,
        (B) which was introduced or delivered for introduction into
      interstate commerce for commercial distribution before December
      1, 1990, and
        (C) for which no final regulation requiring premarket approval
      has been promulgated under section 360e(b) of this title,

    the manufacturer shall certify to the Secretary that the
    manufacturer has conducted a reasonable search of all information
    known or otherwise available to the manufacturer respecting such
    other device and has included in the report under section 360(k) of
    this title a summary of and a citation to all adverse safety and
    effectiveness data respecting such other device and respecting the
    device for which the section 360(k) report is being made and which
    has not been submitted to the Secretary under section 360i of this
    title. The Secretary may require the manufacturer to submit the
    adverse safety and effectiveness data described in the report.
      (5) The Secretary may not withhold a determination of the initial
    classification of a device under paragraph (1) because of a failure
    to comply with any provision of this chapter unrelated to a
    substantial equivalence decision, including a finding that the
    facility in which the device is manufactured is not in compliance
    with good manufacturing requirements as set forth in regulations of
    the Secretary under section 360j(f) of this title (other than a
    finding that there is a substantial likelihood that the failure to
    comply with such regulations will potentially present a serious
    risk to human health).
    (g) Information
      Within sixty days of the receipt of a written request of any
    person for information respecting the class in which a device has
    been classified or the requirements applicable to a device under
    this chapter, the Secretary shall provide such person a written
    statement of the classification (if any) of such device and the
    requirements of this chapter applicable to the device.
    (h) Definitions
      For purposes of this section and sections 351, 360, 360d, 360e,
    360f, 360i, and 360j of this title
        (1) a reference to "general controls" is a reference to the
      controls authorized by or under sections 351, 352, 360, 360f,
      360h, 360i, and 360j of this title,
        (2) a reference to "class I", "class II", or "class III" is a
      reference to a class of medical devices described in subparagraph
      (A), (B), or (C) of subsection (a)(1) of this section, and
        (3) a reference to a "panel under section 360c of this title"
      is a reference to a panel established or authorized to be used
      under this section.
    (i) Substantial equivalence
      (1)(A) For purposes of determinations of substantial equivalence
    under subsection (f) of this section and section 360j(l) of this
    title, the term "substantially equivalent" or "substantial
    equivalence" means, with respect to a device being compared to a
    predicate device, that the device has the same intended use as the
    predicate device and that the Secretary by order has found that the
    device - 
        (i) has the same technological characteristics as the predicate
      device, or
        (ii)(I) has different technological characteristics and the
      information submitted that the device is substantially equivalent
      to the predicate device contains information, including
      appropriate clinical or scientific data if deemed necessary by
      the Secretary or a person accredited under section 360m of this
      title, that demonstrates that the device is as safe and effective
      as a legally marketed device, and (II) does not raise different
      questions of safety and effectiveness than the predicate device.

      (B) For purposes of subparagraph (A), the term "different
    technological characteristics" means, with respect to a device
    being compared to a predicate device, that there is a significant
    change in the materials, design, energy source, or other features
    of the device from those of the predicate device.
      (C) To facilitate reviews of reports submitted to the Secretary
    under section 360(k) of this title, the Secretary shall consider
    the extent to which reliance on postmarket controls may expedite
    the classification of devices under subsection (f)(1) of this
    section.
      (D) Whenever the Secretary requests information to demonstrate
    that devices with differing technological characteristics are
    substantially equivalent, the Secretary shall only request
    information that is necessary to making substantial equivalence
    determinations. In making such request, the Secretary shall
    consider the least burdensome means of demonstrating substantial
    equivalence and request information accordingly.
      (E)(i) Any determination by the Secretary of the intended use of
    a device shall be based upon the proposed labeling submitted in a
    report for the device under section 360(k) of this title. However,
    when determining that a device can be found substantially
    equivalent to a legally marketed device, the director of the
    organizational unit responsible for regulating devices (in this
    subparagraph referred to as the "Director") may require a statement
    in labeling that provides appropriate information regarding a use
    of the device not identified in the proposed labeling if, after
    providing an opportunity for consultation with the person who
    submitted such report, the Director determines and states in
    writing - 
        (I) that there is a reasonable likelihood that the device will
      be used for an intended use not identified in the proposed
      labeling for the device; and
        (II) that such use could cause harm.

      (ii) Such determination shall - 
        (I) be provided to the person who submitted the report within
      10 days from the date of the notification of the Director's
      concerns regarding the proposed labeling;
        (II) specify the limitations on the use of the device not
      included in the proposed labeling; and
        (III) find the device substantially equivalent if the
      requirements of subparagraph (A) are met and if the labeling for
      such device conforms to the limitations specified in subclause
      (II).

      (iii) The responsibilities of the Director under this
    subparagraph may not be delegated.
      (F) Not later than 270 days after November 21, 1997, the
    Secretary shall issue guidance specifying the general principles
    that the Secretary will consider in determining when a specific
    intended use of a device is not reasonably included within a
    general use of such device for purposes of a determination of
    substantial equivalence under subsection (f) of this section or
    section 360j(l) of this title.
      (2) A device may not be found to be substantially equivalent to a
    predicate device that has been removed from the market at the
    initiative of the Secretary or that has been determined to be
    misbranded or adulterated by a judicial order.
      (3)(A) As part of a submission under section 360(k) of this title
    respecting a device, the person required to file a premarket
    notification under such section shall provide an adequate summary
    of any information respecting safety and effectiveness or state
    that such information will be made available upon request by any
    person.
      (B) Any summary under subparagraph (A) respecting a device shall
    contain detailed information regarding data concerning adverse
    health effects and shall be made available to the public by the
    Secretary within 30 days of the issuance of a determination that
    such device is substantially equivalent to another device.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 513, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 540; amended Pub. L. 101-629, Secs. 4(a),
    5(a)-(c)(1), (3), 12(a), 18(a), Nov. 28, 1990, 104 Stat. 4515,
    4517, 4518, 4523, 4528; Pub. L. 102-300, Sec. 6(e), June 16, 1992,
    106 Stat. 240; Pub. L. 103-80, Sec. 3(s), Aug. 13, 1993, 107 Stat.
    778; Pub. L. 105-115, title II, Secs. 205(a), (b), 206(b), (c),
    207, 208, 217, Nov. 21, 1997, 111 Stat. 2336, 2337, 2339, 2340,
    2350; Pub. L. 107-250, title II, Sec. 208, Oct. 26, 2002, 116 Stat.
    1613.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Advisory Committee Act, referred to in subsec.
    (b)(1), (8), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as
    amended, which is set out in the Appendix to Title 5, Government
    Organization and Employees.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (i)(1)(E)(iv). Pub. L. 107-250 struck out cl. (iv)
    which read as follows: "This subparagraph has no legal effect after
    the expiration of the five-year period beginning on November 21,
    1997."
      1997 - Subsec. (a)(3)(A). Pub. L. 105-115, Sec. 217, substituted
    "1 or more clinical investigations" for "clinical investigations".
      Subsec. (a)(3)(C), (D). Pub. L. 105-115, Sec. 205(a), added
    subpars. (C) and (D).
      Subsec. (b)(5) to (8). Pub. L. 105-115, Sec. 208, added pars. (5)
    to (8).
      Subsec. (f)(1). Pub. L. 105-115, Sec. 207(1)(B), substituted
    "paragraph (2) or (3)" for "paragraph (2)" in closing provisions.
      Subsec. (f)(1)(B). Pub. L. 105-115, Sec. 207(1)(A), substituted
    "paragraph (3)" for "paragraph (2)".
      Subsec. (f)(2) to (4). Pub. L. 105-115, Sec. 207(2), (3), added
    par. (2) and redesignated former pars. (2) and (3) as (3) and (4),
    respectively.
      Subsec. (f)(5). Pub. L. 105-115, Sec. 206(b), added par. (5).
      Subsec. (i)(1)(A)(ii). Pub. L. 105-115, Sec. 206(c)(1),
    substituted "appropriate clinical or scientific data" for "clinical
    data", inserted "or a person accredited under section 360m of this
    title" after "Secretary", and substituted "effectiveness" for
    "efficacy".
      Subsec. (i)(1)(C) to (E). Pub. L. 105-115, Sec. 205(b), added
    subpars. (C) to (E).
      Subsec. (i)(1)(F). Pub. L. 105-115, Sec. 206(c)(2), added subpar.
    (F).
      1993 - Subsec. (b)(3). Pub. L. 103-80 substituted "5703" for
    "5703(b)".
      1992 - Subsec. (f)(3). Pub. L. 102-300 redesignated clauses (i)
    to (iii) as subpars. (A) to (C), respectively, and substituted "the
    section 360(k) report" for "the 360(k) report" in closing
    provisions.
      1990 - Subsec. (a)(1)(A)(ii). Pub. L. 101-629, Sec. 5(a)(1),
    substituted "or to establish special controls" for "or to establish
    a performance standard".
      Subsec. (a)(1)(B). Pub. L. 101-629, Sec. 5(a)(2), amended subpar.
    (B) generally. Prior to amendment, subpar. (B) read as follows:
    "Class II, Performance Standards. - A device which cannot be
    classified as a class I device because the controls authorized by
    or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this
    title by themselves are insufficient to provide reasonable
    assurance of the safety and effectiveness of the device, for which
    there is sufficient information to establish a performance standard
    to provide such assurance, and for which it is therefore necessary
    to establish for the device a performance standard under section
    360d of this title to provide reasonable assurance of its safety
    and effectiveness."
      Subsec. (a)(1)(C)(i). Pub. L. 101-629, Sec. 5(a)(3), amended cl.
    (i) generally. Prior to amendment, cl. (i) read as follows: "it (I)
    cannot be classified as a class I device because insufficient
    information exists to determine that the controls authorized by or
    under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this
    title are sufficient to provide reasonable assurance of the safety
    and effectiveness of the device and (II) cannot be classified as a
    class II device because insufficient information exists for the
    establishment of a performance standard to provide reasonable
    assurance of its safety and effectiveness, and".
      Subsec. (e). Pub. L. 101-629, Sec. 5(b), designated existing
    provisions as par. (1), redesignated cls. (1) and (2) as (A) and
    (B), respectively, and added par. (2).
      Subsec. (f). Pub. L. 101-629, Sec. 5(c)(3), inserted "and
    reclassification" before "of" in heading.
      Subsec. (f)(2)(A). Pub. L. 101-629, Sec. 5(c)(1), substituted
    "The Secretary may initiate the reclassification of a device
    classified into class III under paragraph (1) of this subsection or
    the manufacturer" for "The manufacturer".
      Subsec. (f)(2)(B)(i). Pub. L. 101-629, Sec. 18(a), substituted
    "the Secretary may for good cause shown" for "the Secretary shall".
      Subsec. (f)(3). Pub. L. 101-629, Sec. 4(a), added par. (3).
      Subsec. (i). Pub. L. 101-629, Sec. 12(a), added subsec. (i).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                       SHORT TITLE OF 1976 AMENDMENT                   
      Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided
    that: "This Act [enacting sections 360c to 360k, 379, and 379a of
    this title and section 3512 of Title 42, The Public Health and
    Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360,
    374, 379e, and 381 of this title and section 55 of Title 15,
    Commerce and Trade] may be cited as the 'Medical Device Amendments
    of 1976'."

                                REGULATIONS                            
      Section 12(b) of Pub. L. 101-629 provided that: "Within 12 months
    of the date of the enactment of this Act [Nov. 28, 1990], the
    Secretary of Health and Human Services shall issue regulations
    establishing the requirements of the summaries under section
    513(i)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    360c(i)(3)], as added by the amendment made by subsection (a)."

    DAILY WEAR SOFT OR DAILY WEAR NONHYDROPHILIC PLASTIC CONTACT LENSES
      Section 4(b)(3) of Pub. L. 101-629 provided that:
      "(A) Notwithstanding section 520(l)(5) of the Federal Food, Drug,
    and Cosmetic Act [21 U.S.C. 360j(l)(5)], the Secretary of Health
    and Human Services shall not retain any daily wear soft or daily
    wear nonhydrophilic plastic contact lens in class III under such
    Act [this chapter] unless the Secretary finds that it meets the
    criteria set forth in section 513(a)(1)(C) of such Act [21 U.S.C.
    360c(a)(1)(C)]. The finding and the grounds for the finding shall
    be published in the Federal Register. For any such lens, the
    Secretary shall make the determination respecting reclassification
    required in section 520(l)(5)(B) of such Act within 24 months of
    the date of the enactment of this paragraph [Nov. 28, 1990].
      "(B) The Secretary of Health and Human Services may by notice
    published in the Federal Register extend the two-year period
    prescribed by subparagraph (A) for a lens for an additional period
    not to exceed one year.
      "(C)(i) Before classifying a lens in class II pursuant to
    subparagraph (A), the Secretary of Health and Human Services shall
    pursuant to section 513(a)(1)(B) of such Act assure that
    appropriate regulatory safeguards are in effect which provide
    reasonable assurance of the safety and effectiveness of such lens,
    including clinical and preclinical data if deemed necessary by the
    Secretary.
      "(ii) Prior to classifying a lens in class I pursuant to
    subparagraph (A), the Secretary shall assure that appropriate
    regulatory safeguards are in effect which provide reasonable
    assurance of the safety and effectiveness of such lens, including
    clinical and preclinical data if deemed necessary by the Secretary.
      "(D) Notwithstanding section 520(l)(5) of such Act, if the
    Secretary of Health and Human Services has not made the finding and
    published the finding required by subparagraph (A) within 36 months
    of the date of the enactment of this subparagraph [Nov. 28, 1990],
    the Secretary shall issue an order placing the lens in class II.
      "(E) Any person adversely affected by a final regulation under
    this paragraph revising the classification of a lens may challenge
    the revision of the classification of such lens only by filing a
    petition under section 513(e) for a classification change."

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-



-CITE-
    21 USC Sec. 360d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360d. Performance standards

-STATUTE-
    (a) Reasonable assurance of safe and effective performance;
      periodic evaluation
      (1) The special controls required by section 360c(a)(1)(B) of
    this title shall include performance standards for a class II
    device if the Secretary determines that a performance standard is
    necessary to provide reasonable assurance of the safety and
    effectiveness of the device. A class III device may also be
    considered a class II device for purposes of establishing a
    standard for the device under subsection (b) of this section if the
    device has been reclassified as a class II device under a
    regulation under section 360c(e) of this title but such regulation
    provides that the reclassification is not to take effect until the
    effective date of such a standard for the device.
      (2) A performance standard established under subsection (b) of
    this section for a device - 
        (A) shall include provisions to provide reasonable assurance of
      its safe and effective performance;
        (B) shall, where necessary to provide reasonable assurance of
      its safe and effective performance, include - 
          (i) provisions respecting the construction, components,
        ingredients, and properties of the device and its compatibility
        with power systems and connections to such systems,
          (ii) provisions for the testing (on a sample basis or, if
        necessary, on an individual basis) of the device or, if it is
        determined that no other more practicable means are available
        to the Secretary to assure the conformity of the device to the
        standard, provisions for the testing (on a sample basis or, if
        necessary, on an individual basis) by the Secretary or by
        another person at the direction of the Secretary,
          (iii) provisions for the measurement of the performance
        characteristics of the device,
          (iv) provisions requiring that the results of each or of
        certain of the tests of the device required to be made under
        clause (ii) show that the device is in conformity with the
        portions of the standard for which the test or tests were
        required, and
          (v) a provision requiring that the sale and distribution of
        the device be restricted but only to the extent that the sale
        and distribution of a device may be restricted under a
        regulation under section 360j(e) of this title; and

        (C) shall, where appropriate, require the use and prescribe the
      form and content of labeling for the proper installation,
      maintenance, operation, and use of the device.

      (3) The Secretary shall provide for periodic evaluation of
    performance standards established under subsection (b) of this
    section to determine if such standards should be changed to reflect
    new medical, scientific, or other technological data.
      (4) In carrying out his duties under this subsection and
    subsection (b) of this section, the Secretary shall, to the maximum
    extent practicable - 
        (A) use personnel, facilities, and other technical support
      available in other Federal agencies,
        (B) consult with other Federal agencies concerned with standard-
      setting and other nationally or internationally recognized
      standard-setting entities, and
        (C) invite appropriate participation, through joint or other
      conferences, workshops, or other means, by informed persons
      representative of scientific, professional, industry, or consumer
      organizations who in his judgment can make a significant
      contribution.
    (b) Establishment of a standard
      (1)(A) The Secretary shall publish in the Federal Register a
    notice of proposed rulemaking for the establishment, amendment, or
    revocation of any performance standard for a device.
      (B) A notice of proposed rulemaking for the establishment or
    amendment of a performance standard for a device shall - 
        (i) set forth a finding with supporting justification that the
      performance standard is appropriate and necessary to provide
      reasonable assurance of the safety and effectiveness of the
      device,
        (ii) set forth proposed findings with respect to the risk of
      illness or injury that the performance standard is intended to
      reduce or eliminate,
        (iii) invite interested persons to submit to the Secretary,
      within 30 days of the publication of the notice, requests for
      changes in the classification of the device pursuant to section
      360c(e) of this title based on new information relevant to the
      classification, and
        (iv) invite interested persons to submit an existing
      performance standard for the device, including a draft or
      proposed performance standard, for consideration by the
      Secretary.

      (C) A notice of proposed rulemaking for the revocation of a
    performance standard shall set forth a finding with supporting
    justification that the performance standard is no longer necessary
    to provide reasonable assurance of the safety and effectiveness of
    a device.
      (D) The Secretary shall provide for a comment period of not less
    than 60 days.
      (2) If, after publication of a notice in accordance with
    paragraph (1), the Secretary receives a request for a change in the
    classification of the device, the Secretary shall, within 60 days
    of the publication of the notice, after consultation with the
    appropriate panel under section 360c of this title, either deny the
    request or give notice of an intent to initiate such change under
    section 360c(e) of this title.
      (3)(A) After the expiration of the period for comment on a notice
    of proposed rulemaking published under paragraph (1) respecting a
    performance standard and after consideration of such comments and
    any report from an advisory committee under paragraph (5), the
    Secretary shall (i) promulgate a regulation establishing a
    performance standard and publish in the Federal Register findings
    on the matters referred to in paragraph (1), or (ii) publish a
    notice terminating the proceeding for the development of the
    standard together with the reasons for such termination. If a
    notice of termination is published, the Secretary shall (unless
    such notice is issued because the device is a banned device under
    section 360f of this title) initiate a proceeding under section
    360c(e) of this title to reclassify the device subject to the
    proceeding terminated by such notice.
      (B) A regulation establishing a performance standard shall set
    forth the date or dates upon which the standard shall take effect,
    but no such regulation may take effect before one year after the
    date of its publication unless (i) the Secretary determines that an
    earlier effective date is necessary for the protection of the
    public health and safety, or (ii) such standard has been
    established for a device which, effective upon the effective date
    of the standard, has been reclassified from class III to class II.
    Such date or dates shall be established so as to minimize,
    consistent with the public health and safety, economic loss to, and
    disruption or dislocation of, domestic and international trade.
      (4)(A) The Secretary, upon his own initiative or upon petition of
    an interested person may by regulation, promulgated in accordance
    with the requirements of paragraphs (1), (2), and (3)(B) of this
    subsection, amend or revoke a performance standard.
      (B) The Secretary may declare a proposed amendment of a
    performance standard to be effective on and after its publication
    in the Federal Register and until the effective date of any final
    action taken on such amendment if he determines that making it so
    effective is in the public interest. A proposed amendment of a
    performance standard made so effective under the preceding sentence
    may not prohibit, during the period in which it is so effective,
    the introduction or delivery for introduction into interstate
    commerce of a device which conforms to such standard without the
    change or changes provided by such proposed amendment.
      (5)(A) The Secretary - 
        (i) may on his own initiative refer a proposed regulation for
      the establishment, amendment, or revocation of a performance
      standard, or
        (ii) shall, upon the request of an interested person which
      demonstrates good cause for referral and which is made before the
      expiration of the period for submission of comments on such
      proposed regulation refer such proposed regulation,

    to an advisory committee of experts, established pursuant to
    subparagraph (B), for a report and recommendation with respect to
    any matter involved in the proposed regulation which requires the
    exercise of scientific judgment. If a proposed regulation is
    referred under this subparagraph to an advisory committee, the
    Secretary shall provide the advisory committee with the data and
    information on which such proposed regulation is based. The
    advisory committee shall, within sixty days of the referral of a
    proposed regulation and after independent study of the data and
    information furnished to it by the Secretary and other data and
    information before it, submit to the Secretary a report and
    recommendation respecting such regulation, together with all
    underlying data and information and a statement of the reason or
    basis for the recommendation. A copy of such report and
    recommendation shall be made public by the Secretary.
      (B) The Secretary shall establish advisory committees (which may
    not be panels under section 360c of this title) to receive
    referrals under subparagraph (A). The Secretary shall appoint as
    members of any such advisory committee persons qualified in the
    subject matter to be referred to the committee and of appropriately
    diversified professional background, except that the Secretary may
    not appoint to such a committee any individual who is in the
    regular full-time employ of the United States and engaged in the
    administration of this chapter. Each such committee shall include
    as nonvoting members a representative of consumer interests and a
    representative of interests of the device manufacturing industry.
    Members of an advisory committee who are not officers or employees
    of the United States, while attending conferences or meetings of
    their committee or otherwise serving at the request of the
    Secretary, shall be entitled to receive compensation at rates to be
    fixed by the Secretary, which rates may not exceed the daily
    equivalent of the rate in effect for grade GS-18 of the General
    Schedule, for each day (including traveltime) they are so engaged;
    and while so serving away from their homes or regular places of
    business each member may be allowed travel expenses, including per
    diem in lieu of subsistence, as authorized by section 5703 of title
    5 for persons in the Government service employed intermittently.
    The Secretary shall designate one of the members of each advisory
    committee to serve as chairman thereof. The Secretary shall furnish
    each advisory committee with clerical and other assistance, and
    shall by regulation prescribe the procedures to be followed by each
    such committee in acting on referrals made under subparagraph (A).
    (c) Recognition of standard
      (1)(A) In addition to establishing a performance standard under
    this section, the Secretary shall, by publication in the Federal
    Register, recognize all or part of an appropriate standard
    established by a nationally or internationally recognized standard
    development organization for which a person may submit a
    declaration of conformity in order to meet a premarket submission
    requirement or other requirement under this chapter to which such
    standard is applicable.
      (B) If a person elects to use a standard recognized by the
    Secretary under subparagraph (A) to meet the requirements described
    in such subparagraph, the person shall provide a declaration of
    conformity to the Secretary that certifies that the device is in
    conformity with such standard. A person may elect to use data, or
    information, other than data required by a standard recognized
    under subparagraph (A) to meet any requirement regarding devices
    under this chapter.
      (2) The Secretary may withdraw such recognition of a standard
    through publication of a notice in the Federal Register if the
    Secretary determines that the standard is no longer appropriate for
    meeting a requirement regarding devices under this chapter.
      (3)(A) Subject to subparagraph (B), the Secretary shall accept a
    declaration of conformity that a device is in conformity with a
    standard recognized under paragraph (1) unless the Secretary finds -
     
        (i) that the data or information submitted to support such
      declaration does not demonstrate that the device is in conformity
      with the standard identified in the declaration of conformity; or
        (ii) that the standard identified in the declaration of
      conformity is not applicable to the particular device under
      review.

      (B) The Secretary may request, at any time, the data or
    information relied on by the person to make a declaration of
    conformity with respect to a standard recognized under paragraph
    (1).
      (C) A person making a declaration of conformity with respect to a
    standard recognized under paragraph (1) shall maintain the data and
    information demonstrating conformity of the device to the standard
    for a period of two years after the date of the classification or
    approval of the device by the Secretary or a period equal to the
    expected design life of the device, whichever is longer.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 514, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 546; amended Pub. L. 94-460, title III, Sec.
    304, Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101-629, Secs. 6(a),
    (b)(1), 18(b), Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102-
    300, Sec. 6(g), June 16, 1992, 106 Stat. 241; Pub. L. 103-80, Sec.
    4(a)(1), Aug. 13, 1993, 107 Stat. 779; Pub. L. 105-115, title II,
    Sec. 204(a), (d), Nov. 21, 1997, 111 Stat. 2335, 2336.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 204(d)(1),
    substituted "under subsection (b) of this section" for "under this
    section".
      Subsec. (a)(2). Pub. L. 105-115, Sec. 204(d)(2), substituted
    "under subsection (b) of this section" for "under this section" in
    introductory provisions.
      Subsec. (a)(3). Pub. L. 105-115, Sec. 204(d)(3), substituted
    "under subsection (b) of this section" for "under this section".
      Subsec. (a)(4). Pub. L. 105-115, Sec. 204(d)(4), substituted
    "this subsection and subsection (b) of this section" for "this
    section" in introductory provisions.
      Subsec. (c). Pub. L. 105-115, Sec. 204(a), added subsec. (c).
      1993 - Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 103-80 amended
    directory language of Pub. L. 101-619, Sec. 18(b), identical to
    amendment by Pub. L. 102-300, Sec. 6(g)(1). See 1992 and 1990
    Amendment notes below.
      1992 - Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 102-300 made
    technical corrections to directory language of Pub. L. 101-629,
    Sec. 18(b)(1), (2). See 1990 Amendment note below.
      1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 6(a)(1), substituted
    "The special controls required by section 360c(a)(1)(B) of this
    title shall include performance standards for a class II device if
    the Secretary determines that a performance standard is necessary
    to provide reasonable assurance of the safety and effectiveness of
    the device." for "The Secretary may by regulation, promulgated in
    accordance with this section, establish a performance standard for
    a class II device."
      Subsec. (b). Pub. L. 101-629, Sec. 6(a)(2), (3), redesignated
    subsec. (g) as (b) and struck out former subsec. (b) which read as
    follows:
      "(1) A proceeding for the development of a performance standard
    for a device shall be initiated by the Secretary by the publication
    in the Federal Register of notice of the opportunity to submit to
    the Secretary a request (within fifteen days of the date of the
    publication of the notice) for a change in the classification of
    the device based on new information relevant to its classification.
      "(2) If, after publication of a notice pursuant to paragraph (1)
    the Secretary receives a request for a change in the device's
    classification, he shall, within sixty days of the publication of
    such notice and after consultation with the appropriate panel under
    section 360c of this title, by order published in the Federal
    Register, either deny the request for change in classification or
    give notice of his intent to initiate such a change under section
    360c(e) of this title."
      Subsec. (b)(1), (2). Pub. L. 101-629, Sec. 6(a)(4), amended pars.
    (1) and (2) generally. Prior to amendment, pars. (1) and (2) read
    as follows:
      "(1)(A) After publication pursuant to subsection (c) of this
    section of a notice respecting a performance standard for a device,
    the Secretary shall either - 
        "(i) publish, in the Federal Register in a notice of proposed
      rulemaking, a proposed performance standard for the device (I)
      developed by an offeror under such notice and accepted by the
      Secretary, (II) developed under subsection (c)(4) of this
      section, (III) accepted by the Secretary under subsection (d) of
      this section, or (IV) developed by him under subsection (f) of
      this section, or
        "(ii) issue a notice in the Federal Register that the
      proceeding is terminated together with the reasons for such
      termination.
      "(B) If the Secretary issues under subparagraph (A)(ii) a notice
    of termination of a proceeding to establish a performance standard
    for a device, he shall (unless such notice is issued because the
    device is a banned device under section 360f of this title)
    initiate a proceeding under section 360c(e) of this title to
    reclassify the device subject to the proceeding terminated by such
    notice.
      "(2) A notice of proposed rulemaking for the establishment of a
    performance standard for a device published under paragraph
    (1)(A)(i) shall set forth proposed findings with respect to the
    degree of the risk of illness or injury designed to be eliminated
    or reduced by the proposed standard and the benefit to the public
    from the device."
      Subsec. (b)(3)(A)(i). Pub. L. 101-629, Sec. 6(b)(1)(A),
    substituted "paragraph (1)" for "paragraph (2)".
      Subsec. (b)(4)(A). Pub. L. 101-629, Sec. 6(b)(1)(B), substituted
    "paragraphs (1), (2), and (3)(B)" for "paragraphs (2) and (3)(B)".
      Subsec. (b)(4)(B). Pub. L. 101-629, Sec. 18(b)(1), as amended by
    Pub. L. 102-300, Sec. 6(g)(1), (2), and Pub. L. 103-80, Sec.
    4(a)(1), struck out ", after affording all interested persons an
    opportunity for an informal hearing," after "if he determines".
      Subsec. (b)(5)(A)(ii). Pub. L. 101-629, Sec. 18(b)(2), as amended
    by Pub. L. 102-300, Sec. 6(g)(1), (3), and Pub. L. 103-80, Sec.
    4(a)(1), substituted "which demonstrates good cause for referral
    and which is made before the expiration of the period for
    submission of comments on such proposed regulation refer such
    proposed regulation," for "unless the Secretary finds the request
    to be without good cause or the request is made after the
    expiration of the period for submission of comments on such
    proposed regulation refer such proposed regulation,".
      Subsecs. (c) to (f). Pub. L. 101-629, Sec. 6(a)(2), struck out
    subsec. (c) relating to invitations for standards, subsec. (d)
    relating to acceptance of certain existing standards, subsec. (e)
    relating to acceptance of offers to develop standards, and subsec.
    (f) relating to development of standards by the Secretary after
    publication of notice inviting submissions or offers of standards.
      Subsec. (g). Pub. L. 101-629, Sec. 6(a)(3), redesignated subsec.
    (g) as (b).
      1976 - Subsec. (a). Pub. L. 94-460 redesignated pars. (4) and (5)
    as (3) and (4), respectively. Section as originally enacted
    contained no par. (3).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

                    TERMINATION OF ADVISORY COMMITTEES                
      Advisory committees in existence on Jan. 5, 1973, to terminate
    not later than the expiration of the 2-year period following Jan.
    5, 1973, and advisory committees established after Jan. 5, 1973, to
    terminate not later than the expiration of the 2-year period
    beginning on the date of their establishment, unless in the case of
    a committee established by the President or an officer of the
    Federal Government, such committee is renewed by appropriate action
    prior to the expiration of such 2-year period, or in the case of a
    committee established by Congress, its duration is otherwise
    provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

-End-



-CITE-
    21 USC Sec. 360e                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360e. Premarket approval

-STATUTE-
    (a) General requirement
      A class III device - 
        (1) which is subject to a regulation promulgated under
      subsection (b) of this section; or
        (2) which is a class III device because of section 360c(f) of
      this title,

    is required to have, unless exempt under section 360j(g) of this
    title, an approval under this section of an application for
    premarket approval or, as applicable, an approval under subsection
    (c)(2) of this section of a report seeking premarket approval.
    (b) Regulation to require premarket approval
      (1) In the case of a class III device which - 
        (A) was introduced or delivered for introduction into
      interstate commerce for commercial distribution before May 28,
      1976; or
        (B) is (i) of a type so introduced or delivered, and (ii) is
      substantially equivalent to another device within that type,

    the Secretary shall by regulation, promulgated in accordance with
    this subsection, require that such device have an approval under
    this section of an application for premarket approval.
      (2)(A) A proceeding for the promulgation of a regulation under
    paragraph (1) respecting a device shall be initiated by the
    publication in the Federal Register of a notice of proposed
    rulemaking. Such notice shall contain - 
        (i) the proposed regulation;
        (ii) proposed findings with respect to the degree of risk of
      illness or injury designed to be eliminated or reduced by
      requiring the device to have an approved application for
      premarket approval and the benefit to the public from use of the
      device;
        (iii) opportunity for the submission of comments on the
      proposed regulation and the proposed findings; and
        (iv) opportunity to request a change in the classification of
      the device based on new information relevant to the
      classification of the device.

      (B) If, within fifteen days after publication of a notice under
    subparagraph (A), the Secretary receives a request for a change in
    the classification of a device, he shall, within sixty days of the
    publication of such notice and after consultation with the
    appropriate panel under section 360c of this title, by order
    published in the Federal Register, either deny the request for
    change in classification or give notice of his intent to initiate
    such a change under section 360c(e) of this title.
      (3) After the expiration of the period for comment on a proposed
    regulation and proposed findings published under paragraph (2) and
    after consideration of comments submitted on such proposed
    regulation and findings, the Secretary shall (A) promulgate such
    regulation and publish in the Federal Register findings on the
    matters referred to in paragraph (2)(A)(ii), or (B) publish a
    notice terminating the proceeding for the promulgation of the
    regulation together with the reasons for such termination. If a
    notice of termination is published, the Secretary shall (unless
    such notice is issued because the device is a banned device under
    section 360f of this title) initiate a proceeding under section
    360c(e) of this title to reclassify the device subject to the
    proceeding terminated by such notice.
      (4) The Secretary, upon his own initiative or upon petition of an
    interested person, may by regulation amend or revoke any regulation
    promulgated under this subsection. A regulation to amend or revoke
    a regulation under this subsection shall be promulgated in
    accordance with the requirements prescribed by this subsection for
    the promulgation of the regulation to be amended or revoked.
    (c) Application for premarket approval
      (1) Any person may file with the Secretary an application for
    premarket approval for a class III device. Such an application for
    a device shall contain - 
        (A) full reports of all information, published or known to or
      which should reasonably be known to the applicant, concerning
      investigations which have been made to show whether or not such
      device is safe and effective;
        (B) a full statement of the components, ingredients, and
      properties and of the principle or principles of operation, of
      such device;
        (C) a full description of the methods used in, and the
      facilities and controls used for, the manufacture, processing,
      and, when relevant, packing and installation of, such device;
        (D) an identifying reference to any performance standard under
      section 360d of this title which would be applicable to any
      aspect of such device if it were a class II device, and either
      adequate information to show that such aspect of such device
      fully meets such performance standard or adequate information to
      justify any deviation from such standard;
        (E) such samples of such device and of components thereof as
      the Secretary may reasonably require, except that where the
      submission of such samples is impracticable or unduly burdensome,
      the requirement of this subparagraph may be met by the submission
      of complete information concerning the location of one or more
      such devices readily available for examination and testing;
        (F) specimens of the labeling proposed to be used for such
      device; and
        (G) such other information relevant to the subject matter of
      the application as the Secretary, with the concurrence of the
      appropriate panel under section 360c of this title, may require.

      (2)(A) Any person may file with the Secretary a report seeking
    premarket approval for a class III device referred to in subsection
    (a) of this section that is a reprocessed single-use device. Such a
    report shall contain the following:
        (i) The device name, including both the trade or proprietary
      name and the common or usual name.
        (ii) The establishment registration number of the owner or
      operator submitting the report.
        (iii) Actions taken to comply with performance standards under
      section 360d of this title.
        (iv) Proposed labels, labeling, and advertising sufficient to
      describe the device, its intended use, and directions for use.
        (v) Full reports of all information, published or known to or
      which should be reasonably known to the applicant, concerning
      investigations which have been made to show whether or not the
      device is safe or effective.
        (vi) A description of the device's components, ingredients, and
      properties.
        (vii) A full description of the methods used in, and the
      facilities and controls used for, the reprocessing and packing of
      the device.
        (viii) Such samples of the device that the Secretary may
      reasonably require.
        (ix) A financial certification or disclosure statement or both,
      as required by part 54 of title 21, Code of Federal Regulations.
        (x) A statement that the applicant believes to the best of the
      applicant's knowledge that all data and information submitted to
      the Secretary are truthful and accurate and that no material fact
      has been omitted in the report.
        (xi) Any additional data and information, including information
      of the type required in paragraph (1) for an application under
      such paragraph, that the Secretary determines is necessary to
      determine whether there is reasonable assurance of safety and
      effectiveness for the reprocessed device.
        (xii) Validation data described in section 360(o)(1)(A) of this
      title that demonstrates that the reasonable assurance of the
      safety or effectiveness of the device will remain after the
      maximum number of times the device is reprocessed as intended by
      the person submitting such report.

      (B) In the case of a class III device referred to in subsection
    (a) of this section that is a reprocessed single-use device:
        (i) Subparagraph (A) of this paragraph applies in lieu of
      paragraph (1).
        (ii) Subject to clause (i), the provisions of this section
      apply to a report under subparagraph (A) to the same extent and
      in the same manner as such provisions apply to an application
      under paragraph (1).
        (iii) Each reference in other sections of this chapter to an
      application under this section, other than such a reference in
      section 379i or 379j of this title, shall be considered to be a
      reference to a report under subparagraph (A).
        (iv) Each reference in other sections of this chapter to a
      device for which an application under this section has been
      approved, or has been denied, suspended, or withdrawn, other than
      such a reference in section 379i or 379j of this title, shall be
      considered to be a reference to a device for which a report under
      subparagraph (A) has been approved, or has been denied,
      suspended, or withdrawn, respectively.
      (3) Upon receipt of an application meeting the requirements set
    forth in paragraph (1), the Secretary - 
        (A) may on the Secretary's own initiative, or
        (B) shall, upon the request of an applicant unless the
      Secretary finds that the information in the application which
      would be reviewed by a panel substantially duplicates information
      which has previously been reviewed by a panel appointed under
      section 360c of this title,

    refer such application to the appropriate panel under section 360c
    of this title for study and for submission (within such period as
    he may establish) of a report and recommendation respecting
    approval of the application, together with all underlying data and
    the reasons or basis for the recommendation. Where appropriate, the
    Secretary shall ensure that such panel includes, or consults with,
    one or more pediatric experts.
      (4)(A) Prior to the submission of an application under this
    subsection, the Secretary shall accept and review any portion of
    the application that the applicant and the Secretary agree is
    complete, ready, and appropriate for review, except that such
    requirement does not apply, and the Secretary has discretion
    whether to accept and review such portion, during any period in
    which, under section 379j(g) of this title, the Secretary does not
    have the authority to collect fees under section 379j(a) of this
    title.
      (B) Each portion of a submission reviewed under subparagraph (A)
    and found acceptable by the Secretary shall not be further reviewed
    after receipt of an application that satisfies the requirements of
    paragraph (1), unless a significant issue of safety or
    effectiveness provides the Secretary reason to review such accepted
    portion.
      (C) Whenever the Secretary determines that a portion of a
    submission under subparagraph (A) is unacceptable, the Secretary
    shall, in writing, provide to the applicant a description of any
    deficiencies in such portion and identify the information that is
    required to correct these deficiencies, unless the applicant is no
    longer pursuing the application.
    (d) Action on application for premarket approval
      (1)(A) As promptly as possible, but in no event later than one
    hundred and eighty days after the receipt of an application under
    subsection (c) of this section (except as provided in section
    360j(l)(3)(D)(ii) of this title or unless, in accordance with
    subparagraph (B)(i), an additional period as agreed upon by the
    Secretary and the applicant), the Secretary, after considering the
    report and recommendation submitted under paragraph (2) of such
    subsection, shall - 
        (i) issue an order approving the application if he finds that
      none of the grounds for denying approval specified in paragraph
      (2) of this subsection applies; or
        (ii) deny approval of the application if he finds (and sets
      forth the basis for such finding as part of or accompanying such
      denial) that one or more grounds for denial specified in
      paragraph (2) of this subsection apply.

    In making the determination whether to approve or deny the
    application, the Secretary shall rely on the conditions of use
    included in the proposed labeling as the basis for determining
    whether or not there is a reasonable assurance of safety and
    effectiveness, if the proposed labeling is neither false nor
    misleading. In determining whether or not such labeling is false or
    misleading, the Secretary shall fairly evaluate all material facts
    pertinent to the proposed labeling.
      (B)(i) The Secretary may not enter into an agreement to extend
    the period in which to take action with respect to an application
    submitted for a device subject to a regulation promulgated under
    subsection (b) of this section unless he finds that the continued
    availability of the device is necessary for the public health.
      (ii) An order approving an application for a device may require
    as a condition to such approval that the sale and distribution of
    the device be restricted but only to the extent that the sale and
    distribution of a device may be restricted under a regulation under
    section 360j(e) of this title.
      (iii) The Secretary shall accept and review statistically valid
    and reliable data and any other information from investigations
    conducted under the authority of regulations required by section
    360j(g) of this title to make a determination of whether there is a
    reasonable assurance of safety and effectiveness of a device
    subject to a pending application under this section if - 
        (I) the data or information is derived from investigations of
      an earlier version of the device, the device has been modified
      during or after the investigations (but prior to submission of an
      application under subsection (c) of this section) and such a
      modification of the device does not constitute a significant
      change in the design or in the basic principles of operation of
      the device that would invalidate the data or information; or
        (II) the data or information relates to a device approved under
      this section, is available for use under this chapter, and is
      relevant to the design and intended use of the device for which
      the application is pending.

      (2) The Secretary shall deny approval of an application for a
    device if, upon the basis of the information submitted to the
    Secretary as part of the application and any other information
    before him with respect to such device, the Secretary finds that - 
        (A) there is a lack of a showing of reasonable assurance that
      such device is safe under the conditions of use prescribed,
      recommended, or suggested in the proposed labeling thereof;
        (B) there is a lack of a showing of reasonable assurance that
      the device is effective under the conditions of use prescribed,
      recommended, or suggested in the proposed labeling thereof;
        (C) the methods used in, or the facilities or controls used
      for, the manufacture, processing, packing, or installation of
      such device do not conform to the requirements of section 360j(f)
      of this title;
        (D) based on a fair evaluation of all material facts, the
      proposed labeling is false or misleading in any particular; or
        (E) such device is not shown to conform in all respects to a
      performance standard in effect under section 360d of this title
      compliance with which is a condition to approval of the
      application and there is a lack of adequate information to
      justify the deviation from such standard.

    Any denial of an application shall, insofar as the Secretary
    determines to be practicable, be accompanied by a statement
    informing the applicant of the measures required to place such
    application in approvable form (which measures may include further
    research by the applicant in accordance with one or more protocols
    prescribed by the Secretary).
      (3)(A)(i) The Secretary shall, upon the written request of an
    applicant, meet with the applicant, not later than 100 days after
    the receipt of an application that has been filed as complete under
    subsection (c) of this section, to discuss the review status of the
    application.
      (ii) The Secretary shall, in writing and prior to the meeting,
    provide to the applicant a description of any deficiencies in the
    application that, at that point, have been identified by the
    Secretary based on an interim review of the entire application and
    identify the information that is required to correct those
    deficiencies.
      (iii) The Secretary shall notify the applicant promptly of - 
        (I) any additional deficiency identified in the application, or
        (II) any additional information required to achieve completion
      of the review and final action on the application,

    that was not described as a deficiency in the written description
    provided by the Secretary under clause (ii).
      (B) The Secretary and the applicant may, by mutual consent,
    establish a different schedule for a meeting required under this
    paragraph.
      (4) An applicant whose application has been denied approval may,
    by petition filed on or before the thirtieth day after the date
    upon which he receives notice of such denial, obtain review thereof
    in accordance with either paragraph (1) or (2) of subsection (g) of
    this section, and any interested person may obtain review, in
    accordance with paragraph (1) or (2) of subsection (g) of this
    section, of an order of the Secretary approving an application.
      (5) In order to provide for more effective treatment or diagnosis
    of life-threatening or irreversibly debilitating human diseases or
    conditions, the Secretary shall provide review priority for devices
    - 
        (A) representing breakthrough technologies,
        (B) for which no approved alternatives exist,
        (C) which offer significant advantages over existing approved
      alternatives, or
        (D) the availability of which is in the best interest of the
      patients.

      (6)(A)(i) A supplemental application shall be required for any
    change to a device subject to an approved application under this
    subsection that affects safety or effectiveness, unless such change
    is a modification in a manufacturing procedure or method of
    manufacturing and the holder of the approved application submits a
    written notice to the Secretary that describes in detail the
    change, summarizes the data or information supporting the change,
    and informs the Secretary that the change has been made under the
    requirements of section 360j(f) of this title.
      (ii) The holder of an approved application who submits a notice
    under clause (i) with respect to a manufacturing change of a device
    may distribute the device 30 days after the date on which the
    Secretary receives the notice, unless the Secretary within such 30-
    day period notifies the holder that the notice is not adequate and
    describes such further information or action that is required for
    acceptance of such change. If the Secretary notifies the holder
    that a supplemental application is required, the Secretary shall
    review the supplement within 135 days after the receipt of the
    supplement. The time used by the Secretary to review the notice of
    the manufacturing change shall be deducted from the 135-day review
    period if the notice meets appropriate content requirements for
    premarket approval supplements.
      (B)(i) Subject to clause (ii), in reviewing a supplement to an
    approved application, for an incremental change to the design of a
    device that affects safety or effectiveness, the Secretary shall
    approve such supplement if - 
        (I) nonclinical data demonstrate that the design modification
      creates the intended additional capacity, function, or
      performance of the device; and
        (II) clinical data from the approved application and any
      supplement to the approved application provide a reasonable
      assurance of safety and effectiveness for the changed device.

      (ii) The Secretary may require, when necessary, additional
    clinical data to evaluate the design modification of the device to
    provide a reasonable assurance of safety and effectiveness.
    (e) Withdrawal and temporary suspension of approval of application
      (1) The Secretary shall, upon obtaining, where appropriate,
    advice on scientific matters from a panel or panels under section
    360c of this title, and after due notice and opportunity for
    informal hearing to the holder of an approved application for a
    device, issue an order withdrawing approval of the application if
    the Secretary finds - 
        (A) that such device is unsafe or ineffective under the
      conditions of use prescribed, recommended, or suggested in the
      labeling thereof;
        (B) on the basis of new information before him with respect to
      such device, evaluated together with the evidence available to
      him when the application was approved, that there is a lack of a
      showing of reasonable assurance that the device is safe or
      effective under the conditions of use prescribed, recommended, or
      suggested in the labeling thereof;
        (C) that the application contained or was accompanied by an
      untrue statement of a material fact;
        (D) that the applicant (i) has failed to establish a system for
      maintaining records, or has repeatedly or deliberately failed to
      maintain records or to make reports, required by an applicable
      regulation under section 360i(a) of this title, (ii) has refused
      to permit access to, or copying or verification of, such records
      as required by section 374 of this title, or (iii) has not
      complied with the requirements of section 360 of this title;
        (E) on the basis of new information before him with respect to
      such device, evaluated together with the evidence before him when
      the application was approved, that the methods used in, or the
      facilities and controls used for, the manufacture, processing,
      packing, or installation of such device do not conform with the
      requirements of section 360j(f) of this title and were not
      brought into conformity with such requirements within a
      reasonable time after receipt of written notice from the
      Secretary of nonconformity;
        (F) on the basis of new information before him, evaluated
      together with the evidence before him when the application was
      approved, that the labeling of such device, based on a fair
      evaluation of all material facts, is false or misleading in any
      particular and was not corrected within a reasonable time after
      receipt of written notice from the Secretary of such fact; or
        (G) on the basis of new information before him, evaluated
      together with the evidence before him when the application was
      approved, that such device is not shown to conform in all
      respects to a performance standard which is in effect under
      section 360d of this title compliance with which was a condition
      to approval of the application and that there is a lack of
      adequate information to justify the deviation from such standard.

      (2) The holder of an application subject to an order issued under
    paragraph (1) withdrawing approval of the application may, by
    petition filed on or before the thirtieth day after the date upon
    which he receives notice of such withdrawal, obtain review thereof
    in accordance with either paragraph (1) or (2) of subsection (g) of
    this section.
      (3) If, after providing an opportunity for an informal hearing,
    the Secretary determines there is reasonable probability that the
    continuation of distribution of a device under an approved
    application would cause serious, adverse health consequences or
    death, the Secretary shall by order temporarily suspend the
    approval of the application approved under this section. If the
    Secretary issues such an order, the Secretary shall proceed
    expeditiously under paragraph (1) to withdraw such application.
    (f) Product development protocol
      (1) In the case of a class III device which is required to have
    an approval of an application submitted under subsection (c) of
    this section, such device shall be considered as having such an
    approval if a notice of completion of testing conducted in
    accordance with a product development protocol approved under
    paragraph (4) has been declared completed under paragraph (6).
      (2) Any person may submit to the Secretary a proposed product
    development protocol with respect to a device. Such a protocol
    shall be accompanied by data supporting it. If, within thirty days
    of the receipt of such a protocol, the Secretary determines that it
    appears to be appropriate to apply the requirements of this
    subsection to the device with respect to which the protocol is
    submitted, the Secretary - 
        (A) may, at the initiative of the Secretary, refer the proposed
      protocol to the appropriate panel under section 360c of this
      title for its recommendation respecting approval of the protocol;
      or
        (B) shall so refer such protocol upon the request of the
      submitter, unless the Secretary finds that the proposed protocol
      and accompanying data which would be reviewed by such panel
      substantially duplicate a product development protocol and
      accompanying data which have previously been reviewed by such a
      panel.

      (3) A proposed product development protocol for a device may be
    approved only if - 
        (A) the Secretary determines that it is appropriate to apply
      the requirements of this subsection to the device in lieu of the
      requirement of approval of an application submitted under
      subsection (c) of this section; and
        (B) the Secretary determines that the proposed protocol
      provides - 
          (i) a description of the device and the changes which may be
        made in the device,
          (ii) a description of the preclinical trials (if any) of the
        device and a specification of (I) the results from such trials
        to be required before the commencement of clinical trials of
        the device, and (II) any permissible variations in preclinical
        trials and the results therefrom,
          (iii) a description of the clinical trials (if any) of the
        device and a specification of (I) the results from such trials
        to be required before the filing of a notice of completion of
        the requirements of the protocol, and (II) any permissible
        variations in such trials and the results therefrom,
          (iv) a description of the methods to be used in, and the
        facilities and controls to be used for, the manufacture,
        processing, and, when relevant, packing and installation of the
        device,
          (v) an identifying reference to any performance standard
        under section 360d of this title to be applicable to any aspect
        of such device,
          (vi) if appropriate, specimens of the labeling proposed to be
        used for such device,
          (vii) such other information relevant to the subject matter
        of the protocol as the Secretary, with the concurrence of the
        appropriate panel or panels under section 360c of this title,
        may require, and
          (viii) a requirement for submission of progress reports and,
        when completed, records of the trials conducted under the
        protocol which records are adequate to show compliance with the
        protocol.

      (4) The Secretary shall approve or disapprove a proposed product
    development protocol submitted under paragraph (2) within one
    hundred and twenty days of its receipt unless an additional period
    is agreed upon by the Secretary and the person who submitted the
    protocol. Approval of a protocol or denial of approval of a
    protocol is final agency action subject to judicial review under
    chapter 7 of title 5.
      (5) At any time after a product development protocol for a device
    has been approved pursuant to paragraph (4), the person for whom
    the protocol was approved may submit a notice of completion - 
        (A) stating (i) his determination that the requirements of the
      protocol have been fulfilled and that, to the best of his
      knowledge, there is no reason bearing on safety or effectiveness
      why the notice of completion should not become effective, and
      (ii) the data and other information upon which such determination
      was made, and
        (B) setting forth the results of the trials required by the
      protocol and all the information required by subsection (c)(1) of
      this section.

      (6)(A) The Secretary may, after providing the person who has an
    approved protocol and opportunity for an informal hearing and at
    any time prior to receipt of notice of completion of such protocol,
    issue a final order to revoke such protocol if he finds that - 
        (i) such person has failed substantially to comply with the
      requirements of the protocol,
        (ii) the results of the trials obtained under the protocol
      differ so substantially from the results required by the protocol
      that further trials cannot be justified, or
        (iii) the results of the trials conducted under the protocol or
      available new information do not demonstrate that the device
      tested under the protocol does not present an unreasonable risk
      to health and safety.

      (B) After the receipt of a notice of completion of an approved
    protocol the Secretary shall, within the ninety-day period
    beginning on the date such notice is received, by order either
    declare the protocol completed or declare it not completed. An
    order declaring a protocol not completed may take effect only after
    the Secretary has provided the person who has the protocol
    opportunity for an informal hearing on the order. Such an order may
    be issued only if the Secretary finds - 
        (i) such person has failed substantially to comply with the
      requirements of the protocol,
        (ii) the results of the trials obtained under the protocol
      differ substantially from the results required by the protocol,
      or
        (iii) there is a lack of a showing of reasonable assurance of
      the safety and effectiveness of the device under the conditions
      of use prescribed, recommended, or suggested in the proposed
      labeling thereof.

      (C) A final order issued under subparagraph (A) or (B) shall be
    in writing and shall contain the reasons to support the conclusions
    thereof.
      (7) At any time after a notice of completion has become
    effective, the Secretary may issue an order (after due notice and
    opportunity for an informal hearing to the person for whom the
    notice is effective) revoking the approval of a device provided by
    a notice of completion which has become effective as provided in
    subparagraph (B) if he finds that any of the grounds listed in
    subparagraphs (A) through (G) of subsection (e)(1) of this section
    apply. Each reference in such subparagraphs to an application shall
    be considered for purposes of this paragraph as a reference to a
    protocol and the notice of completion of such protocol, and each
    reference to the time when an application was approved shall be
    considered for purposes of this paragraph as a reference to the
    time when a notice of completion took effect.
      (8) A person who has an approved protocol subject to an order
    issued under paragraph (6)(A) revoking such protocol, a person who
    has an approved protocol with respect to which an order under
    paragraph (6)(B) was issued declaring that the protocol had not
    been completed, or a person subject to an order issued under
    paragraph (7) revoking the approval of a device may, by petition
    filed on or before the thirtieth day after the date upon which he
    receives notice of such order, obtain review thereof in accordance
    with either paragraph (1) or (2) of subsection (g) of this section.
    (g) Review
      (1) Upon petition for review of - 
        (A) an order under subsection (d) of this section approving or
      denying approval of an application or an order under subsection
      (e) of this section withdrawing approval of an application, or
        (B) an order under subsection (f)(6)(A) of this section
      revoking an approved protocol, under subsection (f)(6)(B) of this
      section declaring that an approved protocol has not been
      completed, or under subsection (f)(7) of this section revoking
      the approval of a device,

    the Secretary shall, unless he finds the petition to be without
    good cause or unless a petition for review of such order has been
    submitted under paragraph (2), hold a hearing, in accordance with
    section 554 of title 5, on the order. The panel or panels which
    considered the application, protocol, or device subject to such
    order shall designate a member to appear and testify at any such
    hearing upon request of the Secretary, the petitioner, or the
    officer conducting the hearing, but this requirement does not
    preclude any other member of the panel or panels from appearing and
    testifying at any such hearing. Upon completion of such hearing and
    after considering the record established in such hearing, the
    Secretary shall issue an order either affirming the order subject
    to the hearing or reversing such order and, as appropriate,
    approving or denying approval of the application, reinstating the
    application's approval, approving the protocol, or placing in
    effect a notice of completion.
      (2)(A) Upon petition for review of - 
        (i) an order under subsection (d) of this section approving or
      denying approval of an application or an order under subsection
      (e) of this section withdrawing approval of an application, or
        (ii) an order under subsection (f)(6)(A) of this section
      revoking an approved protocol, under subsection (f)(6)(B) of this
      section declaring that an approved protocol has not been
      completed, or under subsection (f)(7) of this section revoking
      the approval of a device,

    the Secretary shall refer the application or protocol subject to
    the order and the basis for the order to an advisory committee of
    experts established pursuant to subparagraph (B) for a report and
    recommendation with respect to the order. The advisory committee
    shall, after independent study of the data and information
    furnished to it by the Secretary and other data and information
    before it, submit to the Secretary a report and recommendation,
    together with all underlying data and information and a statement
    of the reasons or basis for the recommendation. A copy of such
    report shall be promptly supplied by the Secretary to any person
    who petitioned for such referral to the advisory committee.
      (B) The Secretary shall establish advisory committees (which may
    not be panels under section 360c of this title) to receive
    referrals under subparagraph (A). The Secretary shall appoint as
    members of any such advisory committee persons qualified in the
    subject matter to be referred to the committee and of appropriately
    diversified professional backgrounds, except that the Secretary may
    not appoint to such a committee any individual who is in the
    regular full-time employ of the United States and engaged in the
    administration of this chapter. Members of an advisory committee
    (other than officers or employees of the United States), while
    attending conferences or meetings of their committee or otherwise
    serving at the request of the Secretary, shall be entitled to
    receive compensation at rates to be fixed by the Secretary, which
    rates may not exceed the daily equivalent for grade GS-18 of the
    General Schedule for each day (including traveltime) they are so
    engaged; and while so serving away from their homes or regular
    places of business each member may be allowed travel expenses,
    including per diem in lieu of subsistence, as authorized by section
    5703 of title 5 for persons in the Government service employed
    intermittently. The Secretary shall designate the chairman of an
    advisory committee from its members. The Secretary shall furnish
    each advisory committee with clerical and other assistance, and
    shall by regulation prescribe the procedures to be followed by each
    such committee in acting on referrals made under subparagraph (A).
      (C) The Secretary shall make public the report and recommendation
    made by an advisory committee with respect to an application and
    shall by order, stating the reasons therefor, either affirm the
    order referred to the advisory committee or reverse such order and,
    if appropriate, approve or deny approval of the application,
    reinstate the application's approval, approve the protocol, or
    place in effect a notice of completion.
    (h) Service of orders
      Orders of the Secretary under this section shall be served (1) in
    person by any officer or employee of the department designated by
    the Secretary, or (2) by mailing the order by registered mail or
    certified mail addressed to the applicant at his last known address
    in the records of the Secretary.
    (i) Revision
      (1) Before December 1, 1995, the Secretary shall by order require
    manufacturers of devices, which were introduced or delivered for
    introduction into interstate commerce for commercial distribution
    before May 28, 1976, and which are subject to revision of
    classification under paragraph (2), to submit to the Secretary a
    summary of and citation to any information known or otherwise
    available to the manufacturer respecting such devices, including
    adverse safety or effectiveness information which has not been
    submitted under section 360i of this title. The Secretary may
    require the manufacturer to submit the adverse safety or
    effectiveness data for which a summary and citation were submitted,
    if such data are available to the manufacturer.
      (2) After the issuance of an order under paragraph (1) but before
    December 1, 1995, the Secretary shall publish a regulation in the
    Federal Register for each device - 
        (A) which the Secretary has classified as a class III device,
      and
        (B) for which no final regulation has been promulgated under
      subsection (b) of this section,

    revising the classification of the device so that the device is
    classified into class I or class II, unless the regulation requires
    the device to remain in class III. In determining whether to revise
    the classification of a device or to require a device to remain in
    class III, the Secretary shall apply the criteria set forth in
    section 360c(a) of this title. Before the publication of a
    regulation requiring a device to remain in class III or revising
    its classification, the Secretary shall publish a proposed
    regulation respecting the classification of a device under this
    paragraph and provide reasonable opportunity for the submission of
    comments on any such regulation. No regulation requiring a device
    to remain in class III or revising its classification may take
    effect before the expiration of 90 days from the date of its
    publication in the Federal Register as a proposed regulation.
      (3) The Secretary shall, as promptly as is reasonably achievable,
    but not later than 12 months after the effective date of the
    regulation requiring a device to remain in class III, establish a
    schedule for the promulgation of a subsection (b) of this section
    regulation for each device which is subject to the regulation
    requiring the device to remain in class III.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 515, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 552; amended Pub. L. 101-629, Secs. 4(b)(1),
    9(a), 18(c), Nov. 28, 1990, 104 Stat. 4515, 4521, 4528; Pub. L. 103-
    80, Sec. 3(t), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115,
    title II, Secs. 201(b), 202, 205(c), 209(b), 216(b), Nov. 21, 1997,
    111 Stat. 2334, 2338, 2341, 2349; Pub. L. 107-250, title II, Secs.
    209, 210, title III, Sec. 302(c), Oct. 26, 2002, 116 Stat. 1613,
    1614, 1618; Pub. L. 108-214, Sec. 2(d)(1), Apr. 1, 2004, 118 Stat.
    576.)


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (c)(3). Pub. L. 108-214, Sec. 2(d)(1)(B), amended
    directory language of Pub. L. 107-250, Sec. 210. See 2002 Amendment
    note below.
      Pub. L. 108-214, Sec. 2(d)(1)(A)(i), redesignated par. (3)
    relating to acceptance and review of any portion of the application
    prior to submission as (4).
      Subsec. (c)(4). Pub. L. 108-214, Sec. 2(d)(1)(A), redesignated
    par. (3) relating to acceptance and review of any portion of the
    application prior to submission as (4) and substituted "unless a
    significant issue of safety" for "unless an issue of safety" in
    subpar. (B).
      2002 - Subsec. (a). Pub. L. 107-250, Sec. 302(c)(1), inserted
    "or, as applicable, an approval under subsection (c)(2) of this
    section of a report seeking premarket approval" before period in
    concluding provisions.
      Subsec. (c)(2). Pub. L. 107-250, Sec. 302(c)(2)(B), added par.
    (2). Former par. (2) redesignated (3).
      Subsec. (c)(3). Pub. L. 107-250, Sec. 302(c)(2)(A), redesignated
    par. (2) relating to Secretary's referral of application to
    appropriate panel as (3).
      Pub. L. 107-250, Sec. 210, as amended by Pub. L. 108-214, Sec.
    2(d)(1)(B), inserted "Where appropriate, the Secretary shall ensure
    that such panel includes, or consults with, one or more pediatric
    experts." at the end of the concluding provisions of par. (3) as
    redesignated by Pub. L. 107-250, Sec. 302(c)(2)(A).
      Pub. L. 107-250, Sec. 209, added par. (3) relating to acceptance
    and review of any portion of the application prior to submission.
      1997 - Subsec. (d)(1)(A). Pub. L. 105-115, Sec. 205(c)(1),
    inserted at end "In making the determination whether to approve or
    deny the application, the Secretary shall rely on the conditions of
    use included in the proposed labeling as the basis for determining
    whether or not there is a reasonable assurance of safety and
    effectiveness, if the proposed labeling is neither false nor
    misleading. In determining whether or not such labeling is false or
    misleading, the Secretary shall fairly evaluate all material facts
    pertinent to the proposed labeling."
      Subsec. (d)(1)(B)(iii). Pub. L. 105-115, Sec. 201(b), added cl.
    (iii).
      Subsec. (d)(3), (4). Pub. L. 105-115, Sec. 202(1), 209(b), added
    par. (3) and redesignated former par. (3) as (4).
      Subsec. (d)(5). Pub. L. 105-115, Sec. 202(2), added par. (5).
      Subsec. (d)(6). Pub. L. 105-115, Sec. 205(c)(2), added par. (6).
      Subsec. (f)(2). Pub. L. 105-115, Sec. 216(b), substituted "the
    Secretary - " and subpars. (A) and (B) for "he shall refer the
    proposed protocol to the appropriate panel under section 360c of
    this title for its recommendation respecting approval of the
    protocol."
      1993 - Subsec. (c)(2)(A). Pub. L. 103-80 struck out "refer such
    application" after "own initiative".
      1990 - Subsec. (c)(2). Pub. L. 101-629, Sec. 18(c), substituted
    "the Secretary - " for "the Secretary shall" and added subpars. (A)
    and (B).
      Subsec. (e). Pub. L. 101-629, Sec. 9(a)(2), inserted "and
    temporary suspension" after "Withdrawal" in heading.
      Subsec. (e)(3). Pub. L. 101-629, Sec. 9(a)(1), added par. (3).
      Subsec. (i). Pub. L. 101-629, Sec. 4(b)(1), added subsec. (i).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                    TERMINATION OF ADVISORY COMMITTEES                
      Advisory committees in existence on Jan. 5, 1973, to terminate
    not later than the expiration of the 2-year period following Jan.
    5, 1973, and advisory committees established after Jan. 5, 1973, to
    terminate not later than the expiration of the 2-year period
    beginning on the date of their establishment, unless in the case of
    a committee established by the President or an officer of the
    Federal Government, such committee is renewed by appropriate action
    prior to the expiration of such 2-year period, or in the case of a
    committee established by Congress, its duration is otherwise
    provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

                         REPORT ON CERTAIN DEVICES                     
      Pub. L. 107-250, title II, Sec. 205, Oct. 26, 2002, 116 Stat.
    1612, directed the Secretary of Health and Human Services, not
    later than one year after Oct. 26, 2002, to report to the
    appropriate committees of Congress on the timeliness and
    effectiveness of device premarket reviews by centers other than the
    Center for Devices and Radiological Health, including information
    on the times required to log in and review original submissions and
    supplements, times required to review manufacturers' replies to
    submissions, times to approve or clear such devices, and
    recommendations on improvement of performance and reassignment of
    responsibility for regulating such devices.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-



-CITE-
    21 USC Sec. 360f                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360f. Banned devices

-STATUTE-
    (a) General rule
      Whenever the Secretary finds, on the basis of all available data
    and information, that - 
        (1) a device intended for human use presents substantial
      deception or an unreasonable and substantial risk of illness or
      injury; and
        (2) in the case of substantial deception or an unreasonable and
      substantial risk of illness or injury which the Secretary
      determined could be corrected or eliminated by labeling or change
      in labeling and with respect to which the Secretary provided
      written notice to the manufacturer specifying the deception or
      risk of illness or injury, the labeling or change in labeling to
      correct the deception or eliminate or reduce such risk, and the
      period within which such labeling or change in labeling was to be
      done, such labeling or change in labeling was not done within
      such period;

    he may initiate a proceeding to promulgate a regulation to make
    such device a banned device.
    (b) Special effective date
      The Secretary may declare a proposed regulation under subsection
    (a) of this section to be effective upon its publication in the
    Federal Register and until the effective date of any final action
    taken respecting such regulation if (1) he determines, on the basis
    of all available data and information, that the deception or risk
    of illness or injury associated with the use of the device which is
    subject to the regulation presents an unreasonable, direct, and
    substantial danger to the health of individuals, and (2) before the
    date of the publication of such regulation, the Secretary notifies
    the manufacturer of such device that such regulation is to be made
    so effective. If the Secretary makes a proposed regulation so
    effective, he shall, as expeditiously as possible, give interested
    persons prompt notice of his action under this subsection, provide
    reasonable opportunity for an informal hearing on the proposed
    regulation, and either affirm, modify, or revoke such proposed
    regulation.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 516, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 560; amended Pub. L. 101-629, Sec. 18(d),
    Nov. 28, 1990, 104 Stat. 4529.)


-MISC1-
                                AMENDMENTS                            
      1990 - Subsec. (a). Pub. L. 101-629 struck out "and after
    consultation with the appropriate panel or panels under section
    360c of this title" after "data and information" in introductory
    provisions and struck out at end "The Secretary shall afford all
    interested persons opportunity for an informal hearing on a
    regulation proposed under this subsection."

-End-



-CITE-
    21 USC Sec. 360g                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360g. Judicial review

-STATUTE-
    (a) Petition; record
      Not later than thirty days after - 
        (1) the promulgation of a regulation under section 360c of this
      title classifying a device in class I or changing the
      classification of a device to class I or an order under
      subsection (f)(2) of such section reclassifying a device or
      denying a petition for reclassification of a device,
        (2) the promulgation of a regulation under section 360d of this
      title establishing, amending, or revoking a performance standard
      for a device,
        (3) the issuance of an order under section 360d(b)(2) or
      360e(b)(2)(B) of this title denying a request for
      reclassification of a device,
        (4) the promulgation of a regulation under paragraph (3) of
      section 360e(b) of this title requiring a device to have an
      approval of a premarket application, a regulation under paragraph
      (4) of that section amending or revoking a regulation under
      paragraph (3), or an order pursuant to section 360e(g)(1) or
      360e(g)(2)(C) of this title,
        (5) the promulgation of a regulation under section 360f of this
      title (other than a proposed regulation made effective under
      subsection (b) of such section upon the regulation's publication)
      making a device a banned device,
        (6) the issuance of an order under section 360j(f)(2) of this
      title,
        (7) an order under section 360j(g)(4) of this title
      disapproving an application for an exemption of a device for
      investigational use or an order under section 360j(g)(5) of this
      title withdrawing such an exemption for a device,
        (8) an order pursuant to section 360c(i) of this title, or
        (9) a regulation under section 360e(i)(2) or 360j(l)(5)(B) of
      this title,

    any person adversely affected by such regulation or order may file
    a petition with the United States Court of Appeals for the District
    of Columbia or for the circuit wherein such person resides or has
    his principal place of business for judicial review of such
    regulation or order. A copy of the petition shall be transmitted by
    the clerk of the court to the Secretary or other officer designated
    by him for that purpose. The Secretary shall file in the court the
    record of the proceedings on which the Secretary based his
    regulation or order as provided in section 2112 of title 28. For
    purposes of this section, the term "record" means all notices and
    other matter published in the Federal Register with respect to the
    regulation or order reviewed, all information submitted to the
    Secretary with respect to such regulation or order, proceedings of
    any panel or advisory committee with respect to such regulation or
    order, any hearing held with respect to such regulation or order,
    and any other information identified by the Secretary, in the
    administrative proceeding held with respect to such regulation or
    order, as being relevant to such regulation or order.
    (b) Additional data, views, and arguments
      If the petitioner applies to the court for leave to adduce
    additional data, views, or arguments respecting the regulation or
    order being reviewed and shows to the satisfaction of the court
    that such additional data, views, or arguments are material and
    that there were reasonable grounds for the petitioner's failure to
    adduce such data, views, or arguments in the proceedings before the
    Secretary, the court may order the Secretary to provide additional
    opportunity for the oral presentation of data, views, or arguments
    and for written submissions. The Secretary may modify his findings,
    or make new findings by reason of the additional data, views, or
    arguments so taken and shall file with the court such modified or
    new findings, and his recommendation, if any, for the modification
    or setting aside of the regulation or order being reviewed, with
    the return of such additional data, views, or arguments.
    (c) Standard for review
      Upon the filing of the petition under subsection (a) of this
    section for judicial review of a regulation or order, the court
    shall have jurisdiction to review the regulation or order in
    accordance with chapter 7 of title 5 and to grant appropriate
    relief, including interim relief, as provided in such chapter. A
    regulation described in paragraph (2) or (5) of subsection (a) of
    this section and an order issued after the review provided by
    section 360e(g) of this title shall not be affirmed if it is found
    to be unsupported by substantial evidence on the record taken as a
    whole.
    (d) Finality of judgments
      The judgment of the court affirming or setting aside, in whole or
    in part, any regulation or order shall be final, subject to review
    by the Supreme Court of the United States upon certiorari or
    certification, as provided in section 1254 of title 28.
    (e) Remedies
      The remedies provided for in this section shall be in addition to
    and not in lieu of any other remedies provided by law.
    (f) Statement of reasons
      To facilitate judicial review under this section or under any
    other provision of law of a regulation or order issued under
    section 360c, 360d, 360e, 360f, 360h, 360i, 360j, or 360k of this
    title each such regulation or order shall contain a statement of
    the reasons for its issuance and the basis, in the record of the
    proceedings held in connection with its issuance, for its issuance.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 517, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 560; amended Pub. L. 101-629, Sec. 13, Nov.
    28, 1990, 104 Stat. 4524; Pub. L. 102-300, Sec. 6(f), June 16,
    1992, 106 Stat. 240; Pub. L. 105-115, title II, Sec. 216(a)(2),
    Nov. 21, 1997, 111 Stat. 2349.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a)(8). Pub. L. 105-115, Sec. 216(a)(2)(A),
    inserted "or" at end.
      Subsec. (a)(9). Pub. L. 105-115, Sec. 216(a)(2)(B), substituted
    comma for ", or" at end.
      Subsec. (a)(10). Pub. L. 105-115, Sec. 216(a)(2)(C), struck out
    par. (10) which read as follows: "an order under section
    360j(h)(4)(B) of this title,".
      1992 - Subsec. (a)(10). Pub. L. 102-300 substituted
    "360j(h)(4)(B)" for "360j(c)(4)(B)".
      1990 - Subsec. (a)(8) to (10). Pub. L. 101-629 added pars. (8) to
    (10).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

-End-



-CITE-
    21 USC Sec. 360h                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360h. Notification and other remedies

-STATUTE-
    (a) Notification
      If the Secretary determines that - 
        (1) a device intended for human use which is introduced or
      delivered for introduction into interstate commerce for
      commercial distribution presents an unreasonable risk of
      substantial harm to the public health, and
        (2) notification under this subsection is necessary to
      eliminate the unreasonable risk of such harm and no more
      practicable means is available under the provisions of this
      chapter (other than this section) to eliminate such risk,

    the Secretary may issue such order as may be necessary to assure
    that adequate notification is provided in an appropriate form, by
    the persons and means best suited under the circumstances involved,
    to all health professionals who prescribe or use the device and to
    any other person (including manufacturers, importers, distributors,
    retailers, and device users) who should properly receive such
    notification in order to eliminate such risk. An order under this
    subsection shall require that the individuals subject to the risk
    with respect to which the order is to be issued be included in the
    persons to be notified of the risk unless the Secretary determines
    that notice to such individuals would present a greater danger to
    the health of such individuals than no such notification. If the
    Secretary makes such a determination with respect to such
    individuals, the order shall require that the health professionals
    who prescribe or use the device provide for the notification of the
    individuals whom the health professionals treated with the device
    of the risk presented by the device and of any action which may be
    taken by or on behalf of such individuals to eliminate or reduce
    such risk. Before issuing an order under this subsection, the
    Secretary shall consult with the persons who are to give notice
    under the order.
    (b) Repair, replacement, or refund
      (1)(A) If, after affording opportunity for an informal hearing,
    the Secretary determines that - 
        (i) a device intended for human use which is introduced or
      delivered for introduction into interstate commerce for
      commercial distribution presents an unreasonable risk of
      substantial harm to the public health,
        (ii) there are reasonable grounds to believe that the device
      was not properly designed or manufactured with reference to the
      state of the art as it existed at the time of its design or
      manufacture,
        (iii) there are reasonable grounds to believe that the
      unreasonable risk was not caused by failure of a person other
      than a manufacturer, importer, distributor, or retailer of the
      device to exercise due care in the installation, maintenance,
      repair, or use of the device, and
        (iv) the notification authorized by subsection (a) of this
      section would not by itself be sufficient to eliminate the
      unreasonable risk and action described in paragraph (2) of this
      subsection is necessary to eliminate such risk,

    the Secretary may order the manufacturer, importer, or any
    distributor of such device, or any combination of such persons, to
    submit to him within a reasonable time a plan for taking one or
    more of the actions described in paragraph (2). An order issued
    under the preceding sentence which is directed to more than one
    person shall specify which person may decide which action shall be
    taken under such plan and the person specified shall be the person
    who the Secretary determines bears the principal, ultimate
    financial responsibility for action taken under the plan unless the
    Secretary cannot determine who bears such responsibility or the
    Secretary determines that the protection of the public health
    requires that such decision be made by a person (including a device
    user or health professional) other than the person he determines
    bears such responsibility.
      (B) The Secretary shall approve a plan submitted pursuant to an
    order issued under subparagraph (A) unless he determines (after
    affording opportunity for an informal hearing) that the action or
    actions to be taken under the plan or the manner in which such
    action or actions are to be taken under the plan will not assure
    that the unreasonable risk with respect to which such order was
    issued will be eliminated. If the Secretary disapproves a plan, he
    shall order a revised plan to be submitted to him within a
    reasonable time. If the Secretary determines (after affording
    opportunity for an informal hearing) that the revised plan is
    unsatisfactory or if no revised plan or no initial plan has been
    submitted to the Secretary within the prescribed time, the
    Secretary shall (i) prescribe a plan to be carried out by the
    person or persons to whom the order issued under subparagraph (A)
    was directed, or (ii) after affording an opportunity for an
    informal hearing, by order prescribe a plan to be carried out by a
    person who is a manufacturer, importer, distributor, or retailer of
    the device with respect to which the order was issued but to whom
    the order under subparagraph (A) was not directed.
      (2) The actions which may be taken under a plan submitted under
    an order issued under paragraph (1) are as follows:
        (A) To repair the device so that it does not present the
      unreasonable risk of substantial harm with respect to which the
      order under paragraph (1) was issued.
        (B) To replace the device with a like or equivalent device
      which is in conformity with all applicable requirements of this
      chapter.
        (C) To refund the purchase price of the device (less a
      reasonable allowance for use if such device has been in the
      possession of the device user for one year or more - 
          (i) at the time of notification ordered under subsection (a)
        of this section, or
          (ii) at the time the device user receives actual notice of
        the unreasonable risk with respect to which the order was
        issued under paragraph (1),

      whichever first occurs).

      (3) No charge shall be made to any person (other than a
    manufacturer, importer, distributor or retailer) for availing
    himself of any remedy, described in paragraph (2) and provided
    under an order issued under paragraph (1), and the person subject
    to the order shall reimburse each person (other than a
    manufacturer, importer, distributor, or retailer) who is entitled
    to such a remedy for any reasonable and foreseeable expenses
    actually incurred by such person in availing himself of such
    remedy.
    (c) Reimbursement
      An order issued under subsection (b) of this section with respect
    to a device may require any person who is a manufacturer, importer,
    distributor, or retailer of the device to reimburse any other
    person who is a manufacturer, importer, distributor, or retailer of
    such device for such other person's expenses actually incurred in
    connection with carrying out the order if the Secretary determines
    such reimbursement is required for the protection of the public
    health. Any such requirement shall not affect any rights or
    obligations under any contract to which the person receiving
    reimbursement or the person making such reimbursement is a party.
    (d) Effect on other liability
      Compliance with an order issued under this section shall not
    relieve any person from liability under Federal or State law. In
    awarding damages for economic loss in an action brought for the
    enforcement of any such liability, the value to the plaintiff in
    such action of any remedy provided him under such order shall be
    taken into account.
    (e) Recall authority
      (1) If the Secretary finds that there is a reasonable probability
    that a device intended for human use would cause serious, adverse
    health consequences or death, the Secretary shall issue an order
    requiring the appropriate person (including the manufacturers,
    importers, distributors, or retailers of the device) - 
        (A) to immediately cease distribution of such device, and
        (B) to immediately notify health professionals and device user
      facilities of the order and to instruct such professionals and
      facilities to cease use of such device.

    The order shall provide the person subject to the order with an
    opportunity for an informal hearing, to be held not later than 10
    days after the date of the issuance of the order, on the actions
    required by the order and on whether the order should be amended to
    require a recall of such device. If, after providing an opportunity
    for such a hearing, the Secretary determines that inadequate
    grounds exist to support the actions required by the order, the
    Secretary shall vacate the order.
      (2)(A) If, after providing an opportunity for an informal hearing
    under paragraph (1), the Secretary determines that the order should
    be amended to include a recall of the device with respect to which
    the order was issued, the Secretary shall, except as provided in
    subparagraphs (B) and (C), amend the order to require a recall. The
    Secretary shall specify a timetable in which the device recall will
    occur and shall require periodic reports to the Secretary
    describing the progress of the recall.
      (B) An amended order under subparagraph (A) - 
        (i) shall - 
          (I) not include recall of a device from individuals, and
          (II) not include recall of a device from device user
        facilities if the Secretary determines that the risk of
        recalling such device from the facilities presents a greater
        health risk than the health risk of not recalling the device
        from use, and

        (ii) shall provide for notice to individuals subject to the
      risks associated with the use of such device.

    In providing the notice required by clause (ii), the Secretary may
    use the assistance of health professionals who prescribed or used
    such a device for individuals. If a significant number of such
    individuals cannot be identified, the Secretary shall notify such
    individuals pursuant to section 375(b) of this title.
      (3) The remedy provided by this subsection shall be in addition
    to remedies provided by subsections (a), (b), and (c) of this
    section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 518, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 562; amended Pub. L. 101-629, Sec. 8, Nov.
    28, 1990, 104 Stat. 4520; Pub. L. 102-300, Sec. 4, June 16, 1992,
    106 Stat. 239.)


-MISC1-
                                AMENDMENTS                            
      1992 - Subsec. (b)(1)(A)(ii). Pub. L. 102-300 substituted "or"
    for "and" after "properly designed" and "time of its design".
      1990 - Subsec. (e). Pub. L. 101-629 added subsec. (e).

-End-



-CITE-
    21 USC Sec. 360i                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360i. Records and reports on devices

-STATUTE-
    (a) General rule
      Every person who is a manufacturer or importer of a device
    intended for human use shall establish and maintain such records,
    make such reports, and provide such information, as the Secretary
    may by regulation reasonably require to assure that such device is
    not adulterated or misbranded and to otherwise assure its safety
    and effectiveness. Regulations prescribed under the preceding
    sentence - 
        (1) shall require a device manufacturer or importer to report
      to the Secretary whenever the manufacturer or importer receives
      or otherwise becomes aware of information that reasonably
      suggests that one of its marketed devices - 
          (A) may have caused or contributed to a death or serious
        injury, or
          (B) has malfunctioned and that such device or a similar
        device marketed by the manufacturer or importer would be likely
        to cause or contribute to a death or serious injury if the
        malfunction were to recur;

        (2) shall define the term "serious injury" to mean an injury
      that - 
          (A) is life threatening,
          (B) results in permanent impairment of a body function or
        permanent damage to a body structure, or
          (C) necessitates medical or surgical intervention to preclude
        permanent impairment of a body function or permanent damage to
        a body structure;

        (3) shall require reporting of other significant adverse device
      experiences as determined by the Secretary to be necessary to be
      reported;
        (4) shall not impose requirements unduly burdensome to a device
      manufacturer or importer taking into account his cost of
      complying with such requirements and the need for the protection
      of the public health and the implementation of this chapter;
        (5) which prescribe the procedure for making requests for
      reports or information shall require that each request made under
      such regulations for submission of a report or information to the
      Secretary state the reason or purpose for such request and
      identify to the fullest extent practicable such report or
      information;
        (6) which require submission of a report or information to the
      Secretary shall state the reason or purpose for the submission of
      such report or information and identify to the fullest extent
      practicable such report or information;
        (7) may not require that the identity of any patient be
      disclosed in records, reports, or information required under this
      subsection unless required for the medical welfare of an
      individual, to determine the safety or effectiveness of a device,
      or to verify a record, report, or information submitted under
      this chapter; and
        (8) may not require a manufacturer or importer of a class I
      device to - 
          (A) maintain for such a device records respecting information
        not in the possession of the manufacturer or importer, or
          (B) to submit for such a device to the Secretary any report
        or information - 
            (i) not in the possession of the manufacturer or importer,
          or
            (ii) on a periodic basis,

      unless such report or information is necessary to determine if
      the device should be reclassified or if the device is adulterated
      or misbranded. and (!1)


    In prescribing such regulations, the Secretary shall have due
    regard for the professional ethics of the medical profession and
    the interests of patients. The prohibitions of paragraph (7) of
    this subsection continue to apply to records, reports, and
    information concerning any individual who has been a patient,
    irrespective of whether or when he ceases to be a patient. The
    Secretary shall by regulation require distributors to keep records
    and make such records available to the Secretary upon request.
    Paragraphs (4) and (8) apply to distributors to the same extent and
    in the same manner as such paragraphs apply to manufacturers and
    importers.
    (b) User reports
      (1)(A) Whenever a device user facility receives or otherwise
    becomes aware of information that reasonably suggests that a device
    has or may have caused or contributed to the death of a patient of
    the facility, the facility shall, as soon as practicable but not
    later than 10 working days after becoming aware of the information,
    report the information to the Secretary and, if the identity of the
    manufacturer is known, to the manufacturer of the device. In the
    case of deaths, the Secretary may by regulation prescribe a shorter
    period for the reporting of such information.
      (B) Whenever a device user facility receives or otherwise becomes
    aware of - 
        (i) information that reasonably suggests that a device has or
      may have caused or contributed to the serious illness of, or
      serious injury to, a patient of the facility, or
        (ii) other significant adverse device experiences as determined
      by the Secretary by regulation to be necessary to be reported,

    the facility shall, as soon as practicable but not later than 10
    working days after becoming aware of the information, report the
    information to the manufacturer of the device or to the Secretary
    if the identity of the manufacturer is not known.
      (C) Each device user facility shall submit to the Secretary on an
    annual basis a summary of the reports made under subparagraphs (A)
    and (B). Such summary shall be submitted on January 1 of each year.
    The summary shall be in such form and contain such information from
    such reports as the Secretary may require and shall include - 
        (i) sufficient information to identify the facility which made
      the reports for which the summary is submitted,
        (ii) in the case of any product which was the subject of a
      report, the product name, serial number, and model number,
        (iii) the name and the address of the manufacturer of such
      device, and
        (iv) a brief description of the event reported to the
      manufacturer.

      (D) For purposes of subparagraphs (A), (B), and (C), a device
    user facility shall be treated as having received or otherwise
    become aware of information with respect to a device of that
    facility when medical personnel who are employed by or otherwise
    formally affiliated with the facility receive or otherwise become
    aware of information with respect to that device in the course of
    their duties.
      (2) The Secretary may not disclose the identity of a device user
    facility which makes a report under paragraph (1) except in
    connection with - 
        (A) an action brought to enforce section 331(q) of this title,
      or
        (B) a communication to a manufacturer of a device which is the
      subject of a report under paragraph (1).

    This paragraph does not prohibit the Secretary from disclosing the
    identity of a device user facility making a report under paragraph
    (1) or any information in such a report to employees of the
    Department of Health and Human Services, to the Department of
    Justice, or to the duly authorized committees and subcommittees of
    the Congress.
      (3) No report made under paragraph (1) by - 
        (A) a device user facility,
        (B) an individual who is employed by or otherwise formally
      affiliated with such a facility, or
        (C) a physician who is not required to make such a report,

    shall be admissible into evidence or otherwise used in any civil
    action involving private parties unless the facility, individual,
    or physician who made the report had knowledge of the falsity of
    the information contained in the report.
      (4) A report made under paragraph (1) does not affect any
    obligation of a manufacturer who receives the report to file a
    report as required under subsection (a) of this section.
      (5) With respect to device user facilities:
        (A) The Secretary shall by regulation plan and implement a
      program under which the Secretary limits user reporting under
      paragraphs (1) through (4) to a subset of user facilities that
      constitutes a representative profile of user reports for device
      deaths and serious illnesses or serious injuries.
        (B) During the period of planning the program under
      subparagraph (A), paragraphs (1) through (4) continue to apply.
        (C) During the period in which the Secretary is providing for a
      transition to the full implementation of the program, paragraphs
      (1) through (4) apply except to the extent that the Secretary
      determines otherwise.
        (D) On and after the date on which the program is fully
      implemented, paragraphs (1) through (4) do not apply to a user
      facility unless the facility is included in the subset referred
      to in subparagraph (A).
        (E) Not later than 2 years after November 21, 1997, the
      Secretary shall submit to the Committee on Commerce of the House
      of Representatives, and to the Committee on Labor and Human
      Resources of the Senate, a report describing the plan developed
      by the Secretary under subparagraph (A) and the progress that has
      been made toward the implementation of the plan.

      (6) For purposes of this subsection:
        (A) The term "device user facility" means a hospital,
      ambulatory surgical facility, nursing home, or outpatient
      treatment facility which is not a physician's office. The
      Secretary may by regulation include an outpatient diagnostic
      facility which is not a physician's office in such term.
        (B) The terms "serious illness" and "serious injury" mean
      illness or injury, respectively, that - 
          (i) is life threatening,
          (ii) results in permanent impairment of a body function or
        permanent damage to a body structure, or
          (iii) necessitates medical or surgical intervention to
        preclude permanent impairment of a body function or permanent
        damage to a body structure.
    (c) Persons exempt
      Subsection (a) of this section shall not apply to - 
        (1) any practitioner who is licensed by law to prescribe or
      administer devices intended for use in humans and who
      manufactures or imports devices solely for use in the course of
      his professional practice;
        (2) any person who manufactures or imports devices intended for
      use in humans solely for such person's use in research or
      teaching and not for sale (including any person who uses a device
      under an exemption granted under section 360j(g) of this title);
      and
        (3) any other class of persons as the Secretary may by
      regulation exempt from subsection (a) of this section upon a
      finding that compliance with the requirements of such subsection
      by such class with respect to a device is not necessary to (A)
      assure that a device is not adulterated or misbranded or (B)
      otherwise to assure its safety and effectiveness.
    (d) Repealed. Pub. L. 105-115, title II, Sec. 213(a)(2), Nov. 21,
      1997, 111 Stat. 2347
    (e) Device tracking
      (1) The Secretary may by order require a manufacturer to adopt a
    method of tracking a class II or class III device - 
        (A) the failure of which would be reasonably likely to have
      serious adverse health consequences; or
        (B) which is - 
          (i) intended to be implanted in the human body for more than
        one year, or
          (ii) a life sustaining or life supporting device used outside
        a device user facility.

      (2) Any patient receiving a device subject to tracking under
    paragraph (1) may refuse to release, or refuse permission to
    release, the patient's name, address, social security number, or
    other identifying information for the purpose of tracking.
    (f) Reports of removals and corrections
      (1) Except as provided in paragraph (2), the Secretary shall by
    regulation require a manufacturer or importer of a device to report
    promptly to the Secretary any correction or removal of a device
    undertaken by such manufacturer or importer if the removal or
    correction was undertaken - 
        (A) to reduce a risk to health posed by the device, or
        (B) to remedy a violation of this chapter caused by the device
      which may present a risk to health.

    A manufacturer or importer of a device who undertakes a correction
    or removal of a device which is not required to be reported under
    this paragraph shall keep a record of such correction or removal.
      (2) No report of the corrective action or removal of a device may
    be required under paragraph (1) if a report of the corrective
    action or removal is required and has been submitted under
    subsection (a) of this section.
      (3) For purposes of paragraphs (1) and (2), the terms
    "correction" and "removal" do not include routine servicing.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 519, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 564; amended Pub. L. 101-629, Secs. 2(a),
    3(a)(1), (b)(1), 7, Nov. 28, 1990, 104 Stat. 4511, 4513, 4514,
    4520; Pub. L. 102-300, Sec. 5(a), June 16, 1992, 106 Stat. 239;
    Pub. L. 103-80, Sec. 3(u), Aug. 13, 1993, 107 Stat. 778; Pub. L.
    105-115, title II, Secs. 211, 213(a), (c), Nov. 21, 1997, 111 Stat.
    2345-2347.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 213(a)(1)(A), (F), in
    introductory provisions, substituted "manufacturer or importer" for
    "manufacturer, importer, or distributor" and, in closing
    provisions, inserted at end "The Secretary shall by regulation
    require distributors to keep records and make such records
    available to the Secretary upon request. Paragraphs (4) and (8)
    apply to distributors to the same extent and in the same manner as
    such paragraphs apply to manufacturers and importers."
      Subsec. (a)(4). Pub. L. 105-115, Sec. 213(a)(1)(B), substituted
    "manufacturer or importer" for "manufacturer, importer, or
    distributor".
      Subsec. (a)(7). Pub. L. 105-115, Sec. 213(a)(1)(C), inserted
    "and" after semicolon at end.
      Subsec. (a)(8). Pub. L. 105-115, Sec. 213(a)(1)(D), substituted
    "manufacturer or importer" for "manufacturer, importer, or
    distributor" wherever appearing and substituted period for
    semicolon after "misbranded".
      Subsec. (a)(9). Pub. L. 105-115, Sec. 213(a)(1)(E), struck out
    par. (9) which read as follows: "shall require distributors who
    submit such reports to submit copies of the reports to the
    manufacturer of the device for which the report was made."
      Subsec. (b)(1)(C). Pub. L. 105-115, Sec. 213(c)(1)(A), in
    introductory provisions, substituted "on an annual basis" for "on a
    semi-annual basis" and struck out "and July 1" after "January 1"
    and struck out closing provisions which read as follows: "The
    Secretary may by regulation alter the frequency and timing of
    reports required by this subparagraph."
      Subsec. (b)(2)(A). Pub. L. 105-115, Sec. 213(c)(1)(B)(i),
    inserted "or" after comma at end.
      Subsec. (b)(2)(B). Pub. L. 105-115, Sec. 213(c)(1)(B)(ii),
    substituted period for ", or" at end.
      Subsec. (b)(2)(C). Pub. L. 105-115, Sec. 213(c)(1)(B)(iii),
    struck out subpar. (C) which read as follows: "a disclosure
    required under subsection (a) of this section."
      Subsec. (b)(5), (6). Pub. L. 105-115, Sec. 213(c)(2), added par.
    (5) and redesignated former par. (5) as (6).
      Subsec. (d). Pub. L. 105-115, Sec. 213(a)(2), struck out heading
    and text of subsec. (d). Text read as follows: "Each manufacturer,
    importer, and distributor required to make reports under subsection
    (a) of this section shall submit to the Secretary annually a
    statement certifying that - 
        "(1) the manufacturer, importer, or distributor did file a
      certain number of such reports, or
        "(2) the manufacturer, importer, or distributor did not file
      any report under subsection (a) of this section."
      Subsec. (e). Pub. L. 105-115, Sec. 211, amended heading and text
    of subsec. (e) generally. Prior to amendment, text read as follows:
    "Every person who registers under section 360 of this title and is
    engaged in the manufacture of - 
        "(1) a device the failure of which would be reasonably likely
      to have serious adverse health consequences and which is (A) a
      permanently implantable device, or (B) a life sustaining or life
      supporting device used outside a device user facility, or
        "(2) any other device which the Secretary may designate,
    shall adopt a method of device tracking."
      Subsec. (f)(1). Pub. L. 105-115, Sec. 213(a)(3), substituted "or
    importer" for ", importer, or distributor" wherever appearing.
      1993 - Subsec. (a). Pub. L. 103-80 substituted "paragraph (7)"
    for "paragraph (4)" in last sentence.
      1992 - Subsec. (a). Pub. L. 102-300, Sec. 5(a)(1), added pars.
    (1) to (3) and redesignated former pars. (1) to (6) as (4) to (9),
    respectively.
      Subsec. (b)(1)(A). Pub. L. 102-300, Sec. 5(a)(2)(A), substituted
    "a device has or may have" for "there is a probability that a
    device has".
      Subsec. (b)(1)(B). Pub. L. 102-300, Sec. 5(a)(2)(A), (B),
    substituted "a device has or may have" for "there is a probability
    that a device has", designated existing provisions as cl. (i), and
    added cl. (ii).
      Subsec. (b)(5)(B)(iii). Pub. L. 102-300, Sec. 5(a)(2)(C), struck
    out "immediate" before "medical".
      1990 - Subsec. (a)(6). Pub. L. 101-629, Sec. 3(a)(1), added par.
    (6).
      Subsecs. (b), (c). Pub. L. 101-629, Sec. 2(a), added subsec. (b)
    and redesignated former subsec. (b) as (c).
      Subsecs. (d), (e). Pub. L. 101-629, Sec. 3(b)(1), added subsecs.
    (d) and (e).
      Subsec. (f). Pub. L. 101-629, Sec. 7, added subsec. (f).

-CHANGE-
                              CHANGE OF NAME                          
      Committee on Labor and Human Resources of Senate changed to
    Committee on Health, Education, Labor, and Pensions of Senate by
    Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
    1999.


-MISC2-
                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Section 211 of Pub. L. 105-115 provided in part that the
    amendment made by that section is effective 90 days after Nov. 21,
    1997.
      Amendment by section 213(a), (c) of Pub. L. 105-115 effective 90
    days after Nov. 21, 1997, except as otherwise provided, see section
    501 of Pub. L. 105-115, set out as a note under section 321 of this
    title.

                     EFFECTIVE DATE OF 1992 AMENDMENT                 
      Section 2(b) of Pub. L. 102-300 provided that: "The amendments
    made by subsection (a) [amending sections 3(b)(3) and 3(c) of Pub.
    L. 101-629, set out as notes below] shall take effect as of May 27,
    1992 and any rule to implement section 519(e) of the Federal Food,
    Drug, and Cosmetic Act [21 U.S.C. 360i(e)] proposed under section
    3(c)(2) of the Safe Medical Devices Act of 1990 [Pub. L. 101-629,
    set out as a note below] shall revert to its proposed status as of
    such date."
      Section 5(b) of Pub. L. 102-300 provided that: "The amendments
    made by subsection (a) [amending this section] shall take effect - 
        "(1) 1 year after the date of the enactment of this Act [June
      16, 1992]; or
        "(2) on the effective date of regulations of the Secretary to
      implement such amendments,
    whichever occurs first."

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 2(c) of Pub. L. 101-629 provided that: "Section 519(b) of
    the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as
    added by the amendment made by subsection (a), shall take effect - 
        "(1) upon the effective date of regulations promulgated under
      subsection (b) [set out below], or
        "(2) upon the expiration of 12 months from the date of the
      enactment of this Act [Nov. 28, 1990],
    whichever occurs first."
      Section 3(a)(2) of Pub. L. 101-629 provided that: "Section
    519(a)(6) [21 U.S.C. 360i(a)(6)], as added by the amendment made by
    paragraph (1), shall take effect upon the effective date of final
    regulations under subsection (c) [set out below]."
      Section 3(b)(3) of Pub. L. 101-629, as amended by Pub. L. 102-
    300, Sec. 2(a)(1), June 16, 1992, 106 Stat. 238, provided that:
    "Section 519(e) [21 U.S.C. 360i(e)], as added by the amendment made
    by paragraph (1), shall take effect upon the expiration of 9 months
    after the issuance of final regulations under subsection (c) [set
    out below]."
      [For effective date of amendment by Pub. L. 102-300, see section
    2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992
    Amendment note.]

                                REGULATIONS                            
      Section 2(b) of Pub. L. 101-629 provided that: "The Secretary of
    Health and Human Services shall promulgate regulations to implement
    section 519(b) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 360i(b)], as added by the amendment made by subsection (a)
    (including a definition of the summary required by paragraph (1)(C)
    of such section) not later than 12 months after the date of
    enactment of this Act [Nov. 28, 1990]. In promulgating the
    regulations, the Secretary shall minimize the administrative
    burdens on device user facilities consistent with the need to
    assure adequate information."
      Section 3(c) of Pub. L. 101-629, as amended by Pub. L. 102-300,
    Sec. 2(a)(2), (3), June 16, 1992, 106 Stat. 238, provided that:
      "(1)(A) Not later than 9 months after the date of the enactment
    of this Act [Nov. 28, 1990], the Secretary of Health and Human
    Services shall issue proposed regulations - 
        "(i) to require distributors of devices to establish and
      maintain records and to make reports (including reports required
      by part 803 of title 21 of the Code of Federal Regulations) under
      section 519(a)(6) of the Federal Food, Drug, and Cosmetic Act [21
      U.S.C. 360i(a)(6)], and
        "(ii) to implement section 519(e) of such Act.
    The Secretary may exempt from regulations described in clause (i)
    classes of distributors of class I and class II devices from whom
    reports are not necessary for the protection of the public health.
      "(B) Regulations under subparagraph (A) shall - 
        "(i) require appropriate methods for maintenance of records to
      ensure that patients who receive devices can be provided the
      notification required by such Act [this chapter],
        "(ii) require that manufacturers adopt effective methods of
      tracking devices,
        "(iii) take into account the position of distributors in the
      device distribution process, and
        "(iv) include such other requirements as the Secretary deems
      necessary for the adoption of an effective user tracking program
      under section 519(e) of such Act.
      "(2) Not later than 18 months after the date of the enactment of
    this Act, the Secretary shall issue final regulations to implement
    sections [sic] 519(a)(6) of the Federal Food, Drug, and Cosmetic
    Act. If the Secretary does not promulgate such final regulations
    upon the expiration of such 18 months, the Congress finds that
    there is good cause for the proposed regulations to be considered
    as the final regulations without response to comment because the
    implementation of sections [sic] 519(a)(6) of such Act is essential
    to protect the health of patients who use such devices.
    Consequently, in such event, the proposed regulations issued under
    paragraph (1) shall become final regulations as of the expiration
    of such 18 months. There shall be promptly published in the Federal
    Register notice of the new status of the proposed regulations.
      "(3) Not later than November 28, 1992, the Secretary shall issue
    final regulations to implement section 519(e) of the Federal Food,
    Drug, and Cosmetic Act. If the Secretary does not promulgate such
    final regulations by November 28, 1992, the Congress finds that
    there is good cause for the proposed regulations to be considered
    as the final regulations without response to comment because the
    implementation of section 519(e) of such Act is essential to
    protect the health of patients who use devices. In such event, the
    proposed regulations issued under paragraph (1) shall become the
    issued final regulations on November 29, 1992. There shall be
    promptly published in the Federal Register notice of the new status
    of the proposed regulations."
      [For effective date of amendment by Pub. L. 102-300, see section
    2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992
    Amendment note.]

       INFORMATION CONCERNING REPORTING REQUIREMENTS FOR DEVICE USER
                                FACILITIES
      Section 2(d) of Pub. L. 101-629 directed Secretary of Health and
    Human Services, during the 18-month period beginning on Nov. 28,
    1990, to inform device user facilities (as defined in 21 U.S.C.
    360i(b)(5)(A)) and manufacturers and distributors of devices
    respecting the requirements of 21 U.S.C. 360i(b), and, to the
    extent practicable, provide persons subject to such requirements
    assistance in the form of publications regarding such requirements.

        STUDY OF REPORTING REQUIREMENTS; COMPLIANCE BY DEVICE USER
         FACILITIES; ACTIONS BY MANUFACTURERS; COST EFFECTIVENESS;
                              RECOMMENDATIONS
      Section 2(e) of Pub. L. 101-629 directed Comptroller General of
    the United States, not more than 36 months after Nov. 28, 1990, to
    conduct a study of compliance by device user facilities with the
    requirements of 21 U.S.C. 360i(b), actions taken by manufacturers
    of devices in response to reports made to them, cost effectiveness
    of such requirements and their implementation, and any
    recommendations for improvements to such requirements, with
    Comptroller General to complete the study and submit a report on
    the study not later than 45 months from Nov. 28, 1990, to
    appropriate committees of Congress.

       REPORT TO CONGRESS ON REPORTING REQUIREMENTS FOR DEVICE USER
                                FACILITIES
      Section 2(f) of Pub. L. 101-629 directed Secretary of Health and
    Human Services, not later than 36 months after Nov. 28, 1990, to
    prepare and submit to appropriate committees of Congress a report
    containing an evaluation of the requirements of 21 U.S.C. 360i(b),
    consisting of an evaluation of the safety benefits of the
    requirements, the burdens placed on the Food and Drug
    Administration and on device user facilities by the requirements,
    and the cost-effectiveness of the requirements and recommendations
    for legislative reform.

-FOOTNOTE-               

    (!1) So in original. The word "and" probably should not appear.


-End-



-CITE-
    21 USC Sec. 360j                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360j. General provisions respecting control of devices
      intended for human use

-STATUTE-
    (a) General rule
      Any requirement authorized by or under section 351, 352, 360, or
    360i of this title applicable to a device intended for human use
    shall apply to such device until the applicability of the
    requirement to the device has been changed by action taken under
    section 360c, 360d, or 360e of this title or under subsection (g)
    of this section, and any requirement established by or under
    section 351, 352, 360, or 360i of this title which is inconsistent
    with a requirement imposed on such device under section 360d or
    360e of this title or under subsection (g) of this section shall
    not apply to such device.
    (b) Custom devices
      Sections 360d and 360e of this title do not apply to any device
    which, in order to comply with the order of an individual physician
    or dentist (or any other specially qualified person designated
    under regulations promulgated by the Secretary after an opportunity
    for an oral hearing) necessarily deviates from an otherwise
    applicable performance standard or requirement prescribed by or
    under section 360e of this title if (1) the device is not generally
    available in finished form for purchase or for dispensing upon
    prescription and is not offered through labeling or advertising by
    the manufacturer, importer, or distributor thereof for commercial
    distribution, and (2) such device - 
        (A)(i) is intended for use by an individual patient named in
      such order of such physician or dentist (or other specially
      qualified person so designated) and is to be made in a specific
      form for such patient, or
        (ii) is intended to meet the special needs of such physician or
      dentist (or other specially qualified person so designated) in
      the course of the professional practice of such physician or
      dentist (or other specially qualified person so designated), and
        (B) is not generally available to or generally used by other
      physicians or dentists (or other specially qualified persons so
      designated).
    (c) Trade secrets
      Any information reported to or otherwise obtained by the
    Secretary or his representative under section 360c, 360d, 360e,
    360f, 360h, 360i, or 374 of this title or under subsection (f) or
    (g) of this section which is exempt from disclosure pursuant to
    subsection (a) of section 552 of title 5 by reason of subsection
    (b)(4) of such section shall be considered confidential and shall
    not be disclosed and may not be used by the Secretary as the basis
    for the reclassification of a device from class III to class II or
    class I or as the basis for the establishment or amendment of a
    performance standard under section 360d of this title for a device
    reclassified from class III to class II, except (1) in accordance
    with subsection (h) of this section, and (2) that such information
    may be disclosed to other officers or employees concerned with
    carrying out this chapter or when relevant in any proceeding under
    this chapter (other than section 360c or 360d of this title).
    (d) Notices and findings
      Each notice of proposed rulemaking under section 360c, 360d,
    360e, 360f, 360h, or 360i of this title, or under this section, any
    other notice which is published in the Federal Register with
    respect to any other action taken under any such section and which
    states the reasons for such action, and each publication of
    findings required to be made in connection with rulemaking under
    any such section shall set forth - 
        (1) the manner in which interested persons may examine data and
      other information on which the notice or findings is based, and
        (2) the period within which interested persons may present
      their comments on the notice or findings (including the need
      therefor) orally or in writing, which period shall be at least
      sixty days but may not exceed ninety days unless the time is
      extended by the Secretary by a notice published in the Federal
      Register stating good cause therefor.
    (e) Restricted devices
      (1) The Secretary may by regulation require that a device be
    restricted to sale, distribution, or use - 
        (A) only upon the written or oral authorization of a
      practitioner licensed by law to administer or use such device, or
        (B) upon such other conditions as the Secretary may prescribe
      in such regulation,

    if, because of its potentiality for harmful effect or the
    collateral measures necessary to its use, the Secretary determines
    that there cannot otherwise be reasonable assurance of its safety
    and effectiveness. No condition prescribed under subparagraph (B)
    may restrict the use of a device to persons with specific training
    or experience in its use or to persons for use in certain
    facilities unless the Secretary determines that such a restriction
    is required for the safe and effective use of the device. No such
    condition may exclude a person from using a device solely because
    the person does not have the training or experience to make him
    eligible for certification by a certifying board recognized by the
    American Board of Medical Specialties or has not been certified by
    such a Board. A device subject to a regulation under this
    subsection is a restricted device.
      (2) The label of a restricted device shall bear such appropriate
    statements of the restrictions required by a regulation under
    paragraph (1) as the Secretary may in such regulation prescribe.
    (f) Good manufacturing practice requirements
      (1)(A) The Secretary may, in accordance with subparagraph (B),
    prescribe regulations requiring that the methods used in, and the
    facilities and controls used for, the manufacture, pre-production
    design validation (including a process to assess the performance of
    a device but not including an evaluation of the safety or
    effectiveness of a device), packing, storage, and installation of a
    device conform to current good manufacturing practice, as
    prescribed in such regulations, to assure that the device will be
    safe and effective and otherwise in compliance with this chapter.
      (B) Before the Secretary may promulgate any regulation under
    subparagraph (A) he shall - 
        (i) afford the advisory committee established under paragraph
      (3) an opportunity to submit recommendations to him with respect
      to the regulation proposed to be promulgated;
        (ii) afford opportunity for an oral hearing; and
        (iii) ensure that such regulation conforms, to the extent
      practicable, with internationally recognized standards defining
      quality systems, or parts of the standards, for medical devices.

    The Secretary shall provide the advisory committee a reasonable
    time to make its recommendation with respect to proposed
    regulations under subparagraph (A).
      (2)(A) Any person subject to any requirement prescribed by
    regulations under paragraph (1) may petition the Secretary for an
    exemption or variance from such requirement. Such a petition shall
    be submitted to the Secretary in such form and manner as he shall
    prescribe and shall - 
        (i) in the case of a petition for an exemption from a
      requirement, set forth the basis for the petitioner's
      determination that compliance with the requirement is not
      required to assure that the device will be safe and effective and
      otherwise in compliance with this chapter,
        (ii) in the case of a petition for a variance from a
      requirement, set forth the methods proposed to be used in, and
      the facilities and controls proposed to be used for, the
      manufacture, packing, storage, and installation of the device in
      lieu of the methods, facilities, and controls prescribed by the
      requirement, and
        (iii) contain such other information as the Secretary shall
      prescribe.

      (B) The Secretary may refer to the advisory committee established
    under paragraph (3) any petition submitted under subparagraph (A).
    The advisory committee shall report its recommendations to the
    Secretary with respect to a petition referred to it within sixty
    days of the date of the petition's referral. Within sixty days
    after - 
        (i) the date the petition was submitted to the Secretary under
      subparagraph (A), or
        (ii) if the petition was referred to an advisory committee, the
      expiration of the sixty-day period beginning on the date the
      petition was referred to the advisory committee,

    whichever occurs later, the Secretary shall by order either deny
    the petition or approve it.
      (C) The Secretary may approve - 
        (i) a petition for an exemption for a device from a requirement
      if he determines that compliance with such requirement is not
      required to assure that the device will be safe and effective and
      otherwise in compliance with this chapter, and
        (ii) a petition for a variance for a device from a requirement
      if he determines that the methods to be used in, and the
      facilities and controls to be used for, the manufacture, packing,
      storage, and installation of the device in lieu of the methods,
      controls, and facilities prescribed by the requirement are
      sufficient to assure that the device will be safe and effective
      and otherwise in compliance with this chapter.

    An order of the Secretary approving a petition for a variance shall
    prescribe such conditions respecting the methods used in, and the
    facilities and controls used for, the manufacture, packing,
    storage, and installation of the device to be granted the variance
    under the petition as may be necessary to assure that the device
    will be safe and effective and otherwise in compliance with this
    chapter.
      (D) After the issuance of an order under subparagraph (B)
    respecting a petition, the petitioner shall have an opportunity for
    an informal hearing on such order.
      (3) The Secretary shall establish an advisory committee for the
    purpose of advising and making recommendations to him with respect
    to regulations proposed to be promulgated under paragraph (1)(A)
    and the approval or disapproval of petitions submitted under
    paragraph (2). The advisory committee shall be composed of nine
    members as follows:
        (A) Three of the members shall be appointed from persons who
      are officers or employees of any State or local government or of
      the Federal Government.
        (B) Two of the members shall be appointed from persons who are
      representative of interests of the device manufacturing industry;
      two of the members shall be appointed from persons who are
      representative of the interests of physicians and other health
      professionals; and two of the members shall be representative of
      the interests of the general public.

    Members of the advisory committee who are not officers or employees
    of the United States, while attending conferences or meetings of
    the committee or otherwise engaged in its business, shall be
    entitled to receive compensation at rates to be fixed by the
    Secretary, which rates may not exceed the daily equivalent of the
    rate in effect for grade GS-18 of the General Schedule, for each
    day (including traveltime) they are so engaged; and while so
    serving away from their homes or regular places of business each
    member may be allowed travel expenses, including per diem in lieu
    of subsistence, as authorized by section 5703 of title 5 for
    persons in the Government service employed intermittently. The
    Secretary shall designate one of the members of the advisory
    committee to serve as its chairman. The Secretary shall furnish the
    advisory committee with clerical and other assistance. Section 14
    of the Federal Advisory Committee Act shall not apply with respect
    to the duration of the advisory committee established under this
    paragraph.
    (g) Exemption for devices for investigational use
      (1) It is the purpose of this subsection to encourage, to the
    extent consistent with the protection of the public health and
    safety and with ethical standards, the discovery and development of
    useful devices intended for human use and to that end to maintain
    optimum freedom for scientific investigators in their pursuit of
    that purpose.
      (2)(A) The Secretary shall, within the one hundred and twenty-day
    period beginning on May 28, 1976, by regulation prescribe
    procedures and conditions under which devices intended for human
    use may upon application be granted an exemption from the
    requirements of section 352, 360, 360d, 360e, 360f, 360i, or 379e
    of this title or subsection (e) or (f) of this section or from any
    combination of such requirements to permit the investigational use
    of such devices by experts qualified by scientific training and
    experience to investigate the safety and effectiveness of such
    devices.
      (B) The conditions prescribed pursuant to subparagraph (A) shall
    include the following:
        (i) A requirement that an application be submitted to the
      Secretary before an exemption may be granted and that the
      application be submitted in such form and manner as the Secretary
      shall specify.
        (ii) A requirement that the person applying for an exemption
      for a device assure the establishment and maintenance of such
      records, and the making of such reports to the Secretary of data
      obtained as a result of the investigational use of the device
      during the exemption, as the Secretary determines will enable him
      to assure compliance with such conditions, review the progress of
      the investigation, and evaluate the safety and effectiveness of
      the device.
        (iii) Such other requirements as the Secretary may determine to
      be necessary for the protection of the public health and safety.

      (C) Procedures and conditions prescribed pursuant to subparagraph
    (A) for an exemption may appropriately vary depending on (i) the
    scope and duration of clinical testing to be conducted under such
    exemption, (ii) the number of human subjects that are to be
    involved in such testing, (iii) the need to permit changes to be
    made in the device subject to the exemption during testing
    conducted in accordance with a clinical testing plan required under
    paragraph (3)(A), and (iv) whether the clinical testing of such
    device is for the purpose of developing data to obtain approval for
    the commercial distribution of such device.
      (3) Procedures and conditions prescribed pursuant to paragraph
    (2)(A) shall require, as a condition to the exemption of any device
    to be the subject of testing involving human subjects, that the
    person applying for the exemption - 
        (A) submit a plan for any proposed clinical testing of the
      device and a report of prior investigations of the device
      (including, where appropriate, tests on animals) adequate to
      justify the proposed clinical testing - 
          (i) to the local institutional review committee which has
        been established in accordance with regulations of the
        Secretary to supervise clinical testing of devices in the
        facilities where the proposed clinical testing is to be
        conducted, or
          (ii) to the Secretary, if - 
            (I) no such committee exists, or
            (II) the Secretary finds that the process of review by such
          committee is inadequate (whether or not the plan for such
          testing has been approved by such committee),

        for review for adequacy to justify the commencement of such
        testing; and, unless the plan and report are submitted to the
        Secretary, submit to the Secretary a summary of the plan and a
        report of prior investigations of the device (including, where
        appropriate, tests on animals);

        (B) promptly notify the Secretary (under such circumstances and
      in such manner as the Secretary prescribes) of approval by a
      local institutional review committee of any clinical testing plan
      submitted to it in accordance with subparagraph (A);
        (C) in the case of a device to be distributed to investigators
      for testing, obtain signed agreements from each of such
      investigators that any testing of the device involving human
      subjects will be under such investigator's supervision and in
      accordance with subparagraph (D) and submit such agreements to
      the Secretary; and
        (D) assure that informed consent will be obtained from each
      human subject (or his representative) of proposed clinical
      testing involving such device, except where subject to such
      conditions as the Secretary may prescribe, the investigator
      conducting or supervising the proposed clinical testing of the
      device determines in writing that there exists a life threatening
      situation involving the human subject of such testing which
      necessitates the use of such device and it is not feasible to
      obtain informed consent from the subject and there is not
      sufficient time to obtain such consent from his representative.

    The determination required by subparagraph (D) shall be concurred
    in by a licensed physician who is not involved in the testing of
    the human subject with respect to which such determination is made
    unless immediate use of the device is required to save the life of
    the human subject of such testing and there is not sufficient time
    to obtain such concurrence.
      (4)(A) An application, submitted in accordance with the
    procedures prescribed by regulations under paragraph (2), for an
    exemption for a device (other than an exemption from section 360f
    of this title) shall be deemed approved on the thirtieth day after
    the submission of the application to the Secretary unless on or
    before such day the Secretary by order disapproves the application
    and notifies the applicant of the disapproval of the application.
      (B) The Secretary may disapprove an application only if he finds
    that the investigation with respect to which the application is
    submitted does not conform to procedures and conditions prescribed
    under regulations under paragraph (2). Such a notification shall
    contain the order of disapproval and a complete statement of the
    reasons for the Secretary's disapproval of the application and
    afford the applicant opportunity for an informal hearing on the
    disapproval order.
      (5) The Secretary may by order withdraw an exemption granted
    under this subsection for a device if the Secretary determines that
    the conditions applicable to the device under this subsection for
    such exemption are not met. Such an order may be issued only after
    opportunity for an informal hearing, except that such an order may
    be issued before the provision of an opportunity for an informal
    hearing if the Secretary determines that the continuation of
    testing under the exemption with respect to which the order is to
    be issued will result in an unreasonable risk to the public health.
      (6)(A) Not later than 1 year after November 21, 1997, the
    Secretary shall by regulation establish, with respect to a device
    for which an exemption under this subsection is in effect,
    procedures and conditions that, without requiring an additional
    approval of an application for an exemption or the approval of a
    supplement to such an application, permit - 
        (i) developmental changes in the device (including
      manufacturing changes) that do not constitute a significant
      change in design or in basic principles of operation and that are
      made in response to information gathered during the course of an
      investigation; and
        (ii) changes or modifications to clinical protocols that do not
      affect - 
          (I) the validity of data or information resulting from the
        completion of an approved protocol, or the relationship of
        likely patient risk to benefit relied upon to approve a
        protocol;
          (II) the scientific soundness of an investigational plan
        submitted under paragraph (3)(A); or
          (III) the rights, safety, or welfare of the human subjects
        involved in the investigation.

      (B) Regulations under subparagraph (A) shall provide that a
    change or modification described in such subparagraph may be made
    if - 
        (i) the sponsor of the investigation determines, on the basis
      of credible information (as defined by the Secretary) that the
      applicable conditions under subparagraph (A) are met; and
        (ii) the sponsor submits to the Secretary, not later than 5
      days after making the change or modification, a notice of the
      change or modification.

      (7)(A) In the case of a person intending to investigate the
    safety or effectiveness of a class III device or any implantable
    device, the Secretary shall ensure that the person has an
    opportunity, prior to submitting an application to the Secretary or
    to an institutional review committee, to submit to the Secretary,
    for review, an investigational plan (including a clinical
    protocol). If the applicant submits a written request for a meeting
    with the Secretary regarding such review, the Secretary shall, not
    later than 30 days after receiving the request, meet with the
    applicant for the purpose of reaching agreement regarding the
    investigational plan (including a clinical protocol). The written
    request shall include a detailed description of the device, a
    detailed description of the proposed conditions of use of the
    device, a proposed plan (including a clinical protocol) for
    determining whether there is a reasonable assurance of
    effectiveness, and, if available, information regarding the
    expected performance from the device.
      (B) Any agreement regarding the parameters of an investigational
    plan (including a clinical protocol) that is reached between the
    Secretary and a sponsor or applicant shall be reduced to writing
    and made part of the administrative record by the Secretary. Any
    such agreement shall not be changed, except - 
        (i) with the written agreement of the sponsor or applicant; or
        (ii) pursuant to a decision, made in accordance with
      subparagraph (C) by the director of the office in which the
      device involved is reviewed, that a substantial scientific issue
      essential to determining the safety or effectiveness of the
      device involved has been identified.

      (C) A decision under subparagraph (B)(ii) by the director shall
    be in writing, and may be made only after the Secretary has
    provided to the sponsor or applicant an opportunity for a meeting
    at which the director and the sponsor or applicant are present and
    at which the director documents the scientific issue involved.
    (h) Release of information respecting safety and effectiveness
      (1) The Secretary shall promulgate regulations under which a
    detailed summary of information respecting the safety and
    effectiveness of a device which information was submitted to the
    Secretary and which was the basis for - 
        (A) an order under section 360e(d)(1)(A) of this title
      approving an application for premarket approval for the device or
      denying approval of such an application or an order under section
      360e(e) of this title withdrawing approval of such an application
      for the device,
        (B) an order under section 360e(f)(6)(A) of this title revoking
      an approved protocol for the device, an order under section
      360e(f)(6)(B) of this title declaring a protocol for the device
      completed or not completed, or an order under section 360e(f)(7)
      of this title revoking the approval of the device, or
        (C) an order approving an application under subsection (g) of
      this section for an exemption for the device from section 360f of
      this title or an order disapproving, or withdrawing approval of,
      an application for an exemption under such subsection for the
      device,

    shall be made available to the public upon issuance of the order.
    Summaries of information made available pursuant to this paragraph
    respecting a device shall include information respecting any
    adverse effects on health of the device.
      (2) The Secretary shall promulgate regulations under which each
    advisory committee established under section 360e(g)(2)(B) of this
    title shall make available to the public a detailed summary of
    information respecting the safety and effectiveness of a device
    which information was submitted to the advisory committee and which
    was the basis for its recommendation to the Secretary made pursuant
    to section 360e(g)(2)(A) of this title. A summary of information
    upon which such a recommendation is based shall be made available
    pursuant to this paragraph only after the issuance of the order
    with respect to which the recommendation was made and each summary
    shall include information respecting any adverse effect on health
    of the device subject to such order.
      (3) Except as provided in paragraph (4), any information
    respecting a device which is made available pursuant to paragraph
    (1) or (2) of this subsection (A) may not be used to establish the
    safety or effectiveness of another device for purposes of this
    chapter by any person other than the person who submitted the
    information so made available, and (B) shall be made available
    subject to subsection (c) of this section.
      (4)(A) Any information contained in an application for premarket
    approval filed with the Secretary pursuant to section 360e(c) of
    this title (including information from clinical and preclinical
    tests or studies that demonstrate the safety and effectiveness of a
    device, but excluding descriptions of methods of manufacture and
    product composition and other trade secrets) shall be available, 6
    years after the application has been approved by the Secretary, for
    use by the Secretary in - 
        (i) approving another device;
        (ii) determining whether a product development protocol has
      been completed, under section 360e of this title for another
      device;
        (iii) establishing a performance standard or special control
      under this chapter; or
        (iv) classifying or reclassifying another device under section
      360c of this title and subsection (l)(2) of this section.

      (B) The publicly available detailed summaries of information
    respecting the safety and effectiveness of devices required by
    paragraph (1)(A) shall be available for use by the Secretary as the
    evidentiary basis for the agency actions described in subparagraph
    (A).
    (i) Proceedings of advisory panels and committees
      Each panel under section 360c of this title and each advisory
    committee established under section 360d(b)(5)(B) or 360e(g) of
    this title or under subsection (f) of this section shall make and
    maintain a transcript of any proceeding of the panel or committee.
    Each such panel and committee shall delete from any transcript made
    pursuant to this subsection information which under subsection (c)
    of this section is to be considered confidential.
    (j) Traceability
      Except as provided in section 360i(e) of this title, no
    regulation under this chapter may impose on a type or class of
    device requirements for the traceability of such type or class of
    device unless such requirements are necessary to assure the
    protection of the public health.
    (k) Research and development
      The Secretary may enter into contracts for research, testing, and
    demonstrations respecting devices and may obtain devices for
    research, testing, and demonstration purposes without regard to
    section 3324(a) and (b) of title 31 and section 5 of title 41.
    (l) Transitional provisions for devices considered as new drugs
      (1) Any device intended for human use - 
        (A) for which on May 28, 1976 (hereinafter in this subsection
      referred to as the "enactment date") an approval of an
      application submitted under section 355(b) of this title was in
      effect;
        (B) for which such an application was filed on or before the
      enactment date and with respect to which application no order of
      approval or refusing to approve had been issued on such date
      under subsection (c) or (d) of such section;
        (C) for which on the enactment date an exemption under
      subsection (i) of such section was in effect;
        (D) which is within a type of device described in subparagraph
      (A), (B), or (C) and is substantially equivalent to another
      device within that type;
        (E) which the Secretary in a notice published in the Federal
      Register before the enactment date has declared to be a new drug
      subject to section 355 of this title; or
        (F) with respect to which on the enactment date an action is
      pending in a United States court under section 332, 333, or 334
      of this title for an alleged violation of a provision of section
      331 of this title which enforces a requirement of section 355 of
      this title or for an alleged violation of section 355(a) of this
      title,

    is classified in class III unless the Secretary in response to a
    petition submitted under paragraph (2) has classified such device
    in class I or II.
      (2) The Secretary may initiate the reclassification of a device
    classified into class III under paragraph (1) of this subsection or
    the manufacturer or importer of a device classified under paragraph
    (1) may petition the Secretary (in such form and manner as he shall
    prescribe) for the issuance of an order classifying the device in
    class I or class II. Within thirty days of the filing of such a
    petition, the Secretary shall notify the petitioner of any
    deficiencies in the petition which prevent the Secretary from
    making a decision on the petition. Except as provided in paragraph
    (3)(D)(ii), within one hundred and eighty days after the filing of
    a petition under this paragraph, the Secretary shall, after
    consultation with the appropriate panel under section 360c of this
    title, by order either deny the petition or order the
    classification, in accordance with the criteria prescribed by
    section 360c(a)(1)(A) of this title or 360c(a)(1)(B) of this title,
    of the device in class I or class II.
      (3)(A) In the case of a device which is described in paragraph
    (1)(A) and which is in class III - 
        (i) such device shall on the enactment date be considered a
      device with an approved application under section 360e of this
      title, and
        (ii) the requirements applicable to such device before the
      enactment date under section 355 of this title shall continue to
      apply to such device until changed by the Secretary as authorized
      by this chapter.

      (B) In the case of a device which is described in paragraph
    (1)(B) and which is in class III, an application for such device
    shall be considered as having been filed under section 360e of this
    title on the enactment date. The period in which the Secretary
    shall act on such application in accordance with section 360e(d)(1)
    of this title shall be one hundred and eighty days from the
    enactment date (or such greater period as the Secretary and the
    applicant may agree upon after the Secretary has made the finding
    required by section 360e(d)(1)(B)(i) of this title) less the number
    of days in the period beginning on the date an application for such
    device was filed under section 355 of this title and ending on the
    enactment date. After the expiration of such period such device is
    required, unless exempt under subsection (g) of this section, to
    have in effect an approved application under section 360e of this
    title.
      (C) A device which is described in paragraph (1)(C) and which is
    in class III shall be considered a new drug until the expiration of
    the ninety-day period beginning on the date of the promulgation of
    regulations under subsection (g) of this section. After the
    expiration of such period such device is required, unless exempt
    under subsection (g) of this section, to have in effect an approved
    application under section 360e of this title.
      (D)(i) Except as provided in clauses (ii) and (iii), a device
    which is described in subparagraph (D), (E), or (F) of paragraph
    (1) and which is in class III is required, unless exempt under
    subsection (g) of this section, to have on and after sixty days
    after the enactment date in effect an approved application under
    section 360e of this title.
      (ii) If - 
        (I) a petition is filed under paragraph (2) for a device
      described in subparagraph (D), (E), or (F) of paragraph (1), or
        (II) an application for premarket approval is filed under
      section 360e of this title for such a device,

    within the sixty-day period beginning on the enactment date (or
    within such greater period as the Secretary, after making the
    finding required under section 360e(d)(1)(B) of this title, and the
    petitioner or applicant may agree upon), the Secretary shall act on
    such petition or application in accordance with paragraph (2) or
    section 360e of this title except that the period within which the
    Secretary must act on the petition or application shall be within
    the one hundred and twenty-day period beginning on the date the
    petition or application is filed. If such a petition or application
    is filed within such sixty-day (or greater) period, clause (i) of
    this subparagraph shall not apply to such device before the
    expiration of such one hundred and twenty-day period, or if such
    petition is denied or such application is denied approval, before
    the date of such denial, whichever occurs first.
      (iii) In the case of a device which is described in subparagraph
    (E) of paragraph (1), which the Secretary in a notice published in
    the Federal Register after March 31, 1976, declared to be a new
    drug subject to section 355 of this title, and which is in class
    III - 
        (I) the device shall, after eighteen months after the enactment
      date, have in effect an approved application under section 360e
      of this title unless exempt under subsection (g) of this section,
      and
        (II) the Secretary may, during the period beginning one hundred
      and eighty days after the enactment date and ending eighteen
      months after such date, restrict the use of the device to
      investigational use by experts qualified by scientific training
      and experience to investigate the safety and effectiveness of
      such device, and to investigational use in accordance with the
      requirements applicable under regulations under subsection (g) of
      this section to investigational use of devices granted an
      exemption under such subsection.

    If the requirements under subsection (g) of this section are made
    applicable to the investigational use of such a device, they shall
    be made applicable in such a manner that the device shall be made
    reasonably available to physicians meeting appropriate
    qualifications prescribed by the Secretary.
      (4) Repealed. Pub. L. 105-115, title I, Sec. 125(b)(2)(E), Nov.
    21, 1997, 111 Stat. 2325.
      (5)(A) Before December 1, 1991, the Secretary shall by order
    require manufacturers of devices described in paragraph (1), which
    are subject to revision of classification under subparagraph (B),
    to submit to the Secretary a summary of and citation to any
    information known or otherwise available to the manufacturers
    respecting the devices, including adverse safety or effectiveness
    information which has not been submitted under section 360i of this
    title. The Secretary may require a manufacturer to submit the
    adverse safety or effectiveness data for which a summary and
    citation were submitted, if such data are available to the
    manufacturer.
      (B) Except as provided in subparagraph (C), after the issuance of
    an order under subparagraph (A) but before December 1, 1992, the
    Secretary shall publish a regulation in the Federal Register for
    each device which is classified in class III under paragraph (1)
    revising the classification of the device so that the device is
    classified into class I or class II, unless the regulation requires
    the device to remain in class III. In determining whether to revise
    the classification of a device or to require a device to remain in
    class III, the Secretary shall apply the criteria set forth in
    section 360c(a) of this title. Before the publication of a
    regulation requiring a device to remain in class III or revising
    its classification, the Secretary shall publish a proposed
    regulation respecting the classification of a device under this
    subparagraph and provide an opportunity for the submission of
    comments on any such regulation. No regulation under this
    subparagraph requiring a device to remain in class III or revising
    its classification may take effect before the expiration of 90 days
    from the date of the publication in the Federal Register of the
    proposed regulation.
      (C) The Secretary may by notice published in the Federal Register
    extend the period prescribed by subparagraph (B) for a device for
    an additional period not to exceed 1 year.
    (m) Humanitarian device exemption
      (1) To the extent consistent with the protection of the public
    health and safety and with ethical standards, it is the purpose of
    this subsection to encourage the discovery and use of devices
    intended to benefit patients in the treatment and diagnosis of
    diseases or conditions that affect fewer than 4,000 individuals in
    the United States.
      (2) The Secretary may grant a request for an exemption from the
    effectiveness requirements of sections 360d and 360e of this title
    for a device for which the Secretary finds that - 
        (A) the device is designed to treat or diagnose a disease or
      condition that affects fewer than 4,000 individuals in the United
      States,
        (B) the device would not be available to a person with a
      disease or condition referred to in subparagraph (A) unless the
      Secretary grants such an exemption and there is no comparable
      device, other than under this exemption, available to treat or
      diagnose such disease or condition, and
        (C) the device will not expose patients to an unreasonable or
      significant risk of illness or injury and the probable benefit to
      health from the use of the device outweighs the risk of injury or
      illness from its use, taking into account the probable risks and
      benefits of currently available devices or alternative forms of
      treatment.

    The request shall be in the form of an application submitted to the
    Secretary. Not later than 75 days after the date of the receipt of
    the application, the Secretary shall issue an order approving or
    denying the application.
      (3) No person granted an exemption under paragraph (2) with
    respect to a device may sell the device for an amount that exceeds
    the costs of research and development, fabrication, and
    distribution of the device.
      (4) Devices granted an exemption under paragraph (2) may only be
    used - 
        (A) in facilities that have established, in accordance with
      regulations of the Secretary, a local institutional review
      committee to supervise clinical testing of devices in the
      facilities, and
        (B) if, before the use of a device, an institutional review
      committee approves the use in the treatment or diagnosis of a
      disease or condition referred to in paragraph (2)(A), unless a
      physician determines in an emergency situation that approval from
      a local institutional review committee can not be obtained in
      time to prevent serious harm or death to a patient.

    In a case described in subparagraph (B) in which a physician uses a
    device without an approval from an institutional review committee,
    the physician shall, after the use of the device, notify the
    chairperson of the local institutional review committee of such
    use. Such notification shall include the identification of the
    patient involved, the date on which the device was used, and the
    reason for the use.
      (5) The Secretary may require a person granted an exemption under
    paragraph (2) to demonstrate continued compliance with the
    requirements of this subsection if the Secretary believes such
    demonstration to be necessary to protect the public health or if
    the Secretary has reason to believe that the criteria for the
    exemption are no longer met.
      (6) The Secretary may suspend or withdraw an exemption from the
    effectiveness requirements of sections 360d and 360e of this title
    for a humanitarian device only after providing notice and an
    opportunity for an informal hearing.
    (n) Regulation of contact lenses as devices
      (1) All contact lenses shall be deemed to be devices under
    section 321(h) of this title.
      (2) Paragraph (1) shall not be construed as bearing on or being
    relevant to the question of whether any product other than a
    contact lens is a device as defined by section 321(h) of this title
    or a drug as defined by section 321(g) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 520, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 565; amended Pub. L. 101-629, Secs. 3(b)(2),
    4(b)(2), 5(c)(2), 6(b)(2), 11, 14(a), 18(e), (f), Nov. 28, 1990,
    104 Stat. 4514, 4516, 4518, 4519, 4522, 4524, 4529; Pub. L. 102-
    571, title I, Sec. 107(10), Oct. 29, 1992, 106 Stat. 4499; Pub. L.
    105-115, title I, Sec. 125(b)(2)(E), title II, Secs. 201(a), 203,
    216(a)(1), title IV, Sec. 410(a), Nov. 21, 1997, 111 Stat. 2325,
    2332, 2334, 2349, 2372; Pub. L. 109-96, Sec. 1, Nov. 9, 2005, 119
    Stat. 2119.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 14 of the Federal Advisory Committee Act, referred to in
    subsec. (f)(3), is section 14 of Pub. L. 92-463, which is set out
    in the Appendix to Title 5, Government Organization and Employees.

-COD-
                               CODIFICATION                           
      In subsec. (k), "section 3324(a) and (b) of title 31" substituted
    for reference to section 3648 of the Revised Statutes (31 U.S.C.
    529) on authority of Pub. L. 97-258, Sec. 4(b), Sept. 13, 1982, 96
    Stat. 1067, the first section of which enacted Title 31, Money and
    Finance.


-MISC1-
                                AMENDMENTS                            
      2005 - Subsec. (n). Pub. L. 109-96 added subsec. (n).
      1997 - Subsec. (f)(1)(B)(iii). Pub. L. 105-115, Sec. 410(a),
    added cl. (iii).
      Subsec. (g)(6), (7). Pub. L. 105-115, Sec. 201(a), added pars.
    (6) and (7).
      Subsec. (h)(4). Pub. L. 105-115, Sec. 216(a)(1), amended par. (4)
    generally. Prior to amendment, par. (4) related to premarket
    approval of devices.
      Subsec. (l). Pub. L. 105-115, Sec. 125(b)(2)(E), struck out "or
    antibiotic drugs" after "new drugs" in heading.
      Subsec. (l)(4). Pub. L. 105-115, Sec. 125(b)(2)(E), struck out
    par. (4) which read as follows: "Any device intended for human use
    which on the enactment date was subject to the requirements of
    section 357 of this title shall be subject to such requirements as
    follows:
        "(A) In the case of such a device which is classified into
      class I, such requirements shall apply to such device until the
      effective date of the regulation classifying the device into such
      class.
        "(B) In the case of such a device which is classified into
      class II, such requirements shall apply to such device until the
      effective date of a performance standard applicable to the device
      under section 360d of this title.
        "(C) In the case of such a device which is classified into
      class III, such requirements shall apply to such device until the
      date on which the device is required to have in effect an
      approved application under section 360e of this title."
      Subsec. (m)(2). Pub. L. 105-115, Sec. 203(1), inserted at end
    "The request shall be in the form of an application submitted to
    the Secretary. Not later than 75 days after the date of the receipt
    of the application, the Secretary shall issue an order approving or
    denying the application."
      Subsec. (m)(4). Pub. L. 105-115, Sec. 203(2)(B), inserted at end
    "In a case described in subparagraph (B) in which a physician uses
    a device without an approval from an institutional review
    committee, the physician shall, after the use of the device, notify
    the chairperson of the local institutional review committee of such
    use. Such notification shall include the identification of the
    patient involved, the date on which the device was used, and the
    reason for the use."
      Subsec. (m)(4)(B). Pub. L. 105-115, Sec. 203(2)(A), inserted
    before period at end ", unless a physician determines in an
    emergency situation that approval from a local institutional review
    committee can not be obtained in time to prevent serious harm or
    death to a patient".
      Subsec. (m)(5). Pub. L. 105-115, Sec. 203(3), amended par. (5)
    generally. Prior to amendment, par. (5) read as follows: "An
    exemption under paragraph (2) shall be for a term of 18 months and
    may only be initially granted in the 5-year period beginning on the
    date regulations under paragraph (6) take effect. The Secretary may
    extend such an exemption for a period of 18 months if the Secretary
    is able to make the findings set forth in paragraph (2) and if the
    applicant supplies information demonstrating compliance with
    paragraph (3). An exemption may be extended more than once and may
    be extended after the expiration of such 5-year period."
      Subsec. (m)(6). Pub. L. 105-115, Sec. 203(4), amended par. (6)
    generally. Prior to amendment, par. (6) read as follows: "Within
    one year of November 28, 1990, the Secretary shall issue
    regulations to implement this subsection."
      1992 - Subsec. (g)(2)(A). Pub. L. 102-571 substituted "379e" for
    "376".
      1990 - Subsec. (c). Pub. L. 101-629, Sec. 11(1), substituted
    "from class III to class II or class I" for "under section 360c of
    this title from class III to class II" and inserted "(1) in
    accordance with subsection (h) of this section, and (2)" after
    "except".
      Subsec. (f)(1)(A). Pub. L. 101-629, Sec. 18(e), inserted "pre-
    production design validation (including a process to assess the
    performance of a device but not including an evaluation of the
    safety or effectiveness of a device)," after "manufacture,".
      Subsec. (h)(3). Pub. L. 101-629, Sec. 11(2)(A), substituted
    "Except as provided in paragraph (4), any" for "Any".
      Subsec. (h)(4). Pub. L. 101-629, Sec. 11(2)(B), added par. (4).
      Subsec. (i). Pub. L. 101-629, Sec. 6(b)(2), substituted "section
    360d(b)(5)(B)" for "section 360d(g)(5)(B)".
      Subsec. (j). Pub. L. 101-629, Sec. 3(b)(2), substituted "Except
    as provided in section 360i(e) of this title, no" for "No".
      Subsec. (l)(2). Pub. L. 101-629, Sec. 18(f), struck out "and
    after affording the petitioner an opportunity for an informal
    hearing" after "under this paragraph".
      Pub. L. 101-629, Sec. 5(c)(2), substituted "The Secretary may
    initiate the reclassification of a device classified into class III
    under paragraph (1) of this subsection or the manufacturer" for
    "The manufacturer".
      Subsec. (l)(5). Pub. L. 101-629, Sec. 4(b)(2), added par. (5).
      Subsec. (m). Pub. L. 101-629, Sec. 14(a), added subsec. (m).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by sections 201(a), 203, 216(a)(1), and 410(a) of Pub.
    L. 105-115 effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    a note under section 321 of this title.

                     EFFECTIVE DATE OF 1990 AMENDMENT                 
      Section 14(b) of Pub. L. 101-629 provided that: "Subsection (m)
    of section 520 of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 360j(m)], as added by the amendment made by subsection (a),
    shall take effect on the effective date of the regulations issued
    by the Secretary under paragraph (6) of such subsection."

                   GUIDANCE REGARDING PEDIATRIC DEVICES               
      Pub. L. 107-250, title II, Sec. 213, Oct. 26, 2002, 116 Stat.
    1614, provided that: "Not later than 270 days after the date of the
    enactment of this Act [Oct. 26, 2002], the Secretary of Health and
    Human Services shall issue guidance on the following:
        "(1) The type of information necessary to provide reasonable
      assurance of the safety and effectiveness of medical devices
      intended for use in pediatric populations.
        "(2) Protections for pediatric subjects in clinical
      investigations of the safety or effectiveness of such devices."

                 REPORT ON HUMANITARIAN DEVICE EXEMPTIONS             
      Section 14(c) of Pub. L. 101-629 directed Secretary of Health and
    Human Services, within 4 years after issuance of regulations under
    21 U.S.C. 360j(m)(6), to report to Congress on types of devices
    exempted, an evaluation of effects of such section, and a
    recommendation on extension of the section.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-



-CITE-
    21 USC Sec. 360k                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360k. State and local requirements respecting devices

-STATUTE-
    (a) General rule
      Except as provided in subsection (b) of this section, no State or
    political subdivision of a State may establish or continue in
    effect with respect to a device intended for human use any
    requirement - 
        (1) which is different from, or in addition to, any requirement
      applicable under this chapter to the device, and
        (2) which relates to the safety or effectiveness of the device
      or to any other matter included in a requirement applicable to
      the device under this chapter.
    (b) Exempt requirements
      Upon application of a State or a political subdivision thereof,
    the Secretary may, by regulation promulgated after notice and
    opportunity for an oral hearing, exempt from subsection (a) of this
    section, under such conditions as may be prescribed in such
    regulation, a requirement of such State or political subdivision
    applicable to a device intended for human use if - 
        (1) the requirement is more stringent than a requirement under
      this chapter which would be applicable to the device if an
      exemption were not in effect under this subsection; or
        (2) the requirement - 
          (A) is required by compelling local conditions, and
          (B) compliance with the requirement would not cause the
        device to be in violation of any applicable requirement under
        this chapter.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 521, as added Pub. L. 94-295, Sec. 2,
    May 28, 1976, 90 Stat. 574.)

-End-



-CITE-
    21 USC Sec. 360l                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360l. Postmarket surveillance

-STATUTE-
    (a) In general
      The Secretary may by order require a manufacturer to conduct
    postmarket surveillance for any device of the manufacturer which is
    a class II or class III device the failure of which would be
    reasonably likely to have serious adverse health consequences or
    which is intended to be - 
        (1) implanted in the human body for more than one year, or
        (2) a life sustaining or life supporting device used outside a
      device user facility.
    (b) Surveillance approval
      Each manufacturer required to conduct a surveillance of a device
    shall, within 30 days of receiving an order from the Secretary
    prescribing that the manufacturer is required under this section to
    conduct such surveillance, submit, for the approval of the
    Secretary, a plan for the required surveillance. The Secretary,
    within 60 days of the receipt of such plan, shall determine if the
    person designated to conduct the surveillance has appropriate
    qualifications and experience to undertake such surveillance and if
    the plan will result in the collection of useful data that can
    reveal unforeseen adverse events or other information necessary to
    protect the public health. The Secretary, in consultation with the
    manufacturer, may by order require a prospective surveillance
    period of up to 36 months. Any determination by the Secretary that
    a longer period is necessary shall be made by mutual agreement
    between the Secretary and the manufacturer or, if no agreement can
    be reached, after the completion of a dispute resolution process as
    described in section 360bbb-1 of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 522, as added Pub. L. 101-629, Sec.
    10, Nov. 28, 1990, 104 Stat. 4521; amended Pub. L. 102-300, Sec.
    3(b), June 16, 1992, 106 Stat. 239; Pub. L. 105-115, title II, Sec.
    212, Nov. 21, 1997, 111 Stat. 2346.)


-MISC1-
                                AMENDMENTS                            
      1997 - Pub. L. 105-115 amended section generally, substituting
    present provisions for former provisions which related to required
    surveillance, discretionary surveillance, and surveillance
    approval.
      1992 - Subsec. (b). Pub. L. 102-300 substituted "(a)(1)" for
    "(a)", inserted comma after "commerce", and inserted after first
    sentence "Each manufacturer required to conduct a surveillance of a
    device under subsection (a)(2) of this section shall, within 30
    days after receiving notice that the manufacturer is required to
    conduct such surveillance, submit, for the approval of the
    Secretary, a protocol for the required surveillance."

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Section 212 of Pub. L. 105-115 provided in part that the
    amendment made by that section is effective 90 days after Nov. 21,
    1997.

    STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET SURVEILLANCE REGARDING
                           PEDIATRIC POPULATIONS
      Pub. L. 107-250, title II, Sec. 212, Oct. 26, 2002, 116 Stat.
    1614, as amended by Pub. L. 108-214, Sec. 2(d)(3)(C), Apr. 1, 2004,
    118 Stat. 577, provided that:
      "(a) In General. - The Secretary of Health and Human Services
    (referred to in this section as the 'Secretary') shall request the
    Institute of Medicine to enter into an agreement with the Secretary
    under which such Institute conducts a study for the purpose of
    determining whether the system under the Federal Food, Drug, and
    Cosmetic Act [21 U.S.C. 301 et seq.] for the postmarket
    surveillance of medical devices provides adequate safeguards
    regarding the use of devices in pediatric populations.
      "(b) Certain Matters. - The Secretary shall ensure that
    determinations made in the study under subsection (a) include
    determinations of - 
        "(1) whether postmarket surveillance studies of implanted
      medical devices are of long enough duration to evaluate the
      impact of growth and development for the number of years that the
      child will have the implant, and whether the studies are adequate
      to evaluate how children's active lifestyles may affect the
      failure rate and longevity of the implant; and
        "(2) whether the postmarket surveillance by the Food and Drug
      Administration of medical devices used in pediatric populations
      is sufficient to provide adequate safeguards for such
      populations, taking into account the Secretary's monitoring of
      commitments made at the time of approval of medical devices and
      the Secretary's monitoring and use of adverse reaction reports,
      registries, and other postmarket surveillance activities.
      "(c) Report to Congress. - The Secretary shall ensure that, not
    later than four years after the date of the enactment of this Act
    [Oct. 26, 2002], a report describing the findings of the study
    under subsection (a) is submitted to the Congress. The report shall
    include any recommendations of the Secretary for administrative or
    legislative changes to the system of postmarket surveillance
    referred to in such subsection."

-End-



-CITE-
    21 USC Sec. 360m                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part A - Drugs and Devices

-HEAD-
    Sec. 360m. Accredited persons

-STATUTE-
    (a) In general
      (1) Review and classification of devices
        Not later than 1 year after November 21, 1997, the Secretary
      shall, subject to paragraph (3), accredit persons for the purpose
      of reviewing reports submitted under section 360(k) of this title
      and making recommendations to the Secretary regarding the initial
      classification of devices under section 360c(f)(1) of this title.
      (2) Requirements regarding review
        (A) In general
          In making a recommendation to the Secretary under paragraph
        (1), an accredited person shall notify the Secretary in writing
        of the reasons for the recommendation.
        (B) Time period for review
          Not later than 30 days after the date on which the Secretary
        is notified under subparagraph (A) by an accredited person with
        respect to a recommendation of an initial classification of a
        device, the Secretary shall make a determination with respect
        to the initial classification.
        (C) Special rule
          The Secretary may change the initial classification under
        section 360c(f)(1) of this title that is recommended under
        paragraph (1) by an accredited person, and in such case shall
        provide to such person, and the person who submitted the report
        under section 360(k) of this title for the device, a statement
        explaining in detail the reasons for the change.
      (3) Certain devices
        (A) In general
          An accredited person may not be used to perform a review of -
        
            (i) a class III device;
            (ii) a class II device which is intended to be permanently
          implantable or life sustaining or life supporting; or
            (iii) a class II device which requires clinical data in the
          report submitted under section 360(k) of this title for the
          device, except that the number of class II devices to which
          the Secretary applies this clause for a year, less the number
          of such reports to which clauses (i) and (ii) apply, may not
          exceed 6 percent of the number that is equal to the total
          number of reports submitted to the Secretary under such
          section for such year less the number of such reports to
          which such clauses apply for such year.
        (B) Adjustment
          In determining for a year the ratio described in subparagraph
        (A)(iii), the Secretary shall not include in the numerator
        class III devices that the Secretary reclassified into class
        II, and the Secretary shall include in the denominator class II
        devices for which reports under section 360(k) of this title
        were not required to be submitted by reason of the operation of
        section 360(m) of this title.
    (b) Accreditation
      (1) Programs
        The Secretary shall provide for such accreditation through
      programs administered by the Food and Drug Administration, other
      government agencies, or by other qualified nongovernment
      organizations.
      (2) Accreditation
        (A) In general
          Not later than 180 days after November 21, 1997, the
        Secretary shall establish and publish in the Federal Register
        criteria to accredit or deny accreditation to persons who
        request to perform the duties specified in subsection (a) of
        this section. The Secretary shall respond to a request for
        accreditation within 60 days of the receipt of the request. The
        accreditation of such person shall specify the particular
        activities under subsection (a) of this section for which such
        person is accredited.
        (B) Withdrawal of accreditation
          The Secretary may suspend or withdraw accreditation of any
        person accredited under this paragraph, after providing notice
        and an opportunity for an informal hearing, when such person is
        substantially not in compliance with the requirements of this
        section or poses a threat to public health or fails to act in a
        manner that is consistent with the purposes of this section.
        (C) Performance auditing
          To ensure that persons accredited under this section will
        continue to meet the standards of accreditation, the Secretary
        shall - 
            (i) make onsite visits on a periodic basis to each
          accredited person to audit the performance of such person;
          and
            (ii) take such additional measures as the Secretary
          determines to be appropriate.
        (D) Annual report
          The Secretary shall include in the annual report required
        under section 393(g) of this title the names of all accredited
        persons and the particular activities under subsection (a) of
        this section for which each such person is accredited and the
        name of each accredited person whose accreditation has been
        withdrawn during the year.
      (3) Qualifications
        An accredited person shall, at a minimum, meet the following
      requirements:
          (A) Such person may not be an employee of the Federal
        Government.
          (B) Such person shall be an independent organization which is
        not owned or controlled by a manufacturer, supplier, or vendor
        of devices and which has no organizational, material, or
        financial affiliation with such a manufacturer, supplier, or
        vendor.
          (C) Such person shall be a legally constituted entity
        permitted to conduct the activities for which it seeks
        accreditation.
          (D) Such person shall not engage in the design, manufacture,
        promotion, or sale of devices.
          (E) The operations of such person shall be in accordance with
        generally accepted professional and ethical business practices
        and shall agree in writing that as a minimum it will - 
            (i) certify that reported information accurately reflects
          data reviewed;
            (ii) limit work to that for which competence and capacity
          are available;
            (iii) treat information received, records, reports, and
          recommendations as proprietary information;
            (iv) promptly respond and attempt to resolve complaints
          regarding its activities for which it is accredited; and
            (v) protect against the use, in carrying out subsection (a)
          of this section with respect to a device, of any officer or
          employee of the person who has a financial conflict of
          interest regarding the device, and annually make available to
          the public disclosures of the extent to which the person, and
          the officers and employees of the person, have maintained
          compliance with requirements under this clause relating to
          financial conflicts of interest.
      (4) Selection of accredited persons
        The Secretary shall provide each person who chooses to use an
      accredited person to receive a section 360(k) of this title
      report a panel of at least two or more accredited persons from
      which the regulated person may select one for a specific
      regulatory function.
      (5) Compensation of accredited persons
        Compensation for an accredited person shall be determined by
      agreement between the accredited person and the person who
      engages the services of the accredited person, and shall be paid
      by the person who engages such services.
    (c) Duration
      The authority provided by this section terminates October 1,
    2007.
    (d) Report
      Not later than January 10, 2007, the Secretary shall conduct a
    study based on the experience under the program under this section
    and submit to the Committee on Energy and Commerce of the House of
    Representatives, and the Committee on Health, Education, Labor, and
    Pensions of the Senate, a report describing the findings of the
    study. The objectives of the study shall include determining - 
        (1) the number of devices reviewed under this section;
        (2) the number of devices reviewed under this section that were
      ultimately cleared by the Secretary;
        (3) the number of devices reviewed under this section that were
      ultimately not cleared by the Secretary;
        (4) the average time period for a review under this section
      (including the time it takes for the Secretary to review a
      recommendation of an accredited person under subsection (a) of
      this section and determine the initial device classification);
        (5) the average time period identified in paragraph (4)
      compared to the average time period for review of devices solely
      by the Secretary pursuant to section 360(k) of this title;
        (6) if there is a difference in the average time period under
      paragraph (4) and the average time period under paragraph (5),
      the reasons for such difference;
        (7) whether the quality of reviews under this section for
      devices for which no guidance has been issued is qualitatively
      inferior to reviews by the Secretary for devices for which no
      guidance has been issued;
        (8) whether the quality of reviews under this section of
      devices for which no guidance has been issued is qualitatively
      inferior to reviews under this section of devices for which
      guidance has been issued;
        (9) whether this section has in any way jeopardized or improved
      the public health;
        (10) any impact of this section on resources available to the
      Secretary to review reports under section 360(k) of this title;
      and
        (11) any suggestions for continuation, modification (including
      contraction or expansion of device eligibility), or termination
      of this section that the Secretary determines to be appropriate.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 523, as added Pub. L. 105-115, title
    II, Sec. 210(a), Nov. 21, 1997, 111 Stat. 2342; amended Pub. L. 107-
    250, title II, Sec. 202, Oct. 26, 2002, 116 Stat. 1609.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (c). Pub. L. 107-250, Sec. 202(1), substituted
    "The authority provided by this section terminates October 1,
    2007." for "The authority provided by this section terminates - 
        "(1) 5 years after the date on which the Secretary notifies
      Congress that at least 2 persons accredited under subsection (b)
      of this section are available to review at least 60 percent of
      the submissions under section 360(k) of this title, or
        "(2) 4 years after the date on which the Secretary notifies
      Congress that the Secretary has made a determination described in
      paragraph (2)(B) of subsection (a) of this section for at least
      35 percent of the devices that are subject to review under
      paragraph (1) of such subsection,
    whichever occurs first."
      Subsec. (d). Pub. L. 107-250, Sec. 202(2), added subsec. (d).

                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    a note under section 321 of this title.

                    REPORTS ON PROGRAM OF ACCREDITATION                
      Pub. L. 105-115, title II, Sec. 210(d), Nov. 21, 1997, 111 Stat.
    2345, provided that:
      "(1) Comptroller general. - 
        "(A) Implementation of program. - Not later than 5 years after
      the date of the enactment of this Act [Nov. 21, 1997], the
      Comptroller General of the United States shall submit to the
      Committee on Commerce [now Committee on Energy and Commerce] of
      the House of Representatives and the Committee on Labor and Human
      Resources [now Committee on Health, Education, Labor, and
      Pensions] of the Senate a report describing the extent to which
      the program of accreditation required by the amendment made by
      subsection (a) [enacting this section] has been implemented.
        "(B) Evaluation of program. - Not later than 6 months prior to
      the date on which, pursuant to subsection (c) of section 523 of
      the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360m(c)] (as
      added by subsection (a)), the authority provided under subsection
      (a) of such section will terminate, the Comptroller General shall
      submit to the Committee on Commerce [now Committee on Energy and
      Commerce] of the House of Representatives and the Committee on
      Labor and Human Resources [now Committee on Health, Education,
      Labor, and Pensions] of the Senate a report describing the use of
      accredited persons under such section 523, including an
      evaluation of the extent to which such use assisted the Secretary
      in carrying out the duties of the Secretary under such Act [21
      U.S.C. 301 et seq.] with respect to devices, and the extent to
      which such use promoted actions which are contrary to the
      purposes of such Act.
      "(2) Inclusion of certain devices within program. - Not later
    than 3 years after the date of the enactment of this Act [Nov. 21,
    1997], the Secretary of Health and Human Services shall submit to
    the Committee on Commerce of the House of Representatives and the
    Committee on Labor and Human Resources [now Committee on Health,
    Education, Labor, and Pensions] of the Senate a report providing a
    determination by the Secretary of whether, in the program of
    accreditation established pursuant to the amendment made by
    subsection (a), the limitation established in clause (iii) of
    section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act
    [21 U.S.C. 360m(a)(3)(A)] (relating to class II devices for which
    clinical data are required in reports under section 510(k) [21
    U.S.C. 360(k)]) should be removed."

-End-


-CITE-
    21 USC Part B - Drugs for Rare Diseases or Conditions       01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
              PART B - DRUGS FOR RARE DISEASES OR CONDITIONS          

-End-



-CITE-
    21 USC Sec. 360aa                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360aa. Recommendations for investigations of drugs for rare
      diseases or conditions

-STATUTE-
    (a) Request by sponsor; response by Secretary
      The sponsor of a drug for a disease or condition which is rare in
    the States may request the Secretary to provide written
    recommendations for the non-clinical and clinical investigations
    which must be conducted with the drug before - 
        (1) it may be approved for such disease or condition under
      section 355 of this title, or
        (2) if the drug is a biological product, it may be licensed for
      such disease or condition under section 262 of title 42.

    If the Secretary has reason to believe that a drug for which a
    request is made under this section is a drug for a disease or
    condition which is rare in the States, the Secretary shall provide
    the person making the request written recommendations for the non-
    clinical and clinical investigations which the Secretary believes,
    on the basis of information available to the Secretary at the time
    of the request under this section, would be necessary for approval
    of such drug for such disease or condition under section 355 of
    this title or licensing of such drug for such disease or condition
    under section 262 of title 42.
    (b) Regulations
      The Secretary shall by regulation promulgate procedures for the
    implementation of subsection (a) of this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 525, as added Pub. L. 97-414, Sec.
    2(a), Jan. 4, 1983, 96 Stat. 2049; amended Pub. L. 99-91, Sec.
    3(a)(1), Aug. 15, 1985, 99 Stat. 387; Pub. L. 105-115, title I,
    Sec. 125(b)(2)(F), (G), Nov. 21, 1997, 111 Stat. 2325, 2326.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 125(b)(2)(G), struck
    out ", certification of such drug for such disease or condition
    under section 357 of this title," before "or licensing of such
    drug" in closing provisions.
      Subsec. (a)(1) to (3). Pub. L. 105-115, Sec. 125(b)(2)(F),
    inserted "or" at end of par. (1), redesignated par. (3) as (2), and
    struck out former par. (2), which read as follows: "if the drug is
    an antibiotic, it may be certified for such disease or condition
    under section 357 of this title, or".
      1985 - Subsec. (a). Pub. L. 99-91 struck out "or" at end of par.
    (1), inserted par. (2), redesignated former par. (2) as (3) and
    struck out "before" after "product,", and in last sentence inserted
    provisions relating to certification of such drug for disease or
    condition under section 357 of this title and substituted
    "licensing of such drug for such disease or condition under section
    262 of title 42" for "licensing under section 262 of title 42 for
    such disease or condition".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Section 8 of Pub. L. 99-91 provided that:
      "(a) General Rule. - Except as provided in subsection (b), this
    Act and the amendments made by this Act [amending this section,
    sections 360bb, 360cc, and 360ee of this title, and sections 295g-1
    and 6022 of Title 42, The Public Health and Welfare, and enacting
    provisions set out as notes under section 301 of this title and
    section 236 of Title 42] shall take effect October 1, 1985.
      "(b) Exception. - The amendments made by sections 2, 3, and 6(a)
    [amending this section and sections 360bb and 360cc of this title]
    shall take effect on the date of the enactment of this Act [Aug.
    15, 1985]. The amendment made by section 6(b) [amending section
    6022 of Title 42] shall take effect October 19, 1984. The
    amendments made by section 7 [amending section 295g-1 of Title 42]
    shall take effect October 1, 1984 and shall cease to be in effect
    after September 30, 1985."

                                   STUDY                               
      Pub. L. 100-290, Sec. 3(d), Apr. 18, 1988, 102 Stat. 91, directed
    Secretary of Health and Human Services to conduct a study to
    determine whether the application of subchapter B of chapter V of
    the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360aa et seq.
    (relating to drugs for rare diseases and conditions), and 26 U.S.C.
    28 (relating to tax credit) to medical devices or medical foods for
    rare diseases or conditions or to both was needed to encourage
    development of such devices and foods and report results of the
    study to Congress not later than one year after Apr. 18, 1988.

                          CONGRESSIONAL FINDINGS                      
      Section 1(b) of Pub. L. 97-414 provided that: "The Congress finds
    that - 
        "(1) there are many diseases and conditions, such as
      Huntington's disease, myoclonus, ALS (Lou Gehrig's disease),
      Tourette syndrome, and muscular dystrophy which affect such small
      numbers of individuals residing in the United States that the
      diseases and conditions are considered rare in the United States;
        "(2) adequate drugs for many of such diseases and conditions
      have not been developed;
        "(3) drugs for these diseases and conditions are commonly
      referred to as 'orphan drugs';
        "(4) because so few individuals are affected by any one rare
      disease or condition, a pharmaceutical company which develops an
      orphan drug may reasonably expect the drug to generate relatively
      small sales in comparison to the cost of developing the drug and
      consequently to incur a financial loss;
        "(5) there is reason to believe that some promising orphan
      drugs will not be developed unless changes are made in the
      applicable Federal laws to reduce the costs of developing such
      drugs and to provide financial incentives to develop such drugs;
      and
        "(6) it is in the public interest to provide such changes and
      incentives for the development of orphan drugs."

-End-



-CITE-
    21 USC Sec. 360bb                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360bb. Designation of drugs for rare diseases or conditions

-STATUTE-
    (a) Request by sponsor; preconditions; "rare disease or condition"
      defined
      (1) The manufacturer or the sponsor of a drug may request the
    Secretary to designate the drug as a drug for a rare disease or
    condition. A request for designation of a drug shall be made before
    the submission of an application under section 355(b) of this title
    for the drug, or the submission of an application for licensing of
    the drug under section 262 of title 42. If the Secretary finds that
    a drug for which a request is submitted under this subsection is
    being or will be investigated for a rare disease or condition and -
    
        (A) if an application for such drug is approved under section
      355 of this title, or
        (B) if a license for such drug is issued under section 262 of
      title 42,

    the approval, certification, or license would be for use for such
    disease or condition, the Secretary shall designate the drug as a
    drug for such disease or condition. A request for a designation of
    a drug under this subsection shall contain the consent of the
    applicant to notice being given by the Secretary under subsection
    (b) of this section respecting the designation of the drug.
      (2) For purposes of paragraph (1), the term "rare disease or
    condition" means any disease or condition which (A) affects less
    than 200,000 persons in the United States, or (B) affects more than
    200,000 in the United States and for which there is no reasonable
    expectation that the cost of developing and making available in the
    United States a drug for such disease or condition will be
    recovered from sales in the United States of such drug.
    Determinations under the preceding sentence with respect to any
    drug shall be made on the basis of the facts and circumstances as
    of the date the request for designation of the drug under this
    subsection is made.
    (b) Notification of discontinuance of drug or application as
      condition
      A designation of a drug under subsection (a) of this section
    shall be subject to the condition that - 
        (1) if an application was approved for the drug under section
      355(b) of this title or a license was issued for the drug under
      section 262 of title 42, the manufacturer of the drug will notify
      the Secretary of any discontinuance of the production of the drug
      at least one year before discontinuance, and
        (2) if an application has not been approved for the drug under
      section 355(b) of this title or a license has not been issued for
      the drug under section 262 of title 42 and if preclinical
      investigations or investigations under section 355(i) of this
      title are being conducted with the drug, the manufacturer or
      sponsor of the drug will notify the Secretary of any decision to
      discontinue active pursuit of approval of an application under
      section 355(b) of this title or approval of a license under
      section 262 of title 42.
    (c) Notice to public
      Notice respecting the designation of a drug under subsection (a)
    of this section shall be made available to the public.
    (d) Regulations
      The Secretary shall by regulation promulgate procedures for the
    implementation of subsection (a) of this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 526, as added Pub. L. 97-414, Sec.
    2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-551, Sec.
    4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, Sec. 3(a)(2),
    Aug. 15, 1985, 99 Stat. 387; Pub. L. 100-290, Sec. 2, Apr. 18,
    1988, 102 Stat. 90; Pub. L. 105-115, title I, Sec. 125(b)(2)(H),
    (I), Nov. 21, 1997, 111 Stat. 2326.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 125(b)(2)(H), struck
    out "the submission of an application for certification of the drug
    under section 357 of this title," before "or the submission of an
    application for licensing of the drug" in introductory provisions,
    inserted "or" at end of subpar. (A), redesignated subpar. (C) as
    (B), and struck out former subpar. (B) which read as follows: "if a
    certification for such drug is issued under section 357 of this
    title, or".
      Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(I)(i), struck out
    ", a certificate was issued for the drug under section 357 of this
    title," before "or a license was issued".
      Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(I)(ii), struck
    out ", a certificate has not been issued for the drug under section
    357 of this title," before "or a license has not been issued" and
    ", approval of an application for certification under section 357
    of this title," before "or approval of a license".
      1988 - Subsec. (a)(1). Pub. L. 100-290, Sec. 2(a), inserted after
    first sentence "A request for designation of a drug shall be made
    before the submission of an application under section 355(b) of
    this title for the drug, the submission of an application for
    certification of the drug under section 357 of this title, or the
    submission of an application for licensing of the drug under
    section 262 of title 42."
      Subsecs. (b) to (d). Pub. L. 100-290, Sec. 2(b), added subsec.
    (b) and redesignated former subsecs. (b) and (c) as (c) and (d),
    respectively.
      1985 - Subsec. (a)(1). Pub. L. 99-91 struck out "or" at end of
    subpar. (A), struck out subpar. (B) and substituted subpars. (B)
    and (C), and inserted ", certification," after "approval".
      1984 - Subsec. (a)(2). Pub. L. 98-551 substituted "which (A)
    affects less than 200,000 persons in the United States, or (B)
    affects more than 200,000 in the United States and for which" for
    "which occurs so infrequently in the United States that".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section
    8(b) of Pub. L. 99-91, set out as a note under section 360aa of
    this title.

-End-



-CITE-
    21 USC Sec. 360cc                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360cc. Protection for drugs for rare diseases or conditions

-STATUTE-
    (a) Exclusive approval, certification, or license
      Except as provided in subsection (b) of this section, if the
    Secretary - 
        (1) approves an application filed pursuant to section 355 of
      this title, or
        (2) issues a license under section 262 of title 42

    for a drug designated under section 360bb of this title for a rare
    disease or condition, the Secretary may not approve another
    application under section 355 of this title or issue another
    license under section 262 of title 42 for such drug for such
    disease or condition for a person who is not the holder of such
    approved application or of such license until the expiration of
    seven years from the date of the approval of the approved
    application or the issuance of the license. Section 355(c)(2) of
    this title does not apply to the refusal to approve an application
    under the preceding sentence.
    (b) Exceptions
      If an application filed pursuant to section 355 of this title is
    approved for a drug designated under section 360bb of this title
    for a rare disease or condition or if a license is issued under
    section 262 of title 42 for such a drug, the Secretary may, during
    the seven-year period beginning on the date of the application
    approval or of the issuance of the license, approve another
    application under section 355 of this title or issue a license
    under section 262 of title 42, for such drug for such disease or
    condition for a person who is not the holder of such approved
    application or of such license if - 
        (1) the Secretary finds, after providing the holder notice and
      opportunity for the submission of views, that in such period the
      holder of the approved application or of the license cannot
      assure the availability of sufficient quantities of the drug to
      meet the needs of persons with the disease or condition for which
      the drug was designated; or
        (2) such holder provides the Secretary in writing the consent
      of such holder for the approval of other applications or the
      issuance of other licenses before the expiration of such seven-
      year period.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 527, as added Pub. L. 97-414, Sec.
    2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98-417, title I,
    Sec. 102(b)(6), Sept. 24, 1984, 98 Stat. 1593; Pub. L. 99-91, Secs.
    2, 3(a)(3), Aug. 15, 1985, 99 Stat. 387, 388; Pub. L. 103-80, Sec.
    3(v), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title I, Sec.
    125(b)(2)(J), (K), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107-281,
    Sec. 4, Nov. 6, 2002, 116 Stat. 1993.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-281, in concluding provisions,
    struck out ", of such certification," after "such approved
    application" and ", the issuance of the certification," after
    "approval of the approved application".
      1997 - Subsec. (a). Pub. L. 105-115, Sec. 125(b)(2)(J), struck
    out ", issue another certification under section 357 of this
    title," before "or issue another license" in closing provisions,
    inserted "or" at end of par. (1), redesignated par. (3) as (2), and
    struck out former par. (2) which read as follows: "issues a
    certification under section 357 of this title, or".
      Subsec. (b). Pub. L. 105-115, Sec. 125(b)(2)(K), in introductory
    provisions, struck out ", if a certification is issued under
    section 357 of this title for such a drug," after "rare disease or
    condition", ", of the issuance of the certification under section
    357 of this title," after "application approval", ", issue another
    certification under section 357 of this title," after "application
    under section 355 of this title", and ", of such certification,"
    after "approved application".
      Subsec. (b)(1). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out ",
    of the certification," after "holder of the approved application".
      Subsec. (b)(2). Pub. L. 105-115, Sec. 125(b)(2)(K), struck out ",
    issuance of other certifications," after "approval of other
    applications".
      1993 - Subsec. (b). Pub. L. 103-80 struck out extraneous comma
    before "or issue a license under section 262" in introductory
    provisions and substituted "the" for "The" at beginning of par.
    (1).
      1985 - Pub. L. 99-91, Sec. 2(3), struck out "unpatented" before
    "drugs" in section catchline.
      Subsec. (a). Pub. L. 99-91, Secs. 2(1), 3(a)(3)(A)-(D), struck
    out "or" at end of par. (1), added par. (2), redesignated former
    par. (2) as (3), struck out "and for which a United States Letter
    of Patent may not be issued" after "rare disease or condition",
    inserted in first sentence ", issue another certification under
    section 357 of this title," after "section 355 of this title" the
    second time it appeared, inserted ", of such certification," after
    "holder of such approved application", and inserted ", the issuance
    of the certification," after "approval of the approved
    application".
      Subsec. (b). Pub. L. 99-91, Secs. 2(2), 3(a)(3)(E)-(K), struck
    out "and if a United States Letter of Patent may not be issued for
    the drug" after "such a drug", substituted ", if a certification is
    issued under section 357 of this title for such a drug, or if a
    license" for "or a license", inserted ", of the issuance of the
    certification under section 357 of this title," after "application
    approval", struck out ", if the drug is a biological product,"
    before "issue a license", inserted ", issue another certification
    under section 357 of this title," after "section 355 of this
    title", inserted ", of such certification," after "holder of such
    approved application", inserted ", of such certification," after
    "application" in par. (1), and inserted ", issuance of other
    certifications," after "other applications" in par. (2).
      1984 - Subsecs. (a), (b). Pub. L. 98-417 substituted "section
    355" for "section 355(b)" wherever appearing.

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Amendment by Pub. L. 99-91 effective Aug. 15, 1985, see section
    8(b) of Pub. L. 99-91, set out as a note under section 360aa of
    this title.

-End-



-CITE-
    21 USC Sec. 360dd                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360dd. Open protocols for investigations of drugs for rare
      diseases or conditions

-STATUTE-
      If a drug is designated under section 360bb of this title as a
    drug for a rare disease or condition and if notice of a claimed
    exemption under section 355(i) of this title or regulations issued
    thereunder is filed for such drug, the Secretary shall encourage
    the sponsor of such drug to design protocols for clinical
    investigations of the drug which may be conducted under the
    exemption to permit the addition to the investigations of persons
    with the disease or condition who need the drug to treat the
    disease or condition and who cannot be satisfactorily treated by
    available alternative drugs.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 528, as added Pub. L. 97-414, Sec.
    2(a), Jan. 4, 1983, 96 Stat. 2051.)

-End-



-CITE-
    21 USC Sec. 360ee                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part B - Drugs for Rare Diseases or Conditions

-HEAD-
    Sec. 360ee. Grants and contracts for development of drugs for rare
      diseases and conditions

-STATUTE-
    (a) Authority of Secretary
      The Secretary may make grants to and enter into contracts with
    public and private entities and individuals to assist in (1)
    defraying the costs of qualified testing expenses incurred in
    connection with the development of drugs for rare diseases and
    conditions, (2) defraying the costs of developing medical devices
    for rare diseases or conditions, and (3) defraying the costs of
    developing medical foods for rare diseases or conditions.
    (b) Definitions
      For purposes of subsection (a) of this section:
        (1) The term "qualified testing" means - 
          (A) human clinical testing - 
            (i) which is carried out under an exemption for a drug for
          a rare disease or condition under section 355(i) of this
          title (or regulations issued under such section); and
            (ii) which occurs after the date such drug is designated
          under section 360bb of this title and before the date on
          which an application with respect to such drug is submitted
          under section 355(b) of this title or under section 262 of
          title 42; and

          (B) preclinical testing involving a drug for a rare disease
        or condition which occurs after the date such drug is
        designated under section 360bb of this title and before the
        date on which an application with respect to such drug is
        submitted under section 355(b) of this title or under section
        262 of title 42.

        (2) The term "rare disease or condition" means (1) in the case
      of a drug, any disease or condition which (A) affects less than
      200,000 persons in the United States, or (B) affects more than
      200,000 in the United States and for which there is no reasonable
      expectation that the cost of developing and making available in
      the United States a drug for such disease or condition will be
      recovered from sales in the United States of such drug, (2) in
      the case of a medical device, any disease or condition that
      occurs so infrequently in the United States that there is no
      reasonable expectation that a medical device for such disease or
      condition will be developed without assistance under subsection
      (a) of this section, and (3) in the case of a medical food, any
      disease or condition that occurs so infrequently in the United
      States that there is no reasonable expectation that a medical
      food for such disease or condition will be developed without
      assistance under subsection (a) of this section. Determinations
      under the preceding sentence with respect to any drug shall be
      made on the basis of the facts and circumstances as of the date
      the request for designation of the drug under section 360bb of
      this title is made.
        (3) The term "medical food" means a food which is formulated to
      be consumed or administered enterally under the supervision of a
      physician and which is intended for the specific dietary
      management of a disease or condition for which distinctive
      nutritional requirements, based on recognized scientific
      principles, are established by medical evaluation.
    (c) Authorization of appropriations
      For grants and contracts under subsection (a) of this section,
    there are authorized to be appropriated such sums as already have
    been appropriated for fiscal year 2002, and $25,000,000 for each of
    the fiscal years 2003 through 2006.

-SOURCE-
    (Pub. L. 97-414, Sec. 5, Jan. 4, 1983, 96 Stat. 2056; Pub. L. 98-
    551, Sec. 4(b), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99-91, Sec.
    5, Aug. 15, 1985, 99 Stat. 391; Pub. L. 100-290, Sec. 3(a)-(c),
    Apr. 18, 1988, 102 Stat. 90, 91; Pub. L. 105-115, title I, Sec.
    125(b)(2)(N), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 107-281, Sec.
    3, Nov. 6, 2002, 116 Stat. 1993.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Orphan Drug Act, and not as
    part of the Federal Food, Drug, and Cosmetic Act which comprises
    this chapter.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (c). Pub. L. 107-281 amended subsec. (c)
    generally. Prior to amendment, subsec. (c) read as follows: "For
    grants and contracts under subsection (a) of this section there are
    authorized to be appropriated $10,000,000 for fiscal year 1988,
    $12,000,000 for fiscal year 1989, $14,000,000 for fiscal year
    1990."
      1997 - Subsec. (b)(1)(A)(ii), (B). Pub. L. 105-115 struck out "or
    357" after "355(b)".
      1988 - Subsec. (a). Pub. L. 100-290, Sec. 3(a)(1), (b)(1),
    inserted "(1)" after "assist in" and added cls. (2) and (3).
      Subsec. (b)(2). Pub. L. 100-290, Sec. 3(a)(2), (b)(2), inserted
    "(1) in the case of a drug," after "means", added cls. (2) and (3),
    and substituted "under section 360bb of this title" for "under this
    subsection" in last sentence.
      Subsec. (b)(3). Pub. L. 100-290, Sec. 3(b)(3), added par. (3).
      Subsec. (c). Pub. L. 100-290, Sec. 3(c), amended subsec. (c)
    generally. Prior to amendment, subsec. (c) read as follows: "For
    grants and contracts under subsection (a) of this section there are
    authorized to be appropriated $4,000,000 for fiscal year 1986,
    $4,000,000 for fiscal year 1987, and $4,000,000 for fiscal year
    1988."
      1985 - Subsec. (a). Pub. L. 99-91, Sec. 5(a)(1), struck out
    "clinical" before "testing".
      Subsec. (b)(1). Pub. L. 99-91, Sec. 5(a)(2), substituted
    provisions defining "qualified testing" for provisions defining
    "qualified clinical testing".
      Subsec. (c). Pub. L. 99-91, Sec. 5(b), substituted provisions
    authorizing appropriations for fiscal years 1986 to 1988, for
    provisions authorizing appropriations for fiscal years 1983 and the
    two succeeding fiscal years.
      1984 - Subsec. (b)(2). Pub. L. 98-551 substituted "which (A)
    affects less than 200,000 persons in the United States, or (B)
    affects more than 200,000 in the United States and for which" for
    "which occurs so infrequently in the United States that".

                     EFFECTIVE DATE OF 1985 AMENDMENT                 
      Amendment by Pub. L. 99-91 effective Oct. 1, 1985, see section
    8(a) of Pub. L. 99-91, set out as a note under section 360aa of
    this title.

                           FINDINGS AND PURPOSES                       
      Pub. L. 107-281, Sec. 2, Nov. 6, 2002, 116 Stat. 1992, provided
    that:
      "(a) Findings. - Congress makes the following findings:
        "(1) Rare diseases and disorders are those which affect small
      patient populations, typically populations smaller than 200,000
      individuals in the United States. Such diseases and conditions
      include Huntington's disease, amyotrophic lateral sclerosis (Lou
      Gehrig's disease), Tourette syndrome, Crohn's disease, cystic
      fibrosis, cystinosis, and Duchenne muscular dystrophy.
        "(2) For many years, the 25,000,000 Americans suffering from
      the over 6,000 rare diseases and disorders were denied access to
      effective medicines because prescription drug manufacturers could
      rarely make a profit from marketing drugs for such small groups
      of patients. The prescription drug industry did not adequately
      fund research into such treatments. Despite the urgent health
      need for these medicines, they came to be known as 'orphan drugs'
      because no companies would commercialize them.
        "(3) During the 1970s, an organization called the National
      Organization for Rare Disorders (NORD) was founded to provide
      services and to lobby on behalf of patients with rare diseases
      and disorders. NORD was instrumental in pressing Congress for
      legislation to encourage the development of orphan drugs.
        "(4) The Orphan Drug Act [see Short Title of 1983 Amendments
      note set out under section 301 of this title] created financial
      incentives for the research and production of such orphan drugs.
      New Federal programs at the National Institutes of Health and the
      Food and Drug Administration encouraged clinical research and
      commercial product development for products that target rare
      diseases. An Orphan Products Board was established to promote the
      development of drugs and devices for rare diseases or disorders.
        "(5) Before 1983, some 38 orphan drugs had been developed.
      Since the enactment of the Orphan Drug Act [Jan. 4, 1983], more
      than 220 new orphan drugs have been approved and marketed in the
      United States and more than 800 additional drugs are in the
      research pipeline.
        "(6) Despite the tremendous success of the Orphan Drug Act,
      rare diseases and disorders deserve greater emphasis in the
      national biomedical research enterprise.
        "(7) The Food and Drug Administration supports small clinical
      trials through Orphan Products Research Grants. Such grants
      embody successful partnerships of government and industry, and
      have led to the development of at least 23 drugs and four medical
      devices for rare diseases and disorders. Yet the appropriations
      in fiscal year 2001 for such grants were less than in fiscal year
      1995.
      "(b) Purposes. - The purpose of this Act [see Short Title of 2002
    Amendments note set out under section 301 of this title] is to
    increase the national investment in the development of diagnostics
    and treatments for patients with rare diseases and disorders."

-End-


-CITE-
    21 USC Part C - Electronic Product Radiation Control        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
               PART C - ELECTRONIC PRODUCT RADIATION CONTROL           

-COD-
                               CODIFICATION                           
      This part was classified to subpart 3 (Sec. 263c et seq.) of part
    F of subchapter II of chapter 6A of Title 42, The Public Health and
    Welfare, prior to its renumbering by Pub. L. 101-629, Sec.
    19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as amended by Pub. L. 103-
    80, Sec. 4(a)(2), Aug. 13, 1993, 107 Stat. 779.

-End-



-CITE-
    21 USC Sec. 360hh                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360hh. Definitions

-STATUTE-
      As used in this part - 
        (1) the term "electronic product radiation" means - 
          (A) any ionizing or non-ionizing electromagnetic or
        particulate radiation, or
          (B) any sonic, infrasonic, or ultrasonic wave, which is
        emitted from an electronic product as the result of the
        operation of an electronic circuit in such product;

        (2) the term "electronic product" means (A) any manufactured or
      assembled product which, when in operation, (i) contains or acts
      as part of an electronic circuit and (ii) emits (or in the
      absence of effective shielding or other controls would emit)
      electronic product radiation, or (B) any manufactured or
      assembled article which is intended for use as a component, part,
      or accessory of a product described in clause (A) and which when
      in operation emits (or in the absence of effective shielding or
      other controls would emit) such radiation;
        (3) the term "manufacturer" means any person engaged in the
      business of manufacturing, assembling, or importing of electronic
      products;
        (4) the term "commerce" means (A) commerce between any place in
      any State and any place outside thereof; and (B) commerce wholly
      within the District of Columbia; and
        (5) the term "State" includes the District of Columbia, the
      Commonwealth of Puerto Rico, the Northern Mariana Islands, the
      Virgin Islands, Guam, and American Samoa.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 531, formerly act July 1, 1944, ch.
    373, title III, Sec. 531, formerly Sec. 355, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1174; amended Pub. L. 94-
    484, title IX, Sec. 905(b)(1), Oct. 12, 1976, 90 Stat. 2325;
    renumbered Sec. 531 and amended Pub. L. 101-629, Sec. 19(a)(1)(B),
    (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec.
    4(a)(2), Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263c of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263c of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this part"
    for "this subpart" in introductory provisions.
      1976 - Par. (5). Pub. L. 94-484 defined "State" to include
    Northern Mariana Islands.

                                SHORT TITLE                            
      For short title of Pub. L. 90-602, which enacted provisions now
    comprising this part (Secs. 360hh to 360ss), as the "Radiation
    Control for Health and Safety Act of 1968", see section 1 of Pub.
    L. 90-602, set out as a Short Title of 1968 Amendments note under
    section 301 of this title.

                     TRANSFER OF SUBPART; CONSTRUCTION                 
      Section 19(c) of Pub. L. 101-629 provided that: "The transfer of
    subpart 3 of part F of title III of the Public Health Service Act
    [42 U.S.C. 263b et seq.] to the Federal Food, Drug, and Cosmetic
    Act [this chapter] does not change the application of the
    requirements of such subpart and such Act to electronic products
    which were in effect on the date of the enactment of this Act [Nov.
    28, 1990]."

-CROSS-
                DEFINITION OF "SECRETARY" AND "DEPARTMENT"            
      Section 3 of Pub. L. 90-602, as amended Pub. L. 96-88, title V,
    Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: "As used
    in the amendments made by section 2 of this Act [enacting
    provisions now comprising sections 360hh to 360ss of this title],
    except when otherwise specified, the term 'Secretary' means the
    Secretary of Health and Human Services, and the term 'Department'
    means the Department of Health and Human Services."


-MISC2-
                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Section 4 of Pub. L. 90-602 provided that: "The amendments made
    by section 2 of this Act [enacting provisions now comprising
    sections 360hh to 360ss of this title] shall not be construed as
    superseding or limiting the functions, under any other provision of
    law, of any officer or agency of the United States."

-End-



-CITE-
    21 USC Sec. 360ii                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360ii. Program of control

-STATUTE-
    (a) Establishment
      The Secretary shall establish and carry out an electronic product
    radiation control program designed to protect the public health and
    safety from electronic product radiation. As a part of such
    program, he shall - 
        (1) pursuant to section 360kk of this title, develop and
      administer performance standards for electronic products;
        (2) plan, conduct, coordinate, and support research,
      development, training, and operational activities to minimize the
      emissions of and the exposure of people to, unnecessary
      electronic product radiation;
        (3) maintain liaison with and receive information from other
      Federal and State departments and agencies with related
      interests, professional organizations, industry, industry and
      labor associations, and other organizations on present and future
      potential electronic product radiation;
        (4) study and evaluate emissions of, and conditions of exposure
      to, electronic product radiation and intense magnetic fields;
        (5) develop, test, and evaluate the effectiveness of procedures
      and techniques for minimizing exposure to electronic product
      radiation; and
        (6) consult and maintain liaison with the Secretary of
      Commerce, the Secretary of Defense, the Secretary of Labor, the
      Atomic Energy Commission, and other appropriate Federal
      departments and agencies on (A) techniques, equipment, and
      programs for testing and evaluating electronic product radiation,
      and (B) the development of performance standards pursuant to
      section 360kk of this title to control such radiation emissions.
    (b) Powers of Secretary
      In carrying out the purposes of subsection (a) of this section,
    the Secretary is authorized to - 
        (1)(A) collect and make available, through publications and
      other appropriate means, the results of, and other information
      concerning, research and studies relating to the nature and
      extent of the hazards and control of electronic product
      radiation; and (B) make such recommendations relating to such
      hazards and control as he considers appropriate;
        (2) make grants to public and private agencies, organizations,
      and institutions, and to individuals for the purposes stated in
      paragraphs (2), (4), and (5) of subsection (a) of this section;
        (3) contract with public or private agencies, institutions, and
      organizations, and with individuals, without regard to section
      3324 of title 31 and section 5 of title 41; and
        (4) procure (by negotiation or otherwise) electronic products
      for research and testing purposes, and sell or otherwise dispose
      of such products.
    (c) Record keeping
      (1) Each recipient of assistance under this part pursuant to
    grants or contracts entered into under other than competitive
    bidding procedures shall keep such records as the Secretary shall
    prescribe, including records which fully disclose the amount and
    disposition by such recipient of the proceeds of such assistance,
    the total cost of the project or undertaking in connection with
    which such assistance is given or used, and the amount of that
    portion of the cost of the project or undertaking supplied by other
    sources, and such other records as will facilitate an effective
    audit.
      (2) The Secretary and the Comptroller General of the United
    States, or any of their duly authorized representatives, shall have
    access for the purpose of audit and examination to any books,
    documents, papers, and records of the recipients that are pertinent
    to the grants or contracts entered into under this part under other
    than competitive bidding procedures.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 532, formerly act July 1, 1944, ch.
    373, title III, Sec. 532, formerly Sec. 356, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1174; renumbered Sec. 532
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(A), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263d of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263d of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a)(1), (6). Pub. L. 101-629, Sec. 19(a)(2)(A)(i),
    substituted "section 360kk" for "section 263f".
      Subsec. (b)(3). Pub. L. 101-629, Sec. 19(a)(2)(A)(ii),
    substituted reference to section 3324 of title 31 for reference to
    section 3648 of the Revised Statutes (31 U.S.C. 529).
      Subsec. (c)(1), (2). Pub. L. 101-629, Sec. 19(a)(1)(B),
    substituted "this part" for "this subpart".


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Atomic Energy Commission abolished and functions transferred by
    sections 5814 and 5841 of Title 42, The Public Health and Welfare.
    See also Transfer of Functions notes set out under those sections.


-MISC2-
                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law or any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360jj                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360jj. Studies by Secretary

-STATUTE-
    (a) Report to Congress
      The Secretary shall conduct the following studies, and shall make
    a report or reports of the results of such studies to the Congress
    on or before January 1, 1970, and from time to time thereafter as
    he may find necessary, together with such recommendations for
    legislation as he may deem appropriate:
      (1) A study of present State and Federal control of health
    hazards from electronic product radiation and other types of
    ionizing radiation, which study shall include, but not be limited
    to - 
        (A) control of health hazards from radioactive materials other
      than materials regulated under the Atomic Energy Act of 1954 [42
      U.S.C. 2011 et seq.];
        (B) any gaps and inconsistencies in present controls;
        (C) the need for controlling the sale of certain used
      electronic products, particularly antiquated X-ray equipment,
      without upgrading such products to meet the standards for new
      products or separate standards for used products;
        (D) measures to assure consistent and effective control of the
      aforementioned health hazards;
        (E) measures to strengthen radiological health programs of
      State governments; and
        (F) the feasibility of authorizing the Secretary to enter into
      arrangements with individual States or groups of States to define
      their respective functions and responsibilities for the control
      of electronic product radiation and other ionizing radiation;

      (2) A study to determine the necessity for the development of
    standards for the use of nonmedical electronic products for
    commercial and industrial purposes; and
      (3) A study of the development of practicable procedures for the
    detection and measurement of electronic product radiation which may
    be emitted from electronic products manufactured or imported prior
    to the effective date of any applicable standard established
    pursuant to this part.
    (b) Participation of other Federal agencies
      In carrying out these studies, the Secretary shall invite the
    participation of other Federal departments and agencies having
    related responsibilities and interests, State governments -
    particularly those of States which regulate radioactive materials
    under section 274 of the Atomic Energy Act of 1954, as amended [42
    U.S.C. 2021], and interested professional, labor, and industrial
    organizations. Upon request from congressional committees
    interested in these studies, the Secretary shall keep these
    committees currently informed as to the progress of the studies and
    shall permit the committees to send observers to meetings of the
    study groups.
    (c) Organization of studies and participation
      The Secretary or his designee shall organize the studies and the
    participation of the invited participants as he deems best. Any
    dissent from the findings and recommendations of the Secretary
    shall be included in the report if so requested by the dissenter.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 533, formerly act July 1, 1944, ch.
    373, title III, Sec. 533, formerly Sec. 357, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1176; renumbered Sec. 533
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4), Nov. 28,
    1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug. 13,
    1993, 107 Stat. 779.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Atomic Energy Act of 1954, referred to in subsec. (a)(1)(A),
    is act Aug. 1, 1946, ch. 724, as added by act Aug. 30, 1954, ch.
    1073, Sec. 1, 68 Stat. 921, and amended, which is classified
    generally to chapter 23 (Sec. 2011 et seq.) of Title 42, The Public
    Health and Welfare. For complete classification of this Act to the
    Code, see Short Title note set out under section 2011 of Title 42
    and Tables.

-COD-
                               CODIFICATION                           
      Section was classified to section 263e of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263e of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a)(3). Pub. L. 101-629, Sec. 19(a)(1)(B),
    substituted "this part" for "this subpart".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360kk                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360kk. Performance standards for electronic products

-STATUTE-
    (a) Promulgation of regulations
      (1) The Secretary shall by regulation prescribe performance
    standards for electronic products to control the emission of
    electronic product radiation from such products if he determines
    that such standards are necessary for the protection of the public
    health and safety. Such standards may include provisions for the
    testing of such products and the measurement of their electronic
    product radiation emissions, may require the attachment of warning
    signs and labels, and may require the provision of instructions for
    the installation, operation, and use of such products. Such
    standards may be prescribed from time to time whenever such
    determinations are made, but the first of such standards shall be
    prescribed prior to January 1, 1970. In the development of such
    standards, the Secretary shall consult with Federal and State
    departments and agencies having related responsibilities or
    interests and with appropriate professional organizations and
    interested persons, including representatives of industries and
    labor organizations which would be affected by such standards, and
    shall give consideration to - 
        (A) the latest available scientific and medical data in the
      field of electronic product radiation;
        (B) the standards currently recommended by (i) other Federal
      agencies having responsibilities relating to the control and
      measurement of electronic product radiation, and (ii) public or
      private groups having an expertise in the field of electronic
      product radiation;
        (C) the reasonableness and technical feasibility of such
      standards as applied to a particular electronic product;
        (D) the adaptability of such standards to the need for
      uniformity and reliability of testing and measuring procedures
      and equipment; and
        (E) in the case of a component, or accessory described in
      paragraph (2)(B) of section 360hh of this title, the performance
      of such article in the manufactured or assembled product for
      which it is designed.

      (2) The Secretary may prescribe different and individual
    performance standards, to the extent appropriate and feasible, for
    different electronic products so as to recognize their different
    operating characteristics and uses.
      (3) The performance standards prescribed under this section shall
    not apply to any electronic product which is intended solely for
    export if (A) such product and the outside of any shipping
    container used in the export of such product are labeled or tagged
    to show that such product is intended for export, and (B) such
    product meets all the applicable requirements of the country to
    which such product is intended for export.
      (4) The Secretary may by regulation amend or revoke any
    performance standard prescribed under this section.
      (5) The Secretary may exempt from the provisions of this section
    any electronic product intended for use by departments or agencies
    of the United States provided such department or agency has
    prescribed procurement specifications governing emissions of
    electronic product radiation and provided further that such product
    is of a type used solely or predominantly by departments or
    agencies of the United States.
    (b) Administrative procedure
      The provisions of subchapter II of chapter 5 of title 5 (relating
    to the administrative procedure for rulemaking), and of chapter 7
    of title 5 (relating to judicial review), shall apply with respect
    to any regulation prescribing, amending, or revoking any standard
    prescribed under this section.
    (c) Publication in Federal Register
      Each regulation prescribing, amending, or revoking a standard
    shall specify the date on which it shall take effect which, in the
    case of any regulation prescribing, or amending any standard, may
    not be sooner than one year or not later than two years after the
    date on which such regulation is issued, unless the Secretary
    finds, for good cause shown, that an earlier or later effective
    date is in the public interest and publishes in the Federal
    Register his reason for such finding, in which case such earlier or
    later date shall apply.
    (d) Judicial review
      (1) In a case of actual controversy as to the validity of any
    regulation issued under this section prescribing, amending, or
    revoking a performance standard, any person who will be adversely
    affected by such regulation when it is effective may at any time
    prior to the sixtieth day after such regulation is issued file a
    petition with the United States court of appeals for the circuit
    wherein such person resides or has his principal place of business,
    for a judicial review of such regulation. A copy of the petition
    shall be forthwith transmitted by the clerk of the court to the
    Secretary or other officer designated by him for that purpose. The
    Secretary thereupon shall file in the court the record of the
    proceedings on which the Secretary based the regulation, as
    provided in section 2112 of title 28.
      (2) If the petitioner applies to the court for leave to adduce
    additional evidence, and shows to the satisfaction of the court
    that such additional evidence is material and that there were
    reasonable grounds for the failure to adduce such evidence in the
    proceeding before the Secretary, the court may order such
    additional evidence (and evidence in rebuttal thereof) to be taken
    before the Secretary, and to be adduced upon the hearing, in such
    manner and upon such terms and conditions as to the court may seem
    proper. The Secretary may modify his findings, or make new
    findings, by reason of the additional evidence so taken, and he
    shall file such modified or new findings, and his recommendations,
    if any, for the modification or setting aside of his original
    regulation, with the return of such additional evidence.
      (3) Upon the filing of the petition referred to in paragraph (1)
    of this subsection, the court shall have jurisdiction to review the
    regulation in accordance with chapter 7 of title 5 and to grant
    appropriate relief as provided in such chapter.
      (4) The judgment of the court affirming or setting aside, in
    whole or in part, any such regulation of the Secretary shall be
    final, subject to review by the Supreme Court of the United States
    upon certiorari or certification as provided in section 1254 of
    title 28.
      (5) Any action instituted under this subsection shall survive,
    notwithstanding any change in the person occupying the office of
    Secretary or any vacancy in such office.
      (6) The remedies provided for in this subsection shall be in
    addition to and not in substitution for any other remedies provided
    by law.
    (e) Availability of record
      A certified copy of the transcript of the record and
    administrative proceedings under this section shall be furnished by
    the Secretary to any interested party at his request, and payment
    of the costs thereof, and shall be admissible in any criminal,
    exclusion of imports, or other proceeding arising under or in
    respect of this part irrespective of whether proceedings with
    respect to the regulation have previously been initiated or become
    final under this section.
    (f) Technical Electronic Product Radiation Safety Standards
      Committee
      (1)(A) The Secretary shall establish a Technical Electronic
    Product Radiation Safety Standards Committee (hereafter in this
    part referred to as the "Committee") which he shall consult before
    prescribing any standard under this section. The Committee shall be
    appointed by the Secretary, after consultation with public and
    private agencies concerned with the technical aspect of electronic
    product radiation safety, and shall be composed of fifteen members
    each of whom shall be technically qualified by training and
    experience in one or more fields of science or engineering
    applicable to electronic product radiation safety, as follows:
        (i) Five members shall be selected from governmental agencies,
      including State and Federal Governments;
        (ii) Five members shall be selected from the affected
      industries after consultation with industry representatives; and
        (iii) Five members shall be selected from the general public,
      of which at least one shall be a representative of organized
      labor.

      (B) The Committee may propose electronic product radiation safety
    standards to the Secretary for his consideration. All proceedings
    of the Committee shall be recorded and the record of each such
    proceeding shall be available for public inspection.
      (2) Payments to members of the Committee who are not officers or
    employees of the United States pursuant to subsection (c) of
    section 210 of title 42 shall not render members of the Committee
    officers or employees of the United States for any purpose.
    (g) Review and evaluation
      The Secretary shall review and evaluate on a continuing basis
    testing programs carried out by industry to assure the adequacy of
    safeguards against hazardous electronic product radiation and to
    assure that electronic products comply with standards prescribed
    under this section.
    (h) Product certification
      Every manufacturer of an electronic product to which is
    applicable a standard in effect under this section shall furnish to
    the distributor or dealer at the time of delivery of such product,
    in the form of a label or tag permanently affixed to such product
    or in such manner as approved by the Secretary, the certification
    that such product conforms to all applicable standards under this
    section. Such certification shall be based upon a test, in
    accordance with such standard, of the individual article to which
    it is attached or upon a testing program which is in accord with
    good manufacturing practice and which has not been disapproved by
    the Secretary (in such manner as he shall prescribe by regulation)
    on the grounds that it does not assure the adequacy of safeguards
    against hazardous electronic product radiation or that it does not
    assure that electronic products comply with the standards
    prescribed under this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 534, formerly act July 1, 1944, ch.
    373, title III, Sec. 534, formerly Sec. 358, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1177; amended Pub. L. 91-
    515, title VI, Sec. 601(b)(2), (3), Oct. 30, 1970, 84 Stat. 1311;
    renumbered Sec. 534 and amended Pub. L. 101-629, Sec. 19(a)(1)(B),
    (2)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-
    80, Secs. 3(w), 4(a)(2), Aug. 13, 1993, 107 Stat. 778, 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263f of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80, Sec. 4(a)(2), amended directory language
    of Pub. L. 101-629, Sec. 19(a)(4), which renumbered section 263f of
    Title 42, The Public Health and Welfare, as this section.
      Subsec. (f)(2). Pub. L. 103-80, Sec. 3(w), made technical
    amendment to reference to section 210 of title 42 to reflect
    correction of corresponding provision of original act.
      1990 - Subsec. (a)(1)(E). Pub. L. 101-629, Sec. 19(a)(2)(B),
    substituted "section 360hh" for "section 263c".
      Subsecs. (e), (f)(1)(A). Pub. L. 101-629, Sec. 19(a)(1)(B),
    substituted "this part" for "this subpart".
      1970 - Subsec. (f)(2). Pub. L. 91-515 struck out provisions
    related to payment of compensation and travel expenses of members
    of the Committee who are not officers or employees of the United
    States, and substituted "to members of the Committee who are not
    officers or employees of the United States pursuant to subsection
    (c) of section 210 of title 42" for "under this subsection".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360ll                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360ll. Notification of defects in and repair or replacement of
      electronic products

-STATUTE-
    (a) Notification; exemption
      (1) Every manufacturer of electronic products who discovers that
    an electronic product produced, assembled, or imported by him has a
    defect which relates to the safety of use of such product by reason
    of the emission of electronic product radiation, or that an
    electronic product produced, assembled, or imported by him on or
    after the effective date of an applicable standard prescribed
    pursuant to section 360kk of this title fails to comply with such
    standard, shall immediately notify the Secretary of such defect or
    failure to comply if such product has left the place of manufacture
    and shall (except as authorized by paragraph (2)) with reasonable
    promptness furnish notification of such defect or failure to the
    persons (where known to the manufacturer) specified in subsection
    (b) of this section.
      (2) If, in the opinion of such manufacturer, the defect or
    failure to comply is not such as to create a significant risk of
    injury, including genetic injury, to any person, he may, at the
    time of giving notice to the Secretary of such defect or failure to
    comply, apply to the Secretary for an exemption from the
    requirement of notice to the persons specified in subsection (b) of
    this section. If such application states reasonable grounds for
    such exemption, the Secretary shall afford such manufacturer an
    opportunity to present his views and evidence in support of the
    application, the burden of proof being on the manufacturer. If,
    after such presentation, the Secretary is satisfied that such
    defect or failure to comply is not such as to create a significant
    risk of injury, including genetic injury, to any person, he shall
    exempt such manufacturer from the requirement of notice to the
    persons specified in subsection (b) of this section and from the
    requirements of repair or replacement imposed by subsection (f) of
    this section.
    (b) Method of notification
      The notification (other than to the Secretary) required by
    paragraph (1) of subsection (a) of this section shall be
    accomplished - 
        (1) by certified mail to the first purchaser of such product
      for purposes other than resale, and to any subsequent transferee
      of such product; and
        (2) by certified mail or other more expeditious means to the
      dealers or distributors of such manufacturer to whom such product
      was delivered.
    (c) Requisite elements of notification
      The notifications required by paragraph (1) of subsection (a) of
    this section shall contain a clear description of such defect or
    failure to comply with an applicable standard, an evaluation of the
    hazard reasonably related to such defect or failure to comply, and
    a statement of the measures to be taken to repair such defect. In
    the case of a notification to a person referred to in subsection
    (b) of this section, the notification shall also advise the person
    of his rights under subsection (f) of this section.
    (d) Copies to Secretary of communications by manufacturers to
      dealers or distributors regarding defects
      Every manufacturer of electronic products shall furnish to the
    Secretary a true or representative copy of all notices, bulletins,
    and other communications to the dealers or distributors of such
    manufacturer or to purchasers (or subsequent transferees) of
    electronic products of such manufacturer regarding any such defect
    in such product or any such failure to comply with a standard
    applicable to such product. The Secretary shall disclose to the
    public so much of the information contained in such notice or other
    information obtained under section 360nn of this title as he deems
    will assist in carrying out the purposes of this part, but he shall
    not disclose any information which contains or relates to a trade
    secret or other matter referred to in section 1905 of title 18
    unless he determines that it is necessary to carry out the purposes
    of this part.
    (e) Notice from Secretary to manufacturer of defects or failure to
      comply with standards
      If through testing, inspection, investigation, or research
    carried out pursuant to this part, or examination of reports
    submitted pursuant to section 360nn of this title, or otherwise,
    the Secretary determines that any electronic product - 
        (1) does not comply with an applicable standard prescribed
      pursuant to section 360kk of this title; or
        (2) contains a defect which relates to the safety of use of
      such product by reason of the emission of electronic product
      radiation;

    he shall immediately notify the manufacturer of such product of
    such defect or failure to comply. The notice shall contain the
    findings of the Secretary and shall include all information upon
    which the findings are based. The Secretary shall afford such
    manufacturer an opportunity to present his views and evidence in
    support thereof, to establish that there is no failure of
    compliance or that the alleged defect does not exist or does not
    relate to safety of use of the product by reason of the emission of
    such radiation hazard. If after such presentation by the
    manufacturer the Secretary determines that such product does not
    comply with an applicable standard prescribed pursuant to section
    360kk of this title, or that it contains a defect which relates to
    the safety of use of such product by reason of the emission of
    electronic product radiation, the Secretary shall direct the
    manufacturer to furnish the notification specified in subsection
    (c) of this section to the persons specified in paragraphs (1) and
    (2) of subsection (b) of this section (where known to the
    manufacturer), unless the manufacturer has applied for an exemption
    from the requirement of such notification on the ground specified
    in paragraph (2) of subsection (a) of this section and the
    Secretary is satisfied that such noncompliance or defect is not
    such as to create a significant risk of injury, including genetic
    injury, to any person.
    (f) Correction of defects
      If any electronic product is found under subsection (a) or (e) of
    this section to fail to comply with an applicable standard
    prescribed under this part or to have a defect which relates to the
    safety of use of such product, and the notification specified in
    subsection (c) of this section is required to be furnished on
    account of such failure or defect, the manufacturer of such product
    shall (1) without charge, bring such product into conformity with
    such standard or remedy such defect and provide reimbursement for
    any expenses for transportation of such product incurred in
    connection with having such product brought into conformity or
    having such defect remedied, (2) replace such product with a like
    or equivalent product which complies with each applicable standard
    prescribed under this part and which has no defect relating to the
    safety of its use, or (3) make a refund of the cost of such
    product. The manufacturer shall take the action required by this
    subsection in such manner, and with respect to such persons, as the
    Secretary by regulations shall prescribe.
    (g) Effective date
      This section shall not apply to any electronic product that was
    manufactured before October 18, 1968.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 535, formerly act July 1, 1944, ch.
    373, title III, Sec. 535, formerly Sec. 359, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered Sec. 535
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263g of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263g of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 19(a)(2)(C)(i),
    substituted "section 360kk" for "section 263f".
      Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C)(ii),
    substituted "section 360nn" for "section 263i" and "this part" for
    "this subpart" in two places.
      Subsec. (e). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C),
    substituted "this part" for "this subpart" and "section 360nn" for
    "section 263i" in introductory provisions and "section 360kk" for
    "section 263f" in par. (1) and concluding provisions.
      Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
    part" for "this subpart" in two places.

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360mm                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360mm. Imports

-STATUTE-
    (a) Refusal of admission to noncomplying electronic products
      Any electronic product offered for importation into the United
    States which fails to comply with an applicable standard prescribed
    under this part, or to which is not affixed a certification in the
    form of a label or tag in conformity with section 360kk(h) of this
    title shall be refused admission into the United States. The
    Secretary of the Treasury shall deliver to the Secretary of Health
    and Human Services, upon the latter's request, samples of
    electronic products which are being imported or offered for import
    into the United States, giving notice thereof to the owner or
    consignee, who may have a hearing before the Secretary of Health
    and Human Services. If it appears from an examination of such
    samples or otherwise that any electronic product fails to comply
    with applicable standards prescribed pursuant to section 360kk of
    this title, then, unless subsection (b) of this section applies and
    is complied with, (1) such electronic product shall be refused
    admission, and (2) the Secretary of the Treasury shall cause the
    destruction of such electronic product unless such article is
    exported, under regulations prescribed by the Secretary of the
    Treasury, within 90 days after the date of notice of refusal of
    admission or within such additional time as may be permitted by
    such regulations.
    (b) Bond
      If it appears to the Secretary of Health and Human Services that
    any electronic product refused admission pursuant to subsection (a)
    of this section can be brought into compliance with applicable
    standards prescribed pursuant to section 360kk of this title, final
    determination as to admission of such electronic product may be
    deferred upon filing of timely written application by the owner or
    consignee and the execution by him of a good and sufficient bond
    providing for the payment of such liquidated damages in the event
    of default as the Secretary of Health and Human Services may by
    regulation prescribe. If such application is filed and such bond is
    executed the Secretary of Health and Human Services may, in
    accordance with rules prescribed by him, permit the applicant to
    perform such operations with respect to such electronic product as
    may be specified in the notice of permission.
    (c) Liability of owner or consignee for expenses connected with
      refusal of admission
      All expenses (including travel, per diem or subsistence, and
    salaries of officers or employees of the United States) in
    connection with the destruction provided for in subsection (a) of
    this section and the supervision of operations provided for in
    subsection (b) of this section, and all expenses in connection with
    the storage, cartage, or labor with respect to any electronic
    product refused admission pursuant to subsection (a) of this
    section, shall be paid by the owner or consignee, and, in event of
    default, shall constitute a lien against any future importations
    made by such owner or consignee.
    (d) Designation of agent for purposes of service
      It shall be the duty of every manufacturer offering an electronic
    product for importation into the United States to designate in
    writing an agent upon whom service of all administrative and
    judicial processes, notices, orders, decisions, and requirements
    may be made for and on behalf of said manufacturer, and to file
    such designation with the Secretary, which designation may from
    time to time be changed by like writing, similarly filed. Service
    of all administrative and judicial processes, notices, orders,
    decisions, and requirements may be made upon said manufacturer by
    service upon such designated agent at his office or usual place of
    residence with like effect as if made personally upon said
    manufacturer, and in default of such designation of such agent,
    service of process, notice, order, requirement, or decision in any
    proceeding before the Secretary or in any judicial proceeding for
    enforcement of this part or any standards prescribed pursuant to
    this part may be made by posting such process, notice, order,
    requirement, or decision in the Office of the Secretary or in a
    place designated by him by regulation.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 536, formerly act July 1, 1944, ch.
    373, title III, Sec. 536, formerly Sec. 360, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1181; renumbered Sec. 536
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(D), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 102-300, Sec. 6(b)(1),
    June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Sec. 4(a)(2), Aug.
    13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263h of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263h of Title 42, The
    Public Health and Welfare, as this section.
      1992 - Subsecs. (a), (b). Pub. L. 102-300 substituted "Health and
    Human Services" for "Health, Education, and Welfare" wherever
    appearing.
      1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(D),
    substituted "this part" for "this subpart", "section 360kk(h)" for
    "section 263f(h)", and "section 360kk" for "section 263f".
      Subsec. (b). Pub. L. 101-629, Sec. 19(a)(2)(D), substituted
    "section 360kk" for "section 263f".
      Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
    part" for "this subpart" in two places.

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360nn                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360nn. Inspection, records, and reports

-STATUTE-
    (a) Inspection of premises
      If the Secretary finds for good cause that the methods, tests, or
    programs related to electronic product radiation safety in a
    particular factory, warehouse, or establishment in which electronic
    products are manufactured or held, may not be adequate or reliable,
    officers or employees duly designated by the Secretary, upon
    presenting appropriate credentials and a written notice to the
    owner, operator, or agent in charge, are thereafter authorized (1)
    to enter, at reasonable times, any area in such factory, warehouse,
    or establishment in which the manufacturer's tests (or testing
    programs) required by section 360kk(h) of this title are carried
    out, and (2) to inspect, at reasonable times and within reasonable
    limits and in a reasonable manner, the facilities and procedures
    within such area which are related to electronic product radiation
    safety. Each such inspection shall be commenced and completed with
    reasonable promptness. In addition to other grounds upon which good
    cause may be found for purposes of this subsection, good cause will
    be considered to exist in any case where the manufacturer has
    introduced into commerce any electronic product which does not
    comply with an applicable standard prescribed under this part and
    with respect to which no exemption from the notification
    requirements has been granted by the Secretary under section
    360ll(a)(2) or 360ll(e) of this title.
    (b) Record keeping
      Every manufacturer of electronic products shall establish and
    maintain such records (including testing records), make such
    reports, and provide such information, as the Secretary may
    reasonably require to enable him to determine whether such
    manufacturer has acted or is acting in compliance with this part
    and standards prescribed pursuant to this part and shall, upon
    request of an officer or employee duly designated by the Secretary,
    permit such officer or employee to inspect appropriate books,
    papers, records, and documents relevant to determining whether such
    manufacturer has acted or is acting in compliance with standards
    prescribed pursuant to this part.
    (c) Disclosure of technical data
      Every manufacturer of electronic products shall provide to the
    Secretary such performance data and other technical data related to
    safety as may be required to carry out the purposes of this part.
    The Secretary is authorized to require the manufacturer to give
    such notification of such performance and technical data at the
    time of original purchase to the ultimate purchaser of the
    electronic product, as he determines necessary to carry out the
    purposes of this part after consulting with the affected industry.
    (d) Public nature of reports
      Accident and investigation reports made under this part by any
    officer, employee, or agent of the Secretary shall be available for
    use in any civil, criminal, or other judicial proceeding arising
    out of such accident. Any such officer, employee, or agent may be
    required to testify in such proceedings as to the facts developed
    in such investigations. Any such report shall be made available to
    the public in a manner which need not identify individuals. All
    reports on research projects, demonstration projects, and other
    related activities shall be public information.
    (e) Trade secrets
      The Secretary or his representative shall not disclose any
    information reported to or otherwise obtained by him, pursuant to
    subsection (a) or (b) of this section, which concerns any
    information which contains or relates to a trade secret or other
    matter referred to in section 1905 of title 18, except that such
    information may be disclosed to other officers or employees of the
    Department and of other agencies concerned with carrying out this
    part or when relevant in any proceeding under this part. Nothing in
    this section shall authorize the withholding of information by the
    Secretary, or by any officers or employees under his control, from
    the duly authorized committees of the Congress.
    (f) Information required to identify and locate first purchasers of
      electronic products
      The Secretary may by regulation (1) require dealers and
    distributors of electronic products, to which there are applicable
    standards prescribed under this part and the retail prices of which
    is not less than $50, to furnish manufacturers of such products
    such information as may be necessary to identify and locate, for
    purposes of section 360ll of this title, the first purchasers of
    such products for purposes other than resale, and (2) require
    manufacturers to preserve such information. Any regulation
    establishing a requirement pursuant to clause (1) of the preceding
    sentence shall (A) authorize such dealers and distributors to
    elect, in lieu of immediately furnishing such information to the
    manufacturer, to hold and preserve such information until advised
    by the manufacturer or Secretary that such information is needed by
    the manufacturer for purposes of section 360ll of this title, and
    (B) provide that the dealer or distributor shall, upon making such
    election, give prompt notice of such election (together with
    information identifying the notifier and the product) to the
    manufacturer and shall, when advised by the manufacturer or
    Secretary, of the need therefor for the purposes of section 360ll
    of this title, immediately furnish the manufacturer with the
    required information. If a dealer or distributor discontinues the
    dealing in or distribution of electronic products, he shall turn
    the information over to the manufacturer. Any manufacturer
    receiving information pursuant to this subsection concerning first
    purchasers of products for purposes other than resale shall treat
    it as confidential and may use it only if necessary for the purpose
    of notifying persons pursuant to section 360ll(a) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 537, formerly act July 1, 1944, ch.
    373, title III, Sec. 537, formerly Sec. 360A, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1182; renumbered Sec. 537
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263i of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263i of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E),
    substituted "section 360kk(h)" for "section 263f(h)", "this part"
    for "this subpart", and "section 360ll(a)(2) or 360ll(e)" for
    "section 263g(a)(2) or 263g(e)".
      Subsecs. (b) to (e). Pub. L. 101-629, Sec. 19(a)(1)(B),
    substituted "this part" for "this subpart" wherever appearing.
      Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(E)(ii),
    substituted "this part" for "this subpart", "section 360ll" for
    "section 263g" in three places, and "section 360ll(a)" for "section
    263g(a)".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360oo                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360oo. Prohibited acts

-STATUTE-
      (a) It shall be unlawful - 
        (1) for any manufacturer to introduce, or to deliver for
      introduction, into commerce, or to import into the United States,
      any electronic product which does not comply with an applicable
      standard prescribed pursuant to section 360kk of this title;
        (2) for any person to fail to furnish any notification or other
      material or information required by section 360ll or 360nn of
      this title; or to fail to comply with the requirements of section
      360ll(f) of this title;
        (3) for any person to fail or to refuse to establish or
      maintain records required by this part or to permit access by the
      Secretary or any of his duly authorized representatives to, or
      the copying of, such records, or to permit entry or inspection,
      as required by or pursuant to section 360nn of this title;
        (4) for any person to fail or to refuse to make any report
      required pursuant to section 360nn(b) of this title or to furnish
      or preserve any information required pursuant to section 360nn(f)
      of this title; or
        (5) for any person (A) to fail to issue a certification as
      required by section 360kk(h) of this title, or (B) to issue such
      a certification when such certification is not based upon a test
      or testing program meeting the requirements of section 360kk(h)
      of this title or when the issuer, in the exercise of due care,
      would have reason to know that such certification is false or
      misleading in a material respect.

      (b) The Secretary may exempt any electronic product, or class
    thereof, from all or part of subsection (a) of this section, upon
    such conditions as he may find necessary to protect the public
    health or welfare, for the purpose of research, investigations,
    studies, demonstrations, or training, or for reasons of national
    security.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 538, formerly act July 1, 1944, ch.
    373, title III, Sec. 538, formerly Sec. 360B, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered Sec. 538
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(F), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263j of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263j of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a)(1). Pub. L. 101-629, Sec. 19(a)(2)(F)(i),
    substituted "section 360kk" for "section 263f".
      Subsec. (a)(2). Pub. L. 101-629, Sec. 19(a)(2)(F)(ii), (iii),
    substituted "section 360ll or 360nn" for "section 263g or 263i" and
    "section 360ll(f)" for "section 263g(f)".
      Subsec. (a)(3). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(F)(iii),
    substituted "this part" for "this subpart" and "section 360nn" for
    "section 263i".
      Subsec. (a)(4). Pub. L. 101-629, Sec. 19(a)(2)(F)(iii),
    substituted "section 360nn(b)" for "section 263i(b)" and "section
    360nn(f)" for "section 263i(f)".
      Subsec. (a)(5). Pub. L. 101-629, Sec. 19(a)(2)(F)(i), substituted
    "section 360kk(h)" for "section 263f(h)" in two places.

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360pp                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360pp. Enforcement

-STATUTE-
    (a) Jurisdiction of courts
      The district courts of the United States shall have jurisdiction,
    for cause shown, to restrain violations of section 360oo of this
    title and to restrain dealers and distributors of electronic
    products from selling or otherwise disposing of electronic products
    which do not conform to an applicable standard prescribed pursuant
    to section 360kk of this title except when such products are
    disposed of by returning them to the distributor or manufacturer
    from whom they were obtained. The district courts of the United
    States shall also have jurisdiction in accordance with section 1355
    of title 28 to enforce the provisions of subsection (b) of this
    section.
    (b) Penalties
      (1) Any person who violates section 360oo of this title shall be
    subject to a civil penalty of not more than $1,000. For purposes of
    this subsection, any such violation shall with respect to each
    electronic product involved, or with respect to each act or
    omission made unlawful by section 360oo of this title, constitute a
    separate violation, except that the maximum civil penalty imposed
    on any person under this subsection for any related series of
    violations shall not exceed $300,000.
      (2) Any such civil penalty may on application be remitted or
    mitigated by the Secretary. In determining the amount of such
    penalty, or whether it should be remitted or mitigated and in what
    amount, the appropriateness of such penalty to the size of the
    business of the person charged and the gravity of the violation
    shall be considered. The amount of such penalty, when finally
    determined, may be deducted from any sums owing by the United
    States to the person charged.
    (c) Venue; process
      Actions under subsections (a) and (b) of this section may be
    brought in the district court of the United States for the district
    wherein any act or omission or transaction constituting the
    violation occurred, or in such court for the district where the
    defendant is found or transacts business, and process in such cases
    may be served in any other district of which the defendant is an
    inhabitant or wherever the defendant may be found.
    (d) Warnings
      Nothing in this part shall be construed as requiring the
    Secretary to report for the institution of proceedings minor
    violations of this part whenever he believes that the public
    interest will be adequately served by a suitable written notice or
    warning.
    (e) Compliance with regulations
      Except as provided in the first sentence of section 360ss of this
    title, compliance with this part or any regulations issued
    thereunder shall not relieve any person from liability at common
    law or under statutory law.
    (f) Additional remedies
      The remedies provided for in this part shall be in addition to
    and not in substitution for any other remedies provided by law.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 539, formerly act July 1, 1944, ch.
    373, title III, Sec. 539, formerly Sec. 360C, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered Sec. 539
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(G), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263k of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263k of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Subsec. (a). Pub. L. 101-629, Sec. 19(a)(2)(G)(i), (ii),
    substituted "section 360oo" for "section 263j" and "section 360kk"
    for "section 263f".
      Subsec. (b)(1). Pub. L. 101-629, Sec. 19(a)(2)(G)(ii),
    substituted "section 360oo" for "section 263j" in two places.
      Subsec. (d). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
    part" for "this subpart" in two places.
      Subsec. (e). Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(G)(iii),
    substituted "section 360ss" for "section 263n" and "this part" for
    "this subpart".
      Subsec. (f). Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this
    part" for "this subpart".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360qq                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360qq. Repealed.

-MISC1-
    Sec. 360qq. Repealed. Pub. L. 105-362, title VI, Sec. 601(a)(2)(A),
      Nov. 10, 1998, 112 Stat. 3285.
      Section, act June 25, 1938, ch. 675, Sec. 540, formerly act July
    1, 1944, ch. 373, title III, Sec. 540, formerly Sec. 360D, as added
    Pub. L. 90-602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1185; renumbered
    Sec. 540 and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779, related to annual report on
    administration of electronic product radiation control program.

-End-



-CITE-
    21 USC Sec. 360rr                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360rr. Federal-State cooperation

-STATUTE-
      The Secretary is authorized (1) to accept from State and local
    authorities engaged in activities related to health or safety or
    consumer protection, on a reimbursable basis or otherwise, any
    assistance in the administration and enforcement of this part which
    he may request and which they may be able and willing to provide
    and, if so agreed, may pay in advance or otherwise for the
    reasonable cost of such assistance, and (2) he may, for the purpose
    of conducting examinations, investigations, and inspections,
    commission any officer or employee of any such authority as an
    officer of the Department.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 541, formerly act July 1, 1944, ch.
    373, title III, Sec. 541, formerly Sec. 360E, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered Sec. 541
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (3), (4), Nov. 28,
    1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug. 13,
    1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263m of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263m of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), substituted "this part"
    for "this subpart".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-



-CITE-
    21 USC Sec. 360ss                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part C - Electronic Product Radiation Control

-HEAD-
    Sec. 360ss. State standards

-STATUTE-
      Whenever any standard prescribed pursuant to section 360kk of
    this title with respect to an aspect of performance of an
    electronic product is in effect, no State or political subdivision
    of a State shall have any authority either to establish, or to
    continue in effect, any standard which is applicable to the same
    aspect of performance of such product and which is not identical to
    the Federal standard. Nothing in this part shall be construed to
    prevent the Federal Government or the government of any State or
    political subdivision thereof from establishing a requirement with
    respect to emission of radiation from electronic products procured
    for its own use if such requirement imposes a more restrictive
    standard than that required to comply with the otherwise applicable
    Federal standard.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 542, formerly act July 1, 1944, ch.
    373, title III, Sec. 542, formerly Sec. 360F, as added Pub. L. 90-
    602, Sec. 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered Sec. 542
    and amended Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(H), (3), (4),
    Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2),
    Aug. 13, 1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was classified to section 263n of Title 42, The Public
    Health and Welfare, prior to renumbering by Pub. L. 101-629.


-MISC1-
                                AMENDMENTS                            
      1993 - Pub. L. 103-80 amended directory language of Pub. L. 101-
    629, Sec. 19(a)(4), which renumbered section 263n of Title 42, The
    Public Health and Welfare, as this section.
      1990 - Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(H), substituted
    "section 360kk" for "section 263f" and "this part" for "this
    subpart".

                NONINTERFERENCE WITH OTHER FEDERAL AGENCIES            
      Enactment of this section not to be construed to supersede or
    limit the functions under any other provision of law of any officer
    or agency of the United States, see section 4 of Pub. L. 90-602,
    set out as a note under section 360hh of this title.

-End-


-CITE-
    21 USC Part D - Dissemination of Treatment Information      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
              PART D - DISSEMINATION OF TREATMENT INFORMATION          


-STATAMEND-
                            TERMINATION OF PART                        
      For termination of part by section 401(e) of Pub. L. 105-115, see
    Effective and Termination Dates note set out under section 360aaa
    of this title.

-End-



-CITE-
    21 USC Sec. 360aaa                                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa. Requirements for dissemination of treatment
      information on drugs or devices

-STATUTE-
    (a) In general
      Notwithstanding sections 331(d), 352(f), and 355 of this title,
    and section 262 of title 42, a manufacturer may disseminate to - 
        (1) a health care practitioner;
        (2) a pharmacy benefit manager;
        (3) a health insurance issuer;
        (4) a group health plan; or
        (5) a Federal or State governmental agency;

    written information concerning the safety, effectiveness, or
    benefit of a use not described in the approved labeling of a drug
    or device if the manufacturer meets the requirements of subsection
    (b) of this section.
    (b) Specific requirements
      A manufacturer may disseminate information under subsection (a)
    of this section on a new use only if - 
        (1)(A) in the case of a drug, there is in effect for the drug
      an application filed under subsection (b) or (j) of section 355
      of this title or a biologics license issued under section 262 of
      title 42; or
        (B) in the case of a device, the device is being commercially
      distributed in accordance with a regulation under subsection (d)
      or (e) of section 360c of this title, an order under subsection
      (f) of such section, or the approval of an application under
      section 360e of this title;
        (2) the information meets the requirements of section 360aaa-1
      of this title;
        (3) the information to be disseminated is not derived from
      clinical research conducted by another manufacturer or if it was
      derived from research conducted by another manufacturer, the
      manufacturer disseminating the information has the permission of
      such other manufacturer to make the dissemination;
        (4) the manufacturer has, 60 days before such dissemination,
      submitted to the Secretary - 
          (A) a copy of the information to be disseminated; and
          (B) any clinical trial information the manufacturer has
        relating to the safety or effectiveness of the new use, any
        reports of clinical experience pertinent to the safety of the
        new use, and a summary of such information;

        (5) the manufacturer has complied with the requirements of
      section 360aaa-3 of this title (relating to a supplemental
      application for such use);
        (6) the manufacturer includes along with the information to be
      disseminated under this subsection - 
          (A) a prominently displayed statement that discloses - 
            (i) that the information concerns a use of a drug or device
          that has not been approved or cleared by the Food and Drug
          Administration;
            (ii) if applicable, that the information is being
          disseminated at the expense of the manufacturer;
            (iii) if applicable, the name of any authors of the
          information who are employees of, consultants to, or have
          received compensation from, the manufacturer, or who have a
          significant financial interest in the manufacturer;
            (iv) the official labeling for the drug or device and all
          updates with respect to the labeling;
            (v) if applicable, a statement that there are products or
          treatments that have been approved or cleared for the use
          that is the subject of the information being disseminated
          pursuant to subsection (a)(1) of this section; and
            (vi) the identification of any person that has provided
          funding for the conduct of a study relating to the new use of
          a drug or device for which such information is being
          disseminated; and

          (B) a bibliography of other articles from a scientific
        reference publication or scientific or medical journal that
        have been previously published about the use of the drug or
        device covered by the information disseminated (unless the
        information already includes such bibliography).
    (c) Additional information
      If the Secretary determines, after providing notice of such
    determination and an opportunity for a meeting with respect to such
    determination, that the information submitted by a manufacturer
    under subsection (b)(3)(B) of this section, with respect to the use
    of a drug or device for which the manufacturer intends to
    disseminate information, fails to provide data, analyses, or other
    written matter that is objective and balanced, the Secretary may
    require the manufacturer to disseminate - 
        (1) additional objective and scientifically sound information
      that pertains to the safety or effectiveness of the use and is
      necessary to provide objectivity and balance, including any
      information that the manufacturer has submitted to the Secretary
      or, where appropriate, a summary of such information or any other
      information that the Secretary has authority to make available to
      the public; and
        (2) an objective statement of the Secretary, based on data or
      other scientifically sound information available to the
      Secretary, that bears on the safety or effectiveness of the new
      use of the drug or device.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 551, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2356.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note below.


-MISC1-
                      EFFECTIVE AND TERMINATION DATES                  
      Section 401(d) of Pub. L. 105-115 provided that: "The amendments
    made by this section [enacting this part and amending section 331
    of this title] shall take effect 1 year after the date of enactment
    of this Act [Nov. 21, 1997], or upon the Secretary's issuance of
    final regulations pursuant to subsection (c) [section 401(c) of
    Pub. L. 105-115 set out below], whichever is sooner."
      Section 401(e) of Pub. L. 105-115 provided that: "The amendments
    made by this section [enacting this part and amending section 331
    of this title] cease to be effective September 30, 2006, or 7 years
    after the date on which the Secretary promulgates the regulations
    described in subsection (c) [section 401(c) of Pub. L. 105-115 set
    out below], whichever is later."

                                REGULATIONS                            
      Section 401(c) of Pub. L. 105-115 provided that: "Not later than
    1 year after the date of enactment of this Act [Nov. 21, 1997], the
    Secretary of Health and Human Services shall promulgate regulations
    to implement the amendments made by this section [enacting this
    part and amending section 331 of this title]."

                            STUDIES AND REPORTS                        
      Pub. L. 105-115, title IV, Sec. 401(f), Nov. 21, 1997, 111 Stat.
    2364, provided that:
      "(1) General accounting office [now Government Accountability
    Office]. - 
        "(A) In general. - The Comptroller General of the United States
      shall conduct a study to determine the impact of subchapter D of
      chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
      360aaa et seq.], as added by this section, on the resources of
      the Department of Health and Human Services.
        "(B) Report. - Not later than January 1, 2002, the Comptroller
      General of the United States shall prepare and submit to the
      Committee on Labor and Human Resources [now Committee on Health,
      Education, Labor, and Pensions] of the Senate and the Committee
      on Commerce [now Committee on Energy and Commerce] of the House
      of Representatives a report of the results of the study.
      "(2) Department of health and human services. - 
        "(A) In general. - In order to assist Congress in determining
      whether the provisions of such subchapter should be extended
      beyond the termination date specified in subsection (e) [section
      401(e) of Pub. L. 105-115, set out above], the Secretary of
      Health and Human Services shall, in accordance with subparagraph
      (B), arrange for the conduct of a study of the scientific issues
      raised as a result of the enactment of such subchapter including
      issues relating to - 
          "(i) the effectiveness of such subchapter with respect to the
        provision of useful scientific information to health care
        practitioners;
          "(ii) the quality of the information being disseminated
        pursuant to the provisions of such subchapter;
          "(iii) the quality and usefulness of the information
        provided, in accordance with such subchapter, by the Secretary
        or by the manufacturer at the request of the Secretary; and
          "(iv) the impact of such subchapter on research in the area
        of new uses, indications, or dosages, particularly the impact
        on pediatric indications and rare diseases.
      "(3) Procedure for study. - 
        "(A) In general. - The Secretary shall request the Institute of
      Medicine of the National Academy of Sciences to conduct the study
      required by paragraph (2), and to prepare and submit the report
      required by subparagraph (B), under an arrangement by which the
      actual expenses incurred by the Institute of Medicine in
      conducting the study and preparing the report will be paid by the
      Secretary. If the Institute of Medicine is unwilling to conduct
      the study under such an arrangement, the Comptroller General of
      the United States shall conduct such study.
        "(B) Report. - Not later than September 30, 2005, the Institute
      of Medicine or the Comptroller General of the United States, as
      appropriate, shall prepare and submit to the Committee on Labor
      and Human Resources [now Committee on Health, Education, Labor,
      and Pensions] of the Senate, the Committee on Commerce [now
      Committee on Energy and Commerce] of the House of
      Representatives, and the Secretary a report of the results of the
      study required by paragraph (2). The Secretary, after the receipt
      of the report, shall make the report available to the public."

-End-



-CITE-
    21 USC Sec. 360aaa-1                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-1. Information authorized to be disseminated

-STATUTE-
    (a) Authorized information
      A manufacturer may disseminate information under section 360aaa
    of this title on a new use only if the information - 
        (1) is in the form of an unabridged - 
          (A) reprint or copy of an article, peer-reviewed by experts
        qualified by scientific training or experience to evaluate the
        safety or effectiveness of the drug or device involved, which
        was published in a scientific or medical journal (as defined in
        section 360aaa-5(5) of this title), which is about a clinical
        investigation with respect to the drug or device, and which
        would be considered to be scientifically sound by such experts;
        or
          (B) reference publication, described in subsection (b) of
        this section, that includes information about a clinical
        investigation with respect to the drug or device that would be
        considered to be scientifically sound by experts qualified by
        scientific training or experience to evaluate the safety or
        effectiveness of the drug or device that is the subject of such
        a clinical investigation; and

        (2) is not false or misleading and would not pose a significant
      risk to the public health.
    (b) Reference publication
      A reference publication referred to in subsection (a)(1)(B) of
    this section is a publication that - 
        (1) has not been written, edited, excerpted, or published
      specifically for, or at the request of, a manufacturer of a drug
      or device;
        (2) has not been edited or significantly influenced by such a
      manufacturer;
        (3) is not solely distributed through such a manufacturer but
      is generally available in bookstores or other distribution
      channels where medical textbooks are sold;
        (4) does not focus on any particular drug or device of a
      manufacturer that disseminates information under section 360aaa
      of this title and does not have a primary focus on new uses of
      drugs or devices that are marketed or under investigation by a
      manufacturer supporting the dissemination of information; and
        (5) presents materials that are not false or misleading.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 552, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2358.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-2                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-2. Establishment of list of articles and publications
      disseminated and list of providers that received articles and
      reference publications

-STATUTE-
    (a) In general
      A manufacturer may disseminate information under section 360aaa
    of this title on a new use only if the manufacturer prepares and
    submits to the Secretary biannually - 
        (1) a list containing the titles of the articles and reference
      publications relating to the new use of drugs or devices that
      were disseminated by the manufacturer to a person described in
      section 360aaa(a) of this title for the 6-month period preceding
      the date on which the manufacturer submits the list to the
      Secretary; and
        (2) a list that identifies the categories of providers (as
      described in section 360aaa(a) of this title) that received the
      articles and reference publications for the 6-month period
      described in paragraph (1).
    (b) Records
      A manufacturer that disseminates information under section 360aaa
    of this title shall keep records that may be used by the
    manufacturer when, pursuant to section 360aaa-4 of this title, such
    manufacturer is required to take corrective action and shall be
    made available to the Secretary, upon request, for purposes of
    ensuring or taking corrective action pursuant to such section. Such
    records, at the Secretary's discretion, may identify the recipient
    of information provided pursuant to section 360aaa of this title or
    the categories of such recipients.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 553, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-3                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-3. Requirement regarding submission of supplemental
      application for new use; exemption from requirement

-STATUTE-
    (a) In general
      A manufacturer may disseminate information under section 360aaa
    of this title on a new use only if - 
        (1)(A) the manufacturer has submitted to the Secretary a
      supplemental application for such use; or
        (B) the manufacturer meets the condition described in
      subsection (b) or (c) of this section (relating to a
      certification that the manufacturer will submit such an
      application); or
        (2) there is in effect for the manufacturer an exemption under
      subsection (d) of this section from the requirement of paragraph
      (1).
    (b) Certification on supplemental application; condition in case of
      completed studies
      For purposes of subsection (a)(1)(B) of this section, a
    manufacturer may disseminate information on a new use if the
    manufacturer has submitted to the Secretary an application
    containing a certification that - 
        (1) the studies needed for the submission of a supplemental
      application for the new use have been completed; and
        (2) the supplemental application will be submitted to the
      Secretary not later than 6 months after the date of the initial
      dissemination of information under section 360aaa of this title.
    (c) Certification on supplemental application; condition in case of
      planned studies
      (1) In general
        For purposes of subsection (a)(1)(B) of this section, a
      manufacturer may disseminate information on a new use if - 
          (A) the manufacturer has submitted to the Secretary an
        application containing - 
            (i) a proposed protocol and schedule for conducting the
          studies needed for the submission of a supplemental
          application for the new use; and
            (ii) a certification that the supplemental application will
          be submitted to the Secretary not later than 36 months after
          the date of the initial dissemination of information under
          section 360aaa of this title (or, as applicable, not later
          than such date as the Secretary may specify pursuant to an
          extension under paragraph (3)); and

          (B) the Secretary has determined that the proposed protocol
        is adequate and that the schedule for completing such studies
        is reasonable.
      (2) Progress reports on studies
        A manufacturer that submits to the Secretary an application
      under paragraph (1) shall submit to the Secretary periodic
      reports describing the status of the studies involved.
      (3) Extension of time regarding planned studies
        The period of 36 months authorized in paragraph (1)(A)(ii) for
      the completion of studies may be extended by the Secretary if - 
          (A) the Secretary determines that the studies needed to
        submit such an application cannot be completed and submitted
        within 36 months; or
          (B) the manufacturer involved submits to the Secretary a
        written request for the extension and the Secretary determines
        that the manufacturer has acted with due diligence to conduct
        the studies in a timely manner, except that an extension under
        this subparagraph may not be provided for more than 24
        additional months.
    (d) Exemption from requirement of supplemental application
      (1) In general
        For purposes of subsection (a)(2) of this section, a
      manufacturer may disseminate information on a new use if - 
          (A) the manufacturer has submitted to the Secretary an
        application for an exemption from meeting the requirement of
        subsection (a)(1) of this section; and
          (B)(i) the Secretary has approved the application in
        accordance with paragraph (2); or
          (ii) the application is deemed under paragraph (3)(A) to have
        been approved (unless such approval is terminated pursuant to
        paragraph (3)(B)).
      (2) Conditions for approval
        The Secretary may approve an application under paragraph (1)
      for an exemption if the Secretary makes a determination described
      in subparagraph (A) or (B), as follows:
          (A) The Secretary makes a determination that, for reasons
        defined by the Secretary, it would be economically prohibitive
        with respect to such drug or device for the manufacturer to
        incur the costs necessary for the submission of a supplemental
        application. In making such determination, the Secretary shall
        consider (in addition to any other considerations the Secretary
        finds appropriate) - 
            (i) the lack of the availability under law of any period
          during which the manufacturer would have exclusive marketing
          rights with respect to the new use involved; and
            (ii) the size of the population expected to benefit from
          approval of the supplemental application.

          (B) The Secretary makes a determination that, for reasons
        defined by the Secretary, it would be unethical to conduct the
        studies necessary for the supplemental application. In making
        such determination, the Secretary shall consider (in addition
        to any other considerations the Secretary finds appropriate)
        whether the new use involved is the standard of medical care
        for a health condition.
      (3) Time for consideration of application; deemed approval
        (A) In general
          The Secretary shall approve or deny an application under
        paragraph (1) for an exemption not later than 60 days after the
        receipt of the application. If the Secretary does not comply
        with the preceding sentence, the application is deemed to be
        approved.
        (B) Termination of deemed approval
          If pursuant to a deemed approval under subparagraph (A) a
        manufacturer disseminates written information under section
        360aaa of this title on a new use, the Secretary may at any
        time terminate such approval and under section 360aaa-4(b)(3)
        of this title order the manufacturer to cease disseminating the
        information.
    (e) Requirements regarding applications
      Applications under this section shall be submitted in the form
    and manner prescribed by the Secretary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 554, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2359.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-4                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-4. Corrective actions; cessation of dissemination

-STATUTE-
    (a) Postdissemination data regarding safety and effectiveness
      (1) Corrective actions
        With respect to data received by the Secretary after the
      dissemination of information under section 360aaa of this title
      by a manufacturer has begun (whether received pursuant to
      paragraph (2) or otherwise), if the Secretary determines that the
      data indicate that the new use involved may not be effective or
      may present a significant risk to public health, the Secretary
      shall, after consultation with the manufacturer, take such action
      regarding the dissemination of the information as the Secretary
      determines to be appropriate for the protection of the public
      health, which may include ordering that the manufacturer cease
      the dissemination of the information.
      (2) Responsibilities of manufacturers to submit data
        After a manufacturer disseminates information under section
      360aaa of this title, the manufacturer shall submit to the
      Secretary a notification of any additional knowledge of the
      manufacturer on clinical research or other data that relate to
      the safety or effectiveness of the new use involved. If the
      manufacturer is in possession of the data, the notification shall
      include the data. The Secretary shall by regulation establish the
      scope of the responsibilities of manufacturers under this
      paragraph, including such limits on the responsibilities as the
      Secretary determines to be appropriate.
    (b) Cessation of dissemination
      (1) Failure of manufacturer to comply with requirements
        The Secretary may order a manufacturer to cease the
      dissemination of information pursuant to section 360aaa of this
      title if the Secretary determines that the information being
      disseminated does not comply with the requirements established in
      this part. Such an order may be issued only after the Secretary
      has provided notice to the manufacturer of the intent of the
      Secretary to issue the order and (unless paragraph (2)(B)
      applies) has provided an opportunity for a meeting with respect
      to such intent. If the failure of the manufacturer constitutes a
      minor violation of this part, the Secretary shall delay issuing
      the order and provide to the manufacturer an opportunity to
      correct the violation.
      (2) Supplemental applications
        The Secretary may order a manufacturer to cease the
      dissemination of information pursuant to section 360aaa of this
      title if - 
          (A) in the case of a manufacturer that has submitted a
        supplemental application for a new use pursuant to section
        360aaa-3(a)(1) of this title, the Secretary determines that the
        supplemental application does not contain adequate information
        for approval of the new use for which the application was
        submitted;
          (B) in the case of a manufacturer that has submitted a
        certification under section 360aaa-3(b) of this title, the
        manufacturer has not, within the 6-month period involved,
        submitted the supplemental application referred to in the
        certification; or
          (C) in the case of a manufacturer that has submitted a
        certification under section 360aaa-3(c) of this title but has
        not yet submitted the supplemental application referred to in
        the certification, the Secretary determines, after an informal
        hearing, that the manufacturer is not acting with due diligence
        to complete the studies involved.
      (3) Termination of deemed approval of exemption regarding
        supplemental applications
        If under section 360aaa-3(d)(3) of this title the Secretary
      terminates a deemed approval of an exemption, the Secretary may
      order the manufacturer involved to cease disseminating the
      information. A manufacturer shall comply with an order under the
      preceding sentence not later than 60 days after the receipt of
      the order.
    (c) Corrective actions by manufacturers
      (1) In general
        In any case in which under this section the Secretary orders a
      manufacturer to cease disseminating information, the Secretary
      may order the manufacturer to take action to correct the
      information that has been disseminated, except as provided in
      paragraph (2).
      (2) Termination of deemed approval of exemption regarding
        supplemental applications
        In the case of an order under subsection (b)(3) of this section
      to cease disseminating information, the Secretary may not order
      the manufacturer involved to take action to correct the
      information that has been disseminated unless the Secretary
      determines that the new use described in the information would
      pose a significant risk to the public health.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 555, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2361.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-5                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-5. Definitions

-STATUTE-
      For purposes of this part:
        (1) The term "health care practitioner" means a physician, or
      other individual who is a provider of health care, who is
      licensed under the law of a State to prescribe drugs or devices.
        (2) The terms "health insurance issuer" and "group health plan"
      have the meaning given such terms under section 300gg-91 of title
      42.
        (3) The term "manufacturer" means a person who manufactures a
      drug or device, or who is licensed by such person to distribute
      or market the drug or device.
        (4) The term "new use" - 
          (A) with respect to a drug, means a use that is not included
        in the labeling of the approved drug; and
          (B) with respect to a device, means a use that is not
        included in the labeling for the approved or cleared device.

        (5) The term "scientific or medical journal" means a scientific
      or medical publication - 
          (A) that is published by an organization - 
            (i) that has an editorial board;
            (ii) that utilizes experts, who have demonstrated expertise
          in the subject of an article under review by the organization
          and who are independent of the organization, to review and
          objectively select, reject, or provide comments about
          proposed articles; and
            (iii) that has a publicly stated policy, to which the
          organization adheres, of full disclosure of any conflict of
          interest or biases for all authors or contributors involved
          with the journal or organization;

          (B) whose articles are peer-reviewed and published in
        accordance with the regular peer-review procedures of the
        organization;
          (C) that is generally recognized to be of national scope and
        reputation;
          (D) that is indexed in the Index Medicus of the National
        Library of Medicine of the National Institutes of Health; and
          (E) that is not in the form of a special supplement that has
        been funded in whole or in part by one or more manufacturers.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 556, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2362.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-



-CITE-
    21 USC Sec. 360aaa-6                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part D - Dissemination of Treatment Information

-HEAD-
    Sec. 360aaa-6. Rules of construction

-STATUTE-
    (a) Unsolicited request
      Nothing in section 360aaa of this title shall be construed as
    prohibiting a manufacturer from disseminating information in
    response to an unsolicited request from a health care practitioner.
    (b) Dissemination of information on drugs or devices not evidence
      of intended use
      Notwithstanding subsection (a), (f), or (o) of section 352 of
    this title, or any other provision of law, the dissemination of
    information relating to a new use of a drug or device, in
    accordance with section 360aaa of this title, shall not be
    construed by the Secretary as evidence of a new intended use of the
    drug or device that is different from the intended use of the drug
    or device set forth in the official labeling of the drug or device.
    Such dissemination shall not be considered by the Secretary as
    labeling, adulteration, or misbranding of the drug or device.
    (c) Patent protection
      Nothing in section 360aaa of this title shall affect patent
    rights in any manner.
    (d) Authorization for dissemination of articles and fees for
      reprints of articles
      Nothing in section 360aaa of this title shall be construed as
    prohibiting an entity that publishes a scientific journal (as
    defined in section 360aaa-5(5) of this title) from requiring
    authorization from the entity to disseminate an article published
    by such entity or charging fees for the purchase of reprints of
    published articles from such entity.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 557, as added Pub. L. 105-115, title
    IV, Sec. 401(a), Nov. 21, 1997, 111 Stat. 2363.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 401(e) of Pub. L. 105-115,
    see Effective and Termination Dates note set out under section
    360aaa of this title.

-End-


-CITE-
    21 USC Part E - General Provisions Relating to Drugs and
                     Devices                               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
         PART E - GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES     

-End-



-CITE-
    21 USC Sec. 360bbb                                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb. Expanded access to unapproved therapies and
      diagnostics

-STATUTE-
    (a) Emergency situations
      The Secretary may, under appropriate conditions determined by the
    Secretary, authorize the shipment of investigational drugs or
    investigational devices for the diagnosis, monitoring, or treatment
    of a serious disease or condition in emergency situations.
    (b) Individual patient access to investigational products intended
      for serious diseases
      Any person, acting through a physician licensed in accordance
    with State law, may request from a manufacturer or distributor, and
    any manufacturer or distributor may, after complying with the
    provisions of this subsection, provide to such physician an
    investigational drug or investigational device for the diagnosis,
    monitoring, or treatment of a serious disease or condition if - 
        (1) the licensed physician determines that the person has no
      comparable or satisfactory alternative therapy available to
      diagnose, monitor, or treat the disease or condition involved,
      and that the probable risk to the person from the investigational
      drug or investigational device is not greater than the probable
      risk from the disease or condition;
        (2) the Secretary determines that there is sufficient evidence
      of safety and effectiveness to support the use of the
      investigational drug or investigational device in the case
      described in paragraph (1);
        (3) the Secretary determines that provision of the
      investigational drug or investigational device will not interfere
      with the initiation, conduct, or completion of clinical
      investigations to support marketing approval; and
        (4) the sponsor, or clinical investigator, of the
      investigational drug or investigational device submits to the
      Secretary a clinical protocol consistent with the provisions of
      section 355(i) or 360j(g) of this title, including any
      regulations promulgated under section 355(i) or 360j(g) of this
      title, describing the use of the investigational drug or
      investigational device in a single patient or a small group of
      patients.
    (c) Treatment investigational new drug applications and treatment
      investigational device exemptions
      Upon submission by a sponsor or a physician of a protocol
    intended to provide widespread access to an investigational drug or
    investigational device for eligible patients (referred to in this
    subsection as an "expanded access protocol"), the Secretary shall
    permit such investigational drug or investigational device to be
    made available for expanded access under a treatment
    investigational new drug application or treatment investigational
    device exemption if the Secretary determines that - 
        (1) under the treatment investigational new drug application or
      treatment investigational device exemption, the investigational
      drug or investigational device is intended for use in the
      diagnosis, monitoring, or treatment of a serious or immediately
      life-threatening disease or condition;
        (2) there is no comparable or satisfactory alternative therapy
      available to diagnose, monitor, or treat that stage of disease or
      condition in the population of patients to which the
      investigational drug or investigational device is intended to be
      administered;
        (3)(A) the investigational drug or investigational device is
      under investigation in a controlled clinical trial for the use
      described in paragraph (1) under an investigational drug
      application in effect under section 355(i) of this title or
      investigational device exemption in effect under section 360j(g)
      of this title; or
        (B) all clinical trials necessary for approval of that use of
      the investigational drug or investigational device have been
      completed;
        (4) the sponsor of the controlled clinical trials is actively
      pursuing marketing approval of the investigational drug or
      investigational device for the use described in paragraph (1)
      with due diligence;
        (5) in the case of an investigational drug or investigational
      device described in paragraph (3)(A), the provision of the
      investigational drug or investigational device will not interfere
      with the enrollment of patients in ongoing clinical
      investigations under section 355(i) or 360j(g) of this title;
        (6) in the case of serious diseases, there is sufficient
      evidence of safety and effectiveness to support the use described
      in paragraph (1); and
        (7) in the case of immediately life-threatening diseases, the
      available scientific evidence, taken as a whole, provides a
      reasonable basis to conclude that the investigational drug or
      investigational device may be effective for its intended use and
      would not expose patients to an unreasonable and significant risk
      of illness or injury.

    A protocol submitted under this subsection shall be subject to the
    provisions of section 355(i) or 360j(g) of this title, including
    regulations promulgated under section 355(i) or 360j(g) of this
    title. The Secretary may inform national, State, and local medical
    associations and societies, voluntary health associations, and
    other appropriate persons about the availability of an
    investigational drug or investigational device under expanded
    access protocols submitted under this subsection. The information
    provided by the Secretary, in accordance with the preceding
    sentence, shall be the same type of information that is required by
    section 282(i)(3) of title 42.
    (d) Termination
      The Secretary may, at any time, with respect to a sponsor,
    physician, manufacturer, or distributor described in this section,
    terminate expanded access provided under this section for an
    investigational drug or investigational device if the requirements
    under this section are no longer met.
    (e) Definitions
      In this section, the terms "investigational drug",
    "investigational device", "treatment investigational new drug
    application", and "treatment investigational device exemption"
    shall have the meanings given the terms in regulations prescribed
    by the Secretary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 561, as added Pub. L. 105-115, title
    IV, Sec. 402, Nov. 21, 1997, 111 Stat. 2365; amended Pub. L. 109-
    482, title I, Sec. 102(f)(2), Jan. 15, 2007, 120 Stat. 3685.)


-MISC1-
                                AMENDMENTS                            
      2007 - Subsec. (c). Pub. L. 109-482 substituted "section
    282(i)(3)" for "section 282(j)(3)" in concluding provisions.

                     EFFECTIVE DATE OF 2007 AMENDMENT                 
      Amendment by Pub. L. 109-482 applicable only with respect to
    amounts appropriated for fiscal year 2007 or subsequent fiscal
    years, see section 109 of Pub. L. 109-482, set out as a note under
    section 281 of Title 42, The Public Health and Welfare.

                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 360bbb-1                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb-1. Dispute resolution

-STATUTE-
      If, regarding an obligation concerning drugs or devices under
    this Act or section 351 of the Public Health Service Act [42 U.S.C.
    262], there is a scientific controversy between the Secretary and a
    person who is a sponsor, applicant, or manufacturer and no specific
    provision of the Act involved, including a regulation promulgated
    under such Act, provides a right of review of the matter in
    controversy, the Secretary shall, by regulation, establish a
    procedure under which such sponsor, applicant, or manufacturer may
    request a review of such controversy, including a review by an
    appropriate scientific advisory panel described in section 355(n)
    of this title or an advisory committee described in section
    360e(g)(2)(B) of this title. Any such review shall take place in a
    timely manner. The Secretary shall promulgate such regulations
    within 1 year after November 21, 1997.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 562, as added Pub. L. 105-115, title
    IV, Sec. 404, Nov. 21, 1997, 111 Stat. 2368.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      This Act, referred to in text, is the Federal Food, Drug, and
    Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as
    amended, which is classified generally to this chapter. For
    complete classification of this Act to the Code, see section 301 of
    this title and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 360bbb-2                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb-2. Classification of products

-STATUTE-
    (a) Request
      A person who submits an application or submission (including a
    petition, notification, and any other similar form of request)
    under this chapter for a product, may submit a request to the
    Secretary respecting the classification of the product as a drug,
    biological product, device, or a combination product subject to
    section 353(g) of this title or respecting the component of the
    Food and Drug Administration that will regulate the product. In
    submitting the request, the person shall recommend a classification
    for the product, or a component to regulate the product, as
    appropriate.
    (b) Statement
      Not later than 60 days after the receipt of the request described
    in subsection (a) of this section, the Secretary shall determine
    the classification of the product under subsection (a) of this
    section, or the component of the Food and Drug Administration that
    will regulate the product, and shall provide to the person a
    written statement that identifies such classification or such
    component, and the reasons for such determination. The Secretary
    may not modify such statement except with the written consent of
    the person, or for public health reasons based on scientific
    evidence.
    (c) Inaction of Secretary
      If the Secretary does not provide the statement within the 60-day
    period described in subsection (b) of this section, the
    recommendation made by the person under subsection (a) of this
    section shall be considered to be a final determination by the
    Secretary of such classification of the product, or the component
    of the Food and Drug Administration that will regulate the product,
    as applicable, and may not be modified by the Secretary except with
    the written consent of the person, or for public health reasons
    based on scientific evidence.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 563, as added Pub. L. 105-115, title
    IV, Sec. 416, Nov. 21, 1997, 111 Stat. 2378.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 360bbb-3                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb-3. Authorization for medical products for use in
      emergencies

-STATUTE-
    (a) In general
      (1) Emergency uses
        Notwithstanding sections 355, 360(k), and 360e of this title
      and section 262 of title 42, and subject to the provisions of
      this section, the Secretary may authorize the introduction into
      interstate commerce, during the effective period of a declaration
      under subsection (b) of this section, of a drug, device, or
      biological product intended for use in an actual or potential
      emergency (referred to in this section as an "emergency use").
      (2) Approval status of product
        An authorization under paragraph (1) may authorize an emergency
      use of a product that - 
          (A) is not approved, licensed, or cleared for commercial
        distribution under a provision of law referred to in such
        paragraph (referred to in this section as an "unapproved
        product"); or
          (B) is approved, licensed, or cleared under such a provision,
        but which use is not under such provision an approved,
        licensed, or cleared use of the product (referred to in this
        section as an "unapproved use of an approved product").
      (3) Relation to other uses
        An emergency use authorized under paragraph (1) for a product
      is in addition to any other use that is authorized for the
      product under a provision of law referred to in such paragraph.
      (4) Definitions
        For purposes of this section:
          (A) The term "biological product" has the meaning given such
        term in section 262 of title 42.
          (B) The term "emergency use" has the meaning indicated for
        such term in paragraph (1).
          (C) The term "product" means a drug, device, or biological
        product.
          (D) The term "unapproved product" has the meaning indicated
        for such term in paragraph (2)(A).
          (E) The term "unapproved use of an approved product" has the
        meaning indicated for such term in paragraph (2)(B).
    (b) Declaration of emergency
      (1) In general
        The Secretary may declare an emergency justifying the
      authorization under this subsection for a product on the basis of
      - 
          (A) a determination by the Secretary of Homeland Security
        that there is a domestic emergency, or a significant potential
        for a domestic emergency, involving a heightened risk of attack
        with a specified biological, chemical, radiological, or nuclear
        agent or agents;
          (B) a determination by the Secretary of Defense that there is
        a military emergency, or a significant potential for a military
        emergency, involving a heightened risk to United States
        military forces of attack with a specified biological,
        chemical, radiological, or nuclear agent or agents; or
          (C) a determination by the Secretary of a public health
        emergency under section 247d of title 42 that affects, or has a
        significant potential to affect, national security, and that
        involves a specified biological, chemical, radiological, or
        nuclear agent or agents, or a specified disease or condition
        that may be attributable to such agent or agents.
      (2) Termination of declaration
        (A) In general
          A declaration under this subsection shall terminate upon the
        earlier of - 
            (i) a determination by the Secretary, in consultation as
          appropriate with the Secretary of Homeland Security or the
          Secretary of Defense, that the circumstances described in
          paragraph (1) have ceased to exist; or
            (ii) the expiration of the one-year period beginning on the
          date on which the declaration is made.
        (B) Renewal
          Notwithstanding subparagraph (A), the Secretary may renew a
        declaration under this subsection, and this paragraph shall
        apply to any such renewal.
        (C) Disposition of product
          If an authorization under this section with respect to an
        unapproved product ceases to be effective as a result of a
        termination under subparagraph (A) of this paragraph, the
        Secretary shall consult with the manufacturer of such product
        with respect to the appropriate disposition of the product.
      (3) Advance notice of termination
        The Secretary shall provide advance notice that a declaration
      under this subsection will be terminated. The period of advance
      notice shall be a period reasonably determined to provide - 
          (A) in the case of an unapproved product, a sufficient period
        for disposition of the product, including the return of such
        product (except such quantities of product as are necessary to
        provide for continued use consistent with subsection (f)(2) of
        this section) to the manufacturer (in the case of a
        manufacturer that chooses to have such product returned); and
          (B) in the case of an unapproved use of an approved product,
        a sufficient period for the disposition of any labeling, or any
        information under subsection (e)(2)(B)(ii) of this section, as
        the case may be, that was provided with respect to the
        emergency use involved.
      (4) Publication
        The Secretary shall promptly publish in the Federal Register
      each declaration, determination, advance notice of termination,
      and renewal under this subsection.
    (c) Criteria for issuance of authorization
      The Secretary may issue an authorization under this section with
    respect to the emergency use of a product only if, after
    consultation with the Director of the National Institutes of Health
    and the Director of the Centers for Disease Control and Prevention
    (to the extent feasible and appropriate given the circumstances of
    the emergency involved), the Secretary concludes - 
        (1) that an agent specified in a declaration under subsection
      (b) of this section can cause a serious or life-threatening
      disease or condition;
        (2) that, based on the totality of scientific evidence
      available to the Secretary, including data from adequate and well-
      controlled clinical trials, if available, it is reasonable to
      believe that - 
          (A) the product may be effective in diagnosing, treating, or
        preventing - 
            (i) such disease or condition; or
            (ii) a serious or life-threatening disease or condition
          caused by a product authorized under this section, approved
          or cleared under this chapter, or licensed under section 262
          of title 42, for diagnosing, treating, or preventing such a
          disease or condition caused by such an agent; and

          (B) the known and potential benefits of the product, when
        used to diagnose, prevent, or treat such disease or condition,
        outweigh the known and potential risks of the product;

        (3) that there is no adequate, approved, and available
      alternative to the product for diagnosing, preventing, or
      treating such disease or condition; and
        (4) that such other criteria as the Secretary may by regulation
      prescribe are satisfied.
    (d) Scope of authorization
      An authorization of a product under this section shall state - 
        (1) each disease or condition that the product may be used to
      diagnose, prevent, or treat within the scope of the
      authorization;
        (2) the Secretary's conclusions, made under subsection
      (c)(2)(B) of this section, that the known and potential benefits
      of the product, when used to diagnose, prevent, or treat such
      disease or condition, outweigh the known and potential risks of
      the product; and
        (3) the Secretary's conclusions, made under subsection (c) of
      this section, concerning the safety and potential effectiveness
      of the product in diagnosing, preventing, or treating such
      diseases or conditions, including an assessment of the available
      scientific evidence.
    (e) Conditions of authorization
      (1) Unapproved product
        (A) Required conditions
          With respect to the emergency use of an unapproved product,
        the Secretary, to the extent practicable given the
        circumstances of the emergency, shall, for a person who carries
        out any activity for which the authorization is issued,
        establish such conditions on an authorization under this
        section as the Secretary finds necessary or appropriate to
        protect the public health, including the following:
            (i) Appropriate conditions designed to ensure that health
          care professionals administering the product are informed - 
              (I) that the Secretary has authorized the emergency use
            of the product;
              (II) of the significant known and potential benefits and
            risks of the emergency use of the product, and of the
            extent to which such benefits and risks are unknown; and
              (III) of the alternatives to the product that are
            available, and of their benefits and risks.

            (ii) Appropriate conditions designed to ensure that
          individuals to whom the product is administered are informed -
           
              (I) that the Secretary has authorized the emergency use
            of the product;
              (II) of the significant known and potential benefits and
            risks of such use, and of the extent to which such benefits
            and risks are unknown; and
              (III) of the option to accept or refuse administration of
            the product, of the consequences, if any, of refusing
            administration of the product, and of the alternatives to
            the product that are available and of their benefits and
            risks.

            (iii) Appropriate conditions for the monitoring and
          reporting of adverse events associated with the emergency use
          of the product.
            (iv) For manufacturers of the product, appropriate
          conditions concerning recordkeeping and reporting, including
          records access by the Secretary, with respect to the
          emergency use of the product.
        (B) Authority for additional conditions
          With respect to the emergency use of an unapproved product,
        the Secretary may, for a person who carries out any activity
        for which the authorization is issued, establish such
        conditions on an authorization under this section as the
        Secretary finds necessary or appropriate to protect the public
        health, including the following:
            (i) Appropriate conditions on which entities may distribute
          the product with respect to the emergency use of the product
          (including limitation to distribution by government
          entities), and on how distribution is to be performed.
            (ii) Appropriate conditions on who may administer the
          product with respect to the emergency use of the product, and
          on the categories of individuals to whom, and the
          circumstances under which, the product may be administered
          with respect to such use.
            (iii) Appropriate conditions with respect to the collection
          and analysis of information, during the period when the
          authorization is in effect, concerning the safety and
          effectiveness of the product with respect to the emergency
          use of such product.
            (iv) For persons other than manufacturers of the product,
          appropriate conditions concerning recordkeeping and
          reporting, including records access by the Secretary, with
          respect to the emergency use of the product.
      (2) Unapproved use
        With respect to the emergency use of a product that is an
      unapproved use of an approved product:
          (A) For a manufacturer of the product who carries out any
        activity for which the authorization is issued, the Secretary
        shall, to the extent practicable given the circumstances of the
        emergency, establish conditions described in clauses (i) and
        (ii) of paragraph (1)(A), and may establish conditions
        described in clauses (iii) and (iv) of such paragraph.
          (B)(i) If the authorization under this section regarding the
        emergency use authorizes a change in the labeling of the
        product, but the manufacturer of the product chooses not to
        make such change, such authorization may not authorize
        distributors of the product or any other person to alter or
        obscure the labeling provided by the manufacturer.
          (ii) In the circumstances described in clause (i), for a
        person who does not manufacture the product and who chooses to
        act under this clause, an authorization under this section
        regarding the emergency use shall, to the extent practicable
        given the circumstances of the emergency, authorize such person
        to provide appropriate information with respect to such product
        in addition to the labeling provided by the manufacturer,
        subject to compliance with clause (i). While the authorization
        under this section is effective, such additional information
        shall not be considered labeling for purposes of section 352 of
        this title.
          (C) The Secretary may establish with respect to the
        distribution and administration of the product for the
        unapproved use conditions no more restrictive than those
        established by the Secretary with respect to the distribution
        and administration of the product for the approved use.
      (3) Good manufacturing practice
        With respect to the emergency use of a product for which an
      authorization under this section is issued (whether an unapproved
      product or an unapproved use of an approved product), the
      Secretary may waive or limit, to the extent appropriate given the
      circumstances of the emergency, requirements regarding current
      good manufacturing practice otherwise applicable to the
      manufacture, processing, packing, or holding of products subject
      to regulation under this chapter, including such requirements
      established under section 351 of this title.
      (4) Advertising
        The Secretary may establish conditions on advertisements and
      other promotional descriptive printed matter that relate to the
      emergency use of a product for which an authorization under this
      section is issued (whether an unapproved product or an unapproved
      use of an approved product), including, as appropriate - 
          (A) with respect to drugs and biological products,
        requirements applicable to prescription drugs pursuant to
        section 352(n) of this title; or
          (B) with respect to devices, requirements applicable to
        restricted devices pursuant to section 352(r) of this title.
    (f) Duration of authorization
      (1) In general
        Except as provided in paragraph (2), an authorization under
      this section shall be effective until the earlier of the
      termination of the declaration under subsection (b) of this
      section or a revocation under subsection (g) of this section.
      (2) Continued use after end of effective period
        Notwithstanding the termination of the declaration under
      subsection (b) of this section or a revocation under subsection
      (g) of this section, an authorization shall continue to be
      effective to provide for continued use of an unapproved product
      with respect to a patient to whom it was administered during the
      period described by paragraph (1), to the extent found necessary
      by such patient's attending physician.
    (g) Revocation of authorization
      (1) Review
        The Secretary shall periodically review the circumstances and
      the appropriateness of an authorization under this section.
      (2) Revocation
        The Secretary may revoke an authorization under this section if
      the criteria under subsection (c) of this section for issuance of
      such authorization are no longer met or other circumstances make
      such revocation appropriate to protect the public health or
      safety.
    (h) Publication; confidential information
      (1) Publication
        The Secretary shall promptly publish in the Federal Register a
      notice of each authorization, and each termination or revocation
      of an authorization under this section, and an explanation of the
      reasons therefor (which may include a summary of data or
      information that has been submitted to the Secretary in an
      application under section 355(i) of this title or section 360j(g)
      of this title, even if such summary may indirectly reveal the
      existence of such application).
      (2) Confidential information
        Nothing in this section alters or amends section 1905 of title
      18 or section 552(b)(4) of title 5.
    (i) Actions committed to agency discretion
      Actions under the authority of this section by the Secretary, by
    the Secretary of Defense, or by the Secretary of Homeland Security
    are committed to agency discretion.
    (j) Rules of construction
      The following applies with respect to this section:
        (1) Nothing in this section impairs the authority of the
      President as Commander in Chief of the Armed Forces of the United
      States under article II, section 2 of the United States
      Constitution.
        (2) Nothing in this section impairs the authority of the
      Secretary of Defense with respect to the Department of Defense,
      including the armed forces, under other provisions of Federal
      law.
        (3) Nothing in this section (including any exercise of
      authority by a manufacturer under subsection (e)(2)) impairs the
      authority of the United States to use or manage quantities of a
      product that are owned or controlled by the United States
      (including quantities in the stockpile maintained under section
      247d-6b of title 42).
    (k) Relation to other provisions
      If a product is the subject of an authorization under this
    section, the use of such product within the scope of the
    authorization shall not be considered to constitute a clinical
    investigation for purposes of section 355(i) of this title, section
    360j(g) of this title, or any other provision of this chapter or
    section 262 of title 42.
    (l) Option to carry out authorized activities
      Nothing in this section provides the Secretary any authority to
    require any person to carry out any activity that becomes lawful
    pursuant to an authorization under this section, and no person is
    required to inform the Secretary that the person will not be
    carrying out such activity, except that a manufacturer of a sole-
    source unapproved product authorized for emergency use shall
    report to the Secretary within a reasonable period of time after
    the issuance by the Secretary of such authorization if such
    manufacturer does not intend to carry out any activity under the
    authorization. This section only has legal effect on a person who
    carries out an activity for which an authorization under this
    section is issued. This section does not modify or affect
    activities carried out pursuant to other provisions of this chapter
    or section 262 of title 42. Nothing in this subsection may be
    construed as restricting the Secretary from imposing conditions on
    persons who carry out any activity pursuant to an authorization
    under this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 564, as added Pub. L. 108-136, div.
    A, title XVI, Sec. 1603(a), Nov. 24, 2003, 117 Stat. 1684; amended
    Pub. L. 108-276, Sec. 4(a), July 21, 2004, 118 Stat. 853.)


-MISC1-
                                AMENDMENTS                            
      2004 - Pub. L. 108-276 amended section generally, substituting
    provisions of subsecs. (a) to (l) for similar former provisions,
    except for additional provisions in subsec. (b)(1) allowing
    Secretary to authorize use of medical products in actual or
    potential domestic and public health emergencies in addition to
    actual or potential military emergencies.

-End-



-CITE-
    21 USC Sec. 360bbb-4                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part E - General Provisions Relating to Drugs and Devices

-HEAD-
    Sec. 360bbb-4. Technical assistance

-STATUTE-
      The Secretary, in consultation with the Commissioner of Food and
    Drugs, shall establish within the Food and Drug Administration a
    team of experts on manufacturing and regulatory activities
    (including compliance with current Good Manufacturing Practice) to
    provide both off-site and on-site technical assistance to the
    manufacturers of qualified countermeasures (as defined in section
    247d-6a of title 42), security countermeasures (as defined in
    section 247d-6b of title 42), or vaccines, at the request of such a
    manufacturer and at the discretion of the Secretary, if the
    Secretary determines that a shortage or potential shortage may
    occur in the United States in the supply of such vaccines or
    countermeasures and that the provision of such assistance would be
    beneficial in helping alleviate or avert such shortage.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 565, as added Pub. L. 109-417, title
    IV, Sec. 404, Dec. 19, 2006, 120 Stat. 2875.)

-End-


-CITE-
    21 USC Part F - New Animal Drugs for Minor Use and Minor
                     Species                               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part F - New Animal Drugs for Minor Use and Minor Species

-HEAD-
         PART F - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES     

-End-



-CITE-
    21 USC Sec. 360ccc                                          01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part F - New Animal Drugs for Minor Use and Minor Species

-HEAD-
    Sec. 360ccc. Conditional approval of new animal drugs for minor use
      and minor species

-STATUTE-
    (a) Application requirements; contents; restrictions
      (1) Except as provided in paragraph (3) of this section,(!1) any
    person may file with the Secretary an application for conditional
    approval of a new animal drug intended for a minor use or a minor
    species. Such an application may not be a supplement to an
    application approved under section 360b of this title. Such
    application must comply in all respects with the provisions of
    section 360b of this title except sections 360b(a)(4), 360b(b)(2),
    360b(c)(1), 360b(c)(2), 360b(c)(3), 360b(d)(1), 360b(e), 360b(h),
    and 360b(n) of this title unless otherwise stated in this section,
    and any additional provisions of this section. New animal drugs are
    subject to application of the same safety standards that would be
    applied to such drugs under section 360b(d) of this title
    (including, for antimicrobial new animal drugs, with respect to
    antimicrobial resistance).

      (2) The applicant shall submit to the Secretary as part of an
    application for the conditional approval of a new animal drug - 
        (A) all information necessary to meet the requirements of
      section 360b(b)(1) of this title except section 360b(b)(1)(A) of
      this title;
        (B) full reports of investigations which have been made to show
      whether or not such drug is safe under section 360b(d) of this
      title (including, for an antimicrobial new animal drug, with
      respect to antimicrobial resistance) and there is a reasonable
      expectation of effectiveness for use;
        (C) data for establishing a conditional dose;
        (D) projections of expected need and the justification for that
      expectation based on the best information available;
        (E) information regarding the quantity of drug expected to be
      distributed on an annual basis to meet the expected need; and
        (F) a commitment that the applicant will conduct additional
      investigations to meet the requirements for the full
      demonstration of effectiveness under section 360b(d)(1)(E) of
      this title within 5 years.

      (3) A person may not file an application under paragraph (1) if -
    
        (A) the application seeks conditional approval of a new animal
      drug that is contained in, or is a product of, a transgenic
      animal.(!2)

        (B) the person has previously filed an application for
      conditional approval under paragraph (1) for the same drug in the
      same dosage form for the same intended use whether or not
      subsequently conditionally approved by the Secretary under
      subsection (b) of this section, or
        (C) the person obtained the application, or data or other
      information contained therein, directly or indirectly from the
      person who filed for conditional approval under paragraph (1) for
      the same drug in the same dosage form for the same intended use
      whether or not subsequently conditionally approved by the
      Secretary under subsection (b) of this section.
    (b) Order of approval or hearing
      Within 180 days after the filing of an application pursuant to
    subsection (a) of this section, or such additional period as may be
    agreed upon by the Secretary and the applicant, the Secretary shall
    either - 
        (1) issue an order, effective for one year, conditionally
      approving the application if the Secretary finds that none of the
      grounds for denying conditional approval, specified in subsection
      (c) of this section applies and publish a Federal Register notice
      of the conditional approval, or
        (2) give the applicant notice of an opportunity for an informal
      hearing on the question whether such application can be
      conditionally approved.
    (c) Order of approval or refusal after hearing
      If the Secretary finds, after giving the applicant notice and an
    opportunity for an informal hearing, that - 
        (1) any of the provisions of section 360b(d)(1)(A) through (D)
      or (F) through (I) of this title are applicable;
        (2) the information submitted to the Secretary as part of the
      application and any other information before the Secretary with
      respect to such drug, is insufficient to show that there is a
      reasonable expectation that the drug will have the effect it
      purports or is represented to have under the conditions of use
      prescribed, recommended, or suggested in the proposed labeling
      thereof; or
        (3) another person has received approval under section 360b of
      this title for the same drug in the same dosage form for the same
      intended use, and that person is able to assure the availability
      of sufficient quantities of the drug to meet the needs for which
      the drug is intended;

    the Secretary shall issue an order refusing to conditionally
    approve the application. If, after such notice and opportunity for
    an informal hearing, the Secretary finds that paragraphs (1)
    through (3) do not apply, the Secretary shall issue an order
    conditionally approving the application effective for one year and
    publish a Federal Register notice of the conditional approval. Any
    order issued under this subsection refusing to conditionally
    approve an application shall state the findings upon which it is
    based.
    (d) Effective period; renewal; refusal of renewal
      A conditional approval under this section is effective for a 1-
    year period and is thereafter renewable by the Secretary annually
    for up to 4 additional 1-year terms. A conditional approval shall
    be in effect for no more than 5 years from the date of approval
    under subsection (b)(1) or (c) of this section unless extended as
    provided for in subsection (h) of this section. The following shall
    also apply:
        (1) No later than 90 days from the end of the 1-year period for
      which the original or renewed conditional approval is effective,
      the applicant may submit a request to renew a conditional
      approval for an additional 1-year term.
        (2) A conditional approval shall be deemed renewed at the end
      of the 1-year period, or at the end of a 90-day extension that
      the Secretary may, at the Secretary's discretion, grant by letter
      in order to complete review of the renewal request, unless the
      Secretary determines before the expiration of the 1-year period
      or the 90-day extension that - 
          (A) the applicant failed to submit a timely renewal request;
          (B) the request fails to contain sufficient information to
        show that - 
            (i) the applicant is making sufficient progress toward
          meeting approval requirements under section 360b(d)(1)(E) of
          this title, and is likely to be able to fulfill those
          requirements and obtain an approval under section 360b of
          this title before the expiration of the 5-year maximum term
          of the conditional approval;
            (ii) the quantity of the drug that has been distributed is
          consistent with the conditionally approved intended use and
          conditions of use, unless there is adequate explanation that
          ensures that the drug is only used for its intended purpose;
          or
            (iii) the same drug in the same dosage form for the same
          intended use has not received approval under section 360b of
          this title, or if such a drug has been approved, that the
          holder of the approved application is unable to assure the
          availability of sufficient quantities of the drug to meet the
          needs for which the drug is intended; or

          (C) any of the provisions of section 360b(e)(1)(A) through
        (B) or (D) through (F) of this title are applicable.

        (3) If the Secretary determines before the end of the 1-year
      period or the 90-day extension, if granted, that a conditional
      approval should not be renewed, the Secretary shall issue an
      order refusing to renew the conditional approval, and such
      conditional approval shall be deemed withdrawn and no longer in
      effect. The Secretary shall thereafter provide an opportunity for
      an informal hearing to the applicant on the issue whether the
      conditional approval shall be reinstated.
    (e) Withdrawal of conditional approval
      (1) The Secretary shall issue an order withdrawing conditional
    approval of an application filed pursuant to subsection (a) of this
    section if the Secretary finds that another person has received
    approval under section 360b of this title for the same drug in the
    same dosage form for the same intended use and that person is able
    to assure the availability of sufficient quantities of the drug to
    meet the needs for which the drug is intended.
      (2) The Secretary shall, after due notice and opportunity for an
    informal hearing to the applicant, issue an order withdrawing
    conditional approval of an application filed pursuant to subsection
    (a) of this section if the Secretary finds that - 
        (A) any of the provisions of section 360b(e)(1)(A) through (B)
      or (D) through (F) of this title are applicable; or
        (B) on the basis of new information before the Secretary with
      respect to such drug, evaluated together with the evidence
      available to the Secretary when the application was conditionally
      approved, that there is not a reasonable expectation that such
      drug will have the effect it purports or is represented to have
      under the conditions of use prescribed, recommended, or suggested
      in the labeling thereof.

      (3) The Secretary may also, after due notice and opportunity for
    an informal hearing to the applicant, issue an order withdrawing
    conditional approval of an application filed pursuant to subsection
    (a) of this section if the Secretary finds that any of the
    provisions of section 360b(e)(2) of this title are applicable.
    (f) Labeling
      (1) The label and labeling of a new animal drug with a
    conditional approval under this section shall - 
        (A) bear the statement, "conditionally approved by FDA pending
      a full demonstration of effectiveness under application number";
      and
        (B) contain such other information as prescribed by the
      Secretary.

      (2) An intended use that is the subject of a conditional approval
    under this section shall not be included in the same product label
    with any intended use approved under section 360b of this title.
    (g) Amendment of application
      A conditionally approved new animal drug application may not be
    amended or supplemented to add indications for use.
    (h) Order of approval after conditional approval period termination
      180 days prior to the termination date established under
    subsection (d) of this section, an applicant shall have submitted
    all the information necessary to support a complete new animal drug
    application in accordance with section 360b(b)(1) of this title or
    the conditional approval issued under this section is no longer in
    effect. Following review of this information, the Secretary shall
    either - 
        (1) issue an order approving the application under section
      360b(c) of this title if the Secretary finds that none of the
      grounds for denying approval specified in section 360b(d)(1) of
      this title applies, or
        (2) give the applicant an opportunity for a hearing before the
      Secretary under section 360b(d) of this title on the question
      whether such application can be approved.

    Upon issuance of an order approving the application, product
    labeling and administrative records of approval shall be modified
    accordingly. If the Secretary has not issued an order under section
    360b(c) of this title approving such application prior to the
    termination date established under subsection (d) of this section,
    the conditional approval issued under this section is no longer in
    effect unless the Secretary grants an extension of an additional
    180-day period so that the Secretary can complete review of the
    application. The decision to grant an extension is committed to the
    discretion of the Secretary and not subject to judicial review.
    (i) Judicial review
      The decision of the Secretary under subsection (c), (d), or (e)
    of this section refusing or withdrawing conditional approval of an
    application shall constitute final agency action subject to
    judicial review.
    (j) Definition
      In this section and section 360ccc-1 of this title, the term
    "transgenic animal" means an animal whose genome contains a
    nucleotide sequence that has been intentionally modified in vitro,
    and the progeny of such an animal; Provided that the term
    "transgenic animal" does not include an animal of which the
    nucleotide sequence of the genome has been modified solely by
    selective breeding.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 571, as added Pub. L. 108-282, title
    I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 892.)


-MISC1-
                                 FINDINGS                             
      Pub. L. 108-282, title I, Sec. 102(a), Aug. 2, 2004, 118 Stat.
    891, provided that: "Congress makes the following findings:
        "(1) There is a severe shortage of approved new animal drugs
      for use in minor species.
        "(2) There is a severe shortage of approved new animal drugs
      for treating animal diseases and conditions that occur
      infrequently or in limited geographic areas.
        "(3) Because of the small market shares, low-profit margins
      involved, and capital investment required, it is generally not
      economically feasible for new animal drug applicants to pursue
      approvals for these species, diseases, and conditions.
        "(4) Because the populations for which such new animal drugs
      are intended may be small and conditions of animal management may
      vary widely, it is often difficult to design and conduct studies
      to establish drug safety and effectiveness under traditional new
      animal drug approval processes.
        "(5) It is in the public interest and in the interest of animal
      welfare to provide for special procedures to allow the lawful use
      and marketing of certain new animal drugs for minor species and
      minor uses that take into account these special circumstances and
      that ensure that such drugs do not endanger animal or public
      health.
        "(6) Exclusive marketing rights for clinical testing expenses
      have helped encourage the development of 'orphan' drugs for human
      use, and comparable incentives should encourage the development
      of new animal drugs for minor species and minor uses."

                                REGULATIONS                            
      Pub. L. 108-282, title I, Sec. 102(b)(6), Aug. 2, 2004, 118 Stat.
    905, provided that: "On the date of enactment of this Act [Aug. 2,
    2004], the Secretary of Health and Human Services shall implement
    sections 571 and 573 of the Federal Food, Drug, and Cosmetic Act
    [21 U.S.C. 360ccc, 360ccc-2] and subsequently publish implementing
    regulations. Not later than 12 months after the date of enactment
    of this Act, the Secretary shall issue proposed regulations to
    implement section 573 of the Federal Food, Drug, and Cosmetic Act
    (as added by this Act), and not later than 24 months after the date
    of enactment of this Act, the Secretary shall issue final
    regulations implementing section 573 of the Federal Food, Drug, and
    Cosmetic Act. Not later than 18 months after the date of enactment
    of this Act, the Secretary shall issue proposed regulations to
    implement section 572 of the Federal Food, Drug, and Cosmetic Act
    (as added by this Act) [21 U.S.C. 360ccc-1], and not later than 36
    months after the date of enactment of this Act, the Secretary shall
    issue final regulations implementing section 572 of the Federal
    Food, Drug, and Cosmetic Act. Not later than 30 months after the
    date of enactment of this Act, the Secretary shall issue proposed
    regulations to implement section 571 of the Federal Food, Drug, and
    Cosmetic Act (as added by this Act), and not later than 42 months
    after the date of enactment of this Act, the Secretary shall issue
    final regulations implementing section 571 of the Federal Food,
    Drug, and Cosmetic Act. These timeframes shall be extended by 12
    months for each fiscal year, in which the funds authorized to be
    appropriated under subsection (i) [no subsection (i) of section 102
    has been enacted] are not in fact appropriated."

-FOOTNOTE-
    (!1) So in original. Probably should be "this subsection,".

               

    (!2) So in original. The period probably should be a comma.


-End-



-CITE-
    21 USC Sec. 360ccc-1                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part F - New Animal Drugs for Minor Use and Minor Species

-HEAD-
    Sec. 360ccc-1. Index of legally marketed unapproved new animal
      drugs for minor species

-STATUTE-
    (a) Establishment and content
      (1) The Secretary shall establish an index limited to - 
        (A) new animal drugs intended for use in a minor species for
      which there is a reasonable certainty that the animal or edible
      products from the animal will not be consumed by humans or food-
      producing animals; and
        (B) new animal drugs intended for use only in a hatchery, tank,
      pond, or other similar contained man-made structure in an early,
      non-food life stage of a food-producing minor species, where
      safety for humans is demonstrated in accordance with the standard
      of section 360b(d) of this title (including, for an antimicrobial
      new animal drug, with respect to antimicrobial resistance).

      (2) The index shall not include a new animal drug that is
    contained in or a product of a transgenic animal.
    (b) Conferences
      Any person intending to file a request under this section shall
    be entitled to one or more conferences to discuss the requirements
    for indexing a new animal drug.
    (c) Request for determination of eligibility for inclusion in index
      (1) Any person may submit a request to the Secretary for a
    determination whether a new animal drug may be eligible for
    inclusion in the index. Such a request shall include - 
        (A) information regarding the need for the new animal drug, the
      species for which the new animal drug is intended, the proposed
      intended use and conditions of use, and anticipated annual
      distribution;
        (B) information to support the conclusion that the proposed use
      meets the conditions of subparagraph (A) or (B) of subsection
      (a)(1) of this section;
        (C) information regarding the components and composition of the
      new animal drug;
        (D) a description of the methods used in, and the facilities
      and controls used for, the manufacture, processing, and packing
      of such new animal drug;
        (E) an environmental assessment that meets the requirements of
      the National Environmental Policy Act of 1969 [42 U.S.C. 4321 et
      seq.], as amended, and as defined in 21 CFR Part 25, as it
      appears on August 2, 2004, and amended thereafter or information
      to support a categorical exclusion from the requirement to
      prepare an environmental assessment;
        (F) information sufficient to support the conclusion that the
      proposed use of the new animal drug is safe under section 360b(d)
      of this title with respect to individuals exposed to the new
      animal drug through its manufacture or use; and
        (G) such other information as the Secretary may deem necessary
      to make this eligibility determination.

      (2) Within 90 days after the submission of a request for a
    determination of eligibility for indexing based on subsection
    (a)(1)(A) of this section, or 180 days for a request submitted
    based on subsection (a)(1)(B) of this section, the Secretary shall
    grant or deny the request, and notify the person who requested such
    determination of the Secretary's decision. The Secretary shall
    grant the request if the Secretary finds that - 
        (A) the same drug in the same dosage form for the same intended
      use is not approved or conditionally approved;
        (B) the proposed use of the drug meets the conditions of
      subparagraph (A) or (B) of subsection (a)(1) of this section, as
      appropriate;
        (C) the person requesting the determination has established
      appropriate specifications for the manufacture and control of the
      new animal drug and has demonstrated an understanding of the
      requirements of current good manufacturing practices;
        (D) the new animal drug will not significantly affect the human
      environment; and
        (E) the new animal drug is safe with respect to individuals
      exposed to the new animal drug through its manufacture or use.

    If the Secretary denies the request, the Secretary shall thereafter
    provide due notice and an opportunity for an informal conference. A
    decision of the Secretary to deny an eligibility request following
    an informal conference shall constitute final agency action subject
    to judicial review.
    (d) Request for addition to index
      (1) With respect to a new animal drug for which the Secretary has
    made a determination of eligibility under subsection (c) of this
    section, the person who made such a request may ask that the
    Secretary add the new animal drug to the index established under
    subsection (a) of this section. The request for addition to the
    index shall include - 
        (A) a copy of the Secretary's determination of eligibility
      issued under subsection (c) of this section;
        (B) a written report that meets the requirements in subsection
      (d)(2) of this section;
        (C) a proposed index entry;
        (D) facsimile labeling;
        (E) anticipated annual distribution of the new animal drug;
        (F) a written commitment to manufacture the new animal drug and
      animal feeds bearing or containing such new animal drug according
      to current good manufacturing practices;
        (G) a written commitment to label, distribute, and promote the
      new animal drug only in accordance with the index entry;
        (H) upon specific request of the Secretary, information
      submitted to the expert panel described in paragraph (3); and
        (I) any additional requirements that the Secretary may
      prescribe by general regulation or specific order.

      (2) The report required in paragraph (1) shall - 
        (A) be authored by a qualified expert panel;
        (B) include an evaluation of all available target animal safety
      and effectiveness information, including anecdotal information;
        (C) state the expert panel's opinion regarding whether the
      benefits of using the new animal drug for the proposed use in a
      minor species outweigh its risks to the target animal, taking
      into account the harm being caused by the absence of an approved
      or conditionally approved new animal drug for the minor species
      in question;
        (D) include information from which labeling can be written; and
        (E) include a recommendation regarding whether the new animal
      drug should be limited to use under the professional supervision
      of a licensed veterinarian.

      (3) A qualified expert panel, as used in this section, is a panel
    that - 
        (A) is composed of experts qualified by scientific training and
      experience to evaluate the target animal safety and effectiveness
      of the new animal drug under consideration;
        (B) operates external to FDA; and
        (C) is not subject to the Federal Advisory Committee Act.

    The Secretary shall define the criteria for selection of a
    qualified expert panel and the procedures for the operation of the
    panel by regulation.
      (4) Within 180 days after the receipt of a request for listing a
    new animal drug in the index, the Secretary shall grant or deny the
    request. The Secretary shall grant the request if the request for
    indexing continues to meet the eligibility criteria in subsection
    (a) of this section and the Secretary finds, on the basis of the
    report of the qualified expert panel and other information
    available to the Secretary, that the benefits of using the new
    animal drug for the proposed use in a minor species outweigh its
    risks to the target animal, taking into account the harm caused by
    the absence of an approved or conditionally-approved new animal
    drug for the minor species in question. If the Secretary denies the
    request, the Secretary shall thereafter provide due notice and the
    opportunity for an informal conference. The decision of the
    Secretary following an informal conference shall constitute final
    agency action subject to judicial review.
    (e) Index contents; publication
      (1) The index established under subsection (a) of this section
    shall include the following information for each listed drug - 
        (A) the name and address of the person who holds the index
      listing;
        (B) the name of the drug and the intended use and conditions of
      use for which it is being indexed;
        (C) product labeling; and
        (D) conditions and any limitations that the Secretary deems
      necessary regarding use of the drug.

      (2) The Secretary shall publish the index, and revise it
    periodically.
      (3) The Secretary may establish by regulation a process for
    reporting changes in the conditions of manufacturing or labeling of
    indexed products.
    (f) Removal from index; suspended listing
      (1) If the Secretary finds, after due notice to the person who
    requested the index listing and an opportunity for an informal
    conference, that - 
        (A) the expert panel failed to meet the requirements as set
      forth by the Secretary by regulation;
        (B) on the basis of new information before the Secretary,
      evaluated together with the evidence available to the Secretary
      when the new animal drug was listed in the index, the benefits of
      using the new animal drug for the indexed use do not outweigh its
      risks to the target animal;
        (C) the conditions of subsection (c)(2) of this section are no
      longer satisfied;
        (D) the manufacture of the new animal drug is not in accordance
      with current good manufacturing practices;
        (E) the labeling, distribution, or promotion of the new animal
      drug is not in accordance with the index entry;
        (F) the conditions and limitations of use associated with the
      index listing have not been followed; or
        (G) the request for indexing contains any untrue statement of
      material fact,

    the Secretary shall remove the new animal drug from the index. The
    decision of the Secretary following an informal conference shall
    constitute final agency action subject to judicial review.
      (2) If the Secretary finds that there is a reasonable probability
    that the use of the drug would present a risk to the health of
    humans or other animals, the Secretary may - 
        (A) suspend the listing of such drug immediately;
        (B) give the person listed in the index prompt notice of the
      Secretary's action; and
        (C) afford that person the opportunity for an informal
      conference.

    The decision of the Secretary following an informal conference
    shall constitute final agency action subject to judicial review.
    (g) Regulations concerning exemptions for investigational use
      For purposes of indexing new animal drugs under this section, to
    the extent consistent with the public health, the Secretary shall
    promulgate regulations for exempting from the operation of section
    360b of this title minor species new animal drugs and animal feeds
    bearing or containing new animal drugs intended solely for
    investigational use by experts qualified by scientific training and
    experience to investigate the safety and effectiveness of minor
    species animal drugs. Such regulations may, at the discretion of
    the Secretary, among other conditions relating to the protection of
    the public health, provide for conditioning such exemption upon the
    establishment and maintenance of such records, and the making of
    such reports to the Secretary, by the manufacturer or the sponsor
    of the investigation of such article, of data (including but not
    limited to analytical reports by investigators) obtained as a
    result of such investigational use of such article, as the
    Secretary finds will enable the Secretary to evaluate the safety
    and effectiveness of such article in the event of the filing of a
    request for an index listing pursuant to this section.
    (h) Labeling contents
      The labeling of a new animal drug that is the subject of an index
    listing shall state, prominently and conspicuously - 
        (1) "Not approved by fda. - Legally marketed as an FDA indexed
      product. Extra-label use is prohibited.";
        (2) except in the case of new animal drugs indexed for use in
      an early life stage of a food-producing animal, "This product is
      not to be used in animals intended for use as food for humans or
      other animals."; and
        (3) such other information as may be prescribed by the
      Secretary in the index listing.
    (i) Records and reports
      (1) In the case of any new animal drug for which an index listing
    pursuant to subsection (a) of this section is in effect, the person
    who has an index listing shall establish and maintain such records,
    and make such reports to the Secretary, of data relating to
    experience, and other data or information, received or otherwise
    obtained by such person with respect to such drug, or with respect
    to animal feeds bearing or containing such drug, as the Secretary
    may by general regulation, or by order with respect to such
    listing, prescribe on the basis of a finding that such records and
    reports are necessary in order to enable the Secretary to
    determine, or facilitate a determination, whether there is or may
    be ground for invoking subsection (f) of this section. Such
    regulation or order shall provide, where the Secretary deems it to
    be appropriate, for the examination, upon request, by the persons
    to whom such regulation or order is applicable, of similar
    information received or otherwise obtained by the Secretary.
      (2) Every person required under this subsection to maintain
    records, and every person in charge or custody thereof, shall, upon
    request of an officer or employee designated by the Secretary,
    permit such officer or employee at all reasonable times to have
    access to and copy and verify such records.
    (j) Public disclosure of safety and effectiveness data
      (1) Safety and effectiveness data and information which has been
    submitted in support of a request for a new animal drug to be
    indexed under this section and which has not been previously
    disclosed to the public shall be made available to the public, upon
    request, unless extraordinary circumstances are shown - 
        (A) if no work is being or will be undertaken to have the drug
      indexed in accordance with the request,
        (B) if the Secretary has determined that such drug cannot be
      indexed and all legal appeals have been exhausted,
        (C) if the indexing of such drug is terminated and all legal
      appeals have been exhausted, or
        (D) if the Secretary has determined that such drug is not a new
      animal drug.

      (2) Any request for data and information pursuant to paragraph
    (1) shall include a verified statement by the person making the
    request that any data or information received under such paragraph
    shall not be disclosed by such person to any other person - 
        (A) for the purpose of, or as part of a plan, scheme, or device
      for, obtaining the right to make, use, or market, or making,
      using, or marketing, outside the United States, the drug
      identified in the request for indexing; and
        (B) without obtaining from any person to whom the data and
      information are disclosed an identical verified statement, a copy
      of which is to be provided by such person to the Secretary, which
      meets the requirements of this paragraph.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 572, as added Pub. L. 108-282, title
    I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 896.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The National Environmental Policy Act of 1969, referred to in
    subsec. (c)(1)(E), is Pub. L. 91-190, Jan. 1, 1970, 83 Stat. 852,
    as amended, which is classified generally to chapter 55 (Sec. 4321
    et seq.) of Title 42, The Public Health and Welfare. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 4321 of Title 42 and Tables.
      The Federal Advisory Committee Act, referred to in subsec.
    (d)(3)(C), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as
    amended, which is set out in the Appendix to Title 5, Government
    Organization and Employees.

-End-



-CITE-
    21 USC Sec. 360ccc-2                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER V - DRUGS AND DEVICES
    Part F - New Animal Drugs for Minor Use and Minor Species

-HEAD-
    Sec. 360ccc-2. Designated new animal drugs for minor use or minor
      species

-STATUTE-
    (a) Designation
      (1) The manufacturer or the sponsor of a new animal drug for a
    minor use or use in a minor species may request that the Secretary
    declare that drug a "designated new animal drug". A request for
    designation of a new animal drug shall be made before the
    submission of an application under section 360b(b) of this title or
    section 360ccc of this title for the new animal drug.
      (2) The Secretary may declare a new animal drug a "designated new
    animal drug" if - 
        (A) it is intended for a minor use or use in a minor species;
      and
        (B) the same drug in the same dosage form for the same intended
      use is not approved under section 360b or 360ccc of this title or
      designated under this section at the time the request is made.

      (3) Regarding the termination of a designation - 
        (A) the sponsor of a new animal drug shall notify the Secretary
      of any decision to discontinue active pursuit of approval under
      section 360b or 360ccc of this title of an application for a
      designated new animal drug. The Secretary shall terminate the
      designation upon such notification;
        (B) the Secretary may also terminate designation if the
      Secretary independently determines that the sponsor is not
      actively pursuing approval under section 360b or 360ccc of this
      title with due diligence;
        (C) the sponsor of an approved designated new animal drug shall
      notify the Secretary of any discontinuance of the manufacture of
      such new animal drug at least one year before discontinuance. The
      Secretary shall terminate the designation upon such notification;
      and
        (D) the designation shall terminate upon the expiration of any
      applicable exclusivity period under subsection (c) of this
      section.

      (4) Notice respecting the designation or termination of
    designation of a new animal drug shall be made available to the
    public.
    (b) Grants and contracts for development of designated new animal
      drugs
      (1) The Secretary may make grants to and enter into contracts
    with public and private entities and individuals to assist in
    defraying the costs of qualified safety and effectiveness testing
    expenses and manufacturing expenses incurred in connection with the
    development of designated new animal drugs.
      (2) For purposes of paragraph (1) of this section - 
        (A) The term "qualified safety and effectiveness testing" means
      testing - 
          (i) which occurs after the date such new animal drug is
        designated under this section and before the date on which an
        application with respect to such drug is submitted under
        section 360b of this title; and
          (ii) which is carried out under an investigational exemption
        under section 360b(j) of this title.

        (B) The term "manufacturing expenses" means expenses incurred
      in developing processes and procedures associated with
      manufacture of the designated new animal drug which occur after
      the new animal drug is designated under this section and before
      the date on which an application with respect to such new animal
      drug is submitted under section 360b or 360ccc of this title.
    (c) Exclusivity for designated new animal drugs
      (1) Except as provided in subsection (c)(2) of this section, if
    the Secretary approves or conditionally approves an application for
    a designated new animal drug, the Secretary may not approve or
    conditionally approve another application submitted for such new
    animal drug with the same intended use as the designated new animal
    drug for another applicant before the expiration of seven years
    from the date of approval or conditional approval of the
    application.
      (2) If an application filed pursuant to section 360b of this
    title or section 360ccc of this title is approved for a designated
    new animal drug, the Secretary may, during the 7-year exclusivity
    period beginning on the date of the application approval or
    conditional approval, approve or conditionally approve another
    application under section 360b of this title or section 360ccc of
    this title for such drug for such minor use or minor species for
    another applicant if - 
        (A) the Secretary finds, after providing the holder of such an
      approved application notice and opportunity for the submission of
      views, that in the granted exclusivity period the holder of the
      approved application cannot assure the availability of sufficient
      quantities of the drug to meet the needs for which the drug was
      designated; or
        (B) such holder provides written consent to the Secretary for
      the approval or conditional approval of other applications before
      the expiration of such exclusivity period.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 573, as added Pub. L. 108-282, title
    I, Sec. 102(b)(4), Aug. 2, 2004, 118 Stat. 900.)

-End-


-CITE-
    21 USC SUBCHAPTER VI - COSMETICS                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
                         SUBCHAPTER VI - COSMETICS                     

-End-



-CITE-
    21 USC Sec. 361                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
    Sec. 361. Adulterated cosmetics

-STATUTE-
      A cosmetic shall be deemed to be adulterated - 
      (a) If it bears or contains any poisonous or deleterious
    substance which may render it injurious to users under the
    conditions of use prescribed in the labeling thereof, or under such
    conditions of use as are customary or usual, except that this
    provision shall not apply to coal-tar hair dye, the label of which
    bears the following legend conspicuously displayed thereon:
    "Caution - This product contains ingredients which may cause skin
    irritation on certain individuals and a preliminary test according
    to accompanying directions should first be made. This product must
    not be used for dyeing the eyelashes or eyebrows; to do so may
    cause blindness.", and the labeling of which bears adequate
    directions for such preliminary testing. For the purposes of this
    paragraph and paragraph (e) the term "hair dye" shall not include
    eyelash dyes or eyebrow dyes.
      (b) If it consists in whole or in part of any filthy, putrid, or
    decomposed substance.
      (c) If it has been prepared, packed, or held under insanitary
    conditions whereby it may have become contaminated with filth, or
    whereby it may have been rendered injurious to health.
      (d) If its container is composed, in whole or in part, of any
    poisonous or deleterious substance which may render the contents
    injurious to health.
      (e) If it is not a hair dye and it is, or it bears or contains, a
    color additive which is unsafe within the meaning of section
    379e(a) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 601, 52 Stat. 1054; Pub. L. 86-618,
    title I, Sec. 102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L. 102-
    571, title I, Sec. 107(11), Oct. 29, 1992, 106 Stat. 4499; Pub. L.
    103-80, Sec. 3(x), Aug. 13, 1993, 107 Stat. 778.)


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (a). Pub. L. 103-80 substituted "usual, except
    that this" for "usual: Provided, That this".
      1992 - Par. (e). Pub. L. 102-571 substituted "379e(a)" for
    "376(a)".
      1960 - Par. (e). Pub. L. 86-618 substituted "and it is, or it
    bears or contains, a color additive which is unsafe within the
    meaning of section 376(a) of this title" for "and it bears or
    contains a coal-tar color other than one from a batch that has been
    certified in accordance with regulations as provided by section 364
    of this title".

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Par. (e) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
    53 Stat. 853, set out as an Effective Date; Postponement in Certain
    Cases note under section 301 of this title.

                              EFFECTIVE DATE                          
      Section effective twelve months after June 25, 1938, except par.
    (a), which, with certain exceptions, became effective on June 25,
    1938, see section 902(a) of act June 25, 1938, set out as a note
    under section 301 of this title.

-End-



-CITE-
    21 USC Sec. 362                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
    Sec. 362. Misbranded cosmetics

-STATUTE-
      A cosmetic shall be deemed to be misbranded - 
      (a) If its labeling is false or misleading in any particular.
      (b) If in package form unless it bears a label containing (1) the
    name and place of business of the manufacturer, packer, or
    distributor; and (2) an accurate statement of the quantity of the
    contents in terms of weight, measure, or numerical count: Provided,
    That under clause (2) of this paragraph reasonable variations shall
    be permitted, and exemptions as to small packages shall be
    established, by regulations prescribed by the Secretary.
      (c) If any word, statement, or other information required by or
    under authority of this chapter to appear on the label or labeling
    is not prominently placed thereon with such conspicuousness (as
    compared with other words, statements, designs, or devices, in the
    labeling) and in such terms as to render it likely to be read and
    understood by the ordinary individual under customary conditions of
    purchase and use.
      (d) If its container is so made, formed, or filled as to be
    misleading.
      (e) If it is a color additive, unless its packaging and labeling
    are in conformity with such packaging and labeling requirements,
    applicable to such color additive, as may be contained in
    regulations issued under section 379e of this title. This paragraph
    shall not apply to packages of color additives which, with respect
    to their use for cosmetics, are marketed and intended for use only
    in or on hair dyes (as defined in the last sentence of section
    361(a) of this title).
      (f) If its packaging or labeling is in violation of an applicable
    regulation issued pursuant to section 1472 or 1473 of title 15.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 602, 52 Stat. 1054; Pub. L. 86-618,
    title I, Sec. 102(c)(2), July 12, 1960, 74 Stat. 398; Pub. L. 91-
    601, Sec. 6(f), formerly Sec. 7(f), Dec. 30, 1970, 84 Stat. 1673,
    renumbered Pub. L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981,
    95 Stat. 716; Pub. L. 102-571, title I, Sec. 107(12), Oct. 29,
    1992, 106 Stat. 4499.)


-MISC1-
                                AMENDMENTS                            
      1992 - Par. (e). Pub. L. 102-571 substituted "379e" for "376".
      1970 - Par. (f). Pub. L. 91-601 added par. (f).
      1960 - Par. (e). Pub. L. 86-618 added par. (e).

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
    regulations establishing special packaging standards effective no
    sooner than 180 days or later than one year from date regulations
    are final, or an earlier date published in Federal Register, see
    section 8 of Pub. L. 91-601, set out as an Effective Date note
    under section 1471 of Title 15, Commerce and Trade.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

                       EFFECTIVE DATE; POSTPONEMENT                   
      Par. (b) effective Jan. 1, 1940, and such subsection effective
    July 1, 1940, as provided by regulations for certain lithographed
    labeling and containers bearing certain labeling, see act June 23,
    1939, ch. 242, 53 Stat. 853, set out as an Effective Date;
    Postponement in Certain Cases note under section 301 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 363                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
    Sec. 363. Regulations making exemptions

-STATUTE-
      The Secretary shall promulgate regulations exempting from any
    labeling requirement of this chapter cosmetics which are, in
    accordance with the practice of the trade, to be processed,
    labeled, or repacked in substantial quantities at establishments
    other than those where originally processed or packed, on condition
    that such cosmetics are not adulterated or misbranded under the
    provisions of this chapter upon removal from such processing,
    labeling, or repacking establishment.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 603, 52 Stat. 1054.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 364                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VI - COSMETICS

-HEAD-
    Sec. 364. Repealed.

-MISC1-
    Sec. 364. Repealed. Pub. L. 86-618, title I, Sec. 103(a)(3), July
      12, 1960, 74 Stat. 398.
      Section, act June 25, 1938, ch. 675, Sec. 604, 52 Stat. 1055,
    directed Secretary to promulgate regulations for listing of coal-
    tar colors for cosmetics. See section 379e of this title.

                         EFFECTIVE DATE OF REPEAL                     
      Repeal effective July 12, 1960, subject to the provisions of
    section 203 of Pub. L. 86-618, see section 202 of Pub. L. 86-618,
    set out as an Effective Date of 1960 Amendment note under section
    379e of this title.

-End-


-CITE-
    21 USC SUBCHAPTER VII - GENERAL AUTHORITY                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY

-HEAD-
                    SUBCHAPTER VII - GENERAL AUTHORITY                

-End-


-CITE-
    21 USC Part A - General Administrative Provisions           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
                PART A - GENERAL ADMINISTRATIVE PROVISIONS            

-End-



-CITE-
    21 USC Sec. 371                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 371. Regulations and hearings

-STATUTE-
    (a) Authority to promulgate regulations
      The authority to promulgate regulations for the efficient
    enforcement of this chapter, except as otherwise provided in this
    section, is vested in the Secretary.
    (b) Regulations for imports and exports
      The Secretary of the Treasury and the Secretary of Health and
    Human Services shall jointly prescribe regulations for the
    efficient enforcement of the provisions of section 381 of this
    title, except as otherwise provided therein. Such regulations shall
    be promulgated in such manner and take effect at such time, after
    due notice, as the Secretary of Health and Human Services shall
    determine.
    (c) Conduct of hearings
      Hearings authorized or required by this chapter shall be
    conducted by the Secretary or such officer or employee as he may
    designate for the purpose.
    (d) Effectiveness of definitions and standards of identity
      The definitions and standards of identity promulgated in
    accordance with the provisions of this chapter shall be effective
    for the purposes of the enforcement of this chapter,
    notwithstanding such definitions and standards as may be contained
    in other laws of the United States and regulations promulgated
    thereunder.
    (e) Procedure for establishment
      (1) Any action for the issuance, amendment, or repeal of any
    regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or
    (h) of this title, and any action for the amendment or repeal of
    any definition and standard of identity under section 341 of this
    title for any dairy product (including products regulated under
    parts 131, 133 and 135 of title 21, Code of Federal Regulations)
    shall be begun by a proposal made (A) by the Secretary on his own
    initiative, or (B) by petition of any interested person, showing
    reasonable grounds therefor, filed with the Secretary. The
    Secretary shall publish such proposal and shall afford all
    interested persons an opportunity to present their views thereon,
    orally or in writing. As soon as practicable thereafter, the
    Secretary shall by order act upon such proposal and shall make such
    order public. Except as provided in paragraph (2), the order shall
    become effective at such time as may be specified therein, but not
    prior to the day following the last day on which objections may be
    filed under such paragraph.
      (2) On or before the thirtieth day after the date on which an
    order entered under paragraph (1) is made public, any person who
    will be adversely affected by such order if placed in effect may
    file objections thereto with the Secretary, specifying with
    particularity the provisions of the order deemed objectionable,
    stating the grounds therefor, and requesting a public hearing upon
    such objections. Until final action upon such objections is taken
    by the Secretary under paragraph (3), the filing of such objections
    shall operate to stay the effectiveness of those provisions of the
    order to which the objections are made. As soon as practicable
    after the time for filing objections has expired the Secretary
    shall publish a notice in the Federal Register specifying those
    parts of the order which have been stayed by the filing of
    objections and, if no objections have been filed, stating that
    fact.
      (3) As soon as practicable after such request for a public
    hearing, the Secretary, after due notice, shall hold such a public
    hearing for the purpose of receiving evidence relevant and material
    to the issues raised by such objections. At the hearing, any
    interested person may be heard in person or by representative. As
    soon as practicable after completion of the hearing, the Secretary
    shall by order act upon such objections and make such order public.
    Such order shall be based only on substantial evidence of record at
    such hearing and shall set forth, as part of the order, detailed
    findings of fact on which the order is based. The Secretary shall
    specify in the order the date on which it shall take effect, except
    that it shall not be made to take effect prior to the ninetieth day
    after its publication unless the Secretary finds that emergency
    conditions exist necessitating an earlier effective date, in which
    event the Secretary shall specify in the order his findings as to
    such conditions.
    (f) Review of order
      (1) In a case of actual controversy as to the validity of any
    order under subsection (e) of this section, any person who will be
    adversely affected by such order if placed in effect may at any
    time prior to the ninetieth day after such order is issued file a
    petition with the United States court of appeals for the circuit
    wherein such person resides or has his principal place of business,
    for a judicial review of such order. A copy of the petition shall
    be forthwith transmitted by the clerk of the court to the Secretary
    or other officer designated by him for that purpose. The Secretary
    thereupon shall file in the court the record of the proceedings on
    which the Secretary based his order, as provided in section 2112 of
    title 28.
      (2) If the petitioner applies to the court for leave to adduce
    additional evidence, and shows to the satisfaction of the court
    that such additional evidence is material and that there were
    reasonable grounds for the failure to adduce such evidence in the
    proceeding before the Secretary, the court may order such
    additional evidence (and evidence in rebuttal thereof) to be taken
    before the Secretary, and to be adduced upon the hearing, in such
    manner and upon such terms and conditions as to the court may seem
    proper. The Secretary may modify his findings as to the facts, or
    make new findings, by reason of the additional evidence so taken,
    and he shall file such modified or new findings, and his
    recommendation, if any, for the modification or setting aside of
    his original order, with the return of such additional evidence.
      (3) Upon the filing of the petition referred to in paragraph (1)
    of this subsection, the court shall have jurisdiction to affirm the
    order, or to set it aside in whole or in part, temporarily or
    permanently. If the order of the Secretary refuses to issue, amend,
    or repeal a regulation and such order is not in accordance with law
    the court shall by its judgment order the Secretary to take action,
    with respect to such regulation, in accordance with law. The
    findings of the Secretary as to the facts, if supported by
    substantial evidence, shall be conclusive.
      (4) The judgment of the court affirming or setting aside, in
    whole or in part, any such order of the Secretary shall be final,
    subject to review by the Supreme Court of the United States upon
    certiorari or certification as provided in section 1254 of title
    28.
      (5) Any action instituted under this subsection shall survive
    notwithstanding any change in the person occupying the office of
    Secretary or any vacancy in such office.
      (6) The remedies provided for in this subsection shall be in
    addition to and not in substitution for any other remedies provided
    by law.
    (g) Copies of records of hearings
      A certified copy of the transcript of the record and proceedings
    under subsection (e) of this section shall be furnished by the
    Secretary to any interested party at his request, and payment of
    the costs thereof, and shall be admissible in any criminal, libel
    for condemnation, exclusion of imports, or other proceeding arising
    under or in respect to this chapter, irrespective of whether
    proceedings with respect to the order have previously been
    instituted or become final under subsection (f) of this section.
    (h) Guidance documents
      (1)(A) The Secretary shall develop guidance documents with public
    participation and ensure that information identifying the existence
    of such documents and the documents themselves are made available
    to the public both in written form and, as feasible, through
    electronic means. Such documents shall not create or confer any
    rights for or on any person, although they present the views of the
    Secretary on matters under the jurisdiction of the Food and Drug
    Administration.
      (B) Although guidance documents shall not be binding on the
    Secretary, the Secretary shall ensure that employees of the Food
    and Drug Administration do not deviate from such guidances without
    appropriate justification and supervisory concurrence. The
    Secretary shall provide training to employees in how to develop and
    use guidance documents and shall monitor the development and
    issuance of such documents.
      (C) For guidance documents that set forth initial interpretations
    of a statute or regulation, changes in interpretation or policy
    that are of more than a minor nature, complex scientific issues, or
    highly controversial issues, the Secretary shall ensure public
    participation prior to implementation of guidance documents, unless
    the Secretary determines that such prior public participation is
    not feasible or appropriate. In such cases, the Secretary shall
    provide for public comment upon implementation and take such
    comment into account.
      (D) For guidance documents that set forth existing practices or
    minor changes in policy, the Secretary shall provide for public
    comment upon implementation.
      (2) In developing guidance documents, the Secretary shall ensure
    uniform nomenclature for such documents and uniform internal
    procedures for approval of such documents. The Secretary shall
    ensure that guidance documents and revisions of such documents are
    properly dated and indicate the nonbinding nature of the documents.
    The Secretary shall periodically review all guidance documents and,
    where appropriate, revise such documents.
      (3) The Secretary, acting through the Commissioner, shall
    maintain electronically and update and publish periodically in the
    Federal Register a list of guidance documents. All such documents
    shall be made available to the public.
      (4) The Secretary shall ensure that an effective appeals
    mechanism is in place to address complaints that the Food and Drug
    Administration is not developing and using guidance documents in
    accordance with this subsection.
      (5) Not later than July 1, 2000, the Secretary after evaluating
    the effectiveness of the Good Guidance Practices document,
    published in the Federal Register at 62 Fed. Reg. 8961, shall
    promulgate a regulation consistent with this subsection specifying
    the policies and procedures of the Food and Drug Administration for
    the development, issuance, and use of guidance documents.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 701, 52 Stat. 1055; June 25, 1948,
    ch. 646, Sec. 32, 62 Stat. 991; Apr. 15, 1954, ch. 143, Sec. 2, 68
    Stat. 55; Aug. 1, 1956, ch. 861, Sec. 2, 70 Stat. 919; Pub. L. 85-
    791, Sec. 21, Aug. 28, 1958, 72 Stat. 948; Pub. L. 86-618, title
    I, Sec. 103(a)(4), July 12, 1960, 74 Stat. 398; Pub. L. 101-535,
    Sec. 8, Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102-300, Sec.
    6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103-80, Secs. 3(y),
    (dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103-396,
    Sec. 3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105-115, title
    IV, Sec. 405, Nov. 21, 1997, 111 Stat. 2368.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (h). Pub. L. 105-115 added subsec. (h).
      1994 - Subsec. (e)(1). Pub. L. 103-396 which directed the
    amendment of par. (1) by striking out "or maple syrup (regulated
    under section 168.140 of title 21, Code of Federal Regulations).",
    was executed by striking out "or maple sirup (regulated under
    section 168.140 of title 21, Code of Federal Regulations)" before
    "shall be begun by a proposal", to reflect the probable intent of
    Congress.
      1993 - Subsec. (b). Pub. L. 103-80, Sec. 3(dd)(1), substituted
    "Health and Human Services" for "Agriculture" in two places.
      Subsec. (e)(1). Pub. L. 103-80, Sec. 4(c), made technical
    correction to directory language of Pub. L. 101-535, Sec. 8. See
    1990 Amendment note below.
      Pub. L. 103-80, Sec. 3(y)(1), struck out period after second
    reference to "Regulations)".
      Subsec. (f)(4). Pub. L. 103-80, Sec. 3(y)(2), substituted
    reference to section 1254 of title 28 for "sections 239 and 240 of
    the Judicial Code, as amended".
      1992 - Subsec. (b). Pub. L. 102-300, which directed the
    substitution of "Health and Human Services" for "Health, Education,
    and Welfare", could not be executed because such words did not
    appear in the original statutory text. See 1993 Amendment note
    above and Transfer of Functions note below.
      1990 - Subsec. (e)(1). Pub. L. 101-535, Sec. 8, as amended by
    Pub. L. 103-80, Sec. 4(c), substituted "Any action for the
    issuance, amendment, or repeal of any regulation under section
    343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and
    any action for the amendment or repeal of any definition and
    standard of identity under section 341 of this title for any dairy
    product (including products regulated under parts 131, 133 and 135
    of title 21, Code of Federal Regulations) or maple sirup (regulated
    under section 168.140 of title 21, Code of Federal Regulations)"
    for "Any action for the issuance, amendment, or repeal of any
    regulation under section 341, 343(j), 344(a), 346, 351(b), or
    352(d) or (h) of this title".
      1960 - Subsec. (e). Pub. L. 86-618 substituted "section 341,
    343(j), 344(a), 346, 351(b), or 352(d) or (h), of this title" for
    "section 341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or (h),
    354 or 364 of this title".
      1958 - Subsec. (f)(1). Pub. L. 85-791, Sec. 21(a), substituted
    provisions requiring transmission of a copy of the petition by
    clerk to Secretary, and filing of the record by Secretary, for
    provisions which permitted service of summons and petition any
    place in United States and required Secretary to certify and file
    transcript of the proceedings and record upon service.
      Subsec. (f)(3). Pub. L. 85-791, Sec. 21(b), inserted "Upon the
    filing of the petition referred to in paragraph (1) of this
    subsection".
      1956 - Subsec. (e). Act Aug. 1, 1956, simplified procedures
    governing prescribing of regulations under certain provisions of
    this chapter.
      1954 - Subsec. (e). Act Apr. 15, 1954, struck out reference to
    section 341 of this title, before "343(j)", such section 341 now
    containing its own provisions with respect to hearings regarding
    the establishment of food standards.

-CHANGE-
                              CHANGE OF NAME                          
      Circuit Court of Appeals of the United States changed to United
    States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.


-MISC2-
                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                     EFFECTIVE DATE OF 1960 AMENDMENT                 
      Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
    the provisions of section 203 of Pub. L. 86-618, see section 202 of
    Pub. L. 86-618, set out as a note under section 379e of this title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535           
      Amendments by Pub. L. 101-535 not to be construed to alter the
    authority of the Secretary of Health and Human Services and the
    Secretary of Agriculture under the Federal Food, Drug, and Cosmetic
    Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21
    U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.
    451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031
    et seq.), see section 9 of Pub. L. 101-535, set out as a note under
    section 343 of this title.

                             SAVINGS PROVISION                         
      Savings clause of act Aug. 1, 1956, see note set out under
    section 341 of this title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Secretary and Department of Health, Education, and Welfare
    redesignated Secretary and Department of Health and Human Services
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695, which is classified to section 3508(b) of Title 20, Education.
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC3-
        APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS    
      Section 403 of Pub. L. 105-115 provided that:
      "(a) Standards. - Not later than 180 days after the date of
    enactment of this Act [Nov. 21, 1997], the Secretary of Health and
    Human Services shall publish in the Federal Register standards for
    the prompt review of supplemental applications submitted for
    approved articles under the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service
    Act (42 U.S.C. 262).
      "(b) Guidance to Industry. - Not later than 180 days after the
    date of enactment of this Act [Nov. 21, 1997], the Secretary shall
    issue final guidances to clarify the requirements for, and
    facilitate the submission of data to support, the approval of
    supplemental applications for the approved articles described in
    subsection (a). The guidances shall - 
        "(1) clarify circumstances in which published matter may be the
      basis for approval of a supplemental application;
        "(2) specify data requirements that will avoid duplication of
      previously submitted data by recognizing the availability of data
      previously submitted in support of an original application; and
        "(3) define supplemental applications that are eligible for
      priority review.
      "(c) Responsibilities of Centers. - The Secretary shall designate
    an individual in each center within the Food and Drug
    Administration (except the Center for Food Safety and Applied
    Nutrition) to be responsible for - 
        "(1) encouraging the prompt review of supplemental applications
      for approved articles; and
        "(2) working with sponsors to facilitate the development and
      submission of data to support supplemental applications.
      "(d) Collaboration. - The Secretary shall implement programs and
    policies that will foster collaboration between the Food and Drug
    Administration, the National Institutes of Health, professional
    medical and scientific societies, and other persons, to identify
    published and unpublished studies that may support a supplemental
    application, and to encourage sponsors to make supplemental
    applications or conduct further research in support of a
    supplemental application based, in whole or in part, on such
    studies."

    HEARINGS PENDING ON APRIL 15, 1954, WITH RESPECT TO FOOD STANDARDS
      Provisions of this chapter in effect prior to Apr. 15, 1954, as
    applicable with respect to hearings begun prior to such date under
    subsection (e) of this section, regarding food standards, see
    Savings Provisions note set out under section 341 of this title.

-End-



-CITE-
    21 USC Sec. 372                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 372. Examinations and investigations

-STATUTE-
    (a) Authority to conduct
      (1) The Secretary is authorized to conduct examinations and
    investigations for the purposes of this chapter through officers
    and employees of the Department or through any health, food, or
    drug officer or employee of any State, Territory, or political
    subdivision thereof, duly commissioned by the Secretary as an
    officer of the Department.
      (2)(A) In addition to the authority established in paragraph (1),
    the Secretary, pursuant to a memorandum of understanding between
    the Secretary and the head of another Federal department or agency,
    is authorized to conduct examinations and investigations for the
    purposes of this chapter through the officers and employees of such
    other department or agency, subject to subparagraph (B). Such a
    memorandum shall include provisions to ensure adequate training of
    such officers and employees to conduct the examinations and
    investigations. The memorandum of understanding shall contain
    provisions regarding reimbursement. Such provisions may, at the
    sole discretion of the head of the other department or agency,
    require reimbursement, in whole or in part, from the Secretary for
    the examinations or investigations performed under this section by
    the officers or employees of the other department or agency.
      (B) A memorandum of understanding under subparagraph (A) between
    the Secretary and another Federal department or agency is effective
    only in the case of examinations or inspections at facilities or
    other locations that are jointly regulated by the Secretary and
    such department or agency.
      (C) For any fiscal year in which the Secretary and the head of
    another Federal department or agency carries out one or more
    examinations or inspections under a memorandum of understanding
    under subparagraph (A), the Secretary and the head of such
    department or agency shall with respect to their respective
    departments or agencies submit to the committees of jurisdiction
    (authorizing and appropriating) in the House of Representatives and
    the Senate a report that provides, for such year - 
        (i) the number of officers or employees that carried out one or
      more programs, projects, or activities under such memorandum;
        (ii) the number of additional articles that were inspected or
      examined as a result of such memorandum; and
        (iii) the number of additional examinations or investigations
      that were carried out pursuant to such memorandum.

      (3) In the case of food packed in the Commonwealth of Puerto Rico
    or a Territory the Secretary shall attempt to make inspection of
    such food at the first point of entry within the United States
    when, in his opinion and with due regard to the enforcement of all
    the provisions of this chapter, the facilities at his disposal will
    permit of such inspection.
      (4) For the purposes of this subsection, the term "United States"
    means the States and the District of Columbia.
    (b) Availability to owner of part of analysis samples
      Where a sample of a food, drug, or cosmetic is collected for
    analysis under this chapter the Secretary shall, upon request,
    provide a part of such official sample for examination or analysis
    by any person named on the label of the article, or the owner
    thereof, or his attorney or agent; except that the Secretary is
    authorized, by regulations, to make such reasonable exceptions
    from, and impose such reasonable terms and conditions relating to,
    the operation of this subsection as he finds necessary for the
    proper administration of the provisions of this chapter.
    (c) Records of other departments and agencies
      For purposes of enforcement of this chapter, records of any
    department or independent establishment in the executive branch of
    the Government shall be open to inspection by any official of the
    Department duly authorized by the Secretary to make such
    inspection.
    (d) Information on patents for drugs
      The Secretary is authorized and directed, upon request from the
    Under Secretary of Commerce for Intellectual Property and Director
    of the United States Patent and Trademark Office, to furnish full
    and complete information with respect to such questions relating to
    drugs as the Director may submit concerning any patent application.
    The Secretary is further authorized, upon receipt of any such
    request, to conduct or cause to be conducted, such research as may
    be required.
    (e) Powers of enforcement personnel
      Any officer or employee of the Department designated by the
    Secretary to conduct examinations, investigations, or inspections
    under this chapter relating to counterfeit drugs may, when so
    authorized by the Secretary - 
        (1) carry firearms;
        (2) execute and serve search warrants and arrest warrants;
        (3) execute seizure by process issued pursuant to libel under
      section 334 of this title;
        (4) make arrests without warrant for offenses under this
      chapter with respect to such drugs if the offense is committed in
      his presence or, in the case of a felony, if he has probable
      cause to believe that the person so arrested has committed, or is
      committing, such offense; and
        (5) make, prior to the institution of libel proceedings under
      section 334(a)(2) of this title, seizures of drugs or containers
      or of equipment, punches, dies, plates, stones, labeling, or
      other things, if they are, or he has reasonable grounds to
      believe that they are, subject to seizure and condemnation under
      such section 334(a)(2). In the event of seizure pursuant to this
      paragraph (5), libel proceedings under section 334(a)(2) of this
      title shall be instituted promptly and the property seized be
      placed under the jurisdiction of the court.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 702, 52 Stat. 1056; Pub. L. 87-781,
    title III, Secs. 307(b), 308, Oct. 10, 1962, 76 Stat. 796; Pub. L.
    89-74, Sec. 8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91-513,
    title II, Sec. 701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 102-
    300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103-80,
    Sec. 3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L. 106-113, div.
    B, Sec. 1000(a)(9) [title IV, Sec. 4732(b)(12)], Nov. 29, 1999, 113
    Stat. 1536, 1501A-584; Pub. L. 107-188, title III, Sec. 314, June
    12, 2002, 116 Stat. 674.)


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-188 inserted "(1)" before "The
    Secretary is authorized to conduct", added par. (2), inserted "(3)"
    before "In the case of food packed", and substituted "(4) For the
    purposes of this subsection," for "For the purposes of this
    subsection".
      1999 - Subsec. (d). Pub. L. 106-113, in first sentence,
    substituted "Under Secretary of Commerce for Intellectual Property
    and Director of the United States Patent and Trademark Office" for
    "Commissioner of Patents" and "Director" for "Commissioner".
      1993 - Subsec. (c). Pub. L. 103-80 struck out "of Agriculture"
    after "Department".
      1992 - Subsec. (c). Pub. L. 102-300, which directed the amendment
    of subsec. (c) by striking out "of Health, Education, and Welfare",
    could not be executed because such words did not appear in the
    original statutory text. See 1993 Amendment note above and Transfer
    of Functions note below.
      1970 - Subsec. (e). Pub. L. 91-513 struck out reference to
    depressant or stimulant drugs.
      1965 - Subsec. (e). Pub. L. 89-74 added subsec. (e).
      1962 - Subsec. (a). Pub. L. 87-781, Sec. 307(b), inserted "the
    Commonwealth of Puerto Rico or" before "a Territory the Secretary".
      Subsec. (d). Pub. L. 87-781, Sec. 308, added subsec. (d).

                     EFFECTIVE DATE OF 1999 AMENDMENT                 
      Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,
    1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-
    113, set out as a note under section 1 of Title 35, Patents.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1965 AMENDMENT                 
      Amendment by Pub. L. 89-74 effective July 15, 1965, see section
    11 of Pub. L. 89-74, set out as a note under section 321 of this
    title.

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for any violation of law or any civil seizures or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotics and Dangerous
    Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be
    continued and brought to final determination in accord with laws
    and regulations in effect prior to Oct. 27, 1970, see section 702
    of Pub. L. 91-513, set out as a note under section 321 of this
    title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see note set out under
    section 41 of this title.

-End-



-CITE-
    21 USC Sec. 372a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 372a. Transferred

-COD-
                               CODIFICATION                           
      Section, act June 25, 1938, ch. 675, Sec. 702A, formerly June 30,
    1906, ch. 3915, Sec. 10A, as added June 22, 1934, ch. 712, 48 Stat.
    1204, and amended, which related to examination of sea food, was
    renumbered section 706 of act June 25, 1938, by Pub. L. 102-571,
    title I, Sec. 106(3), Oct. 29, 1992, 106 Stat. 4498, and
    transferred to section 376 of this title.

-End-



-CITE-
    21 USC Sec. 373                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 373. Records

-STATUTE-
    (a) In general
      For the purpose of enforcing the provisions of this chapter,
    carriers engaged in interstate commerce, and persons receiving
    food, drugs, devices, or cosmetics in interstate commerce or
    holding such articles so received, shall, upon the request of an
    officer or employee duly designated by the Secretary, permit such
    officer or employee, at reasonable times, to have access to and to
    copy all records showing the movement in interstate commerce of any
    food, drug, device, or cosmetic, or the holding thereof during or
    after such movement, and the quantity, shipper, and consignee
    thereof; and it shall be unlawful for any such carrier or person to
    fail to permit such access to and copying of any such record so
    requested when such request is accompanied by a statement in
    writing specifying the nature or kind of food, drug, device, or
    cosmetic to which such request relates, except that evidence
    obtained under this section, or any evidence which is directly or
    indirectly derived from such evidence, shall not be used in a
    criminal prosecution of the person from whom obtained, and except
    that carriers shall not be subject to the other provisions of this
    chapter by reason of their receipt, carriage, holding, or delivery
    of food, drugs, devices, or cosmetics in the usual course of
    business as carriers, except as provided in subsection (b) of this
    section.
    (b) Food transportation records
      A shipper, carrier by motor vehicle or rail vehicle, receiver, or
    other person subject to section 350e of this title shall, on
    request of an officer or employee designated by the Secretary,
    permit the officer or employee, at reasonable times, to have access
    to and to copy all records that the Secretary requires to be kept
    under section 350e(c)(1)(E) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 703, 52 Stat. 1057; Pub. L. 91-452,
    title II, Sec. 230, Oct. 15, 1970, 84 Stat. 930; Pub. L. 103-80,
    Sec. 3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109-59, title VII,
    Sec. 7202(c), Aug. 10, 2005, 119 Stat. 1913.)


-MISC1-
                                AMENDMENTS                            
      2005 - Pub. L. 109-59 struck out "of interstate shipment" after
    "Records" in section catchline, designated existing provisions as
    subsec. (a), inserted subsec. heading, substituted "carriers,
    except as provided in subsection (b) of this section" for
    "carriers" before period at end, and added subsec. (b).
      1993 - Pub. L. 103-80 substituted ", except that" for ":
    Provided, That" and ", and except that" for ": Provided further,
    That".
      1970 - Pub. L. 91-452 inserted ", or any evidence which is
    directly or indirectly derived from such evidence," after "under
    this section".

                     EFFECTIVE DATE OF 2005 AMENDMENT                 
      Amendment by Pub. L. 109-59 effective Oct. 1, 2005, see section
    7204 of Pub. L. 109-59, set out as a note under section 331 of this
    title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-452 effective on sixtieth day following
    Oct. 15, 1970, and not to affect any immunity to which any
    individual is entitled under this section by reason of any
    testimony given before sixtieth day following Oct. 15, 1970, see
    section 260 of Pub. L. 91-452, set out as an Effective Date;
    Savings Provision note under section 6001 of Title 18, Crimes and
    Criminal Procedure.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 374                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 374. Inspection

-STATUTE-
    (a) Right of agents to enter; scope of inspection; notice;
      promptness; exclusions
      (1) For purposes of enforcement of this chapter, officers or
    employees duly designated by the Secretary, upon presenting
    appropriate credentials and a written notice to the owner,
    operator, or agent in charge, are authorized (A) to enter, at
    reasonable times, any factory, warehouse, or establishment in which
    food, drugs, devices, or cosmetics are manufactured, processed,
    packed, or held, for introduction into interstate commerce or after
    such introduction, or to enter any vehicle being used to transport
    or hold such food, drugs, devices, or cosmetics in interstate
    commerce; and (B) to inspect, at reasonable times and within
    reasonable limits and in a reasonable manner, such factory,
    warehouse, establishment, or vehicle and all pertinent equipment,
    finished and unfinished materials, containers, and labeling
    therein. In the case of any person (excluding farms and
    restaurants) who manufactures, processes, packs, transports,
    distributes, holds, or imports foods, the inspection shall extend
    to all records and other information described in section 350c of
    this title when the Secretary has a reasonable belief that an
    article of food is adulterated and presents a threat of serious
    adverse health consequences or death to humans or animals, subject
    to the limitations established in section 350c(d) of this title. In
    the case of any factory, warehouse, establishment, or consulting
    laboratory in which prescription drugs, nonprescription drugs
    intended for human use, or restricted devices are manufactured,
    processed, packed, or held, the inspection shall extend to all
    things therein (including records, files, papers, processes,
    controls, and facilities) bearing on whether prescription drugs,
    nonprescription drugs intended for human use, or restricted devices
    which are adulterated or misbranded within the meaning of this
    chapter, or which may not be manufactured, introduced into
    interstate commerce, or sold, or offered for sale by reason of any
    provision of this chapter, have been or are being manufactured,
    processed, packed, transported, or held in any such place, or
    otherwise bearing on violation of this chapter. No inspection
    authorized by the preceding sentence or by paragraph (3) shall
    extend to financial data, sales data other than shipment data,
    pricing data, personnel data (other than data as to qualification
    of technical and professional personnel performing functions
    subject to this chapter), and research data (other than data
    relating to new drugs, antibiotic drugs, and devices and subject to
    reporting and inspection under regulations lawfully issued pursuant
    to section 355(i) or (k) (!1) section 360i, or 360j(g) of this
    title, and data relating to other drugs or devices which in the
    case of a new drug would be subject to reporting or inspection
    under lawful regulations issued pursuant to section 355(j) of this
    title). A separate notice shall be given for each such inspection,
    but a notice shall not be required for each entry made during the
    period covered by the inspection. Each such inspection shall be
    commenced and completed with reasonable promptness.

      (2) The provisions of the third sentence of paragraph (1) shall
    not apply to - 
        (A) pharmacies which maintain establishments in conformance
      with any applicable local laws regulating the practice of
      pharmacy and medicine and which are regularly engaged in
      dispensing prescription drugs or devices, upon prescriptions of
      practitioners licensed to administer such drugs or devices to
      patients under the care of such practitioners in the course of
      their professional practice, and which do not, either through a
      subsidiary or otherwise, manufacture, prepare, propagate,
      compound, or process drugs or devices for sale other than in the
      regular course of their business of dispensing or selling drugs
      or devices at retail;
        (B) practitioners licensed by law to prescribe or administer
      drugs, or prescribe or use devices, as the case may be, and who
      manufacture, prepare, propagate, compound, or process drugs, or
      manufacture or process devices, solely for use in the course of
      their professional practice;
        (C) persons who manufacture, prepare, propagate, compound, or
      process drugs or manufacture or process devices, solely for use
      in research, teaching, or chemical analysis and not for sale;
        (D) such other classes of persons as the Secretary may by
      regulation exempt from the application of this section upon a
      finding that inspection as applied to such classes of persons in
      accordance with this section is not necessary for the protection
      of the public health.

      (3) An officer or employee making an inspection under paragraph
    (1) for purposes of enforcing the requirements of section 350a of
    this title applicable to infant formulas shall be permitted, at all
    reasonable times, to have access to and to copy and verify any
    records - 
        (A) bearing on whether the infant formula manufactured or held
      in the facility inspected meets the requirements of section 350a
      of this title, or
        (B) required to be maintained under section 350a of this title.
    (b) Written report to owner; copy to Secretary
      Upon completion of any such inspection of a factory, warehouse,
    consulting laboratory, or other establishment, and prior to leaving
    the premises, the officer or employee making the inspection shall
    give to the owner, operator, or agent in charge a report in writing
    setting forth any conditions or practices observed by him which, in
    his judgment, indicate that any food, drug, device, or cosmetic in
    such establishment (1) consists in whole or in part of any filthy,
    putrid, or decomposed substance, or (2) has been prepared, packed,
    or held under insanitary conditions whereby it may have become
    contaminated with filth, or whereby it may have been rendered
    injurious to health. A copy of such report shall be sent promptly
    to the Secretary.
    (c) Receipt for samples taken
      If the officer or employee making any such inspection of a
    factory, warehouse, or other establishment has obtained any sample
    in the course of the inspection, upon completion of the inspection
    and prior to leaving the premises he shall give to the owner,
    operator, or agent in charge a receipt describing the samples
    obtained.
    (d) Analysis of samples furnished owner
      Whenever in the course of any such inspection of a factory or
    other establishment where food is manufactured, processed, or
    packed, the officer or employee making the inspection obtains a
    sample of any such food, and an analysis is made of such sample for
    the purpose of ascertaining whether such food consists in whole or
    in part of any filthy, putrid, or decomposed substance, or is
    otherwise unfit for food, a copy of the results of such analysis
    shall be furnished promptly to the owner, operator, or agent in
    charge.
    (e) Accessibility of records
      Every person required under section 360i or 360j(g) of this title
    to maintain records and every person who is in charge or custody of
    such records shall, upon request of an officer or employee
    designated by the Secretary, permit such officer or employee at all
    reasonable times to have access to, and to copy and verify, such
    records.
    (f) Recordkeeping
      (1) An accredited person described in paragraph (3) shall
    maintain records documenting the training qualifications of the
    person and the employees of the person, the procedures used by the
    person for handling confidential information, the compensation
    arrangements made by the person, and the procedures used by the
    person to identify and avoid conflicts of interest. Upon the
    request of an officer or employee designated by the Secretary, the
    person shall permit the officer or employee, at all reasonable
    times, to have access to, to copy, and to verify, the records.
      (2) Within 15 days after the receipt of a written request from
    the Secretary to an accredited person described in paragraph (3)
    for copies of records described in paragraph (1), the person shall
    produce the copies of the records at the place designated by the
    Secretary.
      (3) For purposes of paragraphs (1) and (2), an accredited person
    described in this paragraph is a person who - 
        (A) is accredited under subsection (g) of this section; or
        (B) is accredited under section 360m of this title.
    (g) Inspections by accredited persons
      (1) Not later than one year after October 26, 2002, the Secretary
    shall, subject to the provisions of this subsection, accredit
    persons for the purpose of conducting inspections of establishments
    that manufacture, prepare, propagate, compound, or process class II
    or class III devices, which inspections are required under section
    360(h) of this title or are inspections of such establishments
    required to register under section 360(i) of this title. The owner
    or operator of such an establishment that is eligible under
    paragraph (6) may, from the list published under paragraph (4),
    select an accredited person to conduct such inspections.
      (2) Not later than 180 days after October 26, 2002, the Secretary
    shall publish in the Federal Register criteria to accredit or deny
    accreditation to persons who request to perform the duties
    specified in paragraph (1). Thereafter, the Secretary shall inform
    those requesting accreditation, within 60 days after the receipt of
    such request, whether the request for accreditation is adequate for
    review, and the Secretary shall promptly act on the request for
    accreditation. Any resulting accreditation shall state that such
    person is accredited to conduct inspections at device
    establishments identified in paragraph (1). The accreditation of
    such person shall specify the particular activities under this
    subsection for which such person is accredited. In the first year
    following the publication in the Federal Register of criteria to
    accredit or deny accreditation to persons who request to perform
    the duties specified in paragraph (1), the Secretary shall accredit
    no more than 15 persons who request to perform duties specified in
    paragraph (1).
      (3) An accredited person shall, at a minimum, meet the following
    requirements:
        (A) Such person may not be an employee of the Federal
      Government.
        (B) Such person shall be an independent organization which is
      not owned or controlled by a manufacturer, supplier, or vendor of
      articles regulated under this chapter and which has no
      organizational, material, or financial affiliation (including a
      consultative affiliation) with such a manufacturer, supplier, or
      vendor.
        (C) Such person shall be a legally constituted entity permitted
      to conduct the activities for which it seeks accreditation.
        (D) Such person shall not engage in the design, manufacture,
      promotion, or sale of articles regulated under this chapter.
        (E) The operations of such person shall be in accordance with
      generally accepted professional and ethical business practices,
      and such person shall agree in writing that at a minimum the
      person will - 
          (i) certify that reported information accurately reflects
        data reviewed, inspection observations made, other matters that
        relate to or may influence compliance with this chapter, and
        recommendations made during an inspection or at an inspection's
        closing meeting;
          (ii) limit work to that for which competence and capacity are
        available;
          (iii) treat information received, records, reports, and
        recommendations as confidential commercial or financial
        information or trade secret information, except such
        information may be made available to the Secretary;
          (iv) promptly respond and attempt to resolve complaints
        regarding its activities for which it is accredited; and
          (v) protect against the use, in carrying out paragraph (1),
        of any officer or employee of the accredited person who has a
        financial conflict of interest regarding any product regulated
        under this chapter, and annually make available to the public
        disclosures of the extent to which the accredited person, and
        the officers and employees of the person, have maintained
        compliance with requirements under this clause relating to
        financial conflicts of interest.

      (4) The Secretary shall publish on the Internet site of the Food
    and Drug Administration a list of persons who are accredited under
    paragraph (2). Such list shall be updated to ensure that the
    identity of each accredited person, and the particular activities
    for which the person is accredited, is known to the public. The
    updating of such list shall be no later than one month after the
    accreditation of a person under this subsection or the suspension
    or withdrawal of accreditation, or the modification of the
    particular activities for which the person is accredited.
      (5)(A) To ensure that persons accredited under this subsection
    continue to meet the standards of accreditation, the Secretary
    shall (i) audit the performance of such persons on a periodic basis
    through the review of inspection reports and inspections by persons
    designated by the Secretary to evaluate the compliance status of a
    device establishment and the performance of accredited persons, and
    (ii) take such additional measures as the Secretary determines to
    be appropriate.
      (B) The Secretary may withdraw accreditation of any person
    accredited under paragraph (2), after providing notice and an
    opportunity for an informal hearing, when such person is
    substantially not in compliance with the standards of
    accreditation, poses a threat to public health, fails to act in a
    manner that is consistent with the purposes of this subsection, or
    where the Secretary determines that there is a financial conflict
    of interest in the relationship between the accredited person and
    the owner or operator of a device establishment that the accredited
    person has inspected under this subsection. The Secretary may
    suspend the accreditation of such person during the pendency of the
    process under the preceding sentence.
      (6)(A) Subject to subparagraphs (B) and (C), a device
    establishment is eligible for inspections by persons accredited
    under paragraph (2) if the following conditions are met:
        (i) The Secretary classified the results of the most recent
      inspection described in paragraph (1) as "no action indicated" or
      "voluntary action indicated".
        (ii) With respect to inspections to be conducted by an
      accredited person during a 2-year period - 
          (I) the owner or operator of the establishment submits to the
        Secretary a notice requesting clearance to use an accredited
        person to conduct the inspection, and the Secretary provides
        such clearance; and
          (II) such notice identifies the accredited person whom the
        establishment has selected to conduct the inspection, and the
        Secretary agrees to the selected accredited person.

        (iii) With respect to the devices that are manufactured,
      prepared, propagated, compounded, or processed by the
      establishment, at least one of such devices is marketed in the
      United States, and 1 or both of the following additional
      conditions are met:
          (I) At least one of such devices is marketed, or is intended
        to be marketed, in one or more foreign countries, one of which
        countries certifies, accredits, or otherwise recognizes the
        person (accredited under paragraph (2) and identified under
        clause (ii)(II)) as a person authorized to conduct such
        inspections of device establishments.
          (II) The owner or operator of the establishment submits to
        the Secretary a statement that the law of a country in which
        such a device is marketed, or is intended to be marketed,
        recognizes an inspection of the establishment by the Secretary
        or by a person accredited under paragraph (2), and not later
        than 30 days after receiving such statement, the Secretary
        informs the owner or operator of the establishment that the
        owner or operator may submit a notice requesting clearance
        under clause (ii).

        (iv)(I) In the case of an inspection to be conducted pursuant
      to section 360(h) of this title, persons accredited under
      paragraph (2) did not conduct inspections of the establishment
      during the previous 4 years, except that the establishment may
      petition the Secretary for a waiver of such condition. Such a
      waiver may be granted only if the petition states a commercial
      reason for the waiver; the Secretary determines that the public
      health would be served by granting the waiver; and the Secretary
      has conducted an inspection of the establishment during the four-
      year period preceding the date on which the notice under clause
      (ii) is submitted to the Secretary. Such a waiver is deemed to be
      granted only if the Secretary has not determined that the public
      health would not be served by granting the waiver; and the owner
      or operator of the device establishment has requested in writing,
      not later than 18 months following the most recent inspection of
      such establishment by a person accredited under paragraph (2),
      that the Secretary inspect the establishment and the Secretary
      has not conducted an inspection within 30 months after the most
      recent inspection. With respect to such a waiver that is granted
      or deemed to be granted, no additional such waiver may be granted
      or deemed to be granted until after the Secretary has conducted
      an inspection of the establishment.
        (II) In the case of an inspection to be conducted of a device
      establishment required to register pursuant to section 360(i) of
      this title, the Secretary periodically conducts inspections of
      the establishment.

      (B)(i) The Secretary shall respond to a notice under subparagraph
    (A) from a device establishment not later than 30 days after the
    Secretary receives the notice. Through such response, the Secretary
    shall (I) provide clearance under such subparagraph, and agree to
    the selection of an accredited person, or (II) make a request under
    clause (ii). If the Secretary fails to respond to the notice within
    such 30-day period, the establishment is deemed to have such
    clearance, and to have the agreement of the Secretary for such
    selection.
      (ii) The request referred to in clause (i)(II) is - 
        (I) a request to the device establishment involved to submit to
      the Secretary compliance data in accordance with clause (iii); or
        (II) a request to the establishment, or to the accredited
      person identified in the notice under subparagraph (A), for
      information concerning the relationship between the establishment
      and such accredited person, including information about the
      number of inspections of the establishment, or other
      establishments owned or operated by the owner or operator of the
      establishment, that have been conducted by the accredited person.

    The Secretary may make both such requests.
      (iii) The compliance data to be submitted by a device
    establishment under clause (ii) are data describing whether the
    quality controls of the establishment have been sufficient for
    ensuring consistent compliance with current good manufacturing
    practice within the meaning of section 351(h) of this title and
    with other applicable provisions of this chapter. Such data shall
    include complete reports of inspectional findings regarding good
    manufacturing practice or other quality control audits that, during
    the preceding two-year period, were conducted at the establishment
    by persons other than the owner or operator of the establishment,
    together with all other relevant compliance data the Secretary
    deems necessary. Data under the preceding sentence shall
    demonstrate to the Secretary whether the establishment has
    facilitated consistent compliance by promptly correcting any
    compliance problems identified in such inspections.
      (iv)(I) Not later than 60 days after receiving compliance data
    under clause (iii) from a device establishment, the Secretary shall
    provide or deny clearance under subparagraph (A). The Secretary may
    deny clearance if the Secretary determines that the establishment
    has failed to demonstrate consistent compliance for purposes of
    clause (iii). The Secretary shall provide to the establishment a
    statement of such reasons for such determination. If the Secretary
    fails to provide such statement to the establishment within such 60-
    day period, the establishment is deemed to have such clearance.
      (II) If, during the two-year period following clearance under
    subparagraph (A), the Secretary determines that the device
    establishment is substantially not in compliance with this chapter,
    the Secretary may, after notice and a written response, notify the
    establishment that the eligibility of the establishment for the
    inspections by accredited persons has been suspended.
      (v)(I) A request to an accredited person under clause (ii)(II)
    may not seek any information that is not required to be maintained
    by such person in records under subsection (f)(1) of this section.
    Not later than 60 days after receiving the information sought by
    the request, the Secretary shall agree to, or reject, the selection
    of such person by the device establishment involved. The Secretary
    may reject the selection if the Secretary provides to the
    establishment a statement of the reasons for such rejection.
    Reasons for the rejection may include that the establishment or the
    accredited person, as the case may be, has failed to fully respond
    to the request, or that the Secretary has concerns regarding the
    relationship between the establishment and such accredited person.
    If within such 60-day period the Secretary fails to agree to or
    reject the selection in accordance with this subclause, the
    Secretary is deemed to have agreed to the selection.
      (II) If the Secretary rejects the selection of an accredited
    person by a device establishment, the establishment may make an
    additional selection of an accredited person by submitting to the
    Secretary a notice that identifies the additional selection.
    Clauses (i) and (ii), and subclause (I) of this clause, apply to
    the selection of an accredited person through a notice under the
    preceding sentence in the same manner and to the same extent as
    such provisions apply to a selection of an accredited person
    through a notice under subparagraph (A).
      (vi) In the case of a device establishment that under clause (iv)
    is denied clearance under subparagraph (A), or whose selection of
    an accredited person is rejected under clause (v), the Secretary
    shall designate a person to review the findings of the Secretary
    under such clause if, during the 30-day period beginning on the
    date on which the establishment receives the findings, the
    establishment requests the review. The review shall commence not
    later than 30 days after the establishment requests the review,
    unless the Secretary and the establishment otherwise agree.
      (C)(i) In the case of a device establishment for which the
    Secretary classified the results of the most recent inspection of
    the establishment by a person accredited under paragraph (2) as
    "official action indicated", the establishment, if otherwise
    eligible under subparagraph (A), is eligible for further
    inspections by persons accredited under such paragraph if (I) the
    Secretary issues a written statement to the owner or operator of
    the establishment that the violations leading to such
    classification have been resolved, and (II) the Secretary, either
    upon the Secretary's own initiative or a petition of the owner or
    operator of the establishment, notifies the establishment that it
    has clearance to use an accredited person for the inspections. The
    Secretary shall respond to such petition within 30 days after the
    receipt of the petition.
      (ii) If the Secretary denies a petition under clause (i), the
    device establishment involved may, after the expiration of one year
    after such denial, again petition the Secretary for a determination
    of eligibility for inspection by persons accredited by the
    Secretary under paragraph (2). If the Secretary denies such
    petition, the Secretary shall provide the establishment with such
    reasons for such denial within 60 days after the denial. If, as of
    the expiration of 48 months after the receipt of the first
    petition, the establishment has not been inspected by the
    Secretary, the establishment is eligible for further inspections by
    accredited persons.
      (7)(A) Persons accredited under paragraph (2) to conduct
    inspections shall record in writing their inspection observations
    and shall present the observations to the device establishment's
    designated representative and describe each observation.
    Additionally, such accredited person shall prepare an inspection
    report (including for inspections classified as "no action
    indicated") in a form and manner consistent with such reports
    prepared by employees and officials designated by the Secretary to
    conduct inspections.
      (B) At a minimum, an inspection report under subparagraph (A)
    shall identify the persons responsible for good manufacturing
    practice compliance at the inspected device establishment, the
    dates of the inspection, the scope of the inspection, and shall
    describe in detail each observation identified by the accredited
    person, identify other matters that relate to or may influence
    compliance with this chapter, and describe any recommendations
    during the inspection or at the inspection's closing meeting.
      (C) An inspection report under subparagraph (A) shall be sent to
    the Secretary and to the designated representative of the inspected
    device establishment at the same time, but under no circumstances
    later than three weeks after the last day of the inspection. The
    report to the Secretary shall be accompanied by all written
    inspection observations previously provided to the designated
    representative of the establishment.
      (D) Any statement or representation made by an employee or agent
    of a device establishment to a person accredited under paragraph
    (2) to conduct inspections shall be subject to section 1001 of
    title 18.
      (E) If at any time during an inspection by an accredited person
    the accredited person discovers a condition that could cause or
    contribute to an unreasonable risk to the public health, the
    accredited person shall immediately notify the Secretary of the
    identification of the device establishment subject to inspection
    and such condition.
      (8) Compensation for an accredited person shall be determined by
    agreement between the accredited person and the person who engages
    the services of the accredited person, and shall be paid by the
    person who engages such services.
      (9) Nothing in this subsection affects the authority of the
    Secretary to inspect any device establishment pursuant to this
    chapter.
      (10)(A) For fiscal year 2005 and each subsequent fiscal year, no
    device establishment may be inspected during the fiscal year
    involved by a person accredited under paragraph (2) if - 
        (i) of the amounts appropriated for salaries and expenses of
      the Food and Drug Administration for the preceding fiscal year
      (referred to in this subparagraph as the "first prior fiscal
      year"), the amount obligated by the Secretary for inspections of
      device establishments by the Secretary was less than the adjusted
      base amount applicable to such first prior fiscal year; and
        (ii) of the amounts appropriated for salaries and expenses of
      the Food and Drug Administration for the fiscal year preceding
      the first prior fiscal year (referred to in this subparagraph as
      the "second prior fiscal year"), the amount obligated by the
      Secretary for inspections of device establishments by the
      Secretary was less than the adjusted base amount applicable to
      such second prior fiscal year.

      (B)(i) Subject to clause (ii), the Comptroller General of the
    United States shall determine the amount that was obligated by the
    Secretary for fiscal year 2002 for compliance activities of the
    Food and Drug Administration with respect to devices (referred to
    in this subparagraph as the "compliance budget"), and of such
    amount, the amount that was obligated for inspections by the
    Secretary of device establishments (referred to in this
    subparagraph as the "inspection budget").
      (ii) For purposes of determinations under clause (i), the
    Comptroller General shall not include in the compliance budget or
    the inspection budget any amounts obligated for inspections of
    device establishments conducted as part of the process of reviewing
    applications under section 360e of this title.
      (iii) Not later than March 31, 2003, the Comptroller General
    shall complete the determinations required in this subparagraph and
    submit to the Secretary and the Congress a report describing the
    findings made through such determinations.
      (C) For purposes of this paragraph:
        (i) The term "base amount" means the inspection budget
      determined under subparagraph (B) for fiscal year 2002.
        (ii) The term "adjusted base amount", in the case of
      applicability to fiscal year 2003, means an amount equal to the
      base amount increased by 5 percent.
        (iii) The term "adjusted base amount", with respect to
      applicability to fiscal year 2004 or any subsequent fiscal year,
      means the adjusted based amount applicable to the preceding year
      increased by 5 percent.

      (11) The authority provided by this subsection terminates on
    October 1, 2012.
      (12) No later than four years after October 26, 2002, the
    Comptroller General shall report to the Committee on Energy and
    Commerce of the House of Representatives and the Committee on
    Health, Education, Labor and Pensions of the Senate - 
        (A) the number of inspections conducted by accredited persons
      pursuant to this subsection and the number of inspections
      conducted by Federal employees pursuant to section 360(h) of this
      title and of device establishments required to register under
      section 360(i) of this title;
        (B) the number of persons who sought accreditation under this
      subsection, as well as the number of persons who were accredited
      under this subsection;
        (C) the reasons why persons who sought accreditation, but were
      denied accreditation, were denied;
        (D) the number of audits conducted by the Secretary of
      accredited persons, the quality of inspections conducted by
      accredited persons, whether accredited persons are meeting their
      obligations under this chapter, and whether the number of audits
      conducted is sufficient to permit these assessments;
        (E) whether this subsection is achieving the goal of ensuring
      more information about device establishment compliance is being
      presented to the Secretary, and whether that information is of a
      quality consistent with information obtained by the Secretary
      pursuant to inspections conducted by Federal employees;
        (F) whether this subsection is advancing efforts to allow
      device establishments to rely upon third-party inspections for
      purposes of compliance with the laws of foreign governments; and
        (G) whether the Congress should continue, modify, or terminate
      the program under this subsection.

      (13) The Secretary shall include in the annual report required
    under section 393(g) of this title the names of all accredited
    persons and the particular activities under this subsection for
    which each such person is accredited and the name of each
    accredited person whose accreditation has been withdrawn during the
    year.
      (14) Notwithstanding any provision of this subsection, this
    subsection does not have any legal effect on any agreement
    described in section 383(b) of this title between the Secretary and
    a foreign country.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 704, 52 Stat. 1057; Aug. 7, 1953, ch.
    350, Sec. 1, 67 Stat. 476; Pub. L. 87-781, title II, Sec. 201(a),
    (b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94-295, Sec. 6, May
    28, 1976, 90 Stat. 581; Pub. L. 96-359, Sec. 4, Sept. 26, 1980, 94
    Stat. 1193; Pub. L. 103-80, Sec. 3(aa), Aug. 13, 1993, 107 Stat.
    778; Pub. L. 105-115, title I, Sec. 125(b)(2)(L), title II, Sec.
    210(b), title IV, Sec. 412(b), Nov. 21, 1997, 111 Stat. 2326, 2344,
    2375; Pub. L. 107-188, title III, Sec. 306(b), June 12, 2002, 116
    Stat. 670; Pub. L. 107-250, title II, Sec. 201(a), (b), Oct. 26,
    2002, 116 Stat. 1602, 1609; Pub. L. 108-214, Sec. 2(b)(1), Apr. 1,
    2004, 118 Stat. 573.)


-MISC1-
                                AMENDMENTS                            
      2004 - Subsec. (g)(1). Pub. L. 108-214, Sec. 2(b)(1)(A), in first
    sentence, substituted "conducting inspections of establishments
    that manufacture, prepare, propagate, compound, or process class II
    or class III devices, which inspections are required under section
    360(h) of this title or are inspections of such establishments
    required to register under section 360(i) of this title." for
    "conducting inspections of establishments that manufacture,
    prepare, propagate, compound, or process class II or class III
    devices that are required in section 360(h) of this title, or
    inspections of such establishments required to register pursuant to
    section 360(i) of this title."
      Subsec. (g)(5)(B). Pub. L. 108-214, Sec. 2(b)(1)(B), in first
    sentence, substituted "poses a threat to public health, fails to
    act in a manner that is consistent with the purposes of this
    subsection, or where the Secretary determines that there is a
    financial conflict of interest in the relationship between the
    accredited person and the owner or operator of a device
    establishment that the accredited person has inspected under this
    subsection." for "or poses a threat to public health or fails to
    act in a manner that is consistent with the purposes of this
    subsection."
      Subsec. (g)(6)(A)(i). Pub. L. 108-214, Sec. 2(b)(1)(C)(i),
    substituted "described in paragraph (1)" for "of the establishment
    pursuant to subsection (h) or (i) of section 360 of this title".
      Subsec. (g)(6)(A)(ii). Pub. L. 108-214, Sec. 2(b)(1)(C)(ii)(I),
    substituted "inspections" for "each inspection" and inserted
    "during a 2-year period" after "person" in introductory provisions.
      Subsec. (g)(6)(A)(ii)(I). Pub. L. 108-214, Sec.
    2(b)(1)(C)(ii)(II), substituted "an accredited person" for "such a
    person".
      Subsec. (g)(6)(A)(iii). Pub. L. 108-214, Sec. 2(b)(1)(C)(iii)(I),
    substituted "and 1 or both of the following additional conditions
    are met:" for "and the following additional conditions are met:" in
    introductory provisions.
      Subsec. (g)(6)(A)(iii)(I). Pub. L. 108-214, Sec.
    2(b)(1)(C)(iii)(II), substituted "(accredited under paragraph (2)
    and identified under clause (ii)(II)) as a person authorized to
    conduct such inspections of device establishments." for "accredited
    under paragraph (2) and identified under subclause (II) of this
    clause."
      Subsec. (g)(6)(A)(iii)(II). Pub. L. 108-214, Sec.
    2(b)(1)(C)(iii)(III), inserted "or by a person accredited under
    paragraph (2)" after "by the Secretary".
      Subsec. (g)(6)(A)(iv)(I). Pub. L. 108-214, Sec. 2(b)(1)(C)(iv),
    in first sentence, inserted "section" after "pursuant to" and
    substituted "inspections of the establishment during the previous 4
    years" for "the two immediately preceding inspections of the
    establishment", in third sentence, struck out "the petition states
    a commercial reason for the waiver;" after "granted only if" and
    inserted "not" after "the Secretary has not determined that the
    public health would", and, in last sentence, substituted "granted
    or deemed to be granted until" for "granted until".
      Subsec. (g)(6)(A)(iv)(II). Pub. L. 108-214, Sec. 2(b)(1)(C)(v),
    inserted "of a device establishment required to register" after "to
    be conducted" and "section" after "pursuant to".
      Subsec. (g)(6)(B)(iii). Pub. L. 108-214, Sec. 2(b)(1)(D), in
    first sentence, substituted "and with other" for ", and data
    otherwise describing whether the establishment has consistently
    been in compliance with sections 351 and 352 of this title and
    other" and, in second sentence, substituted "inspectional findings"
    for "inspections" and inserted "relevant" after "together with all
    other".
      Subsec. (g)(6)(B)(iv). Pub. L. 108-214, Sec. 2(b)(1)(E),
    designated existing provisions as subcl. (I) and added subcl. (II).
      Subsec. (g)(6)(C)(ii). Pub. L. 108-214, Sec. 2(b)(1)(F), struck
    out "in accordance with section 360(h) of this title, or has not
    during such period been inspected pursuant to section 360(i) of
    this title, as applicable" after "inspected by the Secretary".
      Subsec. (g)(10)(B)(iii). Pub. L. 108-214, Sec. 2(b)(1)(G),
    substituted "a report" for "a reporting".
      Subsec. (g)(12)(A). Pub. L. 108-214, Sec. 2(b)(1)(H)(i), added
    subpar. (A) and struck out former subpar. (A) which read as
    follows: "the number of inspections pursuant to subsections (h) and
    (i) of section 360 of this title conducted by accredited persons
    and the number of inspections pursuant to such subsections
    conducted by Federal employees;".
      Subsec. (g)(12)(E). Pub. L. 108-214, Sec. 2(b)(1)(H)(ii),
    substituted "obtained by the Secretary pursuant to inspections
    conducted by Federal employees;" for "obtained by the Secretary
    pursuant to subsection (h) or (i) of section 360 of this title;".
      2002 - Subsec. (a)(1). Pub. L. 107-188, Sec. 306(b)(1), inserted
    after first sentence "In the case of any person (excluding farms
    and restaurants) who manufactures, processes, packs, transports,
    distributes, holds, or imports foods, the inspection shall extend
    to all records and other information described in section 350c of
    this title when the Secretary has a reasonable belief that an
    article of food is adulterated and presents a threat of serious
    adverse health consequences or death to humans or animals, subject
    to the limitations established in section 350c(d) of this title."
      Subsec. (a)(2). Pub. L. 107-188, Sec. 306(b)(2), substituted
    "third sentence" for "second sentence" in introductory provisions.
      Subsec. (f)(1). Pub. L. 107-250, Sec. 201(b)(1), in first
    sentence, substituted "An accredited person described in paragraph
    (3) shall maintain records" for "A person accredited under section
    360m of this title to review reports made under section 360(k) of
    this title and make recommendations of initial classifications of
    devices to the Secretary shall maintain records".
      Subsec. (f)(2). Pub. L. 107-250, Sec. 201(b)(2), substituted "an
    accredited person described in paragraph (3)" for "a person
    accredited under section 360m of this title".
      Subsec. (f)(3). Pub. L. 107-250, Sec. 201(b)(3), added par. (3).
      Subsec. (g). Pub. L. 107-250, Sec. 201(a), added subsec. (g).
      1997 - Subsec. (a)(1). Pub. L. 105-115, Sec. 412(b), substituted
    "prescription drugs, nonprescription drugs intended for human use,"
    for "prescription drugs" in two places.
      Pub. L. 105-115, Sec. 125(b)(2)(L), struck out ", section 357(d)
    or (g)," before "section 360i".
      Subsec. (f). Pub. L. 105-115, Sec. 210(b), added subsec. (f).
      1993 - Subsec. (a)(1). Pub. L. 103-80 substituted a comma for
    semicolon after "finished and unfinished materials" and "section
    355(i) or (k)" for "section 355(i) or (j)".
      1980 - Subsec. (a)(1). Pub. L. 96-359, Sec. 4(1), (2),
    restructured first five sentences of former subsec. (a) as par. (1)
    and, as so restructured, inserted reference to paragraph (3) and
    substituted "(A)" and "(B)" for "(1)" and "(2)", respectively.
      Subsec. (a)(2). Pub. L. 96-359, Sec. 4(3), redesignated sixth
    sentence of former subsec. (a) as par. (2) and, as so redesignated,
    substituted reference to second sentence of paragraph (1) for
    reference to former second sentence of this subsection, and "(A)",
    "(B)", "(C)", and "(D)", for "(1)", "(2)", "(3)", and "(4)",
    respectively.
      Subsec. (a)(3). Pub. L. 96-359, Sec. 4(4), added par. (3).
      1976 - Subsec. (a). Pub. L. 94-295, Sec. 6(a)-(c), expanded
    existing provisions to encompass medical devices by inserting
    references to factories, warehouses, establishments, and consulting
    laboratories in which restricted devices are manufactured,
    processed, packed, or held, inspections relating to devices,
    reporting and inspection regulations issued pursuant to sections
    360i and 360j(g) of this title, and the manufacture and processing
    of devices.
      Subsec. (e). Pub. L. 94-295, Sec. 6(d), added subsec. (e).
      1962 - Subsec. (a). Pub. L. 87-781, Sec. 201(a), extended the
    inspection, where prescription drugs are manufactured, processed,
    packed, or held, to all things bearing on whether adulterated or
    misbranded drugs, or any which may not be manufactured, introduced
    in interstate commerce, or sold or offered for sale under any
    provision of this chapter, have been or are being manufactured,
    processed, packed, transported or held in any such place, or
    otherwise bearing on violation of this chapter, but excluded from
    such inspection, data concerning finance, sales other than
    shipment, pricing, personnel other than qualifications of technical
    and professional personnel, research other than relating to new
    drugs subject to reporting, provided that provisions of second
    sentence of this subsection shall be inapplicable to pharmacies,
    practitioners and other persons enumerated in pars. (1) to (4), and
    struck out "are held" before "after such introduction".
      Subsec. (b). Pub. L. 87-781, Sec. 201(b), inserted "consulting
    laboratory" after "warehouse".
      1953 - Act Aug. 7, 1953, designated existing provisions as
    subsec. (a) and amended them by substituting provisions permitting
    entry and inspection upon presentation of appropriate credentials
    and a written notice to the owner, operator, or agent in charge for
    provisions which authorized entry and inspection only after making
    a request and obtaining permission from the owner, operator, or
    custodian, and inserting provisions requiring a separate written
    notice for each inspection but not for each entry made during the
    period covered by the inspection, and directing that the inspection
    shall be conducted within reasonable limits, in a reasonable manner
    and completed with reasonable promptness, and added subsecs. (b) to
    (d).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by sections 210(b) and 412(b) of Pub. L. 105-115
    effective 90 days after Nov. 21, 1997, except as otherwise
    provided, see section 501 of Pub. L. 105-115, set out as a note
    under section 321 of this title.

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    203 of Pub. L. 87-781, set out as a note under section 332 of this
    title.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
             AUTHORITY OF SECRETARY PRIOR TO OCTOBER 10, 1962         
      Section 201(d) of Pub. L. 87-781 provided that: "Nothing in the
    amendments made by subsections (a) and (b) of this section
    [amending this section] shall be construed to negate or derogate
    from any authority of the Secretary existing prior to the enactment
    of this Act [Oct. 10, 1962]."

-FOOTNOTE-
    (!1) So in original. Probably should be followed by a comma.


-End-



-CITE-
    21 USC Sec. 374a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 374a. Inspections relating to food allergens

-STATUTE-
      The Secretary of Health and Human Services shall conduct
    inspections consistent with the authority under section 374 of this
    title of facilities in which foods are manufactured, processed,
    packed, or held - 
        (1) to ensure that the entities operating the facilities comply
      with practices to reduce or eliminate cross-contact of a food
      with residues of major food allergens that are not intentional
      ingredients of the food; and
        (2) to ensure that major food allergens are properly labeled on
      foods.

-SOURCE-
    (Pub. L. 108-282, title II, Sec. 205, Aug. 2, 2004, 118 Stat. 909.)

-COD-
                               CODIFICATION                           
      Section was enacted as a part of the Food Allergen Labeling and
    Consumer Protection Act of 2004, and not as part of the Federal
    Food, Drug, and Cosmetic Act which comprises this chapter.

-End-



-CITE-
    21 USC Sec. 375                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 375. Publicity

-STATUTE-
    (a) Reports
      The Secretary shall cause to be published from time to time
    reports summarizing all judgments, decrees, and court orders which
    have been rendered under this chapter, including the nature of the
    charge and the disposition thereof.
    (b) Information regarding certain goods
      The Secretary may also cause to be disseminated information
    regarding food, drugs, devices, or cosmetics in situations
    involving, in the opinion of the Secretary, imminent danger to
    health or gross deception of the consumer. Nothing in this section
    shall be construed to prohibit the Secretary from collecting,
    reporting, and illustrating the results of the investigations of
    the Department.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 705, 52 Stat. 1057.)


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 376                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 376. Examination of sea food on request of packer; marking
      food with results; fees; penalties

-STATUTE-
      The Secretary, upon application of any packer of any sea food for
    shipment or sale within the jurisdiction of this chapter, may, at
    his discretion, designate inspectors to examine and inspect such
    food and the production, packing, and labeling thereof. If on such
    examination and inspection compliance is found with the provisions
    of this chapter and regulations promulgated thereunder, the
    applicant shall be authorized or required to mark the food as
    provided by regulation to show such compliance. Services under this
    section shall be rendered only upon payment by the applicant of
    fees fixed by regulation in such amounts as may be necessary to
    provide, equip, and maintain an adequate and efficient inspection
    service. Receipts from such fees shall be covered into the Treasury
    and shall be available to the Secretary for expenditures incurred
    in carrying out the purposes of this section, including
    expenditures for salaries of additional inspectors when necessary
    to supplement the number of inspectors for whose salaries Congress
    has appropriated. The Secretary is authorized to promulgate
    regulations governing the sanitary and other conditions under which
    the service herein provided shall be granted and maintained, and
    for otherwise carrying out the purposes of this section. Any person
    who forges, counterfeits, simulates, or falsely represents, or
    without proper authority uses any mark, stamp, tag, label, or other
    identification devices authorized or required by the provisions of
    this section or regulations thereunder, shall be guilty of a
    misdemeanor, and shall on conviction thereof be subject to
    imprisonment for not more than one year or a fine of not less than
    $1,000 nor more than $5,000, or both such imprisonment and fine.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 706, formerly Sec. 702A, formerly
    June 30, 1906, ch. 3915, Sec. 10A, as added June 22, 1934, ch. 712,
    48 Stat. 1204; amended Aug. 27, 1935, ch. 739, 49 Stat. 871; June
    25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059; renumbered Sec. 702A
    of act June 25, 1938, July 12, 1943, ch. 221, title II, 57 Stat.
    500; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
    renumbered Sec. 706, Pub. L. 102-571, title I, Sec. 106(3), Oct.
    29, 1992, 106 Stat. 4498; Pub. L. 103-80, Sec. 3(dd)(2), Aug. 13,
    1993, 107 Stat. 779.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 372a of this title
    prior to renumbering by Pub. L. 102-571.
      Section, which formerly was not a part of the Federal Food, Drug,
    and Cosmetic Act, originally was classified to section 14a of this
    title. Section 902(a) of act June 25, 1938, set out as an Effective
    Date note under section 301 of this title, provided that the
    section should remain in force and effect and be applicable to the
    provisions of this chapter. Act July 12, 1943, renumbered this
    section as 702A of the Federal Food, Drug, and Cosmetic Act.


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 376, act June 25, 1938, ch. 675, Sec. 706, 52
    Stat. 1058, as amended, which related to listing and certification
    of color additives for foods, drugs, devices, and cosmetics, was
    renumbered section 721 of act June 25, 1938, by Pub. L. 102-571,
    title I, Sec. 106(4), Oct. 29, 1992, 106 Stat. 4498, and
    transferred to section 379e of this title.

                                AMENDMENTS                            
      1993 - Pub. L. 103-80 struck out "of Agriculture" after
    "Secretary" in two places.
      1992 - Pub. L. 102-300, which directed the amendment of the
    section by striking out "of Health, Education, and Welfare"
    wherever appearing, could not be executed because such words did
    not appear in the original statutory text. See 1993 Amendment note
    above and Transfer of Functions note below.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Secretary and Department of Health, Education, and Welfare
    redesignated Secretary and Department of Health and Human Services
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695, which is classified to section 3508(b) of Title 20, Education.
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 377                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 377. Revision of United States Pharmacopoeia; development of
      analysis and mechanical and physical tests

-STATUTE-
      The Secretary, in carrying into effect the provisions of this
    chapter, is authorized on and after July 12, 1943, to cooperate
    with associations and scientific societies in the revision of the
    United States Pharmacopoeia and in the development of methods of
    analysis and mechanical and physical tests necessary to carry out
    the work of the Food and Drug Administration.

-SOURCE-
    (July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan
    No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Labor-Federal Security
    Appropriation Act, 1944, and not as part of the Federal Food, Drug,
    and Cosmetic Act which comprises this chapter.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.

-End-



-CITE-
    21 USC Sec. 378                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 378. Advertising of foods

-STATUTE-
    (a) Determination of misbranding; notification of Federal Trade
      Commission by Secretary; contents
      (1) Except as provided in subsection (c) of this section, before
    the Secretary may initiate any action under subchapter III of this
    chapter - 
        (A) with respect to any food which the Secretary determines is
      misbranded under section 343(a)(2) of this title because of its
      advertising, or
        (B) with respect to a food's advertising which the Secretary
      determines causes the food to be so misbranded,

    the Secretary shall, in accordance with paragraph (2), notify in
    writing the Federal Trade Commission of the action the Secretary
    proposes to take respecting such food or advertising.
      (2) The notice required by paragraph (1) shall - 
        (A) contain (i) a description of the action the Secretary
      proposes to take and of the advertising which the Secretary has
      determined causes a food to be misbranded, (ii) a statement of
      the reasons for the Secretary's determination that such
      advertising has caused such food to be misbranded, and
        (B) be accompanied by the records, documents, and other written
      materials which the Secretary determines supports his
      determination that such food is misbranded because of such
      advertising.
    (b) Action by Federal Trade Commission precluding action by
      Secretary; exception
      (1) If the Secretary notifies the Federal Trade Commission under
    subsection (a) of this section of action proposed to be taken under
    subchapter III of this chapter with respect to a food or food
    advertising and the Commission notifies the Secretary in writing,
    within the 30-day period beginning on the date of the receipt of
    such notice, that - 
        (A) it has initiated under the Federal Trade Commission Act [15
      U.S.C. 41 et seq.] an investigation of such advertising to
      determine if it is prohibited by such Act or any order or rule
      under such Act,
        (B) it has commenced (or intends to commence) a civil action
      under section 5, 13, or 19 [15 U.S.C. 45, 53, or 57b] with
      respect to such advertising or the Attorney General has commenced
      (or intends to commence) a civil action under section 5 [15
      U.S.C. 45] with respect to such advertising,
        (C) it has issued and served (or intends to issue and serve) a
      complaint under section 5(b) of such Act [15 U.S.C. 45(b)]
      respecting such advertising, or
        (D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it
      has made a certification to the Attorney General respecting such
      advertising,

    the Secretary may not, except as provided by paragraph (2),
    initiate the action described in the Secretary's notice to the
    Federal Trade Commission.
      (2) If, before the expiration of the 60-day period beginning on
    the date the Secretary receives a notice described in paragraph (1)
    from the Federal Trade Commission in response to a notice of the
    Secretary under subsection (a) of this section - 
        (A) the Commission or the Attorney General does not commence a
      civil action described in subparagraph (B) of paragraph (1) of
      this subsection respecting the advertising described in the
      Secretary's notice,
        (B) the Commission does not issue and serve a complaint
      described in subparagraph (C) of such paragraph respecting such
      advertising, or
        (C) the Commission does not (as described in subparagraph (D)
      of such paragraph) make a certification to the Attorney General
      respecting such advertising, or, if the Commission does make such
      a certification to the Attorney General respecting such
      advertising, the Attorney General, before the expiration of such
      period, does not cause appropriate criminal proceedings to be
      brought against such advertising,

    the Secretary may, after the expiration of such period, initiate
    the action described in the notice to the Commission pursuant to
    subsection (a) of this section. The Commission shall promptly
    notify the Secretary of the commencement by the Commission of such
    a civil action, the issuance and service by it of such a complaint,
    or the causing by the Attorney General of criminal proceedings to
    be brought against such advertising.
    (c) Secretary's determination of imminent hazard to health as
      suspending applicability of provisions
      The requirements of subsections (a) and (b) of this section do
    not apply with respect to action under subchapter III of this
    chapter with respect to any food or food advertising if the
    Secretary determines that such action is required to eliminate an
    imminent hazard to health.
    (d) Coordination of action by Secretary with Federal Trade
      Commission
      For the purpose of avoiding unnecessary duplication, the
    Secretary shall coordinate any action taken under subchapter III of
    this chapter because of advertising which the Secretary determines
    causes a food to be misbranded with any action of the Federal Trade
    Commission under the Federal Trade Commission Act [15 U.S.C. 41 et
    seq.] with respect to such advertising.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 707, as added Pub. L. 94-278, title
    V, Sec. 502(b), Apr. 22, 1976, 90 Stat. 412.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Federal Trade Commission Act, referred to in subsecs. (b) and
    (d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, as amended,
    which is classified generally to subchapter I (Sec. 41 et seq.) of
    chapter 2 of Title 15, Commerce and Trade. For complete
    classification of this Act to the Code, see section 58 of Title 15
    and Tables.

-End-



-CITE-
    21 USC Sec. 379                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379. Confidential information

-STATUTE-
      The Secretary may provide any information which is exempt from
    disclosure pursuant to subsection (a) of section 552 of title 5 by
    reason of subsection (b)(4) of such section to a person other than
    an officer or employee of the Department if the Secretary
    determines such other person requires the information in connection
    with an activity which is undertaken under contract with the
    Secretary, which relates to the administration of this chapter, and
    with respect to which the Secretary (or an officer or employee of
    the Department) is not prohibited from using such information. The
    Secretary shall require as a condition to the provision of
    information under this section that the person receiving it take
    such security precautions respecting the information as the
    Secretary may by regulation prescribe.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 708, as added Pub. L. 94-295, Sec. 8,
    May 28, 1976, 90 Stat. 582.)

-End-



-CITE-
    21 USC Sec. 379a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379a. Presumption of existence of jurisdiction

-STATUTE-
      In any action to enforce the requirements of this chapter
    respecting a device, food, drug, or cosmetic the connection with
    interstate commerce required for jurisdiction in such action shall
    be presumed to exist.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 709, as added Pub. L. 94-295, Sec. 8,
    May 28, 1976, 90 Stat. 583; amended Pub. L. 105-115, title IV, Sec.
    419, Nov. 21, 1997, 111 Stat. 2379.)


-MISC1-
                                AMENDMENTS                            
      1997 - Pub. L. 105-115 substituted "a device, food, drug, or
    cosmetic" for "a device".

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

-End-



-CITE-
    21 USC Sec. 379b                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379b. Consolidated administrative and laboratory facility

-STATUTE-
    (a) Authority
      The Secretary, in consultation with the Administrator of the
    General Services Administration, shall enter into contracts for the
    design, construction, and operation of a consolidated Food and Drug
    Administration administrative and laboratory facility.
    (b) Awarding of contract
      The Secretary shall solicit contract proposals under subsection
    (a) of this section from interested parties. In awarding contracts
    under such subsection, the Secretary shall review such proposals
    and give priority to those alternatives that are the most cost
    effective for the Federal Government and that allow for the use of
    donated land, federally owned property, or lease-purchase
    arrangements. A contract under this subsection shall not be entered
    into unless such contract results in a net cost savings to the
    Federal Government over the duration of the contract, as compared
    to the Government purchase price including borrowing by the
    Secretary of the Treasury.
    (c) Donations
      In carrying out this section, the Secretary shall have the power,
    in connection with real property, buildings, and facilities, to
    accept on behalf of the Food and Drug Administration gifts or
    donations of services or property, real or personal, as the
    Secretary determines to be necessary.
    (d) Authorization of appropriations
      There are authorized to be appropriated to carry out this section
    $100,000,000 for fiscal year 1991, and such sums as may be
    necessary for each of the subsequent fiscal years, to remain
    available until expended.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 710, as added Pub. L. 101-635, title
    I, Sec. 101, Nov. 28, 1990, 104 Stat. 4583.)

-End-



-CITE-
    21 USC Sec. 379c                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379c. Transferred

-COD-
                               CODIFICATION                           
      Section, act June 25, 1938, ch. 675, Sec. 711, as added Nov. 28,
    1990, Pub. L. 101-635, title II, Sec. 201, 104 Stat. 4584, which
    related to recovery and retention of fees for freedom of
    information requests, was renumbered section 731 of act June 25,
    1938, by Pub. L. 102-571, title I, Sec. 106(6), Oct. 29, 1992, 106
    Stat. 4499, and transferred to section 379f of this title.

-End-



-CITE-
    21 USC Sec. 379d                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part A - General Administrative Provisions

-HEAD-
    Sec. 379d. Automation of Food and Drug Administration

-STATUTE-
    (a) In general
      The Secretary, acting through the Commissioner of Food and Drugs,
    shall automate appropriate activities of the Food and Drug
    Administration to ensure timely review of activities regulated
    under this chapter.
    (b) Authorization of appropriations
      There are authorized to be appropriated each fiscal year such
    sums as are necessary to carry out this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 711, formerly Sec. 712, as added Pub.
    L. 101-635, title IV, Sec. 401, Nov. 28, 1990, 104 Stat. 4585;
    renumbered Sec. 711, Pub. L. 102-571, title I, Sec. 106(3), Oct.
    29, 1992, 106 Stat. 4498.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 711 of act June 25, 1938, was renumbered section
    731 by Pub. L. 102-571 and is classified to section 379f of this
    title.

-End-


-CITE-
    21 USC Part B - Colors                                      01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part B - Colors

-HEAD-
                              PART B - COLORS                          

-End-



-CITE-
    21 USC Sec. 379e                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part B - Colors

-HEAD-
    Sec. 379e. Listing and certification of color additives for foods,
      drugs, devices, and cosmetics

-STATUTE-
    (a) Unsafe color additives
      A color additive shall, with respect to any particular use (for
    which it is being used or intended to be used or is represented as
    suitable) in or on food or drugs or devices or cosmetics, be deemed
    unsafe for the purposes of the application of section 342(c),
    351(a)(4), or 361(e) of this title, as the case may be, unless - 
        (1)(A) there is in effect, and such additive and such use are
      in conformity with, a regulation issued under subsection (b) of
      this section listing such additive for such use, including any
      provision of such regulation prescribing the conditions under
      which such additive may be safely used, and (B) such additive
      either (i) is from a batch certified, in accordance with
      regulations issued pursuant to subsection (c) of this section,
      for such use, or (ii) has, with respect to such use, been
      exempted by the Secretary from the requirement of certification;
      or
        (2) such additive and such use thereof conform to the terms of
      an exemption which is in effect pursuant to subsection (f) of
      this section.

    While there are in effect regulations under subsections (b) and (c)
    of this section relating to a color additive or an exemption
    pursuant to subsection (f) of this section with respect to such
    additive, an article shall not, by reason of bearing or containing
    such additive in all respects in accordance with such regulations
    or such exemption, be considered adulterated within the meaning of
    clause (1) of section 342(a) of this title if such article is a
    food, or within the meaning of section 361(a) of this title if such
    article is a cosmetic other than a hair dye (as defined in the last
    sentence of section 361(a) of this title). A color additive for use
    in or on a device shall be subject to this section only if the
    color additive comes in direct contact with the body of man or
    other animals for a significant period of time. The Secretary may
    by regulation designate the uses of color additives in or on
    devices which are subject to this section.
    (b) Listing of colors; regulations; issuance, amendment or repeal;
      referral to advisory committee; report and recommendations;
      appointment and compensation of advisory committee
      (1) The Secretary shall, by regulation, provide for separately
    listing color additives for use in or on food, color additives for
    use in or on drugs, or devices, and color additives for use in or
    on cosmetics, if and to the extent that such additives are suitable
    and safe for any such use when employed in accordance with such
    regulations.
      (2)(A) Such regulations may list any color additive for use
    generally in or on food, or in or on drugs or devices, or in or on
    cosmetics, if the Secretary finds that such additive is suitable
    and may safely be employed for such general use.
      (B) If the data before the Secretary do not establish that the
    additive satisfies the requirements for listing such additive on
    the applicable list pursuant to subparagraph (A) of this paragraph,
    or if the proposal is for listing such additive for a more limited
    use or uses, such regulations may list such additive only for any
    more limited use or uses for which it is suitable and may safely be
    employed.
      (3) Such regulations shall, to the extent deemed necessary by the
    Secretary to assure the safety of the use or uses for which a
    particular color additive is listed, prescribe the conditions under
    which such additive may be safely employed for such use or uses
    (including, but not limited to, specifications, hereafter in this
    section referred to as tolerance limitations, as to the maximum
    quantity or quantities which may be used or permitted to remain in
    or on the article or articles in or on which it is used;
    specifications as to the manner in which such additive may be added
    to or used in or on such article or articles; and directions or
    other labeling or packaging requirements for such additive).
      (4) The Secretary shall not list a color additive under this
    section for a proposed use unless the data before him establish
    that such use, under the conditions of use specified in the
    regulations, will be safe: Provided, however, That a color additive
    shall be deemed to be suitable and safe for the purpose of listing
    under this subsection for use generally in or on food, while there
    is in effect a published finding of the Secretary declaring such
    substance exempt from the term "food additive" because of its being
    generally recognized by qualified experts as safe for its intended
    use, as provided in section 321(s) of this title.
      (5)(A) In determining, for the purposes of this section, whether
    a proposed use of a color additive is safe, the Secretary shall
    consider, among other relevant factors - 
        (i) the probable consumption of, or other relevant exposure
      from, the additive and of any substance formed in or on food,
      drugs or devices, or cosmetics because of the use of the
      additive;
        (ii) the cumulative effect, if any, of such additive in the
      diet of man or animals, taking into account the same or any
      chemically or pharmacologically related substance or substances
      in such diet;
        (iii) safety factors which, in the opinion of experts qualified
      by scientific training and experience to evaluate the safety of
      color additives for the use or uses for which the additive is
      proposed to be listed, are generally recognized as appropriate
      for the use of animal experimentation data; and
        (iv) the availability of any needed practicable methods of
      analysis for determining the identity and quantity of (I) the
      pure dye and all intermediates and other impurities contained in
      such color additive, (II) such additive in or on any article of
      food, drug or device, or cosmetic, and (III) any substance formed
      in or on such article because of the use of such additive.

      (B) A color additive (i) shall be deemed unsafe, and shall not be
    listed, for any use which will or may result in ingestion of all or
    part of such additive, if the additive is found by the Secretary to
    induce cancer when ingested by man or animal, or if it is found by
    the Secretary, after tests which are appropriate for the evaluation
    of the safety of additives for use in food, to induce cancer in man
    or animal, and (ii) shall be deemed unsafe, and shall not be
    listed, for any use which will not result in ingestion of any part
    of such additive, if, after tests which are appropriate for the
    evaluation of the safety of additives for such use, or after other
    relevant exposure of man or animal to such additive, it is found by
    the Secretary to induce cancer in man or animal: Provided, That
    clause (i) of this subparagraph (B) shall not apply with respect to
    the use of a color additive as an ingredient of feed for animals
    which are raised for food production, if the Secretary finds that,
    under the conditions of use and feeding specified in proposed
    labeling and reasonably certain to be followed in practice, such
    additive will not adversely affect the animals for which such feed
    is intended, and that no residue of the additive will be found (by
    methods of examination prescribed or approved by the Secretary by
    regulations, which regulations shall not be subject to subsection
    (d) of this section) in any edible portion of such animals after
    slaughter or in any food yielded by or derived from the living
    animal.
      (C)(i) In any proceeding for the issuance, amendment, or repeal
    of a regulation listing a color additive, whether commenced by a
    proposal of the Secretary on his own initiative or by a proposal
    contained in a petition, the petitioner, or any other person who
    will be adversely affected by such proposal or by the Secretary's
    order issued in accordance with paragraph (1) of section 371(e) of
    this title if placed in effect, may request, within the time
    specified in this subparagraph, that the petition or order thereon,
    or the Secretary's proposal, be referred to an advisory committee
    for a report and recommendations with respect to any matter arising
    under subparagraph (B) of this paragraph, which is involved in such
    proposal or order and which requires the exercise of scientific
    judgment. Upon such request, or if the Secretary within such time
    deems such a referral necessary, the Secretary shall forthwith
    appoint an advisory committee under subparagraph (D) of this
    paragraph and shall refer to it, together with all the data before
    him, such matter arising under subparagraph (B) for study thereof
    and for a report and recommendations on such matter. A person who
    has filed a petition or who has requested the referral of a matter
    to an advisory committee pursuant to this subparagraph (C), as well
    as representatives of the Department, shall have the right to
    consult with such advisory committee in connection with the matter
    referred to it. The request for referral under this subparagraph,
    or the Secretary's referral on his own initiative, may be made at
    any time before, or within thirty days after, publication of an
    order of the Secretary acting upon the petition or proposal.
      (ii) Within sixty days after the date of such referral, or within
    an additional thirty days if the committee deems such additional
    time necessary, the committee shall, after independent study of the
    data furnished to it by the Secretary and other data before it,
    certify to the Secretary a report and recommendations, together
    with all underlying data and a statement of the reasons or basis
    for the recommendations. A copy of the foregoing shall be promptly
    supplied by the Secretary to any person who has filed a petition,
    or who has requested such referral to the advisory committee.
    Within thirty days after such certification, and after giving due
    consideration to all data then before him, including such report,
    recommendations, underlying data, and statement, and to any prior
    order issued by him in connection with such matter, the Secretary
    shall by order confirm or modify any order theretofore issued or,
    if no such prior order has been issued, shall by order act upon the
    petition or other proposal.
      (iii) Where - 
        (I) by reason of subparagraph (B) of this paragraph, the
      Secretary has initiated a proposal to remove from listing a color
      additive previously listed pursuant to this section; and
        (II) a request has been made for referral of such proposal to
      an advisory committee;

    the Secretary may not act by order on such proposal until the
    advisory committee has made a report and recommendations to him
    under clause (ii) of this subparagraph and he has considered such
    recommendations, unless the Secretary finds that emergency
    conditions exist necessitating the issuance of an order
    notwithstanding this clause.
      (D) The advisory committee referred to in subparagraph (C) of
    this paragraph shall be composed of experts selected by the
    National Academy of Sciences, qualified in the subject matter
    referred to the committee and of adequately diversified
    professional background, except that in the event of the inability
    or refusal of the National Academy of Sciences to act, the
    Secretary shall select the members of the committee. The size of
    the committee shall be determined by the Secretary. Members of any
    advisory committee established under this chapter, while attending
    conferences or meetings of their committees or otherwise serving at
    the request of the Secretary, shall be entitled to receive
    compensation at rates to be fixed by the Secretary but at rates not
    exceeding the daily equivalent of the rate specified at the time of
    such service for grade GS-18 of the General Schedule, including
    traveltime; and while away from their homes or regular places of
    business they may be allowed travel expenses, including per diem in
    lieu of subsistence, as authorized by section 5703 of title 5 for
    persons in the Government service employed intermittently. The
    members shall not be subject to any other provisions of law
    regarding the appointment and compensation of employees of the
    United States. The Secretary shall furnish the committee with
    adequate clerical and other assistance, and shall by rules and
    regulations prescribe the procedure to be followed by the
    committee.
      (6) The Secretary shall not list a color additive under this
    subsection for a proposed use if the data before him show that such
    proposed use would promote deception of the consumer in violation
    of this chapter or would otherwise result in misbranding or
    adulteration within the meaning of this chapter.
      (7) If, in the judgment of the Secretary, a tolerance limitation
    is required in order to assure that a proposed use of a color
    additive will be safe, the Secretary - 
        (A) shall not list the additive for such use if he finds that
      the data before him do not establish that such additive, if used
      within a safe tolerance limitation, would achieve the intended
      physical or other technical effect; and
        (B) shall not fix such tolerance limitation at a level higher
      than he finds to be reasonably required to accomplish the
      intended physical or other technical effect.

      (8) If, having regard to the aggregate quantity of color additive
    likely to be consumed in the diet or to be applied to the human
    body, the Secretary finds that the data before him fail to show
    that it would be safe and otherwise permissible to list a color
    additive (or pharmacologically related color additives) for all the
    uses proposed therefor and at the levels of concentration proposed,
    the Secretary shall, in determining for which use or uses such
    additive (or such related additives) shall be or remain listed, or
    how the aggregate allowable safe tolerance for such additive or
    additives shall be allocated by him among the uses under
    consideration, take into account, among other relevant factors (and
    subject to the paramount criterion of safety), (A) the relative
    marketability of the articles involved as affected by the proposed
    uses of the color additive (or of such related additives) in or on
    such articles, and the relative dependence of the industries
    concerned on such uses; (B) the relative aggregate amounts of such
    color additive which he estimates would be consumed in the diet or
    applied to the human body by reason of the various uses and levels
    of concentration proposed; and (C) the availability, if any, of
    other color additives suitable and safe for one or more of the uses
    proposed.
    (c) Certification of colors
      The Secretary shall further, by regulation, provide (1) for the
    certification, with safe diluents or without diluents, of batches
    of color additives listed pursuant to subsection (b) of this
    section and conforming to the requirements for such additives
    established by regulations under such subsection and this
    subsection, and (2) for exemption from the requirement of
    certification in the case of any such additive, or any listing or
    use thereof, for which he finds such requirement not to be
    necessary in the interest of the protection of the public health:
    Provided, That, with respect to any use in or on food for which a
    listed color additive is deemed to be safe by reason of the proviso
    to paragraph (4) of subsection (b), the requirement of
    certification shall be deemed not to be necessary in the interest
    of public health protection.
    (d) Procedure for issuance, amendment, or repeal of regulations
      The provisions of section 371(e), (f), and (g) of this title
    shall, subject to the provisions of subparagraph (C) of subsection
    (b)(5) of this section, apply to and in all respects govern
    proceedings for the issuance, amendment, or repeal of regulations
    under subsection (b) or (c) of this section (including judicial
    review of the Secretary's action in such proceedings) and the
    admissibility of transcripts of the record of such proceedings in
    other proceedings, except that - 
        (1) if the proceeding is commenced by the filing of a petition,
      notice of the proposal made by the petition shall be published in
      general terms by the Secretary within thirty days after such
      filing, and the Secretary's order (required by paragraph (1) of
      section 371(e) of this title) acting upon such proposal shall, in
      the absence of prior referral (or request for referral) to an
      advisory committee, be issued within ninety days after the date
      of such filing, except that the Secretary may (prior to such
      ninetieth day), by written notice to the petitioner, extend such
      ninety-day period to such time (not more than one hundred and
      eighty days after the date of filing of the petition) as the
      Secretary deems necessary to enable him to study and investigate
      the petition;
        (2) any report, recommendations, underlying data, and reasons
      certified to the Secretary by an advisory committee appointed
      pursuant to subparagraph (D) of subsection (b)(5) of this
      section, shall be made a part of the record of any hearing if
      relevant and material, subject to the provisions of section
      556(d) of title 5. The advisory committee shall designate a
      member to appear and testify at any such hearing with respect to
      the report and recommendations of such committee upon request of
      the Secretary, the petitioner, or the officer conducting the
      hearing, but this shall not preclude any other member of the
      advisory committee from appearing and testifying at such hearing;
        (3) the Secretary's order after public hearing (acting upon
      objections filed to an order made prior to hearing) shall be
      subject to the requirements of section 348(f)(2) of this title;
      and
        (4) the scope of judicial review of such order shall be in
      accordance with the fourth sentence of paragraph (2), and with
      the provisions of paragraph (3), of section 348(g) of this title.
    (e) Fees
      The admitting to listing and certification of color additives, in
    accordance with regulations prescribed under this chapter, shall be
    performed only upon payment of such fees, which shall be specified
    in such regulations, as may be necessary to provide, maintain, and
    equip an adequate service for such purposes.
    (f) Exemptions
      The Secretary shall by regulations (issued without regard to
    subsection (d) of this section) provide for exempting from the
    requirements of this section any color additive or any specific
    type of use thereof, and any article of food, drug, or device, or
    cosmetic bearing or containing such additive, intended solely for
    investigational use by qualified experts when in his opinion such
    exemption is consistent with the public health.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 721, formerly Sec. 706, 52 Stat.
    1058; Pub. L. 86-618, title I, Sec. 103(b), July 12, 1960, 74 Stat.
    399; Pub. L. 87-781, title I, Sec. 104(f)(2), Oct. 10, 1962, 76
    Stat. 785; Pub. L. 91-515, title VI, Sec. 601(d)(2), Oct. 30, 1970,
    84 Stat. 1311; Pub. L. 94-295, Sec. 9(a), May 28, 1976, 90 Stat.
    583; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695; Pub. L. 102-300, Sec. 6(b)(2), June 16, 1992, 106 Stat. 240;
    renumbered Sec. 721, Pub. L. 102-571, title I, Sec. 106(4), Oct.
    29, 1992, 106 Stat. 4498; Pub. L. 103-80, Sec. 3(bb), Aug. 13,
    1993, 107 Stat. 778.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 376 of this title
    prior to renumbering by Pub. L. 102-571.
      In subsec. (d)(2), "section 556(d) of title 5" substituted for
    "section 7(c) of the Administrative Procedure Act (5 U.S.C., sec.
    1006(c))" on authority of Pub. L. 89-554, Sec. 7(b), Sept. 6, 1966,
    80 Stat. 631, the first section of which enacted Title 5,
    Government Organization and Employees.


-MISC1-
                                AMENDMENTS                            
      1993 - Subsec. (b)(5)(D). Pub. L. 103-80 substituted "section
    5703" for "section 5703(b)".
      1992 - Subsec. (b)(5)(C)(i). Pub. L. 102-300 struck out "of
    Health, Education, and Welfare" after "representatives of the
    Department".
      1976 - Subsec. (a). Pub. L. 94-295, Sec. 9(a)(2), (3), inserted
    reference to devices and inserted provisions directing that color
    additives for use in or on devices be subject to this section only
    if the color additives come in direct contact with the body of man
    or other animals for a significant period of time and authorizing
    the Secretary to designate by regulation the uses of color
    additives in or on devices which are subject to this section.
      Subsec. (b). Pub. L. 94-295, Sec. 9(a)(1), (2), substituted "drug
    or device" for "drug" and "drugs or devices" for "drugs" wherever
    appearing.
      Subsec. (f). Pub. L. 94-295, Sec. 9(a)(1), substituted "drug or
    device" for "drug".
      1970 - Subsec. (b)(5)(D). Pub. L. 91-515 substituted provisions
    authorizing members of an advisory committee to receive
    compensation at rates fixed by the Secretary, with a specific
    maximum amount, and travel expenses, including per diem in lieu of
    subsistence, as authorized by section 5703(b) of Title 5, for
    provisions authorizing such members to receive as compensation a
    reasonable per diem for time actually spent on committee work, and
    necessary traveling and subsistence expenses while serving away
    from their places of residence.
      1962 - Subsec. (b)(5)(B). Pub. L. 87-781 provided that clause (i)
    of this subparagraph shall not apply to a color additive in feed of
    animals raised for food production, if under the conditions of use
    specified in proposed labeling, and which conditions are reasonably
    certain to be followed in practice, such additive will not
    adversely affect the animals and no residue will be found in any
    edible portion of such animal after slaughter or in any food from
    the living animal.
      1960 - Pub. L. 86-618 amended section generally. Prior to
    amendment, section read as follows: "The admitting to listing and
    certification of coal-tar colors, in accordance with regulations
    prescribed under this chapter, shall be performed only upon payment
    of such fees, which shall be specified in such regulations, as may
    be necessary to provide, maintain, and equip an adequate service
    for such purposes."

                     EFFECTIVE DATE OF 1962 AMENDMENT                 
      Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
    107 of Pub. L. 87-781, set out as a note under section 321 of this
    title.

      EFFECTIVE DATE OF 1960 AMENDMENT, TRANSITIONAL PROVISIONS, AND
                           EFFECT ON OTHER LAWS
      Title II of Pub. L. 86-618 provided that:
      "Sec. 201. [Definitions.] As used in this title, the term 'basic
    Act' means the Federal Food, Drug, and Cosmetic Act [this chapter];
    the term 'enactment date' means the date of enactment of this Act
    [July 12, 1960]; and other terms, insofar as also used in the basic
    Act (whether before or after enactment of this Act) shall have the
    same meaning as they have, or had when in effect, under the basic
    Act.
      "Sec. 202. [Effective Date.] This Act [amending this section and
    sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371
    of this title and repealing sections 354 and 364 of this title]
    shall, subject to the provisions of section 203, take effect on the
    enactment date [July 12, 1960].
      "Sec. 203. [Provisional Listings of Commercially Established
    Colors.] (a)(1) The purpose of this section is to make possible, on
    an interim basis for a reasonable period, through provisional
    listings, the use of commercially established color additives to
    the extent consistent with the public health, pending the
    completion of the scientific investigations needed as a basis for
    making determinations as to listing of such additives under the
    basic Act as amended by this Act. A provisional listing (including
    a deemed provisional listing) of a color additive under this
    section for any use shall, unless sooner terminated or expiring
    under the provisions of this section, expire (A) on the closing
    date (as defined in paragraph (2) of this subsection) or (B) on the
    effective date of a listing of such additive for such use under
    section 706 [now 721] of the basic Act, [this section], whichever
    date first occurs.
      "(2) For the purposes of this section, the term 'closing date'
    means (A) the last day of the two and one-half year period
    beginning on the enactment date [July 12, 1960] or (B), with
    respect to a particular provisional listing (or deemed provisional
    listing) of a color additive or use thereof, such later closing
    date as the Secretary may from time to time establish pursuant to
    the authority of this paragraph. The Secretary may by regulation,
    upon application of an interested person or on his own initiative,
    from time to time postpone the original closing date with respect
    to a provisional listing (or deemed provisional listing) under this
    section of a specified color additive, or of a specified use or
    uses of such additive, for such period or periods as he finds
    necessary to carry out the purpose of this section, if in the
    Secretary's judgment such action is consistent with the objective
    of carrying to completion in good faith, as soon as reasonably
    practicable, the scientific investigations necessary for making a
    determination as to listing such additive, or such specified use or
    uses thereof, under section 706 [now 721] of the basic Act [this
    section]. The Secretary may terminate a postponement of the closing
    date at any time if he finds that such postponement should not have
    been granted, or that by reason of a change in circumstances the
    basis for such postponement no longer exists, or that there has
    been a failure to comply with a requirement for submission of
    progress reports or with other conditions attached to such
    postponement.
      "(b) Subject to the other provisions of this section - 
        "(1) any color additive which, on the day preceding the
      enactment date [July 12, 1960], was listed and certifiable for
      any use or uses under section 406(b), 504, or 604 [section
      346(b), 354, or 364 of this title], or under the third proviso of
      section 402(c) [section 342(c) of this title], of the basic Act,
      and of which a batch or batches had been certified for such use
      or uses prior to the enactment date [July 12, 1960], and
        "(2) any color additive which was commercially used or sold
      prior to the enactment date [July 12, 1960] for any use or uses
      in or on any food, drug, or cosmetic, and which either, (A), on
      the day preceding the enactment date [July 12, 1960], was not a
      material within the purview of any of the provisions of the basic
      Act enumerated in paragraph (1) of this subsection, or (B) is the
      color additive known as synthetic beta-carotene,
    shall, beginning on the enactment date [July 12, 1960], be deemed
    to be provisionally listed under this section as a color additive
    for such use or uses.
      "(c) Upon request of any person, the Secretary, by regulations
    issued under subsection (d), shall without delay, if on the basis
    of the data before him he deems such action consistent with the
    protection of the public health, provisionally list a material as a
    color additive for any use for which it was listed, and for which a
    batch or batches of such material had been certified, under section
    406(b), 504, or 604 of the basic Act [section 346(b), 354, or 364
    of this title] prior to the enactment date [July 12, 1960],
    although such color was no longer listed and certifiable for such
    use under such sections on the day preceding the enactment date.
    Such provisional listing shall take effect on the date of
    publication.
      "(d)(1) The Secretary shall, by regulations issued or amended
    from time to time under this section - 
        "(A) insofar as practicable promulgate and keep current a list
      or lists of the color additives, and of the particular uses
      thereof, which he finds are deemed provisionally listed under
      subsection (b), and the presence of a color additive on such a
      list with respect to a particular use shall, in any proceeding
      under the basic Act, be conclusive evidence that such provisional
      listing is in effect;
        "(B) provide for the provisional listing of the color additives
      and particular uses thereof specified in subsection (c);
        "(C) provide, with respect to particular uses for which color
      additives are or are deemed to be provisionally listed, such
      temporary tolerance limitations (including such limitations at
      zero level) and other conditions of use and labeling or packaging
      requirements, if any, as in his judgment are necessary to protect
      the public health pending listing under section 706 [now 721] of
      the basic Act [this section];
        "(D) provide for the certification of batches of such color
      additives (with or without diluents) for the uses for which they
      are so listed or deemed to be listed under this section, except
      that such an additive which is a color additive deemed
      provisionally listed under subsection (b)(2) of this section
      shall be deemed exempt from the requirement of such certification
      while not subject to a tolerance limitation; and
        "(E) provide for the termination of a provisional listing (or
      deemed provisional listing) of a color additive or particular use
      thereof forthwith whenever in his judgment such action is
      necessary to protect the public health.
      "(2)(A) Except as provided in subparagraph (C) of this paragraph,
    regulations under this section shall, from time to time, be issued,
    amended, or repealed by the Secretary without regard to the
    requirements of the basic Act [subsec. (e) of this section], but
    for the purposes of the application of section 706(e) [now 721(e)]
    of the basic Act (relating to fees) and of determining the
    availability of appropriations of fees (and of advance deposits to
    cover fees), proceedings, regulations, and certifications under
    this section shall be deemed to be proceedings, regulations, and
    certifications under such section 706 [now 721, this section].
    Regulations providing for fees (and advance deposits to cover
    fees), which on the day preceding the enactment date [July 12,
    1960] were in effect pursuant to section 706 [now 721] of the basic
    Act [this section], shall be deemed to be regulations under such
    section 706 [now 721, this section] as amended by this Act, and
    appropriations of fees (and advance deposits) available for the
    purposes specified in such section 706 [now 721] as in effect prior
    to the enactment date [July 12, 1960] shall be available for the
    purposes specified in such section 706 [now 721, this section] as
    so amended.
      "(B) If the Secretary, by regulation - 
        "(i) has terminated a provisional listing (or deemed
      provisional listing) of a color additive or particular use
      thereof pursuant to paragraph (1)(E) of this subsection; or
        "(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of
      this subsection, initially established or rendered more
      restrictive a tolerance limitation or other restriction or
      requirement with respect to a provisional listing (or deemed
      provisional listing) which listing had become effective prior to
      such action,
    any person adversely affected by such action may, prior to the
    expiration of the period specified in clause (A) of subsection
    (a)(2) of this section, file with the Secretary a petition for
    amendment of such regulation so as to revoke or modify such action
    of the Secretary, but the filing of such petition shall not operate
    to stay or suspend the effectiveness of such action. Such petition
    shall, in accordance with regulations, set forth the proposed
    amendment and shall contain data (or refer to data which are before
    the Secretary or of which he will take official notice), which show
    that the revocation or modification proposed is consistent with the
    protection of the public health. The Secretary shall, after
    publishing such proposal and affording all interested persons an
    opportunity to present their views thereon orally or in writing,
    act upon such proposal by published order.
      "(C) Any person adversely affected by an order entered under
    subparagraph (B) of this paragraph may, within thirty days after
    its publication, file objections thereto with the Secretary,
    specifying with particularity the provisions of the order deemed
    objectionable, stating reasonable grounds for such objections, and
    requesting a public hearing upon such objections. The Secretary
    shall hold a public hearing on such objections and shall, on the
    basis of the evidence adduced at such hearing, act on such
    objections by published order. Such order may reinstate a
    terminated provisional listing, or increase or dispense with a
    previously established temporary tolerance limitation, or make less
    restrictive any other limitation established by him under paragraph
    (1) or (3) of this subsection, only if in his judgment the evidence
    so adduced shows that such action will be consistent with the
    protection of the public health. An order entered under this
    subparagraph shall be subject to judicial review in accordance with
    section 701(f) of the basic Act [section 371(f) of this title]
    except that the findings and order of the Secretary shall be
    sustained only if based upon a fair evaluation of the entire record
    at such hearing. No stay or suspension of such order shall be
    ordered by the court pending conclusion of such judicial review.
      "(D) On and after the enactment date [July 12, 1960],
    regulations, provisional listings, and certifications (or
    exemptions from certification) in effect under this section shall,
    for the purpose of determining whether an article is adulterated or
    misbranded within the meaning of the basic Act by reason of its
    being, bearing, or containing a color additive, have the same
    effect as would regulations, listings, and certifications (or
    exemptions from certification) under section 706 [now 721] of the
    basic Act [this section]. A regulation, provisional listing or
    termination thereof, tolerance limitation, or certification or
    exemption therefrom, under this section shall not be the basis for
    any presumption or inference in any proceeding under section 706(b)
    or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of
    this section].
      "(3) For the purpose of enabling the Secretary to carry out his
    functions under paragraphs (1)(A) and (C) of this subsection with
    respect to color additives deemed provisionally listed, he shall,
    as soon as practicable after enactment of this Act [July 12, 1960],
    afford by public notice a reasonable opportunity to interested
    persons to submit data relevant thereto. If the data so submitted
    or otherwise before him do not, in his judgment, establish a
    reliable basis for including such a color additive or particular
    use or uses thereof in a list or lists promulgated under paragraph
    (1)(A), or for determining the prevailing level or levels of use
    thereof prior to the enactment date [July 12, 1960] with a view to
    prescribing a temporary tolerance or tolerances for such use or
    uses under paragraph (1)(C), the Secretary shall establish a
    temporary tolerance limitation at zero level for such use or uses
    until such time as he finds that it would not be inconsistent with
    the protection of the public health to increase or dispense with
    such temporary tolerance limitation.
      "Sec. 204. [Effect on Meat Inspection and Poultry Products
    Inspection Acts.] Nothing in this Act [amending this section and
    sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371
    of this title and repealing sections 354 and 364 of this title]
    shall be construed to exempt any meat or meat food product, poultry
    or poultry product, or any person from any requirement imposed by
    or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat.
    1260, as amended or extended (21 U.S.C. 71 and the following) [see
    section 601 et seq. of this title] or the Poultry Products
    Inspection Act (21 U.S.C. 451 and the following)."

                       EFFECTIVE DATE; ACCELERATION                   
      This section was made "immediately effective" by act May 2, 1939,
    ch. 107, title I, Sec. 1, 53 Stat. 631.

                    TERMINATION OF ADVISORY COMMITTEES                
      Advisory committees in existence on Jan. 5, 1973, to terminate
    not later than the expiration of the 2-year period following Jan.
    5, 1973, and advisory committees established after Jan. 5, 1973, to
    terminate not later than the expiration of the 2-year period
    beginning on the date of their establishment, unless in the case of
    a committee established by the President or an officer of the
    Federal Government, such committee is renewed by appropriate action
    prior to the expiration of such 2-year period, or in the case of a
    committee established by Congress, its duration is otherwise
    provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86
    Stat. 776, set out in the Appendix to Title 5, Government
    Organization and Employees.

          REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES      
      References in laws to the rates of pay for GS-16, 17, or 18, or
    to maximum rates of pay under the General Schedule, to be
    considered references to rates payable under specified sections of
    Title 5, Government Organization and Employees, see section 529
    [title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
    under section 5376 of Title 5.

-End-


-CITE-
    21 USC Part C - Fees                                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees

-HEAD-
                               PART C - FEES                           

-End-


-CITE-
    21 USC subpart 1 - freedom of information fees              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 1 - freedom of information fees

-HEAD-
                  SUBPART 1 - FREEDOM OF INFORMATION FEES              

-End-



-CITE-
    21 USC Sec. 379f                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 1 - freedom of information fees

-HEAD-
    Sec. 379f. Recovery and retention of fees for freedom of
      information requests

-STATUTE-
    (a) In general
      The Secretary, acting through the Commissioner of Food and Drugs,
    may - 
        (1) set and charge fees, in accordance with section
      552(a)(4)(A) of title 5, to recover all reasonable costs incurred
      in processing requests made under section 552 of title 5 for
      records obtained or created under this chapter or any other
      Federal law for which responsibility for administration has been
      delegated to the Commissioner by the Secretary;
        (2) retain all fees charged for such requests; and
        (3) establish an accounting system and procedures to control
      receipts and expenditures of fees received under this section.
    (b) Use of fees
      The Secretary and the Commissioner of Food and Drugs shall not
    use fees received under this section for any purpose other than
    funding the processing of requests described in subsection (a)(1)
    of this section. Such fees shall not be used to reduce the amount
    of funds made to carry out other provisions of this chapter.
    (c) Waiver of fees
      Nothing in this section shall supersede the right of a requester
    to obtain a waiver of fees pursuant to section 552(a)(4)(A) of
    title 5.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 731, formerly Sec. 711, as added Pub.
    L. 101-635, title II, Sec. 201, Nov. 28, 1990, 104 Stat. 4584;
    renumbered Sec. 731, Pub. L. 102-571, title I, Sec. 106(6), Oct.
    29, 1992, 106 Stat. 4499.)

-COD-
                               CODIFICATION                           
      Section was formerly classified to section 379c of this title
    prior to renumbering by Pub. L. 102-571.

-End-


-CITE-
    21 USC subpart 2 - fees relating to drugs                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 2 - fees relating to drugs

-HEAD-
                    SUBPART 2 - FEES RELATING TO DRUGS                


-STATAMEND-
                          TERMINATION OF SUBPART                      
      For termination of subpart by section 105 of Pub. L. 102-571, see
    Termination Date note set out under section 379g of this title.

-End-



-CITE-
    21 USC Sec. 379g                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 2 - fees relating to drugs

-HEAD-
    Sec. 379g. Definitions

-STATUTE-
      For purposes of this part:
        (1) The term "human drug application" means an application for -
       
          (A) approval of a new drug submitted under section 355(b)(1)
        of this title,
          (B) approval of a new drug submitted under section 355(b)(2)
        of this title after September 30, 1992, which requests approval
        of - 
            (i) a molecular entity which is an active ingredient
          (including any salt or ester of an active ingredient), or
            (ii) an indication for a use,

        that had not been approved under an application submitted under
        section 355(b) of this title, or
          (C) licensure of a biological product under section 262 of
        title 42.

      Such term does not include a supplement to such an application,
      does not include an application with respect to whole blood or a
      blood component for transfusion, does not include an application
      with respect to a bovine blood product for topical application
      licensed before September 1, 1992, an allergenic extract product,
      or an in vitro diagnostic biologic product licensed under section
      262 of title 42, does not include an application with respect to
      a large volume parenteral drug product approved before September
      1, 1992, does not include an application for a licensure of a
      biological product for further manufacturing use only, and does
      not include an application or supplement submitted by a State or
      Federal Government entity for a drug that is not distributed
      commercially. Such term does include an application for
      licensure, as described in subparagraph (C), of a large volume
      biological product intended for single dose injection for
      intravenous use or infusion.
        (2) The term "supplement" means a request to the Secretary to
      approve a change in a human drug application which has been
      approved.
        (3) The term "prescription drug product" means a specific
      strength or potency of a drug in final dosage form - 
          (A) for which a human drug application has been approved,
          (B) which may be dispensed only under prescription pursuant
        to section 353(b) of this title, and
          (C) which is on the list of products described in section
        355(j)(7)(A) of this title or is on a list created and
        maintained by the Secretary of products approved under human
        drug applications under section 262 of title 42.

      Such term does not include whole blood or a blood component for
      transfusion, does not include a bovine blood product for topical
      application licensed before September 1, 1992, an allergenic
      extract product, or an in vitro diagnostic biologic product
      licensed under section 262 of title 42. Such term does not
      include a biological product that is licensed for further
      manufacturing use only, and does not include a drug that is not
      distributed commercially and is the subject of an application or
      supplement submitted by a State or Federal Government entity.
      Such term does include a large volume biological product intended
      for single dose injection for intravenous use or infusion.
        (4) The term "final dosage form" means, with respect to a
      prescription drug product, a finished dosage form which is
      approved for administration to a patient without substantial
      further manufacturing.
        (5) The term "prescription drug establishment" means a foreign
      or domestic place of business which is at one general physical
      location consisting of one or more buildings all of which are
      within five miles of each other and at which one or more
      prescription drug products are manufactured in final dosage form.
      For purposes of this paragraph, the term "manufactured" does not
      include packaging.
        (6) The term "process for the review of human drug
      applications" means the following activities of the Secretary
      with respect to the review of human drug applications and
      supplements:
          (A) The activities necessary for the review of human drug
        applications and supplements.
          (B) The issuance of action letters which approve human drug
        applications or which set forth in detail the specific
        deficiencies in such applications and, where appropriate, the
        actions necessary to place such applications in condition for
        approval.
          (C) The inspection of prescription drug establishments and
        other facilities undertaken as part of the Secretary's review
        of pending human drug applications and supplements.
          (D) Activities necessary for the review of applications for
        licensure of establishments subject to section 262 of title 42
        and for the release of lots of biologics under such section.
          (E) Monitoring of research conducted in connection with the
        review of human drug applications.
          (F) In the case of drugs approved after October 1, 2002,
        under human drug applications or supplements: collecting,
        developing, and reviewing safety information on the drugs,
        including adverse event reports, during a period of time after
        approval of such applications or supplements, not to exceed
        three years.

        (7) The term "costs of resources allocated for the process for
      the review of human drug applications" means the expenses
      incurred in connection with the process for the review of human
      drug applications for - 
          (A) officers and employees of the Food and Drug
        Administration, contractors of the Food and Drug
        Administration, advisory committees, and costs related to such
        officers, employees, and committees and to contracts with such
        contractors,
          (B) management of information, and the acquisition,
        maintenance, and repair of computer resources,
          (C) leasing, maintenance, renovation, and repair of
        facilities and acquisition, maintenance, and repair of
        fixtures, furniture, scientific equipment, and other necessary
        materials and supplies, and
          (D) collecting fees under section 379h of this title and
        accounting for resources allocated for the review of human drug
        applications and supplements.

        (8) The term "adjustment factor" applicable to a fiscal year is
      the Consumer Price Index for all urban consumers (all items;
      United States city average) for April of the preceding fiscal
      year divided by such Index for April 1997.
        (9) The term "affiliate" means a business entity that has a
      relationship with a second business entity if, directly or
      indirectly - 
          (A) one business entity controls, or has the power to
        control, the other business entity; or
          (B) a third party controls, or has power to control, both of
        the business entities.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 735, as added Pub. L. 102-571, title
    I, Sec. 103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105-
    115, title I, Secs. 102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat.
    2298, 2326; Pub. L. 107-188, title V, Sec. 503, June 12, 2002, 116
    Stat. 688.)


-STATAMEND-
                           AMENDMENT OF SECTION                       
      For termination of amendment by section 509 of Pub. L. 107-188,
    see Effective and Termination Dates of 2002 Amendments note below.
      For termination of amendment by section 107 of Pub. L. 105-115,
    see Effective and Termination Dates of 1997 Amendment note below.

                          TERMINATION OF SECTION                      
      For termination of section by section 105 of Pub. L. 102-571, see
    Termination Date note below.


-MISC1-
                                AMENDMENTS                            
      2002 - Par. (1). Pub. L. 107-188, Secs. 503(1), 509, temporarily
    substituted "licensure, as described in subparagraph (C)" for
    "licensure, as described in subparagraph (D)" in concluding
    provisions. See Effective and Termination Dates of 2002 Amendment
    note below.
      Par. (3). Pub. L. 107-188, Secs. 503(2)(D), 509, which directed
    the temporary amendment of concluding provisions of par. (3) by
    striking "section 262 of title 42" and all that follows through
    "biological product" and inserting "section 262 of title 42. Such
    term does not include a biological product", was executed by
    striking language ending with "biological product" the first time
    appearing, thereby making the substitution for "section 262 of
    title 42, does not include a large volume parenteral drug product
    approved before September 1, 1992, does not include a biological
    product", to reflect the probable intent of Congress. See Effective
    and Termination Dates of 2002 Amendment note below.
      Par. (3)(C). Pub. L. 107-188, Secs. 503(2)(A)-(C), 509,
    temporarily added subpar. (C). See Effective and Termination Dates
    of 2002 Amendment note below.
      Par. (6)(F). Pub. L. 107-188, Secs. 503(3), 509, temporarily
    added subpar. (F). See Effective and Termination Dates of 2002
    Amendment note below.
      Par. (8). Pub. L. 107-188, Secs. 503(4), 509, temporarily struck
    out designations of subpars. (A) and (B) and text of subpar. (B)
    and concluding provisions, substituting definition of "adjustment
    factor" as the Consumer Price Index for definition of Index as the
    lower of the Consumer Price Index or the total of discretionary
    budget authority provided for programs in the domestic category for
    the immediately preceding fiscal year divided by such budget
    authority for fiscal year 1997. See Effective and Termination Dates
    of 2002 Amendment note below.
      1997 - Par. (1). Pub. L. 105-115, Secs. 102(1), 107, in closing
    provisions, temporarily struck out "and" before "does not include
    an application" and substituted "September 1, 1992, does not
    include an application for a licensure of a biological product for
    further manufacturing use only, and does not include an application
    or supplement submitted by a State or Federal Government entity for
    a drug that is not distributed commercially. Such term does include
    an application for licensure, as described in subparagraph (D), of
    a large volume biological product intended for single dose
    injection for intravenous use or infusion" for "September 1, 1992"
    before period at end. See Effective and Termination Dates of 1997
    Amendment note below.
      Par. (1)(B) to (D). Pub. L. 105-115, Sec. 125(b)(2)(M), inserted
    "or" at end of subpar. (B), redesignated subpar. (D) as (C), and
    struck out former subpar. (C) which read as follows: "initial
    certification or initial approval of an antibiotic drug under
    section 357 of this title, or".
      Par. (3). Pub. L. 105-115, Secs. 102(2), 107, in closing
    provisions, temporarily struck out "and" before "does not include a
    large volume parenteral drug" and substituted "September 1, 1992,
    does not include a biological product that is licensed for further
    manufacturing use only, and does not include a drug that is not
    distributed commercially and is the subject of an application or
    supplement submitted by a State or Federal Government entity. Such
    term does include a large volume biological product intended for
    single dose injection for intravenous use or infusion" for
    "September 1, 1992" before period at end. See Effective and
    Termination Dates of 1997 Amendment note below.
      Par. (4). Pub. L. 105-115, Secs. 102(3), 107, temporarily
    substituted "without substantial further manufacturing" for
    "without further manufacturing". See Effective and Termination
    Dates of 1997 Amendment note below.
      Par. (5). Pub. L. 105-115, Secs. 102(4), 107, temporarily amended
    first sentence generally. Prior to amendment, first sentence read
    as follows: "The term 'prescription drug establishment' means a
    foreign or domestic place of business which is - 
        "(A) at one general physical location consisting of one or more
      buildings all of which are within 5 miles of each other, at which
      one or more prescription drug products are manufactured in final
      dosage form, and
        "(B) under the management of a person that is listed as the
      applicant in a human drug application for a prescription drug
      product with respect to at least one such product."
    See Effective and Termination Dates of 1997 Amendment note below.
      Par. (7)(A). Pub. L. 105-115, Secs. 102(5), 107, temporarily
    substituted "contractors of the Food and Drug Administration," for
    "employees under contract with the Food and Drug Administration who
    work in facilities owned or leased for the Food and Drug
    Administration," and "and committees and to contracts with such
    contractors," for "and committees,". See Effective and Termination
    Dates of 1997 Amendment note below.
      Par. (8)(A). Pub. L. 105-115, Secs. 102(6)(A), 107, temporarily
    substituted "April of the preceding fiscal year" for "August of the
    preceding fiscal year" and "April 1997" for "August 1992". See
    Effective and Termination Dates of 1997 Amendment note below.
      Par. (8)(B). Pub. L. 105-115, Secs. 102(6)(B), 107, temporarily
    substituted "section 254(c)" for "section 254(d)", "fiscal year
    1997" for "fiscal year 1992", and "105th Congress, 1st Session" for
    "102d Congress, 2d Session". See Effective and Termination Dates of
    1997 Amendment note below.
      Par. (9). Pub. L. 105-115, Secs. 102(7), 107, temporarily added
    par. (9). See Effective and Termination Dates of 1997 Amendment
    note below.

             EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT         
      Amendment by Pub. L. 107-188 effective Oct. 1, 2002, see section
    508 of Pub. L. 107-188, set out as an Effective Date of 2002
    Amendment note under section 356b of this title.
      Pub. L. 107-188, title V, Sec. 509, June 12, 2002, 116 Stat. 694,
    provided that: "The amendments made by sections 503 and 504
    [amending this section and section 379h of this title] cease to be
    effective October 1, 2007, and section 505 [enacting provisions set
    out as a note below] ceases to be effective 120 days after such
    date."

             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT         
      Section 106 of title I of Pub. L. 105-115 provided that: "The
    amendments made by this subtitle [subtitle A (Secs. 101-107) of
    title I of Pub. L. 105-115, amending this section and section 379h
    of this title] shall take effect October 1, 1997."
      Section 107 of Pub. L. 105-115 provided that: "The amendments
    made by sections 102 and 103 [amending this section and section
    379h of this title] cease to be effective October 1, 2002, and
    section 104 [enacting provisions formerly set out as a note below]
    ceases to be effective 120 days after such date."

                             TERMINATION DATE                         
      Section 105 of Pub. L. 102-571 provided that: "The amendments
    made by section 103 [enacting this subpart] shall not be in effect
    after October 1, 1997 and section 104 [enacting provisions set out
    as a note below] shall not be in effect after 120 days after such
    date."

                             SAVINGS PROVISION                         
      Pub. L. 107-188, title V, Sec. 507, June 12, 2002, 116 Stat. 694,
    provided that: "Notwithstanding section 107 of the Food and Drug
    Administration Modernization Act of 1997 [section 107 of Pub. L.
    105-115, set out as an Effective and Termination Dates of 1997
    Amendment note above], and notwithstanding the amendments made by
    this subtitle [subtitle A (Secs. 501-509) of title V of Pub. L. 107-
    188, amending this section and sections 356b and 379h of this
    title], part 2 of subchapter C of chapter VII of the Federal Food,
    Drug, and Cosmetic Act [this subpart], as in effect on the day
    before the date of the enactment of this Act [June 12, 2002],
    continues to be in effect with respect to human drug applications
    and supplements (as defined in such part as of such day) that, on
    or after October 1, 1997, but before October 1, 2002, were accepted
    by the Food and Drug Administration for filing and with respect to
    assessing and collecting any fee required by such Act for a fiscal
    year prior to fiscal year 2003."
      Section 105 of Pub. L. 105-115 provided that: "Notwithstanding
    section 105 of the Prescription Drug User Fee Act of 1992 [section
    105 of Pub. L. 102-571, set out above], the Secretary shall retain
    the authority to assess and collect any fee required by part 2 of
    subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic
    Act [this subpart] for a human drug application or supplement
    accepted for filing prior to October 1, 1997, and to assess and
    collect any product or establishment fee required by such Act for a
    fiscal year prior to fiscal year 1998."

                        ACCOUNTABILITY AND REPORTS                    
      Pub. L. 107-188, title V, Sec. 505, June 12, 2002, 116 Stat. 692,
    provided that:
      "(a) Public Accountability. - 
        "(1) Consultation. - In developing recommendations to the
      Congress for the goals and plans for meeting the goals for the
      process for the review of human drug applications for the fiscal
      years after fiscal year 2007, and for the reauthorization of
      sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act
      [21 U.S.C. 379g, 379h], the Secretary of Health and Human
      Services (referred to in this section as the 'Secretary') shall
      consult with the Committee on Energy and Commerce of the House of
      Representatives, the Committee on Health, Education, Labor, and
      Pensions of the Senate, appropriate scientific and academic
      experts, health care professionals, representatives of patient
      and consumer advocacy groups, and the regulated industry.
        "(2) Recommendations. - The Secretary shall publish in the
      Federal Register recommendations under paragraph (1), after
      negotiations with the regulated industry; shall present such
      recommendations to the congressional committees specified in such
      paragraph; shall hold a meeting at which the public may present
      its views on such recommendations; and shall provide for a period
      of 30 days for the public to provide written comments on such
      recommendations.
      "(b) Performance Report. - Beginning with fiscal year 2003, not
    later than 60 days after the end of each fiscal year during which
    fees are collected under part 2 of subchapter C of chapter VII of
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.),
    the Secretary of Health and Human Services shall prepare and submit
    to the President, the Committee on Energy and Commerce of the House
    of Representatives, and the Committee on Health, Education, Labor,
    and Pensions of the Senate a report concerning the progress of the
    Food and Drug Administration in achieving the goals identified in
    the letters described in section 502(4) [section 502(4) of Pub. L.
    107-188, set out below] during such fiscal year and the future
    plans of the Food and Drug Administration for meeting the goals.
      "(c) Fiscal Report. - Beginning with fiscal year 2003, not later
    than 120 days after the end of each fiscal year during which fees
    are collected under the part described in subsection (b), the
    Secretary of Health and Human Services shall prepare and submit to
    the Committee on Energy and Commerce of the House of
    Representatives, and the Committee on Health, Education, Labor, and
    Pensions of the Senate, a report on the implementation of the
    authority for such fees during such fiscal year and the use, by the
    Food and Drug Administration, of the fees collected during such
    fiscal year for which the report is made."
      [Section 505 of Pub. L. 107-188, set out above, ceases to be
    effective 120 days after Oct. 1, 2007, see Effective and
    Termination Dates of 2002 Amendment note above.]

         CONGRESSIONAL FINDINGS CONCERNING FEES RELATING TO DRUGS     
      Pub. L. 107-188, title V, Sec. 502, June 12, 2002, 116 Stat. 687,
    provided that: "The Congress finds that - 
        "(1) prompt approval of safe and effective new drugs and other
      therapies is critical to the improvement of the public health so
      that patients may enjoy the benefits provided by these therapies
      to treat and prevent illness and disease;
        "(2) the public health will be served by making additional
      funds available for the purpose of augmenting the resources of
      the Food and Drug Administration that are devoted to the process
      for the review of human drug applications and the assurance of
      drug safety;
        "(3) the provisions added by the Prescription Drug User Fee Act
      of 1992 [see section 101(a) of Pub. L. 102-571, set out as a
      Short Title of 1992 Amendment note under section 301 of this
      title], as amended by the Food and Drug Administration
      Modernization Act of 1997 [see Short Title of 1997 Amendment note
      set out under section 301 of this title], have been successful in
      substantially reducing review times for human drug applications
      and should be - 
          "(A) reauthorized for an additional 5 years, with certain
        technical improvements; and
          "(B) carried out by the Food and Drug Administration with new
        commitments to implement more ambitious and comprehensive
        improvements in regulatory processes of the Food and Drug
        Administration, including - 
            "(i) strengthening and improving the review and monitoring
          of drug safety;
            "(ii) considering greater interaction between the agency
          and sponsors during the review of drugs and biologics
          intended to treat serious diseases and life-threatening
          diseases; and
            "(iii) developing principles for improving first-cycle
          reviews; and
        "(4) the fees authorized by amendments made in this subtitle
      [subtitle A (Secs. 501-509) of title V of Pub. L. 107-188,
      amending this section and sections 356b and 379h of this title]
      will be dedicated towards expediting the drug development process
      and the process for the review of human drug applications as set
      forth in the goals identified for purposes of part 2 of
      subchapter C of chapter VII of the Federal Food, Drug, and
      Cosmetic Act [this subpart], in the letters from the Secretary of
      Health and Human Services to the chairman of the Committee on
      Energy and Commerce of the House of Representatives and the
      chairman of the Committee on Health, Education, Labor and
      Pensions of the Senate, as set forth in the Congressional
      Record."
      Pub. L. 105-115, title I, Sec. 101, Nov. 21, 1997, 111 Stat.
    2298, provided that: "Congress finds that - 
        "(1) prompt approval of safe and effective new drugs and other
      therapies is critical to the improvement of the public health so
      that patients may enjoy the benefits provided by these therapies
      to treat and prevent illness and disease;
        "(2) the public health will be served by making additional
      funds available for the purpose of augmenting the resources of
      the Food and Drug Administration that are devoted to the process
      for review of human drug applications;
        "(3) the provisions added by the Prescription Drug User Fee Act
      of 1992 [see section 101(a) of Pub. L. 102-571, set out as a
      Short Title of 1992 Amendment note under section 301 of this
      title] have been successful in substantially reducing review
      times for human drug applications and should be - 
          "(A) reauthorized for an additional 5 years, with certain
        technical improvements; and
          "(B) carried out by the Food and Drug Administration with new
        commitments to implement more ambitious and comprehensive
        improvements in regulatory processes of the Food and Drug
        Administration; and
        "(4) the fees authorized by amendments made in this subtitle
      [subtitle A (Secs. 101-107) of title I of Pub. L. 105-115,
      amending this section and section 379h of this title] will be
      dedicated toward expediting the drug development process and the
      review of human drug applications as set forth in the goals
      identified, for purposes of part 2 of subchapter C of chapter VII
      of the Federal Food, Drug, and Cosmetic Act [this subpart], in
      the letters from the Secretary of Health and Human Services to
      the chairman of the Committee on Commerce of the House of
      Representatives and the chairman of the Committee on Labor and
      Human Resources [now Committee on Health, Education, Labor, and
      Pensions] of the Senate, as set forth in the Congressional
      Record."

                              ANNUAL REPORTS                          
      Pub. L. 105-115, title I, Sec. 104, Nov. 21, 1997, 111 Stat.
    2304, which directed the Secretary of Health and Human Services to
    prepare and submit to Committee on Commerce of the House of
    Representatives and the Committee on Labor and Human Resources of
    the Senate, within 60 days after the end of each fiscal year during
    which fees are collected under this subpart, a report stating the
    Food and Drug Administration's progress in achieving the goals
    identified in the letters described in section 101(4) of Pub. L.
    105-115, set out above, during such fiscal year and the
    Administration's future plans for meeting the goals, and within 120
    days after the end of each fiscal year during which fees are
    collected, to prepare and submit a report on the implementation of
    the authority for such fees during such fiscal year and on the use
    the Administration made of the fees collected during such fiscal
    year, ceased to be effective 120 days after Oct. 1, 2002. See
    section 107 of Pub. L. 105-115, set out as an Effective and
    Termination Dates of 1997 Amendment note above.

       CONGRESSIONAL FINDINGS CONCERNING PRESCRIPTION DRUG USER FEES   
      Section 102 of title I of Pub. L. 102-571 provided that: "The
    Congress finds that - 
        "(1) prompt approval of safe and effective new drugs is
      critical to the improvement of the public health so that patients
      may enjoy the benefits provided by these therapies to treat and
      prevent illness and disease;
        "(2) the public health will be served by making additional
      funds available for the purpose of augmenting the resources of
      the Food and Drug Administration that are devoted to the process
      for review of human drug applications; and
        "(3) the fees authorized by this title [see Short Title of 1992
      Amendment note, set out under section 301 of this title] will be
      dedicated toward expediting the review of human drug applications
      as set forth in the goals identified in the letters of September
      14, 1992, and September 21, 1992, from the Commissioner of Food
      and Drugs to the Chairman of the Energy and Commerce Committee of
      the House of Representatives and the Chairman of the Labor and
      Human Resources Committee of the Senate, as set forth at 138
      Cong. Rec. H9099-H9100 (daily ed. September 22, 1992)."

                              ANNUAL REPORTS                          
      Pub. L. 102-571, title I, Sec. 104, Oct. 29, 1992, 106 Stat.
    4498, which provided that the Secretary of Health and Human
    Services submit to Committee on Energy and Commerce of the House of
    Representatives and Committee on Labor and Human Resources of the
    Senate, within 60 days after the end of each fiscal year during
    which fees were collected under this subpart, a report stating the
    Food and Drug Administration's progress in achieving the goals
    identified in section 102(3) of Pub. L. 102-571, set out as a note
    above, during such fiscal year and that agency's future plans for
    meeting such goals, and within 120 days after the end of each
    fiscal year during which such fees were collected, a report on the
    implementation of the authority for such fees during such fiscal
    year and on the use the Food and Drug Administration made of the
    fees collected during such fiscal year, ceased to be in effect 120
    days after Oct. 1, 1997. See Termination Date note above.

                        ANIMAL DRUG USER FEE STUDY                    
      Section 108 of Pub. L. 102-571 directed Secretary, in
    consultation with manufacturers of animal drug products and other
    interested persons, to undertake study to evaluate whether, and
    under what conditions, to impose user fees to supplement
    appropriated funds in order to improve process of reviewing
    applications (including abbreviated and supplemental applications)
    for new animal drugs under section 360b of this title, and further
    provided for submission of study to Congress no later than Jan. 4,
    1994.

-End-



-CITE-
    21 USC Sec. 379h                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 2 - fees relating to drugs

-HEAD-
    Sec. 379h. Authority to assess and use drug fees

-STATUTE-
    (a) Types of fees
      Beginning in fiscal year 2003, the Secretary shall assess and
    collect fees in accordance with this section as follows:
      (1) Human drug application and supplement fee
        (A) In general
          Each person that submits, on or after September 1, 1992, a
        human drug application or a supplement shall be subject to a
        fee as follows:
            (i) A fee established under subsection (c)(4) of this
          section for a human drug application for which clinical data
          (other than bioavailability or bioequivalence studies) with
          respect to safety or effectiveness are required for approval.
            (ii) A fee established under subsection (c)(4) of this
          section for a human drug application for which clinical data
          with respect to safety or effectiveness are not required or a
          supplement for which clinical data (other than
          bioavailability or bioequivalence studies) with respect to
          safety or effectiveness are required. Such fee shall be half
          of the amount of the fee established under clause (i).
        (B) Payment
          The fee required by subparagraph (A) shall be due upon
        submission of the application or supplement.
        (C) Exception for previously filed application or supplement
          If a human drug application or supplement was submitted by a
        person that paid the fee for such application or supplement,
        was accepted for filing, and was not approved or was withdrawn
        (without a waiver), the submission of a human drug application
        or a supplement for the same product by the same person (or the
        person's licensee, assignee, or successor) shall not be subject
        to a fee under subparagraph (A).
        (D) Refund of fee if application refused for filing
          The Secretary shall refund 75 percent of the fee paid under
        subparagraph (B) for any application or supplement which is
        refused for filing.
        (E) Exception for designated orphan drug or indication
          A human drug application for a prescription drug product that
        has been designated as a drug for a rare disease or condition
        pursuant to section 360bb of this title shall not be subject to
        a fee under subparagraph (A), unless the human drug application
        includes an indication for other than a rare disease or
        condition. A supplement proposing to include a new indication
        for a rare disease or condition in a human drug application
        shall not be subject to a fee under subparagraph (A), if the
        drug has been designated pursuant to section 360bb of this
        title as a drug for a rare disease or condition with regard to
        the indication proposed in such supplement.
        (F) Refund of fee if application withdrawn
          If an application or supplement is withdrawn after the
        application or supplement was filed, the Secretary may refund
        the fee or a portion of the fee if no substantial work was
        performed on the application or supplement after the
        application or supplement was filed. The Secretary shall have
        the sole discretion to refund a fee or a portion of the fee
        under this subparagraph. A determination by the Secretary
        concerning a refund under this paragraph shall not be
        reviewable.
      (2) Prescription drug establishment fee
        (A) In general
          Except as provided in subparagraph (B), each person that - 
            (i) is named as the applicant in a human drug application;
          and
            (ii) after September 1, 1992, had pending before the
          Secretary a human drug application or supplement,

        shall be assessed an annual fee established under subsection
        (c)(4) of this section for each prescription drug establishment
        listed in its approved human drug application as an
        establishment that manufactures the prescription drug product
        named in the application. The annual establishment fee shall be
        assessed in each fiscal year in which the prescription drug
        product named in the application is assessed a fee under
        paragraph (3) unless the prescription drug establishment listed
        in the application does not engage in the manufacture of the
        prescription drug product during the fiscal year. The
        establishment fee shall be payable on or before October 1 of
        each year. Each such establishment shall be assessed only one
        fee per establishment, notwithstanding the number of
        prescription drug products manufactured at the establishment.
        In the event an establishment is listed in a human drug
        application by more than one applicant, the establishment fee
        for the fiscal year shall be divided equally and assessed among
        the applicants whose prescription drug products are
        manufactured by the establishment during the fiscal year and
        assessed product fees under paragraph (3).
        (B) Exception
          If, during the fiscal year, an applicant initiates or causes
        to be initiated the manufacture of a prescription drug product
        at an establishment listed in its human drug application - 
            (i) that did not manufacture the product in the previous
          fiscal year; and
            (ii) for which the full establishment fee has been assessed
          in the fiscal year at a time before manufacture of the
          prescription drug product was begun;

        the applicant will not be assessed a share of the establishment
        fee for the fiscal year in which the manufacture of the product
        began.
      (3) Prescription drug product fee
        (A) In general
          Except as provided in subparagraph (B), each person who is
        named as the applicant in a human drug application, and who,
        after September 1, 1992, had pending before the Secretary a
        human drug application or supplement, shall pay for each such
        prescription drug product the annual fee established under
        subsection (c)(4) of this section. Such fee shall be payable on
        or before October 1 of each year. Such fee shall be paid only
        once for each product for a fiscal year in which the fee is
        payable.
        (B) Exception
          A prescription drug product shall not be assessed a fee under
        subparagraph (A) if such product is identified on the list
        compiled under section 355(j)(7)(A) of this title with a
        potency described in terms of per 100 mL, or if such product is
        the same product as another product approved under an
        application filed under section 355(b) or 355(j) of this title,
        under an abbreviated application filed under section 357 of
        this title (as in effect on the day before November 21, 1997),
        or under an abbreviated new drug application pursuant to
        regulations in effect prior to the implementation of the Drug
        Price Competition and Patent Term Restoration Act of 1984.
    (b) Fee revenue amounts
      Except as provided in subsections (c), (d), (f), and (g) of this
    section, fees under subsection (a) of this section shall be
    established to generate the following revenue amounts:


    Type of Fee Revenue: Application/Supplement
      Fiscal Year 2003: $74,300,000
      Fiscal Year 2004: $77,000,000
      Fiscal Year 2005: $84,000,000
      Fiscal Year 2006: $86,434,000
      Fiscal Year 2007: $86,434,000
    Type of Fee Revenue: Establishment
      Fiscal Year 2003: $74,300,000
      Fiscal Year 2004: $77,000,000
      Fiscal Year 2005: $84,000,000
      Fiscal Year 2006: $86,433,000
      Fiscal Year 2007: $86,433,000
    Type of Fee Revenue: Product
      Fiscal Year 2003: $74,300,000
      Fiscal Year 2004: $77,000,000
      Fiscal Year 2005: $84,000,000
      Fiscal Year 2006: $86,433,000
      Fiscal Year 2007: $86,433,000
    Type of Fee Revenue: Total Fee Revenue
      Fiscal Year 2003: $222,900,000
      Fiscal Year 2004: $231,000,000
      Fiscal Year 2005: $252,000,000
      Fiscal Year 2006: $259,300,000
      Fiscal Year 2007: $259,300,000
    --------------------------------------------------------------------

    If, after June 12, 2002, legislation is enacted requiring the
    Secretary to fund additional costs of the retirement of Federal
    personnel, fee revenue amounts shall be increased in each year by
    the amount necessary to fully fund the portion of such additional
    costs that are attributable to the process for the review of human
    drug applications.
    (c) Adjustments
      (1) Inflation adjustment
        The revenues established in subsection (b) of this section
      shall be adjusted by the Secretary by notice, published in the
      Federal Register, for a fiscal year to reflect the greater of - 
          (A) the total percentage change that occurred in the Consumer
        Price Index for all urban consumers (all items; U.S. city
        average) for the 12 month period ending June 30 preceding the
        fiscal year for which fees are being established, or
          (B) the total percentage change for the previous fiscal year
        in basic pay under the General Schedule in accordance with
        section 5332 of title 5, as adjusted by any locality-based
        comparability payment pursuant to section 5304 of such title
        for Federal employees stationed in the District of Columbia.

      The adjustment made each fiscal year by this subsection will be
      added on a compounded basis to the sum of all adjustments made
      each fiscal year after fiscal year 2003 under this subsection.
      (2) Workload adjustment
        Beginning with fiscal year 2004, after the fee revenues
      established in subsection (b) of this section are adjusted for a
      fiscal year for inflation in accordance with paragraph (1), the
      fee revenues shall be adjusted further for such fiscal year to
      reflect changes in the workload of the Secretary for the process
      for the review of human drug applications. With respect to such
      adjustment:
          (A) The adjustment shall be determined by the Secretary based
        on a weighted average of the change in the total number of
        human drug applications, commercial investigational new drug
        applications, efficacy supplements, and manufacturing
        supplements submitted to the Secretary. The Secretary shall
        publish in the Federal Register the fee revenues and fees
        resulting from the adjustment and the supporting methodologies.
          (B) Under no circumstances shall the adjustment result in fee
        revenues for a fiscal year that are less than the fee revenues
        for the fiscal year established in subsection (b) of this
        section, as adjusted for inflation under paragraph (1).
      (3) Final year adjustment
        For fiscal year 2007, the Secretary may, in addition to
      adjustments under paragraphs (1) and (2), further increase the
      fee revenues and fees established in subsection (b) of this
      section if such an adjustment is necessary to provide for not
      more than three months of operating reserves of carryover user
      fees for the process for the review of human drug applications
      for the first three months of fiscal year 2008. If such an
      adjustment is necessary, the rationale for the amount of the
      increase shall be contained in the annual notice establishing fee
      revenues and fees for fiscal year 2007. If the Secretary has
      carryover balances for such process in excess of three months of
      such operating reserves, the adjustment under this paragraph
      shall not be made.
      (4) Annual fee setting
        The Secretary shall, 60 days before the start of each fiscal
      year that begins after September 30, 2002, establish, for the
      next fiscal year, application, product, and establishment fees
      under subsection (a) of this section, based on the revenue
      amounts established under subsection (b) of this section and the
      adjustments provided under this subsection.
      (5) Limit
        The total amount of fees charged, as adjusted under this
      subsection, for a fiscal year may not exceed the total costs for
      such fiscal year for the resources allocated for the process for
      the review of human drug applications.
    (d) Fee waiver or reduction
      (1) In general
        The Secretary shall grant a waiver from or a reduction of one
      or more fees assessed under subsection (a) of this section where
      the Secretary finds that - 
          (A) such waiver or reduction is necessary to protect the
        public health,
          (B) the assessment of the fee would present a significant
        barrier to innovation because of limited resources available to
        such person or other circumstances,
          (C) the fees to be paid by such person will exceed the
        anticipated present and future costs incurred by the Secretary
        in conducting the process for the review of human drug
        applications for such person, or
          (D) the applicant involved is a small business submitting its
        first human drug application to the Secretary for review.
      (2) Use of standard costs
        In making the finding in paragraph (1)(C), the Secretary may
      use standard costs.
      (3) Rules relating to small businesses
        (A) "Small business" defined
          In paragraph (1)(D), the term "small business" means an
        entity that has fewer than 500 employees, including employees
        of affiliates.
        (B) Waiver of application fee
          The Secretary shall waive under paragraph (1)(D) the
        application fee for the first human drug application that a
        small business or its affiliate submits to the Secretary for
        review. After a small business or its affiliate is granted such
        a waiver, the small business or its affiliate shall pay - 
            (i) application fees for all subsequent human drug
          applications submitted to the Secretary for review in the
          same manner as an entity that does not qualify as a small
          business; and
            (ii) all supplement fees for all supplements to human drug
          applications submitted to the Secretary for review in the
          same manner as an entity that does not qualify as a small
          business.
    (e) Effect of failure to pay fees
      A human drug application or supplement submitted by a person
    subject to fees under subsection (a) of this section shall be
    considered incomplete and shall not be accepted for filing by the
    Secretary until all fees owed by such person have been paid.
    (f) Limitations
      (1) In general
        Fees under subsection (a) of this section shall be refunded for
      a fiscal year beginning after fiscal year 1997 unless
      appropriations for salaries and expenses of the Food and Drug
      Administration for such fiscal year (excluding the amount of fees
      appropriated for such fiscal year) are equal to or greater than
      the amount of appropriations for the salaries and expenses of the
      Food and Drug Administration for the fiscal year 1997 (excluding
      the amount of fees appropriated for such fiscal year) multiplied
      by the adjustment factor applicable to the fiscal year involved.
      (2) Authority
        If the Secretary does not assess fees under subsection (a) of
      this section during any portion of a fiscal year because of
      paragraph (1) and if at a later date in such fiscal year the
      Secretary may assess such fees, the Secretary may assess and
      collect such fees, without any modification in the rate, for
      human drug applications and supplements, prescription drug
      establishments, and prescription drug products at any time in
      such fiscal year notwithstanding the provisions of subsection (a)
      of this section relating to the date fees are to be paid.
    (g) Crediting and availability of fees
      (1) In general
        Fees authorized under subsection (a) of this section shall be
      collected and available for obligation only to the extent and in
      the amount provided in advance in appropriations Acts. Such fees
      are authorized to remain available until expended. Such sums as
      may be necessary may be transferred from the Food and Drug
      Administration salaries and expenses appropriation account
      without fiscal year limitation to such appropriation account for
      salaries and expenses with such fiscal year limitation. The sums
      transferred shall be available solely for the process for the
      review of human drug applications.
      (2) Collections and appropriation acts
        (A) In general
          The fees authorized by this section - 
            (i) shall be retained in each fiscal year in an amount not
          to exceed the amount specified in appropriation Acts, or
          otherwise made available for obligation, for such fiscal
          year, and
            (ii) shall only be collected and available to defray
          increases in the costs of the resources allocated for the
          process for the review of human drug applications (including
          increases in such costs for an additional number of full-time
          equivalent positions in the Department of Health and Human
          Services to be engaged in such process) over such costs,
          excluding costs paid from fees collected under this section,
          for fiscal year 1997 multiplied by the adjustment factor.
        (B) Compliance
          The Secretary shall be considered to have met the
        requirements of subparagraph (A)(ii) in any fiscal year if the
        costs funded by appropriations and allocated for the process
        for the review of human drug applications - 
            (i) are not more than 3 percent below the level specified
          in subparagraph (A)(ii); or
            (ii)(I) are more than 3 percent below the level specified
          in subparagraph (A)(ii), and fees assessed for the fiscal
          year following the subsequent fiscal year are decreased by
          the amount in excess of 3 percent by which such costs fell
          below the level specified in such subparagraph; and
            (II) such costs are not more than 5 percent below the level
          specified in such subparagraph.
      (3) Authorization of appropriations
        There are authorized to be appropriated for fees under this
      section - 
          (A) $222,900,000 for fiscal year 2003;
          (B) $231,000,000 for fiscal year 2004;
          (C) $252,000,000 for fiscal year 2005;
          (D) $259,300,000 for fiscal year 2006; and
          (E) $259,300,000 for fiscal year 2007;

      as adjusted to reflect adjustments in the total fee revenues made
      under this section and changes in the total amounts collected by
      application, supplement, establishment, and product fees.
      (4) Offset
        Any amount of fees collected for a fiscal year under this
      section that exceeds the amount of fees specified in
      appropriation Acts for such fiscal year shall be credited to the
      appropriation account of the Food and Drug Administration as
      provided in paragraph (1), and shall be subtracted from the
      amount of fees that would otherwise be authorized to be collected
      under this section pursuant to appropriation Acts for a
      subsequent fiscal year.
    (h) Collection of unpaid fees
      In any case where the Secretary does not receive payment of a fee
    assessed under subsection (a) of this section within 30 days after
    it is due, such fee shall be treated as a claim of the United
    States Government subject to subchapter II of chapter 37 of title
    31.
    (i) Written requests for waivers, reductions, and refunds
      To qualify for consideration for a waiver or reduction under
    subsection (d) of this section, or for a refund of any fee
    collected in accordance with subsection (a) of this section, a
    person shall submit to the Secretary a written request for such
    waiver, reduction, or refund not later than 180 days after such fee
    is due.
    (j) Construction
      This section may not be construed to require that the number of
    full-time equivalent positions in the Department of Health and
    Human Services, for officers, employers, and advisory committees
    not engaged in the process of the review of human drug
    applications, be reduced to offset the number of officers,
    employees, and advisory committees so engaged.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 736, as added Pub. L. 102-571, title
    I, Sec. 103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105-
    115, title I, Sec. 103(a)-(g), Nov. 21, 1997, 111 Stat. 2299-2304;
    Pub. L. 107-109, Sec. 5(a), Jan. 4, 2002, 115 Stat. 1413; Pub. L.
    107-188, title V, Sec. 504, June 12, 2002, 116 Stat. 689.)


-STATAMEND-
                           AMENDMENT OF SECTION                       
      For termination of amendment by section 509 of Pub. L. 107-188,
    see Effective and Termination Dates of 2002 Amendments note below.
      For termination of amendment by section 107 of Pub. L. 105-115,
    see Effective and Termination Dates of 1997 Amendment note below.

                          TERMINATION OF SECTION                      
      For termination of section by section 105 of Pub. L. 102-571, see
    Termination Date note below.

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 357 of this title, referred to in subsec. (a)(3)(B), was
    repealed by Pub. L. 105-115, title I, Sec. 125(b)(1), Nov. 21,
    1997, 111 Stat. 2325.
      The Drug Price Competition and Patent Term Restoration Act of
    1984, referred to in subsec. (a)(3)(B), is Pub. L. 98-417, Sept.
    24, 1984, 98 Stat. 1585. For complete classification of this Act to
    the Code, see Short Title of 1984 Amendment note set out under
    section 301 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      2002 - Subsec. (a). Pub. L. 107-188, Secs. 504(a)(1), 509,
    temporarily substituted "fiscal year 2003" for "fiscal year 1998"
    in introductory provisions. See Effective and Termination Dates of
    2002 Amendment note below.
      Subsec. (a)(1)(A)(i). Pub. L. 107-188, Secs. 504(a)(2)(A), 509,
    temporarily substituted "under subsection (c)(4)" for "in
    subsection (b)". See Effective and Termination Dates of 2002
    Amendment note below.
      Subsec. (a)(1)(A)(ii). Pub. L. 107-188, Secs. 504(a)(2), 509,
    temporarily substituted "under subsection (c)(4)" for "in
    subsection (b)" and inserted "Such fee shall be half of the amount
    of the fee established under clause (i)." at end. See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (a)(1)(F), (G). Pub. L. 107-109 redesignated subpar. (G)
    as (F) and struck out heading and text of former subpar. (F). Text
    read as follows: "A supplement to a human drug application
    proposing to include a new indication for use in pediatric
    populations shall not be assessed a fee under subparagraph (A)."
      Subsec. (a)(2)(A). Pub. L. 107-188, Secs. 504(a)(3), 509, in
    concluding provisions, temporarily substituted "under subsection
    (c)(4)" for "in subsection (b)" and "payable on or before October
    1" for "payable on or before January 31". See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (a)(3)(A). Pub. L. 107-188, Secs. 504(a)(4)(A), 509,
    temporarily amended heading and text of subpar. (A) generally.
    Prior to amendment, text read as follows: "Except as provided in
    subparagraph (B), each person - 
        "(i) who is named as the applicant in a human drug application
      for a prescription drug product which has been submitted for
      listing under section 360 of this title, and
        "(ii) who, after September 1, 1992, had pending before the
      Secretary a human drug application or supplement,
    shall pay for each such prescription drug product the annual fee
    established in subsection (b) of this section. Such fee shall be
    payable for the fiscal year in which the product is first submitted
    for listing under section 360 of this title, or is submitted for
    relisting under section 360 of this title if the product has been
    withdrawn from listing and relisted. After such fee is paid for
    that fiscal year, such fee shall be payable on or before January 31
    of each year. Such fee shall be paid only once for each product for
    a fiscal year in which the fee is payable." See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (a)(3)(B). Pub. L. 107-188, Secs. 504(a)(4)(B), 509,
    temporarily substituted "A prescription drug product shall not be
    assessed a fee under subparagraph (A) if such product is identified
    on the list compiled under section 355(j)(7)(A) of this title with
    a potency described in terms of per 100 mL, or if such product is
    the same product as another product approved under an application
    filed under section 355(b)" for "The listing of a prescription drug
    product under section 360 of this title shall not require the
    person who listed such product to pay the fee prescribed by
    subparagraph (A) if such product is the same product as a product
    approved under an application filed under section 355(b)(2)". See
    Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (b). Pub. L. 107-188, Secs. 504(b), 509, temporarily
    amended heading and text of subsec. (b) generally, substituting
    "Fee revenue amounts" for "Fee amounts" in heading and substituting
    fee schedules for fiscal years 2003 to 2007 for fee provisions
    relating to fiscal years 1998 to 2002. See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (c)(1). Pub. L. 107-188, Secs. 504(c)(1)(A), (D), 509,
    temporarily substituted "revenues" for "fees and total fee
    revenues" in introductory provisions and "fiscal year 2003" for
    "fiscal year 1997" in concluding provisions. See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (c)(1)(A). Pub. L. 107-188, Secs. 504(c)(1)(B), 509,
    temporarily struck out "during the preceding fiscal year" before
    "in the Consumer Price Index" and substituted "for the 12 month
    period ending June 30 preceding the fiscal year for which fees are
    being established, or" for ", or". See Effective and Termination
    Dates of 2002 Amendment note below.
      Subsec. (c)(1)(B). Pub. L. 107-188, Secs. 504(c)(1)(C), 509,
    temporarily substituted "for the previous fiscal year" for "for
    such fiscal year". See Effective and Termination Dates of 2002
    Amendment note below.
      Subsec. (c)(2) to (5). Pub. L. 107-188, Secs. 504(c)(2)-(4), 509,
    temporarily added pars. (2) and (3), redesignated former pars. (2)
    and (3) as (4) and (5), respectively, and amended heading and text
    of par. (4) generally. Prior to amendment, text of par. (4) read as
    follows: "Subject to the amount appropriated for a fiscal year
    under subsection (g) of this section, the Secretary shall, within
    60 days after the end of each fiscal year beginning after September
    30, 1997, adjust the establishment and product fees described in
    subsection (b) of this section for the fiscal year in which the
    adjustment occurs so that the revenues collected from each of the
    categories of fees described in paragraphs (2) and (3) of
    subsection (b) of this section shall be set to be equal to the
    revenues collected from the category of application and supplement
    fees described in paragraph (1) of subsection (b) of this section."
    See Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (d)(1)(C) to (E). Pub. L. 107-188, Secs. 504(d)(1), 509,
    temporarily inserted "or" at end of subpar. (C), redesignated
    subpar. (E) as (D), and struck out former subpar. (D) which read as
    follows: "assessment of the fee for an application or a supplement
    filed under section 355(b)(1) of this title pertaining to a drug
    containing an active ingredient would be inequitable because an
    application for a product containing the same active ingredient
    filed by another person under section 355(b)(2) of this title could
    not be assessed fees under subsection (a)(1) of this section, or".
    See Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (d)(3)(A), (B). Pub. L. 107-188, Secs. 504(d)(2), 509,
    temporarily substituted "paragraph (1)(D)" for "paragraph (1)(E)".
    See Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (f). Pub. L. 107-188, Secs. 504(e)(1), 509, temporarily
    substituted "Limitations" for "Assessment of fees" in heading. See
    Effective and Termination Dates of 2002 Amendment note below.
      Subsec. (f)(1). Pub. L. 107-188, Secs. 504(e)(2), 509,
    temporarily substituted "In general" for "Limitation" in heading
    and "Fees under subsection (a) of this section shall be refunded
    for a fiscal year beginning" for "Fees may not be assessed under
    subsection (a) of this section for a fiscal year beginning" in
    text. See Effective and Termination Dates of 2002 Amendment note
    below.
      Subsec. (g)(1). Pub. L. 107-188, Secs. 504(f)(1), 509, which
    directed the temporary amendment of par. (1) by striking "Fees
    collected for a fiscal year" and all that follows through "fiscal
    year limitation." and inserting "Fees authorized under subsection
    (a) of this section shall be collected and available for obligation
    only to the extent and in the amount provided in advance in
    appropriations Acts. Such fees are authorized to remain available
    until expended.", was executed by striking language ending with
    "fiscal year limitation." the first time appearing, thereby making
    the substitution for "Fees collected for a fiscal year pursuant to
    subsection (a) of this section shall be credited to the
    appropriation account for salaries and expenses of the Food and
    Drug Administration and shall be available in accordance with
    appropriation Acts until expended without fiscal year limitation.",
    to reflect the probable intent of Congress. See Effective and
    Termination Dates of 2002 Amendment note below.
      Subsec. (g)(2). Pub. L. 107-188, Secs. 504(f)(2), 509,
    temporarily amended par. (2) by designating existing provisions as
    subpar. (A), inserting subpar. (A) heading, adding subpar. (B),
    redesignating former subpars. (A) and (B) as cls. (i) and (ii),
    respectively, of subpar. (A), substituting "shall be retained in
    each fiscal year in an amount not to exceed the amount specified"
    for "shall be collected in each fiscal year in an amount equal to
    the amount specified" in cl. (i), and realigning margin of cl.
    (ii). See Effective and Termination Dates of 2002 Amendment note
    below.
      Subsec. (g)(3)(A) to (E). Pub. L. 107-188, Secs. 504(f)(3), 509,
    temporarily added subpars. (A) to (E) and struck out former
    subpars. (A) to (E) which read as follows:
      "(A) $106,800,000 for fiscal year 1998;
      "(B) $109,200,000 for fiscal year 1999;
      "(C) $109,200,000 for fiscal year 2000;
      "(D) $114,000,000 for fiscal year 2001; and
      "(E) $110,100,000 for fiscal year 2002,".
    See Effective and Termination Dates of 2002 Amendment note below.
      1997 - Subsec. (a). Pub. L. 105-115, Secs. 103(a)(1), 107,
    temporarily substituted "Beginning in fiscal year 1998" for
    "Beginning in fiscal year 1993" in introductory provisions. See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (a)(1)(B). Pub. L. 105-115, Secs. 103(a)(2)(A), 107,
    temporarily amended heading and text of subpar. (B) generally.
    Prior to amendment, text read as follows:
      "(i) First payment. - 50 percent of the fee required by
    subparagraph (A) shall be due upon submission of the application or
    supplement.
      "(ii) Final payment. - The remaining 50 percent of the fee
    required by subparagraph (A) shall be due upon - 
        "(I) the expiration of 30 days from the date the Secretary
      sends to the applicant a letter designated by the Secretary as an
      action letter described in section 379g(6)(B) of this title, or
        "(II) the withdrawal of the application or supplement after it
      is filed unless the Secretary waives the fee or a portion of the
      fee because no substantial work was performed on such application
      or supplement after it was filed.
    The designation under subclause (I) or the waiver under subclause
    (II) shall be solely in the discretion of the Secretary and shall
    not be reviewable." See Effective and Termination Dates of 1997
    Amendment note below.
      Subsec. (a)(1)(D). Pub. L. 105-115, Secs. 103(a)(2)(B), 107,
    temporarily substituted "refused" for "not accepted" in heading and
    "75 percent" for "50 percent", "subparagraph (B)" for "subparagraph
    (B)(i)", and "refused" for "not accepted" in text. See Effective
    and Termination Dates of 1997 Amendment note below.
      Subsec. (a)(1)(E) to (G). Pub. L. 105-115, Secs. 103(a)(2)(C),
    107, temporarily added subpars. (E) to (G). See Effective and
    Termination Dates of 1997 Amendment note below.
      Subsec. (a)(2). Pub. L. 105-115, Secs. 103(a)(3), 107,
    temporarily reenacted heading without change and amended text
    generally. Prior to amendment, text read as follows: "Each person
    that - 
        "(A) owns a prescription drug establishment, at which is
      manufactured at least 1 prescription drug product which is not
      the, or not the same as a, product approved under an application
      filed under section 355(b)(2) or 355(j) of this title, and
        "(B) after September 1, 1992, had pending before the Secretary
      a human drug application or supplement,
    shall be subject to the annual fee established in subsection (b) of
    this section for each such establishment, payable on or before
    January 31 of each year." See Effective and Termination Dates of
    1997 Amendment note below.
      Subsec. (a)(3)(A). Pub. L. 105-115, Secs. 103(a)(4)(A), 107,
    temporarily substituted, in cl. (i), "has been submitted for
    listing" for "is listed" and, in closing provisions, "Such fee
    shall be payable for the fiscal year in which the product is first
    submitted for listing under section 360 of this title, or is
    submitted for relisting under section 360 of this title if the
    product has been withdrawn from listing and relisted. After such
    fee is paid for that fiscal year, such fee shall be payable on or
    before January 31 of each year. Such fee shall be paid only once
    for each product for a fiscal year in which the fee is payable."
    for "Such fee shall be payable at the time of the first such
    listing of such product in each calendar year. Such fee shall be
    paid only once each year for each listed prescription drug product
    irrespective of the number of times such product is listed under
    section 360 of this title." See Effective and Termination Dates of
    1997 Amendment note below.
      Subsec. (a)(3)(B). Pub. L. 105-115, Secs. 103(a)(4)(B), 107,
    temporarily substituted "355(j) of this title, under an abbreviated
    application filed under section 357 of this title (as in effect on
    the day before November 21, 1997), or under an abbreviated new drug
    application pursuant to regulations in effect prior to the
    implementation of the Drug Price Competition and Patent Term
    Restoration Act of 1984." for "355(j) of this title.". See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (b). Pub. L. 105-115, Secs. 103(b), 107, temporarily
    amended subsec. (b) generally. Prior to amendment, subsec. (b)
    related to fee amounts, including a schedule of fees in par. (1)
    and fee exceptions for certain small businesses in par. (2). See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (c). Pub. L. 105-115, Secs. 103(c)(1), 107, temporarily
    substituted "Adjustments" for "Increases and adjustments" in
    heading. See Effective and Termination Dates of 1997 Amendment note
    below.
      Subsec. (c)(1). Pub. L. 105-115, Secs. 103(c)(2), 107,
    temporarily substituted "Inflation adjustment" for "Revenue
    increase" in heading, "The fees and total fee revenues established
    in subsection (b) of this section shall be adjusted by the
    Secretary" for "The total fee revenues established by the schedule
    in subsection (b)(1) of this section shall be increased by the
    Secretary" in introductory provisions, and "change" for "increase"
    after "total percentage" in subpars. (A) and (B), and inserted at
    end "The adjustment made each fiscal year by this subsection will
    be added on a compounded basis to the sum of all adjustments made
    each fiscal year after fiscal year 1997 under this subsection." See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (c)(2). Pub. L. 105-115, Secs. 103(c)(3), 107,
    temporarily substituted "September 30, 1997, adjust the
    establishment and product fees described in subsection (b) of this
    section for the fiscal year in which the adjustment occurs so that
    the revenues collected from each of the categories of fees
    described in paragraphs (2) and (3) of subsection (b) of this
    section shall be set to be equal to the revenues collected from the
    category of application and supplement fees described in paragraph
    (1) of subsection (b) of this section." for "October 1, 1992,
    adjust the fees established by the schedule in subsection (b)(1) of
    this section for the following fiscal year to achieve the total fee
    revenues, as may be increased under paragraph (1). Such fees shall
    be adjusted under this paragraph to maintain the proportions
    established in such schedule." See Effective and Termination Dates
    of 1997 Amendment note below.
      Subsec. (c)(3). Pub. L. 105-115, Secs. 103(c)(4), 107,
    temporarily substituted "this subsection" for "paragraph (2)". See
    Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (d). Pub. L. 105-115, Secs. 103(d), 107, temporarily
    struck out introductory provisions which read "The Secretary shall
    grant a waiver from or a reduction of 1 or more fees under
    subsection (a) of this section where the Secretary finds that - "
    and closing provisions which read "In making the finding in
    paragraph (3), the Secretary may use standard costs.", inserted
    designation, heading, and introductory provisions of par. (1),
    redesignated former pars. (1) to (4) as subpars. (A) to (D),
    respectively, of par. (1), and added pars. (1)(E), (2), and (3).
    See Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (f)(1). Pub. L. 105-115, Secs. 103(e), 107, temporarily
    substituted "fiscal year 1997" for "fiscal year 1993" and "fiscal
    year 1997 (excluding the amount of fees appropriated for such
    fiscal year)" for "fiscal year 1992". See Effective and Termination
    Dates of 1997 Amendment note below.
      Subsec. (g)(1). Pub. L. 105-115, Secs. 103(f)(1), 107,
    temporarily inserted at end "Such sums as may be necessary may be
    transferred from the Food and Drug Administration salaries and
    expenses appropriation account without fiscal year limitation to
    such appropriation account for salaries and expenses with such
    fiscal year limitation. The sums transferred shall be available
    solely for the process for the review of human drug applications."
    See Effective and Termination Dates of 1997 Amendment note below.
      Subsec. (g)(2)(A). Pub. L. 105-115, Secs. 103(f)(2)(A), 107,
    temporarily substituted "Acts, or otherwise made available for
    obligation," for "Acts". See Effective and Termination Dates of
    1997 Amendment note below.
      Subsec. (g)(2)(B). Pub. L. 105-115, Secs. 103(f)(2)(B), 107,
    temporarily substituted "over such costs, excluding costs paid from
    fees collected under this section, for fiscal year 1997" for "over
    such costs for fiscal year 1992". See Effective and Termination
    Dates of 1997 Amendment note below.
      Subsec. (g)(3), (4). Pub. L. 105-115, Secs. 103(f)(3), 107,
    temporarily added pars. (3) and (4) and struck out heading and text
    of former par. (3). Text read as follows: "There are authorized to
    be appropriated for fees under this section - 
        "(A) $36,000,000 for fiscal year 1993,
        "(B) $54,000,000 for fiscal year 1994,
        "(C) $75,000,000 for fiscal year 1995,
        "(D) $78,000,000 for fiscal year 1996, and
        "(E) $84,000,000 for fiscal year 1997,
    as adjusted to reflect increases in the total fee revenues made
    under subsection (c)(1) of this section." See Effective and
    Termination Dates of 1997 Amendment note below.
      Subsecs. (i), (j). Pub. L. 105-115, Secs. 103(g), 107,
    temporarily added subsec. (i) and redesignated former subsec. (i)
    as (j). See Effective and Termination Dates of 1997 Amendment note
    below.

             EFFECTIVE AND TERMINATION DATES OF 2002 AMENDMENT         
      Amendment by Pub. L. 107-188 effective Oct. 1, 2002, see section
    508 of Pub. L. 107-188, set out as an Effective Date of 2002
    Amendment note under section 356b of this title.
      Amendment by Pub. L. 107-188 to cease to be effective Oct. 1,
    2007, see section 509 of Pub. L. 107-188, set out as a note under
    section 379g of this title.

             EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT         
      Amendment by Pub. L. 105-115 effective Oct. 1, 1997, and ceases
    to be effective Oct. 1, 2002, see sections 106 and 107 of Pub. L.
    105-115, set out as notes under section 379g of this title.

                             TERMINATION DATE                         
      Section not in effect after Oct. 1, 1997, see section 105 of Pub.
    L. 102-571, set out as a note under section 379g of this title.

                   SPECIAL RULE FOR WAIVERS AND REFUNDS               
      Section 103(h) of Pub. L. 105-115 provided that: "Any requests
    for waivers or refunds for fees assessed under section 736 of the
    Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the
    date of enactment of this Act [Nov. 21, 1997] shall be submitted in
    writing to the Secretary of Health and Human Services within 1 year
    after the date of enactment of this Act. Any requests for waivers
    or refunds pertaining to a fee for a human drug application or
    supplement accepted for filing prior to October 1, 1997 or to a
    product or establishment fee required by such Act for a fiscal year
    prior to fiscal year 1998, shall be evaluated according to the
    terms of the Prescription Drug User Fee Act of 1992 [see section
    101(a) of Pub. L. 102-571, set out as a Short Title of 1992
    Amendment note under section 301 of this title] (as in effect on
    September 30, 1997) and part 2 of subchapter C of chapter VII of
    the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.]
    (as in effect on September 30, 1997). The term "person" in such
    Acts shall continue to include an affiliate thereof."

-End-


-CITE-
    21 USC subpart 3 - fees relating to devices                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 3 - fees relating to devices

-HEAD-
                   SUBPART 3 - FEES RELATING TO DEVICES               


-STATAMEND-
                          TERMINATION OF SUBPART                      
      For termination of subpart by section 107 of Pub. L. 107-250, see
    Effective and Termination Dates note set out under section 379i of
    this title.

-End-



-CITE-
    21 USC Sec. 379i                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 3 - fees relating to devices

-HEAD-
    Sec. 379i. Definitions

-STATUTE-
      For purposes of this part:
        (1) The term "premarket application" means - 
          (A) an application for approval of a device submitted under
        section 360e(c) of this title or section 262 of title 42; or
          (B) a product development protocol described in section
        360e(f) of this title.

      Such term does not include a supplement, a premarket report, or a
      premarket notification submission.
        (2) The term "premarket report" means a report submitted under
      section 360e(c)(2) of this title.
        (3) The term "premarket notification submission" means a report
      submitted under section 360(k) of this title.
        (4)(A) The term "supplement", with respect to a panel-track
      supplement, a 180-day supplement, a real-time supplement, or an
      efficacy supplement, means a request to the Secretary to approve
      a change in a device for which - 
          (i) an application or report has been approved under section
        360e(d) of this title, or an application has been approved
        under section 262 of title 42; or
          (ii) a notice of completion has become effective under
        section 360e(f) of this title.

        (B) The term "panel-track supplement" means a supplement to an
      approved premarket application or premarket report under section
      360e of this title that requests a significant change in design
      or performance of the device, or a new indication for use of the
      device, and for which substantial clinical data are necessary to
      provide a reasonable assurance of safety and effectiveness.
        (C) The term "180-day supplement" means a supplement to an
      approved premarket application or premarket report under section
      360e of this title that is not a panel-track supplement and
      requests a significant change in components, materials, design,
      specification, software, color additives, or labeling.
        (D) The term "real-time supplement" means a supplement to an
      approved premarket application or premarket report under section
      360e of this title that requests a minor change to the device,
      such as a minor change to the design of the device, software,
      sterilization, or labeling, and for which the applicant has
      requested and the agency has granted a meeting or similar forum
      to jointly review and determine the status of the supplement.
        (E) The term "efficacy supplement" means a supplement to an
      approved premarket application under section 262 of title 42 that
      requires substantive clinical data.
        (5) The term "process for the review of device applications"
      means the following activities of the Secretary with respect to
      the review of premarket applications, premarket reports,
      supplements, and premarket notification submissions:
          (A) The activities necessary for the review of premarket
        applications, premarket reports, supplements, and premarket
        notification submissions.
          (B) The issuance of action letters that allow the marketing
        of devices or which set forth in detail the specific
        deficiencies in such applications, reports, supplements, or
        submissions and, where appropriate, the actions necessary to
        place them in condition for approval.
          (C) The inspection of manufacturing establishments and other
        facilities undertaken as part of the Secretary's review of
        pending premarket applications, premarket reports, and
        supplements.
          (D) Monitoring of research conducted in connection with the
        review of such applications, reports, supplements, and
        submissions.
          (E) Review of device applications subject to section 262 of
        title 42 for an investigational new drug application under
        section 355(i) of this title or for an investigational device
        exemption under section 360j(g) of this title and activities
        conducted in anticipation of the submission of such
        applications under section 355(i) or 360j(g) of this title.
          (F) The development of guidance, policy documents, or
        regulations to improve the process for the review of premarket
        applications, premarket reports, supplements, and premarket
        notification submissions.
          (G) The development of voluntary test methods, consensus
        standards, or mandatory performance standards under section
        360d of this title in connection with the review of such
        applications, reports, supplements, or submissions and related
        activities.
          (H) The provision of technical assistance to device
        manufacturers in connection with the submission of such
        applications, reports, supplements, or submissions.
          (I) Any activity undertaken under section 360c or 360e(i) of
        this title in connection with the initial classification or
        reclassification of a device or under section 360e(b) of this
        title in connection with any requirement for approval of a
        device.
          (J) Evaluation of postmarket studies required as a condition
        of an approval of a premarket application or premarket report
        under section 360e of this title or a premarket application
        under section 262 of title 42.
          (K) Compiling, developing, and reviewing information on
        relevant devices to identify safety and effectiveness issues
        for devices subject to premarket applications, premarket
        reports, supplements, or premarket notification submissions.

        (6) The term "costs of resources allocated for the process for
      the review of device applications" means the expenses incurred in
      connection with the process for the review of device applications
      for - 
          (A) officers and employees of the Food and Drug
        Administration, contractors of the Food and Drug
        Administration, advisory committees, and costs related to such
        officers, employees, and committees and to contracts with such
        contractors;
          (B) management of information, and the acquisition,
        maintenance, and repair of computer resources;
          (C) leasing, maintenance, renovation, and repair of
        facilities and acquisition, maintenance, and repair of
        fixtures, furniture, scientific equipment, and other necessary
        materials and supplies; and
          (D) collecting fees and accounting for resources allocated
        for the review of premarket applications, premarket reports,
        supplements, and submissions.

        (7) The term "adjustment factor" applicable to a fiscal year is
      the Consumer Price Index for all urban consumers (all items;
      United States city average) for April of the preceding fiscal
      year divided by such Index for April 2002.
        (8) The term "affiliate" means a business entity that has a
      relationship with a second business entity (whether domestic or
      international) if, directly or indirectly - 
          (A) one business entity controls, or has the power to
        control, the other business entity; or
          (B) a third party controls, or has power to control, both of
        the business entities.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 737, as added Pub. L. 107-250, title
    I, Sec. 102(a), Oct. 26, 2002, 116 Stat. 1589; amended Pub. L. 108-
    214, Sec. 2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572, 577.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 107 of Pub. L. 107-250, see
    Effective and Termination Dates note set out below.


-MISC1-
                                AMENDMENTS                            
      2004 - Pub. L. 108-214, Sec. 2(d)(3)(A), made technical
    correction to directory language of Pub. L. 107-250, Sec. 102(a),
    which enacted this section.
      Par. (4)(B). Pub. L. 108-214, Sec. 2(a)(1)(A), substituted "and
    for which substantial clinical data are necessary to provide a
    reasonable assurance of safety and effectiveness" for "and for
    which clinical data are generally necessary to provide a reasonable
    assurance of safety and effectiveness".
      Par. (4)(D). Pub. L. 108-214, Sec. 2(a)(1)(B), struck out
    "manufacturing," after "software,".
      Par. (5)(J). Pub. L. 108-214, Sec. 2(a)(1)(C), substituted "a
    premarket application or premarket report under section 360e of
    this title or a premarket application under section 262 of title
    42." for "a premarket application under section 360e of this title
    or section 262 of title 42."
      Par. (8). Pub. L. 108-214, Sec. 2(a)(1)(D), substituted "The term
    'affiliate' means a business entity that has a relationship with a
    second business entity (whether domestic or international)" for
    "The term 'affiliate' means a business entity that has a
    relationship with a second business entity".

                      EFFECTIVE AND TERMINATION DATES                  
      Pub. L. 107-250, title I, Sec. 106, Oct. 26, 2002, 116 Stat.
    1602, provided that: "The amendments made by this title [enacting
    this subpart] shall take effect on the date of the enactment of
    this Act [Oct. 26, 2002], except that fees shall be assessed for
    all premarket applications, premarket reports, supplements, and
    premarket notification submissions received on or after October 1,
    2002, regardless of the date of enactment."
      Pub. L. 107-250, title I, Sec. 107, Oct. 26, 2002, 116 Stat.
    1602, provided that: "The amendments made by this title [enacting
    this subpart] cease to be effective October 1, 2007, except that
    section 103 [set out as a note below] with respect to annual
    reports ceases to be effective January 31, 2008."

                                 FINDINGS                             
      Pub. L. 107-250, title I, Sec. 101, Oct. 26, 2002, 116 Stat.
    1589, provided that: "The Congress finds that - 
        "(1) prompt approval and clearance of safe and effective
      devices is critical to the improvement of the public health so
      that patients may enjoy the benefits of devices to diagnose,
      treat, and prevent disease;
        "(2) the public health will be served by making additional
      funds available for the purpose of augmenting the resources of
      the Food and Drug Administration that are devoted to the process
      for the review of devices and the assurance of device safety and
      effectiveness so that statutorily mandated deadlines may be met;
      and
        "(3) the fees authorized by this title [enacting this subpart
      and provisions set out as notes under this section and section
      379j of this title] will be dedicated to meeting the goals
      identified in the letters from the Secretary of Health and Human
      Services to the Committee on Energy and Commerce of the House of
      Representatives and the Committee on Health, Education, Labor,
      and Pensions of the Senate, as set forth in the Congressional
      Record."

                              ANNUAL REPORTS                          
      Pub. L. 107-250, title I, Sec. 103, Oct. 26, 2002, 116 Stat.
    1600, as amended by Pub. L. 109-43, Sec. 2(b), Aug. 1, 2005, 119
    Stat. 441, provided that:
      "(a) In General. - Beginning with fiscal year 2003, the Secretary
    shall prepare and submit to the Committee on Energy and Commerce of
    the House of Representatives and the Committee on Health,
    Education, Labor and Pensions of the Senate a report concerning - 
        "(1) the progress of the Food and Drug Administration in
      achieving the goals identified in the letters described in
      section 101(3) [set out as a note above] during such fiscal year
      and the future plans of the Food and Drug Administration for
      meeting the goals, not later than 60 days after the end of each
      fiscal year during which fees are collected under this part
      [title I of Pub. L. 107-250 does not contain parts]; and
        "(2) the implementation of the authority for such fees during
      such fiscal year, and the use, by the Food and Drug
      Administration, of the fees collected during such fiscal year,
      not later than 120 days after the end of each fiscal year during
      which fees are collected under the medical device user-fee
      program established under the amendment made by section 102
      [enacting this subpart].
      "(b) Additional Information. - For fiscal years 2006 and 2007,
    the report described under subsection (a)(2) shall include - 
        "(1) information on the number of different types of
      applications and notifications, and the total amount of fees paid
      for each such type of application or notification, from
      businesses with gross receipts or sales from $0 to $100,000,000,
      with such businesses categorized in $10,000,000 intervals; and
        "(2) a certification by the Secretary that the amounts
      appropriated for salaries and expenses of the Food and Drug
      Administration for such fiscal year and obligated by the
      Secretary for the performance of any function relating to devices
      that is not for the process for the review of device
      applications, as defined in paragraph (5) of section 737 of the
      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not
      less than such amounts for fiscal year 2002 multiplied by the
      adjustment factor, as defined in paragraph (7) of such section
      737."
      [Section 103 of Pub. L. 107-250, set out above, ceases to be
    effective Jan. 31, 2008, see Effective and Termination Dates note
    above.]

                                   STUDY                               
      Pub. L. 107-250, title I, Sec. 104(b), Oct. 26, 2002, 116 Stat.
    1601, directed the Secretary of Health and Human Services to
    conduct a study for the purpose of making certain determinations
    regarding the medical device user-fee program established under the
    amendment made by section 102 of Pub. L. 107-250 and to submit a
    report to Congress by Jan. 10, 2007.

                               CONSULTATION                           
      Pub. L. 107-250, title I, Sec. 105, Oct. 26, 2002, 116 Stat.
    1601, provided that:
      "(a) In General. - In developing recommendations to the Congress
    for the goals and plans for meeting the goals for the process for
    the review of medical device applications for fiscal years after
    fiscal year 2007, and for the reauthorization of sections 737 and
    738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i,
    379j], the Secretary of Health and Human Services (referred to in
    this section as the 'Secretary') shall consult with the Committee
    on Energy and Commerce of the House of Representatives, the
    Committee on Health, Education, Labor, and Pensions of the Senate,
    appropriate scientific and academic experts, health care
    professionals, representatives of patient and consumer advocacy
    groups, and the regulated industry.
      "(b) Recommendations. - The Secretary shall publish in the
    Federal Register recommendations under subsection (a), after
    negotiations with the regulated industry; shall present such
    recommendations to the congressional committees specified in such
    paragraph; shall hold a meeting at which the public may present its
    views on such recommendations; and shall provide for a period of 30
    days for the public to provide written comments on such
    recommendations."

-End-



-CITE-
    21 USC Sec. 379j                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 3 - fees relating to devices

-HEAD-
    Sec. 379j. Authority to assess and use device fees

-STATUTE-
    (a) Types of fees
      (1) In general
        Beginning on October 26, 2002, the Secretary shall assess and
      collect fees in accordance with this section.
      (2) Premarket application, premarket report, supplement, and
        submission fee
        (A) In general
          Except as provided in subparagraph (B) and subsections (d)
        and (e) of this section, each person who submits any of the
        following, on or after October 1, 2002, shall be subject to a
        fee established under subsection (c)(1) of this section for the
        fiscal year involved in accordance with the following:
            (i) A premarket application.
            (ii) For a premarket report, a fee equal to the fee that
          applies under clause (i).
            (iii) For a panel track supplement, a fee equal to the fee
          that applies under clause (i).
            (iv) For a 180-day supplement, a fee equal to 21.5 percent
          of the fee that applies under clause (i).
            (v) For a real-time supplement, a fee equal to 7.2 percent
          of the fee that applies under clause (i).
            (vi) For an efficacy supplement, a fee equal to the fee
          that applies under clause (i).
            (vii) For a premarket notification submission, a fee equal
          to 1.42 percent of the fee that applies under clause (i),
          subject to any adjustment under subsection (e)(2)(C)(ii) of
          this section.
        (B) Exceptions
          (i) Humanitarian device exemption
            An application under section 360j(m) of this title is not
          subject to any fee under subparagraph (A).
          (ii) Further manufacturing use
            No fee shall be required under subparagraph (A) for the
          submission of a premarket application under section 262 of
          title 42 for a product licensed for further manufacturing use
          only.
          (iii) State or Federal Government sponsors
            No fee shall be required under subparagraph (A) for a
          premarket application, premarket report, supplement, or
          premarket notification submission submitted by a State or
          Federal Government entity unless the device involved is to be
          distributed commercially.
          (iv) Premarket notifications by third parties
            No fee shall be required under subparagraph (A) for a
          premarket notification submission reviewed by an accredited
          person pursuant to section 360m of this title.
          (v) Pediatric conditions of use
            (I) In general
              No fee shall be required under subparagraph (A) for a
            premarket application, premarket report, or premarket
            notification submission if the proposed conditions of use
            for the device involved are solely for a pediatric
            population. No fee shall be required under such
            subparagraph for a supplement if the sole purpose of the
            supplement is to propose conditions of use for a pediatric
            population.
            (II) Subsequent proposal of adult conditions of use
              In the case of a person who submits a premarket
            application or premarket report for which, under subclause
            (I), a fee under subparagraph (A) is not required, any
            supplement to such application that proposes conditions of
            use for any adult population is subject to the fee that
            applies under such subparagraph for a premarket
            application.
        (C) Payment
          The fee required by subparagraph (A) shall be due upon
        submission of the premarket application, premarket report,
        supplement, or premarket notification submission except that
        invoices for applications submitted between October 1, 2002,
        and October 26, 2002, shall be payable on October 30, 2002.
        Applicants submitting portions of applications pursuant to
        section 360e(c)(3) (!1) of this title shall pay such fees upon
        submission of the first portion of such applications. The fees
        credited to fiscal year 2003 under this section shall include
        all fees payable from October 1, 2002, through September 30,
        2003.

        (D) Refunds
          (i) Application refused for filing
            The Secretary shall refund 75 percent of the fee paid under
          subparagraph (A) for any application, report, or supplement
          that is refused for filing.
          (ii) Application withdrawn before filing
            The Secretary shall refund 75 percent of the fee paid under
          subparagraph (A) for any application, report, or supplement
          that is withdrawn prior to the filing decision of the
          Secretary.
          (iii) Application withdrawn before first action
            After receipt of a request for a refund of the fee paid
          under subparagraph (A) for a premarket application, premarket
          report, or supplement that is withdrawn after filing but
          before a first action, the Secretary may return some or all
          of the fee. The amount of refund, if any, shall be based on
          the level of effort already expended on the review of such
          application, report, or supplement. The Secretary shall have
          sole discretion to refund a fee or portion of the fee under
          this subparagraph. A determination by the Secretary
          concerning a refund under this paragraph shall not be
          reviewable.
    (b) Fee revenue amounts
      Except as provided in subsections (c), (d), (e), (g), and (h) of
    this section, the fees under subsection (a) of this section shall
    be established to generate the following revenue amounts:
    $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004;
    and $29,785,000 in fiscal year 2005. If legislation is enacted
    after October 26, 2002, requiring the Secretary to fund additional
    costs of the retirement of Federal personnel, fee revenue amounts
    under this subsection shall be increased in each year by the amount
    necessary to fully fund the portion of such additional costs that
    are attributable to the process for the review of device
    applications.
    (c) Annual fee setting
      (1) In general
        The Secretary shall, 60 days before the start of each fiscal
      year after September 30, 2002, publish in the Federal Register
      fees under subsection (a) of this section. The fees established
      for fiscal year 2006 shall be based on a premarket application
      fee of $259,600, and the fees established for fiscal year 2007
      shall be based on a premarket application fee of $281,600.
      (2) Limit
        The total amount of fees charged, as adjusted under this
      subsection, for a fiscal year may not exceed the total costs for
      such fiscal year for the resources allocated for the process for
      the review of device applications.
      (3) Supplement
        (A) In general
          For fiscal years 2006 and 2007, the Secretary may use
        unobligated carryover balances from fees collected in previous
        fiscal years to ensure that sufficient fee revenues are
        available in that fiscal year, so long as the Secretary
        maintains unobligated carryover balances of not less than 1
        month of operating reserves for the first month of fiscal year
        2008.
        (B) Notice to Congress
          Not later than 14 days before the Secretary anticipates the
        use of funds described in subparagraph (A), the Secretary shall
        provide notice to the Committee on Health, Education, Labor,
        and Pensions and the Committee on Appropriations of the Senate
        and the Committee on Energy and Commerce and the Committee on
        Appropriations of the House of Representatives.
    (d) Small businesses; fee waiver and fee reduction regarding
      premarket approval fees
      (1) In general
        The Secretary shall grant a waiver of the fee required under
      subsection (a) of this section for one premarket application, or
      one premarket report, where the Secretary finds that the
      applicant involved is a small business submitting its first
      premarket application to the Secretary, or its first premarket
      report, respectively, for review. For the purposes of this
      paragraph, the term "small business" means an entity that
      reported $30,000,000 or less of gross receipts or sales in its
      most recent Federal income tax return for a taxable year,
      including such returns of all of its affiliates, partners, and
      parent firms. In addition, for subsequent premarket applications,
      premarket reports, and supplements where the Secretary finds that
      the applicant involved is a small business, the fees specified in
      clauses (i) through (vi) of subsection (a)(2)(A) of this section
      may be paid at a reduced rate in accordance with paragraph
      (2)(C).
      (2) Rules relating to premarket approval fees
        (A) Definition
            For purposes of this paragraph, the term "small business"
          means an entity that reported $100,000,000 or less of gross
          receipts or sales in its most recent Federal income tax
          return for a taxable year, including such returns of all of
          its affiliates, partners, and parent firms.
        (B) Evidence of qualification
          An applicant shall pay the higher fees established by the
        Secretary each year unless the applicant submits evidence that
        it qualifies for a waiver of the fee or the lower fee rate. The
        applicant shall support its claim that it meets the definition
        under subparagraph (A) by submission of a copy of its most
        recent Federal income tax return for a taxable year, and a copy
        of such returns of its affiliates, partners, and parent firms,
        which show an amount of gross sales or receipts that is less
        than the maximum established in subparagraph (A). The
        applicant, and each of such affiliates, partners, and parent
        firms, shall certify that the information provided is a true
        and accurate copy of the actual tax forms they submitted to the
        Internal Revenue Service. If no tax forms are submitted for
        affiliates, partners, or parent firms, the applicant shall
        certify that the applicant has no affiliates, partners, or
        parent firms, respectively.
        (C) Reduced fees
          Where the Secretary finds that the applicant involved meets
        the definition under subparagraph (A), the fees established
        under subsection (c)(1) of this section may be paid at a
        reduced rate of 38 percent of the fee established under such
        subsection for a premarket application, a premarket report, or
        a supplement.
        (D) Request for fee waiver or reduction
          An applicant seeking a fee waiver or reduction under this
        subsection shall submit supporting information to the Secretary
        at least 60 days before the fee is required pursuant to
        subsection (a) of this section. The decision of the Secretary
        regarding whether an entity qualifies for such a waiver or
        reduction is not reviewable.
    (e) Small businesses; fee reduction regarding premarket
      notification submissions
      (1) In general
        For fiscal year 2004 and each subsequent fiscal year, where the
      Secretary finds that the applicant involved is a small business,
      the fee specified in subsection (a)(2)(A)(vii) of this section
      may be paid at a reduced rate in accordance with paragraph
      (2)(C).
      (2) Rules relating to premarket notification submissions
        (A) Definition
          For purposes of this subsection, the term "small business"
        means an entity that reported $100,000,000 or less of gross
        receipts or sales in its most recent Federal income tax return
        for a taxable year, including such returns of all of its
        affiliates, partners, and parent firms.
        (B) Evidence of qualification
          An applicant shall pay the higher fees established by the
        Secretary each year unless the applicant submits evidence that
        it qualifies for the lower fee rate. The applicant shall
        support its claim that it meets the definition under
        subparagraph (A) by submission of a copy of its most recent
        Federal income tax return for a taxable year, and a copy of
        such returns of its affiliates, partners, and parent firms,
        which show an amount of gross sales or receipts that is less
        than the maximum established in subparagraph (A). The
        applicant, and each of such affiliates, partners, and parent
        firms, shall certify that the information provided is a true
        and accurate copy of the actual tax forms they submitted to the
        Internal Revenue Service. If no tax forms are submitted for
        affiliates, partners, or parent firms, the applicant shall
        certify that the applicant has no affiliates, partners, or
        parent firms, respectively.
        (C) Reduced fees
          (i) In general
            For fiscal year 2004 and each subsequent fiscal year, where
          the Secretary finds that the applicant involved meets the
          definition under subparagraph (A), the fee for a premarket
          notification submission may be paid at 80 percent of the fee
          that applies under subsection (a)(2)(A)(vii) of this section,
          as adjusted under clause (ii) and as established under
          subsection (c)(1) of this section.
          (ii) Adjustment per fee revenue amount
            For fiscal year 2004 and each subsequent fiscal year, the
          Secretary, in setting the revenue amount under subsection
          (c)(1) of this section for premarket notification
          submissions, shall determine the revenue amount that would
          apply if all such submissions for the fiscal year involved
          paid a fee equal to 1.42 percent of the amount that applies
          under subsection (a)(2)(A)(i) of this section for premarket
          applications, and shall adjust the fee under subsection
          (a)(2)(A)(vii) of this section for premarket notification
          submissions such that the reduced fees collected under clause
          (i) of this subparagraph, when added to fees for such
          submissions that are not paid at the reduced rate, will equal
          such revenue amount for the fiscal year.
        (D) Request for reduction
          An applicant seeking a fee reduction under this subsection
        shall submit supporting information to the Secretary at least
        60 days before the fee is required pursuant to subsection (a)
        of this section. The decision of the Secretary regarding
        whether an entity qualifies for such a reduction is not
        reviewable.
    (f) Effect of failure to pay fees
      A premarket application, premarket report, supplement, or
    premarket notification submission submitted by a person subject to
    fees under subsection (a) of this section shall be considered
    incomplete and shall not be accepted by the Secretary until all
    fees owed by such person have been paid.
    (g) Conditions
      (1) Performance goals through fiscal year 2005; termination of
        program after fiscal year 2005
        With respect to the amount that, under the salaries and
      expenses account of the Food and Drug Administration, is
      appropriated for a fiscal year for devices and radiological
      products:
          (A)(i) For each of the fiscal years 2003 and 2004, the
        Secretary is expected to meet all of the goals identified for
        the fiscal year involved in any letter referred to in section
        101(3) of the Medical Device User Fee and Modernization Act of
        2002 (referred to in this paragraph as "performance goals") if
        the amount so appropriated for such fiscal year, excluding the
        amount of fees appropriated for such fiscal year, is equal to
        or greater than $205,720,000 multiplied by the adjustment
        factor applicable to the fiscal year.
          (ii) For each of the fiscal years 2003 and 2004, if the
        amount so appropriated for the fiscal year involved, excluding
        the amount of fees appropriated for such fiscal year, is less
        than the amount that applies under clause (i) for such fiscal
        year, the following applies:
            (I) The Secretary is expected to meet such goals to the
          extent practicable, taking into account the amounts that are
          available to the Secretary for such purpose, whether from
          fees under subsection (a) of this section or otherwise.
            (II) The Comptroller General of the United States shall
          submit to the Congress a report describing whether and to
          what extent the Secretary is meeting the performance goals
          identified for such fiscal year, and whether the Secretary
          will be able to meet all performance goals identified for
          fiscal year 2005. A report under the preceding sentence shall
          be submitted to the Congress not later than July 1 of the
          fiscal year with which the report is concerned.

          (B)(i) For fiscal year 2005, the Secretary is expected to
        meet all of the performance goals identified for the fiscal
        year if the amount so appropriated for such fiscal year,
        excluding the amount of fees appropriated for such fiscal year,
        is equal to or greater than $205,720,000 multiplied by the
        adjustment factor applicable to the fiscal year.
          (ii) For fiscal year 2005, if the amount so appropriated for
        such fiscal year, excluding the amount of fees appropriated for
        such fiscal year, is more than 1 percent less than the amount
        that applies under clause (i), the following applies:
            (I) The Secretary is expected to meet such goals to the
          extent practicable, taking into account the amounts that are
          available to the Secretary for such purpose, whether from
          fees under subsection (a) of this section or otherwise.
            (II) The Comptroller General of the United States shall
          submit to the Congress a report describing whether and to
          what extent the Secretary is meeting the performance goals
          identified for such fiscal year, and whether the Secretary
          will be able to meet all performance goals identified for
          fiscal year 2006. The report under the preceding sentence
          shall be submitted to the Congress not later than July 1,
          2005.

          (C) For fiscal year 2006, fees may not be assessed under
        subsection (a) of this section for the fiscal year, and the
        Secretary is not expected to meet any performance goals
        identified for the fiscal year, if the total of the amounts so
        appropriated for fiscal years 2005 and 2006, excluding the
        amount of fees appropriated for such fiscal years, is more than
        1 percent less than the sum of - 
            (i) $205,720,000 multiplied by the adjustment factor
          applicable to fiscal year 2006; and
            (ii) an amount equal to the amount that applies for
          purposes of subparagraph (B)(i).

          (D) For fiscal year 2007, fees may not be assessed under
        subsection (a) of this section for the fiscal year, and the
        Secretary is not expected to meet any performance goals
        identified for the fiscal year, if - 
            (i) the amount so appropriated for the fiscal year,
          excluding the amount of fees appropriated for the fiscal
          year, is more than 1 percent less than $205,720,000
          multiplied by the adjustment factor applicable to fiscal year
          2007; or
            (ii) pursuant to subparagraph (C), fees were not assessed
          under subsection (a) of this section for fiscal year 2006.
      (2) Authority
        If the Secretary does not assess fees under subsection (a) of
      this section during any portion of a fiscal year because of
      subparagraph (C) or (D) of paragraph (1) and if at a later date
      in such fiscal year the Secretary may assess such fees, the
      Secretary may assess and collect such fees, without any
      modification in the rate for premarket applications, supplements,
      premarket reports, and premarket notification submissions, and at
      any time in such fiscal year, notwithstanding the provisions of
      subsection (a) of this section relating to the date fees are to
      be paid.
    (h) Crediting and availability of fees
      (1) In general
        Fees authorized under subsection (a) of this section shall be
      collected and available for obligation only to the extent and in
      the amount provided in advance in appropriation Acts. Such fees
      are authorized to be appropriated to remain available until
      expended. Such sums as may be necessary may be transferred from
      the Food and Drug Administration salaries and expenses
      appropriation account without fiscal year limitation to such
      appropriation account for salaries and expenses with such fiscal
      year limitation. The sums transferred shall be available solely
      for the process for the review of device applications.
      (2) Collections and appropriation acts
        (A) In general
          The fees authorized by this section - 
            (i) shall be retained in each fiscal year in an amount not
          to exceed the amount specified in appropriation Acts, or
          otherwise made available for obligation, for such fiscal
          year, and
            (ii) shall only be collected and available to defray
          increases in the costs of the resources allocated for the
          process for the review of device applications (including
          increases in such costs for an additional number of full-time
          equivalent positions in the Department of Health and Human
          Services to be engaged in such process) over such costs,
          excluding costs paid from fees collected under this section,
          for fiscal year 2002 multiplied by the adjustment factor.
        (B) Compliance
          (i) In general
            The Secretary shall be considered to have met the
          requirements of subparagraph (A)(ii) in any fiscal year if
          the costs funded by appropriations and allocated for the
          process for the review of device applications - 
              (I) are not more than 3 percent below the level specified
            in subparagraph (A)(ii); or
              (II)(aa) are more than 3 percent below the level
            specified in subparagraph (A)(ii), and fees assessed for a
            subsequent fiscal year are decreased by the amount in
            excess of 3 percent by which such costs fell below the
            level specified in such subparagraph; and
              (bb) such costs are not more than 5 percent below the
            level specified in such subparagraph.
          (ii) More than 5 percent
            To the extent such costs are more than 5 percent below the
          specified level in subparagraph (A)(ii), fees may not be
          collected under this section for that fiscal year.
      (3) Authorization of appropriations
        There are authorized to be appropriated for fees under this
      section - 
          (A) $25,125,000 for fiscal year 2003;
          (B) $27,255,000 for fiscal year 2004;
          (C) $29,785,000 for fiscal year 2005; and
          (D) such sums as may be necessary for each of fiscal years
        2006 and 2007.(!2)


      as adjusted to reflect adjustments in the total fee revenues made
      under this section and changes in the total amounts collected by
      application fees.
      (4) Offset
        Any amount of fees collected for a fiscal year under this
      section that exceeds the amount of fees specified in
      appropriation Acts for such fiscal year shall be credited to the
      appropriation account of the Food and Drug Administration as
      provided in paragraph (1), and shall be subtracted from the
      amount of fees that would otherwise be authorized to be collected
      under this section pursuant to appropriation Acts for a
      subsequent fiscal year.
    (i) Collection of unpaid fees
      In any case where the Secretary does not receive payment of a fee
    assessed under subsection (a) of this section within 30 days after
    it is due, such fee shall be treated as a claim of the United
    States Government subject to subchapter II of chapter 37 of title
    31.
    (j) Written requests for refunds
      To qualify for consideration for a refund under subsection
    (a)(2)(D) of this section, a person shall submit to the Secretary a
    written request for such refund not later than 180 days after such
    fee is due.
    (k) Construction
      This section may not be construed to require that the number of
    full-time equivalent positions in the Department of Health and
    Human Services, for officers, employees, and advisory committees
    not engaged in the process of the review of device applications, be
    reduced to offset the number of officers, employees, and advisory
    committees so engaged.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 738, as added Pub. L. 107-250, title
    I, Sec. 102(a), Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108-
    214, Sec. 2(a)(2), (d)(2)(A), (B), (3)(A), Apr. 1, 2004, 118 Stat.
    572, 576, 577; Pub. L. 109-43, Sec. 2(a), Aug. 1, 2005, 119 Stat.
    439.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 107 of Pub. L. 107-250, see
    Effective and Termination Dates note set out under section 379i of
    this title.

-REFTEXT-
                            REFERENCES IN TEXT                        
      Section 360e(c)(3) of this title, referred to in subsec.
    (a)(2)(C), which related to submission of portions of applications,
    was redesignated section 360e(c)(4) of this title by Pub. L. 108-
    214, Sec. 2(d)(1)(A)(i), Apr. 1, 2004, 118 Stat. 576.
      Section 101(3) of the Medical Device User Fee and Modernization
    Act of 2002, referred to in subsec. (g)(1)(A)(i), is section 101(3)
    of Pub. L. 107-250, which is set out as a note under section 379i
    of this title.


-MISC1-
                                AMENDMENTS                            
      2005 - Subsec. (a)(2)(A). Pub. L. 109-43, Sec. 2(a)(7),
    substituted "subsection (c)(1)" for "subsection (c)(5)".
      Subsec. (b). Pub. L. 109-43, Sec. 2(a)(1), inserted "and" after
    "2004;" and substituted "2005" for "2005; $32,615,000 in fiscal
    year 2006, and $35,000,000 in fiscal year 2007".
      Subsec. (c). Pub. L. 109-43, Sec. 2(a)(2)(A), substituted "Annual
    fee setting" for "Adjustments" in heading.
      Subsec. (c)(1). Pub. L. 109-43, Sec. 2(a)(2)(B)-(D), redesignated
    par. (5) as (1), substituted "In general" for "Annual fee setting"
    in heading, "publish in the Federal Register fees under subsection
    (a) of this section. The fees" for "establish, for the next fiscal
    year, and publish in the Federal Register, fees under subsection
    (a) of this section, based on the revenue amounts established under
    subsection (b) of this section and the adjustment provided under
    this subsection and subsection (e)(2)(C)(ii) of this section,
    except that the fees", "2006" for "2003", and "$259,600, and the
    fees established for fiscal year 2007 shall be based on a premarket
    application fee of $281,600." for "$154,000." in text, and struck
    out former par. (1) which required an annual inflation adjustment
    of the revenues established in subsec. (b).
      Subsec. (c)(2). Pub. L. 109-43, Sec. 2(a)(2)(B), (C),
    redesignated par. (6) as (2) and struck out former par. (2) which
    required an annual adjustment of the fee revenues established in
    subsec. (b) to reflect changes in the workload of the Secretary for
    the process for the review of device applications.
      Subsec. (c)(3). Pub. L. 109-43, Sec. 2(a)(2)(B), (E), added par.
    (3) and struck out former par. (3) which required an annual
    compensating adjustment of the fee revenues established in subsec.
    (b).
      Subsec. (c)(4). Pub. L. 109-43, Sec. 2(a)(2)(B), struck out par.
    (4) which provided for a fiscal year 2007 adjustment of the fee
    revenues established in subsec. (b) to provide for operating
    reserves of carryover user fees.
      Subsec. (c)(5), (6). Pub. L. 109-43, Sec. 2(a)(2)(C),
    redesignated pars. (5) and (6) as (1) and (2), respectively.
      Subsec. (d)(1). Pub. L. 109-43, Sec. 2(a)(3)(A), inserted after
    first sentence "For the purposes of this paragraph, the term 'small
    business' means an entity that reported $30,000,000 or less of
    gross receipts or sales in its most recent Federal income tax
    return for a taxable year, including such returns of all of its
    affiliates, partners, and parent firms."
      Subsec. (d)(2)(A). Pub. L. 109-43, Sec. 2(a)(3)(B), struck out
    cl. (i) designation and heading before "For purposes", substituted
    "paragraph," for "subsection," and "$100,000,000" for
    "$30,000,000", and struck out heading and text of clause (ii). Text
    read as follows: "The Secretary may adjust the $30,000,000
    threshold established in clause (i) if the Secretary has evidence
    from actual experience that this threshold results in a reduction
    in revenues from premarket applications, premarket reports, and
    supplements that is 16 percent or more than would occur without
    small business exemptions and lower fee rates. To adjust this
    threshold, the Secretary shall publish a notice in the Federal
    Register setting out the rationale for the adjustment, and the new
    threshold."
      Subsec. (d)(2)(C). Pub. L. 109-43, Sec. 2(a)(7), substituted
    "subsection (c)(1)" for "subsection (c)(5)".
      Subsec. (e)(2)(A). Pub. L. 109-43, Sec. 2(a)(4), substituted
    "$100,000,000" for "$30,000,000".
      Subsec. (e)(2)(C). Pub. L. 109-43, Sec. 2(a)(7), substituted
    "subsection (c)(1)" for "subsection (c)(5)" in cls. (i) and (ii).
      Subsec. (g)(1)(B)(i). Pub. L. 109-43, Sec. 2(a)(5)(A)(i), added
    cl. (i) and struck out former cl. (i) which read as follows: "For
    fiscal year 2005, the Secretary is expected to meet all of the
    performance goals identified for the fiscal year if the total of
    the amounts so appropriated for fiscal years 2003 through 2005,
    excluding the amount of fees appropriated for such fiscal years, is
    equal to or greater than the sum of - 
        "(I) $205,720,000 multiplied by the adjustment factor
      applicable to fiscal year 2003;
        "(II) $205,720,000 multiplied by the adjustment factor
      applicable to fiscal year 2004; and
        "(III) $205,720,000 multiplied by the adjustment factor
      applicable to fiscal year 2005."
      Subsec. (g)(1)(B)(ii). Pub. L. 109-43, Sec. 2(a)(5)(A)(ii), added
    introductory provisions and struck out former introductory
    provisions which read as follows: "For fiscal year 2005, if the
    total of the amounts so appropriated for fiscal years 2003 through
    2005, excluding the amount of fees appropriated for such fiscal
    years, is less than the sum that applies under clause (i) for
    fiscal year 2005, the following applies:".
      Subsec. (g)(1)(C). Pub. L. 109-43, Sec. 2(a)(5)(B)(i),
    substituted "2005 and" for "2003 through" and inserted "more than 1
    percent" after "years, is".
      Subsec. (g)(1)(C)(ii). Pub. L. 109-43, Sec. 2(a)(5)(B)(ii),
    substituted "amount that applies" for "sum that applies".
      Subsec. (g)(1)(D)(i). Pub. L. 109-43, Sec. 2(a)(5)(C), inserted
    "more than 1 percent" after "year, is".
      Subsec. (h)(3)(D), (E). Pub. L. 109-43, Sec. 2(a)(6), added
    subpar. (D) and struck out former subpars. (D) and (E) which read
    as follows:
      "(D) $32,615,000 for fiscal year 2006; and
      "(E) $35,000,000 for fiscal year 2007,".
      2004 - Pub. L. 108-214, Sec. 2(d)(3)(A), made technical
    correction to directory language of Pub. L. 107-250, Sec. 102(a),
    which enacted this section.
      Subsec. (a). Pub. L. 108-214, Sec. 2(d)(2)(A), designated
    introductory provisions of subsec. (a) as par. (1), inserted
    heading, substituted "this section." for "this section as
    follows:", and redesignated former par. (1) as (2).
      Subsec. (a)(1)(A). Pub. L. 108-214, Sec. 2(a)(2)(A)(i),
    substituted, in introductory provisions, "subsections (d) and (e)"
    for "subsection (d)", in cl. (iv), "clause (i)" for "clause (i),
    subject to any adjustment under subsection (c)(3) of this section",
    and, in cl. (vii), "clause (i), subject to any adjustment under
    subsection (e)(2)(C)(ii)" for "clause (i), subject to any
    adjustment under subsection (c)(3) of this section and any
    adjustment under subsection (e)(2)(C)(ii)".
      Subsec. (a)(1)(D)(i), (ii). Pub. L. 108-214, Sec. 2(a)(2)(A)(ii),
    substituted "application, report," for "application".
      Subsec. (d)(1). Pub. L. 108-214, Sec. 2(d)(2)(B)(i), substituted
    "subsection (a)(2)(A)" for "subsection (a)(1)(A)" in last sentence.
      Subsec. (d)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(B), substituted
    "firms, which show" for "firms. which show" in second sentence.
      Subsec. (e)(1). Pub. L. 108-214, Sec. 2(a)(2)(C)(i),
    (d)(2)(B)(ii), substituted "For fiscal year 2004 and each
    subsequent fiscal year, where" for "Where" and "subsection
    (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)".
      Subsec. (e)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(C)(ii)(I),
    substituted "firms, which show" for "firms. which show".
      Subsec. (e)(2)(C). Pub. L. 108-214, Sec. 2(a)(2)(C)(ii)(II),
    (d)(2)(B)(iii), substituted "For fiscal year 2004 and each
    subsequent fiscal year, where" for "Where" in cl. (i), "subsection
    (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)" in cls. (i) and
    (ii), and "subsection (a)(2)(A)(i)" for "subsection (a)(1)(A)(i)"
    in cl. (ii).
      Subsec. (f). Pub. L. 108-214, Sec. 2(a)(2)(D), struck out "for
    filing" after "accepted".
      Subsec. (h)(2)(B). Pub. L. 108-214, Sec. 2(a)(2)(E), designated
    existing provisions as cl. (i), inserted heading, redesignated
    former cls. (i) and (ii) as subcls. (I) and (II), respectively, of
    cl. (i), redesignated former subcls. (I) and (II) of cl. (i) as
    items (aa) and (bb), respectively, of cl. (i)(II), and added cl.
    (ii).
      Subsec. (j). Pub. L. 108-214, Sec. 2(d)(2)(B)(iv), substituted
    "subsection (a)(2)(D)" for "subsection (a)(1)(D)".

                      EFFECTIVE AND TERMINATION DATES                  
      Section effective Oct. 26, 2002, except for certain premarket
    fees, and ceases to be effective Oct. 1, 2007, see sections 106 and
    107 of Pub. L. 107-250, set out as notes under section 379i of this
    title.

      FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PREMARKET REPORTS  
      Pub. L. 107-250, title I, Sec. 102(b), Oct. 26, 2002, 116 Stat.
    1600, as amended by Pub. L. 108-214, Sec. 2(d)(2)(C), (3)(B), Apr.
    1, 2004, 118 Stat. 577, provided that: "A person submitting a
    premarket report to the Secretary of Health and Human Services is
    exempt from the fee under section 738(a)(2)(A)(ii) of the Federal
    Food, Drug, and Cosmetic Act [21 U.S.C. 379j(a)(2)(A)(ii)] (as
    added by subsection (a) of this section) if - 
        "(1) the premarket report is the first such report submitted to
      the Secretary by the person; and
        "(2) before October 1, 2002, the person submitted a premarket
      application to the Secretary for the same device as the device
      for which the person is submitting the premarket report."

-FOOTNOTE-
    (!1) See References in Text note below.

               

    (!2) So in original. The period probably should be a comma.


-End-


-CITE-
    21 USC subpart 4 - fees relating to animal drugs            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 4 - fees relating to animal drugs

-HEAD-
                 SUBPART 4 - FEES RELATING TO ANIMAL DRUGS             


-STATAMEND-
                          TERMINATION OF SUBPART                      
      For termination of subpart by section 5 of Pub. L. 108-130, see
    Termination Date note set out under section 379j-11 of this title.

-End-



-CITE-
    21 USC Sec. 379j-11                                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 4 - fees relating to animal drugs

-HEAD-
    Sec. 379j-11. Definitions

-STATUTE-
      For purposes of this part:
        (1) The term "animal drug application" means an application for
      approval of any new animal drug submitted under section
      360b(b)(1) of this title. Such term does not include either a new
      animal drug application submitted under section 360b(b)(2) of
      this title or a supplemental animal drug application.
        (2) The term "supplemental animal drug application" means - 
          (A) a request to the Secretary to approve a change in an
        animal drug application which has been approved; or
          (B) a request to the Secretary to approve a change to an
        application approved under section 360b(c)(2) of this title for
        which data with respect to safety or effectiveness are
        required.

        (3) The term "animal drug product" means each specific strength
      or potency of a particular active ingredient or ingredients in
      final dosage form marketed by a particular manufacturer or
      distributor, which is uniquely identified by the labeler code and
      product code portions of the national drug code, and for which an
      animal drug application or a supplemental animal drug application
      has been approved.
        (4) The term "animal drug establishment" means a foreign or
      domestic place of business which is at one general physical
      location consisting of one or more buildings all of which are
      within 5 miles of each other, at which one or more animal drug
      products are manufactured in final dosage form.
        (5) The term "investigational animal drug submission" means - 
          (A) the filing of a claim for an investigational exemption
        under section 360b(j) of this title for a new animal drug
        intended to be the subject of an animal drug application or a
        supplemental animal drug application, or
          (B) the submission of information for the purpose of enabling
        the Secretary to evaluate the safety or effectiveness of an
        animal drug application or supplemental animal drug application
        in the event of their filing.

        (6) The term "animal drug sponsor" means either an applicant
      named in an animal drug application, except for an approved
      application for which all subject products have been removed from
      listing under section 360 of this title, or a person who has
      submitted an investigational animal drug submission that has not
      been terminated or otherwise rendered inactive by the Secretary.
        (7) The term "final dosage form" means, with respect to an
      animal drug product, a finished dosage form which is approved for
      administration to an animal without substantial further
      manufacturing. Such term includes animal drug products intended
      for mixing in animal feeds.
        (8) The term "process for the review of animal drug
      applications" means the following activities of the Secretary
      with respect to the review of animal drug applications,
      supplemental animal drug applications, and investigational animal
      drug submissions:
          (A) The activities necessary for the review of animal drug
        applications, supplemental animal drug applications, and
        investigational animal drug submissions.
          (B) The issuance of action letters which approve animal drug
        applications or supplemental animal drug applications or which
        set forth in detail the specific deficiencies in animal drug
        applications, supplemental animal drug applications, or
        investigational animal drug submissions and, where appropriate,
        the actions necessary to place such applications, supplements
        or submissions in condition for approval.
          (C) The inspection of animal drug establishments and other
        facilities undertaken as part of the Secretary's review of
        pending animal drug applications, supplemental animal drug
        applications, and investigational animal drug submissions.
          (D) Monitoring of research conducted in connection with the
        review of animal drug applications, supplemental animal drug
        applications, and investigational animal drug submissions.
          (E) The development of regulations and policy related to the
        review of animal drug applications, supplemental animal drug
        applications, and investigational animal drug submissions.
          (F) Development of standards for products subject to review.
          (G) Meetings between the agency and the animal drug sponsor.
          (H) Review of advertising and labeling prior to approval of
        an animal drug application or supplemental animal drug
        application, but not such activities after an animal drug has
        been approved.

        (9) The term "costs of resources allocated for the process for
      the review of animal drug applications" means the expenses
      incurred in connection with the process for the review of animal
      drug applications for - 
          (A) officers and employees of the Food and Drug
        Administration, contractors of the Food and Drug
        Administration, advisory committees consulted with respect to
        the review of specific animal drug applications, supplemental
        animal drug applications, or investigational animal drug
        submissions, and costs related to such officers, employees,
        committees, and contractors, including costs for travel,
        education, and recruitment and other personnel activities,
          (B) management of information, and the acquisition,
        maintenance, and repair of computer resources,
          (C) leasing, maintenance, renovation, and repair of
        facilities and acquisition, maintenance, and repair of
        fixtures, furniture, scientific equipment, and other necessary
        materials and supplies, and
          (D) collecting fees under section 379j-12 of this title and
        accounting for resources allocated for the review of animal
        drug applications, supplemental animal drug applications, and
        investigational animal drug submissions.

        (10) The term "adjustment factor" applicable to a fiscal year
      refers to the formula set forth in section 379g(8) of this title
      with the base or comparator year being 2003.
        (11) The term "affiliate" refers to the definition set forth in
      section 379g(9) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 739, as added Pub. L. 108-130, Sec.
    3, Nov. 18, 2003, 117 Stat. 1361.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 5 of Pub. L. 108-130, see
    Termination Date note below.


-MISC1-
                             TERMINATION DATE                         
      Pub. L. 108-130, Sec. 5, Nov. 18, 2003, 117 Stat. 1371, provided
    that: "The amendments made by section 3 [enacting this subpart]
    shall not be in effect after October 1, 2008, and section 4
    [enacting provisions set out as a note below] shall not be in
    effect after 120 days after such date."

                                 FINDINGS                             
      Pub. L. 108-130, Sec. 2, Nov. 18, 2003, 117 Stat. 1361, provided
    that: "Congress finds as follows:
        "(1) Prompt approval of safe and effective new animal drugs is
      critical to the improvement of animal health and the public
      health.
        "(2) Animal health and the public health will be served by
      making additional funds available for the purpose of augmenting
      the resources of the Food and Drug Administration that are
      devoted to the process for review of new animal drug
      applications.
        "(3) The fees authorized by this Act [enacting this subpart and
      provisions set out as notes under this section and section 301 of
      this title] will be dedicated toward expediting the animal drug
      development process and the review of new and supplemental animal
      drug applications and investigational animal drug submissions as
      set forth in the goals identified, for purposes of part 4 of
      subchapter C of chapter VII of the Federal Food, Drug, and
      Cosmetic Act [this subpart], in the letters from the Secretary of
      Health and Human Services to the Chairman of the Committee on
      Energy and Commerce of the House of Representatives and the
      Chairman of the Committee on Health, Education, Labor, and
      Pensions of the Senate as set forth in the Congressional Record."

                        ACCOUNTABILITY AND REPORTS                    
      Pub. L. 108-130, Sec. 4, Nov. 18, 2003, 117 Stat. 1370, provided
    that:
      "(a) Public Accountability. - 
        "(1) Consultation. - In developing recommendations to Congress
      for the goals and plans for meeting the goals for the process for
      the review of animal drug applications for the fiscal years after
      fiscal year 2008, and for the reauthorization of sections 739 and
      740 of the Federal Food, Drug, and Cosmetic Act (as added by
      section 3) [42 U.S.C. 379j-11, 379j-12], the Secretary of Health
      and Human Services (referred to in this section as the
      'Secretary') shall consult with the Committee on Energy and
      Commerce of the House of Representatives, the Committee on
      Health, Education, Labor, and Pensions of the Senate, appropriate
      scientific and academic experts, veterinary professionals,
      representatives of consumer advocacy groups, and the regulated
      industry.
        "(2) Recommendations. - The Secretary shall - 
          "(A) publish in the Federal Register recommendations under
        paragraph (1), after negotiations with the regulated industry;
          "(B) present the recommendations to the Committees referred
        to in that paragraph;
          "(C) hold a meeting at which the public may comment on the
        recommendations; and
          "(D) provide for a period of 30 days for the public to
        provide written comments on the recommendations.
      "(b) Performance Reports. - Beginning with fiscal year 2004, not
    later than 60 days after the end of each fiscal year during which
    fees are collected under part 4 of subchapter C of chapter VII of
    the Federal Food, Drug, and Cosmetic Act [this subpart], the
    Secretary shall prepare and submit to the Committee on Energy and
    Commerce of the House of Representatives and the Committee on
    Health, Education, Labor, and Pensions of the Senate a report
    concerning the progress of the Food and Drug Administration in
    achieving the goals identified in the letters described in section
    2(3) of this Act [set out as a note above] toward expediting the
    animal drug development process and the review of the new and
    supplemental animal drug applications and investigational animal
    drug submissions during such fiscal year, the future plans of the
    Food and Drug Administration for meeting the goals, the review
    times for abbreviated new animal drug applications, and the
    administrative procedures adopted by the Food and Drug
    Administration to ensure that review times for abbreviated new
    animal drug applications are not increased from their current level
    due to activities under the user fee program.
      "(c) Fiscal Report. - Beginning with fiscal year 2004, not later
    than 120 days after the end of each fiscal year during which fees
    are collected under the part described in subsection (b), the
    Secretary shall prepare and submit to the Committee on Energy and
    Commerce of the House of Representatives and the Committee on
    Health, Education, Labor, and Pensions of the Senate a report on
    the implementation of the authority for such fees during such
    fiscal year and the use, by the Food and Drug Administration, of
    the fees collected during such fiscal year for which the report is
    made."

-End-



-CITE-
    21 USC Sec. 379j-12                                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part C - Fees
    subpart 4 - fees relating to animal drugs

-HEAD-
    Sec. 379j-12. Authority to assess and use animal drug fees

-STATUTE-
    (a) Types of fees
      Beginning in fiscal year 2004, the Secretary shall assess and
    collect fees in accordance with this section as follows:
      (1) Animal drug application and supplement fee
        (A) In general
          Each person that submits, on or after September 1, 2003, an
        animal drug application or a supplemental animal drug
        application shall be subject to a fee as follows:
            (i) A fee established in subsection (b) of this section for
          an animal drug application; and
            (ii) A fee established in subsection (b) of this section
          for a supplemental animal drug application for which safety
          or effectiveness data are required, in an amount that is
          equal to 50 percent of the amount of the fee under clause
          (i).
        (B) Payment
          The fee required by subparagraph (A) shall be due upon
        submission of the animal drug application or supplemental
        animal drug application.
        (C) Exception for previously filed application or supplement
          If an animal drug application or a supplemental animal drug
        application was submitted by a person that paid the fee for
        such application or supplement, was accepted for filing, and
        was not approved or was withdrawn (without a waiver or refund),
        the submission of an animal drug application or a supplemental
        animal drug application for the same product by the same person
        (or the person's licensee, assignee, or successor) shall not be
        subject to a fee under subparagraph (A).
        (D) Refund of fee if application refused for filing
          The Secretary shall refund 75 percent of the fee paid under
        subparagraph (B) for any animal drug application or
        supplemental animal drug application which is refused for
        filing.
        (E) Refund of fee if application withdrawn
          If an animal drug application or a supplemental animal drug
        application is withdrawn after the application or supplement
        was filed, the Secretary may refund the fee or portion of the
        fee paid under subparagraph (B) if no substantial work was
        performed on the application or supplement after the
        application or supplement was filed. The Secretary shall have
        the sole discretion to refund the fee under this paragraph. A
        determination by the Secretary concerning a refund under this
        paragraph shall not be reviewable.
      (2) Animal drug product fee
        Each person - 
          (A) who is named as the applicant in an animal drug
        application or supplemental animal drug application for an
        animal drug product which has been submitted for listing under
        section 360 of this title, and
          (B) who, after September 1, 2003, had pending before the
        Secretary an animal drug application or supplemental animal
        drug application;

      shall pay for each such animal drug product the annual fee
      established in subsection (b) of this section. Such fee shall be
      payable for the fiscal year in which the animal drug product is
      first submitted for listing under section 360 of this title, or
      is submitted for relisting under section 360 of this title if the
      animal drug product has been withdrawn from listing and relisted.
      After such fee is paid for that fiscal year, such fee shall be
      payable on or before January 31 of each year. Such fee shall be
      paid only once for each animal drug product for a fiscal year in
      which the fee is payable.
      (3) Animal drug establishment fee
        Each person - 
          (A) who owns or operates, directly or through an affiliate,
        an animal drug establishment, and
          (B) who is named as the applicant in an animal drug
        application or supplemental animal drug application for an
        animal drug product which has been submitted for listing under
        section 360 of this title, and
          (C) who, after September 1, 2003, had pending before the
        Secretary an animal drug application or supplemental animal
        drug application,

      shall be assessed an annual fee established in subsection (b) of
      this section for each animal drug establishment listed in its
      approved animal drug application as an establishment that
      manufactures the animal drug product named in the application.
      The annual establishment fee shall be assessed in each fiscal
      year in which the animal drug product named in the application is
      assessed a fee under paragraph (2) unless the animal drug
      establishment listed in the application does not engage in the
      manufacture of the animal drug product during the fiscal year.
      The fee shall be paid on or before January 31 of each year. The
      establishment shall be assessed only one fee per fiscal year
      under this section: Provided, however, that where a single
      establishment manufactures both animal drug products and
      prescription drug products, as defined in section 379g(3) of this
      title, such establishment shall be assessed both the animal drug
      establishment fee and the prescription drug establishment fee, as
      set forth in section 379h(a)(2) of this title, within a single
      fiscal year.
      (4) Animal drug sponsor fee
        Each person - 
          (A) who meets the definition of an animal drug sponsor within
        a fiscal year; and
          (B) who, after September 1, 2003, had pending before the
        Secretary an animal drug application, a supplemental animal
        drug application, or an investigational animal drug submission,

      shall be assessed an annual fee established under subsection (b)
      of this section. The fee shall be paid on or before January 31 of
      each year. Each animal drug sponsor shall pay only one such fee
      each fiscal year.
    (b) Fee amounts
      Except as provided in subsection (a)(1) of this section and
    subsections (c), (d), (f), and (g) of this section, the fees
    required under subsection (a) of this section shall be established
    to generate fee revenue amounts as follows:
      (1) Total fee revenues for application and supplement fees
        The total fee revenues to be collected in animal drug
      application fees under subsection (a)(1)(A)(i) of this section
      and supplemental animal drug application fees under subsection
      (a)(1)(A)(ii) of this section shall be $1,250,000 in fiscal year
      2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal
      years 2006, 2007, and 2008.
      (2) Total fee revenues for product fees
        The total fee revenues to be collected in product fees under
      subsection (a)(2) of this section shall be $1,250,000 in fiscal
      year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in
      fiscal years 2006, 2007, and 2008.
      (3) Total fee revenues for establishment fees
        The total fee revenues to be collected in establishment fees
      under subsection (a)(3) of this section shall be $1,250,000 in
      fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000
      in fiscal years 2006, 2007, and 2008.
      (4) Total fee revenues for sponsor fees
        The total fee revenues to be collected in sponsor fees under
      subsection (a)(4) of this section shall be $1,250,000 in fiscal
      year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in
      fiscal years 2006, 2007, and 2008.
    (c) Adjustments
      (1) Inflation adjustment
        The revenues established in subsection (b) of this section
      shall be adjusted by the Secretary by notice, published in the
      Federal Register, for a fiscal year to reflect the greater of - 
          (A) the total percentage change that occurred in the Consumer
        Price Index for all urban consumers (all items; United States
        city average) for the 12-month period ending June 30 preceding
        the fiscal year for which fees are being established; or
          (B) the total percentage change for the previous fiscal year
        in basic pay under the General Schedule in accordance with
        section 5332 of title 5, as adjusted by any locality-based
        comparability payment pursuant to section 5304 of such title
        for Federal employees stationed in the District of Columbia.

      The adjustment made each fiscal year by this subsection will be
      added on a compounded basis to the sum of all adjustments made
      each fiscal year after fiscal year 2004 under this subsection.
      (2) Workload adjustment
        After the fee revenues are adjusted for inflation in accordance
      with paragraph (1), the fee revenues shall be further adjusted
      each fiscal year after fiscal year 2004 to reflect changes in
      review workload. With respect to such adjustment:
          (A) This adjustment shall be determined by the Secretary
        based on a weighted average of the change in the total number
        of animal drug applications, supplemental animal drug
        applications for which data with respect to safety or
        effectiveness are required, manufacturing supplemental animal
        drug applications, investigational animal drug study
        submissions, and investigational animal drug protocol
        submissions submitted to the Secretary. The Secretary shall
        publish in the Federal Register the fees resulting from this
        adjustment and the supporting methodologies.
          (B) Under no circumstances shall this workload adjustment
        result in fee revenues for a fiscal year that are less than the
        fee revenues for that fiscal year established in subsection (b)
        of this section, as adjusted for inflation under paragraph (1).
      (3) Final year adjustment
        For fiscal year 2008, the Secretary may further increase the
      fees to provide for up to 3 months of operating reserves of
      carryover user fees for the process for the review of animal drug
      applications for the first 3 months of fiscal year 2009. If the
      Food and Drug Administration has carryover balances for the
      process for the review of animal drug applications in excess of 3
      months of such operating reserves, then this adjustment will not
      be made. If this adjustment is necessary, then the rationale for
      the amount of the increase shall be contained in the annual
      notice setting fees for fiscal year 2008.
      (4) Annual fee setting
        The Secretary shall establish, 60 days before the start of each
      fiscal year beginning after September 30, 2003, for that fiscal
      year, animal drug application fees, supplemental animal drug
      application fees, animal drug sponsor fees, animal drug
      establishment fees, and animal drug product fees based on the
      revenue amounts established under subsection (b) of this section
      and the adjustments provided under this subsection.
      (5) Limit
        The total amount of fees charged, as adjusted under this
      subsection, for a fiscal year may not exceed the total costs for
      such fiscal year for the resources allocated for the process for
      the review of animal drug applications.
    (d) Fee waiver or reduction
      (1) In general
        The Secretary shall grant a waiver from or a reduction of 1 or
      more fees assessed under subsection (a) of this section where the
      Secretary finds that - 
          (A) the assessment of the fee would present a significant
        barrier to innovation because of limited resources available to
        such person or other circumstances,
          (B) the fees to be paid by such person will exceed the
        anticipated present and future costs incurred by the Secretary
        in conducting the process for the review of animal drug
        applications for such person,
          (C) the animal drug application or supplemental animal drug
        application is intended solely to provide for use of the animal
        drug in - 
            (i) a Type B medicated feed (as defined in section
          558.3(b)(3) of title 21, Code of Federal Regulations (or any
          successor regulation)) intended for use in the manufacture of
          Type C free-choice medicated feeds, or
            (ii) a Type C free-choice medicated feed (as defined in
          section 558.3(b)(4) of title 21, Code of Federal Regulations
          (or any successor regulation)),

          (D) the animal drug application or supplemental animal drug
        application is intended solely to provide for a minor use or
        minor species indication, or
          (E) the sponsor involved is a small business submitting its
        first animal drug application to the Secretary for review.
      (2) Use of standard costs
        In making the finding in paragraph (1)(B), the Secretary may
      use standard costs.
      (3) Rules for small businesses
        (A) Definition
          In paragraph (1)(E), the term "small business" means an
        entity that has fewer than 500 employees, including employees
        of affiliates.
        (B) Waiver of application fee
          The Secretary shall waive under paragraph (1)(E) the
        application fee for the first animal drug application that a
        small business or its affiliate submits to the Secretary for
        review. After a small business or its affiliate is granted such
        a waiver, the small business or its affiliate shall pay
        application fees for all subsequent animal drug applications
        and supplemental animal drug applications for which safety or
        effectiveness data are required in the same manner as an entity
        that does not qualify as a small business.
        (C) Certification
          The Secretary shall require any person who applies for a
        waiver under paragraph (1)(E) to certify their qualification
        for the waiver. The Secretary shall periodically publish in the
        Federal Register a list of persons making such certifications.
    (e) Effect of failure to pay fees
      An animal drug application or supplemental animal drug
    application submitted by a person subject to fees under subsection
    (a) of this section shall be considered incomplete and shall not be
    accepted for filing by the Secretary until all fees owed by such
    person have been paid. An investigational animal drug submission
    under section 379j-11(5)(B) of this title that is submitted by a
    person subject to fees under subsection (a) of this section shall
    be considered incomplete and shall not be accepted for review by
    the Secretary until all fees owed by such person have been paid.
    The Secretary may discontinue review of any animal drug
    application, supplemental animal drug application or
    investigational animal drug submission from a person if such person
    has not submitted for payment all fees owed under this section by
    30 days after the date upon which they are due.
    (f) Assessment of fees
      (1) Limitation
        Fees may not be assessed under subsection (a) of this section
      for a fiscal year beginning after fiscal year 2003 unless
      appropriations for salaries and expenses of the Food and Drug
      Administration for such fiscal year (excluding the amount of fees
      appropriated for such fiscal year) are equal to or greater than
      the amount of appropriations for the salaries and expenses of the
      Food and Drug Administration for the fiscal year 2003 (excluding
      the amount of fees appropriated for such fiscal year) multiplied
      by the adjustment factor applicable to the fiscal year involved.
      (2) Authority
        If the Secretary does not assess fees under subsection (a) of
      this section during any portion of a fiscal year because of
      paragraph (1) and if at a later date in such fiscal year the
      Secretary may assess such fees, the Secretary may assess and
      collect such fees, without any modification in the rate, for
      animal drug applications, supplemental animal drug applications,
      investigational animal drug submissions, animal drug sponsors,
      animal drug establishments and animal drug products at any time
      in such fiscal year notwithstanding the provisions of subsection
      (a) of this section relating to the date fees are to be paid.
    (g) Crediting and availability of fees
      (1) In general
        Fees authorized under subsection (a) of this section shall be
      collected and available for obligation only to the extent and in
      the amount provided in advance in appropriations Acts. Such fees
      are authorized to be appropriated to remain available until
      expended. Such sums as may be necessary may be transferred from
      the Food and Drug Administration salaries and expenses
      appropriation account without fiscal year limitation to such
      appropriation account for salary and expenses with such fiscal
      year limitation. The sums transferred shall be available solely
      for the process for the review of animal drug applications.
      (2) Collections and appropriation acts
        (A) In general
          The fees authorized by this section - 
            (i) shall be retained in each fiscal year in an amount not
          to exceed the amount specified in appropriation Acts, or
          otherwise made available for obligation for such fiscal year,
          and
            (ii) shall only be collected and available to defray
          increases in the costs of the resources allocated for the
          process for the review of animal drug applications (including
          increases in such costs for an additional number of full-time
          equivalent positions in the Department of Health and Human
          Services to be engaged in such process) over such costs,
          excluding costs paid from fees collected under this section,
          for fiscal year 2003 multiplied by the adjustment factor.
        (B) Compliance
          The Secretary shall be considered to have met the
        requirements of subparagraph (A)(ii) in any fiscal year if the
        costs funded by appropriations and allocated for the process
        for the review of animal drug applications - 
            (i) are not more than 3 percent below the level specified
          in subparagraph (A)(ii); or
            (ii)(I) are more than 3 percent below the level specified
          in subparagraph (A)(ii), and fees assessed for the fiscal
          year following the subsequent fiscal year are decreased by
          the amount in excess of 3 percent by which such costs fell
          below the level specified in subparagraph (A)(ii); and
            (II) such costs are not more than 5 percent below the level
          specified in subparagraph (A)(ii).
      (3) Authorization of appropriations
        There are authorized to be appropriated for fees under this
      section - 
          (A) $5,000,000 for fiscal year 2004;
          (B) $8,000,000 for fiscal year 2005;
          (C) $10,000,000 for fiscal year 2006;
          (D) $10,000,000 for fiscal year 2007; and
          (E) $10,000,000 for fiscal year 2008;

      as adjusted to reflect adjustments in the total fee revenues made
      under this section and changes in the total amounts collected by
      animal drug application fees, supplemental animal drug
      application fees, animal drug sponsor fees, animal drug
      establishment fees, and animal drug product fees.
      (4) Offset
        Any amount of fees collected for a fiscal year under this
      section that exceeds the amount of fees specified in
      appropriations Acts for such fiscal year shall be credited to the
      appropriation account of the Food and Drug Administration as
      provided in paragraph (1), and shall be subtracted from the
      amount of fees that would otherwise be authorized to be collected
      under this section pursuant to appropriation Acts for a
      subsequent fiscal year.
    (h) Collection of unpaid fees
      In any case where the Secretary does not receive payment of a fee
    assessed under subsection (a) of this section within 30 days after
    it is due, such fee shall be treated as a claim of the United
    States Government subject to subchapter II of chapter 37 of title
    31.
    (i) Written requests for waivers, reductions, and refunds
      To qualify for consideration for a waiver or reduction under
    subsection (d) of this section, or for a refund of any fee
    collected in accordance with subsection (a) of this section, a
    person shall submit to the Secretary a written request for such
    waiver, reduction, or refund not later than 180 days after such fee
    is due.
    (j) Construction
      This section may not be construed to require that the number of
    full-time equivalent positions in the Department of Health and
    Human Services, for officers, employees, and advisory committees
    not engaged in the process of the review of animal drug
    applications, be reduced to offset the number of officers,
    employees, and advisory committees so engaged.
    (k) Abbreviated new animal drug applications
      The Secretary shall - 
        (1) to the extent practicable, segregate the review of
      abbreviated new animal drug applications from the process for the
      review of animal drug applications, and
        (2) adopt other administrative procedures to ensure that review
      times of abbreviated new animal drug applications do not increase
      from their current level due to activities under the user fee
      program.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 740, as added Pub. L. 108-130, Sec.
    3, Nov. 18, 2003, 117 Stat. 1363.)


-STATAMEND-
                          TERMINATION OF SECTION                      
      For termination of section by section 5 of Pub. L. 108-130, see
    Termination Date note below.


-MISC1-
                             TERMINATION DATE                         
      Section not effective after Oct. 1, 2008, see section 5 of Pub.
    L. 108-130, set out as a note under section 379j-11 of this title.

-End-


-CITE-
    21 USC Part D - Information and Education                   01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part D - Information and Education

-HEAD-
                    PART D - INFORMATION AND EDUCATION                

-End-



-CITE-
    21 USC Sec. 379k                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part D - Information and Education

-HEAD-
    Sec. 379k. Information system

-STATUTE-
      The Secretary shall establish and maintain an information system
    to track the status and progress of each application or submission
    (including a petition, notification, or other similar form of
    request) submitted to the Food and Drug Administration requesting
    agency action.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 741, as added Pub. L. 105-115, title
    IV, Sec. 407(a), Nov. 21, 1997, 111 Stat. 2370.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

                        REPORT ON STATUS OF SYSTEM                    
      Section 407(b) of Pub. L. 105-115 provided that not later than 1
    year after Nov. 21, 1997, Secretary of Health and Human Services
    was to submit report to Congress on status of system to be
    established under this section, including projected costs of system
    and concerns about confidentiality.

-End-



-CITE-
    21 USC Sec. 379l                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part D - Information and Education

-HEAD-
    Sec. 379l. Education

-STATUTE-
    (a) In general
      The Secretary shall conduct training and education programs for
    the employees of the Food and Drug Administration relating to the
    regulatory responsibilities and policies established by this
    chapter, including programs for - 
        (1) scientific training;
        (2) training to improve the skill of officers and employees
      authorized to conduct inspections under section 374 of this
      title;
        (3) training to achieve product specialization in such
      inspections; and
        (4) training in administrative process and procedure and
      integrity issues.
    (b) Intramural fellowships and other training programs
      The Secretary, acting through the Commissioner, may, through
    fellowships and other training programs, conduct and support
    intramural research training for predoctoral and postdoctoral
    scientists and physicians.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 742, as added Pub. L. 105-115, title
    IV, Sec. 408(a), Nov. 21, 1997, 111 Stat. 2371.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-


-CITE-
    21 USC Part E - Environmental Impact Review                 01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part E - Environmental Impact Review

-HEAD-
                   PART E - ENVIRONMENTAL IMPACT REVIEW               

-End-



-CITE-
    21 USC Sec. 379o                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part E - Environmental Impact Review

-HEAD-
    Sec. 379o. Environmental impact

-STATUTE-
      Notwithstanding any other provision of law, an environmental
    impact statement prepared in accordance with the regulations
    published in part 25 of title 21, Code of Federal Regulations (as
    in effect on August 31, 1997) in connection with an action carried
    out under (or a recommendation or report relating to) this chapter,
    shall be considered to meet the requirements for a detailed
    statement under section 4332(2)(C) of title 42.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 746, as added Pub. L. 105-115, title
    IV, Sec. 411, Nov. 21, 1997, 111 Stat. 2373.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-


-CITE-
    21 USC Part F - National Uniformity for Nonprescription
                     Drugs and Preemption for Labeling
                     or Packaging of Cosmetics             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part F - National Uniformity for Nonprescription Drugs and
              Preemption for Labeling or Packaging of Cosmetics

-HEAD-
        PART F - NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
             PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS

-End-



-CITE-
    21 USC Sec. 379r                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part F - National Uniformity for Nonprescription Drugs and
              Preemption for Labeling or Packaging of Cosmetics

-HEAD-
    Sec. 379r. National uniformity for nonprescription drugs

-STATUTE-
    (a) In general
      Except as provided in subsection (b), (c)(1), (d), (e), or (f) of
    this section, no State or political subdivision of a State may
    establish or continue in effect any requirement - 
        (1) that relates to the regulation of a drug that is not
      subject to the requirements of section 353(b)(1) or 353(f)(1)(A)
      of this title; and
        (2) that is different from or in addition to, or that is
      otherwise not identical with, a requirement under this chapter,
      the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
      seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
      seq.).
    (b) Exemption
      (1) In general
        Upon application of a State or political subdivision thereof,
      the Secretary may by regulation, after notice and opportunity for
      written and oral presentation of views, exempt from subsection
      (a) of this section, under such conditions as may be prescribed
      in such regulation, a State or political subdivision requirement
      that - 
          (A) protects an important public interest that would
        otherwise be unprotected, including the health and safety of
        children;
          (B) would not cause any drug to be in violation of any
        applicable requirement or prohibition under Federal law; and
          (C) would not unduly burden interstate commerce.
      (2) Timely action
        The Secretary shall make a decision on the exemption of a State
      or political subdivision requirement under paragraph (1) not
      later than 120 days after receiving the application of the State
      or political subdivision under paragraph (1).
    (c) Scope
      (1) In general
        This section shall not apply to - 
          (A) any State or political subdivision requirement that
        relates to the practice of pharmacy; or
          (B) any State or political subdivision requirement that a
        drug be dispensed only upon the prescription of a practitioner
        licensed by law to administer such drug.
      (2) Safety or effectiveness
        For purposes of subsection (a) of this section, a requirement
      that relates to the regulation of a drug shall be deemed to
      include any requirement relating to public information or any
      other form of public communication relating to a warning of any
      kind for a drug.
    (d) Exceptions
      (1) In general
        In the case of a drug described in subsection (a)(1) of this
      section that is not the subject of an application approved under
      section 355 of this title or section 357 of this title (as in
      effect on the day before November 21, 1997) or a final regulation
      promulgated by the Secretary establishing conditions under which
      the drug is generally recognized as safe and effective and not
      misbranded, subsection (a) of this section shall apply only with
      respect to a requirement of a State or political subdivision of a
      State that relates to the same subject as, but is different from
      or in addition to, or that is otherwise not identical with - 
          (A) a regulation in effect with respect to the drug pursuant
        to a statute described in subsection (a)(2) of this section; or
          (B) any other requirement in effect with respect to the drug
        pursuant to an amendment to such a statute made on or after
        November 21, 1997.
      (2) State initiatives
        This section shall not apply to a State requirement adopted by
      a State public initiative or referendum enacted prior to
      September 1, 1997.
    (e) No effect on product liability law
      Nothing in this section shall be construed to modify or otherwise
    affect any action or the liability of any person under the product
    liability law of any State.
    (f) State enforcement authority
      Nothing in this section shall prevent a State or political
    subdivision thereof from enforcing, under any relevant civil or
    other enforcement authority, a requirement that is identical to a
    requirement of this chapter.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 751, as added Pub. L. 105-115, title
    IV, Sec. 412(a), Nov. 21, 1997, 111 Stat. 2373.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Poison Prevention Packaging Act of 1970, referred to in
    subsec. (a)(2), is Pub. L. 91-601, Dec. 30, 1970, 84 Stat. 1670, as
    amended, which is classified principally to chapter 39A (Sec. 1471
    et seq.) of Title 15, Commerce and Trade. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 1471 of Title 15 and Tables.
      The Fair Packaging and Labeling Act, referred to in subsec.
    (a)(2), is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended,
    which is classified generally to chapter 39 (Sec. 1451 et seq.) of
    Title 15, Commerce and Trade. For complete classification of this
    Act to the Code, see Short Title note set out under section 1451 of
    Title 15 and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 379s                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part F - National Uniformity for Nonprescription Drugs and
              Preemption for Labeling or Packaging of Cosmetics

-HEAD-
    Sec. 379s. Preemption for labeling or packaging of cosmetics

-STATUTE-
    (a) In general
      Except as provided in subsection (b), (d), or (e) of this
    section, no State or political subdivision of a State may establish
    or continue in effect any requirement for labeling or packaging of
    a cosmetic that is different from or in addition to, or that is
    otherwise not identical with, a requirement specifically applicable
    to a particular cosmetic or class of cosmetics under this chapter,
    the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et
    seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et
    seq.).
    (b) Exemption
      Upon application of a State or political subdivision thereof, the
    Secretary may by regulation, after notice and opportunity for
    written and oral presentation of views, exempt from subsection (a)
    of this section, under such conditions as may be prescribed in such
    regulation, a State or political subdivision requirement for
    labeling or packaging that - 
        (1) protects an important public interest that would otherwise
      be unprotected;
        (2) would not cause a cosmetic to be in violation of any
      applicable requirement or prohibition under Federal law; and
        (3) would not unduly burden interstate commerce.
    (c) Scope
      For purposes of subsection (a) of this section, a reference to a
    State requirement that relates to the packaging or labeling of a
    cosmetic means any specific requirement relating to the same aspect
    of such cosmetic as a requirement specifically applicable to that
    particular cosmetic or class of cosmetics under this chapter for
    packaging or labeling, including any State requirement relating to
    public information or any other form of public communication.
    (d) No effect on product liability law
      Nothing in this section shall be construed to modify or otherwise
    affect any action or the liability of any person under the product
    liability law of any State.
    (e) State initiative
      This section shall not apply to a State requirement adopted by a
    State public initiative or referendum enacted prior to September 1,
    1997.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 752, as added Pub. L. 105-115, title
    IV, Sec. 412(d), Nov. 21, 1997, 111 Stat. 2376.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Poison Prevention Packaging Act of 1970, referred to in
    subsec. (a), is Pub. L. 91-601, Dec. 30, 1970, 84 Stat. 1670, as
    amended, which is classified principally to chapter 39A (Sec. 1471
    et seq.) of Title 15, Commerce and Trade. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 1471 of Title 15 and Tables.
      The Fair Packaging and Labeling Act, referred to in subsec. (a),
    is Pub. L. 89-755, Nov. 3, 1966, 80 Stat. 1296, as amended, which
    is classified generally to chapter 39 (Sec. 1451 et seq.) of Title
    15, Commerce and Trade. For complete classification of this Act to
    the Code, see Short Title note set out under section 1451 of Title
    15 and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-


-CITE-
    21 USC Part G - Safety Reports                              01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part G - Safety Reports

-HEAD-
                          PART G - SAFETY REPORTS                      

-End-



-CITE-
    21 USC Sec. 379v                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part G - Safety Reports

-HEAD-
    Sec. 379v. Safety report disclaimers

-STATUTE-
      With respect to any entity that submits or is required to submit
    a safety report or other information in connection with the safety
    of a product (including a product that is a food, drug, device,
    dietary supplement, or cosmetic) under this chapter (and any
    release by the Secretary of that report or information), such
    report or information shall not be construed to reflect necessarily
    a conclusion by the entity or the Secretary that the report or
    information constitutes an admission that the product involved
    malfunctioned, caused or contributed to an adverse experience, or
    otherwise caused or contributed to a death, serious injury, or
    serious illness. Such an entity need not admit, and may deny, that
    the report or information submitted by the entity constitutes an
    admission that the product involved malfunctioned, caused or
    contributed to an adverse experience, or caused or contributed to a
    death, serious injury, or serious illness.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 756, as added Pub. L. 105-115, title
    IV, Sec. 420, Nov. 21, 1997, 111 Stat. 2379.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-


-CITE-
    21 USC Part H - Serious Adverse Event Reports               01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part H - Serious Adverse Event Reports

-HEAD-
                  PART H - SERIOUS ADVERSE EVENT REPORTS              

-End-



-CITE-
    21 USC Sec. 379aa                                           01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part H - Serious Adverse Event Reports

-HEAD-
    Sec. 379aa. Serious adverse event reporting for nonprescription
      drugs

-STATUTE-
    (a) Definitions
      In this section:
      (1) Adverse event
        The term "adverse event" means any health-related event
      associated with the use of a nonprescription drug that is
      adverse, including - 
          (A) an event occurring from an overdose of the drug, whether
        accidental or intentional;
          (B) an event occurring from abuse of the drug;
          (C) an event occurring from withdrawal from the drug; and
          (D) any failure of expected pharmacological action of the
        drug.
      (2) Nonprescription drug
        The term "nonprescription drug" means a drug that is - 
          (A) not subject to section 353(b) of this title; and
          (B) not subject to approval in an application submitted under
        section 355 of this title.
      (3) Serious adverse event
        The term "serious adverse event" is an adverse event that - 
          (A) results in - 
            (i) death;
            (ii) a life-threatening experience;
            (iii) inpatient hospitalization;
            (iv) a persistent or significant disability or incapacity;
          or
            (v) a congenital anomaly or birth defect; or

          (B) requires, based on reasonable medical judgment, a medical
        or surgical intervention to prevent an outcome described under
        subparagraph (A).
      (4) Serious adverse event report
        The term "serious adverse event report" means a report that is
      required to be submitted to the Secretary under subsection (b).
    (b) Reporting requirement
      (1) In general
        The manufacturer, packer, or distributor whose name (pursuant
      to section 352(b)(1) of this title) appears on the label of a
      nonprescription drug marketed in the United States (referred to
      in this section as the "responsible person") shall submit to the
      Secretary any report received of a serious adverse event
      associated with such drug when used in the United States,
      accompanied by a copy of the label on or within the retail
      package of such drug.
      (2) Retailer
        A retailer whose name appears on the label described in
      paragraph (1) as a distributor may, by agreement, authorize the
      manufacturer or packer of the nonprescription drug to submit the
      required reports for such drugs to the Secretary so long as the
      retailer directs to the manufacturer or packer all adverse events
      associated with such drug that are reported to the retailer
      through the address or telephone number described in section
      352(x) of this title.
    (c) Submission of reports
      (1) Timing of reports
        The responsible person shall submit to the Secretary a serious
      adverse event report no later than 15 business days after the
      report is received through the address or phone number described
      in section 352(x) of this title.
      (2) New medical information
        The responsible person shall submit to the Secretary any new
      medical information, related to a submitted serious adverse event
      report that is received by the responsible person within 1 year
      of the initial report, no later than 15 business days after the
      new information is received by the responsible person.
      (3) Consolidation of reports
        The Secretary shall develop systems to ensure that duplicate
      reports of, and new medical information related to, a serious
      adverse event shall be consolidated into a single report.
      (4) Exemption
        The Secretary, after providing notice and an opportunity for
      comment from interested parties, may establish an exemption to
      the requirements under paragraphs (1) and (2) if the Secretary
      determines that such exemption would have no adverse effect on
      public health.
    (d) Contents of reports
      Each serious adverse event report under this section shall be
    submitted to the Secretary using the MedWatch form, which may be
    modified by the Secretary for nonprescription drugs, and may be
    accompanied by additional information.
    (e) Maintenance and inspection of records
      (1) Maintenance
        The responsible person shall maintain records related to each
      report of an adverse event received by the responsible person for
      a period of 6 years.
      (2) Records inspection
        (A) In general
          The responsible person shall permit an authorized person to
        have access to records required to be maintained under this
        section, during an inspection pursuant to section 374 of this
        title.
        (B) Authorized person
          For purposes of this paragraph, the term "authorized person"
        means an officer or employee of the Department of Health and
        Human Services who has - 
            (i) appropriate credentials, as determined by the
          Secretary; and
            (ii) been duly designated by the Secretary to have access
          to the records required under this section.
    (f) Protected information
      A serious adverse event report submitted to the Secretary under
    this section, including any new medical information submitted under
    subsection (c)(2), or an adverse event report voluntarily submitted
    to the Secretary shall be considered to be - 
        (1) a safety report under section 379v of this title and may be
      accompanied by a statement, which shall be a part of any report
      that is released for public disclosure, that denies that the
      report or the records constitute an admission that the product
      involved caused or contributed to the adverse event; and
        (2) a record about an individual under section 552a of title 5
      (commonly referred to as the "Privacy Act of 1974") and a medical
      or similar file the disclosure of which would constitute a
      violation of section 552 of such title 5 (commonly referred to as
      the "Freedom of Information Act"), and shall not be publicly
      disclosed unless all personally identifiable information is
      redacted.
    (g) Rule of construction
      The submission of any adverse event report in compliance with
    this section shall not be construed as an admission that the
    nonprescription drug involved caused or contributed to the adverse
    event.
    (h) Preemption
      (1) In general
        No State or local government shall establish or continue in
      effect any law, regulation, order, or other requirement, related
      to a mandatory system for adverse event reports for
      nonprescription drugs, that is different from, in addition to, or
      otherwise not identical to, this section.
      (2) Effect of section
        (A) In general
          Nothing in this section shall affect the authority of the
        Secretary to provide adverse event reports and information to
        any health, food, or drug officer or employee of any State,
        territory, or political subdivision of a State or territory,
        under a memorandum of understanding between the Secretary and
        such State, territory, or political subdivision.
        (B) Personally-identifiable information
          Notwithstanding any other provision of law, personally-
        identifiable information in adverse event reports provided by
        the Secretary to any health, food, or drug officer or employee
        of any State, territory, or political subdivision of a State or
        territory, shall not - 
            (i) be made publicly available pursuant to any State or
          other law requiring disclosure of information or records; or
            (ii) otherwise be disclosed or distributed to any party
          without the written consent of the Secretary and the person
          submitting such information to the Secretary.
        (C) Use of safety reports
          Nothing in this section shall permit a State, territory, or
        political subdivision of a State or territory, to use any
        safety report received from the Secretary in a manner
        inconsistent with subsection (g) or section 379v of this title.
    (i) Authorization of appropriations
      There are authorized to be appropriated to carry out this section
    such sums as may be necessary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 760, as added Pub. L. 109-462, Sec.
    2(a), Dec. 22, 2006, 120 Stat. 3469.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 1 year after Dec. 22, 2006, see section 2(e)(1)
    of Pub. L. 109-462, set out as an Effective Date of 2006 Amendment
    note under section 352 of this title.

                               MODIFICATIONS                           
      Pub. L. 109-462, Sec. 2(b), Dec. 22, 2006, 120 Stat. 3472,
    provided that: "The Secretary of Health and Human Services may
    modify requirements under the amendments made by this section
    [enacting this section and amending sections 331 and 352 of this
    title] in accordance with section 553 of title 5, United States
    Code, to maintain consistency with international harmonization
    efforts over time."

                                 GUIDANCE                             
      Pub. L. 109-462, Sec. 2(e)(3), Dec. 22, 2006, 120 Stat. 3472,
    provided that: "Not later than 270 days after the date of enactment
    of this Act [Dec. 22, 2006], the Secretary of Health and Human
    Services shall issue guidance on the minimum data elements that
    should be included in a serious adverse event report described
    under the amendments made by this Act [see Short Title of 2006
    Amendment note set out under section 301 of this title]."
      Pub. L. 109-462, Sec. 3(d)(3), Dec. 22, 2006, 120 Stat. 3475,
    enacted provisions substantially identical to those enacted by Pub.
    L. 109-462, Sec. 2(b), set out above.

-End-



-CITE-
    21 USC Sec. 379aa-1                                         01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VII - GENERAL AUTHORITY
    Part H - Serious Adverse Event Reports

-HEAD-
    Sec. 379aa-1. Serious adverse event reporting for dietary
      supplements

-STATUTE-
    (a) Definitions
      In this section:
      (1) Adverse event
        The term "adverse event" means any health-related event
      associated with the use of a dietary supplement that is adverse.
      (2) Serious adverse event
        The term "serious adverse event" is an adverse event that - 
          (A) results in - 
            (i) death;
            (ii) a life-threatening experience;
            (iii) inpatient hospitalization;
            (iv) a persistent or significant disability or incapacity;
          or
            (v) a congenital anomaly or birth defect; or

          (B) requires, based on reasonable medical judgment, a medical
        or surgical intervention to prevent an outcome described under
        subparagraph (A).
      (3) Serious adverse event report
        The term "serious adverse event report" means a report that is
      required to be submitted to the Secretary under subsection (b).
    (b) Reporting requirement
      (1) In general
        The manufacturer, packer, or distributor of a dietary
      supplement whose name (pursuant to section 343(e)(1) of this
      title) appears on the label of a dietary supplement marketed in
      the United States (referred to in this section as the
      "responsible person") shall submit to the Secretary any report
      received of a serious adverse event associated with such dietary
      supplement when used in the United States, accompanied by a copy
      of the label on or within the retail packaging of such dietary
      supplement.
      (2) Retailer
        A retailer whose name appears on the label described in
      paragraph (1) as a distributor may, by agreement, authorize the
      manufacturer or packer of the dietary supplement to submit the
      required reports for such dietary supplements to the Secretary so
      long as the retailer directs to the manufacturer or packer all
      adverse events associated with such dietary supplement that are
      reported to the retailer through the address or telephone number
      described in section 343(y) of this title.
    (c) Submission of reports
      (1) Timing of reports
        The responsible person shall submit to the Secretary a serious
      adverse event report no later than 15 business days after the
      report is received through the address or phone number described
      in section 343(y) of this title.
      (2) New medical information
        The responsible person shall submit to the Secretary any new
      medical information, related to a submitted serious adverse event
      report that is received by the responsible person within 1 year
      of the initial report, no later than 15 business days after the
      new information is received by the responsible person.
      (3) Consolidation of reports
        The Secretary shall develop systems to ensure that duplicate
      reports of, and new medical information related to, a serious
      adverse event shall be consolidated into a single report.
      (4) Exemption
        The Secretary, after providing notice and an opportunity for
      comment from interested parties, may establish an exemption to
      the requirements under paragraphs (1) and (2) if the Secretary
      determines that such exemption would have no adverse effect on
      public health.
    (d) Contents of reports
      Each serious adverse event report under this section shall be
    submitted to the Secretary using the MedWatch form, which may be
    modified by the Secretary for dietary supplements, and may be
    accompanied by additional information.
    (e) Maintenance and inspection of records
      (1) Maintenance
        The responsible person shall maintain records related to each
      report of an adverse event received by the responsible person for
      a period of 6 years.
      (2) Records inspection
        (A) In general
          The responsible person shall permit an authorized person to
        have access to records required to be maintained under this
        section during an inspection pursuant to section 374 of this
        title.
        (B) Authorized person
          For purposes of this paragraph, the term "authorized person"
        means an officer or employee of the Department of Health and
        Human Services, who has - 
            (i) appropriate credentials, as determined by the
          Secretary; and
            (ii) been duly designated by the Secretary to have access
          to the records required under this section.
    (f) Protected information
      A serious adverse event report submitted to the Secretary under
    this section, including any new medical information submitted under
    subsection (c)(2), or an adverse event report voluntarily submitted
    to the Secretary shall be considered to be - 
        (1) a safety report under section 379v of this title and may be
      accompanied by a statement, which shall be a part of any report
      that is released for public disclosure, that denies that the
      report or the records constitute an admission that the product
      involved caused or contributed to the adverse event; and
        (2) a record about an individual under section 552a of title 5
      (commonly referred to as the "Privacy Act of 1974") and a medical
      or similar file the disclosure of which would constitute a
      violation of section 552 of such title 5 (commonly referred to as
      the "Freedom of Information Act"), and shall not be publicly
      disclosed unless all personally identifiable information is
      redacted.
    (g) Rule of construction
      The submission of any adverse event report in compliance with
    this section shall not be construed as an admission that the
    dietary supplement involved caused or contributed to the adverse
    event.
    (h) Preemption
      (1) In general
        No State or local government shall establish or continue in
      effect any law, regulation, order, or other requirement, related
      to a mandatory system for adverse event reports for dietary
      supplements, that is different from, in addition to, or otherwise
      not identical to, this section.
      (2) Effect of section
        (A) In general
          Nothing in this section shall affect the authority of the
        Secretary to provide adverse event reports and information to
        any health, food, or drug officer or employee of any State,
        territory, or political subdivision of a State or territory,
        under a memorandum of understanding between the Secretary and
        such State, territory, or political subdivision.
        (B) Personally-identifiable information
          Notwithstanding any other provision of law, personally-
        identifiable information in adverse event reports provided by
        the Secretary to any health, food, or drug officer or employee
        of any State, territory, or political subdivision of a State or
        territory, shall not - 
            (i) be made publicly available pursuant to any State or
          other law requiring disclosure of information or records; or
            (ii) otherwise be disclosed or distributed to any party
          without the written consent of the Secretary and the person
          submitting such information to the Secretary.
        (C) Use of safety reports
          Nothing in this section shall permit a State, territory, or
        political subdivision of a State or territory, to use any
        safety report received from the Secretary in a manner
        inconsistent with subsection (g) or section 379v of this title.
    (i) Authorization of appropriations
      There are authorized to be appropriated to carry out this section
    such sums as may be necessary.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 761, as added Pub. L. 109-462, Sec.
    3(a), Dec. 22, 2006, 120 Stat. 3472.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 1 year after Dec. 22, 2006, see section 3(d)(1)
    of Pub. L. 109-462, set out as an Effective Date of 2006 Amendment
    note under section 343 of this title.

-End-


-CITE-
    21 USC SUBCHAPTER VIII - IMPORTS AND EXPORTS                01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
                   SUBCHAPTER VIII - IMPORTS AND EXPORTS               

-End-



-CITE-
    21 USC Sec. 381                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
    Sec. 381. Imports and exports

-STATUTE-
    (a) Imports; list of registered foreign establishments; samples
      from unregistered foreign establishments; examination and refusal
      of admission
      The Secretary of the Treasury shall deliver to the Secretary of
    Health and Human Services, upon his request, samples of food,
    drugs, devices, and cosmetics which are being imported or offered
    for import into the United States, giving notice thereof to the
    owner or consignee, who may appear before the Secretary of Health
    and Human Services and have the right to introduce testimony. The
    Secretary of Health and Human Services shall furnish to the
    Secretary of the Treasury a list of establishments registered
    pursuant to subsection (i) of section 360 of this title and shall
    request that if any drugs and devices manufactured, prepared,
    propagated, compounded, or processed in an establishment not so
    registered are imported or offered for import into the United
    States, samples of such drugs and devices be delivered to the
    Secretary of Health and Human Services, with notice of such
    delivery to the owner or consignee, who may appear before the
    Secretary of Health and Human Services and have the right to
    introduce testimony. If it appears from the examination of such
    samples or otherwise that (1) such article has been manufactured,
    processed, or packed under insanitary conditions or, in the case of
    a device, the methods used in, or the facilities or controls used
    for, the manufacture, packing, storage, or installation of the
    device do not conform to the requirements of section 360j(f) of
    this title, or (2) such article is forbidden or restricted in sale
    in the country in which it was produced or from which it was
    exported, or (3) such article is adulterated, misbranded, or in
    violation of section 355 of this title, then such article shall be
    refused admission, except as provided in subsection (b) of this
    section. If such article is subject to a requirement under section
    379aa or 379aa-1 of this title and if the Secretary has credible
    evidence or information indicating that the responsible person (as
    defined in such section 379aa or 379aa-1 of this title) has not
    complied with a requirement of such section 379aa or 379aa-1 of
    this title with respect to any such article, or has not allowed
    access to records described in such section 379aa or 379aa-1 of
    this title, then such article shall be refused admission, except as
    provided in subsection (b) of this section. The Secretary of the
    Treasury shall cause the destruction of any such article refused
    admission unless such article is exported, under regulations
    prescribed by the Secretary of the Treasury, within ninety days of
    the date of notice of such refusal or within such additional time
    as may be permitted pursuant to such regulations. Clause (2) of the
    third sentence of this paragraph (!1) shall not be construed to
    prohibit the admission of narcotic drugs the importation of which
    is permitted under the Controlled Substances Import and Export Act
    [21 U.S.C. 951 et seq.].

    (b) Disposition of refused articles
      Pending decision as to the admission of an article being imported
    or offered for import, the Secretary of the Treasury may authorize
    delivery of such article to the owner or consignee upon the
    execution by him of a good and sufficient bond providing for the
    payment of such liquidated damages in the event of default as may
    be required pursuant to regulations of the Secretary of the
    Treasury. If it appears to the Secretary of Health and Human
    Services that (1) an article included within the provisions of
    clause (3) of subsection (a) of this section can, by relabeling or
    other action, be brought into compliance with this chapter or
    rendered other than a food, drug, device, or cosmetic, or (2) with
    respect to an article included within the provision of the fourth
    sentence of subsection (a), the responsible person (as defined in
    section 379aa or 379aa-1 of this title) can take action that would
    assure that the responsible person is in compliance with section
    379aa or 379aa-1 of this title, as the case may be, final
    determination as to admission of such article may be deferred and,
    upon filing of timely written application by the owner or consignee
    and the execution by him of a bond as provided in the preceding
    provisions of this subsection, the Secretary may, in accordance
    with regulations, authorize the applicant, or, with respect to
    clause (2), the responsible person, to perform such relabeling or
    other action specified in such authorization (including destruction
    or export of rejected articles or portions thereof, as may be
    specified in the Secretary's authorization). All such relabeling or
    other action pursuant to such authorization shall in accordance
    with regulations be under the supervision of an officer or employee
    of the Department of Health and Human Services designated by the
    Secretary, or an officer or employee of the Department of the
    Treasury designated by the Secretary of the Treasury.
    (c) Charges concerning refused articles
      All expenses (including travel, per diem or subsistence, and
    salaries of officers or employees of the United States) in
    connection with the destruction provided for in subsection (a) of
    this section and the supervision of the relabeling or other action
    authorized under the provisions of subsection (b) of this section,
    the amount of such expenses to be determined in accordance with
    regulations, and all expenses in connection with the storage,
    cartage, or labor with respect to any article refused admission
    under subsection (a) of this section, shall be paid by the owner or
    consignee and, in default of such payment, shall constitute a lien
    against any future importations made by such owner or consignee.
    (d) Reimportation
      (1) Except as provided in paragraph (2) and section 384 of this
    title, no drug subject to section 353(b) of this title or composed
    wholly or partly of insulin which is manufactured in a State and
    exported may be imported into the United States unless the drug is
    imported by the manufacturer of the drug.
      (2) The Secretary may authorize the importation of a drug the
    importation of which is prohibited by paragraph (1) if the drug is
    required for emergency medical care.
      (3)(A) Subject to subparagraph (B), no component of a drug, no
    component part or accessory of a device, or other article of device
    requiring further processing, which is ready or suitable for use
    for health-related purposes, and no article of a food additive,
    color additive, or dietary supplement, including a product in bulk
    form, shall be excluded from importation into the United States
    under subsection (a) of this section if each of the following
    conditions is met:
        (i) The importer of such article of a drug or device or
      importer of such article of a food additive, color additive, or
      dietary supplement submits to the Secretary, at the time of
      initial importation, a statement in accordance with the
      following:
          (I) Such statement provides that such article is intended to
        be further processed by the initial owner or consignee, or
        incorporated by the initial owner or consignee, into a drug,
        biological product, device, food, food additive, color
        additive, or dietary supplement that will be exported by the
        initial owner or consignee from the United States in accordance
        with subsection (e) of this section or section 382 of this
        title, or with section 262(h) of title 42.
          (II) The statement identifies the manufacturer of such
        article and each processor, packer, distributor, or other
        entity that had possession of the article in the chain of
        possession of the article from the manufacturer to such
        importer of the article.
          (III) The statement is accompanied by such certificates of
        analysis as are necessary to identify such article, unless the
        article is a device or is an article described in paragraph
        (4).

        (ii) At the time of initial importation and before the delivery
      of such article to the importer or the initial owner or
      consignee, such owner or consignee executes a good and sufficient
      bond providing for the payment of such liquidated damages in the
      event of default as may be required pursuant to regulations of
      the Secretary of the Treasury.
        (iii) Such article is used and exported by the initial owner or
      consignee in accordance with the intent described under clause
      (i)(I), except for any portions of the article that are
      destroyed.
        (iv) The initial owner or consignee maintains records on the
      use or destruction of such article or portions thereof, as the
      case may be, and submits to the Secretary any such records
      requested by the Secretary.
        (v) Upon request of the Secretary, the initial owner or
      consignee submits a report that provides an accounting of the
      exportation or destruction of such article or portions thereof,
      and the manner in which such owner or consignee complied with the
      requirements of this subparagraph.

      (B) Notwithstanding subparagraph (A), the Secretary may refuse
    admission to an article that otherwise would be imported into the
    United States under such subparagraph if the Secretary determines
    that there is credible evidence or information indicating that such
    article is not intended to be further processed by the initial
    owner or consignee, or incorporated by the initial owner or
    consignee, into a drug, biological product, device, food, food
    additive, color additive, or dietary supplement that will be
    exported by the initial owner or consignee from the United States
    in accordance with subsection (e) of this section or section 382 of
    this title, or with section 262(h) of title 42.
      (C) This section may not be construed as affecting the
    responsibility of the Secretary to ensure that articles imported
    into the United States under authority of subparagraph (A) meet
    each of the conditions established in such subparagraph for
    importation.
      (4) The importation into the United States of blood, blood
    components, source plasma, or source leukocytes or of a component,
    accessory, or part thereof is not permitted pursuant to paragraph
    (3) unless the importation complies with section 262(a) of title 42
    or the Secretary permits the importation under appropriate
    circumstances and conditions, as determined by the Secretary. The
    importation of tissue or a component or part of tissue is not
    permitted pursuant to paragraph (3) unless the importation complies
    with section 264 of title 42.
    (e) Exports
      (1) A food, drug, device, or cosmetic intended for export shall
    not be deemed to be adulterated or misbranded under this chapter if
    it - 
        (A) accords to the specifications of the foreign purchaser,
        (B) is not in conflict with the laws of the country to which it
      is intended for export,
        (C) is labeled on the outside of the shipping package that it
      is intended for export, and
        (D) is not sold or offered for sale in domestic commerce.

      (2) Paragraph (1) does not apply to any device - 
        (A) which does not comply with an applicable requirement of
      section 360d or 360e of this title,
        (B) which under section 360j(g) of this title is exempt from
      either such section, or
        (C) which is a banned device under section 360f of this title,

    unless, in addition to the requirements of paragraph (1), either
    (i) the Secretary has determined that the exportation of the device
    is not contrary to public health and safety and has the approval of
    the country to which it is intended for export or (ii) the device
    is eligible for export under section 382 of this title.
      (3) A new animal drug that requires approval under section 360b
    of this title shall not be exported pursuant to paragraph (1) if
    such drug has been banned in the United States.
      (4)(A) Any person who exports a drug, animal drug, or device may
    request that the Secretary - 
        (i) certify in writing that the exported drug, animal drug, or
      device meets the requirements of paragraph (1) or section 382 of
      this title; or
        (ii) certify in writing that the drug, animal drug, or device
      being exported meets the applicable requirements of this chapter
      upon a showing that the drug or device meets the applicable
      requirements of this chapter.

    The Secretary shall issue such a certification within 20 days of
    the receipt of a request for such certification.
      (B) If the Secretary issues a written export certification within
    the 20 days prescribed by subparagraph (A), a fee for such
    certification may be charged but shall not exceed $175 for each
    certification. Fees collected for a fiscal year pursuant to this
    subparagraph shall be credited to the appropriation account for
    salaries and expenses of the Food and Drug Administration and shall
    be available in accordance with appropriations Acts until expended
    without fiscal year limitation. Such fees shall be collected in
    each fiscal year in an amount equal to the amount specified in
    appropriations Acts for such fiscal year and shall only be
    collected and available for the costs of the Food and Drug
    Administration.
    (f) Labeling of exported drugs
      (1) If a drug (other than insulin, an antibiotic drug, an animal
    drug, or a drug exported under section 382 of this title) being
    exported in accordance with subsection (e) of this section is being
    exported to a country that has different or additional labeling
    requirements or conditions for use and such country requires the
    drug to be labeled in accordance with those requirements or uses,
    such drug may be labeled in accordance with such requirements and
    conditions for use in the country to which such drug is being
    exported if it also is labeled in accordance with the requirements
    of this chapter.
      (2) If, pursuant to paragraph (1), the labeling of an exported
    drug includes conditions for use that have not been approved under
    this chapter, the labeling must state that such conditions for use
    have not been approved under this chapter. A drug exported under
    section 382 of this title is exempt from this section.
    (g) Warning notice of importation in violation of chapter
      (1) With respect to a prescription drug being imported or offered
    for import into the United States, the Secretary, in the case of an
    individual who is not in the business of such importations, may not
    send a warning notice to the individual unless the following
    conditions are met:
        (A) The notice specifies, as applicable to the importation of
      the drug, that the Secretary has made a determination that - 
          (i) importation is in violation of subsection (a) of this
        section because the drug is or appears to be adulterated,
        misbranded, or in violation of section 355 of this title;
          (ii) importation is in violation of subsection (a) of this
        section because the drug is or appears to be forbidden or
        restricted in sale in the country in which it was produced or
        from which it was exported;
          (iii) importation is or appears to be in violation of
        subsection (d)(1) of this section; or
          (iv) importation otherwise is or appears to be in violation
        of Federal law.

        (B) The notice does not specify any provision described in
      subparagraph (A) that is not applicable to the importation of the
      drug.
        (C) The notice states the reasons underlying such determination
      by the Secretary, including a brief application to the principal
      facts involved of the provision of law described in subparagraph
      (A) that is the basis of the determination by the Secretary.

      (2) For purposes of this section, the term "warning notice", with
    respect to the importation of a drug, means a communication from
    the Secretary (written or otherwise) notifying a person, or clearly
    suggesting to the person, that importing the drug for personal use
    is, or appears to be, a violation of this chapter.
    (h) Protection against adulteration of food
      (1) The Secretary shall give high priority to increasing the
    number of inspections under this section for the purpose of
    enabling the Secretary to inspect food offered for import at ports
    of entry into the United States, with the greatest priority given
    to inspections to detect the intentional adulteration of food.
      (2) The Secretary shall give high priority to making necessary
    improvements to the information management systems of the Food and
    Drug Administration that contain information related to foods
    imported or offered for import into the United States for purposes
    of improving the ability of the Secretary to allocate resources,
    detect the intentional adulteration of food, and facilitate the
    importation of food that is in compliance with this chapter.
      (3) The Secretary shall improve linkages with other regulatory
    agencies of the Federal Government that share responsibility for
    food safety, and shall with respect to such safety improve linkages
    with the States and Indian tribes (as defined in section 450b(e) of
    title 25).
    (i) Testing for rapid detection of adulteration of food
      (1) For use in inspections of food under this section, the
    Secretary shall provide for research on the development of tests
    and sampling methodologies - 
        (A) whose purpose is to test food in order to rapidly detect
      the adulteration of the food, with the greatest priority given to
      detect the intentional adulteration of food; and
        (B) whose results offer significant improvements over the
      available technology in terms of accuracy, timing, or costs.

      (2) In providing for research under paragraph (1), the Secretary
    shall give priority to conducting research on the development of
    tests that are suitable for inspections of food at ports of entry
    into the United States.
      (3) In providing for research under paragraph (1), the Secretary
    shall as appropriate coordinate with the Director of the Centers
    for Disease Control and Prevention, the Director of the National
    Institutes of Health, the Administrator of the Environmental
    Protection Agency, and the Secretary of Agriculture.
      (4) The Secretary shall annually submit to the Committee on
    Energy and Commerce of the House of Representatives, and the
    Committee on Health, Education, Labor, and Pensions of the Senate,
    a report describing the progress made in research under paragraph
    (1), including progress regarding paragraph (2).
    (j) Temporary holds at ports of entry
      (1) If an officer or qualified employee of the Food and Drug
    Administration has credible evidence or information indicating that
    an article of food presents a threat of serious adverse health
    consequences or death to humans or animals, and such officer or
    qualified employee is unable to inspect, examine, or investigate
    such article upon the article being offered for import at a port of
    entry into the United States, the officer or qualified employee
    shall request the Secretary of Treasury to hold the food at the
    port of entry for a reasonable period of time, not to exceed 24
    hours, for the purpose of enabling the Secretary to inspect,
    examine, or investigate the article as appropriate.
      (2) The Secretary shall request the Secretary of Treasury to
    remove an article held pursuant to paragraph (1) to a secure
    facility, as appropriate. During the period of time that such
    article is so held, the article shall not be transferred by any
    person from the port of entry into the United States for the
    article, or from the secure facility to which the article has been
    removed, as the case may be. Subsection (b) of this section does
    not authorize the delivery of the article pursuant to the execution
    of a bond while the article is so held.
      (3) An officer or qualified employee of the Food and Drug
    Administration may make a request under paragraph (1) only if the
    Secretary or an official designated by the Secretary approves the
    request. An official may not be so designated unless the official
    is the director of the district under this chapter in which the
    article involved is located, or is an official senior to such
    director.
      (4) With respect to an article of food for which a request under
    paragraph (1) is made, the Secretary, promptly after the request is
    made, shall notify the State in which the port of entry involved is
    located that the request has been made, and as applicable, that
    such article is being held under this subsection.
    (k) Importation by debarred persons
      (1) If an article of food is being imported or offered for import
    into the United States, and the importer, owner, or consignee of
    the article is a person who has been debarred under section
    335a(b)(3) of this title, such article shall be held at the port of
    entry for the article, and may not be delivered to such person.
    Subsection (b) of this section does not authorize the delivery of
    the article pursuant to the execution of a bond while the article
    is so held. The article shall be removed to a secure facility, as
    appropriate. During the period of time that such article is so
    held, the article shall not be transferred by any person from the
    port of entry into the United States for the article, or from the
    secure facility to which the article has been removed, as the case
    may be.
      (2) An article of food held under paragraph (1) may be delivered
    to a person who is not a debarred person under section 335a(b)(3)
    of this title if such person affirmatively establishes, at the
    expense of the person, that the article complies with the
    requirements of this chapter, as determined by the Secretary.
    (l) Failure to register
      (1) (!2) If an article of food is being imported or offered for
    import into the United States, and such article is from a foreign
    facility for which a registration has not been submitted to the
    Secretary under section 350d of this title, such article shall be
    held at the port of entry for the article, and may not be delivered
    to the importer, owner, or consignee of the article, until the
    foreign facility is so registered. Subsection (b) of this section
    does not authorize the delivery of the article pursuant to the
    execution of a bond while the article is so held. The article shall
    be removed to a secure facility, as appropriate. During the period
    of time that such article is so held, the article shall not be
    transferred by any person from the port of entry into the United
    States for the article, or from the secure facility to which the
    article has been removed, as the case may be.

    (m) Prior notice of imported food shipments
      (1) In the case of an article of food that is being imported or
    offered for import into the United States, the Secretary, after
    consultation with the Secretary of the Treasury, shall by
    regulation require, for the purpose of enabling such article to be
    inspected at ports of entry into the United States, the submission
    to the Secretary of a notice providing the identity of each of the
    following: The article; the manufacturer and shipper of the
    article; if known within the specified period of time that notice
    is required to be provided, the grower of the article; the country
    from which the article originates; the country from which the
    article is shipped; and the anticipated port of entry for the
    article. An article of food imported or offered for import without
    submission of such notice in accordance with the requirements under
    this paragraph shall be refused admission into the United States.
    Nothing in this section may be construed as a limitation on the
    port of entry for an article of food.
      (2)(A) Regulations under paragraph (1) shall require that a
    notice under such paragraph be provided by a specified period of
    time in advance of the time of the importation of the article of
    food involved or the offering of the food for import, which period
    shall be no less than the minimum amount of time necessary for the
    Secretary to receive, review, and appropriately respond to such
    notification, but may not exceed five days. In determining the
    specified period of time required under this subparagraph, the
    Secretary may consider, but is not limited to consideration of, the
    effect on commerce of such period of time, the locations of the
    various ports of entry into the United States, the various modes of
    transportation, the types of food imported into the United States,
    and any other such consideration. Nothing in the preceding sentence
    may be construed as a limitation on the obligation of the Secretary
    to receive, review, and appropriately respond to any notice under
    paragraph (1).
      (B)(i) If an article of food is being imported or offered for
    import into the United States and a notice under paragraph (1) is
    not provided in advance in accordance with the requirements under
    paragraph (1), such article shall be held at the port of entry for
    the article, and may not be delivered to the importer, owner, or
    consignee of the article, until such notice is submitted to the
    Secretary, and the Secretary examines the notice and determines
    that the notice is in accordance with the requirements under
    paragraph (1). Subsection (b) of this section does not authorize
    the delivery of the article pursuant to the execution of a bond
    while the article is so held. The article shall be removed to a
    secure facility, as appropriate. During the period of time that
    such article is so held, the article shall not be transferred by
    any person from the port of entry into the United States for the
    article, or from the secure facility to which the article has been
    removed, as the case may be.
      (ii) In carrying out clause (i) with respect to an article of
    food, the Secretary shall determine whether there is in the
    possession of the Secretary any credible evidence or information
    indicating that such article presents a threat of serious adverse
    health consequences or death to humans or animals.
      (3)(A) This subsection may not be construed as limiting the
    authority of the Secretary to obtain information under any other
    provision of this chapter.
      (B) This subsection may not be construed as authorizing the
    Secretary to impose any requirements with respect to a food to the
    extent that it is within the exclusive jurisdiction of the
    Secretary of Agriculture pursuant to the Federal Meat Inspection
    Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act
    (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21
    U.S.C. 1031 et seq.).
    (n) Labeling of food refused admission
      (1) If a food has been refused admission under subsection (a) of
    this section, other than such a food that is required to be
    destroyed, the Secretary may require the owner or consignee of the
    food to affix to the container of the food a label that clearly and
    conspicuously bears the statement: "UNITED STATES: REFUSED ENTRY".
      (2) All expenses in connection with affixing a label under
    paragraph (1) shall be paid by the owner or consignee of the food
    involved, and in default of such payment, shall constitute a lien
    against future importations made by such owner or consignee.
      (3) A requirement under paragraph (1) remains in effect until the
    Secretary determines that the food involved has been brought into
    compliance with this chapter.
    (o) Registration statement
      If an article that is a drug or device is being imported or
    offered for import into the United States, and the importer, owner,
    or consignee of such article does not, at the time of offering the
    article for import, submit to the Secretary a statement that
    identifies the registration under section 360(i) of this title of
    each establishment that with respect to such article is required
    under such section to register with the Secretary, the article may
    be refused admission. If the article is refused admission for
    failure to submit such a statement, the article shall be held at
    the port of entry for the article, and may not be delivered to the
    importer, owner, or consignee of the article, until such a
    statement is submitted to the Secretary. Subsection (b) of this
    section does not authorize the delivery of the article pursuant to
    the execution of a bond while the article is so held. The article
    shall be removed to a secure facility, as appropriate. During the
    period of time that such article is so held, the article shall not
    be transferred by any person from the port of entry into the United
    States for the article, or from the secure facility to which the
    article has been removed, as the case may be.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 801, 52 Stat. 1058; Oct. 18, 1949,
    ch. 696, Secs. 1-3, 63 Stat. 882; Pub. L. 87-781, title III, Sec.
    306, Oct. 10, 1962, 76 Stat. 796; Pub. L. 90-399, Sec. 106, July
    13, 1968, 82 Stat. 353; Pub. L. 91-513, title II, Sec. 701(h), Oct.
    27, 1970, 84 Stat. 1282; Pub. L. 94-295, Secs. 3(f), 4(b)(3), May
    28, 1976, 90 Stat. 578, 580; Pub. L. 100-293, Sec. 3, Apr. 22,
    1988, 102 Stat. 96; Pub. L. 102-300, Sec. 6(b)(1), June 16, 1992,
    106 Stat. 240; Pub. L. 102-353, Sec. 5, Aug. 26, 1992, 106 Stat.
    943; Pub. L. 103-80, Sec. 3(cc), (dd)(1), Aug. 13, 1993, 107 Stat.
    778, 779; Pub. L. 104-134, title II, Sec. 2102(a)-(c), Apr. 26,
    1996, 110 Stat. 1321-313, 1321-314; Pub. L. 104-180, title VI, Sec.
    603(a), (b), Aug. 6, 1996, 110 Stat. 1594, 1595; Pub. L. 105-115,
    title I, Sec. 125(a)(2)(D), Nov. 21, 1997, 111 Stat. 2325; Pub. L.
    106-387, Sec. 1(a) [title VII, Secs. 745(c)(1), 746(c)], Oct. 28,
    2000, 114 Stat. 1549, 1549A-36, 1549A-40; Pub. L. 107-188, title
    III, Secs. 302(a)-(d), 303(c), 304(e), 305(c), 307(a), 308(a),
    321(b)(1), 322(a), June 12, 2002, 116 Stat. 662, 663, 665, 667,
    668, 670, 672, 676; Pub. L. 109-462, Sec. 5(a), Dec. 22, 2006, 120
    Stat. 3475.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Controlled Substances Import and Export Act, referred to in
    subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84
    Stat. 1285, as amended, which is classified principally to
    subchapter II (Sec. 951 et seq.) of chapter 13 of this title. For
    complete classification of this Act to the Code, see Short Title
    note set out under section 951 of this title and Tables.
      The Federal Meat Inspection Act, referred to in subsec.
    (m)(3)(B), is titles I to IV of act Mar. 4, 1907, ch. 2907, as
    added Pub. L. 90-201, Dec. 15, 1967, 81 Stat. 584, and amended,
    which are classified generally to subchapters I to IV (Sec. 601 et
    seq.) of chapter 12 of this title. For complete classification of
    this Act to the Code, see Short Title note set out under section
    601 of this title and Tables.
      The Poultry Products Inspection Act, referred to in subsec.
    (m)(3)(B), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as
    amended, which is classified generally to chapter 10 (Sec. 451 et
    seq.) of this title. For complete classification of this Act to the
    Code, see Short Title note set out under section 451 of this title
    and Tables.
      The Egg Products Inspection Act, referred to in subsec.
    (m)(3)(B), is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as
    amended, which is classified generally to chapter 15 (Sec. 1031 et
    seq.) of this title. For complete classification of this Act to the
    Code, see Short Title note set out under section 1031 of this title
    and Tables.


-MISC1-
                                AMENDMENTS                            
      2006 - Subsec. (a). Pub. L. 109-462, Sec. 5(a)(1), inserted after
    third sentence "If such article is subject to a requirement under
    section 379aa or 379aa-1 of this title and if the Secretary has
    credible evidence or information indicating that the responsible
    person (as defined in such section 379aa or 379aa-1 of this title)
    has not complied with a requirement of such section 379aa or 379aa-
    1 of this title with respect to any such article, or has not
    allowed access to records described in such section 379aa or 379aa-
    1 of this title, then such article shall be refused admission,
    except as provided in subsection (b) of this section."
      Subsec. (b). Pub. L. 109-462, Sec. 5(a)(2), in second sentence,
    inserted "(1)" before "an article included", "or (2) with respect
    to an article included within the provision of the fourth sentence
    of subsection (a), the responsible person (as defined in section
    379aa or 379aa-1 of this title) can take action that would assure
    that the responsible person is in compliance with section 379aa or
    379aa-1 of this title, as the case may be," before "final
    determination", and ", or, with respect to clause (2), the
    responsible person," before "to perform".
      2002 - Subsec. (d)(3). Pub. L. 107-188, Sec. 322(a), amended par.
    (3) generally. Prior to amendment, par. (3) read as follows: "No
    component of a drug, no component part or accessory of a device, or
    other article of device requiring further processing, which is
    ready or suitable for use for health-related purposes, and no food
    additive, color additive, or dietary supplement, including a
    product in bulk form, shall be excluded from importation into the
    United States under subsection (a) of this section if - 
        "(A) the importer of such article of a drug or device or
      importer of the food additive, color additive, or dietary
      supplement submits a statement to the Secretary, at the time of
      initial importation, that such article of a drug or device, food
      additive, color additive, or dietary supplement is intended to be
      further processed by the initial owner or consignee, or
      incorporated by the initial owner or consignee into a drug,
      biological product, device, food, food additive, color additive,
      or dietary supplement that will be exported by such owner or
      consignee from the United States in accordance with subsection
      (e) of this section or section 382 of this title or section
      262(h) of title 42;
        "(B) the initial owner or consignee responsible for such
      imported article maintains records that identify the use of such
      imported article and upon request of the Secretary submits a
      report that provides an accounting of the exportation or the
      disposition of the imported article, including portions that have
      been destroyed, and the manner in which such person complied with
      the requirements of this paragraph; and
        "(C) any imported component, part, article, or accessory of a
      drug or device and any food additive, color additive, or dietary
      supplement not incorporated or further processed as described in
      subparagraph (A) is destroyed or exported by the owner or
      consignee."
      Subsec. (h). Pub. L. 107-188, Sec. 302(a)-(c), added subsec. (h).
      Subsec. (i). Pub. L. 107-188, Sec. 302(d), added subsec. (i).
      Subsec. (j). Pub. L. 107-188, Sec. 303(c), added subsec. (j).
      Subsec. (k). Pub. L. 107-188, Sec. 304(e), added subsec. (k).
      Subsec. (l). Pub. L. 107-188, Sec. 305(c), added subsec. (l).
      Subsec. (m). Pub. L. 107-188, Sec. 307(a), added subsec. (m).
      Subsec. (n). Pub. L. 107-188, Sec. 308(a), added subsec. (n).
      Subsec. (o). Pub. L. 107-188, Sec. 321(b)(1), added subsec. (o).
      2000 - Subsec. (d)(1). Pub. L. 106-387, Sec. 1(a) [title VII,
    Sec. 745(c)(1)], inserted "and section 384 of this title" after
    "paragraph (2)".
      Subsec. (g). Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(c)],
    added subsec. (g).
      1997 - Subsec. (d)(1). Pub. L. 105-115 inserted "or composed
    wholly or partly of insulin" after "353(b) of this title".
      1996 - Subsec. (d)(3). Pub. L. 104-180, Sec. 603(a), substituted
    "accessory of a device, or other article of device requiring
    further processing, which is ready" for "accessory of a device
    which is ready" in introductory provisions, inserted "further
    processed by the initial owner or consignee, or" after "is intended
    to be" in subpar. (A), and inserted "article," after "part," and
    "or further processed" after "incorporated" in subpar. (C).
      Pub. L. 104-134, Sec. 2102(a)(1), added par. (3)
      Subsec. (d)(4). Pub. L. 104-134, Sec. 2102(a)(1), added par. (4).
      Subsec. (e)(1). Pub. L. 104-134, Sec. 2102(b)(1), struck out
    concluding provisions which read as follows: "This paragraph does
    not authorize the exportation of any new animal drug, or an animal
    feed bearing or containing a new animal drug, which is unsafe
    within the meaning of section 360b of this title."
      Subsec. (e)(2). Pub. L. 104-134, Sec. 2102(b)(2), in concluding
    provisions, substituted "either (i) the Secretary" for "the
    Secretary" and added cl. (ii).
      Subsec. (e)(3), (4). Pub. L. 104-134, Sec. 2102(b)(3), added
    pars. (3) and (4).
      Subsec. (f). Pub. L. 104-180, Sec. 603(b), inserted "(other than
    insulin, an antibiotic drug, an animal drug, or a drug exported
    under section 382 of this title)" after "If a drug" in par. (1) and
    "A drug exported under section 382 of this title is exempt from
    this section." at end of par. (2).
      Pub. L. 104-134, Sec. 2102(c), added subsec. (f).
      1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(dd)(1), substituted
    "Health and Human Services" for "Agriculture" after "Secretary of"
    in two places in first sentence.
      Subsec. (b). Pub. L. 103-80, Sec. 3(cc), substituted "Secretary
    of Health and Human Services" for "Administrator" after "If it
    appears to the", "Secretary" for "Administrator" after "provisions
    of this subsection, the", "Secretary's" for "Administrator's" after
    "as may be specified in the", "Department of Health and Human
    Services" for "Federal Security Agency", and "Secretary" for
    "Administrator" after "designated by the".
      1992 - Subsecs. (a), (b). Pub. L. 102-300, which directed the
    substitution of "Health and Human Services" for "Health, Education,
    and Welfare" wherever appearing, was executed in second sentence of
    subsec. (a), but could not be executed in first sentence of subsec.
    (a) or in subsec. (b) because such words did not appear. See 1993
    Amendment note above and Transfer of Functions note below.
      Subsec. (d)(1). Pub. L. 102-353 substituted "manufacturer of" for
    "person who manufactured".
      1988 - Subsecs. (d), (e). Pub. L. 100-293 added subsec. (d) and
    redesignated former subsec. (d) as (e).
      1976 - Subsec. (a). Pub. L. 94-295, Secs. 3(f)(2), 4(b)(3),
    expanded provisions requiring the Secretary of Health, Education,
    and Welfare to request that the Secretary of the Treasury deliver
    to the Secretary of Health, Education, and Welfare items imported
    or offered for import into the United States that were
    manufactured, prepared, propagated, compounded, or processed in non-
    registered establishments by extending the provisions to include
    devices imported or offered for import, and, in cl. (1), inserted
    reference to devices which were manufactured, packed, stored, or
    installed using methods, facilities, or controls not conforming to
    the requirements of section 360j(f) of this title.
      Subsec. (d). Pub. L. 94-295, Sec. 3(f)(1), designated existing
    provisions as par. (1) and added par. (2).
      1970 - Subsec. (a). Pub. L. 91-513 substituted "Clause (2) of the
    third sentence of this paragraph" for "This paragraph" and "the
    Controlled Substances Import and Export Act" for "section 173 of
    this title" in last sentence.
      1968 - Subsec. (d). Pub. L. 90-399 provided that nothing in
    subsec. (d) shall authorize the exportation of any new animal drug,
    or an animal feed bearing or containing a new animal drug, which is
    unsafe within the meaning of section 360b of this title.
      1962 - Subsec. (a). Pub. L. 87-781 inserted provisions requiring
    the Secretary of Health, Education, and Welfare to furnish the
    Secretary of the Treasury a list of establishments registered under
    section 360(i) of this title, and to request that samples of any
    drugs from any establishments not so registered be delivered to the
    Secretary of Health, Education, and Welfare, with notice of
    delivery to the consignee who may appear before the Secretary to
    testify.
      1949 - Subsec. (a). Act Oct. 18, 1949, Sec. 1, inserted before
    period at end of second sentence ", except as provided in
    subsection (b) of this section. The Secretary of the Treasury shall
    cause the destruction of any such article refused admission unless
    such article is exported, under regulations prescribed by the
    Secretary of the Treasury within ninety days of the notice of such
    refusal or within such additional time as may be permitted pursuant
    to such regulations".
      Subsec. (b). Act Oct. 18, 1949, Sec. 2, provided for express
    statutory authority for the long-standing administrative practice
    of releasing imported articles that do not comply with the
    requirements of the law so that they may be relabeled or given
    appropriate treatment to bring them into compliance.
      Subsec. (c). Act Oct. 18, 1949, Sec. 3, charged all costs,
    including salaries and travel and subsistence expenses of officers
    and employees, against importers.

                     EFFECTIVE DATE OF 2006 AMENDMENT                 
      Pub. L. 109-462, Sec. 5(b), Dec. 22, 2006, 120 Stat. 3476,
    provided that: "The amendments made by this section [amending this
    section] shall take effect 1 year after the date of enactment of
    this Act [Dec. 22, 2006]."

                     EFFECTIVE DATE OF 2002 AMENDMENT                 
      Amendment by section 321(b)(1) of Pub. L. 107-188 effective upon
    the expiration of the 180-day period beginning June 12, 2002, see
    section 321(c) of Pub. L. 107-188, set out as a note under section
    331 of this title.
      Amendment by section 322(a) of Pub. L. 107-188 effective upon the
    expiration of the 90-day period beginning June 12, 2002, see
    section 322(c) of Pub. L. 107-188, set out as a note under section
    331 of this title.

                     EFFECTIVE DATE OF 1988 AMENDMENT                 
      Amendment by Pub. L. 100-293 effective upon expiration of 90 days
    after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
    as a note under section 353 of this title.

                     EFFECTIVE DATE OF 1970 AMENDMENT                 
      Amendment by Pub. L. 91-513 effective on first day of seventh
    calendar month that begins after Oct. 26, 1970, see section 704 of
    Pub. L. 91-513, set out as an Effective Date note under section 801
    of this title.

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment of subsec. (d) by Pub. L. 90-399 effective on first day
    of thirteenth calendar month after July 13, 1968, see section
    108(a) of Pub. L. 90-399, set out as an Effective Date and
    Transitional Provisions note under section 360b of this title.

                                REGULATIONS                            
      Pub. L. 107-188, title III, Sec. 307(c), June 12, 2002, 116 Stat.
    672, provided that:
      "(1) In general. - Not later than 18 months after the date of the
    enactment of this Act [June 12, 2002], the Secretary of Health and
    Human Services shall promulgate proposed and final regulations for
    the requirement of providing notice in accordance with section
    801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
    381(m)] (as added by subsection (a) of this section). Such
    requirement of notification takes effect - 
        "(A) upon the effective date of such final regulations; or
        "(B) upon the expiration of such 18-month period if the final
      regulations have not been made effective as of the expiration of
      such period, subject to compliance with the final regulations
      when the final regulations are made effective.
      "(2) Default; minimum period of advance notice. - If under
    paragraph (1) the requirement for providing notice in accordance
    with section 801(m) of the Federal Food, Drug, and Cosmetic Act [21
    U.S.C. 381(m)] takes effect without final regulations having been
    made effective, then for purposes of such requirement, the
    specified period of time that the notice is required to be made in
    advance of the time of the importation of the article of food
    involved or the offering of the food for import shall be not fewer
    than eight hours and not more than five days, which shall remain in
    effect until the final regulations are made effective."

                             SAVINGS PROVISION                         
      Amendment by Pub. L. 91-513 not to affect or abate any
    prosecutions for violation of law or any civil seizure or
    forfeitures and injunctive proceedings commenced prior to the
    effective date of such amendment, and all administrative
    proceedings pending before the Bureau of Narcotic and Dangerous
    Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be
    continued and brought to final determination in accord with laws
    and regulations in effect prior to Oct. 27, 1970, see section 702
    of Pub. L. 91-513, set out as a note under section 321 of this
    title.

               CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188           
      Pub. L. 107-188, title III, Sec. 308(c), June 12, 2002, 116 Stat.
    673, provided that: "With respect to articles of food that are
    imported or offered for import into the United States, nothing in
    this section [amending this section and section 343 of this title]
    shall be construed to limit the authority of the Secretary of
    Health and Human Services or the Secretary of the Treasury to
    require the marking of refused articles of food under any other
    provision of law."


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      Secretary and Department of Health, Education, and Welfare
    redesignated Secretary and Department of Health and Human Services
    by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
    695, which is classified to section 3508(b) of Title 20, Education.
      For transfer of functions of Federal Security Administrator to
    Secretary of Health, Education, and Welfare [now Health and Human
    Services], and of Food and Drug Administration in the Department of
    Agriculture to Federal Security Agency, see notes set out under
    section 321 of this title.


-MISC2-
               STUDY AND REPORT ON TRADE IN PHARMACEUTICALS           
      Pub. L. 108-173, title XI, Sec. 1123, Dec. 8, 2003, 117 Stat.
    2469, provided that: "The President's designees shall conduct a
    study and report on issues related to trade and pharmaceuticals."

                                 FINDINGS                             
      Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(b)], Oct. 28,
    2000, 114 Stat. 1549, 1549A-40, provided that: "The Congress finds
    as follows:
        "(1) Patients and their families sometimes have reason to
      import into the United States drugs that have been approved by
      the Food and Drug Administration ('FDA').
        "(2) There have been circumstances in which - 
          "(A) an individual seeking to import such a drug has received
        a notice from FDA that importing the drug violates or may
        violate the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301
        et seq.]; and
          "(B) the notice failed to inform the individual of the
        reasons underlying the decision to send the notice.
        "(3) FDA should not send a warning notice regarding the
      importation of a drug without providing to the individual
      involved a statement of the underlying reasons for the notice."

-FOOTNOTE-
    (!1) So in original. Probably should be "subsection".

    (!2) So in original. No par. (2) has been enacted.


-End-



-CITE-
    21 USC Sec. 382                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
    Sec. 382. Exports of certain unapproved products

-STATUTE-
    (a) Drugs or devices intended for human or animal use which require
      approval or licensing
      A drug or device - 
        (1) which, in the case of a drug - 
          (A)(i) requires approval by the Secretary under section 355
        of this title before such drug may be introduced or delivered
        for introduction into interstate commerce; or
          (ii) requires licensing by the Secretary under section 262 of
        title 42 or by the Secretary of Agriculture under the Act of
        March 4, 1913 [21 U.S.C. 151 et seq.] (known as the Virus-Serum
        Toxin Act) before it may be introduced or delivered for
        introduction into interstate commerce;
          (B) does not have such approval or license; and
          (C) is not exempt from such sections or Act; and

        (2) which, in the case of a device - 
          (A) does not comply with an applicable requirement under
        section 360d or 360e of this title;
          (B) under section 360j(g) of this title is exempt from either
        such section; or
          (C) is a banned device under section 360f of this title, is
        adulterated, misbranded, and in violation of such sections or
        Act unless the export of the drug or device is, except as
        provided in subsection (f) of this section, authorized under
        subsection (b), (c), (d), or (e) of this section or section
        381(e)(2) of this title. If a drug or device described in
        paragraphs (1) and (2) may be exported under subsection (b) of
        this section and if an application for such drug or device
        under section 355 or 360e of this title or section 262 of title
        42 was disapproved, the Secretary shall notify the appropriate
        public health official of the country to which such drug will
        be exported of such disapproval.
    (b) List of eligible countries for export; criteria for addition to
      list; direct export; petition for exemption
      (1)(A) A drug or device described in subsection (a) of this
    section may be exported to any country, if the drug or device
    complies with the laws of that country and has valid marketing
    authorization by the appropriate authority - 
        (i) in Australia, Canada, Israel, Japan, New Zealand,
      Switzerland, or South Africa; or
        (ii) in the European Union or a country in the European
      Economic Area (the countries in the European Union and the
      European Free Trade Association) if the drug or device is
      marketed in that country or the drug or device is authorized for
      general marketing in the European Economic Area.

      (B) The Secretary may designate an additional country to be
    included in the list of countries described in clauses (i) and (ii)
    of subparagraph (A) if all of the following requirements are met in
    such country:
        (i) Statutory or regulatory requirements which require the
      review of drugs and devices for safety and effectiveness by an
      entity of the government of such country and which authorize the
      approval of only those drugs and devices which have been
      determined to be safe and effective by experts employed by or
      acting on behalf of such entity and qualified by scientific
      training and experience to evaluate the safety and effectiveness
      of drugs and devices on the basis of adequate and well-controlled
      investigations, including clinical investigations, conducted by
      experts qualified by scientific training and experience to
      evaluate the safety and effectiveness of drugs and devices.
        (ii) Statutory or regulatory requirements that the methods used
      in, and the facilities and controls used for - 
          (I) the manufacture, processing, and packing of drugs in the
        country are adequate to preserve their identity, quality,
        purity, and strength; and
          (II) the manufacture, preproduction design validation,
        packing, storage, and installation of a device are adequate to
        assure that the device will be safe and effective.

        (iii) Statutory or regulatory requirements for the reporting of
      adverse reactions to drugs and devices and procedures to withdraw
      approval and remove drugs and devices found not to be safe or
      effective.
        (iv) Statutory or regulatory requirements that the labeling and
      promotion of drugs and devices must be in accordance with the
      approval of the drug or device.
        (v) The valid marketing authorization system in such country or
      countries is equivalent to the systems in the countries described
      in clauses (i) and (ii) of subparagraph (A).

    The Secretary shall not delegate the authority granted under this
    subparagraph.
      (C) An appropriate country official, manufacturer, or exporter
    may request the Secretary to take action under subparagraph (B) to
    designate an additional country or countries to be added to the
    list of countries described in clauses (i) and (ii) of subparagraph
    (A) by submitting documentation to the Secretary in support of such
    designation. Any person other than a country requesting such
    designation shall include, along with the request, a letter from
    the country indicating the desire of such country to be designated.
      (2) A drug described in subsection (a) of this section may be
    directly exported to a country which is not listed in clause (i) or
    (ii) of paragraph (1)(A) if - 
        (A) the drug complies with the laws of that country and has
      valid marketing authorization by the responsible authority in
      that country; and
        (B) the Secretary determines that all of the following
      requirements are met in that country:
          (i) Statutory or regulatory requirements which require the
        review of drugs for safety and effectiveness by an entity of
        the government of such country and which authorize the approval
        of only those drugs which have been determined to be safe and
        effective by experts employed by or acting on behalf of such
        entity and qualified by scientific training and experience to
        evaluate the safety and effectiveness of drugs on the basis of
        adequate and well-controlled investigations, including clinical
        investigations, conducted by experts qualified by scientific
        training and experience to evaluate the safety and
        effectiveness of drugs.
          (ii) Statutory or regulatory requirements that the methods
        used in, and the facilities and controls used for the
        manufacture, processing, and packing of drugs in the country
        are adequate to preserve their identity, quality, purity, and
        strength.
          (iii) Statutory or regulatory requirements for the reporting
        of adverse reactions to drugs and procedures to withdraw
        approval and remove drugs found not to be safe or effective.
          (iv) Statutory or regulatory requirements that the labeling
        and promotion of drugs must be in accordance with the approval
        of the drug.

      (3) The exporter of a drug described in subsection (a) of this
    section which would not meet the conditions for approval under this
    chapter or conditions for approval of a country described in clause
    (i) or (ii) of paragraph (1)(A) may petition the Secretary for
    authorization to export such drug to a country which is not
    described in clause (i) or (ii) of paragraph (1)(A) or which is not
    described in paragraph (2). The Secretary shall permit such export
    if - 
        (A) the person exporting the drug - 
          (i) certifies that the drug would not meet the conditions for
        approval under this chapter or the conditions for approval of a
        country described in clause (i) or (ii) of paragraph (1)(A);
        and
          (ii) provides the Secretary with credible scientific
        evidence, acceptable to the Secretary, that the drug would be
        safe and effective under the conditions of use in the country
        to which it is being exported; and

        (B) the appropriate health authority in the country to which
      the drug is being exported - 
          (i) requests approval of the export of the drug to such
        country;
          (ii) certifies that the health authority understands that the
        drug is not approved under this chapter or in a country
        described in clause (i) or (ii) of paragraph (1)(A); and
          (iii) concurs that the scientific evidence provided pursuant
        to subparagraph (A) is credible scientific evidence that the
        drug would be reasonably safe and effective in such country.

    The Secretary shall take action on a request for export of a drug
    under this paragraph within 60 days of receiving such request.
    (c) Investigational use exemption
      A drug or device intended for investigational use in any country
    described in clause (i) or (ii) of subsection (b)(1)(A) of this
    section may be exported in accordance with the laws of that country
    and shall be exempt from regulation under section 355(i) or 360j(g)
    of this title.
    (d) Anticipation of market authorization
      A drug or device intended for formulation, filling, packaging,
    labeling, or further processing in anticipation of market
    authorization in any country described in clause (i) or (ii) of
    subsection (b)(1)(A) of this section may be exported for use in
    accordance with the laws of that country.
    (e) Diagnosis, prevention, or treatment of tropical disease
      (1) A drug or device which is used in the diagnosis, prevention,
    or treatment of a tropical disease or another disease not of
    significant prevalence in the United States and which does not
    otherwise qualify for export under this section shall, upon
    approval of an application, be permitted to be exported if the
    Secretary finds that the drug or device will not expose patients in
    such country to an unreasonable risk of illness or injury and the
    probable benefit to health from the use of the drug or device
    (under conditions of use prescribed, recommended, or suggested in
    the labeling or proposed labeling of the drug or device) outweighs
    the risk of injury or illness from its use, taking into account the
    probable risks and benefits of currently available drug or device
    treatment.
      (2) The holder of an approved application for the export of a
    drug or device under this subsection shall report to the Secretary -
     
        (A) the receipt of any credible information indicating that the
      drug or device is being or may have been exported from a country
      for which the Secretary made a finding under paragraph (1)(A) to
      a country for which the Secretary cannot make such a finding; and
        (B) the receipt of any information indicating adverse reactions
      to such drug.

      (3)(A) If the Secretary determines that - 
        (i) a drug or device for which an application is approved under
      paragraph (1) does not continue to meet the requirements of such
      paragraph; or
        (ii) the holder of an approved application under paragraph (1)
      has not made the report required by paragraph (2),

    the Secretary may, after providing the holder of the application an
    opportunity for an informal hearing, withdraw the approved
    application.
      (B) If the Secretary determines that the holder of an approved
    application under paragraph (1) or an importer is exporting a drug
    or device from the United States to an importer and such importer
    is exporting the drug or device to a country for which the
    Secretary cannot make a finding under paragraph (1) and such export
    presents an imminent hazard, the Secretary shall immediately
    prohibit the export of the drug or device to such importer, provide
    the person exporting the drug or device from the United States
    prompt notice of the prohibition, and afford such person an
    opportunity for an expedited hearing.
    (f) Prohibition of export of drug or device
      A drug or device may not be exported under this section - 
        (1) if the drug or device is not manufactured, processed,
      packaged, and held in substantial conformity with current good
      manufacturing practice requirements or does not meet
      international standards as certified by an international
      standards organization recognized by the Secretary;
        (2) if the drug or device is adulterated under clause (1),
      (2)(A), or (3) of section 351(a) or subsection (c) or (d) of
      section 351 of this title;
        (3) if the requirements of subparagraphs (A) through (D) of
      section 381(e)(1) of this title have not been met;
        (4)(A) if the drug or device is the subject of a notice by the
      Secretary or the Secretary of Agriculture of a determination that
      the probability of reimportation of the exported drug or device
      would present an imminent hazard to the public health and safety
      of the United States and the only means of limiting the hazard is
      to prohibit the export of the drug or device; or
        (B) if the drug or device presents an imminent hazard to the
      public health of the country to which the drug or device would be
      exported;
        (5) if the labeling of the drug or device is not - 
          (A) in accordance with the requirements and conditions for
        use in - 
            (i) the country in which the drug or device received valid
          marketing authorization under subsection (b) of this section;
          and
            (ii) the country to which the drug or device would be
          exported; and

          (B) in the language and units of measurement of the country
        to which the drug or device would be exported or in the
        language designated by such country; or

        (6) if the drug or device is not promoted in accordance with
      the labeling requirements set forth in paragraph (5).

    In making a finding under paragraph (4)(B), (5), or (6) the
    Secretary shall consult with the appropriate public health official
    in the affected country.
    (g) Notification of Secretary
      The exporter of a drug or device exported under subsection (b)(1)
    of this section shall provide a simple notification to the
    Secretary identifying the drug or device when the exporter first
    begins to export such drug or device to any country listed in
    clause (i) or (ii) of subsection (b)(1)(A) of this section. When an
    exporter of a drug or device first begins to export a drug or
    device to a country which is not listed in clause (i) or (ii) of
    subsection (b)(1)A) (!1) of this section, the exporter shall
    provide a simple notification to the Secretary identifying the drug
    or device and the country to which such drug or device is being
    exported. Any exporter of a drug or device shall maintain records
    of all drugs or devices exported and the countries to which they
    were exported.

    (h) References to Secretary and term "drug"
      For purposes of this section - 
        (1) a reference to the Secretary shall in the case of a
      biological product which is required to be licensed under the Act
      of March 4, 1913 [21 U.S.C. 151 et seq.] (37 Stat. 832-833)
      (commonly known as the Virus-Serum Toxin Act) be considered to be
      a reference to the Secretary of Agriculture, and
        (2) the term "drug" includes drugs for human use as well as
      biologicals under section 262 of title 42 or the Act of March 4,
      1913 (37 Stat. 832-833) (commonly known as the Virus-Serum Toxin
      Act).
    (i) Exportation
      Insulin and antibiotic drugs may be exported without regard to
    the requirements in this section if the insulin and antibiotic
    drugs meet the requirements of section 381(e)(1) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 802, as added Pub. L. 99-660, title
    I, Sec. 102(2), Nov. 14, 1986, 100 Stat. 3743; amended Pub. L. 104-
    134, title III, Sec. 2102(d)(1), Apr. 26, 1996, 110 Stat. 1321-
    315; Pub. L. 104-180, title VI, Sec. 603(c), Aug. 6, 1996, 110
    Stat. 1595; Pub. L. 105-115, title I, Sec. 125(c), Nov. 21, 1997,
    111 Stat. 2326.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      Act of March 4, 1913 (known as the Virus-Serum Toxin Act),
    referred to in subsecs. (a)(1)(A)(ii), (C), (2)(C) and (h), is the
    eighth paragraph under the heading "Bureau of Animal Industry" of
    act Mar. 4, 1913, ch. 145, 37 Stat. 832, as amended, which is
    classified generally to chapter 5 (Sec. 151 et seq.) of this title.
    For complete classification of this Act to the Code, see Short
    Title note set out under section 151 of this title and Tables.


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (i). Pub. L. 105-115 added subsec. (i).
      1996 - Pub. L. 104-134 reenacted section catchline without change
    and amended text generally. Prior to amendment, text related to
    exports of certain unapproved products, including provisions
    relating to drugs intended for human or animal use which required
    approval or licensing, conditions for export, active pursuit of
    drug approval or licensing, application for export, contents,
    approval or disapproval, list of eligible countries for export, and
    criteria for list change, report to Secretary by holder of approved
    application, events requiring report, and annual report to
    Secretary on pursuit of approval of drug, export of drug under
    approved application prohibited under certain conditions,
    determination by Secretary of noncompliance, failure of active
    pursuit of drug approval, imminent hazard of drug to public health,
    or exportation of drug to noneligible country, notices, hearings,
    and prohibition on exportation of drug under certain circumstances,
    drugs used in prevention or treatment of tropical disease, and
    reference to Secretary and holder of application.
      Subsec. (f)(5). Pub. L. 104-180 substituted "if the labeling of
    the drug or device is not" for "if the drug or device is not
    labeled".

-FOOTNOTE-
    (!1) So in original. Probably should be subsection "(b)(1)(A)".


-End-



-CITE-
    21 USC Sec. 383                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
    Sec. 383. Office of International Relations

-STATUTE-
    (a) Establishment
      There is established in the Department of Health and Human
    Services an Office of International Relations.
    (b) Agreements with foreign countries
      In carrying out the functions of the office under subsection (a)
    of this section, the Secretary may enter into agreements with
    foreign countries to facilitate commerce in devices between the
    United States and such countries consistent with the requirements
    of this chapter. In such agreements, the Secretary shall encourage
    the mutual recognition of - 
        (1) good manufacturing practice regulations promulgated under
      section 360j(f) of this title, and
        (2) other regulations and testing protocols as the Secretary
      determines to be appropriate.
    (c) Harmonizing regulatory requirements
      (1) The Secretary shall support the Office of the United States
    Trade Representative, in consultation with the Secretary of
    Commerce, in meetings with representatives of other countries to
    discuss methods and approaches to reduce the burden of regulation
    and harmonize regulatory requirements if the Secretary determines
    that such harmonization continues consumer protections consistent
    with the purposes of this chapter.
      (2) The Secretary shall support the Office of the United States
    Trade Representative, in consultation with the Secretary of
    Commerce, in efforts to move toward the acceptance of mutual
    recognition agreements relating to the regulation of drugs,
    biological products, devices, foods, food additives, and color
    additives, and the regulation of good manufacturing practices,
    between the European Union and the United States.
      (3) The Secretary shall regularly participate in meetings with
    representatives of other foreign governments to discuss and reach
    agreement on methods and approaches to harmonize regulatory
    requirements.
      (4) The Secretary shall, not later than 180 days after November
    21, 1997, make public a plan that establishes a framework for
    achieving mutual recognition of good manufacturing practices
    inspections.
      (5) Paragraphs (1) through (4) shall not apply with respect to
    products defined in section 321(ff) of this title.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 803, as added Pub. L. 101-629, Sec.
    15(a), Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105-115,
    title IV, Sec. 410(b), Nov. 21, 1997, 111 Stat. 2373.)


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (c). Pub. L. 105-115 added subsec. (c).

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

         REPORT ON ACTIVITIES OF OFFICE OF INTERNATIONAL RELATIONS     
      Section 15(b) of Pub. L. 101-629 directed Secretary of Health and
    Human Services, not later than 2 years after Nov. 28, 1990, to
    prepare and submit to the appropriate committees of Congress a
    report on the activities of the Office of International Relations
    under 21 U.S.C. 383.

-End-



-CITE-
    21 USC Sec. 384                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER VIII - IMPORTS AND EXPORTS

-HEAD-
    Sec. 384. Importation of prescription drugs

-STATUTE-
    (a) Definitions
      In this section:
      (1) Importer
        The term "importer" means a pharmacist or wholesaler.
      (2) Pharmacist
        The term "pharmacist" means a person licensed by a State to
      practice pharmacy, including the dispensing and selling of
      prescription drugs.
      (3) Prescription drug
        The term "prescription drug" means a drug subject to section
      353(b) of this title, other than - 
          (A) a controlled substance (as defined in section 802 of this
        title);
          (B) a biological product (as defined in section 262 of title
        42);
          (C) an infused drug (including a peritoneal dialysis
        solution);
          (D) an intravenously injected drug;
          (E) a drug that is inhaled during surgery; or
          (F) a drug which is a parenteral drug, the importation of
        which pursuant to subsection (b) of this section is determined
        by the Secretary to pose a threat to the public health, in
        which case section 381(d)(1) of this title shall continue to
        apply.
      (4) Qualifying laboratory
        The term "qualifying laboratory" means a laboratory in the
      United States that has been approved by the Secretary for the
      purposes of this section.
      (5) Wholesaler
        (A) In general
          The term "wholesaler" means a person licensed as a wholesaler
        or distributor of prescription drugs in the United States under
        section 353(e)(2)(A) of this title.
        (B) Exclusion
          The term "wholesaler" does not include a person authorized to
        import drugs under section 381(d)(1) of this title.
    (b) Regulations
      The Secretary, after consultation with the United States Trade
    Representative and the Commissioner of Customs, shall promulgate
    regulations permitting pharmacists and wholesalers to import
    prescription drugs from Canada into the United States.
    (c) Limitation
      The regulations under subsection (b) of this section shall - 
        (1) require that safeguards be in place to ensure that each
      prescription drug imported under the regulations complies with
      section 355 of this title (including with respect to being safe
      and effective for the intended use of the prescription drug),
      with sections 351 and 352 of this title, and with other
      applicable requirements of this chapter;
        (2) require that an importer of a prescription drug under the
      regulations comply with subsections (d)(1) and (e) of this
      section; and
        (3) contain any additional provisions determined by the
      Secretary to be appropriate as a safeguard to protect the public
      health or as a means to facilitate the importation of
      prescription drugs.
    (d) Information and records
      (1) In general
        The regulations under subsection (b) of this section shall
      require an importer of a prescription drug under subsection (b)
      of this section to submit to the Secretary the following
      information and documentation:
          (A) The name and quantity of the active ingredient of the
        prescription drug.
          (B) A description of the dosage form of the prescription
        drug.
          (C) The date on which the prescription drug is shipped.
          (D) The quantity of the prescription drug that is shipped.
          (E) The point of origin and destination of the prescription
        drug.
          (F) The price paid by the importer for the prescription drug.
          (G) Documentation from the foreign seller specifying - 
            (i) the original source of the prescription drug; and
            (ii) the quantity of each lot of the prescription drug
          originally received by the seller from that source.

          (H) The lot or control number assigned to the prescription
        drug by the manufacturer of the prescription drug.
          (I) The name, address, telephone number, and professional
        license number (if any) of the importer.
          (J)(i) In the case of a prescription drug that is shipped
        directly from the first foreign recipient of the prescription
        drug from the manufacturer:
            (I) Documentation demonstrating that the prescription drug
          was received by the recipient from the manufacturer and
          subsequently shipped by the first foreign recipient to the
          importer.
            (II) Documentation of the quantity of each lot of the
          prescription drug received by the first foreign recipient
          demonstrating that the quantity being imported into the
          United States is not more than the quantity that was received
          by the first foreign recipient.
            (III)(aa) In the case of an initial imported shipment,
          documentation demonstrating that each batch of the
          prescription drug in the shipment was statistically sampled
          and tested for authenticity and degradation.
            (bb) In the case of any subsequent shipment, documentation
          demonstrating that a statistically valid sample of the
          shipment was tested for authenticity and degradation.

          (ii) In the case of a prescription drug that is not shipped
        directly from the first foreign recipient of the prescription
        drug from the manufacturer, documentation demonstrating that
        each batch in each shipment offered for importation into the
        United States was statistically sampled and tested for
        authenticity and degradation.
          (K) Certification from the importer or manufacturer of the
        prescription drug that the prescription drug - 
            (i) is approved for marketing in the United States and is
          not adulterated or misbranded; and
            (ii) meets all labeling requirements under this chapter.

          (L) Laboratory records, including complete data derived from
        all tests necessary to ensure that the prescription drug is in
        compliance with established specifications and standards.
          (M) Documentation demonstrating that the testing required by
        subparagraphs (J) and (L) was conducted at a qualifying
        laboratory.
          (N) Any other information that the Secretary determines is
        necessary to ensure the protection of the public health.
      (2) Maintenance by the Secretary
        The Secretary shall maintain information and documentation
      submitted under paragraph (1) for such period of time as the
      Secretary determines to be necessary.
    (e) Testing
      The regulations under subsection (b) of this section shall
    require - 
        (1) that testing described in subparagraphs (J) and (L) of
      subsection (d)(1) of this section be conducted by the importer or
      by the manufacturer of the prescription drug at a qualified
      laboratory;
        (2) if the tests are conducted by the importer - 
          (A) that information needed to - 
            (i) authenticate the prescription drug being tested; and
            (ii) confirm that the labeling of the prescription drug
          complies with labeling requirements under this chapter;

        be supplied by the manufacturer of the prescription drug to the
        pharmacist or wholesaler; and
          (B) that the information supplied under subparagraph (A) be
        kept in strict confidence and used only for purposes of testing
        or otherwise complying with this chapter; and

        (3) may include such additional provisions as the Secretary
      determines to be appropriate to provide for the protection of
      trade secrets and commercial or financial information that is
      privileged or confidential.
    (f) Registration of foreign sellers
      Any establishment within Canada engaged in the distribution of a
    prescription drug that is imported or offered for importation into
    the United States shall register with the Secretary the name and
    place of business of the establishment and the name of the United
    States agent for the establishment.
    (g) Suspension of importation
      The Secretary shall require that importations of a specific
    prescription drug or importations by a specific importer under
    subsection (b) of this section be immediately suspended on
    discovery of a pattern of importation of that specific prescription
    drug or by that specific importer of drugs that are counterfeit or
    in violation of any requirement under this section, until an
    investigation is completed and the Secretary determines that the
    public is adequately protected from counterfeit and violative
    prescription drugs being imported under subsection (b) of this
    section.
    (h) Approved labeling
      The manufacturer of a prescription drug shall provide an importer
    written authorization for the importer to use, at no cost, the
    approved labeling for the prescription drug.
    (i) Charitable contributions
      Notwithstanding any other provision of this section, section
    381(d)(1) of this title continues to apply to a prescription drug
    that is donated or otherwise supplied at no charge by the
    manufacturer of the drug to a charitable or humanitarian
    organization (including the United Nations and affiliates) or to a
    government of a foreign country.
    (j) Waiver authority for importation by individuals
      (1) Declarations
        Congress declares that in the enforcement against individuals
      of the prohibition of importation of prescription drugs and
      devices, the Secretary should - 
          (A) focus enforcement on cases in which the importation by an
        individual poses a significant threat to public health; and
          (B) exercise discretion to permit individuals to make such
        importations in circumstances in which - 
            (i) the importation is clearly for personal use; and
            (ii) the prescription drug or device imported does not
          appear to present an unreasonable risk to the individual.
      (2) Waiver authority
        (A) In general
          The Secretary may grant to individuals, by regulation or on a
        case-by-case basis, a waiver of the prohibition of importation
        of a prescription drug or device or class of prescription drugs
        or devices, under such conditions as the Secretary determines
        to be appropriate.
        (B) Guidance on case-by-case waivers
          The Secretary shall publish, and update as necessary,
        guidance that accurately describes circumstances in which the
        Secretary will consistently grant waivers on a case-by-case
        basis under subparagraph (A), so that individuals may know with
        the greatest practicable degree of certainty whether a
        particular importation for personal use will be permitted.
      (3) Drugs imported from Canada
        In particular, the Secretary shall by regulation grant
      individuals a waiver to permit individuals to import into the
      United States a prescription drug that - 
          (A) is imported from a licensed pharmacy for personal use by
        an individual, not for resale, in quantities that do not exceed
        a 90-day supply;
          (B) is accompanied by a copy of a valid prescription;
          (C) is imported from Canada, from a seller registered with
        the Secretary;
          (D) is a prescription drug approved by the Secretary under
        subchapter V of this chapter;
          (E) is in the form of a final finished dosage that was
        manufactured in an establishment registered under section 360
        of this title; and
          (F) is imported under such other conditions as the Secretary
        determines to be necessary to ensure public safety.
    (k) Construction
      Nothing in this section limits the authority of the Secretary
    relating to the importation of prescription drugs, other than with
    respect to section 381(d)(1) of this title as provided in this
    section.
    (l) Effectiveness of section
      (1) Commencement of program
        This section shall become effective only if the Secretary
      certifies to the Congress that the implementation of this section
      will - 
          (A) pose no additional risk to the public's health and
        safety; and
          (B) result in a significant reduction in the cost of covered
        products to the American consumer.
      (2) Termination of program
        (A) In general
          If, after the date that is 1 year after the effective date of
        the regulations under subsection (b) of this section and before
        the date that is 18 months after the effective date, the
        Secretary submits to Congress a certification that, in the
        opinion of the Secretary, based on substantial evidence
        obtained after the effective date, the benefits of
        implementation of this section do not outweigh any detriment of
        implementation of this section, this section shall cease to be
        effective as of the date that is 30 days after the date on
        which the Secretary submits the certification.
        (B) Procedure
          The Secretary shall not submit a certification under
        subparagraph (A) unless, after a hearing on the record under
        sections 556 and 557 of title 5, the Secretary - 
            (i)(I) determines that it is more likely than not that
          implementation of this section would result in an increase in
          the risk to the public health and safety;
            (II) identifies specifically, in qualitative and
          quantitative terms, the nature of the increased risk;
            (III) identifies specifically the causes of the increased
          risk; and
            (IV)(aa) considers whether any measures can be taken to
          avoid, reduce, or mitigate the increased risk; and
            (bb) if the Secretary determines that any measures
          described in item (aa) would require additional statutory
          authority, submits to Congress a report describing the
          legislation that would be required;
            (ii) identifies specifically, in qualitative and
          quantitative terms, the benefits that would result from
          implementation of this section (including the benefit of
          reductions in the cost of covered products to consumers in
          the United States, allowing consumers to procure needed
          medication that consumers might not otherwise be able to
          procure without foregoing other necessities of life); and
            (iii)(I) compares in specific terms the detriment
          identified under clause (i) with the benefits identified
          under clause (ii); and
            (II) determines that the benefits do not outweigh the
          detriment.
    (m) Authorization of appropriations
      There are authorized to be appropriated such sums as are
    necessary to carry out this section.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 804, as added Pub. L. 108-173, title
    XI, Sec. 1121(a), Dec. 8, 2003, 117 Stat. 2464.)


-MISC1-
                             PRIOR PROVISIONS                         
      A prior section 384, act June 25, 1938, ch. 675, Sec. 804, as
    added Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(c)(2)], Oct.
    28, 2000, 114 Stat. 1549, 1549A-36, related to importation of
    covered products, prior to repeal by Pub. L. 108-173, title XI,
    Sec. 1121(a), Dec. 8, 2003, 117 Stat. 2464.


-TRANS-
                           TRANSFER OF FUNCTIONS                       
      For transfer of functions, personnel, assets, and liabilities of
    the United States Customs Service of the Department of the
    Treasury, including functions of the Secretary of the Treasury
    relating thereto, to the Secretary of Homeland Security, and for
    treatment of related references, see sections 203(1), 551(d),
    552(d), and 557 of Title 6, Domestic Security, and the Department
    of Homeland Security Reorganization Plan of November 25, 2002, as
    modified, set out as a note under section 542 of Title 6.


-MISC2-
                 STUDY AND REPORT ON IMPORTATION OF DRUGS             
      Pub. L. 108-173, title XI, Sec. 1122, Dec. 8, 2003, 117 Stat.
    2469, directed the Secretary of Health and Human Services to
    conduct a study on the importation of drugs into the United States
    pursuant to this section and to submit to Congress, not later than
    12 months after Dec. 8, 2003, a report providing the findings of
    such study.

-End-


-CITE-
    21 USC SUBCHAPTER IX - MISCELLANEOUS                        01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
                       SUBCHAPTER IX - MISCELLANEOUS                   

-End-



-CITE-
    21 USC Sec. 391                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 391. Separability clause

-STATUTE-
      If any provision of this chapter is declared unconstitutional, or
    the applicability thereof to any person or circumstances is held
    invalid, the constitutionality of the remainder of the chapter and
    the applicability thereof to other persons and circumstances shall
    not be affected thereby.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 901, 52 Stat. 1059.)

-End-



-CITE-
    21 USC Sec. 392                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 392. Exemption of meats and meat food products

-STATUTE-
    (a) Law determinative of exemption
      Meats and meat food products shall be exempt from the provisions
    of this chapter to the extent of the application or the extension
    thereto of the Meat Inspection Act, approved March 4, 1907, as
    amended [21 U.S.C. 601 et seq.].
    (b) Laws unaffected
      Nothing contained in this chapter shall be construed as in any
    way affecting, modifying, repealing, or superseding the provisions
    of section 351 of Public Health Service Act [42 U.S.C. 262]
    (relating to viruses, serums, toxins, and analogous products
    applicable to man); the virus, serum, toxin, and analogous products
    provisions, applicable to domestic animals, of the Act of Congress
    approved March 4, 1913 (37 Stat. 832-833) [21 U.S.C. 151 et seq.];
    the Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title 26,
    ch. 10), the Filled Milk Act of March 4, 1923 [21 U.S.C. 61 et
    seq.]; or the Import Milk Act of February 15, 1927 [21 U.S.C. 141
    et seq.].

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 902(b), (c), 52 Stat. 1059; Pub. L.
    90-399, Sec. 107, July 13, 1968, 82 Stat. 353.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Meat Inspection Act, approved March 4, 1907, as amended,
    referred to in subsec. (a), is act Mar. 4, 1907, ch. 2907, titles I
    to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81 Stat. 584, which
    are classified generally to subchapters I to IV (Sec. 601 et seq.)
    of chapter 12 of this title. For complete classification of this
    Act to the Code, see Short Title note set out under section 601 of
    this title and Tables.
      Act of March 4, 1913, referred to in subsec. (b), is act Mar. 4,
    1913, ch. 145, 37 Stat. 828, as amended. The provisions of such act
    referred to relating to viruses, etc., applicable to domestic
    animals, are contained in the eighth paragraph under the heading
    "Bureau of Animal Industry", 37 Stat. 832, as amended, popularly
    known as the Virus-Serum-Toxin Act, which is classified generally
    to chapter 5 (Sec. 151 et seq.) of this title. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 151 of this title and Tables.
      The Filled Cheese Act of June 6, 1896 (U.S.C., 1934 ed., title
    26, ch. 10), referred to in subsec. (b), is act June 6, 1896, ch.
    337, 29 Stat. 253, as amended, which had been classified to chapter
    10 (Sec. 1000 et seq.) of Title 26, Internal Revenue, and included
    as chapter 17 (Sec. 2350 et seq.) of Title 26, Internal Revenue
    Code of 1939. Such chapter 17 was covered by section 4831 et seq.
    of Title 26, Internal Revenue Code, prior to the repeal of section
    4831 et seq. of Title 26 by Pub. L. 93-490, Sec. 3(a)(1), Oct. 26,
    1974, 88 Stat. 1466.
      The Filled Milk Act of March 4, 1923, referred to in subsec. (b),
    is act Mar. 4, 1923, ch. 262, 42 Stat. 1486, as amended, which is
    classified generally to chapter 3 (Sec. 61 et seq.) of this title.
    For complete classification of this Act to the Code, see Short
    Title note set out under section 61 of this title and Tables.
      The Import Milk Act of February 15, 1927, referred to in subsec.
    (b), is act Feb. 15, 1927, ch. 155, 44 Stat. 1101, as amended,
    which is classified generally to subchapter IV (Sec. 141 et seq.)
    of chapter 4 of this title. For complete classification of this Act
    to the Code, see Short Title note set out under section 141 of this
    title and Tables.

-COD-
                               CODIFICATION                           
      Subsecs. (a) and (b) of this section comprise respectively
    subsecs. (b) and (c) of section 902 of act June 25, 1938. Subsecs.
    (a) and (d) of section 902 of act June 25, 1938, which prescribed
    the effective date of this chapter and made appropriations
    available, are set out as notes under section 301 of this title and
    this section, respectively.


-MISC1-
                                AMENDMENTS                            
      1968 - Subsec. (b). Pub. L. 90-399 substituted "section 262 of
    title 42 (relating to viruses, serums, toxins, and analogous
    products applicable to man)" for "the virus serum, and toxin Act of
    July 1, 1902" and inserted reference to "the virus, serum, toxin,
    and analogous products provisions, applicable to domestic animals,
    of the Act of Congress approved March 4, 1913".

                     EFFECTIVE DATE OF 1968 AMENDMENT                 
      Amendment by Pub. L. 90-399 effective on first day of thirteenth
    calendar month after July 13, 1968, see section 108(a) of Pub. L.
    90-399, set out as an Effective Date and Transitional Provisions
    note under section 360b of this title.

                      AVAILABILITY OF APPROPRIATIONS                  
      Section 902(d) of act June 25, 1938, provided that: "In order to
    carry out the provisions of this Act which take effect [see section
    902(a) of act June 25, 1938, set out as an Effective Date note
    under section 301 of this title] prior to the repeal of the Food
    and Drugs Act of June 30, 1906, as amended [sections 1 to 15 of
    this title], appropriations available for the enforcement of such
    Act of June 30, 1906, are also authorized to be made available to
    carry out such provisions."

-End-



-CITE-
    21 USC Sec. 393                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 393. Food and Drug Administration

-STATUTE-
    (a) In general
      There is established in the Department of Health and Human
    Services the Food and Drug Administration (hereinafter in this
    section referred to as the "Administration").
    (b) Mission
      The Administration shall - 
        (1) promote the public health by promptly and efficiently
      reviewing clinical research and taking appropriate action on the
      marketing of regulated products in a timely manner;
        (2) with respect to such products, protect the public health by
      ensuring that - 
          (A) foods are safe, wholesome, sanitary, and properly
        labeled;
          (B) human and veterinary drugs are safe and effective;
          (C) there is reasonable assurance of the safety and
        effectiveness of devices intended for human use;
          (D) cosmetics are safe and properly labeled; and
          (E) public health and safety are protected from electronic
        product radiation;

        (3) participate through appropriate processes with
      representatives of other countries to reduce the burden of
      regulation, harmonize regulatory requirements, and achieve
      appropriate reciprocal arrangements; and
        (4) as determined to be appropriate by the Secretary, carry out
      paragraphs (1) through (3) in consultation with experts in
      science, medicine, and public health, and in cooperation with
      consumers, users, manufacturers, importers, packers,
      distributors, and retailers of regulated products.
    (c) Interagency collaboration
      The Secretary shall implement programs and policies that will
    foster collaboration between the Administration, the National
    Institutes of Health, and other science-based Federal agencies, to
    enhance the scientific and technical expertise available to the
    Secretary in the conduct of the duties of the Secretary with
    respect to the development, clinical investigation, evaluation, and
    postmarket monitoring of emerging medical therapies, including
    complementary therapies, and advances in nutrition and food
    science.
    (d) Commissioner
      (1) Appointment
        There shall be in the Administration a Commissioner of Food and
      Drugs (hereinafter in this section referred to as the
      "Commissioner") who shall be appointed by the President by and
      with the advice and consent of the Senate.
      (2) General powers
        The Secretary, through the Commissioner, shall be responsible
      for executing this chapter and for - 
          (A) providing overall direction to the Food and Drug
        Administration and establishing and implementing general
        policies respecting the management and operation of programs
        and activities of the Food and Drug Administration;
          (B) coordinating and overseeing the operation of all
        administrative entities within the Administration;
          (C) research relating to foods, drugs, cosmetics, and devices
        in carrying out this chapter;
          (D) conducting educational and public information programs
        relating to the responsibilities of the Food and Drug
        Administration; and
          (E) performing such other functions as the Secretary may
        prescribe.
    (e) Technical and scientific review groups
      The Secretary through the Commissioner of Food and Drugs may,
    without regard to the provisions of title 5 governing appointments
    in the competitive service and without regard to the provisions of
    chapter 51 and subchapter III of chapter 53 of such title relating
    to classification and General Schedule pay rates, establish such
    technical and scientific review groups as are needed to carry out
    the functions of the Administration, including functions under this
    chapter, and appoint and pay the members of such groups, except
    that officers and employees of the United States shall not receive
    additional compensation for service as members of such groups.
    (f) Agency plan for statutory compliance
      (1) In general
        Not later than 1 year after November 21, 1997, the Secretary,
      after consultation with appropriate scientific and academic
      experts, health care professionals, representatives of patient
      and consumer advocacy groups, and the regulated industry, shall
      develop and publish in the Federal Register a plan bringing the
      Secretary into compliance with each of the obligations of the
      Secretary under this chapter. The Secretary shall review the plan
      biannually and shall revise the plan as necessary, in
      consultation with such persons.
      (2) Objectives of agency plan
        The plan required by paragraph (1) shall establish objectives
      and mechanisms to achieve such objectives, including objectives
      related to - 
          (A) maximizing the availability and clarity of information
        about the process for review of applications and submissions
        (including petitions, notifications, and any other similar
        forms of request) made under this chapter;
          (B) maximizing the availability and clarity of information
        for consumers and patients concerning new products;
          (C) implementing inspection and postmarket monitoring
        provisions of this chapter;
          (D) ensuring access to the scientific and technical expertise
        needed by the Secretary to meet obligations described in
        paragraph (1);
          (E) establishing mechanisms, by July 1, 1999, for meeting the
        time periods specified in this chapter for the review of all
        applications and submissions described in subparagraph (A) and
        submitted after November 21, 1997; and
          (F) eliminating backlogs in the review of applications and
        submissions described in subparagraph (A), by January 1, 2000.
    (g) Annual report
      The Secretary shall annually prepare and publish in the Federal
    Register and solicit public comment on a report that - 
        (1) provides detailed statistical information on the
      performance of the Secretary under the plan described in
      subsection (f) of this section;
        (2) compares such performance of the Secretary with the
      objectives of the plan and with the statutory obligations of the
      Secretary; and
        (3) identifies any regulatory policy that has a significant
      negative impact on compliance with any objective of the plan or
      any statutory obligation and sets forth any proposed revision to
      any such regulatory policy.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 903, as added Pub. L. 100-607, title
    V, Sec. 503(a), Nov. 4, 1988, 102 Stat. 3121; amended Pub. L. 100-
    690, title II, Sec. 2631, Nov. 18, 1988, 102 Stat. 4244; Pub. L.
    105-115, title IV, Secs. 406, 414, Nov. 21, 1997, 111 Stat. 2369,
    2377.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The provisions of title 5 governing appointments in the
    competitive service, referred to in subsec. (e), are classified
    generally to section 3301 et seq. of Title 5, Government
    Organization and Employees.

-COD-
                               CODIFICATION                           
      Another section 903 of the Federal Food, Drug, and Cosmetic Act
    was renumbered section 904 and is classified to section 394 of this
    title.


-MISC1-
                                AMENDMENTS                            
      1997 - Subsec. (b). Pub. L. 105-115, Sec. 406(a)(2), added
    subsec. (b). Former subsec. (b) redesignated (d).
      Subsec. (c). Pub. L. 105-115, Sec. 414, added subsec. (c). Former
    subsec. (c) redesignated (e).
      Subsecs. (d), (e). Pub. L. 105-115, Sec. 406(a)(1), redesignated
    subsecs. (b) and (c) as (d) and (e), respectively.
      Subsecs. (f), (g). Pub. L. 105-115, Sec. 406(b), added subsecs.
    (f) and (g).
      1988 - Subsec. (b)(2). Pub. L. 100-690 substituted "shall be
    responsible for executing this chapter and" for "shall be
    responsible".

                     EFFECTIVE DATE OF 1997 AMENDMENT                 
      Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
    1997, except as otherwise provided, see section 501 of Pub. L. 105-
    115, set out as a note under section 321 of this title.

                              EFFECTIVE DATE                          
      Section 503(c) of title V of Pub. L. 100-607 provided that:
      "(1) Except as provided in paragraph (2), the amendments made by
    this title [enacting this section and amending sections 5315 and
    5316 of Title 5, Government Organization and Employees] shall take
    effect on the date of enactment of this Act [Nov. 4, 1988].
      "(2) Section 903(b)(1) of the Federal Food, Drug, and Cosmetic
    Act [21 U.S.C. 393(b)(1)] (as added by subsection (a) of this
    section) shall apply to the appointments of Commissioners of Food
    and Drugs made after the date of enactment of this Act."

       OFFICE OF MINOR USE AND MINOR SPECIES ANIMAL DRUG DEVELOPMENT   
      Pub. L. 108-282, title I, Sec. 102(b)(7), Aug. 2, 2004, 118 Stat.
    905, provided that: "The Secretary of Health and Human Services
    shall establish within the Center for Veterinary Medicine (of the
    Food and Drug Administration), an Office of Minor Use and Minor
    Species Animal Drug Development that reports directly to the
    Director of the Center for Veterinary Medicine. This office shall
    be responsible for overseeing the development and legal marketing
    of new animal drugs for minor uses and minor species. There is
    authorized to be appropriated to carry out this subsection
    $1,200,000 for fiscal year 2004 and such sums as may be necessary
    for each fiscal year thereafter."

                    REGULATIONS FOR SUNSCREEN PRODUCTS                
      Section 129 of Pub. L. 105-115 provided that: "Not later than 18
    months after the date of enactment of this Act [Nov. 21, 1997], the
    Secretary of Health and Human Services shall issue regulations for
    over-the-counter sunscreen products for the prevention or treatment
    of sunburn."

             FDA STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD         
      Section 413 of Pub. L. 105-115 provided that:
      "(a) List and Analysis. - The Secretary of Health and Human
    Services shall, acting through the Food and Drug Administration - 
        "(1) compile a list of drugs and foods that contain
      intentionally introduced mercury compounds, and
        "(2) provide a quantitative and qualitative analysis of the
      mercury compounds in the list under paragraph (1).
    The Secretary shall compile the list required by paragraph (1)
    within 2 years after the date of enactment of the Food and Drug
    Administration Modernization Act of 1997 [Nov. 21, 1997] and shall
    provide the analysis required by paragraph (2) within 2 years after
    such date of enactment.
      "(b) Study. - The Secretary of Health and Human Services, acting
    through the Food and Drug Administration, shall conduct a study of
    the effect on humans of the use of mercury compounds in nasal
    sprays. Such study shall include data from other studies that have
    been made of such use.
      "(c) Study of Mercury Sales. - 
        "(1) Study. - The Secretary of Health and Human Services,
      acting through the Food and Drug Administration and subject to
      appropriations, shall conduct, or shall contract with the
      Institute of Medicine of the National Academy of Sciences to
      conduct, a study of the effect on humans of the use of elemental,
      organic, or inorganic mercury when offered for sale as a drug or
      dietary supplement. Such study shall, among other things,
      evaluate - 
          "(A) the scope of mercury use as a drug or dietary
        supplement; and
          "(B) the adverse effects on health of children and other
        sensitive populations resulting from exposure to, or ingestion
        or inhalation of, mercury when so used.
      In conducting such study, the Secretary shall consult with the
      Administrator of the Environmental Protection Agency, the Chair
      of the Consumer Product Safety Commission, and the Administrator
      of the Agency for Toxic Substances and Disease Registry, and, to
      the extent the Secretary believes necessary or appropriate, with
      any other Federal or private entity.
        "(2) Regulations. - If, in the opinion of the Secretary, the
      use of elemental, organic, or inorganic mercury offered for sale
      as a drug or dietary supplement poses a threat to human health,
      the Secretary shall promulgate regulations restricting the sale
      of mercury intended for such use. At a minimum, such regulations
      shall be designed to protect the health of children and other
      sensitive populations from adverse effects resulting from
      exposure to, or ingestion or inhalation of, mercury. Such
      regulations, to the extent feasible, should not unnecessarily
      interfere with the availability of mercury for use in religious
      ceremonies."

                        MANAGEMENT ACTIVITIES STUDY                    
      Pub. L. 102-571, title II, Sec. 205, Oct. 29, 1992, 106 Stat.
    4502, directed Comptroller General to conduct a study of management
    of activities of the Food and Drug Administration that are related
    to dietary supplements of vitamins, minerals, herbs, or other
    similar nutritional substances and submit an interim report to
    Congress, not later than 6 months after Oct. 29, 1992, with a final
    report to be submitted not later than 12 months after Oct. 29,
    1992.

                          CONGRESSIONAL FINDINGS                      
      Section 502 of Pub. L. 100-607 provided that: "Congress finds
    that - 
        "(1) the public health has been effectively protected by the
      presence of the Food and Drug Administration during the last
      eighty years;
        "(2) the presence and importance of the Food and Drug
      Administration must be guaranteed; and
        "(3) the independence and integrity of the Food and Drug
      Administration need to be enhanced in order to ensure the
      continuing protection of the public health."

-End-



-CITE-
    21 USC Sec. 393a                                            01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 393a. Office of Pediatric Therapeutics

-STATUTE-
    (a) Establishment
      The Secretary of Health and Human Services shall establish an
    Office of Pediatric Therapeutics within the Food and Drug
    Administration.
    (b) Duties
      The Office of Pediatric Therapeutics shall be responsible for
    coordination and facilitation of all activities of the Food and
    Drug Administration that may have any effect on a pediatric
    population or the practice of pediatrics or may in any other way
    involve pediatric issues.
    (c) Staff
      The staff of the Office of Pediatric Therapeutics shall
    coordinate with employees of the Department of Health and Human
    Services who exercise responsibilities relating to pediatric
    therapeutics and shall include - 
        (1) one or more additional individuals with expertise
      concerning ethical issues presented by the conduct of clinical
      research in the pediatric population; and
        (2) one or more additional individuals with expertise in
      pediatrics as may be necessary to perform the activities
      described in subsection (b) of this section.

-SOURCE-
    (Pub. L. 107-109, Sec. 6, Jan. 4, 2002, 115 Stat. 1414.)

-COD-
                               CODIFICATION                           
      Section was enacted as part of the Best Pharmaceuticals for
    Children Act, and not as part of the Federal Food, Drug, and
    Cosmetic Act which comprises this chapter.

-End-



-CITE-
    21 USC Sec. 394                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 394. Scientific review groups

-STATUTE-
      Without regard to the provisions of title 5 governing
    appointments in the competitive service and without regard to the
    provisions of chapter 51 and subchapter III of chapter 53 of such
    title relating to classification and General Schedule pay rates,
    the Commissioner of Food and Drugs may - 
        (1) establish such technical and scientific review groups as
      are needed to carry out the functions of the Food and Drug
      Administration (including functions prescribed under this
      chapter); and
        (2) appoint and pay the members of such groups, except that
      officers and employees of the United States shall not receive
      additional compensation for service as members of such groups.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 904, formerly Sec. 903, as added Pub.
    L. 101-635, title III, Sec. 301, Nov. 28, 1990, 104 Stat. 4584;
    renumbered Sec. 904, Pub. L. 103-43, title XX, Sec. 2006(1), June
    10, 1993, 107 Stat. 209.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The provisions of title 5 governing appointments in the
    competitive service, referred to in text, are classified generally
    to section 3301 et seq. of Title 5, Government Organization and
    Employees.

-End-



-CITE-
    21 USC Sec. 395                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 395. Loan repayment program

-STATUTE-
    (a) In general
      (1) Authority for program
        Subject to paragraph (2), the Secretary shall carry out a
      program of entering into contracts with appropriately qualified
      health professionals under which such health professionals agree
      to conduct research, as employees of the Food and Drug
      Administration, in consideration of the Federal Government
      agreeing to repay, for each year of such service, not more than
      $20,000 of the principal and interest of the educational loans of
      such health professionals.
      (2) Limitation
        The Secretary may not enter into an agreement with a health
      professional pursuant to paragraph (1) unless such professional -
      
          (A) has a substantial amount of educational loans relative to
        income; and
          (B) agrees to serve as an employee of the Food and Drug
        Administration for purposes of paragraph (1) for a period of
        not less than 3 years.
    (b) Applicability of certain provisions
      With respect to the National Health Service Corps Loan Repayment
    Program established in subpart III of part D of title III of the
    Public Health Service Act [42 U.S.C. 254l et seq.], the provisions
    of such subpart shall, except as inconsistent with subsection (a)
    of this section, apply to the program established in such
    subsection in the same manner and to the same extent as such
    provisions apply to the National Health Service Corps Loan
    Repayment Program.
    (c) Authorization of appropriations
      For the purpose of carrying out this section, there are
    authorized to be appropriated such sums as may be necessary for
    each of the fiscal years 1994 through 1996.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 905, as added Pub. L. 103-43, title
    XX, Sec. 2006(2), June 10, 1993, 107 Stat. 210.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Public Health Service Act, referred to in subsec. (b), is act
    July 1, 1944, ch. 373, 58 Stat. 682, as amended. Subpart III of
    part D of title III of the Act is classified generally to subpart
    III [Sec. 254l et seq.] of part D of subchapter II of chapter 6A of
    Title 42, The Public Health and Welfare. For complete
    classification of this Act to the Code, see Short Title note set
    out under section 201 of Title 42 and Tables.

-End-



-CITE-
    21 USC Sec. 396                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 396. Practice of medicine

-STATUTE-
      Nothing in this chapter shall be construed to limit or interfere
    with the authority of a health care practitioner to prescribe or
    administer any legally marketed device to a patient for any
    condition or disease within a legitimate health care practitioner-
    patient relationship. This section shall not limit any existing
    authority of the Secretary to establish and enforce restrictions on
    the sale or distribution, or in the labeling, of a device that are
    part of a determination of substantial equivalence, established as
    a condition of approval, or promulgated through regulations.
    Further, this section shall not change any existing prohibition on
    the promotion of unapproved uses of legally marketed devices.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 906, as added Pub. L. 105-115, title
    II, Sec. 214, Nov. 21, 1997, 111 Stat. 2348.)


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 397                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 397. Contracts for expert review

-STATUTE-
    (a) In general
      (1) Authority
        The Secretary may enter into a contract with any organization
      or any individual (who is not an employee of the Department) with
      relevant expertise, to review and evaluate, for the purpose of
      making recommendations to the Secretary on, part or all of any
      application or submission (including a petition, notification,
      and any other similar form of request) made under this chapter
      for the approval or classification of an article or made under
      section 351(a) of the Public Health Service Act (42 U.S.C.
      262(a)) with respect to a biological product. Any such contract
      shall be subject to the requirements of section 379 of this title
      relating to the confidentiality of information.
      (2) Increased efficiency and expertise through contracts
        The Secretary may use the authority granted in paragraph (1)
      whenever the Secretary determines that use of a contract
      described in paragraph (1) will improve the timeliness of the
      review of an application or submission described in paragraph
      (1), unless using such authority would reduce the quality, or
      unduly increase the cost, of such review. The Secretary may use
      such authority whenever the Secretary determines that use of such
      a contract will improve the quality of the review of an
      application or submission described in paragraph (1), unless
      using such authority would unduly increase the cost of such
      review. Such improvement in timeliness or quality may include
      providing the Secretary increased scientific or technical
      expertise that is necessary to review or evaluate new therapies
      and technologies.
    (b) Review of expert review
      (1) In general
        Subject to paragraph (2), the official of the Food and Drug
      Administration responsible for any matter for which expert review
      is used pursuant to subsection (a) of this section shall review
      the recommendations of the organization or individual who
      conducted the expert review and shall make a final decision
      regarding the matter in a timely manner.
      (2) Limitation
        A final decision by the Secretary on any such application or
      submission shall be made within the applicable prescribed time
      period for review of the matter as set forth in this chapter or
      in the Public Health Service Act (42 U.S.C. 201 et seq.).

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 907, as added Pub. L. 105-115, title
    IV, Sec. 415, Nov. 21, 1997, 111 Stat. 2377.)

-REFTEXT-
                            REFERENCES IN TEXT                        
      The Public Health Service Act, referred to in subsec. (b)(2), is
    act July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is
    classified generally to chapter 6A (Sec. 201 et seq.) of Title 42,
    The Public Health and Welfare. For complete classification of this
    Act to the Code, see Short Title note set out under section 201 of
    Title 42 and Tables.


-MISC1-
                              EFFECTIVE DATE                          
      Section effective 90 days after Nov. 21, 1997, except as
    otherwise provided, see section 501 of Pub. L. 105-115, set out as
    an Effective Date of 1997 Amendment note under section 321 of this
    title.

-End-



-CITE-
    21 USC Sec. 398                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 398. Notices to States regarding imported food

-STATUTE-
    (a) In general
      If the Secretary has credible evidence or information indicating
    that a shipment of imported food or portion thereof presents a
    threat of serious adverse health consequences or death to humans or
    animals, the Secretary shall provide notice regarding such threat
    to the States in which the food is held or will be held, and to the
    States in which the manufacturer, packer, or distributor of the
    food is located, to the extent that the Secretary has knowledge of
    which States are so involved. In providing notice to a State, the
    Secretary shall request the State to take such action as the State
    considers appropriate, if any, to protect the public health
    regarding the food involved.
    (b) Rule of construction
      Subsection (a) of this section may not be construed as limiting
    the authority of the Secretary with respect to food under any other
    provision of this chapter.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 908, as added Pub. L. 107-188, title
    III, Sec. 310, June 12, 2002, 116 Stat. 673.)

-End-



-CITE-
    21 USC Sec. 399                                             01/03/2007

-EXPCITE-
    TITLE 21 - FOOD AND DRUGS
    CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
    SUBCHAPTER IX - MISCELLANEOUS

-HEAD-
    Sec. 399. Grants to States for inspections

-STATUTE-
    (a) In general
      The Secretary is authorized to make grants to States,
    territories, and Indian tribes (as defined in section 450b(e) of
    title 25) that undertake examinations, inspections, and
    investigations, and related activities under section 372 of this
    title. The funds provided under such grants shall only be available
    for the costs of conducting such examinations, inspections,
    investigations, and related activities.
    (b) Notices regarding adulterated imported food
      The Secretary may make grants to the States for the purpose of
    assisting the States with the costs of taking appropriate action to
    protect the public health in response to notification under section
    398 of this title, including planning and otherwise preparing to
    take such action.
    (c) Authorization of appropriations
      For the purpose of carrying out this section, there are
    authorized to be appropriated $10,000,000 for fiscal year 2002, and
    such sums as may be necessary for each of the fiscal years 2003
    through 2006.

-SOURCE-
    (June 25, 1938, ch. 675, Sec. 909, as added Pub. L. 107-188, title
    III, Sec. 311, June 12, 2002, 116 Stat. 673.)

-End-