PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 823 

Public Law 110–85 

110th Congress 

An Act 

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the 

user-fee programs for prescription drugs and for medical devices, to enhance 

the postmarket authorities of the Food and Drug Administration with respect 

to the safety of drugs, and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Food and Drug Administration 

Amendments Act of 2007’’. 

SEC. 2. TABLE OF CONTENTS. 

The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007 

Sec. 101. Short title; references in title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use drug fees. 

Sec. 104. Fees relating to advisory review of prescription-drug television advertising. 

Sec. 105. Reauthorization; reporting requirements. 

Sec. 106. Sunset dates. 

Sec. 107. Effective date. 

Sec. 108. Savings clause. 

Sec. 109. Technical amendment; conforming amendment. 

TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2007 

Sec. 201. Short title; references in title; finding. 

Subtitle A—Fees Related to Medical Devices 

Sec. 211. Definitions. 

Sec. 212. Authority to assess and use device fees. 

Sec. 213. Reauthorization; reporting requirements. 

Sec. 214. Savings clause. 

Sec. 215. Additional authorization of appropriations for postmarket safety information. 

Sec. 216. Effective date. 

Sec. 217. Sunset clause. 

Subtitle B—Amendments Regarding Regulation of Medical Devices 

Sec. 221. Extension of authority for third party review of premarket notification. 

Sec. 222. Registration. 

Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, 

and compounded by registrants; statements; accompanying disclosures. 

Sec. 224. Electronic registration and listing. 

Sec. 225. Report by Government Accountability Office. 

Sec. 226. Unique device identification system. 

Sec. 227. Frequency of reporting for certain devices. 

21 USC 301 note. 

Food and Drug 

Administration 

Amendments Act 

of 2007. 

Sept. 27, 2007 

[H.R. 3580] 


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Sec. 228. Inspections by accredited persons. 

Sec. 229. Study of nosocomial infections relating to medical devices. 

Sec. 230. Report by the Food and Drug Administration regarding labeling information on the relationship between the use of indoor tanning devices and 

development of skin cancer or other skin damage. 

TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT 

OF 2007 

Sec. 301. Short title. 

Sec. 302. Tracking pediatric device approvals. 

Sec. 303. Modification to humanitarian device exemption. 

Sec. 304. Encouraging pediatric medical device research. 

Sec. 305. Demonstration grants for improving pediatric device availability. 

Sec. 306. Amendments to office of pediatric therapeutics and pediatric advisory 

committee. 

Sec. 307. Postmarket surveillance. 

TITLE IV—PEDIATRIC RESEARCH EQUITY ACT OF 2007 

Sec. 401. Short title. 

Sec. 402. Reauthorization of Pediatric Research Equity Act. 

Sec. 403. Establishment of internal committee. 

Sec. 404. Government Accountability Office report. 

TITLE V—BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007 

Sec. 501. Short title. 

Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act. 

Sec. 503. Training of pediatric pharmacologists. 

TITLE VI—REAGAN-UDALL FOUNDATION 

Sec. 601. The Reagan-Udall Foundation for the Food and Drug Administration. 

Sec. 602. Office of the Chief Scientist. 

Sec. 603. Critical path public-private partnerships. 

TITLE VII—CONFLICTS OF INTEREST 

Sec. 701. Conflicts of interest. 

TITLE VIII—CLINICAL TRIAL DATABASES 

Sec. 801. Expanded clinical trial registry data bank. 

TITLE IX—ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY 

OF DRUGS 

Subtitle A—Postmarket Studies and Surveillance 

Sec. 901. Postmarket studies and clinical trials regarding human drugs; risk evaluation and mitigation strategies. 

Sec. 902. Enforcement. 

Sec. 903. No effect on withdrawal or suspension of approval. 

Sec. 904. Benefit-risk assessments. 

Sec. 905. Active postmarket risk identification and analysis. 

Sec. 906. Statement for inclusion in direct-to-consumer advertisements of drugs. 

Sec. 907. No effect on veterinary medicine. 

Sec. 908. Authorization of appropriations. 

Sec. 909. Effective date and applicability. 

Subtitle B—Other Provisions to Ensure Drug Safety and Surveillance 

Sec. 911. Clinical trial guidance for antibiotic drugs. 

Sec. 912. Prohibition against food to which drugs or biological products have been 

added. 

Sec. 913. Assuring pharmaceutical safety. 

Sec. 914. Citizen petitions and petitions for stay of agency action. 

Sec. 915. Postmarket drug safety information for patients and providers. 

Sec. 916. Action package for approval. 

Sec. 917. Risk communication. 

Sec. 918. Referral to advisory committee. 

Sec. 919. Response to the institute of medicine. 

Sec. 920. Database for authorized generic drugs. 

Sec. 921. Adverse drug reaction reports and postmarket safety. 

TITLE X—FOOD SAFETY 

Sec. 1001. Findings. 


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Sec. 1002. Ensuring the safety of pet food. 

Sec. 1003. Ensuring efficient and effective communications during a recall. 

Sec. 1004. State and Federal Cooperation. 

Sec. 1005. Reportable Food Registry. 

Sec. 1006. Enhanced aquaculture and seafood inspection. 

Sec. 1007. Consultation regarding genetically engineered seafood products. 

Sec. 1008. Sense of Congress. 

Sec. 1009. Annual report to Congress. 

Sec. 1010. Publication of annual reports. 

Sec. 1011. Rule of construction. 

TITLE XI—OTHER PROVISIONS 

Subtitle A—In General 

Sec. 1101. Policy on the review and clearance of scientific articles published by 

FDA employees. 

Sec. 1102. Priority review to encourage treatments for tropical diseases. 

Sec. 1103. Improving genetic test safety and quality. 

Sec. 1104. NIH Technical amendments. 

Sec. 1105. Severability clause. 

Subtitle B—Antibiotic Access and Innovation 

Sec. 1111. Identification of clinically susceptible concentrations of antimicrobials. 

Sec. 1112. Orphan antibiotic drugs. 

Sec. 1113. Exclusivity of certain drugs containing single enantiomers. 

Sec. 1114. Report. 

TITLE I—PRESCRIPTION DRUG USER 

FEE AMENDMENTS OF 2007 

SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Prescription 

Drug User Fee Amendments of 2007’’. 

(b) REFERENCES IN TITLE.—Except as otherwise specified, 

amendments made by this title to a section or other provision 

of law are amendments to such section or other provision of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

(c) FINDING.—The Congress finds that the fees authorized by 

the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review 

of human drug applications, including postmarket drug safety 

activities, 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, in the letters from the Secretary of Health and 

Human Services to the Chairman of the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Chairman 

of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. 

SEC. 102. DEFINITIONS. 

Section 735 (21 U.S.C. 379g) is amended— 

(1) in the matter before paragraph (1), by striking ‘‘For 

purposes of this subchapter’’ and inserting ‘‘For purposes of 

this part’’; 

(2) in paragraph (1)— 

(A) in subparagraph (A), by striking ‘‘505(b)(1),’’ and 

inserting ‘‘505(b), or’’; 

(B) by striking subparagraph (B); 

(C) by redesignating subparagraph (C) as subparagraph (B); and 

21 USC 379g 

note. 

21 USC 301 note. 

Prescription 

Drug User Fee 

Amendments of 

2007. 


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121 STAT. 826 PUBLIC LAW 110–85—SEPT. 27, 2007 

(D) in the matter following subparagraph (B), as so 

redesignated, by striking ‘‘subparagraph (C)’’ and inserting 

‘‘subparagraph (B)’’; 

(3) in paragraph (3)(C)— 

(A) by striking ‘‘505(j)(7)(A)’’ and inserting ‘‘505(j)(7)(A) 

(not including the discontinued section of such list)’’; and 

(B) by inserting before the period ‘‘(not including the 

discontinued section of such list)’’; 

(4) in paragraph (4), by inserting before the period at 

the end the following: ‘‘(such as capsules, tablets, or lyophilized 

products before reconstitution)’’; 

(5) by amending paragraph (6)(F) to read as follows: 

‘‘(F) Postmarket safety activities with respect to drugs 

approved under human drug applications or supplements, 

including the following activities: 

‘‘(i) Collecting, developing, and reviewing safety 

information on approved drugs, including adverse 

event reports. 

‘‘(ii) Developing and using improved adverse-event 

data-collection systems, including information technology systems. 

‘‘(iii) Developing and using improved analytical 

tools to assess potential safety problems, including 

access to external data bases. 

‘‘(iv) Implementing and enforcing section 505(o) 

(relating to postapproval studies and clinical trials and 

labeling changes) and section 505(p) (relating to risk 

evaluation and mitigation strategies). 

‘‘(v) Carrying out section 505(k)(5) (relating to 

adverse event reports and postmarket safety activities).’’; 

(6) in paragraph (8)— 

(A) by striking ‘‘April of the preceding fiscal year’’ 

and inserting ‘‘October of the preceding fiscal year’’; and 

(B) by striking ‘‘April 1997’’ and inserting ‘‘October 

1996’’; 

(7) by redesignating paragraph (9) as paragraph (11); and 

(8) by inserting after paragraph (8) the following paragraphs: 

‘‘(9) The term ‘person’ includes an affiliate thereof. 

‘‘(10) The term ‘active’, with respect to a commercial investigational new drug application, means such an application 

to which information was submitted during the relevant 

period.’’. 

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 

(a) TYPES OF FEES.—Section 736(a) (21 U.S.C. 379h(a)) is 

amended— 

(1) in the matter preceding paragraph (1), by striking 

‘‘2003’’ and inserting ‘‘2008’’; 

(2) in paragraph (1)— 

(A) in subparagraph (D)— 

(i) in the heading, by inserting ‘‘OR WITHDRAWN

BEFORE FILING’’ after ‘‘REFUSED FOR FILING’’; and 

(ii) by inserting before the period at the end the 

following: ‘‘or withdrawn without a waiver before 

filing’’; 


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(B) by redesignating subparagraphs (E) and (F) as 

subparagraphs (F) and (G), respectively; and 

(C) by inserting after subparagraph (D) the following: 

‘‘(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR

FILING OR WITHDRAWN BEFORE FILING.—A human drug 

application or supplement that was submitted but was 

refused for filing, or was withdrawn before being accepted 

or refused for filing, shall be subject to the full fee under 

subparagraph (A) upon being resubmitted or filed over 

protest, unless the fee is waived or reduced under subsection (d).’’; and 

(3) in paragraph (2)— 

(A) in subparagraph (A), by striking ‘‘subparagraph 

(B)’’ and inserting ‘‘subparagraphs (B) and (C)’’; and 

(B) by adding at the end the following: 

‘‘(C) SPECIAL RULES FOR POSITRON EMISSION TOMOGRAPHY DRUGS.— 

‘‘(i) IN GENERAL.—Except as provided in clause 

(ii), each person who is named as the applicant in 

an approved human drug application for a positron 

emission tomography drug shall be subject under 

subparagraph (A) to one-sixth of an annual establishment fee with respect to each such establishment 

identified in the application as producing positron 

emission tomography drugs under the approved 

application. 

‘‘(ii) EXCEPTION FROM ANNUAL ESTABLISHMENT

FEE.—Each person who is named as the applicant in 

an application described in clause (i) shall not be 

assessed an annual establishment fee for a fiscal year 

if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified 

by the Secretary, that— 

‘‘(I) the person is a not-for-profit medical center 

that has only 1 establishment for the production 

of positron emission tomography drugs; and 

‘‘(II) at least 95 percent of the total number 

of doses of each positron emission tomography drug 

produced by such establishment during such fiscal 

year will be used within the medical center. 

‘‘(iii) DEFINITION.—For purposes of this subparagraph, the term ‘positron emission tomography drug’ 

has the meaning given to the term ‘compounded 

positron emission tomography drug’ in section 201(ii), 

except that paragraph (1)(B) of such section shall not 

apply.’’. 

(b) FEE REVENUE AMOUNTS.—Section 736(b) (21 U.S.C. 379h(b)) 

is amended to read as follows: 

‘‘(b) FEE REVENUE AMOUNTS.— 

‘‘(1) IN GENERAL.—For each of the fiscal years 2008 through 

2012, fees under subsection (a) shall, except as provided in 

subsections (c), (d), (f), and (g), be established to generate 

a total revenue amount under such subsection that is equal 

to the sum of— 

‘‘(A) $392,783,000; and 


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‘‘(B) an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)). 

‘‘(2) TYPES OF FEES.—Of the total revenue amount determined for a fiscal year under paragraph (1)— 

‘‘(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and 

supplements); 

‘‘(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); 

and 

‘‘(C) one-third shall be derived from fees under subsection (a)(3) (relating to prescription drug products). 

‘‘(3) MODIFIED WORKLOAD ADJUSTMENT FACTOR FOR FISCAL

YEAR 2007.—For purposes of paragraph (1)(B), the Secretary 

shall determine the modified workload adjustment factor by 

determining the dollar amount that results from applying the 

methodology that was in effect under subsection (c)(2) for fiscal 

year 2007 to the amount $354,893,000, except that, with respect 

to the portion of such determination that is based on the 

change in the total number of commercial investigational new 

drug applications, the Secretary shall count the number of 

such applications that were active during the most recent 12- 

month period for which data on such submissions is available. 

‘‘(4) ADDITIONAL FEE REVENUES FOR DRUG SAFETY.— 

‘‘(A) IN GENERAL.—For each of the fiscal years 2008 

through 2012, paragraph (1)(A) shall be applied by substituting the amount determined under subparagraph (B) 

for ‘$392,783,000’. 

‘‘(B) AMOUNT DETERMINED.—For each of the fiscal years 

2008 through 2012, the amount determined under this 

subparagraph is the sum of— 

‘‘(i) $392,783,000; plus 

‘‘(ii)(I) for fiscal year 2008, $25,000,000; 

‘‘(II) for fiscal year 2009, $35,000,000; 

‘‘(III) for fiscal year 2010, $45,000,000; 

‘‘(IV) for fiscal year 2011, $55,000,000; and 

‘‘(V) for fiscal year 2012, $65,000,000.’’. 

(c) ADJUSTMENTS TO FEES.— 

(1) INFLATION ADJUSTMENT.—Section 736(c)(1) (21 U.S.C. 

379h(c)(1)) is amended— 

(A) in the matter preceding subparagraph (A), by 

striking ‘‘The revenues established in subsection (b)’’ and 

inserting ‘‘For fiscal year 2009 and subsequent fiscal years, 

the revenues established in subsection (b)’’; 

(B) in subparagraph (A), by striking ‘‘or’’ at the end; 

(C) in subparagraph (B), by striking the period at 

the end and inserting ‘‘, or’’; 

(D) by inserting after subparagraph (B) the following: 

‘‘(C) the average annual change in the cost, per fulltime equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with 

respect to such positions for the first 5 years of the preceding 6 fiscal years.’’; and 

(E) in the matter following subparagraph (C) (as added 

by subparagraph (D)), by striking ‘‘fiscal year 2003’’ and 

inserting ‘‘fiscal year 2008’’. 

Applicability. 


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(2) WORKLOAD ADJUSTMENT.—Section 736(c)(2) (21 U.S.C. 

379h(c)(2)) is amended— 

(A) in the matter preceding subparagraph (A), by 

striking ‘‘Beginning with fiscal year 2004,’’ and inserting 

‘‘For fiscal year 2009 and subsequent fiscal years,’’; 

(B) in subparagraph (A), in the first sentence— 

(i) by striking ‘‘human drug applications,’’ and 

inserting ‘‘human drug applications (adjusted for 

changes in review activities, as described in the notice 

that the Secretary is required to publish in the Federal 

Register under this subparagraph),’’; 

(ii) by striking ‘‘commercial investigational new 

drug applications,’’; and 

(iii) by inserting before the period the following: 

‘‘, and the change in the total number of active commercial investigational new drug applications (adjusted 

for changes in review activities, as so described) during 

the most recent 12-month period for which data on 

such submissions is available’’; 

(C) in subparagraph (B), by adding at the end the 

following: ‘‘Any adjustment for changes in review activities 

made in setting fees and revenue amounts for fiscal year 

2009 may not result in the total workload adjustment 

being more than 2 percentage points higher than it would 

have been in the absence of the adjustment for changes 

in review activities.’’; and 

(D) by adding at the end the following: 

‘‘(C) The Secretary shall contract with an independent 

accounting firm to study the adjustment for changes in 

review activities applied in setting fees and revenue 

amounts for fiscal year 2009 and to make recommendations, 

if warranted, for future changes in the methodology for 

calculating the adjustment. After review of the recommendations, the Secretary shall, if warranted, make 

appropriate changes to the methodology, and the changes 

shall be effective for each of the fiscal years 2010 through 

2012. The Secretary shall not make any adjustment for 

changes in review activities for any fiscal year after 2009 

unless such study has been completed.’’. 

(3) RENT AND RENT-RELATED COST ADJUSTMENT.—Section 

736(c) (21 U.S.C. 379h(c)) is amended— 

(A) by redesignating paragraphs (3), (4), and (5) as 

paragraphs (4), (5), and (6), respectively; and 

(B) by inserting after paragraph (2) the following: 

‘‘(3) RENT AND RENT-RELATED COST ADJUSTMENT.—For fiscal 

year 2010 and each subsequent fiscal year, the Secretary shall, 

before making adjustments under paragraphs (1) and (2), 

decrease the fee revenue amount established in subsection (b) 

if actual costs paid for rent and rent-related expenses for the 

preceding fiscal year are less than estimates made for such 

year in fiscal year 2006. Any reduction made under this paragraph shall not exceed the amount by which such costs fall 

below the estimates made in fiscal year 2006 for such fiscal 

year, and shall not exceed $11,721,000 for any fiscal year.’’. 

(4) FINAL YEAR ADJUSTMENT.—Paragraph (4) of section 

736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), 

is amended to read as follows: 

Effective date. 

Contracts. 

Study. 


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‘‘(4) FINAL YEAR ADJUSTMENT.— 

‘‘(A) INCREASE IN FEES.—For fiscal year 2012, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), further increase 

the fee revenues and fees established in subsection (b) 

if such an adjustment is necessary to provide for not more 

than 3 months of operating reserves of carryover user 

fees for the process for the review of human drug applications for the first 3 months of fiscal year 2013. 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 2012. 

If the Secretary has carryover balances for such process 

in excess of 3 months of such operating reserves, the adjustment under this subparagraph shall not be made. 

‘‘(B) DECREASE IN FEES.— 

‘‘(i) IN GENERAL.—For fiscal year 2012, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), decrease the 

fee revenues and fees established in subsection (b) 

by the amount determined in clause (ii), if, for fiscal 

year 2009 or 2010— 

‘‘(I) the amount of the total appropriations for 

the Food and Drug Administration for such fiscal 

year (excluding the amount of fees appropriated 

for such fiscal year) exceeds the amount of the 

total appropriations for the Food and Drug 

Administration for fiscal year 2008 (excluding the 

amount of fees appropriated for such fiscal year), 

adjusted as provided under paragraph (1); and 

‘‘(II) the amount of the total appropriations 

expended for the process for the review of human 

drug applications at the Food and Drug Administration for such fiscal year (excluding the amount 

of fees appropriated for such fiscal year) exceeds 

the amount of appropriations expended for the 

process for the review of human drug applications 

at the Food and Drug Administration for fiscal 

year 2008 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided 

under paragraph (1). 

‘‘(ii) AMOUNT OF DECREASE.—The amount determined in this clause is the lesser of— 

‘‘(I) the amount equal to the sum of the 

amounts that, for each of fiscal years 2009 and 

2010, is the lesser of— 

‘‘(aa) the excess amount described in 

clause (i)(II) for such fiscal year; or 

‘‘(bb) the amount specified in subsection 

(b)(4)(B)(ii) for such fiscal year; or 

‘‘(II) $65,000,000. 

‘‘(iii) LIMITATIONS.— 

‘‘(I) FISCAL YEAR CONDITION.—In making the 

determination under clause (ii), an amount 

described in subclause (I) of such clause for fiscal 

year 2009 or 2010 shall be taken into account 


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only if subclauses (I) and (II) of clause (i) apply 

to such fiscal year. 

‘‘(II) RELATION TO SUBPARAGRAPH (A).—The 

Secretary shall limit any decrease under this paragraph if such a limitation is necessary to provide 

for the 3 months of operating reserves described 

in subparagraph (A).’’. 

(5) LIMIT.—Paragraph (5) of section 736(c) (21 U.S.C. 

379h(c)), as redesignated by paragraph (3)(A), is amended by 

striking ‘‘2002’’ and inserting ‘‘2007’’. 

(d) FEE WAIVER OR REDUCTION.—Section 736(d) (21 U.S.C. 

379h(d)) is amended— 

(1) in paragraph (1), in the matter preceding subparagraph 

(A)— 

(A) by inserting after ‘‘The Secretary shall grant’’ the 

following: ‘‘to a person who is named as the applicant 

in a human drug application’’; and 

(B) by inserting ‘‘to that person’’ after ‘‘one or more 

fees assessed’’; 

(2) by redesignating paragraphs (2) and (3) as paragraphs 

(3) and (4), respectively; 

(3) by inserting after paragraph (1) the following: 

‘‘(2) CONSIDERATIONS.—In determining whether to grant 

a waiver or reduction of a fee under paragraph (1), the Secretary 

shall consider only the circumstances and assets of the 

applicant involved and any affiliate of the applicant.’’; and 

(4) in paragraph (4) (as redesignated by paragraph (2)), 

in subparagraph (A), by inserting before the period the following: ‘‘, and that does not have a drug product that has 

been approved under a human drug application and introduced 

or delivered for introduction into interstate commerce’’. 

(e) CREDITING AND AVAILABILITY OF FEES.— 

(1) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3) 

(21 U.S.C. 379h(g)(3)) is amended to read as follows: 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 

fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the 

total revenue amount determined under subsection (b) for the 

fiscal year, as adjusted or otherwise affected under subsection 

(c) and paragraph (4) of this subsection.’’. 

(2) OFFSET.—Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 

amended to read as follows: 

‘‘(4) OFFSET.—If the sum of the cumulative amount of fees 

collected under this section for the fiscal years 2008 through 

2010 and the amount of fees estimated to be collected under 

this section for fiscal year 2011 exceeds the cumulative amount 

appropriated under paragraph (3) for the fiscal years 2008 

through 2011, the excess 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 fiscal year 

2012.’’. 

(f) EXEMPTION FOR ORPHAN DRUGS.—Section 736 (21 U.S.C. 

379h) is further amended by adding at the end the following: 

‘‘(k) ORPHAN DRUGS.— 


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‘‘(1) EXEMPTION.—A drug designated under section 526 for 

a rare disease or condition and approved under section 505 

or under section 351 of the Public Health Service Act shall 

be exempt from product and establishment fees under this 

section, if the drug meets all of the following conditions: 

‘‘(A) The drug meets the public health requirements 

contained in this Act as such requirements are applied 

to requests for waivers for product and establishment fees. 

‘‘(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross 

worldwide revenue during the previous year. 

‘‘(2) EVIDENCE OF QUALIFICATION.—An exemption under 

paragraph (1) applies with respect to a drug only if the 

applicant involved submits a certification that its gross annual 

revenues did not exceed $50,000,000 for the preceding 12 

months before the exemption was requested.’’. 

(g) CONFORMING AMENDMENT.—Section 736(a) (21 U.S.C. 

379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and 

(3)(A) by striking ‘‘(c)(4)’’ each place such term appears and inserting 

‘‘(c)(5)’’. 

(h) TECHNICAL AMENDMENT.— (1) AMENDMENT.—Section 736(g)(1) (21 U.S.C. 379h(g)(1)) 

is amended by striking the first sentence and inserting the 

following: ‘‘Fees authorized under subsection (a) 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.’’. 

(2) EFFECTIVE DATE.—Paragraph (1) shall take effect as 

if included in section 504 of the Prescription Drug User Fee 

Amendments of 2002 (Public Law 107–188; 116 Stat. 687). 

SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTIONDRUG TELEVISION ADVERTISING. 

Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et 

seq.) is amended by adding after section 736 the following: 

‘‘SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTIONDRUG TELEVISION ADVERTISING. 

‘‘(a) TYPES OF DIRECT-TO-CONSUMER TELEVISION ADVERTISE- MENT REVIEW FEES.—Beginning in fiscal year 2008, the Secretary 

shall assess and collect fees in accordance with this section as 

follows: 

‘‘(1) ADVISORY REVIEW FEE.— ‘‘(A) IN GENERAL.—With respect to a proposed directto-consumer television advertisement (referred to in this 

section as a ‘DTC advertisement’), each person that on 

or after October 1, 2007, submits such an advertisement 

for advisory review by the Secretary prior to its initial 

public dissemination shall, except as provided in subparagraph (B), be subject to a fee established under subsection 

(c)(3). 

‘‘(B) EXCEPTION FOR REQUIRED SUBMISSIONS.—A DTC 

advertisement that is required to be submitted to the Secretary prior to initial public dissemination is not subject 

to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for advisory review. 

‘‘(C) NOTICE TO SECRETARY OF NUMBER OF

Deadlines. ADVERTISEMENTS.—Not later than June 1 of each fiscal 

Federal Register, 

publication. 

Effective date. 

21 USC 379h–1. 

21 USC 379h 

note. 


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year, the Secretary shall publish a notice in the Federal 

Register requesting any person to notify the Secretary 

within 30 days of the number of DTC advertisements the 

person intends to submit for advisory review in the next 

fiscal year. Notwithstanding the preceding sentence, for 

fiscal year 2008, the Secretary shall publish such a notice 

in the Federal Register not later than 30 days after the 

date of the enactment of the Food and Drug Administration 

Amendments Act of 2007. 

‘‘(D) PAYMENT.— ‘‘(i) IN GENERAL.—The fee required by subparagraph (A) (referred to in this section as ‘an advisory 

review fee’) shall be due not later than October 1 

of the fiscal year in which the DTC advertisement 

involved is intended to be submitted for advisory 

review, subject to subparagraph (F)(i). Notwithstanding 

the preceding sentence, the advisory review fee for 

any DTC advertisement that is intended to be submitted for advisory review during fiscal year 2008 shall 

be due not later than 120 days after the date of the 

enactment of the Food and Drug Administration 

Amendments of 2007 or an earlier date as specified 

by the Secretary. 

‘‘(ii) EFFECT OF SUBMISSION.—Notification of the 

Secretary under subparagraph (C) of the number of 

DTC advertisements a person intends to submit for 

advisory review is a legally binding commitment by 

that person to pay the annual advisory review fee 

for that number of submissions on or before October 

1 of the fiscal year in which the advertisement is 

intended to be submitted. Notwithstanding the preceding sentence, the commitment shall be a legally 

binding commitment by that person to pay the annual 

advisory review fee for that number of submissions 

for fiscal year 2008 by the date specified in clause 

(i). 

‘‘(iii) NOTICE REGARDING CARRYOVER SUBMISSIONS.—In making a notification under subparagraph 

(C), the person involved shall in addition notify the 

Secretary if under subparagraph (F)(i) the person 

intends to submit a DTC advertisement for which the 

advisory review fee has already been paid. If the person 

does not so notify the Secretary, each DTC advertisement submitted by the person for advisory review in 

the fiscal year involved shall be subject to the advisory 

review fee. 

‘‘(E) MODIFICATION OF ADVISORY REVIEW FEE.— 

‘‘(i) LATE PAYMENT.—If a person has submitted 

a notification under subparagraph (C) with respect 

to a fiscal year and has not paid all advisory review 

fees due under subparagraph (D) not later than 

November 1 of such fiscal year (or, in the case of 

such a notification submitted with respect to fiscal 

year 2008, not later than 150 days after the date 

of the enactment of the Food and Drug Administration 

Amendments Act of 2007 or an earlier date specified 

by the Secretary), the fees shall be regarded as late 

Applicability. 

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and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, all advisory review 

fees for such fiscal year shall be due and payable 

20 days before any direct-to-consumer advertisement 

is submitted to the Secretary for advisory review, and 

each such fee shall be equal to 150 percent of the 

fee that otherwise would have applied pursuant to 

subsection (c)(3). 

‘‘(ii) EXCEEDING IDENTIFIED NUMBER OF SUBMISSIONS.—If a person submits a number of DTC 

advertisements for advisory review in a fiscal year 

that exceeds the number identified by the person under 

subparagraph (C), an increase in the amount of fees 

applies under this clause for each submission in excess 

of such number, notwithstanding any other provision 

of this section. For each such DTC advertisement, the 

advisory review fee shall be due and payable 20 days 

before the advertisement is submitted to the Secretary, 

and the fee shall be equal to 150 percent of the fee 

that otherwise would have applied pursuant to subsection (c)(3). 

‘‘(F) LIMITS.— 

‘‘(i) SUBMISSIONS.—For each advisory review fee 

paid by a person for a fiscal year, the person is entitled 

to acceptance for advisory review by the Secretary 

of one DTC advertisement and acceptance of one 

resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review 

in the fiscal year for which the fee was assessed, except 

that a person may carry over not more than one paid 

advisory review submission to the next fiscal year. 

Resubmissions may be submitted without regard to 

the fiscal year of the initial advisory review submission. 

‘‘(ii) NO REFUNDS.—Except as provided by subsections (d)(4) and (f), fees paid under this section 

shall not be refunded. 

‘‘(iii) NO WAIVERS, EXEMPTIONS, OR REDUCTIONS.— 

The Secretary shall not grant a waiver, exemption, 

or reduction of any fees due or payable under this 

section. 

‘‘(iv) RIGHT TO ADVISORY REVIEW NOT TRANSFERABLE.—The right to an advisory review under this 

paragraph is not transferable, except to a successor 

in interest. 

‘‘(2) OPERATING RESERVE FEE.— 

‘‘(A) IN GENERAL.—Each person that on or after October 

1, 2007, is assessed an advisory review fee under paragraph 

(1) shall be subject to fee established under subsection 

(d)(2) (referred to in this section as an ‘operating reserve 

fee’) for the first fiscal year in which an advisory review 

fee is assessed to such person. The person is not subject 

to an operating reserve fee for any other fiscal year. 

‘‘(B) PAYMENT.—Except as provided in subparagraph 

(C), the operating reserve fee shall be due no later than— 

Deadlines. 

Deadline. 

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‘‘(i) October 1 of the first fiscal year in which 

the person is required to pay an advisory review fee 

under paragraph (1); or 

‘‘(ii) for fiscal year 2008, 120 days after the date 

of the enactment of the Food and Drug Administration 

Amendments Act of 2007 or an earlier date specified 

by the Secretary. 

‘‘(C) LATE NOTICE OF SUBMISSION.—If, in the first fiscal 

year of a person’s participation in the program under this 

section, that person submits any DTC advertisements for 

advisory review that are in excess of the number identified 

by that person in response to the Federal Register notice 

described in subsection (a)(1)(C), that person shall pay 

an operating reserve fee for each of those advisory reviews 

equal to the advisory review fee for each submission established under paragraph (1)(E)(ii). Fees required by this 

subparagraph shall be in addition to any fees required 

by subparagraph (A). Fees under this subparagraph shall 

be due 20 days before any DTC advertisement is submitted 

by such person to the Secretary for advisory review. 

‘‘(D) LATE PAYMENT.— 

‘‘(i) IN GENERAL.—Notwithstanding subparagraph 

(B), and subject to clause (ii), an operating reserve 

fee shall be regarded as late if the person required 

to pay the fee has not paid the complete operating 

reserve fee by— 

‘‘(I) for fiscal year 2008, 150 days after the 

date of the enactment of the Food and Drug 

Administration Amendments Act of 2007 or an 

earlier date specified by the Secretary; or 

‘‘(II) in any subsequent year, November 1. 

‘‘(ii) COMPLETE PAYMENT.—The complete operating 

reserve fee shall be due and payable 20 days before 

any DTC advertisement is submitted by such person 

to the Secretary for advisory review. 

‘‘(iii) AMOUNT.—Notwithstanding any other provision of this section, an operating reserve fee that is 

regarded as late under this subparagraph shall be 

equal to 150 percent of the operating reserve fee that 

otherwise would have applied pursuant to subsection 

(d). 

‘‘(b) ADVISORY REVIEW FEE REVENUE AMOUNTS.—Fees under 

subsection (a)(1) shall be established to generate revenue amounts 

of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted 

pursuant to subsections (c) and (g)(4). 

‘‘(c) ADJUSTMENTS.— 

‘‘(1) INFLATION ADJUSTMENT.—Beginning with fiscal year 

2009, the revenues established in subsection (b) 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; 

‘‘(B) the total percentage change for the previous fiscal 

year in basic pay under the General Schedule in accordance 

Effective date. 

Notice. 

Federal Register, 

publication. 

Deadlines. 

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with section 5332 of title 5, United States Code, as adjusted 

by any locality-based comparability payment pursuant to 

section 5304 of such title for Federal employees stationed 

in the District of Columbia; or 

‘‘(C) the average annual change in the cost, per fulltime equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with 

respect to such positions for the first 5 fiscal years of 

the previous 6 fiscal years. 

The adjustment made each fiscal year by this subsection shall 

be added on a compounded basis to the sum of all adjustments 

made each fiscal year after fiscal year 2008 under this subsection. 

‘‘(2) WORKLOAD ADJUSTMENT.—Beginning with fiscal year 

2009, after the fee revenues established in subsection (b) 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 

with respect to the submission of DTC advertisements for 

advisory review prior to initial dissemination. With respect 

to such adjustment: 

‘‘(A) The adjustment shall be determined by the Secretary based upon the number of DTC advertisements 

identified pursuant to subsection (a)(1)(C) for the upcoming 

fiscal year, excluding allowable previously paid carry over 

submissions. The adjustment shall be determined by multiplying the number of such advertisements projected for 

that fiscal year that exceeds 150 by $27,600 (adjusted 

each year beginning with fiscal year 2009 for inflation 

in accordance with paragraph (1)). 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 established for the prior fiscal year. 

‘‘(3) ANNUAL FEE SETTING FOR ADVISORY REVIEW.— 

‘‘(A) IN GENERAL.—Not later than August 1 of each 

fiscal year (or, with respect to fiscal year 2008, not later 

than 90 days after the date of the enactment of the Food 

and Drug Administration Amendments Act of 2007), the 

Secretary shall establish for the next fiscal year the DTC 

advertisement advisory review fee under subsection (a)(1), 

based on the revenue amounts established under subsection 

(b), the adjustments provided under paragraphs (1) and 

(2), and the number of DTC advertisements identified 

pursuant to subsection (a)(1)(C), excluding allowable previously-paid carry over submissions. The annual advisory 

review fee shall be established by dividing the fee revenue 

for a fiscal year (as adjusted pursuant to this subsection) 

by the number of DTC advertisements so identified, 

excluding allowable previously-paid carry over submissions 

under subsection (a)(1)(F)(i). 

‘‘(B) FISCAL YEAR 2008 FEE LIMIT.—Notwithstanding 

subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for 

Deadlines. 

Federal Register, 

publication. 

Effective date. 


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fiscal year 2008 may not be more than $83,000 per submission for advisory review. 

‘‘(C) ANNUAL FEE LIMIT.—Notwithstanding subsection 

(b) and the adjustments pursuant to this subsection, the 

fee established under subparagraph (A) for a fiscal year 

after fiscal year 2008 may not be more than 50 percent 

more than the fee established for the prior fiscal year. 

‘‘(D) LIMIT.—The total amount of fees obligated for 

a fiscal year may not exceed the total costs for such fiscal 

year for the resources allocated for the process for the 

advisory review of prescription drug advertising. 

‘‘(d) OPERATING RESERVES.— ‘‘(1) IN GENERAL.—The Secretary shall establish in the Food 

and Drug Administration salaries and expenses appropriation 

account without fiscal year limitation a Direct-to-Consumer 

Advisory Review Operating Reserve, of at least $6,250,000 in 

fiscal year 2008, to continue the program under this section 

in the event the fees collected in any subsequent fiscal year 

pursuant to subsection (a)(1) do not generate the fee revenue 

amount established for that fiscal year. 

‘‘(2) FEE SETTING.—The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person 

required to pay the fee by multiplying the number of DTC 

advertisements identified by that person pursuant to subsection 

(a)(1)(C) by the advisory review fee established pursuant to 

subsection (c)(3) for that fiscal year, except that in no case 

shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated 

in the program under this section in fiscal year 2008. 

‘‘(3) USE OF OPERATING RESERVE.—The Secretary may use 

funds from the reserves only to the extent necessary in any 

fiscal year to make up the difference between the fee revenue 

amount established for that fiscal year under subsections (b) 

and (c) and the amount of fees actually collected for that fiscal 

year pursuant to subsection (a)(1), or to pay costs of ending 

the program under this section if it is terminated pursuant 

to subsection (f) or not reauthorized beyond fiscal year 2012. 

‘‘(4) REFUND OF OPERATING RESERVES.—Within 120 days 

after the end of fiscal year 2012, or if the program under 

this section ends early pursuant to subsection (f), the Secretary, 

after setting aside sufficient operating reserve amounts to 

terminate the program under this section, shall refund all 

amounts remaining in the operating reserve on a pro rata 

basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the 

total amount of operating reserve fees paid by such person 

pursuant to subsection (a)(2). 

‘‘(e) EFFECT OF FAILURE TO PAY FEES.—Notwithstanding any 

other requirement, a submission for advisory review of a DTC 

advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted 

for review by the Secretary until all fees owed by such person 

under this section have been paid. 

‘‘(f) EFFECT OF INADEQUATE FUNDING OF PROGRAM.— 

‘‘(1) INITIAL FUNDING.—If on November 1, 2007, or 120 

days after the date of the enactment of the Food and Drug 

Administration Amendments Act of 2007, whichever is later, 

Effective date. 

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the Secretary has not received at least $11,250,000 in advisory 

review fees and operating reserve fees combined, the program 

under this section shall not commence and all collected fees 

shall be refunded. 

‘‘(2) LATER FISCAL YEARS.—Beginning in fiscal year 2009, 

if, on November 1 of the fiscal year, the combination of the 

operating reserves, annual fee revenues from that fiscal year, 

and unobligated fee revenues from prior fiscal years falls below 

$9,000,000, adjusted for inflation (as described in subsection 

(c)(1)), the program under this section shall terminate, and 

the Secretary shall notify all participants, retain any money 

from the unused advisory review fees and the operating 

reserves needed to terminate the program, and refund the 

remainder of the unused fees and operating reserves. To the 

extent required to terminate the program, the Secretary shall 

first use unobligated advisory review fee revenues from prior 

fiscal years, then the operating reserves, and finally, unused 

advisory review fees from the relevant fiscal year. 

‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 

‘‘(1) IN GENERAL.—Fees authorized under subsection (a) 

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 advisory review of prescription drug advertising. 

‘‘(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 be available for obligation only if the 

amounts appropriated as budget authority for such 

fiscal year are sufficient to support a number of fulltime equivalent review employees that is not fewer 

than the number of such employees supported in fiscal 

year 2007. 

‘‘(B) REVIEW EMPLOYEES.—For purposes of subparagraph (A)(ii), the term ‘full-time equivalent review 

employees’ means the total combined number of full-time 

equivalent employees in— 

‘‘(i) the Center for Drug Evaluation and Research, 

Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and 

‘‘(ii) the Center for Biologics Evaluation and 

Research, Advertising and Promotional Labeling 

Branch, Food and Drug Administration. 

‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the 

fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the 

total revenue amount determined under subsection (b) for the 

Effective date. 

Notification. 


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fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, plus amounts collected for the 

reserve fund under subsection (d). 

‘‘(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 collected 

under this section pursuant to appropriation Acts for a subsequent fiscal year. 

‘‘(h) DEFINITIONS.—For purposes of this section: 

‘‘(1) The term ‘advisory review’ means reviewing and providing advisory comments on DTC advertisements regarding 

compliance of a proposed advertisement with the requirements 

of this Act prior to its initial public dissemination. 

‘‘(2) The term ‘advisory review fee’ has the meaning 

indicated for such term in subsection (a)(1)(D). 

‘‘(3) The term ‘carry over submission’ means a submission 

for an advisory review for which a fee was paid in one fiscal 

year that is submitted for review in the following fiscal year. 

‘‘(4) The term ‘direct-to-consumer television advertisement’ 

means an advertisement for a prescription drug product (as 

defined in section 735(3)) intended to be displayed on any 

television channel for less than 3 minutes. 

‘‘(5) The term ‘DTC advertisement’ has the meaning 

indicated for such term in subsection (a)(1)(A). 

‘‘(6) The term ‘operating reserve fee’ has the meaning 

indicated for such term in subsection (a)(2)(A). 

‘‘(7) The term ‘person’ includes an individual, partnership, 

corporation, and association, and any affiliate thereof or successor in interest. 

‘‘(8) The term ‘process for the advisory review of prescription drug advertising’ means the activities necessary to review 

and provide advisory comments on DTC advertisements prior 

to public dissemination and, to the extent the Secretary has 

additional staff resources available under the program under 

this section that are not necessary for the advisory review 

of DTC advertisements, the activities necessary to review and 

provide advisory comments on other proposed advertisements 

and promotional material prior to public dissemination. 

‘‘(9) The term ‘resources allocated for the process for the 

advisory review of prescription drug advertising’ means the 

expenses incurred in connection with the process for the 

advisory review of prescription drug advertising 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; 


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‘‘(D) collection of fees under this section and accounting 

for resources allocated for the advisory review of prescription drug advertising; and 

‘‘(E) terminating the program under this section pursuant to subsection (f)(2) if that becomes necessary. 

‘‘(10) The term ‘resubmission’ means a subsequent submission for advisory review of a direct-to-consumer television 

advertisement that has been revised in response to the Secretary’s comments on an original submission. A resubmission 

may not introduce significant new concepts or creative themes 

into the television advertisement. 

‘‘(11) The term ‘submission for advisory review’ means an 

original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.’’. 

SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et 

seq.), as amended by section 104, is further amended by inserting 

after section 736A the following: 

‘‘SEC. 736B. REAUTHORIZATION; REPORTING REQUIREMENTS. 

‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal year 2008, 

not later than 120 days after the end of each fiscal year for which 

fees are collected under this part, 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 101(c) of the Food and Drug 

Administration Amendments Act of 2007 during such fiscal year 

and the future plans of the Food and Drug Administration for 

meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given 

a complete response on all human drug applications and supplements in the cohort. 

‘‘(b) FISCAL REPORT.—Beginning with fiscal year 2008, not later 

than 120 days after the end of each fiscal year for which fees 

are collected under this part, 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 for such 

fiscal year. 

‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make the 

reports required under subsections (a) and (b) available to the 

public on the Internet Web site of the Food and Drug Administration. 

‘‘(d) REAUTHORIZATION.— 

‘‘(1) CONSULTATION.—In developing recommendations to 

present to the Congress with respect to the goals, and plans 

for meeting the goals, for the process for the review of human 

drug applications for the first 5 fiscal years after fiscal year 

2012, and for the reauthorization of this part for such fiscal 

years, the Secretary shall consult with— 

‘‘(A) the Committee on Energy and Commerce of the 

House of Representatives; 

Website. 

21 USC 379h–2. 


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‘‘(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

‘‘(C) scientific and academic experts; 

‘‘(D) health care professionals; 

‘‘(E) representatives of patient and consumer advocacy 

groups; and 

‘‘(F) the regulated industry. 

‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the regulated industry on the reauthorization of this part, 

the Secretary shall— 

‘‘(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

‘‘(B) hold a public meeting at which the public may 

present its views on the reauthorization, including specific 

suggestions for changes to the goals referred to in subsection (a); 

‘‘(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

‘‘(D) publish the comments on the Food and Drug 

Administration’s Internet Web site. 

‘‘(3) PERIODIC CONSULTATION.—Not less frequently than 

once every month during negotiations with the regulated 

industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue 

discussions of their views on the reauthorization and their 

suggestions for changes to this part as expressed under paragraph (2). 

‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

‘‘(A) present the recommendations developed under 

paragraph (1) to the Congressional committees specified 

in such paragraph; 

‘‘(B) publish such recommendations in the Federal Register; 

‘‘(C) provide for a period of 30 days for the public 

to provide written comments on such recommendations; 

‘‘(D) hold a meeting at which the public may present 

its views on such recommendations; and 

‘‘(E) after consideration of such public views and comments, revise such recommendations as necessary. 

‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2012, the Secretary shall transmit to the Congress 

the revised recommendations under paragraph (4), a summary 

of the views and comments received under such paragraph, 

and any changes made to the recommendations in response 

to such views and comments. 

‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 

‘‘(A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) 

to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted 

under this subsection between the Food and Drug Administration and the regulated industry. 

‘‘(B) CONTENT.—The minutes described under subparagraph (A) shall summarize any substantive proposal made 

Website. 

Deadline. 

Federal Register, 

publication. 

Website. 

Federal Register, 

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by any party to the negotiations as well as significant 

controversies or differences of opinion during the negotiations and their resolution.’’. 

SEC. 106. SUNSET DATES. 

(a) AUTHORIZATION.—The amendments made by sections 102, 

103, and 104 cease to be effective October 1, 2012. 

(b) REPORTING REQUIREMENTS.—The amendment made by section 105 ceases to be effective January 31, 2013. 

SEC. 107. EFFECTIVE DATE. 

The amendments made by this title shall take effect on October 

1, 2007, or the date of the enactment of this Act, whichever is 

later, except that fees under part 2 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 

for all human drug applications received on or after October 1, 

2007, regardless of the date of the enactment of this Act. 

SEC. 108. SAVINGS CLAUSE. 

Notwithstanding section 509 of the Prescription Drug User 

Fee Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the amendments made by this title, part 2 of subchapter 

C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 

as in effect on the day before the date of the enactment of this 

title, shall continue 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, 2002, but before October 1, 2007, 

were accepted by the Food and Drug Administration for filing 

with respect to assessing and collecting any fee required by such 

part for a fiscal year prior to fiscal year 2008. 

SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT. 

(a) Section 739 (21 U.S.C. 379j–11) is amended in the matter 

preceding paragraph (1) by striking ‘‘subchapter’’ and inserting 

‘‘part’’. 

(b) Paragraph (11) of section 739 (21 U.S.C. 379j–11) is amended 

by striking ‘‘735(9)’’ and inserting ‘‘735(11)’’. 

TITLE II—MEDICAL DEVICE USER FEE 

AMENDMENTS OF 2007 

SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING. 

(a) SHORT TITLE.—This title may be cited as the ‘‘Medical 

Device User Fee Amendments of 2007’’. 

(b) REFERENCES IN TITLE.—Except as otherwise specified, 

amendments made by this title to a section or other provision 

of law are amendments to such section or other provision of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

(c) FINDING.—The Congress finds that the fees authorized under 

the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for 

assuring the safety and effectiveness of devices, as set forth in 

the goals identified for purposes of part 3 of subchapter C of 

chapter VII of the Federal Food, Drug, and Cosmetic Act in the 

letters from the Secretary of Health and Human Services to the 

Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy 

21 USC 379i 

note. 

21 USC 301 note. 

Medical Device 

User Fee 

Amendments of 

2007. 

21 USC 379g 

note. 

21 USC 379g 

note. 

21 USC 379h–2. 

21 USC 379g 

note. 


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and Commerce of the House of Representatives, as set forth in 

the Congressional Record. 

Subtitle A—Fees Related to Medical 

Devices 

SEC. 211. DEFINITIONS. 

Section 737 is amended— 

(1) in the matter preceding paragraph (1), by striking ‘‘For 

purposes of this subchapter’’ and inserting ‘‘For purposes of 

this part’’; 

(2) by redesignating paragraphs (5), (6), (7), and (8) as 

paragraphs (8), (9), (10), and (12), respectively; 

(3) by inserting after paragraph (4) the following: 

‘‘(5) The term ‘30-day notice’ means a notice under section 

515(d)(6) that is limited to a request to make modifications 

to manufacturing procedures or methods of manufacture 

affecting the safety and effectiveness of the device. 

‘‘(6) The term ‘request for classification information’ means 

a request made under section 513(g) for information respecting 

the class in which a device has been classified or the requirements applicable to a device. 

‘‘(7) The term ‘annual fee’, for periodic reporting concerning 

a class III device, means the annual fee associated with periodic 

reports required by a premarket application approval order.’’; 

(4) in paragraph (10), as so redesignated— 

(A) by striking ‘‘April of the preceding fiscal year’’ 

and inserting ‘‘October of the preceding fiscal year’’; and 

(B) by striking ‘‘April 2002’’ and inserting ‘‘October 

2001’’; 

(5) by inserting after paragraph (10), as so amended, the 

following: 

‘‘(11) The term ‘person’ includes an affiliate thereof.’’; and 

(6) by inserting after paragraph (12), as so redesignated, 

the following: 

‘‘(13) The term ‘establishment subject to a registration fee’ 

means an establishment that is required to register with the 

Secretary under section 510 and is one of the following types 

of establishments: 

‘‘(A) MANUFACTURER.—An establishment that makes 

by any means any article that is a device, including an 

establishment that sterilizes or otherwise makes such 

article for or on behalf of a specification developer or any 

other person. 

‘‘(B) SINGLE-USE DEVICE REPROCESSOR.—An establishment that, within the meaning of section 201(ll)(2)(A), performs additional processing and manufacturing operations 

on a single-use device that has previously been used on 

a patient. 

‘‘(C) SPECIFICATION DEVELOPER.—An establishment 

that develops specifications for a device that is distributed 

under the establishment’s name but which performs no 

manufacturing, including an establishment that, in addition to developing specifications, also arranges for the 

manufacturing of devices labeled with another establishment’s name by a contract manufacturer.’’. 

21 USC 379i. 


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121 STAT. 844 PUBLIC LAW 110–85—SEPT. 27, 2007 

SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

(a) TYPES OF FEES.— (1) IN GENERAL.—Section 738(a) (21 U.S.C. 379j(a)) is 

amended— 

(A) in paragraph (1), by striking ‘‘Beginning on the 

date of the enactment of the Medical Device User Fee 

and Modernization Act of 2002’’ and inserting ‘‘Beginning 

in fiscal year 2008’’; and 

(B) by amending the designation and heading of paragraph (2) to read as follows: 

‘‘(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLE- MENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR PERIODIC

REPORTING CONCERNING A CLASS III DEVICE.—’’. 

(2) FEE AMOUNTS.—Section 738(a)(2)(A) (21 U.S.C. 

379j(a)(2)(A)) is amended— 

(A) in clause (iii), by striking ‘‘a fee equal to the fee 

that applies’’ and inserting ‘‘a fee equal to 75 percent 

of the fee that applies’’; 

(B) in clause (iv), by striking ‘‘21.5 percent’’ and 

inserting ‘‘15 percent’’; 

(C) in clause (v), by striking ‘‘7.2 percent’’ and inserting 

‘‘7 percent’’; 

(D) by redesignating clauses (vi) and (vii) as clauses 

(vii) and (viii), respectively; 

(E) by inserting after clause (v) the following: 

‘‘(vi) For a 30-day notice, a fee equal to 1.6 percent 

of the fee that applies under clause (i).’’; 

(F) in clause (viii), as so redesignated— 

(i) by striking ‘‘1.42 percent’’ and inserting ‘‘1.84 

percent’’; and 

(ii) by striking ‘‘, subject to any adjustment under 

subsection (e)(2)(C)(ii)’’; and 

(G) by inserting after such clause (viii) the following: 

‘‘(ix) For a request for classification information, 

a fee equal to 1.35 percent of the fee that applies 

under clause (i). 

‘‘(x) For periodic reporting concerning a class III 

device, an annual fee equal to 3.5 percent of the fee 

that applies under clause (i).’’. 

(3) PAYMENT.—Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C)) 

is amended to read as follows: 

‘‘(C) PAYMENT.—The fee required by subparagraph (A) 

shall be due upon submission of the premarket application, 

premarket report, supplement, premarket notification 

submission, 30-day notice, request for classification 

information, or periodic reporting concerning a class III 

device. Applicants submitting portions of applications 

pursuant to section 515(c)(4) shall pay such fees upon 

submission of the first portion of such applications.’’. 

(4) REFUNDS.—Section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D)) 

is amended— 

(A) in clause (iii), by striking the last two sentences; 

and 

(B) by adding after clause (iii) the following: 

‘‘(iv) MODULAR APPLICATIONS WITHDRAWN BEFORE

FIRST ACTION.—The Secretary shall refund 75 percent 

of the application fee paid for an application submitted 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 845 

under section 515(c)(4) that is withdrawn before a 

second portion is submitted and before a first action 

on the first portion. 

‘‘(v) LATER WITHDRAWN MODULAR APPLICATIONS.— If an application submitted under section 515(c)(4) is 

withdrawn after a second or subsequent portion is 

submitted but before any first action, the Secretary 

may return a portion of the fee. The amount of refund, 

if any, shall be based on the level of effort already 

expended on the review of the portions submitted. 

‘‘(vi) SOLE DISCRETION TO REFUND.—The Secretary 

shall have sole discretion to refund a fee or portion 

of the fee under clause (iii) or (v). A determination 

by the Secretary concerning a refund under clause 

(iii) or (v) shall not be reviewable.’’. 

(5) ANNUAL ESTABLISHMENT REGISTRATION FEE.—Section 

738(a) (21 U.S.C. 379j(a)) is amended by adding after paragraph 

(2) the following: 

‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION FEE.— 

‘‘(A) IN GENERAL.—Except as provided in subparagraph 

(B), each establishment subject to a registration fee shall 

be subject to a fee for each initial or annual registration 

under section 510 beginning with its registration for fiscal 

year 2008. 

‘‘(B) EXCEPTION.—No fee shall be required under 

subparagraph (A) for an establishment operated by a State 

or Federal governmental entity or an Indian tribe (as 

defined in the Indian Self Determination and Educational 

Assistance Act), unless a device manufactured by the 

establishment is to be distributed commercially. 

‘‘(C) PAYMENT.—The fee required under subparagraph 

(A) shall be due once each fiscal year, upon the initial 

registration of the establishment or upon the annual registration under section 510.’’. 

(b) FEE AMOUNTS.—Section 738(b) (21 U.S.C. 379j(b)) is 

amended to read as follows: 

‘‘(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), 

(e), and (h) the fees under subsection (a) shall be based on the 

following fee amounts: 

Fee Type 

Fiscal 

Year 

2008 

Fiscal 

Year 

2009 

Fiscal 

Year 

2010 

Fiscal 

Year 

2011 

Fiscal 

Year 

2012 

Premarket Application .... $185,000 $200,725 $217,787 $236,298 $256,384

................

Establishment Registration ................................ $1,706 $1,851 $2,008 $2,179 $2,364.’’. 

(c) ANNUAL FEE SETTING.— (1) IN GENERAL.—Section 738(c) (21 U.S.C. 379j(c)(1)) is 

amended— 

(A) in the subsection heading, by striking ‘‘Annual 

Fee Setting’’ and inserting ‘‘ANNUAL FEE SETTING’’; and 

(B) in paragraph (1), by striking the last sentence. 


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121 STAT. 846 PUBLIC LAW 110–85—SEPT. 27, 2007 

(2) ADJUSTMENT OF ANNUAL ESTABLISHMENT FEE.—Section 

738(c) (21 U.S.C. 379j(c)), as amended by paragraph (1), is 

further amended— 

(A) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; 

(B) by inserting after paragraph (1) the following: 

‘‘(2) ADJUSTMENT.— 

‘‘(A) IN GENERAL.—When setting fees for fiscal year 

2010, the Secretary may increase the fee under subsection 

(a)(3)(A) (applicable to establishments subject to registration) only if the Secretary estimates that the number of 

establishments submitting fees for fiscal year 2009 is fewer 

than 12,250. The percentage increase shall be the percentage by which the estimate of establishments submitting 

fees in fiscal year 2009 is fewer than 12,750, but in no 

case may the percentage increase be more than 8.5 percent 

over that specified in subsection (b) for fiscal year 2010. 

If the Secretary makes any adjustment to the fee under 

subsection (a)(3)(A) for fiscal year 2010, then such fee for 

fiscal years 2011 and 2012 shall be adjusted so that such 

fee for fiscal year 2011 is equal to the adjusted fee for 

fiscal year 2010 increased by 8.5 percent, and such fee 

for fiscal year 2012 is equal to the adjusted fee for fiscal 

year 2011 increased by 8.5 percent. 

‘‘(B) PUBLICATION.—For any adjustment made under 

subparagraph (A), the Secretary shall publish in the Federal Register the Secretary’s determination to make the 

adjustment and the rationale for the determination.’’; and 

(C) in paragraph (4), as redesignated by this paragraph, in subparagraph (A)— 

(i) by striking ‘‘For fiscal years 2006 and 2007, 

the Secretary’’ and inserting ‘‘The Secretary’’; and 

(ii) by striking ‘‘for the first month of fiscal year 

2008’’ and inserting ‘‘for the first month of the next 

fiscal year’’. 

(d) SMALL BUSINESSES; FEE WAIVER AND FEE REDUCTION

REGARDING PREMARKET APPROVAL.— 

(1) IN GENERAL.—Section 738(d)(1) (21 U.S.C. 379j(d)(1)) 

is amended— 

(A) by striking ‘‘, partners, and parent firms’’; and 

(B) by striking ‘‘clauses (i) through (vi) of subsection 

(a)(2)(A)’’ and inserting ‘‘clauses (i) through (v) and clauses 

(vii), (ix), and (x) of subsection (a)(2)(A)’’. 

(2) RULES RELATING TO PREMARKET APPROVAL FEES.— 

(A) DEFINITION.—Section 738(d)(2)(A) (21 U.S.C. 

379j(d)(2)(A)) is amended by striking ‘‘, partners, and 

parent firms’’. 

(B) EVIDENCE OF QUALIFICATION.—Section 738(d)(2)(B) 

(21 U.S.C. 379j(d)(2)(B)) is amended— 

(i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— 

An applicant’’ and inserting the following: 

‘‘(B) EVIDENCE OF QUALIFICATION.— 

‘‘(i) IN GENERAL.—An applicant’’; 

(ii) by striking ‘‘The applicant shall support its 

claim’’ and inserting the following: 

Federal Register, 

publication. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 847 

‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO THE

UNITED STATES INTERNAL REVENUE SERVICE.—The 

applicant shall support its claim’’; 

(iii) by striking ‘‘, partners, and parent firms’’ each 

place it appears; 

(iv) by striking the last sentence and inserting 

‘‘If no tax forms are submitted for any affiliate, the 

applicant shall certify that the applicant has no affiliates.’’; and 

(v) by adding at the end the following: 

‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE

UNITED STATES INTERNAL REVENUE SERVICE.—In the 

case of an applicant that has not previously submitted 

a Federal income tax return, the applicant and each 

of its affiliates shall demonstrate that it meets the 

definition under subparagraph (A) by submission of 

a signed certification, in such form as the Secretary 

may direct through a notice published in the Federal 

Register, that the applicant or affiliate meets the criteria for a small business and a certification, in 

English, from the national taxing authority of the 

country in which the applicant or, if applicable, affiliate 

is headquartered. The certification from such taxing 

authority shall bear the official seal of such taxing 

authority and shall provide the applicant’s or affiliate’s 

gross receipts or sales for the most recent year in 

both the local currency of such country and in United 

States dollars, the exchange rate used in converting 

such local currency to dollars, and the dates during 

which these receipts or sales were collected. The 

applicant shall also submit a statement signed by the 

head of the applicant’s firm or by its chief financial 

officer that the applicant has submitted certifications 

for all of its affiliates, or that the applicant has no 

affiliates.’’. 

(3) REDUCED FEES.—Section 738(d)(2)(C) (21 U.S.C. 

379j(d)(2)(C)) is amended to read as follows: 

‘‘(C) REDUCED FEES.—Where the Secretary finds that 

the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may 

be paid at a reduced rate of— 

‘‘(i) 25 percent of the fee established under such 

subsection for a premarket application, a premarket 

report, a supplement, or periodic reporting concerning 

a class III device; and 

‘‘(ii) 50 percent of the fee established under such 

subsection for a 30-day notice or a request for classification information.’’. 

(e) SMALL BUSINESSES; FEE REDUCTION REGARDING PREMARKET

NOTIFICATION SUBMISSIONS.— 

(1) IN GENERAL.—Section 738(e)(1) (21 U.S.C. 379j(e)(1)) 

is amended— 

(A) by striking ‘‘2004’’ and inserting ‘‘2008’’; and 

(B) by striking ‘‘(a)(2)(A)(vii)’’ and inserting 

‘‘(a)(2)(A)(viii)’’. 

(2) RULES RELATING TO PREMARKET NOTIFICATION SUBMIS- SIONS.— 

Certification. 

Federal Register, 

publication. 


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121 STAT. 848 PUBLIC LAW 110–85—SEPT. 27, 2007 

(A) DEFINITION.—Section 738(e)(2)(A) (21 U.S.C. 

379j(e)(2)(A)) is amended by striking ‘‘, partners, and parent 

firms’’. 

(B) EVIDENCE OF QUALIFICATION.—Section 738(e)(2)(B) 

(21 U.S.C. 379j(e)(2)(B)) is amended— 

(i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— An applicant’’ and inserting the following: 

‘‘(B) EVIDENCE OF QUALIFICATION.— ‘‘(i) IN GENERAL.—An applicant’’; 

(ii) by striking ‘‘The applicant shall support its 

claim’’ and inserting the following: 

‘‘(ii) FIRMS SUBMITTING TAX RETURNS TO THE

UNITED STATES INTERNAL REVENUE SERVICE.—The 

applicant shall support its claim’’; 

(iii) by striking ‘‘, partners, and parent firms’’ each 

place it appears; 

(iv) by striking the last sentence and inserting 

‘‘If no tax forms are submitted for any affiliate, the 

applicant shall certify that the applicant has no affiliates.’’; and 

(v) by adding at the end the following: 

‘‘(iii) FIRMS NOT SUBMITTING TAX RETURNS TO THE

UNITED STATES INTERNAL REVENUE SERVICE.—In the 

case of an applicant that has not previously submitted 

a Federal income tax return, the applicant and each 

of its affiliates shall demonstrate that it meets the 

definition under subparagraph (A) by submission of 

a signed certification, in such form as the Secretary 

may direct through a notice published in the Federal 

Register, that the applicant or affiliate meets the criteria for a small business and a certification, in 

English, from the national taxing authority of the 

country in which the applicant or, if applicable, affiliate 

is headquartered. The certification from such taxing 

authority shall bear the official seal of such taxing 

authority and shall provide the applicant’s or affiliate’s 

gross receipts or sales for the most recent year in 

both the local currency of such country and in United 

States dollars, the exchange rate used in converting 

such local currency to dollars, and the dates during 

which these receipts or sales were collected. The 

applicant shall also submit a statement signed by the 

head of the applicant’s firm or by its chief financial 

officer that the applicant has submitted certifications 

for all of its affiliates, or that the applicant has no 

affiliates.’’. 

(3) REDUCED FEES.—Section 738(e)(2)(C) (21 U.S.C. 

379j(e)(2)(C)) is amended to read as follows: 

‘‘(C) REDUCED FEES.—For fiscal year 2008 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 50 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection 

(c)(1).’’. 

(f) EFFECT OF FAILURE TO PAY FEES.—Section 738(f) (21 U.S.C. 

379j(f)) is amended to read as follows: 

Certification. 

Federal Register, 

publication. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 849 

‘‘(f) EFFECT OF FAILURE TO PAY FEES.— 

‘‘(1) NO ACCEPTANCE OF SUBMISSIONS.—A premarket 

application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification 

information, or periodic reporting concerning a class III device 

submitted by a person subject to fees under subsections (a)(2) 

and (a)(3) shall be considered incomplete and shall not be 

accepted by the Secretary until all fees owed by such person 

have been paid. 

‘‘(2) NO REGISTRATION.—Registration information submitted 

under section 510 by an establishment subject to a registration 

fee shall be considered incomplete and shall not be accepted 

by the Secretary until the registration fee under subsection 

(a)(3) owed for the establishment has been paid. Until the 

fee is paid and the registration is complete, the establishment 

is deemed to have failed to register in accordance with section 

510.’’. 

(g) CONDITIONS.—Section 738(g) (21 U.S.C. 379j(g)) is 

amended— 

(1) by striking paragraph (1) and inserting the following: 

‘‘(1) PERFORMANCE GOALS; TERMINATION OF PROGRAM.— 

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, fees may not be assessed under subsection (a) for the 

fiscal year, and the Secretary is not expected to meet any 

performance goals identified for the fiscal year, if— 

‘‘(A) 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 such fiscal 

year; or 

‘‘(B) fees were not assessed under subsection (a) for 

the previous fiscal year.’’; and 

(2) by amending paragraph (2) to read as follows: 

‘‘(2) AUTHORITY.—If the Secretary does not assess fees 

under subsection (a) 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 premarket applications, supplements, premarket reports, 

premarket notification submissions, 30-day notices, requests 

for classification information, periodic reporting concerning a 

class III device, and establishment registrations at any time 

in such fiscal year, notwithstanding the provisions of subsection 

(a) relating to the date fees are to be paid.’’. 

(h) CREDITING AND AVAILABILITY OF FEES.— 

(1) AUTHORIZATION OF APPROPRIATIONS.—Section 738(h)(3) 

(21 U.S.C. 379j(h)(3)) is amended to read as follows: 

‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.—There are 

authorized to be appropriated for fees under this section— 

‘‘(A) $48,431,000 for fiscal year 2008; 

‘‘(B) $52,547,000 for fiscal year 2009; 

‘‘(C) $57,014,000 for fiscal year 2010; 

‘‘(D) $61,860,000 for fiscal year 2011; and 

‘‘(E) $67,118,000 for fiscal year 2012.’’. 


jbridges on GSDDPC57 with PUBLIC LAWS
121 STAT. 850 PUBLIC LAW 110–85—SEPT. 27, 2007 

(2) OFFSET.—Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is 

amended to read as follows: 

‘‘(4) OFFSET.—If the cumulative amount of fees collected 

during fiscal years 2008, 2009, and 2010, added to the amount 

estimated to be collected for fiscal year 2011, which estimate 

shall be based upon the amount of fees received by the Secretary through June 30, 2011, exceeds the amount of fees 

specified in aggregate in paragraph (3) for these four fiscal 

years, the aggregate amount in excess 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 fiscal year 2012.’’. 

SEC. 213. REAUTHORIZATION; REPORTING REQUIREMENTS. 

Part 3 of subchapter C of chapter VII is amended by inserting 

after section 738 the following: 

‘‘SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS. 

‘‘(a) REPORTS.— 

‘‘(1) PERFORMANCE REPORT.—For fiscal years 2008 through 

2012, not later than 120 days after the end of each fiscal 

year during which fees are collected under this part, the Secretary shall prepare and 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 concerning the progress of the Food and Drug 

Administration in achieving the goals identified in the letters 

described in section 201(c) of the Food and Drug Administration 

Amendments Act of 2007 during such fiscal year and the future 

plans of the Food and Drug Administration for meeting the 

goals. The report for a fiscal year shall include information 

on all previous cohorts for which the Secretary has not given 

a complete response on all device premarket applications and 

reports, supplements, and premarket notifications in the cohort. 

‘‘(2) FISCAL REPORT.—For fiscal years 2008 through 2012, 

not later than 120 days after the end of each fiscal year during 

which fees are collected under this part, the Secretary shall 

prepare and 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 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. 

‘‘(3) PUBLIC AVAILABILITY.—The Secretary shall make the 

reports required under paragraphs (1) and (2) available to 

the public on the Internet Web site of the Food and Drug 

Administration. 

‘‘(b) REAUTHORIZATION.— ‘‘(1) CONSULTATION.—In developing recommendations to 

present to Congress with respect to the goals, and plans for 

meeting the goals, for the process for the review of device 

applications for the first 5 fiscal years after fiscal year 2012, 

and for the reauthorization of this part for such fiscal years, 

the Secretary shall consult with— 

Website. 

21 USC 379j–1. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 851 

‘‘(A) the Committee on Energy and Commerce of the 

House of Representatives; 

‘‘(B) the Committee on Health, Education, Labor, and 

Pensions of the Senate; 

‘‘(C) scientific and academic experts; 

‘‘(D) health care professionals; 

‘‘(E) representatives of patient and consumer advocacy 

groups; and 

‘‘(F) the regulated industry. 

‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 

with the regulated industry on the reauthorization of this part, 

the Secretary shall— 

‘‘(A) publish a notice in the Federal Register requesting 

public input on the reauthorization; 

‘‘(B) hold a public meeting at which the public may 

present its views on the reauthorization, including specific 

suggestions for changes to the goals referred to in subsection (a)(1); 

‘‘(C) provide a period of 30 days after the public meeting 

to obtain written comments from the public suggesting 

changes to this part; and 

‘‘(D) publish the comments on the Food and Drug 

Administration’s Internet Web site. 

‘‘(3) PERIODIC CONSULTATION.—Not less frequently than 

once every month during negotiations with the regulated 

industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue 

discussions of their views on the reauthorization and their 

suggestions for changes to this part as expressed under paragraph (2). 

‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.—After negotiations with the regulated industry, the Secretary shall— 

‘‘(A) present the recommendations developed under 

paragraph (1) to the Congressional committees specified 

in such paragraph; 

‘‘(B) publish such recommendations in the Federal Register; 

‘‘(C) provide for a period of 30 days for the public 

to provide written comments on such recommendations; 

‘‘(D) hold a meeting at which the public may present 

its views on such recommendations; and 

‘‘(E) after consideration of such public views and comments, revise such recommendations as necessary. 

‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not later than 

January 15, 2012, the Secretary shall transmit to Congress 

the revised recommendations under paragraph (4), a summary 

of the views and comments received under such paragraph, 

and any changes made to the recommendations in response 

to such views and comments. 

‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 

‘‘(A) PUBLIC AVAILABILITY.—Before presenting the recommendations developed under paragraphs (1) through (5) 

to the Congress, the Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted 

under this subsection between the Food and Drug Administration and the regulated industry. 

Website. 

Deadline. 

Federal Register, 

publication. 

Website. 

Federal Register, 

publication. 


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121 STAT. 852 PUBLIC LAW 110–85—SEPT. 27, 2007 

‘‘(B) CONTENT.—The minutes described under subparagraph (A) shall summarize any substantive proposal made 

by any party to the negotiations as well as significant 

controversies or differences of opinion during the negotiations and their resolution.’’. 

SEC. 214. SAVINGS CLAUSE. 

Notwithstanding section 107 of the Medical Device User Fee 

and Modernization Act of 2002 (Public Law 107–250), and notwithstanding the amendments made by this subtitle, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 379i et seq.), as in effect on the day before the 

date of the enactment of this subtitle, shall continue to be in 

effect with respect to premarket applications, premarket reports, 

premarket notification submissions, and supplements (as defined 

in such part as of such day) that on or after October 1, 2002, 

but before October 1, 2007, were accepted by the Food and Drug 

Administration for filing with respect to assessing and collecting 

any fee required by such part for a fiscal year prior to fiscal 

year 2008. 

SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR 

POSTMARKET SAFETY INFORMATION. 

For the purpose of collecting, developing, reviewing, and evaluating postmarket safety information on medical devices, there are 

authorized to be appropriated to the Food and Drug Administration, 

in addition to the amounts authorized by other provisions of law 

for such purpose— (1) $7,100,000 for fiscal year 2008; 

(2) $7,455,000 for fiscal year 2009; 

(3) $7,827,750 for fiscal year 2010; 

(4) $8,219,138 for fiscal year 2011; and 

(5) $8,630,094 for fiscal year 2012. 

SEC. 216. EFFECTIVE DATE. 

The amendments made by this subtitle shall take effect on 

October 1, 2007, or the date of the enactment of this Act, whichever 

is later, except that fees under part 3 of subchapter C of chapter 

VII of the Federal Food, Drug, and Cosmetic Act shall be assessed 

for all premarket applications, premarket reports, supplements, 

30-day notices, and premarket notification submissions received 

on or after October 1, 2007, regardless of the date of the enactment 

of this Act. 

SEC. 217. SUNSET CLAUSE. 

The amendments made by this subtitle cease to be effective 

October 1, 2012, except that section 738A of the Federal Food, 

Drug, and Cosmetic Act (regarding annual performance and financial reports) ceases to be effective January 31, 2013. 

Subtitle B—Amendments Regarding 

Regulation of Medical Devices 

SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF 

PREMARKET NOTIFICATION. 

Section 523(c) (21 U.S.C. 360m(c)) is amended by striking 

‘‘2007’’ and inserting ‘‘2012’’. 

21 USC 379i 

note. 

21 USC 379i 

note. 

21 USC 379i 

note. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 853 

SEC. 222. REGISTRATION. 

(a) ANNUAL REGISTRATION OF PRODUCERS OF DRUGS AND

DEVICES.—Section 510(b) (21 U.S.C. 360(b)) is amended— 

(1) by striking ‘‘(b) On or before’’ and inserting ‘‘(b)(1) 

On or before’’; 

(2) by striking ‘‘or a device or devices’’; and 

(3) by adding at the end the following: 

‘‘(2) During the period beginning on October 1 and ending 

on 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 device 

or devices shall register with the Secretary his name, places of 

business, and all such establishments.’’. 

(b) REGISTRATION OF FOREIGN ESTABLISHMENTS.—Section 

510(i)(1) (21 U.S.C. 360(i)(1)) is amended by striking ‘‘On or before 

December 31’’ and all that follows and inserting the following: 

‘‘Any establishment within any foreign country engaged in the 

manufacture, preparation, propagation, compounding, or processing 

of a drug or device that is imported or offered for import into 

the United States shall, through electronic means in accordance 

with the criteria of the Secretary— 

‘‘(A) upon first engaging in any such activity, immediately 

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; and 

‘‘(B) each establishment subject to the requirements of 

subparagraph (A) shall thereafter— 

‘‘(i) with respect to drugs, register with the Secretary 

on or before December 31 of each year; and 

‘‘(ii) with respect to devices, register with the Secretary 

during the period beginning on October 1 and ending on 

December 31 of each year.’’. 

SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED, 

PREPARED, PROPAGATED, AND COMPOUNDED BY REGISTRANTS; STATEMENTS; ACCOMPANYING DISCLOSURES. 

Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the matter 

preceding subparagraph (A), by striking ‘‘Each person’’ and all 

that follows through ‘‘the following information:’’ and inserting 

‘‘Each person who registers with the Secretary under this section 

shall report to the Secretary, with regard to drugs once during 

the month of June of each year and once during the month of 

December of each year, and with regard to devices once each year 

during the period beginning on October 1 and ending on December 

31, the following information:’’. 

SEC. 224. ELECTRONIC REGISTRATION AND LISTING. 

Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows: 

‘‘(p) Registrations and listings under this section (including 

the submission of updated information) shall be submitted to the 

Secretary by electronic means 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.’’. 

Reports. 

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SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE. 

(a) IN GENERAL.—The Comptroller General of the United States 

shall conduct a study on the appropriate use of the process under 

section 510(k) of the Federal Food, Drug, and Cosmetic Act as 

part of the device classification process to determine whether a 

new device is as safe and effective as a classified device. 

(b) CONSIDERATION.—In determining the effectiveness of the 

premarket notification and classification authority under section 

510(k) and subsections (f) and (i) of section 513 of the Federal 

Food, Drug, and Cosmetic Act, the study under subsection (a) shall 

consider the Secretary of Health and Human Services’s evaluation 

of the respective intended uses and technologies of such devices, 

including the effectiveness of such Secretary’s comparative assessment of technological characteristics such as device materials, principles of operations, and power sources. 

(c) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall complete the study 

under subsection (a) and submit to the Congress a report on the 

results of such study. 

SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM. 

(a) IN GENERAL.—Section 519 (21 U.S.C. 360i) is amended— 

(1) by redesignating subsection (f) as subsection (g); and 

(2) by inserting after subsection (e) the following: 

‘‘Unique Device Identification System 

‘‘(f) The Secretary shall promulgate regulations establishing 

a unique device identification system for medical devices requiring 

the label of devices to bear a unique identifier, unless the Secretary 

requires an alternative placement or provides an exception for 

a particular device or type of device. The unique identifier shall 

adequately identify the device through distribution and use, and 

may include information on the lot or serial number.’’. 

(b) CONFORMING AMENDMENT.—Section 303 (21 U.S.C. 333) 

is amended— 

(1) by redesignating the subsection that follows subsection 

(e) as subsection (f); and 

(2) in paragraph (1)(B)(ii) of subsection (f), as so redesignated, by striking ‘‘519(f)’’ and inserting ‘‘519(g)’’. 

SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES. 

Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) 

is amended by striking ‘‘were to recur;’’ and inserting the following: 

‘‘were to recur, which report under this subparagraph— 

‘‘(i) shall be submitted in accordance with part 

803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an 

exemption or variance from, or an alternative to, a 

requirement under such regulations pursuant to section 803.19 of such part, if the device involved is— 

‘‘(I) a class III device; 

‘‘(II) a class II device that is permanently 

implantable, is life supporting, or is life sustaining; 

or 

‘‘(III) a type of device which the Secretary 

has, by notice published in the Federal Register 

or letter to the person who is the manufacturer 

Federal Register, 

publication. 

Regulations. 

Study. 


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or importer of the device, indicated should be subject to such part 803 in order to protect the public 

health; 

‘‘(ii) shall, if the device is not subject to clause 

(i), be submitted in accordance with criteria established 

by the Secretary for reports made pursuant to this 

clause, which criteria shall require the reports to be 

in summary form and made on a quarterly basis; or 

‘‘(iii) shall, if the device is imported into the United 

States and for which part 803 of title 21, Code of 

Federal Regulations (or successor regulations) requires 

an importer to submit a report to the manufacturer, 

be submitted by the importer to the manufacturer in 

accordance with part 803 of title 21, Code of Federal 

Regulations (or successor regulations)’’. 

SEC. 228. INSPECTIONS BY ACCREDITED PERSONS. 

Section 704(g) (21 U.S.C. 374(g)) is amended— 

(1) in paragraph (1), by striking ‘‘Not later than one year 

after the date of the enactment of this subsection, the Secretary’’ 

and inserting ‘‘The Secretary’’; 

(2) in paragraph (2), by— 

(A) striking ‘‘Not later than 180 days after the date 

of enactment of this subsection, the Secretary’’ and 

inserting ‘‘The Secretary’’; and 

(B) striking the fifth sentence; 

(3) in paragraph (3), by adding at the end the following: 

‘‘(F) Such person shall notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of 

conformance with the quality systems standard referred to 

in paragraph (7) for any device establishment that such person 

inspects under this subsection not later than 30 days after 

such withdrawal, suspension, restriction, or expiration. 

‘‘(G) Such person may conduct audits to establish conformance with the quality systems standard referred to in paragraph 

(7).’’; 

(4) by amending paragraph (6) to read as follows: 

‘‘(6)(A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspection by persons accredited under paragraph (2) if the following conditions are met: 

‘‘(i) The Secretary classified the results of the most recent 

inspection of the establishment as ‘no action indicated’ or ‘voluntary action indicated’. 

‘‘(ii) With respect to inspections of the establishment to 

be conducted by an accredited person, the owner or operator 

of the establishment submits to the Secretary a notice that— 

‘‘(I) provides the date of the last inspection of the 

establishment by the Secretary and the classification of 

that inspection; 

‘‘(II) states the intention of the owner or operator to 

use an accredited person to conduct inspections of the 

establishment; 

‘‘(III) identifies the particular accredited person the 

owner or operator intends to select to conduct such inspections; and 

Notification. 

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‘‘(IV) includes a certification that, with respect to the 

devices that are manufactured, prepared, propagated, compounded, or processed in the establishment— 

‘‘(aa) at least 1 of such devices is marketed in 

the United States; and 

‘‘(bb) at least 1 of such devices is marketed, or 

is intended to be marketed, in 1 or more foreign countries, 1 of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph 

(2) and identified under subclause (III) as a person 

authorized to conduct inspections of device establishments. 

‘‘(B)(i) Except with respect to the requirement of subparagraph 

(A)(i), a device establishment is deemed to have clearance to participate in the program and to use the accredited person identified 

in the notice under subparagraph (A)(ii) for inspections of the 

establishment unless the Secretary, not later than 30 days after 

receiving such notice, issues a response that— 

‘‘(I) denies clearance to participate as provided under 

subparagraph (C); or 

‘‘(II) makes a request under clause (ii). 

‘‘(ii) The Secretary may request from the owner or operator 

of a device establishment in response to the notice under subparagraph (A)(ii) with respect to the establishment, or from the particular accredited person identified in such notice— 

‘‘(I) compliance data for the establishment in accordance 

with clause (iii)(I); or 

‘‘(II) information concerning the relationship between the 

owner or operator of the establishment and the accredited 

person identified in such notice in accordance with clause 

(iii)(II). 

The owner or operator of the establishment, or such accredited 

person, as the case may be, shall respond to such a request not 

later than 60 days after receiving such request. 

‘‘(iii)(I) The compliance data to be submitted by the owner 

or operator of a device establishment in response to a request 

under clause (ii)(I) 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 501(h) and with other applicable provisions 

of this Act. Such data shall include complete reports of inspectional 

findings regarding good manufacturing practice or other quality 

control audits that, during the preceding 2-year period, were conducted at the establishment by persons other than the owner or 

operator of the establishment, together with all other 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. 

‘‘(II) 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). 

‘‘(iv) A device establishment is deemed to have clearance to 

participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of 

the establishment unless the Secretary, not later than 60 days 

after receiving the information requested under clause (ii), issues 

Deadline. 

Deadline. 

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a response that denies clearance to participate as provided under 

subparagraph (C). 

‘‘(C)(i) The Secretary may deny clearance to a device establishment if the Secretary has evidence that the certification under 

subparagraph (A)(ii)(IV) is untrue and the Secretary provides to 

the owner or operator of the establishment a statement summarizing such evidence. 

‘‘(ii) The Secretary may deny clearance to a device establishment if the Secretary determines that the establishment has failed 

to demonstrate consistent compliance for purposes of subparagraph 

(B)(iii)(I) and the Secretary provides to the owner or operator of 

the establishment a statement of the reasons for such determination. 

‘‘(iii)(I) The Secretary may reject the selection of the accredited 

person identified in the notice under subparagraph (A)(ii) if the 

Secretary provides to the owner or operator of 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. 

‘‘(II) If the Secretary rejects the selection of an accredited 

person by the owner or operator of a device establishment, the 

owner or operator 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) of subparagraph (B), 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)(ii). 

‘‘(iv) In the case of a device establishment that is denied clearance under clause (i) or (ii) or with respect to which the selection 

of the accredited person is rejected under clause (iii), the Secretary 

shall designate a person to review the statement of reasons, or 

statement summarizing such evidence, as the case may be, of the 

Secretary under such clause if, during the 30-day period beginning 

on the date on which the owner or operator of the establishment 

receives such statement, the owner or operator requests the review. 

The review shall commence not later than 30 days after the owner 

or operator requests the review, unless the Secretary and the owner 

or operator otherwise agree.’’; 

(5) in paragraph (7)— 

(A) in subparagraph (A), by striking ‘‘(A) Persons’’ and 

all that follows through the end and inserting the following: 

‘‘(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 in a form and manner designated by the Secretary to conduct inspections, taking 

into consideration the goals of international harmonization 

of quality systems standards. Any official classification of 

the inspection shall be determined by the Secretary.’’; and 

(B) by adding at the end the following: 

Reports. 

Records. 

Deadline. 

Applicability. 

Notification. 


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‘‘(F) For the purpose of setting risk-based inspectional priorities, 

the Secretary shall accept voluntary submissions of reports of audits 

assessing conformance with appropriate quality systems standards 

set by the International Organization for Standardization (ISO) 

and identified by the Secretary in public notice. If the owner or 

operator of an establishment elects to submit audit reports under 

this subparagraph, the owner or operator shall submit all such 

audit reports with respect to the establishment during the preceding 

2-year periods.’’; and 

(6) in paragraph (10)(C)(iii), by striking ‘‘based’’ and 

inserting ‘‘base’’. 

SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL 

DEVICES. 

(a) IN GENERAL.—The Comptroller General of the United States 

shall conduct a study on— 

(1) the number of nosocomial infections attributable to 

new and reused medical devices; and 

(2) the causes of such nosocomial infections, including the 

following: 

(A) Reprocessed single-use devices. 

(B) Handling of sterilized medical devices. 

(C) In-hospital sterilization of medical devices. 

(D) Health care professionals’ practices for patient 

examination and treatment. 

(E) Hospital-based policies and procedures for infection 

control and prevention. 

(F) Hospital-based practices for handling of medical 

waste. 

(G) Other causes. 

(b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall complete the study 

under subsection (a) and submit to the Congress a report on the 

results of such study. 

(c) DEFINITION.—In this section, the term ‘‘nosocomial infection’’ 

means an infection that is acquired while an individual is a patient 

at a hospital and was neither present nor incubating in the patient 

prior to receiving services in the hospital. 

SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION 

REGARDING LABELING INFORMATION ON THE RELATIONSHIP BETWEEN THE USE OF INDOOR TANNING DEVICES 

AND DEVELOPMENT OF SKIN CANCER OR OTHER SKIN 

DAMAGE. 

(a) IN GENERAL.—The Secretary of Health and Human Services 

(referred to in this section as the ‘‘Secretary’’), acting through the 

Commissioner of Food and Drugs, shall determine— 

(1) whether the labeling requirements for indoor tanning 

devices, including the positioning requirements, provide sufficient information to consumers regarding the risks that the 

use of such devices pose for the development of irreversible 

damage to the eyes and skin, including skin cancer; and 

(2)(A) whether modifying the warning label required on 

tanning beds to read, ‘‘Ultraviolet radiation can cause skin 

cancer’’, or any other additional warning, would communicate 

the risks of indoor tanning more effectively; or 

(B) whether there is no warning that would be capable 

of adequately communicating such risks. 

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(b) CONSUMER TESTING.—In making the determinations under 

subsection (a), the Secretary shall conduct appropriate consumer 

testing to determine consumer understanding of label warnings. 

(c) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to the Congress a 

report that provides the determinations under subsection (a). In 

addition, the Secretary shall include in the report the measures 

being implemented by the Secretary to significantly reduce the 

risks associated with indoor tanning devices. 

TITLE III—PEDIATRIC MEDICAL DEVICE 

SAFETY AND IMPROVEMENT ACT OF 

2007 

SEC. 301. SHORT TITLE. 

This title may be cited as the ‘‘Pediatric Medical Device Safety 

and Improvement Act of 2007’’. 

SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS. 

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 351 et seq.) is amended by inserting after section 515 the 

following: 

‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. 

‘‘(a) NEW DEVICES.— 

‘‘(1) IN GENERAL.—A person that submits to the Secretary 

an application under section 520(m), or an application (or 

supplement to an application) or a product development protocol 

under section 515, shall include in the application or protocol 

the information described in paragraph (2). 

‘‘(2) REQUIRED INFORMATION.—The application or protocol 

described in paragraph (1) shall include, with respect to the 

device for which approval is sought and if readily available— 

‘‘(A) a description of any pediatric subpopulations that 

suffer from the disease or condition that the device is 

intended to treat, diagnose, or cure; and 

‘‘(B) the number of affected pediatric patients. 

‘‘(3) ANNUAL REPORT.—Not later than 18 months after the 

date of the enactment of this section, and annually thereafter, 

the Secretary 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 that includes— 

‘‘(A) the number of devices approved in the year preceding the year in which the report is submitted, for which 

there is a pediatric subpopulation that suffers from the 

disease or condition that the device is intended to treat, 

diagnose, or cure; 

‘‘(B) the number of devices approved in the year preceding the year in which the report is submitted, labeled 

for use in pediatric patients; 

‘‘(C) the number of pediatric devices approved in the 

year preceding the year in which the report is submitted, 

exempted from a fee pursuant to section 738(a)(2)(B)(v); 

and 

21 USC 360e–1. 

21 USC 301 note. 

Pediatric Medical 

Device Safety 

and 

Improvement Act 

of 2007. 


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‘‘(D) the review time for each device described in subparagraphs (A), (B), and (C). 

‘‘(b) DETERMINATION OF PEDIATRIC EFFECTIVENESS BASED ON

SIMILAR COURSE OF DISEASE OR CONDITION OR SIMILAR EFFECT

OF DEVICE ON ADULTS.— ‘‘(1) IN GENERAL.—If the course of the disease or condition 

and the effects of the device are sufficiently similar in adults 

and pediatric patients, the Secretary may conclude that adult 

data may be used to support a determination of a reasonable 

assurance of effectiveness in pediatric populations, as appropriate. 

‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULATIONS.—A study 

may not be needed in each pediatric subpopulation if data 

from one subpopulation can be extrapolated to another subpopulation. 

‘‘(c) PEDIATRIC SUBPOPULATION.—For purposes of this section, 

the term ‘pediatric subpopulation’ has the meaning given the term 

in section 520(m)(6)(E)(ii).’’. 

SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION. 

(a) IN GENERAL.—Section 520(m) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360j(m)) is amended— 

(1) in paragraph (3), by striking ‘‘No’’ and inserting ‘‘Except 

as provided in paragraph (6), no’’; 

(2) in paragraph (5)— 

(A) by inserting ‘‘, if the Secretary has reason to believe 

that the requirements of paragraph (6) are no longer met,’’ 

after ‘‘public health’’; and 

(B) by adding at the end the following: ‘‘If the person 

granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of 

this subsection, the Secretary may suspend or withdraw 

the exemption from the effectiveness requirements of sections 514 and 515 for a humanitarian device only after 

providing notice and an opportunity for an informal 

hearing.’’; and 

(3) by striking paragraph (6) and inserting after paragraph 

(5) the following new paragraphs: 

‘‘(6)(A) Except as provided in subparagraph (D), the prohibition 

in paragraph (3) shall not apply with respect to a person granted 

an exemption under paragraph (2) if each of the following conditions 

apply: 

‘‘(i)(I) The device with respect to which the exemption is 

granted is intended for the treatment or diagnosis of a disease 

or condition that occurs in pediatric patients or in a pediatric 

subpopulation, and such device is labeled for use in pediatric 

patients or in a pediatric subpopulation in which the disease 

or condition occurs. 

‘‘(II) The device was not previously approved under this 

subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to the date of the enactment 

of the Pediatric Medical Device Safety and Improvement Act 

of 2007. 

‘‘(ii) During any calendar year, the number of such devices 

distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary 

grants such exemption. The annual distribution number shall 


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be based on the number of individuals affected by the disease 

or condition that such device is intended to treat, diagnose, 

or cure, and of that number, the number of individuals likely 

to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual 

distribution number exceed the number identified in paragraph 

(2)(A). 

‘‘(iii) Such person immediately notifies the Secretary if 

the number of such devices distributed during any calendar 

year exceeds the annual distribution number referred to in 

clause (ii). 

‘‘(iv) The request for such exemption is submitted on or 

before October 1, 2012. 

‘‘(B) The Secretary may inspect the records relating to the 

number of devices distributed during any calendar year of a person 

granted an exemption under paragraph (2) for which the prohibition 

in paragraph (3) does not apply. 

‘‘(C) A person may petition the Secretary to modify the annual 

distribution number specified by the Secretary under subparagraph 

(A)(ii) with respect to a device if additional information on the 

number of individuals affected by the disease or condition arises, 

and the Secretary may modify such number but in no case shall 

the annual distribution number exceed the number identified in 

paragraph (2)(A). 

‘‘(D) If a person notifies the Secretary, or the Secretary determines through an inspection under subparagraph (B), that the 

number of devices distributed during any calendar year exceeds 

the annual distribution number, as required under subparagraph 

(A)(iii), and modified under subparagraph (C), if applicable, then 

the prohibition in paragraph (3) shall apply with respect to such 

person for such device for any sales of such device after such 

notification. 

‘‘(E)(i) In this subsection, the term ‘pediatric patients’ means 

patients who are 21 years of age or younger at the time of the 

diagnosis or treatment. 

‘‘(ii) In this subsection, the term ‘pediatric subpopulation’ means 

1 of the following populations: 

‘‘(I) Neonates. 

‘‘(II) Infants. 

‘‘(III) Children. 

‘‘(IV) Adolescents. 

‘‘(7) The Secretary shall refer any report of an adverse event 

regarding a device for which the prohibition under paragraph (3) 

does not apply pursuant to paragraph (6)(A) that the Secretary 

receives to the Office of Pediatric Therapeutics, established under 

section 6 of the Best Pharmaceuticals for Children Act (Public 

Law 107–109). In considering the report, the Director of the Office 

of Pediatric Therapeutics, in consultation with experts in the Center 

for Devices and Radiological Health, shall provide for periodic 

review of the report by the Pediatric Advisory Committee, including 

obtaining any recommendations of such committee regarding 

whether the Secretary should take action under this Act in response 

to the report. 

‘‘(8) The Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, shall 

provide for an annual review by the Pediatric Advisory Committee 

Annual review. 

Applicability. 

Deadline. 

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of all devices described in paragraph (6) to ensure that the exemption under paragraph (2) remains appropriate for the pediatric 

populations for which it is granted.’’. 

(b) REPORT.—Not later than January 1, 2012, the Comptroller 

General of the United States 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 the impact of allowing persons granted an exemption under section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a device to profit 

from such device pursuant to section 520(m)(6) of such Act (21 

U.S.C. 360j(m)(6)) (as amended by subsection (a)), including— 

(1) an assessment of whether such section 520(m)(6) (as 

amended by subsection (a)) has increased the availability of 

pediatric devices for conditions that occur in small numbers 

of children, including any increase or decrease in the number 

of— 

(A) exemptions granted under such section 520(m)(2) 

for pediatric devices; and 

(B) applications approved under section 515 of such 

Act (21 U.S.C. 360e) for devices intended to treat, diagnose, 

or cure conditions that occur in pediatric patients or for 

devices labeled for use in a pediatric population; 

(2) the conditions or diseases the pediatric devices were 

intended to treat or diagnose and the estimated size of the 

pediatric patient population for each condition or disease; 

(3) the costs of purchasing pediatric devices, based on a 

representative sampling of children’s hospitals; 

(4) the extent to which the costs of such devices are covered 

by health insurance; 

(5) the impact, if any, of allowing profit on access to such 

devices for patients; 

(6) the profits made by manufacturers for each device that 

receives an exemption; 

(7) an estimate of the extent of the use of the pediatric 

devices by both adults and pediatric populations for a condition 

or disease other than the condition or disease on the label 

of such devices; 

(8) recommendations of the Comptroller General of the 

United States regarding the effectiveness of such section 

520(m)(6) (as amended by subsection (a)) and whether any 

modifications to such section 520(m)(6) (as amended by subsection (a)) should be made; 

(9) existing obstacles to pediatric device development; and 

(10) an evaluation of the demonstration grants described 

in section 305, which shall include an evaluation of the number 

of pediatric medical devices— 

(A) that have been or are being studied in children; 

and 

(B) that have been submitted to the Food and Drug 

Administration for approval, clearance, or review under 

such section 520(m) (as amended by this Act) and any 

regulatory actions taken. 

(c) GUIDANCE.—Not later than 180 days after the date of the 

enactment of this Act, the Commissioner of Food and Drugs shall 

issue guidance for institutional review committees on how to 

evaluate requests for approval for devices for which a humanitarian 

Deadline. 

21 USC 360j 

note. 


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device exemption under section 520(m)(2) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted. 

SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH. 

(a) CONTACT POINT FOR AVAILABLE FUNDING.—Section 402(b) 

of the Public Health Service Act (42 U.S.C. 282(b)) is amended— 

(1) in paragraph (21), by striking ‘‘and’’ after the semicolon 

at the end; 

(2) in paragraph (22), by striking the period at the end 

and inserting ‘‘; and’’; and 

(3) by inserting after paragraph (22) the following: 

‘‘(23) shall designate a contact point or office to help 

innovators and physicians identify sources of funding available 

for pediatric medical device development.’’. 

(b) PLAN FOR PEDIATRIC MEDICAL DEVICE RESEARCH.— (1) IN GENERAL.—Not later than 180 days after the date 

of the enactment of this Act, the Secretary of Health and 

Human Services, acting through the Commissioner of Food 

and Drugs, the Director of the National Institutes of Health, 

and the Director of the Agency for Healthcare Research and 

Quality, 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 plan 

for expanding pediatric medical device research and development. In developing such plan, the Secretary of Health and 

Human Services shall consult with individuals and organizations with appropriate expertise in pediatric medical devices. 

(2) CONTENTS.—The plan under paragraph (1) shall 

include— 

(A) the current status of federally funded pediatric 

medical device research; 

(B) any gaps in such research, which may include 

a survey of pediatric medical providers regarding unmet 

pediatric medical device needs, as needed; and 

(C) a research agenda for improving pediatric medical 

device development and Food and Drug Administration 

clearance or approval of pediatric medical devices, and 

for evaluating the short- and long-term safety and effectiveness of pediatric medical devices. 

SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC 

DEVICE AVAILABILITY. 

(a) IN GENERAL.— (1) REQUEST FOR PROPOSALS.—Not later than 90 days after 

the date of the enactment of this Act, the Secretary of Health 

and Human Services shall issue a request for proposals for 

1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development. 

(2) DETERMINATION ON GRANTS OR CONTRACTS.—Not later 

than 180 days after the date the Secretary of Health and 

Human Services issues a request for proposals under paragraph 

(1), the Secretary shall make a determination on the grants 

or contracts under this section. 

(b) APPLICATION.—A nonprofit consortium that desires to 

receive a grant or contract under this section shall submit an 

application to the Secretary of Health and Human Services at 

such time, in such manner, and containing such information as 

the Secretary may require. 

Deadline. 

42 USC 282 note. 

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(c) USE OF FUNDS.—A nonprofit consortium that receives a 

grant or contract under this section shall facilitate the development, 

production, and distribution of pediatric medical devices by— 

(1) encouraging innovation and connecting qualified 

individuals with pediatric device ideas with potential manufacturers; 

(2) mentoring and managing pediatric device projects 

through the development process, including product identification, prototype design, device development, and marketing; 

(3) connecting innovators and physicians to existing Federal 

and non-Federal resources, including resources from the Food 

and Drug Administration, the National Institutes of Health, 

the Small Business Administration, the Department of Energy, 

the Department of Education, the National Science Foundation, 

the Department of Veterans Affairs, the Agency for Healthcare 

Research and Quality, and the National Institute of Standards 

and Technology; 

(4) assessing the scientific and medical merit of proposed 

pediatric device projects; and 

(5) providing assistance and advice as needed on business 

development, personnel training, prototype development, 

postmarket needs, and other activities consistent with the purposes of this section. 

(d) COORDINATION.— 

(1) NATIONAL INSTITUTES OF HEALTH.—Each consortium 

that receives a grant or contract under this section shall— 

(A) coordinate with the National Institutes of Health’s 

pediatric device contact point or office, designated under 

section 402(b)(23) of the Public Health Service Act, as 

added by section 304(a) of this Act; and 

(B) provide to the National Institutes of Health any 

identified pediatric device needs that the consortium lacks 

sufficient capacity to address or those needs in which the 

consortium has been unable to stimulate manufacturer 

interest. 

(2) FOOD AND DRUG ADMINISTRATION.—Each consortium 

that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device 

companies to facilitate the application for approval or clearance 

of devices labeled for pediatric use. 

(3) EFFECTIVENESS AND OUTCOMES.—Each consortium that 

receives a grant or contract under this section shall annually 

report to the Secretary of Health and Human Services on 

the status of pediatric device development, production, and 

distribution that has been facilitated by the consortium. 

(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated to carry out this section $6,000,000 for each 

of fiscal years 2008 through 2012. 

SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS 

AND PEDIATRIC ADVISORY COMMITTEE. 

(a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 6(b) of the 

Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is 

amended by inserting ‘‘, including increasing pediatric access to 

medical devices’’ after ‘‘pediatric issues’’. 

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(b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 of the Best 

Pharmaceuticals for Children Act (42 U.S.C. 284m note) is 

amended— 

(1) in subsection (a), by inserting ‘‘(including drugs and 

biological products) and medical devices’’ after ‘‘therapeutics’’; 

and 

(2) in subsection (b)— 

(A) in paragraph (1), by inserting ‘‘(including drugs 

and biological products) and medical devices’’ after ‘‘therapeutics’’; and 

(B) in paragraph (2)— 

(i) in subparagraph (A), by striking ‘‘and 505B’’ 

and inserting ‘‘505B, 510(k), 515, and 520(m)’’; 

(ii) by striking subparagraph (B) and inserting 

the following: 

‘‘(B) identification of research priorities related to 

therapeutics (including drugs and biological products) and 

medical devices for pediatric populations and the need for 

additional diagnostics and treatments for specific pediatric 

diseases or conditions;’’; and 

(iii) in subparagraph (C), by inserting ‘‘(including 

drugs and biological products) and medical devices’’ 

after ‘‘therapeutics’’. 

SEC. 307. POSTMARKET SURVEILLANCE. 

Section 522 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360l) is amended— 

(1) by amending the section heading and designation to 

read as follows: 

‘‘SEC. 522. POSTMARKET SURVEILLANCE.’’; 

(2) by striking subsection (a) and inserting the following: 

‘‘(a) POSTMARKET SURVEILLANCE.— ‘‘(1) IN GENERAL.— ‘‘(A) CONDUCT.—The Secretary may by order require 

a manufacturer to conduct postmarket surveillance for any 

device of the manufacturer that is a class II or class III 

device— 

‘‘(i) the failure of which would be reasonably likely 

to have serious adverse health consequences; 

‘‘(ii) that is expected to have significant use in 

pediatric populations; or 

‘‘(iii) that is intended to be— 

‘‘(I) implanted in the human body for more 

than 1 year; or 

‘‘(II) a life-sustaining or life-supporting device 

used outside a device user facility. 

‘‘(B) CONDITION.—The Secretary may order a 

postmarket surveillance under subparagraph (A) as a condition to approval or clearance of a device described in 

subparagraph (A)(ii). 

‘‘(2) RULE OF CONSTRUCTION.—The provisions of paragraph 

(1) shall have no effect on authorities otherwise provided under 

the Act or regulations issued under this Act.’’; and 

(3) in subsection (b)— 

(A) by striking ‘‘(b) SURVEILLANCE APPROVAL.—Each’’ 

and inserting the following: 

‘‘(b) SURVEILLANCE APPROVAL.— 


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‘‘(1) IN GENERAL.—Each’’; 

(B) by striking ‘‘The Secretary, in consultation’’ and 

inserting ‘‘Except as provided in paragraph (2), the Secretary, in consultation’’; 

(C) by striking ‘‘Any determination’’ and inserting 

‘‘Except as provided in paragraph (2), any determination’’; 

and 

(D) by adding at the end the following: 

‘‘(2) LONGER SURVEILLANCE FOR PEDIATRIC DEVICES.—The 

Secretary may by order require a prospective surveillance 

period of more than 36 months with respect to a device that 

is expected to have significant use in pediatric populations 

if such period of more than 36 months is necessary in order 

to assess the impact of the device on growth and development, 

or the effects of growth, development, activity level, or other 

factors on the safety or efficacy of the device. 

‘‘(c) DISPUTE RESOLUTION.—A manufacturer may request review 

under section 562 of any order or condition requiring postmarket 

surveillance under this section. During the pendency of such review, 

the device subject to such a postmarket surveillance order or condition shall not, because of noncompliance with such order or condition, be deemed in violation of section 301(q)(1)(C), adulterated 

under section 501(f)(1), misbranded under section 502(t)(3), or in 

violation of, as applicable, section 510(k) or section 515, unless 

deemed necessary to protect the public health.’’. 

TITLE IV—PEDIATRIC RESEARCH 

EQUITY ACT OF 2007 

SEC. 401. SHORT TITLE. 

This title may be cited as the ‘‘Pediatric Research Equity Act 

of 2007’’. 

SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT. 

(a) IN GENERAL.—Section 505B of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355c) is amended to read as follows: 

‘‘SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND 

BIOLOGICAL PRODUCTS. 

‘‘(a) NEW DRUGS AND BIOLOGICAL PRODUCTS.— 

‘‘(1) IN GENERAL.—A person that submits, on or after the 

date of the enactment of the Pediatric Research Equity Act 

of 2007, an application (or supplement to an application)— 

‘‘(A) under section 505 for a new active ingredient, 

new indication, new dosage form, new dosing regimen, 

or new route of administration, or 

‘‘(B) under section 351 of the Public Health Service 

Act (42 U.S.C. 262) 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 

21 USC 301 note. 

Pediatric 

Research Equity 

Act of 2007. 


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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. 

‘‘(iii) INFORMATION ON EXTRAPOLATION.—A brief 

documentation of the scientific data supporting the 

conclusion under clauses (i) and (ii) shall be included 

in any pertinent reviews for the application under section 505 of this Act or section 351 of the Public Health 

Service Act (42 U.S.C. 262). 

‘‘(3) DEFERRAL.— 

‘‘(A) IN GENERAL.—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— 

‘‘(i) 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 

‘‘(ii) the applicant submits to the Secretary— 

‘‘(I) certification of the grounds for deferring 

the assessments; 

‘‘(II) a description of the planned or ongoing 

studies; 

‘‘(III) evidence that the studies are being conducted or will be conducted with due diligence 

and at the earliest possible time; and 

‘‘(IV) a timeline for the completion of such 

studies. 

‘‘(B) ANNUAL REVIEW.— 

‘‘(i) IN GENERAL.—On an annual basis following 

the approval of a deferral under subparagraph (A), 

the applicant shall submit to the Secretary the following information: 


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‘‘(I) Information detailing the progress made 

in conducting pediatric studies. 

‘‘(II) If no progress has been made in conducting such studies, evidence and documentation 

that such studies will be conducted with due diligence and at the earliest possible time. 

‘‘(ii) PUBLIC AVAILABILITY.—The information submitted through the annual review under clause (i) 

shall promptly be made available to the public in an 

easily accessible manner, including through the Web 

site of the Food and Drug Administration. 

‘‘(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 

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to develop a pediatric formulation, the waiver shall cover 

only the pediatric groups requiring that formulation. An 

applicant seeking either a full or partial waiver shall 

submit to the Secretary documentation detailing why a 

pediatric formulation cannot be developed and, if the waiver 

is granted, the applicant’s submission shall promptly be 

made available to the public in an easily accessible manner, 

including through posting on the Web site of the Food 

and Drug Administration. 

‘‘(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 (that, for a drug approved under section 505, references 

a declined written request under section 505A for a labeled 

indication which written request is not referred under section 

505A(n)(1)(A) to the Foundation of the National Institutes of 

Health for the pediatric studies), the Secretary may (by order 

in the form of a letter) require the sponsor or holder of an 

approved application for a drug under section 505 or the holder 

of a license for a biological product under section 351 of the 

Public Health Service Act to submit by a specified date the 

assessments described in subsection (a)(2), 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) adequate pediatric labeling could confer a benefit 

on pediatric patients; 

‘‘(B) there is reason to believe that the drug or 

biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients 

for 1 or more of the claimed indications; or 

‘‘(C) the absence of adequate pediatric labeling could 

pose a risk 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— 

Public 

information. 

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‘‘(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. An 

applicant seeking either a full or partial waiver shall 

submit to the Secretary documentation detailing why a 

pediatric formulation cannot be developed and, if the waiver 

is granted, the applicant’s submission shall promptly be 

made available to the public in an easily accessible manner, 

including through posting on the Web site of the Food 

and Drug Administration. 

‘‘(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) EFFECT OF SUBSECTION.—Nothing in this subsection 

alters or amends section 301(j) of this Act or section 552 of 

title 5 or section 1905 of title 18, United States Code. 

‘‘(c) MEANINGFUL THERAPEUTIC BENEFIT.—For the purposes of 

paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and paragraphs (1)(B) and (2)(B)(iii)(I)(aa) of subsection (b), a drug or 

biological product shall be considered to represent a meaningful 

therapeutic benefit over existing therapies if the Secretary determines that— 

‘‘(1) if approved, the drug or biological product could represent an 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), or a request for 

approval of a pediatric formulation described in subsection (a) or 

(b), in accordance with applicable provisions of subsections (a) and 

(b)— 

Public 

information. 

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‘‘(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 303); 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 

505(e); or 

‘‘(B) to revoke the license for a biological product under 

section 351 of the Public Health Service Act. 

‘‘(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) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, 

AND WAIVERS.— 

‘‘(1) REVIEW.—Beginning not later than 30 days after the 

date of the enactment of the Pediatric Research Equity Act 

of 2007, the Secretary shall utilize the internal committee established under section 505C to provide consultation to reviewing 

divisions on all pediatric plans and assessments prior to 

approval of an application or supplement for which a pediatric 

assessment is required under this section and all deferral and 

waiver requests granted pursuant to this section. 

‘‘(2) ACTIVITY BY COMMITTEE.—The committee referred to 

in paragraph (1) may operate using appropriate members of 

such committee and need not convene all members of the committee. 

‘‘(3) DOCUMENTATION OF COMMITTEE ACTION.—For each 

drug or biological product, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (4) or (5), which members of the committee participated 

in such activity. 

‘‘(4) REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, 

AND WAIVERS.—Consultation on pediatric plans and assessments by the committee referred to in paragraph (1) pursuant 

to this section shall occur prior to approval of an application 

or supplement for which a pediatric assessment is required 

under this section. The committee shall review all requests 

for deferrals and waivers from the requirement to submit a 

pediatric assessment granted under this section and shall provide recommendations as needed to reviewing divisions, 

including with respect to whether such a supplement, when 

submitted, shall be considered for priority review. 

‘‘(5) RETROSPECTIVE REVIEW OF PEDIATRIC ASSESSMENTS, 

DEFERRALS, AND WAIVERS.—Not later than 1 year after the 

date of the enactment of the Pediatric Research Equity Act 

of 2007, the committee referred to in paragraph (1) shall conduct a retrospective review and analysis of a representative 

sample of assessments submitted and deferrals and waivers 

approved under this section since the enactment of the Pediatric 

Research Equity Act of 2003. Such review shall include an 

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analysis of the quality and consistency of pediatric information 

in pediatric assessments and the appropriateness of waivers 

and deferrals granted. Based on such review, the Secretary 

shall issue recommendations to the review divisions for 

improvements and initiate guidance to industry related to the 

scope of pediatric studies required under this section. 

‘‘(6) TRACKING OF ASSESSMENTS AND LABELING CHANGES.— 

The Secretary, in consultation with the committee referred 

to in paragraph (1), shall track and make available to the 

public in an easily accessible manner, including through posting 

on the Web site of the Food and Drug Administration— 

‘‘(A) the number of assessments conducted under this 

section; 

‘‘(B) the specific drugs and biological products and their 

uses assessed under this section; 

‘‘(C) the types of assessments conducted under this 

section, including trial design, the number of pediatric 

patients studied, and the number of centers and countries 

involved; 

‘‘(D) the total number of deferrals requested and 

granted under this section and, if granted, the reasons 

for such deferrals, the timeline for completion, and the 

number completed and pending by the specified date, as 

outlined in subsection (a)(3); 

‘‘(E) the number of waivers requested and granted 

under this section and, if granted, the reasons for the 

waivers; 

‘‘(F) the number of pediatric formulations developed 

and the number of pediatric formulations not developed 

and the reasons any such formulation was not developed; 

‘‘(G) the labeling changes made as a result of assessments conducted under this section; 

‘‘(H) an annual summary of labeling changes made 

as a result of assessments conducted under this section 

for distribution pursuant to subsection (h)(2); 

‘‘(I) an annual summary of information submitted 

pursuant to subsection (a)(3)(B); and 

‘‘(J) the number of times the committee referred to 

in paragraph (1) made a recommendation to the Secretary 

under paragraph (4) regarding priority review, the number 

of times the Secretary followed or did not follow such 

a recommendation, and, if not followed, the reasons why 

such a recommendation was not followed. 

‘‘(g) LABELING CHANGES.— 

‘‘(1) DISPUTE RESOLUTION.— 

‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO

AGREE.—If, on or after the date of the enactment of the 

Pediatric Research Equity Act of 2007, the Commissioner 

determines that a sponsor and the Commissioner have 

been unable to reach agreement on appropriate changes 

to the labeling for the drug that is the subject of the 

application or supplement, not later than 180 days after 

the date of the submission of the application or supplement— 

‘‘(i) the Commissioner shall request that the 

sponsor of the application make any labeling change 

Deadline. 

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that the Commissioner determines to be appropriate; 

and 

‘‘(ii) if the sponsor does not agree within 30 days 

after the Commissioner’s request 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 or supplement 

to make any labeling changes that the Commissioner determines to be appropriate. 

‘‘(D) MISBRANDING.—If the sponsor of the application 

or supplement, 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 

or supplement 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 Act 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. 

‘‘(2) OTHER LABELING CHANGES.—If, on or after the date 

of the enactment of the Pediatric Research Equity Act of 2007, 

the Secretary makes a determination that a pediatric assessment conducted under this section does or does not demonstrate 

that the drug that is the subject of such assessment is safe 

and effective in pediatric populations or subpopulations, 

including whether such assessment results are inconclusive, 

the Secretary shall order the label of such product to include 

information about the results of the assessment and a statement of the Secretary’s determination. 

‘‘(h) DISSEMINATION OF PEDIATRIC INFORMATION.— 

‘‘(1) IN GENERAL.—Not later than 210 days after the date 

of submission of a pediatric assessment under this section, 

the Secretary shall make available to the public in an easily 

accessible manner the medical, statistical, and clinical pharmacology reviews of such pediatric assessments, and shall post 

such assessments on the Web site of the Food and Drug 

Administration. 

‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING

CHANGES.—Beginning on the date of the enactment of the Pediatric Research Equity Act of 2007, the Secretary shall require 

that the sponsors of the assessments that result in labeling 

Effective date. 

Deadline. 

Public 

information. 

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changes that are reflected in the annual summary developed 

pursuant to subsection (f)(6)(H) distribute such information 

to physicians and other health care providers. 

‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection 

shall alter or amend section 301(j) of this Act or section 552 

of title 5 or section 1905 of title 18, United States Code. 

‘‘(i) ADVERSE EVENT REPORTING.— 

‘‘(1) REPORTING IN YEAR ONE.—Beginning on the date of 

the enactment of the Pediatric Research Equity Act of 2007, 

during the one-year period beginning on the date a labeling 

change is made pursuant to subsection (g), the Secretary shall 

ensure that all adverse event reports that have been received 

for such drug (regardless of when such report was received) 

are referred to the Office of Pediatric Therapeutics. In considering such reports, the Director of such Office shall provide 

for the review of such reports by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action 

under this Act in response to such reports. 

‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the oneyear period described in paragraph (1), the Secretary shall, 

as appropriate, refer to the Office of Pediatric Therapeutics 

all pediatric adverse event reports for a drug for which a 

pediatric study was conducted under this section. In considering 

such reports, the Director of such Office may provide for the 

review of such reports by the Pediatric Advisory Committee, 

including obtaining any recommendation of such Committee 

regarding whether the Secretary should take action in response 

to such reports. 

‘‘(3) EFFECT.—The requirements of this subsection shall 

supplement, not supplant, other review of such adverse event 

reports by the Secretary. 

‘‘(j) 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. 

‘‘(k) 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 

526. 

‘‘(l) INSTITUTE OF MEDICINE STUDY.— 

‘‘(1) IN GENERAL.—Not later than three years after the 

date of the enactment of the Pediatric Research Equity Act 

of 2007, the Secretary shall contract with the Institute of Medicine to conduct a study and report to Congress regarding the 

pediatric studies conducted pursuant to this section or precursor 

regulations since 1997 and labeling changes made as a result 

of such studies. 

‘‘(2) CONTENT OF STUDY.—The study under paragraph (1) 

shall review and assess the use of extrapolation for pediatric 

subpopulations, the use of alternative endpoints for pediatric 

populations, neonatal assessment tools, the number and type 

of pediatric adverse events, and ethical issues in pediatric clinical trials. 

Deadline. 

Contracts. 

Reports. 

Effective date. 


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‘‘(3) REPRESENTATIVE SAMPLE.—The Institute of Medicine 

may devise an appropriate mechanism to review a representative sample of studies conducted pursuant to this section from 

each review division within the Center for Drug Evaluation 

and Research in order to make the requested assessment. 

‘‘(m) 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 505A(q).’’. 

(b) APPLICABILITY.— (1) IN GENERAL.—Notwithstanding subsection (h) of section 

505B of the Federal Food, Drug and Cosmetic Act, as in effect 

on the day before the date of the enactment of this Act, a 

pending assessment, including a deferred assessment, required 

under such section 505B shall be deemed to have been required 

under section 505B of the Federal Food, Drug and Cosmetic 

Act as in effect on or after the date of the enactment of this 

Act. 

(2) CERTAIN ASSESSMENTS AND WAIVER REQUESTS.—An 

assessment pending on or after the date that is 1 year prior 

to the date of the enactment of this Act shall be subject to 

the tracking and disclosure requirements established under 

such section 505B, as in effect on or after such date of enactment, except that any such assessments submitted or waivers 

of such assessments requested before such date of enactment 

shall not be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), 

and (h) of such section 505B. 

SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE. 

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 351 et seq.) is amended by inserting after section 505B 

the following: 

‘‘SEC. 505C. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, 

ASSESSMENTS, DEFERRALS, AND WAIVERS. 

‘‘The Secretary shall establish an internal committee within 

the Food and Drug Administration to carry out the activities as 

described in sections 505A(f) and 505B(f). Such internal committee 

shall include employees of the Food and Drug Administration, with 

expertise in pediatrics (including representation from the Office 

of Pediatric Therapeutics), biopharmacology, statistics, chemistry, 

legal issues, pediatric ethics, and the appropriate expertise pertaining to the pediatric product under review, such as expertise 

in child and adolescent psychiatry, and other individuals designated 

by the Secretary.’’. 

SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT. 

Not later than January 1, 2011, the Comptroller General of 

the United States, in consultation with the Secretary of Health 

and Human Services, shall submit to the Congress a report that 

addresses the effectiveness of sections 505A and 505B of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and section 

409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring 

that medicines used by children are tested and properly labeled. 

Such report shall include— 

(1) the number and importance of drugs and biological 

products for children that are being tested as a result of the 

amendments made by this title and title V and the importance 

Establishment. 

21 USC 355d. 

21 USC 355c 

note. 


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for children, health care providers, parents, and others of 

labeling changes made as a result of such testing; 

(2) the number and importance of drugs and biological 

products for children that are not being tested for their use 

notwithstanding the provisions of this title and title V and 

possible reasons for the lack of testing; 

(3) the number of drugs and biological products for which 

testing is being done and labeling changes required, including 

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 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; 

(4) any recommendations for modifications to the programs 

established under sections 505A and 505B 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) that the 

Secretary determines to be appropriate, including a detailed 

rationale for each recommendation; and 

(5)(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 the studies ethical and 

safe. 

TITLE V—BEST PHARMACEUTICALS 

FOR CHILDREN ACT OF 2007 

SEC. 501. SHORT TITLE. 

This title may be cited as the ‘‘Best Pharmaceuticals for Children Act of 2007’’. 

SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT. 

(a) PEDIATRIC STUDIES OF DRUGS.— 

(1) IN GENERAL.—Section 505A of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355a) is amended to read as 

follows: 

‘‘SEC. 505A. PEDIATRIC STUDIES OF DRUGS. 

‘‘(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, and, at the discretion 

of the Secretary, may include preclinical studies. 

‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— ‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 

if, prior to approval of an application that is submitted under 

section 505(b)(1), 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 

21 USC 301 note. 

Best 

Pharmaceuticals 

for Children Act 

of 2007. 


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include a timeframe for completing such studies), the applicant 

agrees to the request, such studies are completed using appropriate formulations for each age group for which the study 

is requested within any such timeframe, and the reports thereof 

are submitted and accepted in accordance with subsection 

(d)(3)— 

‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) 

of section 505, 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)(E)(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)(E) 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 

‘‘(ii) if the drug is designated under section 526 for 

a rare disease or condition, the period referred to in section 

527(a) is deemed to be seven years and six months rather 

than seven years; and 

‘‘(B)(i) 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 505 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 505, 

the period during which an application may not be 

approved under section 505(c)(3) or section 505(j)(5)(B) 

shall be extended by a period of six months after the 

date the patent expires (including any patent extensions); 

or 

‘‘(ii) 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 505, 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 505(c)(3) or section 

505(j)(5)(B) shall be extended by a period of six months 

after the date the patent expires (including any patent 

extensions). 

‘‘(2) EXCEPTION.—The Secretary shall not extend the period 

referred to in paragraph (1)(A) or (1)(B) if the determination 

made under subsection (d)(3) is made later than 9 months 

prior to the expiration of such period. 

‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS.— 

‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 

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 


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121 STAT. 878 PUBLIC LAW 110–85—SEPT. 27, 2007 

505(b)(1) for pediatric studies (which shall include a timeframe 

for completing such studies), the holder agrees to the request, 

such studies are completed using appropriate formulations for 

each age group for which the study is requested within any 

such timeframe, and the reports thereof are submitted and 

accepted in accordance with subsection (d)(3)— 

‘‘(A)(i)(I) the period referred to in subsection (c)(3)(E)(ii) 

of section 505, 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)(E)(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 

‘‘(ii) if the drug is designated under section 526 for 

a rare disease or condition, the period referred to in section 

527(a) is deemed to be seven years and six months rather 

than seven years; and 

‘‘(B)(i) 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 505 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 505, 

the period during which an application may not be 

approved under section 505(c)(3) or section 505(j)(5)(B)(ii) 

shall be extended by a period of six months after the 

date the patent expires (including any patent extensions); 

or 

‘‘(ii) 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 505, 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 505(c)(3) or section 

505(j)(5)(B) shall be extended by a period of six months 

after the date the patent expires (including any patent 

extensions). 

‘‘(2) EXCEPTION.—The Secretary shall not extend the period 

referred to in paragraph (1)(A) or (1)(B) if the determination 

made under subsection (d)(3) is made later than 9 months 

prior to the expiration of such period. 

‘‘(d) CONDUCT OF PEDIATRIC STUDIES.— 

‘‘(1) REQUEST FOR STUDIES.— 

‘‘(A) IN GENERAL.—The Secretary may, after consultation with the sponsor of an application for an investigational new drug under section 505(i), the sponsor of an 

application for a new drug under section 505(b)(1), or the 

Deadline. 


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holder of an approved application for a drug under section 

505(b)(1), issue to the sponsor or holder a written request 

for the conduct of pediatric studies for such drug. In issuing 

such request, the Secretary shall take into account adequate representation of children of ethnic and racial minorities. Such request to conduct pediatric studies shall be 

in writing and shall include a timeframe for such studies 

and a request to the sponsor or holder to propose pediatric 

labeling resulting from such studies. 

‘‘(B) SINGLE WRITTEN REQUEST.—A single written 

request— 

‘‘(i) may relate to more than one use of a drug; 

and 

‘‘(ii) may include uses that are both approved and 

unapproved. 

‘‘(2) WRITTEN REQUEST FOR PEDIATRIC STUDIES.— 

‘‘(A) REQUEST AND RESPONSE.— 

‘‘(i) IN GENERAL.—If the Secretary makes a written 

request for pediatric studies (including neonates, as 

appropriate) under subsection (b) or (c), the applicant 

or holder, not later than 180 days after receiving the 

written request, shall respond to the Secretary as to 

the intention of the applicant or holder to act on the 

request by— 

‘‘(I) indicating when the pediatric studies will 

be initiated, if the applicant or holder agrees to 

the request; or 

‘‘(II) indicating that the applicant or holder 

does not agree to the request and stating the reasons for declining the request. 

‘‘(ii) DISAGREE WITH REQUEST.—If, on or after the 

date of the enactment of the Best Pharmaceuticals 

for Children Act of 2007, the applicant or holder does 

not agree to the request on the grounds that it is 

not possible to develop the appropriate pediatric formulation, the applicant or holder shall submit to the 

Secretary the reasons such pediatric formulation 

cannot be developed. 

‘‘(B) ADVERSE EVENT REPORTS.—An applicant or holder 

that, on or after the date of the enactment of the Best 

Pharmaceuticals for Children Act of 2007, agrees to the 

request for such studies shall provide the Secretary, at 

the same time as the submission of the reports of such 

studies, with all postmarket adverse event reports 

regarding the drug that is the subject of such studies 

and are available prior to submission of such reports. 

‘‘(3) MEETING THE STUDIES REQUIREMENT.—Not later than 

180 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 180-day period, 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. 

Deadline. 

Notification. 

Timeframe. 

Minorities. 


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‘‘(4) EFFECT OF SUBSECTION.—Nothing in this subsection 

alters or amends section 301(j) of this Act or section 552 of 

title 5 or section 1905 of title 18, United States Code. 

‘‘(e) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT.— ‘‘(1) IN GENERAL.—The Secretary shall publish a notice 

of any determination, made on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, 

that the requirements of subsection (d) have been met and 

that submissions and approvals under subsection (b)(2) or (j) 

of section 505 for a drug will be subject to the provisions 

of this section. Such notice shall be published not later than 

30 days after the date of the Secretary’s determination 

regarding market exclusivity and shall include a copy of the 

written request made under subsection (b) or (c). 

‘‘(2) IDENTIFICATION OF CERTAIN DRUGS.—The Secretary 

shall publish a notice identifying any drug for which, on or 

after the date of the enactment of the Best Pharmaceuticals 

for Children Act of 2007, a pediatric formulation was developed, 

studied, and found to be safe and effective in the pediatric 

population (or specified subpopulation) if the pediatric formulation for such drug is not introduced onto the market within 

one year after the date that the Secretary publishes the notice 

described in paragraph (1). Such notice identifying such drug 

shall be published not later than 30 days after the date of 

the expiration of such one year period. 

‘‘(f) INTERNAL REVIEW OF WRITTEN REQUESTS AND PEDIATRIC

STUDIES.— 

‘‘(1) INTERNAL REVIEW.—The Secretary shall utilize the 

internal review committee established under section 505C to 

review all written requests issued on or after the date of the 

enactment of the Best Pharmaceuticals for Children Act of 

2007, in accordance with paragraph (2). 

‘‘(2) REVIEW OF WRITTEN REQUESTS.—The committee 

referred to in paragraph (1) shall review all written requests 

issued pursuant to this section prior to being issued. 

‘‘(3) REVIEW OF PEDIATRIC STUDIES.—The committee 

referred to in paragraph (1) may review studies conducted 

pursuant to this section to make a recommendation to the 

Secretary whether to accept or reject such reports under subsection (d)(3). 

‘‘(4) ACTIVITY BY COMMITTEE.—The committee referred to 

in paragraph (1) may operate using appropriate members of 

such committee and need not convene all members of the committee. 

‘‘(5) DOCUMENTATION OF COMMITTEE ACTION.—For each 

drug, the committee referred to in paragraph (1) shall document, for each activity described in paragraph (2) or (3), which 

members of the committee participated in such activity. 

‘‘(6) TRACKING PEDIATRIC STUDIES AND LABELING

CHANGES.—The Secretary, in consultation with the committee 

referred to in paragraph (1), shall track and make available 

to the public, in an easily accessible manner, including through 

posting on the Web site of the Food and Drug Administration— 

‘‘(A) the number of studies conducted under this section 

and under section 409I of the Public Health Service Act; 

‘‘(B) the specific drugs and drug uses, including labeled 

and off-labeled indications, studied under such sections; 

Public 

information. 

Website. 

Deadline. 

Publication. 

Deadline. 

Records. 

Publication. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 881 

‘‘(C) the types of studies conducted under such sections, 

including trial design, the number of pediatric patients 

studied, and the number of centers and countries involved; 

‘‘(D) the number of pediatric formulations developed 

and the number of pediatric formulations not developed 

and the reasons such formulations were not developed; 

‘‘(E) the labeling changes made as a result of studies 

conducted under such sections; 

‘‘(F) an annual summary of labeling changes made 

as a result of studies conducted under such sections for 

distribution pursuant to subsection (k)(2); and 

‘‘(G) information regarding reports submitted on or 

after the date of the enactment of the Best Pharmaceuticals 

for Children Act of 2007. 

‘‘(g) LIMITATIONS.—Notwithstanding subsection (c)(2), a drug 

to which the six-month period under subsection (b) or (c) has already 

been applied— 

‘‘(1) may receive an additional six-month period under subsection (c)(1)(A)(i)(II) for a supplemental application if all other 

requirements under this section are satisfied, except that such 

drug may not receive any additional such period under subsection (c)(1)(B); and 

‘‘(2) may not receive any additional such period under 

subsection (c)(1)(A)(ii). 

‘‘(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 CHANGES.— 

‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLICATIONS AND

SUPPLEMENTS.—Any application or supplement to an application under section 505 proposing a labeling change as a result 

of any pediatric study conducted pursuant to this section— 

‘‘(A) shall be considered to be a priority application 

or 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, on or after the date of the enactment of the 

Best Pharmaceuticals for Children Act of 2007, the 

Commissioner determines that the sponsor and the 

Commissioner have been unable to reach agreement 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 

within 30 days after the Commissioner’s request to 

Deadline. 

Deadline. 


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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 Act 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) OTHER LABELING CHANGES.—If, on or after the date of 

the enactment of the Best Pharmaceuticals for Children Act of 

2007, the Secretary determines that a pediatric study conducted 

under this section does or does not demonstrate that the drug 

that is the subject of the study is safe and effective, including 

whether such study results are inconclusive, in pediatric populations 

or subpopulations, the Secretary shall order the labeling of such 

product to include information about the results of the study and 

a statement of the Secretary’s determination. 

‘‘(k) DISSEMINATION OF PEDIATRIC INFORMATION.— 

‘‘(1) IN GENERAL.—Not later than 210 days after the date 

of submission of a report on a pediatric study under this section, 

the Secretary shall make available to the public the medical, 

statistical, and clinical pharmacology reviews of pediatric 

studies conducted under subsection (b) or (c). 

‘‘(2) DISSEMINATION OF INFORMATION REGARDING LABELING

CHANGES.—Beginning on the date of the enactment of the Best 

Pharmaceuticals for Children Act of 2007, the Secretary shall 

include as a requirement of a written request that the sponsors 

of the studies that result in labeling changes that are reflected 

in the annual summary developed pursuant to subsection 

(f)(3)(F) distribute, at least annually (or more frequently if 

the Secretary determines that it would be beneficial to the 

public health), such information to physicians and other health 

care providers. 

Deadline. 

Public 

information. 

Deadline. 

Deadline. 

Deadline. 


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‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection 

alters or amends section 301(j) of this Act or section 552 of 

title 5 or section 1905 of title 18, United States Code. 

‘‘(l) ADVERSE EVENT REPORTING.— ‘‘(1) REPORTING IN YEAR ONE.—Beginning on the date of 

the enactment of the Best Pharmaceuticals for Children Act 

of 2007, during the one-year period beginning on the date 

a labeling change is approved pursuant to subsection (i), the 

Secretary shall ensure that all adverse event reports that have 

been received for such drug (regardless of when such report 

was received) are referred to the Office of Pediatric Therapeutics established under section 6 of the Best Pharmaceuticals 

for Children Act (Public Law 107–109). In considering the 

reports, the Director of such Office shall provide for the review 

of the reports by the Pediatric Advisory Committee, including 

obtaining any recommendations of such Committee regarding 

whether the Secretary should take action under this Act in 

response to such reports. 

‘‘(2) REPORTING IN SUBSEQUENT YEARS.—Following the oneyear period described in paragraph (1), the Secretary shall, 

as appropriate, refer to the Office of Pediatric Therapeutics 

all pediatric adverse event reports for a drug for which a 

pediatric study was conducted under this section. In considering 

such reports, the Director of such Office may provide for the 

review of such reports by the Pediatric Advisory Committee, 

including obtaining any recommendation of such Committee 

regarding whether the Secretary should take action in response 

to such reports. 

‘‘(3) EFFECT.—The requirements of this subsection shall 

supplement, not supplant, other review of such adverse event 

reports by the Secretary. 

‘‘(m) CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY

UNDER THIS SECTION AND MARKET EXCLUSIVITY AWARDED TO AN

APPLICANT FOR APPROVAL OF A DRUG UNDER SECTION 505(j).— 

If a 180-day period under section 505(j)(5)(B)(iv) overlaps with 

a 6-month exclusivity period under this section, so that the 

applicant for approval of a drug under section 505(j) 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. 

‘‘(n) REFERRAL IF PEDIATRIC STUDIES NOT COMPLETED.— 

‘‘(1) IN GENERAL.—Beginning on the date of the enactment 

of the Best Pharmaceuticals for Children Act of 2007, if pediatric studies of a drug have not been completed under subsection (d) and if the Secretary, through the committee established under section 505C, 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 carry out the following: 

Effective date. 

Effective date. 


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‘‘(A) For a drug for which a listed patent has not 

expired, make a determination regarding whether an 

assessment shall be required to be submitted under section 

505B(b). Prior to making such a determination, the Secretary may not take more than 30 days to certify whether 

the Foundation for the National Institutes of Health has 

sufficient funding at the time of such certification to initiate 

and fund all of the studies in the written request in their 

entirety within the timeframes specified within the written 

request. Only if the Secretary makes such certification 

in the affirmative, the Secretary shall refer all pediatric 

studies in the written request to the Foundation for the 

National Institutes of Health for the conduct of such 

studies, and such Foundation shall fund such studies. If 

no certification has been made at the end of the 30-day 

period, or if the Secretary certifies that funds are not 

sufficient to initiate and fund all the studies in their 

entirety, the Secretary shall consider whether assessments 

shall be required under section 505B(b) for such drug. 

‘‘(B) For a drug that has no listed patents or has 

1 or more listed patents that have expired, the Secretary 

shall refer the drug for inclusion on the list established 

under section 409I of the Public Health Service Act for 

the conduct of studies. 

‘‘(2) PUBLIC NOTICE.—The Secretary shall give the public 

notice of a decision under paragraph (1)(A) not to require an 

assessment under section 505B and the basis for such decision. 

‘‘(3) EFFECT OF SUBSECTION.—Nothing in this subsection 

alters or amends section 301(j) of this Act or section 552 of 

title 5 or section 1905 of title 18, United States Code. 

‘‘(o) PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN

PEDIATRIC INFORMATION IS ADDED TO LABELING.— 

‘‘(1) GENERAL RULE.—A drug for which an application has 

been submitted or approved under section 505(j) shall not be 

considered ineligible for approval under that section or misbranded under section 502 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 505(j)(5)(F). 

‘‘(2) LABELING.—Notwithstanding clauses (iii) and (iv) of 

section 505(j)(5)(F), the Secretary may require that the labeling 

of a drug approved under section 505(j) 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— 

Deadline. 

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‘‘(A) the availability or scope of exclusivity under this 

section; 

‘‘(B) the availability or scope of exclusivity under section 505 for pediatric formulations; 

‘‘(C) the question of the eligibility for approval of any 

application under section 505(j) that omits any other conditions of approval entitled to exclusivity under clause (iii) 

or (iv) of section 505(j)(5)(F); or 

‘‘(D) except as expressly provided in paragraphs (1) 

and (2), the operation of section 505. 

‘‘(p) INSTITUTE OF MEDICINE STUDY.—Not later than 3 years 

after the date of the enactment of the Best Pharmaceuticals for 

Children Act of 2007, the Secretary shall enter into a contract 

with the Institute of Medicine to conduct a study and report to 

Congress regarding the written requests made and the studies 

conducted pursuant to this section. The Institute of Medicine may 

devise an appropriate mechanism to review a representative sample 

of requests made and studies conducted pursuant to this section 

in order to conduct such study. Such study shall— 

‘‘(1) review such representative written requests issued by 

the Secretary since 1997 under subsections (b) and (c); 

‘‘(2) review and assess such representative pediatric studies 

conducted under subsections (b) and (c) since 1997 and labeling 

changes made as a result of such studies; 

‘‘(3) review the use of extrapolation for pediatric subpopulations, the use of alternative endpoints for pediatric populations, 

neonatal assessment tools, and ethical issues in pediatric clinical trials; 

‘‘(4) review and assess the pediatric studies of biological 

products as required under subsections (a) and (b) of section 

505B; and 

‘‘(5) make recommendations regarding appropriate incentives for encouraging pediatric studies of biologics. 

‘‘(q) SUNSET.—A drug may not receive any 6-month period 

under subsection (b) or (c) unless— 

‘‘(1) on or before October 1, 2012, the Secretary makes 

a written request for pediatric studies of the drug; 

‘‘(2) on or before October 1, 2012, an application for the 

drug is accepted for filing under section 505(b); and 

‘‘(3) all requirements of this section are met.’’. 

(2) APPLICABILITY.— 

(A) IN GENERAL.—The amendment made by this subsection shall apply to written requests under section 505A 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355a) issued on or after the date of the enactment of 

this Act. 

(B) CERTAIN WRITTEN REQUESTS.—A written request 

issued under section 505A of the Federal Food, Drug, and 

Cosmetic Act, as in effect on the day before the date of 

the enactment of this Act, which has been accepted and 

for which no determination under subsection (d)(2) of such 

section has been made before such date of enactment, shall 

be subject to such section 505A, except that such written 

requests shall be subject to subsections (d)(2)(A)(ii), (e)(1) 

and (2), (f), (i)(2)(A), (j), (k)(1), (l)(1), and (n) of section 

505A of the Federal Food, Drug, and Cosmetic Act, as 

21 USC 355a 

note. 

Deadline. 

Deadline. 

Deadline. 

Contracts. 

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in effect on or after the date of the enactment of this 

Act. 

(b) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.—Section 409I 

of the Public Health Service Act (42 U.S.C. 284m) is amended 

to read as follows: 

‘‘SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 

‘‘(a) LIST OF PRIORITY ISSUES IN PEDIATRIC THERAPEUTICS.— 

‘‘(1) IN GENERAL.—Not later than one year after the date 

of the enactment of the Best Pharmaceuticals for Children 

Act of 2007, the Secretary, acting through the Director of the 

National Institutes of Health and in consultation with the 

Commissioner of Food and Drugs and experts in pediatric 

research, shall develop and publish a priority list of needs 

in pediatric therapeutics, including drugs or indications that 

require study. The list shall be revised every three years. 

‘‘(2) CONSIDERATION OF AVAILABLE INFORMATION.—In developing and prioritizing the list under paragraph (1), the Secretary shall consider— 

‘‘(A) therapeutic gaps in pediatrics that may include 

developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials; 

‘‘(B) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial 

in pediatric populations; and 

‘‘(C) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research 

networks and trained pediatric investigators. 

‘‘(b) PEDIATRIC STUDIES AND RESEARCH.—The Secretary, acting 

through the National Institutes of Health, shall award funds to 

entities that have the expertise to conduct pediatric clinical trials 

or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally 

funded programs such as pediatric pharmacology research units, 

other public or private institutions, or individuals) to enable the 

entities to conduct the drug studies or other research on the issues 

described in subsection (a). The Secretary may use contracts, grants, 

or other appropriate funding mechanisms to award funds under 

this subsection. 

‘‘(c) PROCESS FOR PROPOSED PEDIATRIC STUDY REQUESTS AND

LABELING CHANGES.— 

‘‘(1) SUBMISSION OF PROPOSED PEDIATRIC STUDY REQUEST.— 

The Director of the National Institutes of Health shall, as 

appropriate, submit proposed pediatric study requests for 

consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under 

subsection (a). Such a proposed pediatric study request shall 

be made in a manner equivalent to a written request made 

under subsection (b) or (c) of section 505A of the Federal 

Food, Drug, and Cosmetic Act, including with respect to the 

information provided on the pediatric studies to be conducted 

pursuant to the request. The Director of the National Institutes 

of Health may submit a proposed pediatric study request for 

a drug for which— 

Deadline. 

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‘‘(A)(i) there is an approved application under section 

505(j) of the Federal Food, Drug, and Cosmetic Act; or 

‘‘(ii) there is a submitted application that could be 

approved under the criteria of such section; and 

‘‘(B) there is no patent protection or market exclusivity 

protection for at least one form of the drug under the 

Federal Food, Drug, and Cosmetic Act; and 

‘‘(C) additional studies are needed to assess the safety 

and effectiveness of the use of the drug in the pediatric 

population. 

‘‘(2) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA- TIONS FOR DRUGS LACKING EXCLUSIVITY.—The Commissioner 

of Food and Drugs, in consultation with the Director of the 

National Institutes of Health, may issue a written request 

based on the proposed pediatric study request for the indication 

or indications submitted pursuant to paragraph (1) (which shall 

include a timeframe for negotiations for an agreement) for 

pediatric studies concerning a drug identified under subsection 

(a) to all holders of an approved application for the drug under 

section 505 of the Federal Food, Drug, and Cosmetic Act. Such 

a written request shall be made in a manner equivalent to 

the manner in which a written request is made under subsection (b) or (c) of section 505A of such Act, including with 

respect to information provided on the pediatric studies to 

be conducted pursuant to the request and using appropriate 

formulations for each age group for which the study is 

requested. 

‘‘(3) REQUESTS FOR PROPOSALS.—If the Commissioner of 

Food and Drugs does not receive a response to a written request 

issued under paragraph (2) not later than 30 days after the 

date on which a request was issued, the Secretary, acting 

through the Director of the National Institutes of Health and 

in consultation with the Commissioner of Food and Drugs, 

shall publish a request for proposals to conduct the pediatric 

studies described in the written request in accordance with 

subsection (b). 

‘‘(4) DISQUALIFICATION.—A holder that receives a first right 

of refusal shall not be entitled to respond to a request for 

proposals under paragraph (3). 

‘‘(5) CONTRACTS, GRANTS, OR OTHER FUNDING MECHANISMS.—A contract, grant, or other funding may be awarded 

under this section only if a proposal is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines 

to be necessary to carry out this section. 

‘‘(6) REPORTING OF STUDIES.— 

‘‘(A) IN GENERAL.—On completion of a pediatric study 

in accordance with an award under this section, a report 

concerning the study shall be submitted to the Director 

of the National Institutes of Health and the Commissioner 

of Food and Drugs. The report shall include all data generated in connection with the study, including a written 

request if issued. 

‘‘(B) AVAILABILITY OF REPORTS.—Each report submitted 

under subparagraph (A) shall be considered to be in the 

public domain (subject to section 505A(d)(4) of the Federal 

Food, Drug, and Cosmetic Act) and shall be assigned a 

Deadline. 

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docket number by the Commissioner of Food and Drugs. 

An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food 

and Drugs, and the written comments shall become part 

of the docket file with respect to each of the drugs. 

‘‘(C) ACTION BY COMMISSIONER.—The Commissioner of 

Food and Drugs shall take appropriate action in response 

to the reports submitted under subparagraph (A) in accordance with paragraph (7). 

‘‘(7) REQUESTS FOR LABELING CHANGE.—During the 180- 

day period after the date on which a report is submitted under 

paragraph (6)(A), the Commissioner of Food and Drugs shall— 

‘‘(A) review the report and such other data as are 

available concerning the safe and effective use in the pediatric population of the drug studied; 

‘‘(B) negotiate with the holders of approved applications 

for the drug studied for any labeling changes that the 

Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and 

‘‘(C)(i) place in the public docket file a copy of the 

report and of any requested labeling changes; and 

‘‘(ii) publish in the Federal Register and through a 

posting on the Web site of the Food and Drug Administration a summary of the report and a copy of any requested 

labeling changes. 

‘‘(8) DISPUTE RESOLUTION.— 

‘‘(A) REFERRAL TO PEDIATRIC ADVISORY COMMITTEE.— 

If, not later than the end of the 180-day period specified 

in paragraph (7), the holder of an approved application 

for the drug involved does not agree to any labeling change 

requested by the Commissioner of Food and Drugs under 

that paragraph, the Commissioner of Food and Drugs shall 

refer the request to the Pediatric Advisory Committee. 

‘‘(B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— 

Not later than 90 days after receiving a referral under 

subparagraph (A), the Pediatric Advisory Committee 

shall— 

‘‘(i) review the available information on the safe 

and effective use of the drug in the pediatric population, including study reports submitted under this 

section; and 

‘‘(ii) make a recommendation to the Commissioner 

of Food and Drugs as to appropriate labeling changes, 

if any. 

‘‘(9) FDA DETERMINATION.—Not later than 30 days after 

receiving a recommendation from the Pediatric Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the 

Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders 

of approved applications for the drug to make any labeling 

change that the Commissioner of Food and Drugs determines 

to be appropriate. 

‘‘(10) FAILURE TO AGREE.—If a holder of an approved 

application for a drug, within 30 days after receiving a request 

to make a labeling change under paragraph (9), does not agree 

to make a requested labeling change, the Commissioner of 

Deadline. 

Deadline. 

Recommendations. 

Deadline. 

Deadline. 

Federal Register, 

publication. 

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Food and Drugs may deem the drug to be misbranded under 

the Federal Food, Drug, and Cosmetic Act. 

‘‘(11) NO EFFECT ON AUTHORITY.—Nothing in this subsection limits the authority of the United States to bring an 

enforcement action under the Federal Food, Drug, and Cosmetic 

Act 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. 

‘‘(d) DISSEMINATION OF PEDIATRIC INFORMATION.—Not later 

than one year after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary, acting through 

the Director of the National Institutes of Health, shall study the 

feasibility of establishing a compilation of information on pediatric 

drug use and report the findings to Congress. 

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 

‘‘(1) IN GENERAL.—There are authorized to be appropriated 

to carry out this section— 

‘‘(A) $200,000,000 for fiscal year 2008; and 

‘‘(B) such sums as are necessary for each of the four 

succeeding fiscal years. 

‘‘(2) AVAILABILITY.—Any amount appropriated under paragraph (1) shall remain available to carry out this section until 

expended.’’. 

(c) FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.— 

Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 

290b(c)(1)(C)) is amended by striking ‘‘and studies listed by the 

Secretary pursuant to section 409I(a)(1)(A) of this Act and referred 

under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic 

Act (21 U.S.C. 355(a)(d)(4)(C)’ ’’ and inserting ‘‘and studies for which 

the Secretary issues a certification in the affirmative under section 

505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act’’. 

(d) CONTINUATION OF OPERATION OF COMMITTEE.—Section 14 

of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m 

note) is amended by adding at the end the following new subsection: 

‘‘(d) CONTINUATION OF OPERATION OF COMMITTEE.—Notwithstanding section 14 of the Federal Advisory Committee Act, the 

advisory committee shall continue to operate during the five-year 

period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007.’’. 

(e) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS

ADVISORY COMMITTEE.—Section 15 of the Best Pharmaceuticals 

for Children Act (42 U.S.C. 284m note) is amended— 

(1) in subsection (a)— 

(A) in paragraph (1)— 

(i) in subparagraph (B), by striking ‘‘and’’ after 

the semicolon; 

(ii) in subparagraph (C), by striking the period 

at the end and inserting ‘‘; and’’; and 

(iii) by adding at the end the following new 

subparagraph: 

‘‘(D) provide recommendations to the internal review 

committee created under section 505B(f) of the Federal 

Food, Drug, and Cosmetic Act regarding the implementation of amendments to sections 505A and 505B of the 

Deadline. 

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Federal Food, Drug, and Cosmetic Act with respect to 

the treatment of pediatric cancers.’’; and 

(B) by adding at the end the following new paragraph: 

‘‘(3) CONTINUATION OF OPERATION OF SUBCOMMITTEE.—Notwithstanding section 14 of the Federal Advisory Committee 

Act, the Subcommittee shall continue to operate during the 

five-year period beginning on the date of the enactment of 

the Best Pharmaceuticals for Children Act of 2007.’’; and 

(2) in subsection (d), by striking ‘‘2003’’ and inserting 

‘‘2009’’. 

(f) EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO

TOLL-FREE NUMBER FOR ADVERSE EVENTS ON LABELING FOR HUMAN

DRUG PRODUCTS.— 

(1) IN GENERAL.—Notwithstanding subchapter II of chapter 

5, and chapter 7, of title 5, United States Code (commonly 

known as the ‘‘Administrative Procedure Act’’) and any other 

provision of law, the proposed rule issued by the Commissioner 

of Food and Drugs entitled ‘‘Toll-Free Number for Reporting 

Adverse Events on Labeling for Human Drug Products,’’ 69 

Fed. Reg. 21778, (April 22, 2004) shall take effect on January 

1, 2008, unless such Commissioner issues the final rule before 

such date. 

(2) LIMITATION.—The proposed rule that takes effect under 

subsection (a), or the final rule described under subsection 

(a), shall, notwithstanding section 17(a) of the Best Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not apply to 

a drug— 

(A) for which an application is approved under section 

505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

355); 

(B) that is not described under section 503(b)(1) of 

such Act (21 U.S.C. 353(b)(1)); and 

(C) the packaging of which includes a toll-free number 

through which consumers can report complaints to the 

manufacturer or distributor of the drug. 

SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS. 

(a) INVESTMENT IN TOMORROW’S PEDIATRIC RESEARCHERS.—Section 452G(2) of the Public Health Service Act (42 U.S.C. 285g– 

10(2)) is amended by adding before the period at the end the 

following: ‘‘, including pediatric pharmacological research’’. 

(b) PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM.—Section 

487F(a)(1) of the Public Health Service Act (42 U.S.C. 288–6(a)(1)) 

is amended by inserting ‘‘including pediatric pharmacological 

research,’’ after ‘‘pediatric research,’’. 

TITLE VI—REAGAN-UDALL 

FOUNDATION 

SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 

ADMINISTRATION. 

(a) IN GENERAL.—Chapter VII of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at 

the end the following: 


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‘‘Subchapter I—Reagan-Udall Foundation for the Food and 

Drug Administration 

‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION. 

‘‘(a) IN GENERAL.—A nonprofit corporation to be known as 

the Reagan-Udall Foundation for the Food and Drug Administration 

(referred to in this subchapter as the ‘Foundation’) shall be established in accordance with this section. The Foundation shall be 

headed by an Executive Director, appointed by the members of 

the Board of Directors under subsection (e). The Foundation shall 

not be an agency or instrumentality of the United States Government. 

‘‘(b) PURPOSE OF FOUNDATION.—The purpose of the Foundation 

is to advance the mission of the Food and Drug Administration 

to modernize medical, veterinary, food, food ingredient, and cosmetic 

product development, accelerate innovation, and enhance product 

safety. 

‘‘(c) DUTIES OF THE FOUNDATION.—The Foundation shall— 

‘‘(1) taking into consideration the Critical Path reports 

and priorities published by the Food and Drug Administration, 

identify unmet needs in the development, manufacture, and 

evaluation of the safety and effectiveness, including postapproval, of devices, including diagnostics, biologics, and drugs, 

and the safety of food, food ingredients, and cosmetics, and 

including the incorporation of more sensitive and predictive 

tools and devices to measure safety; 

‘‘(2) establish goals and priorities in order to meet the 

unmet needs identified in paragraph (1); 

‘‘(3) in consultation with the Secretary, identify existing 

and proposed Federal intramural and extramural research and 

development programs relating to the goals and priorities established under paragraph (2), coordinate Foundation activities 

with such programs, and minimize Foundation duplication of 

existing efforts; 

‘‘(4) award grants to, or enter into contracts, memoranda 

of understanding, or cooperative agreements with, scientists 

and entities, which may include the Food and Drug Administration, university consortia, public-private partnerships, institutions of higher education, entities described in section 501(c)(3) 

of the Internal Revenue Code (and exempt from tax under 

section 501(a) of such Code), and industry, to efficiently and 

effectively advance the goals and priorities established under 

paragraph (2); 

‘‘(5) recruit meeting participants and hold or sponsor (in 

whole or in part) meetings as appropriate to further the goals 

and priorities established under paragraph (2); 

‘‘(6) release and publish information and data and, to the 

extent practicable, license, distribute, and release material, reagents, and techniques to maximize, promote, and coordinate 

the availability of such material, reagents, and techniques for 

use by the Food and Drug Administration, nonprofit organizations, and academic and industrial researchers to further the 

goals and priorities established under paragraph (2); 

‘‘(7) ensure that— 

‘‘(A) action is taken as necessary to obtain patents 

for inventions developed by the Foundation or with funds 

from the Foundation; 

Publication. 

Grants. 

Contracts. 

Memorandums. 

21 USC 379dd. 


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‘‘(B) action is taken as necessary to enable the licensing 

of inventions developed by the Foundation or with funds 

from the Foundation; and 

‘‘(C) executed licenses, memoranda of understanding, 

material transfer agreements, contracts, and other such 

instruments, promote, to the maximum extent practicable, 

the broadest conversion to commercial and noncommercial 

applications of licensed and patented inventions of the 

Foundation to further the goals and priorities established 

under paragraph (2); 

‘‘(8) provide objective clinical and scientific information to 

the Food and Drug Administration and, upon request, to other 

Federal agencies to assist in agency determinations of how 

to ensure that regulatory policy accommodates scientific 

advances and meets the agency’s public health mission; 

‘‘(9) conduct annual assessments of the unmet needs identified in paragraph (1); and 

‘‘(10) carry out such other activities consistent with the 

purposes of the Foundation as the Board determines appropriate. 

‘‘(d) BOARD OF DIRECTORS.— 

‘‘(1) ESTABLISHMENT.— 

‘‘(A) IN GENERAL.—The Foundation shall have a Board 

of Directors (referred to in this subchapter as the ‘Board’), 

which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members. 

‘‘(B) EX OFFICIO MEMBERS.—The ex officio members 

of the Board shall be the following individuals or their 

designees: 

‘‘(i) The Commissioner. 

‘‘(ii) The Director of the National Institutes of 

Health. 

‘‘(iii) The Director of the Centers for Disease Control and Prevention. 

‘‘(iv) The Director of the Agency for Healthcare 

Research and Quality. 

‘‘(C) APPOINTED MEMBERS.— 

‘‘(i) IN GENERAL.—The ex officio members of the 

Board under subparagraph (B) shall, by majority vote, 

appoint to the Board 14 individuals, of which 9 shall 

be from a list of candidates to be provided by the 

National Academy of Sciences and 5 shall be from 

lists of candidates provided by patient and consumer 

advocacy groups, professional scientific and medical 

societies, and industry trade organizations. Of such 

appointed members— 

‘‘(I) 4 shall be representatives of the general 

pharmaceutical, device, food, cosmetic, and biotechnology industries; 

‘‘(II) 3 shall be representatives of academic 

research organizations; 

‘‘(III) 2 shall be representatives of patient or 

consumer advocacy organizations; 

‘‘(IV) 1 shall be a representative of health care 

providers; and 


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‘‘(V) 4 shall be at-large members with expertise 

or experience relevant to the purpose of the 

Foundation. 

‘‘(ii) REQUIREMENTS.— ‘‘(I) EXPERTISE.—The ex officio members shall 

ensure the Board membership includes individuals 

with expertise in areas including the sciences of 

developing, manufacturing, and evaluating the 

safety and effectiveness of devices, including 

diagnostics, biologics, and drugs, and the safety 

of food, food ingredients, and cosmetics. 

‘‘(II) FEDERAL EMPLOYEES.—No employee of 

the Federal Government shall be appointed as a 

member of the Board under this subparagraph 

or under paragraph (3)(B). 

‘‘(D) INITIAL MEETING.— ‘‘(i) IN GENERAL.—Not later than 30 days after 

the date of the enactment of this subchapter, the Secretary shall convene a meeting of the ex officio members of the Board to— 

‘‘(I) incorporate the Foundation; and 

‘‘(II) appoint the members of the Board in 

accordance with subparagraph (C). 

‘‘(ii) SERVICE OF EX OFFICIO MEMBERS.—Upon the 

appointment of the members of the Board under clause 

(i)(II)— 

‘‘(I) the terms of service of the Director of 

the Centers for Disease Control and Prevention 

and of the Director of the Agency for Healthcare 

Research and Quality as ex officio members of 

the Board shall terminate; and 

‘‘(II) the Commissioner and the Director of 

the National Institutes of Health shall continue 

to serve as ex officio members of the Board, but 

shall be nonvoting members. 

‘‘(iii) CHAIR.—The ex officio members of the Board 

under subparagraph (B) shall designate an appointed 

member of the Board to serve as the Chair of the 

Board. 

‘‘(2) DUTIES OF BOARD.—The Board shall— 

‘‘(A) establish bylaws for the Foundation that— 

‘‘(i) are published in the Federal Register and 

available for public comment; 

‘‘(ii) establish policies for the selection of the officers, employees, agents, and contractors of the Foundation; 

‘‘(iii) establish policies, including ethical standards, 

for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation, including appropriate limits on the ability of donors to designate, 

by stipulation or restriction, the use or recipient of 

donated funds; 

‘‘(iv) establish policies that would subject all 

employees, fellows, and trainees of the Foundation to 

the conflict of interest standards under section 208 

of title 18, United States Code; 

Federal Register, 

publication. 

Deadline. 


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‘‘(v) establish licensing, distribution, and publication policies that support the widest and least restrictive use by the public of information and inventions 

developed by the Foundation or with Foundation funds 

to carry out the duties described in paragraphs (6) 

and (7) of subsection (c), and may include charging 

cost-based fees for published material produced by the 

Foundation; 

‘‘(vi) specify principles for the review of proposals 

and awarding of grants and contracts that include 

peer review and that are consistent with those of the 

Foundation for the National Institutes of Health, to 

the extent determined practicable and appropriate by 

the Board; 

‘‘(vii) specify a cap on administrative expenses for 

recipients of a grant, contract, or cooperative agreement from the Foundation; 

‘‘(viii) establish policies for the execution of memoranda of understanding and cooperative agreements 

between the Foundation and other entities, including 

the Food and Drug Administration; 

‘‘(ix) establish policies for funding training fellowships, whether at the Foundation, academic or scientific institutions, or the Food and Drug Administration, for scientists, doctors, and other professionals who 

are not employees of regulated industry, to foster 

greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, 

and potential barriers to translating basic research 

into clinical and regulatory practice; 

‘‘(x) specify a process for annual Board review of 

the operations of the Foundation; and 

‘‘(xi) establish specific duties of the Executive 

Director; 

‘‘(B) prioritize and provide overall direction to the 

activities of the Foundation; 

‘‘(C) evaluate the performance of the Executive 

Director; and 

‘‘(D) carry out any other necessary activities regarding 

the functioning of the Foundation. 

‘‘(3) TERMS AND VACANCIES.— 

‘‘(A) TERM.—The term of office of each member of the 

Board appointed under paragraph (1)(C) shall be 4 years, 

except that the terms of offices for the initial appointed 

members of the Board shall expire on a staggered basis 

as determined by the ex officio members. 

‘‘(B) VACANCY.—Any vacancy in the membership of 

the Board— 

‘‘(i) shall not affect the power of the remaining 

members to execute the duties of the Board; and 

‘‘(ii) shall be filled by appointment by the appointed 

members described in paragraph (1)(C) by majority 

vote. 

‘‘(C) PARTIAL TERM.—If a member of the Board does 

not serve the full term applicable under subparagraph (A), 

the individual appointed under subparagraph (B) to fill 


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the resulting vacancy shall be appointed for the remainder 

of the term of the predecessor of the individual. 

‘‘(D) SERVING PAST TERM.—A member of the Board 

may continue to serve after the expiration of the term 

of the member until a successor is appointed. 

‘‘(4) COMPENSATION.—Members of the Board may not 

receive compensation for service on the Board. Such members 

may be reimbursed for travel, subsistence, and other necessary 

expenses incurred in carrying out the duties of the Board, 

as set forth in the bylaws issued by the Board. 

‘‘(e) INCORPORATION.—The ex officio members of the Board shall 

serve as incorporators and shall take whatever actions necessary 

to incorporate the Foundation. 

‘‘(f) NONPROFIT STATUS.—In carrying out subsection (b), the 

Board shall establish such policies and bylaws under subsection 

(d), and the Executive Director shall carry out such activities under 

subsection (g), as may be necessary to ensure that the Foundation 

maintains status as an organization that— 

‘‘(1) is described in subsection (c)(3) of section 501 of the 

Internal Revenue Code of 1986; and 

‘‘(2) is, under subsection (a) of such section, exempt from 

taxation. 

‘‘(g) EXECUTIVE DIRECTOR.— 

‘‘(1) IN GENERAL.—The Board shall appoint an Executive 

Director who shall serve at the pleasure of the Board. The 

Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties 

and responsibilities as the Board shall prescribe. 

‘‘(2) COMPENSATION.—The compensation of the Executive 

Director shall be fixed by the Board but shall not be greater 

than the compensation of the Commissioner. 

‘‘(h) ADMINISTRATIVE POWERS.—In carrying out this subchapter, 

the Board, acting through the Executive Director, may— 

‘‘(1) adopt, alter, and use a corporate seal, which shall 

be judicially noticed; 

‘‘(2) hire, promote, compensate, and discharge 1 or more 

officers, employees, and agents, as may be necessary, and define 

their duties; 

‘‘(3) prescribe the manner in which— 

‘‘(A) real or personal property of the Foundation is 

acquired, held, and transferred; 

‘‘(B) general operations of the Foundation are to be 

conducted; and 

‘‘(C) the privileges granted to the Board by law are 

exercised and enjoyed; 

‘‘(4) with the consent of the applicable executive department 

or independent agency, use the information, services, and facilities of such department or agencies in carrying out this section; 

‘‘(5) enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books 

and other material; 

‘‘(6) hold, administer, invest, and spend any gift, devise, 

or bequest of real or personal property made to the Foundation 

under subsection (i); 

‘‘(7) enter into such other contracts, leases, cooperative 

agreements, and other transactions as the Board considers 

appropriate to conduct the activities of the Foundation; 


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‘‘(8) modify or consent to the modification of any contract 

or agreement to which it is a party or in which it has an 

interest under this subchapter; 

‘‘(9) take such action as may be necessary to obtain patents 

and licenses for devices and procedures developed by the 

Foundation and its employees; 

‘‘(10) sue and be sued in its corporate name, and complain 

and defend in courts of competent jurisdiction; 

‘‘(11) appoint other groups of advisors as may be determined 

necessary to carry out the functions of the Foundation; and 

‘‘(12) exercise other powers as set forth in this section, 

and such other incidental powers as are necessary to carry 

out its powers, duties, and functions in accordance with this 

subchapter. 

‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER SOURCES.—The Executive Director may solicit and accept on behalf of the Foundation, 

any funds, gifts, grants, devises, or bequests of real or personal 

property made to the Foundation, including from private entities, 

for the purposes of carrying out the duties of the Foundation. 

‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal Government 

employees may serve on committees advisory to the Foundation 

and otherwise cooperate with and assist the Foundation in carrying 

out its functions, so long as such employees do not direct or control 

Foundation activities. 

‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES; FELLOWSHIPS.— 

‘‘(1) DETAIL FROM FEDERAL AGENCIES.—Federal Government employees may be detailed from Federal agencies with 

or without reimbursement to those agencies to the Foundation 

at any time, and such detail shall be without interruption 

or loss of civil service status or privilege. Each such employee 

shall abide by the statutory, regulatory, ethical, and procedural 

standards applicable to the employees of the agency from which 

such employee is detailed and those of the Foundation. 

‘‘(2) VOLUNTARY SERVICE; ACCEPTANCE OF FEDERAL

EMPLOYEES.— ‘‘(A) FOUNDATION.—The Executive Director of the 

Foundation may accept the services of employees detailed 

from Federal agencies with or without reimbursement to 

those agencies. 

‘‘(B) FOOD AND DRUG ADMINISTRATION.—The Commissioner may accept the uncompensated services of Foundation fellows or trainees. Such services shall be considered 

to be undertaking an activity under contract with the Secretary as described in section 708. 

‘‘(l) ANNUAL REPORTS.— 

‘‘(1) REPORTS TO FOUNDATION.—Any recipient of a grant, 

contract, fellowship, memorandum of understanding, or 

cooperative agreement from the Foundation under this section 

shall submit to the Foundation a report on an annual basis 

for the duration of such grant, contract, fellowship, memorandum of understanding, or cooperative agreement, that 

describes the activities carried out under such grant, contract, 

fellowship, memorandum of understanding, or cooperative 

agreement. 

‘‘(2) REPORT TO CONGRESS AND THE FDA.—Beginning with 

fiscal year 2009, the Executive Director shall submit to Congress and the Commissioner an annual report that— 


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‘‘(A) describes the activities of the Foundation and 

the progress of the Foundation in furthering the goals 

and priorities established under subsection (c)(2), including 

the practical impact of the Foundation on regulated product 

development; 

‘‘(B) provides a specific accounting of the source and 

use of all funds used by the Foundation to carry out such 

activities; and 

‘‘(C) provides information on how the results of Foundation activities could be incorporated into the regulatory 

and product review activities of the Food and Drug 

Administration. 

‘‘(m) SEPARATION OF FUNDS.—The Executive Director shall 

ensure that the funds received from the Treasury are held in 

separate accounts from funds received from entities under subsection (i). 

‘‘(n) FUNDING.—From amounts appropriated to the Food and 

Drug Administration for each fiscal year, the Commissioner shall 

transfer not less than $500,000 and not more than $1,250,000, 

to the Foundation to carry out subsections (a), (b), and (d) through 

(m).’’. 

(b) OTHER FOUNDATION PROVISIONS.—Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) (as 

amended by subsection (a)) is amended by adding at the end the 

following: 

‘‘SEC. 771. LOCATION OF FOUNDATION. 

‘‘The Foundation shall, if practicable, be located not more than 

20 miles from the District of Columbia. 

‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION. 

‘‘(a) IN GENERAL.—The Commissioner shall receive and assess 

the report submitted to the Commissioner by the Executive Director 

of the Foundation under section 770(l)(2). 

‘‘(b) REPORT TO CONGRESS.—Beginning with fiscal year 2009, 

the Commissioner shall submit to Congress an annual report 

summarizing the incorporation of the information provided by the 

Foundation in the report described under section 770(l)(2) and 

by other recipients of grants, contracts, memoranda of understanding, or cooperative agreements into regulatory and product 

review activities of the Food and Drug Administration. 

‘‘(c) EXTRAMURAL GRANTS.—The provisions of this subchapter 

and section 566 shall have no effect on any grant, contract, memorandum of understanding, or cooperative agreement between the 

Food and Drug Administration and any other entity entered into 

before, on, or after the date of the enactment of this subchapter.’’. 

(c) CONFORMING AMENDMENT.—Section 742(b) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended by 

adding at the end the following: ‘‘Any such fellowships and training 

programs under this section or under section 770(d)(2)(A)(ix) may 

include provision by such scientists and physicians of services on 

a voluntary and uncompensated basis, as the Secretary determines 

appropriate. Such scientists and physicians shall be subject to all 

legal and ethical requirements otherwise applicable to officers or 

employees of the Department of Health and Human Services.’’. 

21 USC 379dd–2. 

21 USC 379dd–1. 


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SEC. 602. OFFICE OF THE CHIEF SCIENTIST. 

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 391 et seq.) is amended by adding at the end the following: 

‘‘SEC. 910. OFFICE OF THE CHIEF SCIENTIST. 

‘‘(a) ESTABLISHMENT; APPOINTMENT.—The Secretary shall establish within the Office of the Commissioner an office to be known 

as the Office of the Chief Scientist. The Secretary shall appoint 

a Chief Scientist to lead such Office. 

‘‘(b) DUTIES OF THE OFFICE.—The Office of the Chief Scientist 

shall— 

‘‘(1) oversee, coordinate, and ensure quality and regulatory 

focus of the intramural research programs of the Food and 

Drug Administration; 

‘‘(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research 

efforts supported by the Reagan-Udall Foundation for the Food 

and Drug Administration; 

‘‘(3) develop and advocate for a budget to support intramural research; 

‘‘(4) develop a peer review process by which intramural 

research can be evaluated; 

‘‘(5) identify and solicit intramural research proposals from 

across the Food and Drug Administration through an advisory 

board composed of employees of the Administration that shall 

include— 

‘‘(A) representatives of each of the centers and the 

science-based offices within the Office of the Commissioner; 

and 

‘‘(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public 

health; and 

‘‘(6) develop postmarket safety performance measures that 

are as measurable and rigorous as the ones already developed 

for premarket review.’’. 

SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 

Subchapter E of chapter V of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding 

at the end the following: 

‘‘SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS. 

‘‘(a) ESTABLISHMENT.—The Secretary, acting through the 

Commissioner of Food and Drugs, may enter into collaborative 

agreements, to be known as Critical Path Public-Private Partnerships, with one or more eligible entities to implement the Critical 

Path Initiative of the Food and Drug Administration by developing 

innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, 

enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical 

product safety. 

‘‘(b) ELIGIBLE ENTITY.—In this section, the term ‘eligible entity’ 

means an entity that meets each of the following: 

‘‘(1) The entity is— 

21 USC 

360bbb–5. 

21 USC 399a. 


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‘‘(A) an institution of higher education (as such term 

is defined in section 101 of the Higher Education Act of 

1965) or a consortium of such institutions; or 

‘‘(B) an organization described in section 501(c)(3) of 

the Internal Revenue Code of 1986 and exempt from tax 

under section 501(a) of such Code. 

‘‘(2) The entity has experienced personnel and clinical and 

other technical expertise in the biomedical sciences, which may 

include graduate training programs in areas relevant to priorities of the Critical Path Initiative. 

‘‘(3) The entity demonstrates to the Secretary’s satisfaction 

that the entity is capable of— 

‘‘(A) developing and critically evaluating tools, methods, 

and processes— 

‘‘(i) to increase efficiency, predictability, and 

productivity of medical product development; and 

‘‘(ii) to more accurately identify the benefits and 

risks of new and existing medical products; 

‘‘(B) establishing partnerships, consortia, and collaborations with health care practitioners and other providers 

of health care goods or services; pharmacists; pharmacy 

benefit managers and purchasers; health maintenance 

organizations and other managed health care organizations; health care insurers; government agencies; patients 

and consumers; manufacturers of prescription drugs, 

biological products, diagnostic technologies, and devices; 

and academic scientists; and 

‘‘(C) securing funding for the projects of a Critical 

Path Public-Private Partnership from Federal and nonfederal governmental sources, foundations, and private 

individuals. 

‘‘(c) FUNDING.—The Secretary may not enter into a collaborative 

agreement under subsection (a) unless the eligible entity involved 

provides an assurance that the entity will not accept funding for 

a Critical Path Public-Private Partnership project from any 

organization that manufactures or distributes products regulated 

by the Food and Drug Administration unless the entity provides 

assurances in its agreement with the Food and Drug Administration 

that the results of the Critical Path Public-Private Partnership 

project will not be influenced by any source of funding. 

‘‘(d) ANNUAL REPORT.—Not later than 18 months after the 

date of the enactment of this section, and annually thereafter, 

the Secretary, in collaboration with the parties to each Critical 

Path Public-Private Partnership, shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate 

and the Committee on Energy and Commerce of the House of 

Representatives— 

‘‘(1) reviewing the operations and activities of the Partnerships in the previous year; and 

‘‘(2) addressing such other issues relating to this section 

as the Secretary determines to be appropriate. 

‘‘(e) DEFINITION.—In this section, the term ‘medical product’ 

includes a drug, a biological product as defined in section 351 

of the Public Health Service Act, a device, and any combination 

of such products. 

‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $5,000,000 for fiscal 


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year 2008 and such sums as may be necessary for each of fiscal 

years 2009 through 2012.’’. 

TITLE VII—CONFLICTS OF INTEREST 

SEC. 701. CONFLICTS OF INTEREST. 

(a) IN GENERAL.—Subchapter A of chapter VII of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended 

by inserting at the end the following: 

‘‘SEC. 712. CONFLICTS OF INTEREST. 

‘‘(a) DEFINITIONS.—For purposes of this section: 

‘‘(1) ADVISORY COMMITTEE.—The term ‘advisory committee’ 

means an advisory committee under the Federal Advisory Committee Act that provides advice or recommendations to the 

Secretary regarding activities of the Food and Drug Administration. 

‘‘(2) FINANCIAL INTEREST.—The term ‘financial interest’ 

means a financial interest under section 208(a) of title 18, 

United States Code. 

‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 

‘‘(1) RECRUITMENT.— 

‘‘(A) IN GENERAL.—The Secretary shall— 

‘‘(i) develop and implement strategies on effective 

outreach to potential members of advisory committees 

at universities, colleges, other academic research centers, professional and medical societies, and patient 

and consumer groups; 

‘‘(ii) seek input from professional medical and scientific societies to determine the most effective 

informational and recruitment activities; and 

‘‘(iii) take into account the advisory committees 

with the greatest number of vacancies. 

‘‘(B) RECRUITMENT ACTIVITIES.—The recruitment activities under subparagraph (A) may include— 

‘‘(i) advertising the process for becoming an 

advisory committee member at medical and scientific 

society conferences; 

‘‘(ii) making widely available, including by using 

existing electronic communications channels, the contact information for the Food and Drug Administration 

point of contact regarding advisory committee nominations; and 

‘‘(iii) developing a method through which an entity 

receiving funding from the National Institutes of 

Health, the Agency for Healthcare Research and 

Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person who the Food and Drug Administration 

can contact regarding the nomination of individuals 

to serve on advisory committees. 

‘‘(2) EVALUATION AND CRITERIA.—When considering a term 

appointment to an advisory committee, the Secretary shall 

review the expertise of the individual and the financial disclosure report filed by the individual pursuant to the Ethics in 

Government Act of 1978 for each individual under consideration 

21 USC 379d–1. 


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for the appointment, so as to reduce the likelihood that an 

appointed individual will later require a written determination 

as referred to in section 208(b)(1) of title 18, United States 

Code, a written certification as referred to in section 208(b)(3) 

of title 18, United States Code, or a waiver as referred to 

in subsection (c)(2) of this section for service on the committee 

at a meeting of the committee. 

‘‘(c) DISCLOSURES; PROHIBITIONS ON PARTICIPATION; WAIVERS.— 

‘‘(1) DISCLOSURE OF FINANCIAL INTEREST.—Prior to a 

meeting of an advisory committee regarding a ‘particular 

matter’ (as that term is used in section 208 of title 18, United 

States Code), each member of the committee who is a fulltime Government employee or special Government employee 

shall disclose to the Secretary financial interests in accordance 

with subsection (b) of such section 208. 

‘‘(2) PROHIBITIONS AND WAIVERS ON PARTICIPATION.— 

‘‘(A) IN GENERAL.—Except as provided under subparagraph (B), a member of an advisory committee may not 

participate with respect to a particular matter considered 

in an advisory committee meeting if such member (or an 

immediate family member of such member) has a financial 

interest that could be affected by the advice given to the 

Secretary with respect to such matter, excluding interests 

exempted in regulations issued by the Director of the Office 

of Government Ethics as too remote or inconsequential 

to affect the integrity of the services of the Government 

officers or employees to which such regulations apply. 

‘‘(B) WAIVER.—If the Secretary determines it necessary 

to afford the advisory committee essential expertise, the 

Secretary may grant a waiver of the prohibition in subparagraph (A) to permit a member described in such subparagraph to— 

‘‘(i) participate as a non-voting member with 

respect to a particular matter considered in a committee meeting; or 

‘‘(ii) participate as a voting member with respect 

to a particular matter considered in a committee 

meeting. 

‘‘(C) LIMITATION ON WAIVERS AND OTHER EXCEPTIONS.— 

‘‘(i) DEFINITION.—For purposes of this subparagraph, the term ‘exception’ means each of the following 

with respect to members of advisory committees: 

‘‘(I) A waiver under section 505(n)(4) (as in 

effect on the day before the date of the enactment 

of the Food and Drug Administration Amendments 

Act of 2007). 

‘‘(II) A written determination under section 

208(b) of title 18, United States Code. 

‘‘(III) A written certification under section 

208(b)(3) of such title. 

‘‘(ii) DETERMINATION OF TOTAL NUMBER OF MEMBERS SLOTS AND MEMBER EXCEPTIONS DURING FISCAL

YEAR 2007.—The Secretary shall determine— 

‘‘(I)(aa) for each meeting held by any advisory 

committee during fiscal year 2007, the number 

of members who participated in the meeting; and 


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‘‘(bb) the sum of the respective numbers determined under item (aa) (referred to in this subparagraph as the ‘‘total number of 2007 meeting slots’’); 

and 

‘‘(II)(aa) for each meeting held by any advisory 

committee during fiscal year 2007, the number 

of members who received an exception for the 

meeting; and 

‘‘(bb) the sum of the respective numbers determined under item (aa) (referred to in this subparagraph as the ‘‘total number of 2007 meeting exceptions’’). 

‘‘(iii) DETERMINATION OF PERCENTAGE REGARDING

EXCEPTIONS DURING FISCAL YEAR 2007.—The Secretary 

shall determine the percentage constituted by— 

‘‘(I) the total number of 2007 meeting exceptions; divided by 

‘‘(II) the total number of 2007 meeting slots. 

‘‘(iv) LIMITATION FOR FISCAL YEARS 2008 THROUGH

2012.—The number of exceptions at the Food and Drug 

Administration for members of advisory committees 

for a fiscal year may not exceed the following: 

‘‘(I) For fiscal year 2008, 95 percent of the 

percentage determined under clause (iii) (referred 

to in this clause as the ‘‘base percentage’’). 

‘‘(II) For fiscal year 2009, 90 percent of the 

base percentage. 

‘‘(III) For fiscal year 2010, 85 percent of the 

base percentage. 

‘‘(IV) For fiscal year 2011, 80 percent of the 

base percentage. 

‘‘(V) For fiscal year 2012, 75 percent of the 

base percentage. 

‘‘(v) ALLOCATION OF EXCEPTIONS.—The exceptions 

authorized under clause (iv) for a fiscal year may be 

allocated within the centers or other organizational 

units of the Food and Drug Administration as determined appropriate by the Secretary. 

‘‘(3) DISCLOSURE OF WAIVER.—Notwithstanding section 

107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), 

the following shall apply: 

‘‘(A) 15 OR MORE DAYS IN ADVANCE.—As soon as practicable, but (except as provided in subparagraph (B)) not 

later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to 

in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 

18, United States Code, or a waiver as referred to in 

paragraph (2)(B) applies, the Secretary shall disclose (other 

than information exempted from disclosure under section 

552 of title 5, United States Code, and section 552a of 

title 5, United States Code (popularly known as the 

Freedom of Information Act and the Privacy Act of 1974, 

respectively)) on the Internet Web site of the Food and 

Drug Administration— 

‘‘(i) the type, nature, and magnitude of the financial interests of the advisory committee member to 

Applicability. 

Website. 


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which such determination, certification, or waiver 

applies; and 

‘‘(ii) the reasons of the Secretary for such determination, certification, or waiver. 

‘‘(B) LESS THAN 30 DAYS IN ADVANCE.—In the case 

of a financial interest that becomes known to the Secretary 

less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to 

in section 208(b)(1) of title 18, United States Code, a written certification as referred to in section 208(b)(3) of title 

18, United States Code, or a waiver as referred to in 

paragraph (2)(B) applies, the Secretary shall disclose (other 

than information exempted from disclosure under section 

552 of title 5, United States Code, and section 552a of 

title 5, United States Code) on the Internet Web site of 

the Food and Drug Administration, the information 

described in clauses (i) and (ii) of subparagraph (A) as 

soon as practicable after the Secretary makes such determination, certification, or waiver, but in no case later than 

the date of such meeting. 

‘‘(d) PUBLIC RECORD.—The Secretary shall ensure that the 

public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c)(3) (other 

than information exempted from disclosure under section 552 of 

title 5, United States Code, and section 552a of title 5, United 

States Code). 

‘‘(e) ANNUAL REPORT.—Not later than February 1 of each year, 

the Secretary shall submit to the Committee on Appropriations 

and the Committee on Health, Education, Labor, and Pensions 

of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives 

a report that describes— 

‘‘(1) with respect to the fiscal year that ended on September 

30 of the previous year, the number of vacancies on each 

advisory committee, the number of nominees received for each 

committee, and the number of such nominees willing to serve; 

‘‘(2) with respect to such year, the aggregate number of 

disclosures required under subsection (c)(3) for each meeting 

of each advisory committee and the percentage of individuals 

to whom such disclosures did not apply who served on such 

committee for each such meeting; 

‘‘(3) with respect to such year, the number of times the 

disclosures required under subsection (c)(3) occurred under 

subparagraph (B) of such subsection; and 

‘‘(4) how the Secretary plans to reduce the number of 

vacancies reported under paragraph (1) during the fiscal year 

following such year, and mechanisms to encourage the nomination of individuals for service on an advisory committee, 

including those who are classified by the Food and Drug 

Administration as academicians or practitioners. 

‘‘(f) PERIODIC REVIEW OF GUIDANCE.—Not less than once every 

5 years, the Secretary shall review guidance of the Food and Drug 

Administration regarding conflict of interest waiver determinations 

with respect to advisory committees and update such guidance 

as necessary.’’. 

(b) CONFORMING AMENDMENTS.—Section 505(n) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by— 


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(1) striking paragraph (4); and 

(2) redesignating paragraphs (5), (6), (7), and (8) as paragraphs (4), (5), (6), and (7), respectively. 

(c) EFFECTIVE DATE.—The amendments made by this section 

shall take effect on October 1, 2007. 

TITLE VIII—CLINICAL TRIAL 

DATABASES 

SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK. 

(a) IN GENERAL.—Section 402 of the Public Health Service 

Act (42 U.S.C. 282) is amended by— 

(1) redesignating subsections (j) and (k) as subsections 

(k) and (l), respectively; and 

(2) inserting after subsection (i) the following: 

‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.— ‘‘(1) DEFINITIONS; REQUIREMENT.— ‘‘(A) DEFINITIONS.—In this subsection: 

‘‘(i) APPLICABLE CLINICAL TRIAL.—The term 

‘applicable clinical trial’ means an applicable device 

clinical trial or an applicable drug clinical trial. 

‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The term 

‘applicable device clinical trial’ means— 

‘‘(I) a prospective clinical study of health outcomes comparing an intervention with a device 

subject to section 510(k), 515, or 520(m) of the 

Federal Food, Drug, and Cosmetic Act against a 

control in human subjects (other than a small clinical trial to determine the feasibility of a device, 

or a clinical trial to test prototype devices where 

the primary outcome measure relates to feasibility 

and not to health outcomes); and 

‘‘(II) a pediatric postmarket surveillance as 

required under section 522 of the Federal Food, 

Drug, and Cosmetic Act. 

‘‘(iii) APPLICABLE DRUG CLINICAL TRIAL.— ‘‘(I) IN GENERAL.—The term ‘applicable drug 

clinical trial’ means a controlled clinical investigation, other than a phase I clinical investigation, 

of a drug subject to section 505 of the Federal 

Food, Drug, and Cosmetic Act or to section 351 

of this Act. 

‘‘(II) CLINICAL INVESTIGATION.—For purposes 

of subclause (I), the term ‘clinical investigation’ 

has the meaning given that term in section 312.3 

of title 21, Code of Federal Regulations (or any 

successor regulation). 

‘‘(III) PHASE I.—For purposes of subclause (I), 

the term ‘phase I’ has the meaning given that 

term in section 312.21 of title 21, Code of Federal 

Regulations (or any successor regulation). 

‘‘(iv) CLINICAL TRIAL INFORMATION.—The term ‘clinical trial information’ means, with respect to an 

applicable clinical trial, those data elements that the 

responsible party is required to submit under paragraph (2) or under paragraph (3). 

21 USC 355 note. 


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‘‘(v) COMPLETION DATE.—The term ‘completion 

date’ means, with respect to an applicable clinical trial, 

the date that the final subject was examined or 

received an intervention for the purposes of final collection of data for the primary outcome, whether the 

clinical trial concluded according to the prespecified 

protocol or was terminated. 

‘‘(vi) DEVICE.—The term ‘device’ means a device 

as defined in section 201(h) of the Federal Food, Drug, 

and Cosmetic Act. 

‘‘(vii) DRUG.—The term ‘drug’ means a drug as 

defined in section 201(g) of the Federal Food, Drug, 

and Cosmetic Act or a biological product as defined 

in section 351 of this Act. 

‘‘(viii) ONGOING.—The term ‘ongoing’ means, with 

respect to a clinical trial of a drug or a device and 

to a date, that— 

‘‘(I) 1 or more patients is enrolled in the clinical trial; and 

‘‘(II) the date is before the completion date 

of the clinical trial. 

‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible 

party’, with respect to a clinical trial of a drug or 

device, means— 

‘‘(I) the sponsor of the clinical trial (as defined 

in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or 

‘‘(II) the principal investigator of such clinical 

trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has 

access to and control over the data from the clinical 

trial, has the right to publish the results of the 

trial, and has the ability to meet all of the requirements under this subsection for the submission 

of clinical trial information. 

‘‘(B) REQUIREMENT.—The Secretary shall develop a 

mechanism by which the responsible party for each 

applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary 

at the time of submission of clinical trial information under 

paragraph (2). 

‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK

WITH RESPECT TO CLINICAL TRIAL INFORMATION.— 

‘‘(A) IN GENERAL.— 

‘‘(i) EXPANSION OF DATA BANK.—To enhance patient 

enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting 

through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry 

of the data bank described under subsection (i)(1) 

(referred to in this subsection as the ‘registry data 

bank’). The Director of NIH shall ensure that the registry data bank is made publicly available through 

the Internet. 

Public 

information. 

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‘‘(ii) CONTENT.—The clinical trial information 

required to be submitted under this paragraph for 

an applicable clinical trial shall include— 

‘‘(I) descriptive information, including— 

‘‘(aa) a brief title, intended for the lay 

public; 

‘‘(bb) a brief summary, intended for the 

lay public; 

‘‘(cc) the primary purpose; 

‘‘(dd) the study design; 

‘‘(ee) for an applicable drug clinical trial, 

the study phase; 

‘‘(ff) study type; 

‘‘(gg) the primary disease or condition 

being studied, or the focus of the study; 

‘‘(hh) the intervention name and intervention type; 

‘‘(ii) the study start date; 

‘‘(jj) the expected completion date; 

‘‘(kk) the target number of subjects; and 

‘‘(ll) outcomes, including primary and secondary outcome measures; 

‘‘(II) recruitment information, including— 

‘‘(aa) eligibility criteria; 

‘‘(bb) gender; 

‘‘(cc) age limits; 

‘‘(dd) whether the trial accepts healthy volunteers; 

‘‘(ee) overall recruitment status; 

‘‘(ff) individual site status; and 

‘‘(gg) in the case of an applicable drug 

clinical trial, if the drug is not approved under 

section 505 of the Federal Food, Drug, and 

Cosmetic Act or licensed under section 351 

of this Act, specify whether or not there is 

expanded access to the drug under section 561 

of the Federal Food, Drug, and Cosmetic Act 

for those who do not qualify for enrollment 

in the clinical trial and how to obtain information about such access; 

‘‘(III) location and contact information, 

including— 

‘‘(aa) the name of the sponsor; 

‘‘(bb) the responsible party, by official title; 

and 

‘‘(cc) the facility name and facility contact 

information (including the city, State, and zip 

code for each clinical trial location, or a tollfree number through which such location 

information may be accessed); and 

‘‘(IV) administrative data (which the Secretary 

may make publicly available as necessary), 

including— 

‘‘(aa) the unique protocol identification 

number; 

‘‘(bb) other protocol identification numbers, if any; and 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 907 

‘‘(cc) the Food and Drug Administration 

IND/IDE protocol number and the record 

verification date. 

‘‘(iii) MODIFICATIONS.—The Secretary may by regulation modify the requirements for clinical trial 

information under this paragraph, if the Secretary provides a rationale for why such a modification improves 

and does not reduce such clinical trial information. 

‘‘(B) FORMAT AND STRUCTURE.— ‘‘(i) SEARCHABLE CATEGORIES.—The Director of 

NIH shall ensure that the public may, in addition 

to keyword searching, search the entries in the registry 

data bank by 1 or more of the following criteria: 

‘‘(I) The disease or condition being studied in 

the clinical trial, using Medical Subject Headers 

(MeSH) descriptors. 

‘‘(II) The name of the intervention, including 

any drug or device being studied in the clinical 

trial. 

‘‘(III) The location of the clinical trial. 

‘‘(IV) The age group studied in the clinical 

trial, including pediatric subpopulations. 

‘‘(V) The study phase of the clinical trial. 

‘‘(VI) The sponsor of the clinical trial, which 

may be the National Institutes of Health or 

another Federal agency, a private industry source, 

or a university or other organization. 

‘‘(VII) The recruitment status of the clinical 

trial. 

‘‘(VIII) The National Clinical Trial number or 

other study identification for the clinical trial. 

‘‘(ii) ADDITIONAL SEARCHABLE CATEGORY.—Not 

later than 18 months after the date of the enactment 

of the Food and Drug Administration Amendments 

Act of 2007, the Director of NIH shall ensure that 

the public may search the entries of the registry data 

bank by the safety issue, if any, being studied in the 

clinical trial as a primary or secondary outcome. 

‘‘(iii) OTHER ELEMENTS.—The Director of NIH shall 

also ensure that the public may search the entries 

of the registry data bank by such other elements as 

the Director deems necessary on an ongoing basis. 

‘‘(iv) FORMAT.—The Director of the NIH shall 

ensure that the registry data bank is easily used by 

the public, and that entries are easily compared. 

‘‘(C) DATA SUBMISSION.—The responsible party for an 

applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date 

that is 90 days after, the date of the enactment of the 

Food and Drug Administration Amendments Act of 2007, 

shall submit to the Director of NIH for inclusion in the 

registry data bank the clinical trial information described 

in of subparagraph (A)(ii) not later than the later of— 

‘‘(i) 90 days after such date of enactment; 

‘‘(ii) 21 days after the first patient is enrolled in 

such clinical trial; or 

Deadlines. 

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‘‘(iii) in the case of a clinical trial that is not 

for a serious or life-threatening disease or condition 

and that is ongoing on such date of enactment, 1 

year after such date of enactment. 

‘‘(D) POSTING OF DATA.— ‘‘(i) APPLICABLE DRUG CLINICAL TRIAL.—The 

Director of NIH shall ensure that clinical trial information for an applicable drug clinical trial submitted in 

accordance with this paragraph is posted in the registry data bank not later than 30 days after such 

submission. 

‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The 

Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted 

in accordance with this paragraph is posted publicly 

in the registry data bank— 

‘‘(I) not earlier than the date of clearance 

under section 510(k) of the Federal Food, Drug, 

and Cosmetic Act, or approval under section 515 

or 520(m) of such Act, as applicable, for a device 

that was not previously cleared or approved, and 

not later than 30 days after such date; or 

‘‘(II) for a device that was previously cleared 

or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is 

required to be posted by the Secretary. 

‘‘(3) EXPANSION OF REGISTRY DATA BANK TO INCLUDE

RESULTS OF CLINICAL TRIALS.— 

‘‘(A) LINKING REGISTRY DATA BANK TO EXISTING

RESULTS.— 

‘‘(i) IN GENERAL.—Beginning not later than 90 days 

after the date of the enactment of the Food and Drug 

Administration Amendments Act of 2007, for those 

clinical trials that form the primary basis of an efficacy 

claim or are conducted after the drug involved is 

approved or after the device involved is cleared or 

approved, the Secretary shall ensure that the registry 

data bank includes links to results information as 

described in clause (ii) for such clinical trial— 

‘‘(I) not earlier than 30 days after the date 

of the approval of the drug involved or clearance 

or approval of the device involved; or 

‘‘(II) not later than 30 days after the results 

information described in clause (ii) becomes publicly available. 

‘‘(ii) REQUIRED INFORMATION.— 

‘‘(I) FDA INFORMATION.—The Secretary shall 

ensure that the registry data bank includes links 

to the following information: 

‘‘(aa) If an advisory committee considered 

at a meeting an applicable clinical trial, any 

posted Food and Drug Administration summary document regarding such applicable clinical trial. 

‘‘(bb) If an applicable drug clinical trial 

was conducted under section 505A or 505B 

of the Federal Food, Drug, and Cosmetic Act, 

Deadlines. 

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a link to the posted Food and Drug Administration assessment of the results of such trial. 

‘‘(cc) Food and Drug Administration public 

health advisories regarding the drug or device 

that is the subject of the applicable clinical 

trial, if any. 

‘‘(dd) For an applicable drug clinical trial, 

the Food and Drug Administration action 

package for approval document required under 

section 505(l)(2) of the Federal Food, Drug, 

and Cosmetic Act. 

‘‘(ee) For an applicable device clinical trial, 

in the case of a premarket application under 

section 515 of the Federal Food, Drug, and 

Cosmetic Act, the detailed summary of 

information respecting the safety and 

effectiveness of the device required under section 520(h)(1) of such Act, or, in the case of 

a report under section 510(k) of such Act, the 

section 510(k) summary of the safety and 

effectiveness data required under section 

807.95(d) of title 21, Code of Federal Regulations (or any successor regulation). 

‘‘(II) NIH INFORMATION.—The Secretary shall 

ensure that the registry data bank includes links 

to the following information: 

‘‘(aa) Medline citations to any publications 

focused on the results of an applicable clinical 

trial. 

‘‘(bb) The entry for the drug that is the 

subject of an applicable drug clinical trial in 

the National Library of Medicine database of 

structured product labels, if available. 

‘‘(iii) RESULTS FOR EXISTING DATA BANK ENTRIES.— 

The Secretary may include the links described in clause 

(ii) for data bank entries for clinical trials submitted 

to the data bank prior to enactment of the Food and 

Drug Administration Amendments Act of 2007, as 

available. 

‘‘(B) INCLUSION OF RESULTS.—The Secretary, acting 

through the Director of NIH, shall— 

‘‘(i) expand the registry data bank to include the 

results of applicable clinical trials (referred to in this 

subsection as the ‘registry and results data bank’); 

‘‘(ii) ensure that such results are made publicly 

available through the Internet; 

‘‘(iii) post publicly a glossary for the lay public 

explaining technical terms related to the results of 

clinical trials; and 

‘‘(iv) in consultation with experts on risk communication, provide information with the information 

included under subparagraph (C) in the registry and 

results data bank to help ensure that such information 

does not mislead the patients or the public. 

‘‘(C) BASIC RESULTS.—Not later than 1 year after the 

date of the enactment of the Food and Drug Administration 

Amendments Act of 2007, the Secretary shall include in 

Deadline. 

Public 

information. 

Internet. 


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121 STAT. 910 PUBLIC LAW 110–85—SEPT. 27, 2007 

the registry and results data bank the following elements 

for drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 

351 of this Act and devices that are cleared under section 

510(k) of the Federal Food, Drug, and Cosmetic Act or 

approved under section 515 or 520(m) of such Act: 

‘‘(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS

OF PATIENT SAMPLE.—A table of the demographic and 

baseline data collected overall and for each arm of 

the clinical trial to describe the patients who participated in the clinical trial, including the number of 

patients who dropped out of the clinical trial and the 

number of patients excluded from the analysis, if any. 

‘‘(ii) PRIMARY AND SECONDARY OUTCOMES.—The 

primary and secondary outcome measures as submitted 

under paragraph (2)(A)(ii)(I)(ll), and a table of values 

for each of the primary and secondary outcome measures for each arm of the clinical trial, including the 

results of scientifically appropriate tests of the statistical significance of such outcome measures. 

‘‘(iii) POINT OF CONTACT.—A point of contact for 

scientific information about the clinical trial results. 

‘‘(iv) CERTAIN AGREEMENTS.—Whether there exists 

an agreement (other than an agreement solely to 

comply with applicable provisions of law protecting 

the privacy of participants) between the sponsor or 

its agent and the principal investigator (unless the 

sponsor is an employer of the principal investigator) 

that restricts in any manner the ability of the principal 

investigator, after the completion date of the trial, 

to discuss the results of the trial at a scientific meeting 

or any other public or private forum, or to publish 

in a scientific or academic journal information concerning the results of the trial. 

‘‘(D) EXPANDED REGISTRY AND RESULTS DATA BANK.— ‘‘(i) EXPANSION BY RULEMAKING.—To provide more 

complete results information and to enhance patient 

access to and understanding of the results of clinical 

trials, not later than 3 years after the date of the 

enactment of the Food and Drug Administration 

Amendments Act of 2007, the Secretary shall by regulation expand the registry and results data bank as 

provided under this subparagraph. 

‘‘(ii) CLINICAL TRIALS.— 

‘‘(I) APPROVED PRODUCTS.—The regulations 

under this subparagraph shall require the inclusion of the results information described in clause 

(iii) for— 

‘‘(aa) each applicable drug clinical trial for 

a drug that is approved under section 505 

of the Federal Food, Drug, and Cosmetic Act 

or licensed under section 351 of this Act; and 

‘‘(bb) each applicable device clinical trial 

for a device that is cleared under section 

510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 

520(m) of such Act. 

Deadline. 


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‘‘(II) UNAPPROVED PRODUCTS.—The regulations 

under this subparagraph shall establish whether 

or not the results information described in clause 

(iii) shall be required for— 

‘‘(aa) an applicable drug clinical trial for 

a drug that is not approved under section 505 

of the Federal Food, Drug, and Cosmetic Act 

and not licensed under section 351 of this 

Act (whether approval or licensure was sought 

or not); and 

‘‘(bb) an applicable device clinical trial for 

a device that is not cleared under section 

510(k) of the Federal Food, Drug, and Cosmetic Act and not approved under section 515 

or section 520(m) of such Act (whether clearance or approval was sought or not). 

‘‘(iii) REQUIRED ELEMENTS.—The regulations under 

this subparagraph shall require, in addition to the 

elements described in subparagraph (C), information 

within each of the following categories: 

‘‘(I) A summary of the clinical trial and its 

results that is written in non-technical, understandable language for patients, if the Secretary 

determines that such types of summary can be 

included without being misleading or promotional. 

‘‘(II) A summary of the clinical trial and its 

results that is technical in nature, if the Secretary 

determines that such types of summary can be 

included without being misleading or promotional. 

‘‘(III) The full protocol or such information 

on the protocol for the trial as may be necessary 

to help to evaluate the results of the trial. 

‘‘(IV) Such other categories as the Secretary 

determines appropriate. 

‘‘(iv) RESULTS SUBMISSION.—The results information described in clause (iii) shall be submitted to the 

Director of NIH for inclusion in the registry and results 

data bank as provided by subparagraph (E), except 

that the Secretary shall by regulation determine— 

‘‘(I) whether the 1-year period for submission 

of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to 

a period not to exceed 18 months; 

‘‘(II) whether the clinical trial information 

described in clause (iii) should be required to be 

submitted for an applicable clinical trial for which 

the clinical trial information described in subparagraph (C) is submitted to the registry and results 

data bank before the effective date of the regulations issued under this subparagraph; and 

‘‘(III) in the case when the clinical trial 

information described in clause (iii) is required 

to be submitted for the applicable clinical trials 

described in clause (ii)(II), the date by which such 

clinical trial information shall be required to be 

submitted, taking into account— 

Regulations. 


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121 STAT. 912 PUBLIC LAW 110–85—SEPT. 27, 2007 

‘‘(aa) the certification process under 

subparagraph (E)(iii) when approval, licensure, or clearance is sought; and 

‘‘(bb) whether there should be a delay of 

submission when approval, licensure, or clearance will not be sought. 

‘‘(v) ADDITIONAL PROVISIONS.—The regulations 

under this subparagraph shall also establish— 

‘‘(I) a standard format for the submission of 

clinical trial information under this paragraph to 

the registry and results data bank; 

‘‘(II) additional information on clinical trials 

and results that is written in nontechnical, understandable language for patients; 

‘‘(III) considering the experience under the 

pilot quality control project described in paragraph 

(5)(C), procedures for quality control, including 

using representative samples, with respect to 

completeness and content of clinical trial information under this subsection, to help ensure that 

data elements are not false or misleading and are 

non-promotional; 

‘‘(IV) the appropriate timing and requirements 

for updates of clinical trial information, and 

whether and, if so, how such updates should be 

tracked; 

‘‘(V) a statement to accompany the entry for 

an applicable clinical trial when the primary and 

secondary outcome measures for such clinical trial 

are submitted under paragraph (4)(A) after the 

date specified for the submission of such information in paragraph (2)(C); and 

‘‘(VI) additions or modifications to the manner 

of reporting of the data elements established under 

subparagraph (C). 

‘‘(vi) CONSIDERATION OF WORLD HEALTH ORGANIZATION DATA SET.—The Secretary shall consider the 

status of the consensus data elements set for reporting 

clinical trial results of the World Health Organization 

when issuing the regulations under this subparagraph. 

‘‘(vii) PUBLIC MEETING.—The Secretary shall hold 

a public meeting no later than 18 months after the 

date of the enactment of the Food and Drug Administration Amendments Act of 2007 to provide an opportunity for input from interested parties with regard 

to the regulations to be issued under this subparagraph. 

‘‘(E) SUBMISSION OF RESULTS INFORMATION.— 

‘‘(i) IN GENERAL.—Except as provided in clauses 

(iii), (iv), (v), and (vi) the responsible party for an 

applicable clinical trial that is described in clause (ii) 

shall submit to the Director of NIH for inclusion in 

the registry and results data bank the clinical trial 

information described in subparagraph (C) not later 

than 1 year, or such other period as may be provided 

by regulation under subparagraph (D), after the earlier 

of— 

Deadline. 

Deadline. 

Procedures. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 913 

‘‘(I) the estimated completion date of the trial 

as described in paragraph (2)(A)(ii)(I)(jj)); or 

‘‘(II) the actual date of completion. 

‘‘(ii) CLINICAL TRIALS DESCRIBED.—An applicable 

clinical trial described in this clause is an applicable 

clinical trial subject to— 

‘‘(I) paragraph (2)(C); and 

‘‘(II)(aa) subparagraph (C); or 

‘‘(bb) the regulations issued under subparagraph (D). 

‘‘(iii) DELAYED SUBMISSION OF RESULTS WITH CERTIFICATION.—If the responsible party for an applicable 

clinical trial submits a certification that clause (iv) 

or (v) applies to such clinical trial, the responsible 

party shall submit to the Director of NIH for inclusion 

in the registry and results data bank the clinical trial 

information described in subparagraphs (C) and (D) 

as required under the applicable clause. 

‘‘(iv) SEEKING INITIAL APPROVAL OF A DRUG OR

DEVICE.—With respect to an applicable clinical trial 

that is completed before the drug is initially approved 

under section 505 of the Federal Food, Drug, and Cosmetic Act or initially licensed under section 351 of 

this Act, or the device is initially cleared under section 

510(k) or initially approved under section 515 or 520(m) 

of the Federal Food, Drug, and Cosmetic Act, the 

responsible party shall submit to the Director of NIH 

for inclusion in the registry and results data bank 

the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the 

drug or device is approved under such section 505, 

licensed under such section 351, cleared under such 

section 510(k), or approved under such section 515 

or 520(m), as applicable. 

‘‘(v) SEEKING APPROVAL OF A NEW USE FOR THE

DRUG OR DEVICE.— 

‘‘(I) IN GENERAL.—With respect to an 

applicable clinical trial where the manufacturer 

of the drug or device is the sponsor of an applicable 

clinical trial, and such manufacturer has filed, or 

will file within 1 year, an application seeking 

approval under section 505 of the Federal Food, 

Drug, and Cosmetic Act, licensing under section 

351 of this Act, or clearance under section 510(k), 

or approval under section 515 or 520(m), of the 

Federal Food, Drug, and Cosmetic Act for the use 

studied in such clinical trial (which use is not 

included in the labeling of the approved drug or 

device), then the responsible party shall submit 

to the Director of NIH for inclusion in the registry 

and results data bank the clinical trial information 

described in subparagraphs (C) and (D) on the 

earlier of the date that is 30 days after the date— 

‘‘(aa) the new use of the drug or device 

is approved under such section 505, licensed 

under such section 351, cleared under such 

Deadlines. 

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121 STAT. 914 PUBLIC LAW 110–85—SEPT. 27, 2007 

section 510(k), or approved under such section 

515 or 520(m); 

‘‘(bb) the Secretary issues a letter, such 

as a complete response letter, not approving 

the submission or not clearing the submission, 

a not approvable letter, or a not substantially 

equivalent letter for the new use of the drug 

or device under such section 505, 351, 510(k), 

515, or 520(m); or 

‘‘(cc) except as provided in subclause (III), 

the application or premarket notification 

under such section 505, 351, 510(k), 515, or 

520(m) is withdrawn without resubmission for 

no less than 210 days. 

‘‘(II) REQUIREMENT THAT EACH CLINICAL TRIAL

IN APPLICATION BE TREATED THE SAME.—If a manufacturer makes a certification under clause (iii) 

that this clause applies with respect to a clinical 

trial, the manufacturer shall make such a certification with respect to each applicable clinical trial 

that is required to be submitted in an application 

or report for licensure, approval, or clearance 

(under section 351 of this Act or section 505, 

510(k), 515, or 520(m) of the Federal Food, Drug, 

and Cosmetic Act, as applicable) of the use studied 

in the clinical trial. 

‘‘(III) TWO-YEAR LIMITATION.—The responsible 

party shall submit to the Director of NIH for inclusion in the registry and results data bank the 

clinical trial information subject to subclause (I) 

on the date that is 2 years after the date a certification under clause (iii) was made to the Director 

of NIH, if an action referred to in item (aa), (bb), 

or (cc) of subclause (I) has not occurred by such 

date. 

‘‘(vi) EXTENSIONS.—The Director of NIH may provide an extension of the deadline for submission of 

clinical trial information under clause (i) if the responsible party for the trial submits to the Director a 

written request that demonstrates good cause for the 

extension and provides an estimate of the date on 

which the information will be submitted. The Director 

of NIH may grant more than one such extension for 

a clinical trial. 

‘‘(F) NOTICE TO DIRECTOR OF NIH.—The Commissioner 

of Food and Drugs shall notify the Director of NIH when 

there is an action described in subparagraph (E)(iv) or 

item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect 

to an application or a report that includes a certification 

required under paragraph (5)(B) of such action not later 

than 30 days after such action. 

‘‘(G) POSTING OF DATA.—The Director of NIH shall 

ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly 

in the registry and results database not later than 30 

days after such submission. 

Public 

information. 

Deadline. 

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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 915 

‘‘(H) WAIVERS REGARDING CERTAIN CLINICAL TRIAL

RESULTS.—The Secretary may waive any applicable 

requirements of this paragraph for an applicable clinical 

trial, upon a written request from the responsible party, 

if the Secretary determines that extraordinary circumstances justify the waiver and that providing the 

waiver is consistent with the protection of public health, 

or in the interest of national security. Not later than 30 

days after any part of a waiver is granted, the Secretary 

shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why 

the waiver was granted. 

‘‘(I) ADVERSE EVENTS.— ‘‘(i) REGULATIONS.—Not later than 18 months after 

the date of the enactment of the Food and Drug 

Administration Amendments Act of 2007, the Secretary 

shall by regulation determine the best method for 

including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for drugs described in subparagraph (C) in a manner and form that is useful and 

not misleading to patients, physicians, and scientists. 

‘‘(ii) DEFAULT.—If the Secretary fails to issue the 

regulation required by clause (i) by the date that is 

24 months after the date of the enactment of the 

Food and Drug Administration Amendments Act of 

2007, clause (iii) shall take effect. 

‘‘(iii) ADDITIONAL ELEMENTS.—Upon the application 

of clause (ii), the Secretary shall include in the registry 

and results data bank for drugs described in subparagraph (C), in addition to the clinical trial information 

described in subparagraph (C), the following elements: 

‘‘(I) SERIOUS ADVERSE EVENTS.—A table of 

anticipated and unanticipated serious adverse 

events grouped by organ system, with number and 

frequency of such event in each arm of the clinical 

trial. 

‘‘(II) FREQUENT ADVERSE EVENTS.—A table of 

anticipated and unanticipated adverse events that 

are not included in the table described in subclause 

(I) that exceed a frequency of 5 percent within 

any arm of the clinical trial, grouped by organ 

system, with number and frequency of such event 

in each arm of the clinical trial. 

‘‘(iv) POSTING OF OTHER INFORMATION.—In carrying 

out clause (iii), the Secretary shall, in consultation 

with experts in risk communication, post with the 

tables information to enhance patient understanding 

and to ensure such tables do not mislead patients 

or the lay public. 

‘‘(v) RELATION TO SUBPARAGRAPH (C).—Clinical trial 

information included in the registry and results data 

bank pursuant to this subparagraph is deemed to be 

clinical trial information included in such data bank 

pursuant to subparagraph (C). 

‘‘(4) ADDITIONAL SUBMISSIONS OF CLINICAL TRIAL INFORMA- TION.— 

Effective date. 

Deadline. 

Deadline. 

Notification. 


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121 STAT. 916 PUBLIC LAW 110–85—SEPT. 27, 2007 

‘‘(A) VOLUNTARY SUBMISSIONS.—A responsible party for 

a clinical trial that is not an applicable clinical trial, or 

that is an applicable clinical trial that is not subject to 

paragraph (2)(C), may submit complete clinical trial 

information described in paragraph (2) or paragraph (3) 

provided the responsible party submits clinical trial 

information for each applicable clinical trial that is required 

to be submitted under section 351 or under section 505, 

510(k), 515, or 520(m) of the Federal Food, Drug, and 

Cosmetic Act in an application or report for licensure, 

approval, or clearance of the drug or device for the use 

studied in the clinical trial. 

‘‘(B) REQUIRED SUBMISSIONS.— ‘‘(i) IN GENERAL.—Notwithstanding paragraphs (2) 

and (3) and subparagraph (A), in any case in which 

the Secretary determines for a specific clinical trial 

described in clause (ii) that posting in the registry 

and results data bank of clinical trial information for 

such clinical trial is necessary to protect the public 

health— 

‘‘(I) the Secretary may require by notification 

that such information be submitted to the Secretary in accordance with paragraphs (2) and (3) 

except with regard to timing of submission; 

‘‘(II) unless the responsible party submits a 

certification under paragraph (3)(E)(iii), such 

information shall be submitted not later than 30 

days after the date specified by the Secretary in 

the notification; and 

‘‘(III) failure to comply with the requirements 

under subclauses (I) and (II) shall be treated as 

a violation of the corresponding requirement of 

such paragraphs. 

‘‘(ii) CLINICAL TRIALS DESCRIBED.—A clinical trial 

described in this clause is— 

‘‘(I) an applicable clinical trial for a drug that 

is approved under section 505 of the Federal Food, 

Drug, and Cosmetic Act or licensed under section 

351 of this Act or for a device that is cleared 

under section 510(k) of the Federal Food, Drug, 

and Cosmetic Act or approved under section 515 

or section 520(m) of such Act, whose completion 

date is on or after the date 10 years before the 

date of the enactment of the Food and Drug 

Administration Amendments Act of 2007; or 

‘‘(II) an applicable clinical trial that is 

described by both by paragraph (2)(C) and paragraph (3)(D)(ii)(II)). 

‘‘(C) UPDATES TO CLINICAL TRIAL DATA BANK.— 

‘‘(i) SUBMISSION OF UPDATES.—The responsible 

party for an applicable clinical trial shall submit to 

the Director of NIH for inclusion in the registry and 

results data bank updates to reflect changes to the 

clinical trial information submitted under paragraph 

(2). Such updates— 

‘‘(I) shall be provided not less than once every 

12 months, unless there were no changes to the 

Deadlines. 

Deadline. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 917 

clinical trial information during the preceding 12- 

month period; 

‘‘(II) shall include identification of the dates 

of any such changes; 

‘‘(III) not later than 30 days after the recruitment status of such clinical trial changes, shall 

include an update of the recruitment status; and 

‘‘(IV) not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete. 

‘‘(ii) PUBLIC AVAILABILITY OF UPDATES.—The 

Director of NIH shall make updates submitted under 

clause (i) publicly available in the registry data bank. 

Except with regard to overall recruitment status, individual site status, location, and contact information, 

the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph 

(2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding 

updates, and information in such databases is presented in a manner that enables users to readily access 

each original element submission and to track the 

changes made by the updates. The Director of NIH 

shall provide a link from the table of primary and 

secondary outcomes required under paragraph (3)(C)(ii) 

to the tracked history required under this clause of 

the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll). 

‘‘(5) COORDINATION AND COMPLIANCE.— 

‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FEDERAL AGENCIES.— 

‘‘(i) GRANTS FROM CERTAIN FEDERAL AGENCIES.— 

If an applicable clinical trial is funded in whole or 

in part by a grant from any agency of the Department 

of Health and Human Services, including the Food 

and Drug Administration, the National Institutes of 

Health, or the Agency for Healthcare Research and 

Quality, any grant or progress report forms required 

under such grant shall include a certification that the 

responsible party has made all required submissions 

to the Director of NIH under paragraphs (2) and (3). 

‘‘(ii) VERIFICATION BY FEDERAL AGENCIES.—The 

heads of the agencies referred to in clause (i), as 

applicable, shall verify that the clinical trial information for each applicable clinical trial for which a 

grantee is the responsible party has been submitted 

under paragraphs (2) and (3) before releasing any 

remaining funding for a grant or funding for a future 

grant to such grantee. 

‘‘(iii) NOTICE AND OPPORTUNITY TO REMEDY.—If the 

head of an agency referred to in clause (i), as 

applicable, verifies that a grantee has not submitted 

clinical trial information as described in clause (ii), 

such agency head shall provide notice to such grantee 

of such non-compliance and allow such grantee 30 days 

Deadline. 

Certification. 


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to correct such non-compliance and submit the required 

clinical trial information. 

‘‘(iv) CONSULTATION WITH OTHER FEDERAL AGENCIES.—The Secretary shall— 

‘‘(I) consult with other agencies that conduct 

research involving human subjects in accordance 

with any section of part 46 of title 45, Code of 

Federal Regulations (or any successor regulations), 

to determine if any such research is an applicable 

clinical trial; and 

‘‘(II) develop with such agencies procedures 

comparable to those described in clauses (i), (ii), 

and (iii) to ensure that clinical trial information 

for such applicable clinical trial is submitted under 

paragraphs (2) and (3). 

‘‘(B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL

PRODUCT, AND DEVICE SUBMISSIONS.—At the time of submission of an application under section 505 of the Federal 

Food, Drug, and Cosmetic Act, section 515 of such Act, 

section 520(m) of such Act, or section 351 of this Act, 

or submission of a report under section 510(k) of such 

Act, such application or submission shall be accompanied 

by a certification that all applicable requirements of this 

subsection have been met. Where available, such certification shall include the appropriate National Clinical Trial 

control numbers. 

‘‘(C) QUALITY CONTROL.— 

‘‘(i) PILOT QUALITY CONTROL PROJECT.—Until the 

effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director 

of NIH and the Commissioner of Food and Drugs, 

shall conduct a pilot project to determine the optimal 

method of verification to help to ensure that the clinical 

trial information submitted under paragraph (3)(C) is 

non-promotional and is not false or misleading in any 

particular under subparagraph (D). The Secretary shall 

use the publicly available information described in 

paragraph (3)(A) and any other information available 

to the Secretary about applicable clinical trials to verify 

the accuracy of the clinical trial information submitted 

under paragraph (3)(C). 

‘‘(ii) NOTICE OF COMPLIANCE.—If the Secretary 

determines that any clinical trial information was not 

submitted as required under this subsection, or was 

submitted but is false or misleading in any particular, 

the Secretary shall notify the responsible party and 

give such party an opportunity to remedy such noncompliance by submitting the required revised clinical 

trial information not later than 30 days after such 

notification. 

‘‘(D) TRUTHFUL CLINICAL TRIAL INFORMATION.— 

‘‘(i) IN GENERAL.—The clinical trial information 

submitted by a responsible party under this subsection 

shall not be false or misleading in any particular. 

‘‘(ii) EFFECT.—Clause (i) shall not have the effect 

of— 

Deadline. 

Procedures. 


jbridges on GSDDPC57 with PUBLIC LAWS
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‘‘(I) requiring clinical trial information with 

respect to an applicable clinical trial to include 

information from any source other than such clinical trial involved; or 

‘‘(II) requiring clinical trial information 

described in paragraph (3)(D) to be submitted for 

purposes of paragraph (3)(C). 

‘‘(E) PUBLIC NOTICES.— 

‘‘(i) NOTICE OF VIOLATIONS.—If the responsible 

party for an applicable clinical trial fails to submit 

clinical trial information for such clinical trial as 

required under paragraphs (2) or (3), the Director of 

NIH shall include in the registry and results data 

bank entry for such clinical trial a notice— 

‘‘(I) that the responsible party is not in compliance with this Act by— 

‘‘(aa) failing to submit required clinical 

trial information; or 

‘‘(bb) submitting false or misleading clinical trial information; 

‘‘(II) of the penalties imposed for the violation, 

if any; and 

‘‘(III) whether the responsible party has corrected the clinical trial information in the registry 

and results data bank. 

‘‘(ii) NOTICE OF FAILURE TO SUBMIT PRIMARY AND

SECONDARY OUTCOMES.—If the responsible party for 

an applicable clinical trial fails to submit the primary 

and secondary outcomes as required under section 

2(A)(ii)(I)(ll), the Director of NIH shall include in the 

registry and results data bank entry for such clinical 

trial a notice that the responsible party is not in 

compliance by failing to register the primary and secondary outcomes in accordance with this act, and that 

the primary and secondary outcomes were not publicly 

disclosed in the database before conducting the clinical 

trial. 

‘‘(iii) FAILURE TO SUBMIT STATEMENT.—The notice 

under clause (i) for a violation described in clause 

(i)(I)(aa) shall include the following statement: ‘The 

entry for this clinical trial was not complete at the 

time of submission, as required by law. This may or 

may not have any bearing on the accuracy of the 

information in the entry.’. 

‘‘(iv) SUBMISSION OF FALSE INFORMATION STATEMENT.—The notice under clause (i) for a violation 

described in clause (i)(I)(bb) shall include the following 

statement: ‘The entry for this clinical trial was found 

to be false or misleading and therefore not in compliance with the law.’. 

‘‘(v) NON-SUBMISSION OF STATEMENT.—The notice 

under clause (ii) for a violation described in clause 

(ii) shall include the following statement: ‘The entry 

for this clinical trial did not contain information on 

the primary and secondary outcomes at the time of 

submission, as required by law. This may or may not 


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121 STAT. 920 PUBLIC LAW 110–85—SEPT. 27, 2007 

have any bearing on the accuracy of the information 

in the entry.’. 

‘‘(vi) COMPLIANCE SEARCHES.—The Director of NIH 

shall provide that the public may easily search the 

registry and results data bank for entries that include 

notices required under this subparagraph. 

‘‘(6) LIMITATION ON DISCLOSURE OF CLINICAL TRIAL

INFORMATION.— 

‘‘(A) IN GENERAL.—Nothing in this subsection (or under 

section 552 of title 5, United States Code) shall require 

the Secretary to publicly disclose, by any means other 

than the registry and results data bank, information 

described in subparagraph (B). 

‘‘(B) INFORMATION DESCRIBED.—Information described 

in this subparagraph is— 

‘‘(i) information submitted to the Director of NIH 

under this subsection, or information of the same general nature as (or integrally associated with) the 

information so submitted; and 

‘‘(ii) information not otherwise publicly available, 

including because it is protected from disclosure under 

section 552 of title 5, United States Code. 

‘‘(7) AUTHORIZATION OF APPROPRIATIONS.—There are 

authorized to be appropriated to carry out this subsection 

$10,000,000 for each fiscal year.’’. 

(b) CONFORMING AMENDMENTS.— 

(1) PROHIBITED ACTS.—Section 301 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding 

at the end the following: 

‘‘(jj)(1) The failure to submit the certification required by section 

402(j)(5)(B) of the Public Health Service Act, or knowingly submitting a false certification under such section. 

‘‘(2) The failure to submit clinical trial information required 

under subsection (j) of section 402 of the Public Health Service 

Act. 

‘‘(3) The submission of clinical trial information under subsection (j) of section 402 of the Public Health Service Act that 

is false or misleading in any particular under paragraph (5)(D) 

of such subsection (j).’’. 

(2) CIVIL MONEY PENALTIES.—Subsection (f) of section 303 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), 

as redesignated by section 226, is amended— 

(A) by redesignating paragraphs (3), (4), and (5) as 

paragraphs (5), (6), and (7), respectively; 

(B) by inserting after paragraph (2) the following: 

‘‘(3)(A) Any person who violates section 301(jj) shall be subject 

to a civil monetary penalty of not more than $10,000 for all violations adjudicated in a single proceeding. 

‘‘(B) If a violation of section 301(jj) is not corrected within 

the 30-day period following notification under section 402(j)(5)(C)(ii), 

the person shall, in addition to any penalty under subparagraph 

(A), be subject to a civil monetary penalty of not more than $10,000 

for each day of the violation after such period until the violation 

is corrected.’’; 

(C) in paragraph (2)(C), by striking ‘‘paragraph (3)(A)’’ 

and inserting ‘‘paragraph (5)(A)’’; 

Deadline. 

Penalties. 


jbridges on GSDDPC57 with PUBLIC LAWS
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(D) in paragraph (5), as so redesignated, by striking 

‘‘paragraph (1) or (2)’’ each place it appears and inserting 

‘‘paragraph (1), (2), or (3)’’; 

(E) in paragraph (6), as so redesignated, by striking 

‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph (5)(A)’’; and 

(F) in paragraph (7), as so redesignated, by striking 

‘‘paragraph (4)’’ each place it appears and inserting ‘‘paragraph (6)’’. 

(3) NEW DRUGS AND DEVICES.— (A) INVESTIGATIONAL NEW DRUGS.—Section 505(i) of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) 

is amended in paragraph (4), by adding at the end the 

following: ‘‘The Secretary shall update such regulations 

to require inclusion in the informed consent documents 

and process a statement that clinical trial information for 

such clinical investigation has been or will be submitted 

for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the Public Health Service Act.’’. 

(B) NEW DRUG APPLICATIONS.—Section 505(b) of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 

is amended by adding at the end the following: 

‘‘(6) An application submitted under this subsection shall 

be accompanied by the certification required under section 

402(j)(5)(B) of the Public Health Service Act. Such certification 

shall not be considered an element of such application.’’. 

(C) DEVICE REPORTS UNDER SECTION 510(k).—Section 

510(k) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 360(k)) is amended by adding at the end the following: 

‘‘A notification submitted under this subsection that contains clinical trial data for an applicable device clinical trial (as defined 

in section 402(j)(1) of the Public Health Service Act) shall be accompanied by the certification required under section 402(j)(5)(B) of 

such Act. Such certification shall not be considered an element 

of such notification.’’. 

(D) DEVICE PREMARKET APPROVAL APPLICATION.—Section 515(c)(1) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 360e(c)(1)) is amended— 

(i) in subparagraph (F), by striking ‘‘; and’’ and 

inserting a semicolon; 

(ii) by redesignating subparagraph (G) as subparagraph (H); and 

(iii) by inserting after subparagraph (F) the following: 

‘‘(G) the certification required under section 402(j)(5)(B) 

of the Public Health Service Act (which shall not be considered an element of such application); and’’. 

(E) HUMANITARIAN DEVICE EXEMPTION.—Section 

520(m)(2) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360e(c)) is amended in the first sentence in 

the matter following subparagraph (C), by inserting at 

the end before the period ‘‘and such application shall 

include the certification required under section 402(j)(5)(B) 

of the Public Health Service Act (which shall not be considered an element of such application)’’. 

(c) SURVEILLANCES.—Not later than 12 months after the date 

of the enactment of this Act, the Secretary of Health and Human 

Deadline. 

Guidance. 

42 USC 282 note. 

21 USC 360j. 

Regulations. 

Certification. 


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121 STAT. 922 PUBLIC LAW 110–85—SEPT. 27, 2007 

Services shall issue guidance on how the requirements of section 

402(j) of the Public Health Service Act, as added by this section, 

apply to a pediatric postmarket surveillance described in paragraph 

(1)(A)(ii)(II) of such section 402(j) that is not a clinical trial. 

(d) PREEMPTION.— (1) IN GENERAL.—Upon the expansion of the registry and 

results data bank under section 402(j)(3)(D) of the Public Health 

Service Act, as added by this section, no State or political 

subdivision of a State may establish or continue in effect any 

requirement for the registration of clinical trials or for the 

inclusion of information relating to the results of clinical trials 

in a database. 

(2) RULE OF CONSTRUCTION.—The fact of submission of 

clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public Health Service Act 

(as amended by this section), that relates to a use of a drug 

or device not included in the official labeling of the approved 

drug or device shall not be construed by the Secretary of 

Health and Human Services or in any administrative or judicial 

proceeding, 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. 

The availability of clinical trial information through the registry 

and results data bank under such subsection (j), if submitted 

in compliance with such subsection, shall not be considered 

as labeling, adulteration, or misbranding of the drug or device 

under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq.). 

TITLE IX—ENHANCED AUTHORITIES 

REGARDING POSTMARKET SAFETY OF 

DRUGS 

Subtitle A—Postmarket Studies and 

Surveillance 

SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING 

HUMAN DRUGS; RISK EVALUATION AND MITIGATION 

STRATEGIES. 

(a) IN GENERAL.—Section 505 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355) is amended by adding at the end 

the following subsections: 

‘‘(o) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING.— 

‘‘(1) IN GENERAL.—A responsible person may not introduce 

or deliver for introduction into interstate commerce the new 

drug involved if the person is in violation of a requirement 

established under paragraph (3) or (4) with respect to the 

drug. 

‘‘(2) DEFINITIONS.—For purposes of this subsection: 

‘‘(A) RESPONSIBLE PERSON.—The term ‘responsible person’ means a person who— 

‘‘(i) has submitted to the Secretary a covered 

application that is pending; or 

42 USC 282 note. 


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‘‘(ii) is the holder of an approved covered application. 

‘‘(B) COVERED APPLICATION.—The term ‘covered 

application’ means— 

‘‘(i) an application under subsection (b) for a drug 

that is subject to section 503(b); and 

‘‘(ii) an application under section 351 of the Public 

Health Service Act. 

‘‘(C) NEW SAFETY INFORMATION; SERIOUS RISK.—The 

terms ‘new safety information’, ‘serious risk’, and ‘signal 

of a serious risk’ have the meanings given such terms 

in section 505–1(b). 

‘‘(3) STUDIES AND CLINICAL TRIALS.— ‘‘(A) IN GENERAL.—For any or all of the purposes specified in subparagraph (B), the Secretary may, subject to 

subparagraph (D), require a responsible person for a drug 

to conduct a postapproval study or studies of the drug, 

or a postapproval clinical trial or trials of the drug, on 

the basis of scientific data deemed appropriate by the Secretary, including information regarding chemically-related 

or pharmacologically-related drugs. 

‘‘(B) PURPOSES OF STUDY OR CLINICAL TRIAL.—The purposes referred to in this subparagraph with respect to 

a postapproval study or postapproval clinical trial are the 

following: 

‘‘(i) To assess a known serious risk related to the 

use of the drug involved. 

‘‘(ii) To assess signals of serious risk related to 

the use of the drug. 

‘‘(iii) To identify an unexpected serious risk when 

available data indicates the potential for a serious 

risk. 

‘‘(C) ESTABLISHMENT OF REQUIREMENT AFTER APPROVAL

OF COVERED APPLICATION.—The Secretary may require a 

postapproval study or studies or postapproval clinical trial 

or trials for a drug for which an approved covered application is in effect as of the date on which the Secretary 

seeks to establish such requirement only if the Secretary 

becomes aware of new safety information. 

‘‘(D) DETERMINATION BY SECRETARY.— 

‘‘(i) POSTAPPROVAL STUDIES.—The Secretary may 

not require the responsible person to conduct a study 

under this paragraph, unless the Secretary makes a 

determination that the reports under subsection (k)(1) 

and the active postmarket risk identification and analysis system as available under subsection (k)(3) will 

not be sufficient to meet the purposes set forth in 

subparagraph (B). 

‘‘(ii) POSTAPPROVAL CLINICAL TRIALS.—The Secretary may not require the responsible person to conduct a clinical trial under this paragraph, unless the 

Secretary makes a determination that a postapproval 

study or studies will not be sufficient to meet the 

purposes set forth in subparagraph (B). 

‘‘(E) NOTIFICATION; TIMETABLES; PERIODIC REPORTS.— ‘‘(i) NOTIFICATION.—The Secretary shall notify the 

responsible person regarding a requirement under this 


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121 STAT. 924 PUBLIC LAW 110–85—SEPT. 27, 2007 

paragraph to conduct a postapproval study or clinical 

trial by the target dates for communication of feedback 

from the review team to the responsible person 

regarding proposed labeling and postmarketing study 

commitments as set forth in the letters described in 

section 101(c) of the Food and Drug Administration 

Amendments Act of 2007. 

‘‘(ii) TIMETABLE; PERIODIC REPORTS.—For each 

study or clinical trial required to be conducted under 

this paragraph, the Secretary shall require that the 

responsible person submit a timetable for completion 

of the study or clinical trial. With respect to each 

study required to be conducted under this paragraph 

or otherwise undertaken by the responsible person to 

investigate a safety issue, the Secretary shall require 

the responsible person to periodically report to the 

Secretary on the status of such study including 

whether any difficulties in completing the study have 

been encountered. With respect to each clinical trial 

required to be conducted under this paragraph or 

otherwise undertaken by the responsible person to 

investigate a safety issue, the Secretary shall require 

the responsible person to periodically report to the 

Secretary on the status of such clinical trial including 

whether enrollment has begun, the number of participants enrolled, the expected completion date, whether 

any difficulties completing the clinical trial have been 

encountered, and registration information with respect 

to the requirements under section 402(j) of the Public 

Health Service Act. If the responsible person fails to 

comply with such timetable or violates any other 

requirement of this subparagraph, the responsible person shall be considered in violation of this subsection, 

unless the responsible person demonstrates good cause 

for such noncompliance or such other violation. The 

Secretary shall determine what constitutes good cause 

under the preceding sentence. 

‘‘(F) DISPUTE RESOLUTION.—The responsible person 

may appeal a requirement to conduct a study or clinical 

trial under this paragraph using dispute resolution procedures established by the Secretary in regulation and guidance. 

‘‘(4) SAFETY LABELING CHANGES REQUESTED BY SECRETARY.— 

‘‘(A) NEW SAFETY INFORMATION.—If the Secretary 

becomes aware of new safety information that the Secretary 

believes should be included in the labeling of the drug, 

the Secretary shall promptly notify the responsible person 

or, if the same drug approved under section 505(b) is not 

currently marketed, the holder of an approved application 

under 505(j). 

‘‘(B) RESPONSE TO NOTIFICATION.—Following notification pursuant to subparagraph (A), the responsible person 

or the holder of the approved application under section 

505(j) shall within 30 days— 

‘‘(i) submit a supplement proposing changes to the 

approved labeling to reflect the new safety information, 

Notification. 

Deadlines. 


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including changes to boxed warnings, contraindications, warnings, precautions, or adverse reactions; or 

‘‘(ii) notify the Secretary that the responsible person or the holder of the approved application under 

section 505(j) does not believe a labeling change is 

warranted and submit a statement detailing the reasons why such a change is not warranted. 

‘‘(C) REVIEW.—Upon receipt of such supplement, the 

Secretary shall promptly review and act upon such supplement. If the Secretary disagrees with the proposed changes 

in the supplement or with the statement setting forth 

the reasons why no labeling change is necessary, the Secretary shall initiate discussions to reach agreement on 

whether the labeling for the drug should be modified to 

reflect the new safety information, and if so, the contents 

of such labeling changes. 

‘‘(D) DISCUSSIONS.—Such discussions shall not extend 

for more than 30 days after the response to the notification 

under subparagraph (B), unless the Secretary determines 

an extension of such discussion period is warranted. 

‘‘(E) ORDER.—Within 15 days of the conclusion of the 

discussions under subparagraph (D), the Secretary may 

issue an order directing the responsible person or the holder 

of the approved application under section 505(j) to make 

such a labeling change as the Secretary deems appropriate 

to address the new safety information. Within 15 days 

of such an order, the responsible person or the holder 

of the approved application under section 505(j) shall 

submit a supplement containing the labeling change. 

‘‘(F) DISPUTE RESOLUTION.—Within 5 days of receiving 

an order under subparagraph (E), the responsible person 

or the holder of the approved application under section 

505(j) may appeal using dispute resolution procedures 

established by the Secretary in regulation and guidance. 

‘‘(G) VIOLATION.—If the responsible person or the 

holder of the approved application under section 505(j) 

has not submitted a supplement within 15 days of the 

date of such order under subparagraph (E), and there is 

no appeal or dispute resolution proceeding pending, the 

responsible person or holder shall be considered to be in 

violation of this subsection. If at the conclusion of any 

dispute resolution procedures the Secretary determines 

that a supplement must be submitted and such a supplement is not submitted within 15 days of the date of that 

determination, the responsible person or holder shall be 

in violation of this subsection. 

‘‘(H) PUBLIC HEALTH THREAT.—Notwithstanding subparagraphs (A) through (F), if the Secretary concludes that 

such a labeling change is necessary to protect the public 

health, the Secretary may accelerate the timelines in such 

subparagraphs. 

‘‘(I) RULE OF CONSTRUCTION.—This paragraph shall not 

be construed to affect the responsibility of the responsible 

person or the holder of the approved application under 

section 505(j) to maintain its label in accordance with 

existing requirements, including subpart B of part 201 

Notification. 


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121 STAT. 926 PUBLIC LAW 110–85—SEPT. 27, 2007 

and sections 314.70 and 601.12 of title 21, Code of Federal 

Regulations (or any successor regulations). 

‘‘(5) NON-DELEGATION.—Determinations by the Secretary 

under this subsection for a drug shall be made by individuals 

at or above the level of individuals empowered to approve 

a drug (such as division directors within the Center for Drug 

Evaluation and Research). 

‘‘(p) RISK EVALUATION AND MITIGATION STRATEGY.— 

‘‘(1) IN GENERAL.—A person may not introduce or deliver 

for introduction into interstate commerce a new drug if— 

‘‘(A)(i) the application for such drug is approved under 

subsection (b) or (j) and is subject to section 503(b); or 

‘‘(ii) the application for such drug is approved under 

section 351 of the Public Health Service Act; and 

‘‘(B) a risk evaluation and mitigation strategy is 

required under section 505–1 with respect to the drug 

and the person fails to maintain compliance with the 

requirements of the approved strategy or with other 

requirements under section 505–1, including requirements 

regarding assessments of approved strategies. 

‘‘(2) CERTAIN POSTMARKET STUDIES.—The failure to conduct 

a postmarket study under section 506, subpart H of part 314, 

or subpart E of part 601 of title 21, Code of Federal Regulations 

(or any successor regulations), is deemed to be a violation 

of paragraph (1).’’. 

(b) REQUIREMENTS REGARDING STRATEGIES.—Chapter V of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) 

is amended by inserting after section 505 the following section: 

‘‘SEC. 505–1. RISK EVALUATION AND MITIGATION STRATEGIES. 

‘‘(a) SUBMISSION OF PROPOSED STRATEGY.— 

‘‘(1) INITIAL APPROVAL.—If the Secretary, in consultation 

with the office responsible for reviewing the drug and the 

office responsible for postapproval safety with respect to the 

drug, determines that a risk evaluation and mitigation strategy 

is necessary to ensure that the benefits of the drug outweigh 

the risks of the drug, and informs the person who submits 

such application of such determination, then such person shall 

submit to the Secretary as part of such application a proposed 

risk evaluation and mitigation strategy. In making such a 

determination, the Secretary shall consider the following factors: 

‘‘(A) The estimated size of the population likely to 

use the drug involved. 

‘‘(B) The seriousness of the disease or condition that 

is to be treated with the drug. 

‘‘(C) The expected benefit of the drug with respect 

to such disease or condition. 

‘‘(D) The expected or actual duration of treatment with 

the drug. 

‘‘(E) The seriousness of any known or potential adverse 

events that may be related to the drug and the background 

incidence of such events in the population likely to use 

the drug. 

‘‘(F) Whether the drug is a new molecular entity. 

‘‘(2) POSTAPPROVAL REQUIREMENT.— 

21 USC 355–1. 


jbridges on GSDDPC57 with PUBLIC LAWS
PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 927 

‘‘(A) IN GENERAL.—If the Secretary has approved a 

covered application (including an application approved 

before the effective date of this section) and did not when 

approving the application require a risk evaluation and 

mitigation strategy under paragraph (1), the Secretary, 

in consultation with the offices described in paragraph 

(1), may subsequently require such a strategy for the drug 

involved (including when acting on a supplemental application seeking approval of a new indication for use of the 

drug) if the Secretary becomes aware of new safety information and makes a determination that such a strategy is 

necessary to ensure that the benefits of the drug outweigh 

the risks of the drug. 

‘‘(B) SUBMISSION OF PROPOSED STRATEGY.—Not later 

than 120 days after the Secretary notifies the holder of 

an approved covered application that the Secretary has 

made a determination under subparagraph (A) with respect 

to the drug involved, or within such other reasonable time 

as the Secretary requires to protect the public health, the 

holder shall submit to the Secretary a proposed risk evaluation and mitigation strategy. 

‘‘(3) ABBREVIATED NEW DRUG APPLICATIONS.—The applicability of this section to an application under section 505(j) 

is subject to subsection (i). 

‘‘(4) NON-DELEGATION.—Determinations by the Secretary 

under this subsection for a drug shall be made by individuals 

at or above the level of individuals empowered to approve 

a drug (such as division directors within the Center for Drug 

Evaluation and Research). 

‘‘(b) DEFINITIONS.—For purposes of this section: 

‘‘(1) ADVERSE DRUG EXPERIENCE.—The term ‘adverse drug 

experience’ means any adverse event associated with the use 

of a drug in humans, whether or not considered drug related, 

including— 

‘‘(A) an adverse event occurring in the course of the 

use of the drug in professional practice; 

‘‘(B) an adverse event occurring from an overdose of 

the drug, whether accidental or intentional; 

‘‘(C) an adverse event occurring from abuse of the 

drug; 

‘‘(D) an adverse event occurring from withdrawal of 

the drug; and 

‘‘(E) any failure of expected pharmacological action of 

the drug. 

‘‘(2) COVERED APPLICATION.—The term ‘covered application’ 

means an application referred to in section 505(p)(1)(A). 

‘‘(3) NEW SAFETY INFORMATION.—The term ‘new safety 

information’, with respect to a drug, means information derived 

from a clinical trial, an adverse event report, a postapproval 

study (including a study under section 505(o)(3)), or peerreviewed biomedical literature; data derived from the 

postmarket risk identification and analysis system under section 505(k); or other scientific data deemed appropriate by 

the Secretary about— 

‘‘(A) a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become 

aware of (that may be based on a new analysis of existing 

Applicability. 

Deadline. 

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information) since the drug was approved, since the risk 

evaluation and mitigation strategy was required, or since 

the last assessment of the approved risk evaluation and 

mitigation strategy for the drug; or 

‘‘(B) the effectiveness of the approved risk evaluation 

and mitigation strategy for the drug obtained since the 

last assessment of such strategy. 

‘‘(4) SERIOUS ADVERSE DRUG EXPERIENCE.—The term 

‘serious adverse drug experience’ is an adverse drug experience 

that— 

‘‘(A) results in— 

‘‘(i) death; 

‘‘(ii) an adverse drug experience that places the 

patient at immediate risk of death from the adverse 

drug experience as it occurred (not including an 

adverse drug experience that might have caused death 

had it occurred in a more severe form); 

‘‘(iii) inpatient hospitalization or prolongation of 

existing hospitalization; 

‘‘(iv) a persistent or significant incapacity or 

substantial disruption of the ability to conduct normal 

life functions; or 

‘‘(v) a congenital anomaly or birth defect; or 

‘‘(B) based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical 

intervention to prevent an outcome described under 

subparagraph (A). 

‘‘(5) SERIOUS RISK.—The term ‘serious risk’ means a risk 

of a serious adverse drug experience. 

‘‘(6) SIGNAL OF A SERIOUS RISK.—The term ‘signal of a 

serious risk’ means information related to a serious adverse 

drug experience associated with use of a drug and derived 

from— 

‘‘(A) a clinical trial; 

‘‘(B) adverse event reports; 

‘‘(C) a postapproval study, including a study under 

section 505(o)(3); 

‘‘(D) peer-reviewed biomedical literature; 

‘‘(E) data derived from the postmarket risk identification and analysis system under section 505(k)(4); or 

‘‘(F) other scientific data deemed appropriate by the 

Secretary. 

‘‘(7) RESPONSIBLE PERSON.—The term ‘responsible person’ 

means the person submitting a covered application or the holder 

of the approved such application. 

‘‘(8) UNEXPECTED SERIOUS RISK.—The term ‘unexpected 

serious risk’ means a serious adverse drug experience that 

is not listed in the labeling of a drug, or that may be symptomatically and pathophysiologically related to an adverse drug 

experience identified in the labeling, but differs from such 

adverse drug experience because of greater severity, specificity, 

or prevalence. 

‘‘(c) CONTENTS.—A proposed risk evaluation and mitigation 

strategy under subsection (a) shall— 

‘‘(1) include the timetable required under subsection (d); 

and 


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‘‘(2) to the extent required by the Secretary, in consultation 

with the office responsible for reviewing the drug and the 

office responsible for postapproval safety with respect to the 

drug, include additional elements described in subsections (e) 

and (f). 

‘‘(d) MINIMAL STRATEGY.—For purposes of subsection (c)(1), the 

risk evaluation and mitigation strategy for a drug shall require 

a timetable for submission of assessments of the strategy that— 

‘‘(1) includes an assessment, by the date that is 18 months 

after the strategy is initially approved; 

‘‘(2) includes an assessment by the date that is 3 years 

after the strategy is initially approved; 

‘‘(3) includes an assessment in the seventh year after the 

strategy is so approved; and 

‘‘(4) subject to paragraphs (1), (2), and (3)— 

‘‘(A) is at a frequency specified in the strategy; 

‘‘(B) is increased or reduced in frequency as necessary 

as provided for in subsection (g)(4)(A); and 

‘‘(C) is eliminated after the 3-year period described 

in paragraph (1) if the Secretary determines that serious 

risks of the drug have been adequately identified and 

assessed and are being adequately managed. 

‘‘(e) ADDITIONAL POTENTIAL ELEMENTS OF STRATEGY.— 

‘‘(1) IN GENERAL.—The Secretary, in consultation with the 

offices described in subsection (c)(2), may under such subsection 

require that the risk evaluation and mitigation strategy for 

a drug include 1 or more of the additional elements described 

in this subsection if the Secretary makes the determination 

required with respect to each element involved. 

‘‘(2) MEDICATION GUIDE; PATIENT PACKAGE INSERT.—The 

risk evaluation and mitigation strategy for a drug may require 

that, as applicable, the responsible person develop for distribution to each patient when the drug is dispensed— 

‘‘(A) a Medication Guide, as provided for under part 

208 of title 21, Code of Federal Regulations (or any successor regulations); and 

‘‘(B) a patient package insert, if the Secretary determines that such insert may help mitigate a serious risk 

of the drug. 

‘‘(3) COMMUNICATION PLAN.—The risk evaluation and mitigation strategy for a drug may require that the responsible 

person conduct a communication plan to health care providers, 

if, with respect to such drug, the Secretary determines that 

such plan may support implementation of an element of the 

strategy (including under this paragraph). Such plan may 

include— 

‘‘(A) sending letters to health care providers; 

‘‘(B) disseminating information about the elements of 

the risk evaluation and mitigation strategy to encourage 

implementation by health care providers of components 

that apply to such health care providers, or to explain 

certain safety protocols (such as medical monitoring by 

periodic laboratory tests); or 

‘‘(C) disseminating information to health care providers 

through professional societies about any serious risks of 

the drug and any protocol to assure safe use. 

Deadlines. 


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121 STAT. 930 PUBLIC LAW 110–85—SEPT. 27, 2007 

‘‘(f) PROVIDING SAFE ACCESS FOR PATIENTS TO DRUGS WITH

KNOWN SERIOUS RISKS THAT WOULD OTHERWISE BE UNAVAILABLE.— 

‘‘(1) ALLOWING SAFE ACCESS TO DRUGS WITH KNOWN SERIOUS

RISKS.—The Secretary, in consultation with the offices described 

in subsection (c)(2), may require that the risk evaluation and 

mitigation strategy for a drug include such elements as are 

necessary to assure safe use of the drug, because of its inherent 

toxicity or potential harmfulness, if the Secretary determines 

that— 

‘‘(A) the drug, which has been shown to be effective, 

but is associated with a serious adverse drug experience, 

can be approved only if, or would be withdrawn unless, 

such elements are required as part of such strategy to 

mitigate a specific serious risk listed in the labeling of 

the drug; and 

‘‘(B) for a drug initially approved without elements 

to assure safe use, other elements under subsections (c), 

(d), and (e) are not sufficient to mitigate such serious 

risk. 

‘‘(2) ASSURING ACCESS AND MINIMIZING BURDEN.—Such elements to assure safe use under paragraph (1) shall— 

‘‘(A) be commensurate with the specific serious risk 

listed in the labeling of the drug; 

‘‘(B) within 30 days of the date on which any element 

under paragraph (1) is imposed, be posted publicly by the 

Secretary with an explanation of how such elements will 

mitigate the observed safety risk; 

‘‘(C) considering such risk, not be unduly burdensome 

on patient access to the drug, considering in particular— 

‘‘(i) patients with serious or life-threatening diseases or conditions; and 

‘‘(ii) patients who have difficulty accessing health 

care (such as patients in rural or medically underserved areas); and 

‘‘(D) to the extent practicable, so as to minimize the 

burden on the health care delivery system— 

‘‘(i) conform with elements to assure safe use for 

other drugs with similar, serious risks; and 

‘‘(ii) be designed to be compatible with established 

distribution, procurement, and dispensing systems for 

drugs. 

‘‘(3) ELEMENTS TO ASSURE SAFE USE.—The elements to 

assure safe use under paragraph (1) shall include 1 or more 

goals to mitigate a specific serious risk listed in the labeling 

of the drug and, to mitigate such risk, may require that— 

‘‘(A) health care providers who prescribe the drug have 

particular training or experience, or are specially certified 

(the opportunity to obtain such training or certification 

with respect to the drug shall be available to any willing 

provider from a frontier area in a widely available training 

or certification method (including an on-line course or via 

mail) as approved by the Secretary at reasonable cost to 

the provider); 

Deadline. 


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‘‘(B) pharmacies, practitioners, or health care settings 

that dispense the drug are specially certified (the opportunity to obtain such certification shall be available to 

any willing provider from a frontier area); 

‘‘(C) the drug be dispensed to patients only in certain 

health care settings, such as hospitals; 

‘‘(D) the drug be dispensed to patients with evidence 

or other documentation of safe-use conditions, such as laboratory test results; 

‘‘(E) each patient using the drug be subject to certain 

monitoring; or 

‘‘(F) each patient using the drug be enrolled in a registry. 

‘‘(4) IMPLEMENTATION SYSTEM.—The elements to assure safe 

use under paragraph (1) that are described in subparagraphs 

(B), (C), and (D) of paragraph (3) may include a system through 

which the applicant is able to take reasonable steps to— 

‘‘(A) monitor and evaluate implementation of such elements by health care providers, pharmacists, and other 

parties in the health care system who are responsible for 

implementing such elements; and 

‘‘(B) work to improve implementation of such elements 

by such persons. 

‘‘(5) EVALUATION OF ELEMENTS TO ASSURE SAFE USE.—The 

Secretary, through the Drug Safety and Risk Management 

Advisory Committee (or successor committee) of the Food and 

Drug Administration, shall— 

‘‘(A) seek input from patients, physicians, pharmacists, 

and other health care providers about how elements to 

assure safe use under this subsection for 1 or more drugs 

may be standardized so as not to be— 

‘‘(i) unduly burdensome on patient access to the 

drug; and 

‘‘(ii) to the extent practicable, minimize the burden 

on the health care delivery system; 

‘‘(B) at least annually, evaluate, for 1 or more drugs, 

the elements to assure safe use of such drug to assess 

whether the elements— 

‘‘(i) assure safe use of the drug; 

‘‘(ii) are not unduly burdensome on patient access 

to the drug; and 

‘‘(iii) to the extent practicable, minimize the burden 

on the health care delivery system; and 

‘‘(C) considering such input and evaluations— 

‘‘(i) issue or modify agency guidance about how 

to implement the requirements of this subsection; and 

‘‘(ii) modify elements under this subsection for 1 

or more drugs as appropriate. 

‘‘(6) ADDITIONAL MECHANISMS TO ASSURE ACCESS.—The 

mechanisms under section 561 to provide for expanded access 

for patients with serious or life-threatening diseases or conditions may be used to provide access for patients with a serious 

or life-threatening disease or condition, the treatment of which 

is not an approved use for the drug, to a drug that is subject 

to elements to assure safe use under this subsection. The Secretary shall promulgate regulations for how a physician may 

provide the drug under the mechanisms of section 561. 

Regulations. 


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121 STAT. 932 PUBLIC LAW 110–85—SEPT. 27, 2007 

‘‘(7) WAIVER IN PUBLIC HEALTH EMERGENCIES.—The Secretary may waive any requirement of this subsection during 

the period described in section 319(a) of the Public Health 

Service Act with respect to a qualified countermeasure 

described under section 319F–1(a)(2) of such Act, to which 

a requirement under this subsection has been applied, if the 

Secretary has— 

‘‘(A) declared a public health emergency under such 

section 319; and 

‘‘(B) determined that such waiver is required to mitigate the effects of, or reduce the severity of, such public 

health emergency. 

‘‘(8) LIMITATION.—No holder of an approved covered 

application shall use any element to assure safe use required 

by the Secretary under this subsection to block or delay 

approval of an application under section 505(b)(2) or (j) or 

to prevent application of such element under subsection (i)(1)(B) 

to a drug that is the subject of an abbreviated new drug 

application. 

‘‘(g) ASSESSMENT AND MODIFICATION OF APPROVED STRATEGY.— 

‘‘(1) VOLUNTARY ASSESSMENTS.—After the approval of a 

risk evaluation and mitigation strategy under subsection (a), 

the responsible person involved may, subject to paragraph (2), 

submit to the Secretary an assessment of, and propose a modification to, the approved strategy for the drug involved at 

any time. 

‘‘(2) REQUIRED ASSESSMENTS.—A responsible person shall, 

subject to paragraph (5), submit an assessment of, and may 

propose a modification to, the approved risk evaluation and 

mitigation strategy for a drug— 

‘‘(A) when submitting a supplemental application for 

a new indication for use under section 505(b) or under 

section 351 of the Public Health Service Act, unless the 

drug is not subject to section 503(b) and the risk evaluation 

and mitigation strategy for the drug includes only the 

timetable under subsection (d); 

‘‘(B) when required by the strategy, as provided for 

in such timetable under subsection (d); 

‘‘(C) within a time period to be determined by the 

Secretary, if the Secretary, in consultation with the offices 

described in subsection (c)(2), determines that new safety 

or effectiveness information indicates that— 

‘‘(i) an element under subsection (d) or (e) should 

be modified or included in the strategy; or 

‘‘(ii) an element under subsection (f) should be 

modified or included in the strategy; or 

‘‘(D) within 15 days when ordered by the Secretary, 

in consultation with the offices described in subsection 

(c)(2), if the Secretary determines that there may be a 

cause for action by the Secretary under section 505(e). 

‘‘(3) REQUIREMENTS FOR ASSESSMENTS.—An assessment 

under paragraph (1) or (2) of an approved risk evaluation 

and mitigation strategy for a drug shall include— 

‘‘(A) with respect to any goal under subsection (f), 

an assessment of the extent to which the elements to 

assure safe use are meeting the goal or whether the goal 

or such elements should be modified; 

Deadline. 


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‘‘(B) with respect to any postapproval study required 

under section 505(o) or otherwise undertaken by the 

responsible person to investigate a safety issue, the status 

of such study, including whether any difficulties completing 

the study have been encountered; and 

‘‘(C) with respect to any postapproval clinical trial 

required under section 505(o) or otherwise undertaken by 

the responsible party to investigate a safety issue, the 

status of such clinical trial, including whether enrollment 

has begun, the number of participants enrolled, the 

expected completion date, whether any difficulties completing the clinical trial have been encountered, and registration information with respect to requirements under 

subsections (i) and (j) of section 402 of the Public Health 

Service Act. 

‘‘(4) MODIFICATION.—A modification (whether an enhancement or a reduction) to the approved risk evaluation and mitigation strategy for a drug may include the addition or modification 

of any element under subsection (d) or the addition, modification, or removal of any element under subsection (e) or (f), 

such as— 

‘‘(A) modifying the timetable for assessments of the 

strategy as provided in subsection (d)(3), including to eliminate assessments; or 

‘‘(B) adding, modifying, or removing an element to 

assure safe use under subsection (f). 

‘‘(h) REVIEW OF PROPOSED STRATEGIES; REVIEW OF ASSESSMENTS OF APPROVED STRATEGIES.— 

‘‘(1) IN GENERAL.—The Secretary, in consultation with the 

offices described in subsection (c)(2), shall promptly review 

each proposed risk evaluation and mitigation strategy for a 

drug submitted under subsection (a) and each assessment of 

an approved risk evaluation and mitigation strategy for a drug 

submitted under subsection (g). 

‘‘(2) DISCUSSION.—The Secretary, in consultation with the 

offices described in subsection (c)(2), shall initiate discussions 

with the responsible person for purposes of this subsection 

to determine a strategy not later than 60 days after any such 

assessment is submitted or, in the case of an assessment submitted under subsection (g)(2)(D), not later than 30 days after 

such assessment is submitted. 

‘‘(3) ACTION.— 

‘‘(A) IN GENERAL.—Unless the dispute resolution 

process described under paragraph (4) or (5) applies, the 

Secretary, in consultation with the offices described in subsection (c)(2), shall describe any required risk evaluation 

and mitigation strategy for a drug, or any modification 

to any required strategy— 

‘‘(i) as part of the action letter on the application, 

when a proposed strategy is submitted under subsection (a) or a modification to the strategy is proposed 

as part of an assessment of the strategy submitted 

under subsection (g)(1); or 

‘‘(ii) in an order issued not later than 90 days 

after the date discussions of such modification begin 

under paragraph (2), when a modification to the 

strategy is proposed as part of an assessment of the 

Deadline. 

Deadlines. 


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121 STAT. 934 PUBLIC LAW 110–85—SEPT. 27, 2007 

strategy submitted under subsection (g)(1) or under 

any of subparagraphs (B) through (D) of subsection 

(g)(2). 

‘‘(B) INACTION.—An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary 

acts, if the Secretary fails to act as provided under subparagraph (A). 

‘‘(C) PUBLIC AVAILABILITY.—Any action letter described 

in subparagraph (A)(i) or order described in subparagraph 

(A)(ii) shall be made publicly available. 

‘‘(4) DISPUTE RESOLUTION AT INITIAL APPROVAL.—If a proposed risk evaluation and mitigation strategy is submitted 

under subsection (a)(1) in an application for initial approval 

of a drug and there is a dispute about the strategy, the responsible person shall use the major dispute resolution procedures 

as set forth in the letters described in section 101(c) of the 

Food and Drug Administration Amendments Act of 2007. 

‘‘(5) DISPUTE RESOLUTION IN ALL OTHER CASES.— 

‘‘(A) REQUEST FOR REVIEW.— 

‘‘(i) IN GENERAL.—Not earlier than 15 days, and 

not later than 35 days, after discussions under paragraph (2) have begun, the responsible person may 

request in writing that a dispute about the strategy 

be reviewed by the Drug Safety Oversight Board under 

subsection (j), except that the determination of the 

Secretary to require a risk evaluation and mitigation 

strategy is not subject to review under this paragraph. 

The preceding sentence does not prohibit review under 

this paragraph of the particular elements of such a 

strategy. 

‘‘(ii) SCHEDULING.—Upon receipt of a request under 

clause (i), the Secretary shall schedule the dispute 

involved for review under subparagraph (B) and, not 

later than 5 business days of scheduling the dispute 

for review, shall publish by posting on the Internet 

or otherwise a notice that the dispute will be reviewed 

by the Drug Safety Oversight Board. 

‘‘(B) SCHEDULING REVIEW.—If a responsible person 

requests review under subparagraph (A), the Secretary— 

‘‘(i) shall schedule the dispute for review at 1 of 

the next 2 regular meetings of the Drug Safety Oversight Board, whichever meeting date is more practicable; or 

‘‘(ii) may convene a special meeting of the Drug 

Safety Oversight Board to review the matter more 

promptly, including to meet an action deadline on an 

application (including a supplemental application). 

‘‘(C) AGREEMENT AFTER DISCUSSION OR ADMINISTRATIVE

APPEALS.— 

‘‘(i) FURTHER DISCUSSION OR ADMINISTRATIVE

APPEALS.—A request for review under subparagraph 

(A) shall not preclude further discussions to reach 

agreement on the risk evaluation and mitigation 

strategy, and such a request shall not preclude the 

use of administrative appeals within the Food and 

Drug Administration to reach agreement on the 

strategy, including appeals as described in the letters 

Deadlines. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 935 

described in section 101(c) of the Food and Drug 

Administration Amendments Act of 2007 for procedural 

or scientific matters involving the review of human 

drug applications and supplemental applications that 

cannot be resolved at the divisional level. At the time 

a review has been scheduled under subparagraph (B) 

and notice of such review has been posted, the responsible person shall either withdraw the request under 

subparagraph (A) or terminate the use of such administrative appeals. 

‘‘(ii) AGREEMENT TERMINATES DISPUTE RESOLUTION.—At any time before a decision and order is issued 

under subparagraph (G) , the Secretary (in consultation 

with the offices described in subsection (c)(2)) and the 

responsible person may reach an agreement on the 

risk evaluation and mitigation strategy through further 

discussion or administrative appeals, terminating the 

dispute resolution process, and the Secretary shall 

issue an action letter or order, as appropriate, that 

describes the strategy. 

‘‘(D) MEETING OF THE BOARD.—At a meeting of the 

Drug Safety Oversight Board described in subparagraph 

(B), the Board shall— 

‘‘(i) hear from both parties via written or oral 

presentation; and 

‘‘(ii) review the dispute. 

‘‘(E) RECORD OF PROCEEDINGS.—The Secretary shall 

ensure that the proceedings of any such meeting are 

recorded, transcribed, and made public within 90 days of 

the meeting. The Secretary shall redact the transcript to 

protect any trade secrets and other information that is 

exempted from disclosure under section 552 of title 5, 

United States Code, or section 552a of title 5, United 

States Code. 

‘‘(F) RECOMMENDATION OF THE BOARD.—Not later than 

5 days after any such meeting, the Drug Safety Oversight 

Board shall provide a written recommendation on resolving 

the dispute to the Secretary. Not later than 5 days after 

the Board provides such written recommendation to the 

Secretary, the Secretary shall make the recommendation 

available to the public. 

‘‘(G) ACTION BY THE SECRETARY.— 

‘‘(i) ACTION LETTER.—With respect to a proposal 

or assessment referred to in paragraph (1), the Secretary shall issue an action letter that resolves the 

dispute not later than the later of— 

‘‘(I) the action deadline for the action letter 

on the application; or 

‘‘(II) 7 days after receiving the recommendation of the Drug Safety Oversight Board. 

‘‘(ii) ORDER.—With respect to an assessment of 

an approved risk evaluation and mitigation strategy 

under subsection (g)(1) or under any of subparagraphs 

(B) through (D) of subsection (g)(2), the Secretary shall 

issue an order, which shall be made public, that 

resolves the dispute not later than 7 days after 

Deadlines. 

Deadlines. 

Public 

information. 

Public 

information. 

Deadline. 


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121 STAT. 936 PUBLIC LAW 110–85—SEPT. 27, 2007 

receiving the recommendation of the Drug Safety Oversight Board. 

‘‘(H) INACTION.—An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary 

acts, if the Secretary fails to act as provided for under 

subparagraph (G). 

‘‘(I) EFFECT ON ACTION DEADLINE.—With respect to a 

proposal or assessment referred to in paragraph (1), the 

Secretary shall be considered to have met the action deadline for the action letter on the application if the responsible 

person requests the dispute resolution process described 

in this paragraph and if the Secretary— 

‘‘(i) has initiated the discussions described under 

paragraph (2) not less than 60 days before such action 

deadline; and 

‘‘(ii) has complied with the timing requirements 

of scheduling review by the Drug Safety Oversight 

Board, providing a written recommendation, and 

issuing an action letter under subparagraphs (B), (F), 

and (G), respectively. 

‘‘(J) DISQUALIFICATION.—No individual who is an 

employee of the Food and Drug Administration and who 

reviews a drug or who participated in an administrative 

appeal under subparagraph (C)(i) with respect to such drug 

may serve on the Drug Safety Oversight Board at a meeting 

under subparagraph (D) to review a dispute about the 

risk evaluation and mitigation strategy for such drug. 

‘‘(K) ADDITIONAL EXPERTISE.—The Drug Safety Oversight Board may add members with relevant expertise 

from the Food and Drug Administration, including the 

Office of Pediatrics, the Office of Women’s Health, or the 

Office of Rare Diseases, or from other Federal public health 

or health care agencies, for a meeting under subparagraph 

(D) of the Drug Safety Oversight Board. 

‘‘(6) USE OF ADVISORY COMMITTEES.—The Secretary may 

convene a meeting of 1 or more advisory committees of the 

Food and Drug Administration to— 

‘‘(A) review a concern about the safety of a drug or 

class of drugs, including before an assessment of the risk 

evaluation and mitigation strategy or strategies of such 

drug or drugs is required to be submitted under any of 

subparagraphs (B) through (D) of subsection (g)(2); 

‘‘(B) review the risk evaluation and mitigation strategy 

or strategies of a drug or group of drugs; or 

‘‘(C) review a dispute under paragraph (4) or (5). 

‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS.— 

‘‘(A) IN GENERAL.—When a concern about a serious 

risk of a drug may be related to the pharmacological class 

of the drug, the Secretary, in consultation with the offices 

described in subsection (c)(2), may defer assessments of 

the approved risk evaluation and mitigation strategies for 

such drugs until the Secretary has convened 1 or more 

public meetings to consider possible responses to such concern. 

‘‘(B) NOTICE.—If the Secretary defers an assessment 

under subparagraph (A), the Secretary shall— 


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‘‘(i) give notice of the deferral to the holder of 

the approved covered application not later than 5 days 

after the deferral; 

‘‘(ii) publish the deferral in the Federal Register; 

and 

‘‘(iii) give notice to the public of any public 

meetings to be convened under subparagraph (A), 

including a description of the deferral. 

‘‘(C) PUBLIC MEETINGS.—Such public meetings may 

include— 

‘‘(i) 1 or more meetings of the responsible person 

for such drugs; 

‘‘(ii) 1 or more meetings of 1 or more advisory 

committees of the Food and Drug Administration, as 

provided for under paragraph (6); or 

‘‘(iii) 1 or more workshops of scientific experts and 

other stakeholders. 

‘‘(D) ACTION.—After considering the discussions from 

any meetings under subparagraph (A), the Secretary may— 

‘‘(i) announce in the Federal Register a planned 

regulatory action, including a modification to each risk 

evaluation and mitigation strategy, for drugs in the 

pharmacological class; 

‘‘(ii) seek public comment about such action; and 

‘‘(iii) after seeking such comment, issue an order 

addressing such regulatory action. 

‘‘(8) INTERNATIONAL COORDINATION.—The Secretary, in consultation with the offices described in subsection (c)(2), may 

coordinate the timetable for submission of assessments under 

subsection (d), or a study or clinical trial under section 505(o)(3), 

with efforts to identify and assess the serious risks of such 

drug by the marketing authorities of other countries whose 

drug approval and risk management processes the Secretary 

deems comparable to the drug approval and risk management 

processes of the United States. If the Secretary takes action 

to coordinate such timetable, the Secretary shall give notice 

to the responsible person. 

‘‘(9) EFFECT.—Use of the processes described in paragraphs 

(7) and (8) shall not be the sole source of delay of action 

on an application or a supplement to an application for a 

drug. 

‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— 

‘‘(1) IN GENERAL.—A drug that is the subject of an abbreviated new drug application under section 505(j) is subject 

to only the following elements of the risk evaluation and mitigation strategy required under subsection (a) for the applicable 

listed drug: 

‘‘(A) A Medication Guide or patient package insert, 

if required under subsection (e) for the applicable listed 

drug. 

‘‘(B) Elements to assure safe use, if required under 

subsection (f) for the listed drug. A drug that is the subject 

of an abbreviated new drug application and the listed drug 

shall use a single, shared system under subsection (f). 

The Secretary may waive the requirement under the preceding sentence for a drug that is the subject of an abbreviated new drug application, and permit the applicant to 

Public 

information. 

Federal Register, 

publication. 

Deadline. 


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121 STAT. 938 PUBLIC LAW 110–85—SEPT. 27, 2007 

use a different, comparable aspect of the elements to assure 

safe use, if the Secretary determines that— 

‘‘(i) the burden of creating a single, shared system 

outweighs the benefit of a single, system, taking into 

consideration the impact on health care providers, 

patients, the applicant for the abbreviated new drug 

application, and the holder of the reference drug 

product; or 

‘‘(ii) an aspect of the elements to assure safe use 

for the applicable listed drug is claimed by a patent 

that has not expired or is a method or process that, 

as a trade secret, is entitled to protection, and the 

applicant for the abbreviated new drug application certifies that it has sought a license for use of an aspect 

of the elements to assure safe use for the applicable 

listed drug and that it was unable to obtain a license. 

A certification under clause (ii) shall include a description 

of the efforts made by the applicant for the abbreviated 

new drug application to obtain a license. In a case described 

in clause (ii), the Secretary may seek to negotiate a voluntary agreement with the owner of the patent, method, 

or process for a license under which the applicant for 

such abbreviated new drug application may use an aspect 

of the elements to assure safe use, if required under subsection (f) for the applicable listed drug, that is claimed 

by a patent that has not expired or is a method or process 

that as a trade secret is entitled to protection. 

‘‘(2) ACTION BY SECRETARY.—For an applicable listed drug 

for which a drug is approved under section 505(j), the Secretary— 

‘‘(A) shall undertake any communication plan to health 

care providers required under subsection (e)(3) for the 

applicable listed drug; and 

‘‘(B) shall inform the responsible person for the drug 

that is so approved if the risk evaluation and mitigation 

strategy for the applicable listed drug is modified. 

‘‘(j) DRUG SAFETY OVERSIGHT BOARD.— 

‘‘(1) IN GENERAL.—There is established a Drug Safety Oversight Board. 

‘‘(2) COMPOSITION; MEETINGS.—The Drug Safety Oversight 

Board shall— 

‘‘(A) be composed of scientists and health care practitioners appointed by the Secretary, each of whom is an 

employee of the Federal Government; 

‘‘(B) include representatives from offices throughout 

the Food and Drug Administration, including the offices 

responsible for postapproval safety of drugs; 

‘‘(C) include at least 1 representative each from the 

National Institutes of Health and the Department of Health 

and Human Services (other than the Food and Drug 

Administration); 

‘‘(D) include such representatives as the Secretary shall 

designate from other appropriate agencies that wish to 

provide representatives; and 

‘‘(E) meet at least monthly to provide oversight and 

advice to the Secretary on the management of important 

drug safety issues.’’. 

Establishment. 


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(c) REGULATION OF BIOLOGICAL PRODUCTS.—Section 351 of the 

Public Health Service Act (42 U.S.C. 262) is amended— 

(1) in subsection (a)(2), by adding at the end the following: 

‘‘(D) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING; 

RISK EVALUATION AND MITIGATION STRATEGY.—A person that submits an application for a license under this paragraph is subject 

to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, 

and Cosmetic Act.’’; and 

(2) in subsection (j), by inserting ‘‘, including the requirements under sections 505(o), 505(p), and 505–1 of such Act,’’ 

after ‘‘, and Cosmetic Act’’. 

(d) ADVERTISEMENTS OF DRUGS.—The Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section 801(b), 

is amended— 

(1) in section 301 (21 U.S.C. 331), by adding at the end 

the following: 

‘‘(kk) The dissemination of a television advertisement without 

complying with section 503B.’’; and 

(2) by inserting after section 503A the following: 

‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS. 

‘‘(a) IN GENERAL.—The Secretary may require the submission 

of any television advertisement for a drug (including any script, 

story board, rough, or a completed video production of the television 

advertisement) to the Secretary for review under this section not 

later than 45 days before dissemination of the television advertisement. 

‘‘(b) REVIEW.—In conducting a review of a television advertisement under this section, the Secretary may make recommendations 

with respect to information included in the label of the drug— 

‘‘(1) on changes that are— 

‘‘(A) necessary to protect the consumer good and wellbeing; or 

‘‘(B) consistent with prescribing information for the 

product under review; and 

‘‘(2) if appropriate and if information exists, on statements 

for inclusion in the advertisement to address the specific efficacy of the drug as it relates to specific population groups, 

including elderly populations, children, and racial and ethnic 

minorities. 

‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided 

by subsection (e), this section does not authorize the Secretary 

to make or direct changes in any material submitted pursuant 

to subsection (a). 

‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY AND ETHNICALLY DIVERSE COMMUNITIES.—In formulating recommendations 

under subsection (b), the Secretary shall take into consideration 

the impact of the advertised drug on elderly populations, children, 

and racially and ethnically diverse communities. 

‘‘(e) SPECIFIC DISCLOSURES.— 

‘‘(1) SERIOUS RISK; SAFETY PROTOCOL.—In conducting a 

review of a television advertisement under this section, if the 

Secretary determines that the advertisement would be false 

or misleading without a specific disclosure about a serious 

risk listed in the labeling of the drug involved, the Secretary 

may require inclusion of such disclosure in the advertisement. 

Deadline. 

21 USC 353b. 


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‘‘(2) DATE OF APPROVAL.—In conducting a review of a television advertisement under this section, the Secretary may 

require the advertisement to include, for a period not to exceed 

2 years from the date of the approval of the drug under section 

505 or section 351 of the Public Health Service Act, a specific 

disclosure of such date of approval if the Secretary determines 

that the advertisement would otherwise be false or misleading. 

‘‘(f) RULE OF CONSTRUCTION.—Nothing in this section may be 

construed as having any effect on requirements under section 502(n) 

or on the authority of the Secretary under section 314.550, 314.640, 

601.45, or 601.94 of title 21, Code of Federal Regulations (or successor regulations).’’. 

(3) DIRECT-TO-CONSUMER ADVERTISEMENTS.— 

(A) IN GENERAL.—Section 502(n) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended 

by adding at the end the following: ‘‘In the case of an 

advertisement for a drug subject to section 503(b)(1) presented directly to consumers in television or radio format 

and stating the name of the drug and its conditions of 

use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and 

neutral manner.’’. 

(B) REGULATIONS TO DETERMINE CLEAR, CONSPICUOUS, 

AND NEUTRAL MANNER.—Not later than 30 months after 

the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary of Health 

and Human Services shall by regulation establish standards for determining whether a major statement relating 

to side effects and contraindications of a drug, described 

in section 502(n) of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 352(n)) (as amended by subparagraph (A)) 

is presented in the manner required under such section. 

(4) CIVIL PENALTIES.—Section 303 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 333), as amended by section 

801(b), is amended by adding at the end the following: 

‘‘(g)(1) With respect to a person who is a holder of an approved 

application under section 505 for a drug subject to section 503(b) 

or under section 351 of the Public Health Service Act, any such 

person who disseminates or causes another party to disseminate 

a direct-to-consumer advertisement that is false or misleading shall 

be liable to the United States for a civil penalty in an amount 

not to exceed $250,000 for the first such violation in any 3-year 

period, and not to exceed $500,000 for each subsequent violation 

in any 3-year period. No other civil monetary penalties in this 

Act (including the civil penalty in section 303(f)(4)) shall apply 

to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same 

or similar advertisement prior to the receipt of the written notice 

referred to in paragraph (2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of 

such a notice, all violations under this paragraph occurring in 

a single day shall be considered one violation. With respect to 

advertisements that appear in magazines or other publications that 

are published less frequently than daily, each issue date (whether 

weekly or monthly) shall be treated as a single day for the purpose 

of calculating the number of violations under this paragraph. 

Deadline. 

21 USC 352 note. 


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‘‘(2) A civil penalty under paragraph (1) shall be assessed 

by the Secretary by an order made on the record after providing 

written notice to the person to be assessed a civil penalty and 

an opportunity for a hearing in accordance with this paragraph 

and section 554 of title 5, United States Code. If upon receipt 

of the written notice, the person to be assessed a civil penalty 

objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary may issue subpoenas 

requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, 

including information pertaining to the factors described in paragraph (3). 

‘‘(3) The Secretary, in determining the amount of the civil 

penalty under paragraph (1), shall take into account the nature, 

circumstances, extent, and gravity of the violation or violations, 

including the following factors: 

‘‘(A) Whether the person submitted the advertisement or 

a similar advertisement for review under section 736A. 

‘‘(B) Whether the person submitted the advertisement for 

review if required under section 503B. 

‘‘(C) Whether, after submission of the advertisement as 

described in subparagraph (A) or (B), the person disseminated 

or caused another party to disseminate the advertisement 

before the end of the 45-day comment period. 

‘‘(D) Whether the person incorporated any comments made 

by the Secretary with regard to the advertisement into the 

advertisement prior to its dissemination. 

‘‘(E) Whether the person ceased distribution of the 

advertisement upon receipt of the written notice referred to 

in paragraph (2) for such advertisement. 

‘‘(F) Whether the person had the advertisement reviewed 

by qualified medical, regulatory, and legal reviewers prior to 

its dissemination. 

‘‘(G) Whether the violations were material. 

‘‘(H) Whether the person who created the advertisement 

or caused the advertisement to be created acted in good faith. 

‘‘(I) Whether the person who created the advertisement 

or caused the advertisement to be created has been assessed 

a civil penalty under this provision within the previous 1- 

year period. 

‘‘(J) The scope and extent of any voluntary, subsequent 

remedial action by the person. 

‘‘(K) Such other matters, as justice may require. 

‘‘(4)(A) Subject to subparagraph (B), no person shall be required 

to pay a civil penalty under paragraph (1) if the person submitted 

the advertisement to the Secretary and disseminated or caused 

another party to disseminate such advertisement after incorporating 

each comment received from the Secretary. 

‘‘(B) The Secretary may retract or modify any prior comments 

the Secretary has provided to an advertisement submitted to the 

Secretary based on new information or changed circumstances, so 

long as the Secretary provides written notice to the person of 

the new views of the Secretary on the advertisement and provides 

a reasonable time for modification or correction of the advertisement 

prior to seeking any civil penalty under paragraph (1). 

‘‘(5) The Secretary may compromise, modify, or remit, with 

or without conditions, any civil penalty which may be assessed 

Public record. 

Notification. 


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121 STAT. 942 PUBLIC LAW 110–85—SEPT. 27, 2007 

under paragraph (1). The amount of such penalty, when finally 

determined, or the amount charged upon in compromise, may be 

deducted from any sums owed by the United States to the person 

charged. 

‘‘(6) Any person who requested, in accordance with paragraph 

(2), a hearing with respect to the assessment of a civil penalty 

and who is aggrieved by an order assessing a civil penalty, may 

file a petition for de novo 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 assessments 

was issued. 

‘‘(7) If any person fails to pay an assessment of a civil penalty 

under paragraph (1)— 

‘‘(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 (6), or 

‘‘(B) after a court in an action brought under paragraph 

(6) has entered a final judgment in favor of the Secretary, 

the Attorney General of the United States 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 

(6) 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.’’. 

(5) REPORT ON DIRECT-TO-CONSUMER ADVERTISING.—Not 

later than 24 months after the date of the enactment of this 

Act, the Secretary of Health and Human Services shall report 

to the Congress on direct-to-consumer advertising and its ability 

to communicate to subsets of the general population, including 

elderly populations, children, and racial and ethnic minority 

communities. The Secretary shall utilize the Advisory Committee on Risk Communication established under this Act to 

advise the Secretary with respect to such report. The Advisory 

Committee shall study direct-to-consumer advertising as it 

relates to increased access to health information and decreased 

health disparities for these populations. The report required 

by this paragraph shall recommend effective ways to present 

and disseminate information to these populations. Such report 

shall also make recommendations regarding impediments to 

the participation of elderly populations, children, racially and 

ethnically diverse communities, and medically underserved 

populations in clinical drug trials and shall recommend best 

practice approaches for increasing the inclusion of such subsets 

of the general population. The Secretary of Health and Human 

Services shall submit the report under this paragraph to the 

Committee on Health, Education, Labor, and Pensions of the 

Senate and the Committee on Energy and Commerce of the 

House of Representatives. 

(6) RULEMAKING.—Section 502(n) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by 

striking ‘‘the procedure specified in section 701(e) of this Act’’ 

and inserting ‘‘section 701(a)’’. 

(e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— This title and the amendments made by this title may not be 

21 USC 355a 

note. 

Deadline. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 943 

construed as affecting the authority of the Secretary of Health 

and Human Services to request pediatric studies under section 

505A of the Federal Food, Drug, and Cosmetic Act or to require 

such studies under section 505B of such Act. 

SEC. 902. ENFORCEMENT. 

(a) MISBRANDING.—Section 502 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 352) is amended by adding at the end 

the following: 

‘‘(y) If it is a drug subject to an approved risk evaluation 

and mitigation strategy pursuant to section 505(p) and the responsible person (as such term is used in section 505–1) fails to comply 

with a requirement of such strategy provided for under subsection 

(d), (e), or (f) of section 505–1. 

‘‘(z) If it is a drug, and the responsible person (as such term 

is used in section 505(o)) is in violation of a requirement established 

under paragraph (3) (relating to postmarket studies and clinical 

trials) or paragraph (4) (relating to labeling) of section 505(o) with 

respect to such drug.’’. 

(b) CIVIL PENALTIES.—Section 303(f) of the Federal Food, Drug, 

and Cosmetic Act, as amended by section 801(b), is amended— 

(1) by inserting after paragraph (3), as added by section 

801(b)(2), the following: 

‘‘(4)(A) Any responsible person (as such term is used in section 

505–1) that violates a requirement of section 505(o), 505(p), or 

505–1 shall be subject to a civil monetary penalty of— 

‘‘(i) not more than $250,000 per violation, and not to exceed 

$1,000,000 for all such violations adjudicated in a single proceeding; or 

‘‘(ii) in the case of a violation that continues after the 

Secretary provides written notice to the responsible person, 

the responsible person shall be subject to a civil monetary 

penalty of $250,000 for the first 30-day period (or any portion 

thereof) that the responsible person continues to be in violation, 

and such amount shall double for every 30-day period thereafter 

that the violation continues, not to exceed $1,000,000 for any 

30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. 

‘‘(B) In determining the amount of a civil penalty under 

subparagraph (A)(ii), the Secretary shall take into consideration 

whether the responsible person is making efforts toward correcting 

the violation of the requirement of section 505(o), 505(p), or 505– 

1 for which the responsible person is subject to such civil penalty.’’; 

and 

(2) in paragraph (5), as redesignated by section 801(b)(2)(A), 

by striking ‘‘paragraph (1), (2), or (3)’’ each place it appears 

and inserting ‘‘paragraph (1), (2), (3), or (4)’’. 

SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL. 

Section 505(e) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(e)) is amended by adding at the end the following: 

‘‘The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an 

application, as provided under this subsection, without first ordering 

the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under section 505– 

1(g)(2)(D).’’. 


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121 STAT. 944 PUBLIC LAW 110–85—SEPT. 27, 2007 

SEC. 904. BENEFIT-RISK ASSESSMENTS. 

Not later than 1 year after the date of the enactment of this 

Act, the Commissioner of Food and Drugs shall submit to the 

Congress a report on how best to communicate to the public the 

risks and benefits of new drugs and the role of the risk evaluation 

and mitigation strategy in assessing such risks and benefits. As 

part of such study, the Commissioner may consider the possibility 

of including in the labeling and any direct-to-consumer 

advertisements of a newly approved drug or indication a unique 

symbol indicating the newly approved status of the drug or indication for a period after approval. 

SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS. 

(a) IN GENERAL.—Subsection (k) of section 505 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 

adding at the end the following: 

‘‘(3) ACTIVE POSTMARKET RISK IDENTIFICATION.— 

‘‘(A) DEFINITION.—In this paragraph, the term ‘data’ 

refers to information with respect to a drug approved under 

this section or under section 351 of the Public Health 

Service Act, including claims data, patient survey data, 

standardized analytic files that allow for the pooling and 

analysis of data from disparate data environments, and 

any other data deemed appropriate by the Secretary. 

‘‘(B) DEVELOPMENT OF POSTMARKET RISK IDENTIFICATION AND ANALYSIS METHODS.—The Secretary shall, not 

later than 2 years after the date of the enactment of 

the Food and Drug Administration Amendments Act of 

2007, in collaboration with public, academic, and private 

entities— 

‘‘(i) develop methods to obtain access to disparate 

data sources including the data sources specified in 

subparagraph (C); 

‘‘(ii) develop validated methods for the establishment of a postmarket risk identification and analysis 

system to link and analyze safety data from multiple 

sources, with the goals of including, in aggregate— 

‘‘(I) at least 25,000,000 patients by July 1, 

2010; and 

‘‘(II) at least 100,000,000 patients by July 1, 

2012; and 

‘‘(iii) convene a committee of experts, including 

individuals who are recognized in the field of protecting 

data privacy and security, to make recommendations 

to the Secretary on the development of tools and 

methods for the ethical and scientific uses for, and 

communication of, postmarketing data specified under 

subparagraph (C), including recommendations on the 

development of effective research methods for the study 

of drug safety questions. 

‘‘(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTIFICATION AND ANALYSIS SYSTEM.— 

‘‘(i) IN GENERAL.—The Secretary shall, not later 

than 1 year after the development of the risk identification and analysis methods under subparagraph (B), 

establish and maintain procedures— 

Deadline. 

Procedures. 

Committee. 

Deadline. 

Deadline. 

Reports. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 945 

‘‘(I) for risk identification and analysis based 

on electronic health data, in compliance with the 

regulations promulgated under section 264(c) of 

the Health Insurance Portability and Accountability Act of 1996, and in a manner that does 

not disclose individually identifiable health 

information in violation of paragraph (4)(B); 

‘‘(II) for the reporting (in a standardized form) 

of data on all serious adverse drug experiences 

(as defined in section 505–1(b)) submitted to the 

Secretary under paragraph (1), and those adverse 

events submitted by patients, providers, and drug 

sponsors, when appropriate; 

‘‘(III) to provide for active adverse event 

surveillance using the following data sources, as 

available: 

‘‘(aa) Federal health-related electronic 

data (such as data from the Medicare program 

and the health systems of the Department 

of Veterans Affairs); 

‘‘(bb) private sector health-related electronic data (such as pharmaceutical purchase 

data and health insurance claims data); and 

‘‘(cc) other data as the Secretary deems 

necessary to create a robust system to identify 

adverse events and potential drug safety signals; 

‘‘(IV) to identify certain trends and patterns 

with respect to data accessed by the system; 

‘‘(V) to provide regular reports to the Secretary 

concerning adverse event trends, adverse event 

patterns, incidence and prevalence of adverse 

events, and other information the Secretary determines appropriate, which may include data on 

comparative national adverse event trends; and 

‘‘(VI) to enable the program to export data 

in a form appropriate for further aggregation, 

statistical analysis, and reporting. 

‘‘(ii) TIMELINESS OF REPORTING.—The procedures 

established under clause (i) shall ensure that such 

data are accessed, analyzed, and reported in a timely, 

routine, and systematic manner, taking into consideration the need for data completeness, coding, cleansing, 

and standardized analysis and transmission. 

‘‘(iii) PRIVATE SECTOR RESOURCES.—To ensure the 

establishment of the active postmarket risk identification and analysis system under this subsection not 

later than 1 year after the development of the risk 

identification and analysis methods under subparagraph (B), as required under clause (i), the Secretary 

may, on a temporary or permanent basis, implement 

systems or products developed by private entities. 

‘‘(iv) COMPLEMENTARY APPROACHES.—To the extent 

the active postmarket risk identification and analysis 

system under this subsection is not sufficient to gather 

data and information relevant to a priority drug safety 

question, the Secretary shall develop, support, and 

Deadline. 

Reports. 


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121 STAT. 946 PUBLIC LAW 110–85—SEPT. 27, 2007 

participate in complementary approaches to gather and 

analyze such data and information, including— 

‘‘(I) approaches that are complementary with 

respect to assessing the safety of use of a drug 

in domestic populations not included, or underrepresented, in the trials used to approve the drug 

(such as older people, people with comorbidities, 

pregnant women, or children); and 

‘‘(II) existing approaches such as the Vaccine 

Adverse Event Reporting System and the Vaccine 

Safety Datalink or successor databases. 

‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary 

may enter into contracts with public and private entities to fulfill the requirements of this subparagraph. 

‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.— 

‘‘(A) PURPOSE.—The Secretary shall establish collaborations with public, academic, and private entities, which 

may include the Centers for Education and Research on 

Therapeutics under section 912 of the Public Health Service 

Act, to provide for advanced analysis of drug safety data 

described in paragraph (3)(C) and other information that 

is publicly available or is provided by the Secretary, in 

order to— 

‘‘(i) improve the quality and efficiency of 

postmarket drug safety risk-benefit analysis; 

‘‘(ii) provide the Secretary with routine access to 

outside expertise to study advanced drug safety questions; and 

‘‘(iii) enhance the ability of the Secretary to make 

timely assessments based on drug safety data. 

‘‘(B) PRIVACY.—Such analysis shall not disclose individually identifiable health information when presenting such 

drug safety signals and trends or when responding to 

inquiries regarding such drug safety signals and trends. 

‘‘(C) PUBLIC PROCESS FOR PRIORITY QUESTIONS.—At 

least biannually, the Secretary shall seek recommendations 

from the Drug Safety and Risk Management Advisory Committee (or any successor committee) and from other 

advisory committees, as appropriate, to the Food and Drug 

Administration on— 

‘‘(i) priority drug safety questions; and 

‘‘(ii) mechanisms for answering such questions, 

including through— 

‘‘(I) active risk identification under paragraph 

(3); and 

‘‘(II) when such risk identification is not sufficient, postapproval studies and clinical trials under 

subsection (o)(3). 

‘‘(D) PROCEDURES FOR THE DEVELOPMENT OF DRUG

SAFETY COLLABORATIONS.— 

‘‘(i) IN GENERAL.—Not later than 180 days after 

the date of the establishment of the active postmarket 

risk identification and analysis system under this subsection, the Secretary shall establish and implement 

procedures under which the Secretary may routinely 

contract with one or more qualified entities to— 

Deadline. 


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PUBLIC LAW 110–85—SEPT. 27, 2007 121 STAT. 947 

‘‘(I) classify, analyze, or aggregate data 

described in paragraph (3)(C) and information that 

is publicly available or is provided by the Secretary; 

‘‘(II) allow for prompt investigation of priority 

drug safety questions, including— 

‘‘(aa) unresolved safety questions for drugs 

or classes of drugs; and 

‘‘(bb) for a newly-approved drugs, safety 

signals from clinical trials used to approve 

the drug and other preapproval trials; rare, 

serious drug side effects; and the safety of 

use in domestic populations not included, or 

underrepresented, in the trials used to approve 

the drug (such as older people, people with 

comorbidities, pregnant women, or children); 

‘‘(III) perform advanced research and analysis 

on identified drug safety risks; 

‘‘(IV) focus postapproval studies and clinical 

trials under subsection (o)(3) more effectively on 

cases for which reports under paragraph (1) and 

other safety signal detection is not sufficient to 

resolve whether there is an elevated risk of a 

serious adverse event associated with the use of 

a drug; and 

‘‘(V) carry out other activities as the Secretary 

deems necessary to carry out the purposes of this 

paragraph. 

‘‘(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The 

procedures described in clause (i) shall permit the Secretary to request that a specific methodology be used 

by the qualified entity. The qualified entity shall work 

with the Secretary to finalize the methodology to be 

used. 

‘‘(E) USE OF ANALYSES.—The Secretary shall provide 

the analyses described in this paragraph, including the 

methods and results of such analyses, about a drug to 

the sponsor or sponsors of such drug. 

‘‘(F) QUALIFIED ENTITIES.— 

‘‘(i) IN GENERAL.—The Secretary shall enter into 

contracts with a sufficient number of qualified entities 

to develop and provide information to the Secretary 

in a timely manner. 

‘‘(ii) QUALIFICATION.—The Secretary shall enter 

into a contract with an entity under clause (i) only 

if the Secretary determines that the entity has a 

significant presence in the United States and has one 

or more of the following qualifications: 

‘‘(I) The research, statistical, epidemiologic, or 

clinical capability and expertise to conduct and 

complete the activities under this paragraph, 

including the capability and expertise to provide 

the Secretary de-identified data consistent with 

the requirements of this subsection. 

‘‘(II) An information technology infrastructure 

in place to support electronic data and operational 

standards to provide security for such data. 

Contracts. 


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121 STAT. 948 PUBLIC LAW 110–85—SEPT. 27, 2007 

‘‘(III) Experience with, and expertise on, the 

development of drug safety and effectiveness 

research using electronic population data. 

‘‘(IV) An understanding of drug development 

or risk/benefit balancing in a clinical setting. 

‘‘(V) Other expertise which the Secretary 

deems necessary to fulfill the activities under this 

paragraph. 

‘‘(G) CONTRACT REQUIREMENTS.—Each contract with a 

qualified entity under subparagraph (F)(i) shall contain 

the following requirements: 

‘‘(i) ENSURING PRIVACY.—The qualified entity shall 

ensure that the entity will not use data under this 

subsection in a manner that— 

‘‘(I) violates the regulations promulgated under 

section 264(c) of the Health Insurance Portability 

and Accountability Act of 1996; 

‘‘(II) violates sections 552 or 552a of title 5, 

United States Code, with regard to the privacy 

of individually-identifiable beneficiary health 

information; or 

‘‘(III) discloses individually identifiable health 

information when presenting drug safety signals 

and trends or when responding to inquiries 

regarding drug safety signals and trends. 

Nothing in this clause prohibits lawful disclosure for 

other purposes. 

‘‘(ii) COMPONENT OF ANOTHER ORGANIZATION.—If 

a qualified entity is a component of another organization— 

‘‘(I) the qualified entity shall establish appropriate security measures to maintain the confidentiality and privacy of such data; and 

‘‘(II) the entity shall not make an unauthorized 

disclosure of such data to the other components 

of the organization in breach of such confidentiality 

and privacy requirement. 

‘‘(iii) TERMINATION OR NONRENEWAL.—If a contract 

with a qualified entity under this subparagraph is 

terminated or not renewed, the following requirements 

shall apply: 

‘‘(I) CONFIDENTIALITY AND PRIVACY PROTECTIONS.—The entity shall continue to comply with 

the confidentiality and privacy requirements under 

this paragraph with respect to all data disclosed 

to the entity. 

‘‘(II) DISPOSITION OF DATA.—The entity shall 

return any data disclosed to such entity under 

this subsection to which it would not otherwise 

have access or, if returning the data is not practicable, destroy the data. 

‘‘(H) COMPETITIVE PROCEDURES.—The Secretary shall 

use competitive procedures (as defined in section 4(5) of 

the Federal Procurement Policy Act) to enter into contracts 

under subparagraph (G). 

‘‘(I) REVIEW OF CONTRACT IN THE EVENT OF A MERGER

OR ACQUISITION.—The Secretary shall review the contract 

Applicability. 


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with a qualified entity under this paragraph in the event 

of a merger or acquisition of the entity in order to ensure 

that the requirements under this paragraph will continue 

to be met. 

‘‘(J) COORDINATION.—In carrying out this paragraph, 

the Secretary shall provide for appropriate communications 

to the public, scientific, public health, and medical communities, and other key stakeholders, and to the extent practicable shall coordinate with the activities of private entities, professional associations, or other entities that may 

have sources of drug safety data.’’. 

(b) RULE OF CONSTRUCTION.—Nothing in this section or the 

amendment made by this section shall be construed to prohibit 

the lawful disclosure or use of data or information by an entity 

other than as described in paragraph (4)(B) or (4)(G) of section 

505(k) of the Federal Food, Drug, and Cosmetic Act, as added 

by subsection (a). 

(c) REPORT TO CONGRESS.—Not later than 4 years after the 

date of the enactment of this Act, the Secretary shall report to 

the Congress on the ways in which the Secretary has used the 

active postmarket risk identification and analysis system described 

in paragraphs (3) and (4) of section 505(k) of the Federal Food, 

Drug, and Cosmetic Act, as added by subsection (a), to identify 

specific drug safety signals and to better understand the outcomes 

associated with drugs marketed in the United States. 

(d) AUTHORIZATION OF APPROPRIATIONS.—To carry out activities 

under the amendment made by this section for which funds are 

made available under section 736 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 379h), there are authorized to be appropriated to carry out the amendment made by this section, in addition to such funds, $25,000,000 for each of fiscal years 2008 through 

2012. 

(e) GAO REPORT.—Not later than 18 months after the date 

of the enactment of this Act, the Comptroller General of the United 

States shall evaluate data privacy, confidentiality, and security 

issues relating to accessing, transmitting, and maintaining data 

for the active postmarket risk identification and analysis system 

described in paragraphs (3) and (4) of section 505(k) of the Federal 

Food, Drug, and Cosmetic Act, as added by subsection (a), and 

make recommendations to the Committee on Energy and Commerce 

of the House of Representatives and the Committee on Health, 

Education, Labor and Pensions of the Senate, and any other 

congressional committees of relevant jurisdiction, regarding the 

need for any additional legislative or regulatory actions to ensure 

privacy, confidentiality, and security of this data or otherwise 

address privacy, confidentiality, and security issues to ensure the 

effective operation of such active postmarket identification and analysis system. 

SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER 

ADVERTISEMENTS OF DRUGS. 

(a) PUBLISHED DIRECT-TO-CONSUMER ADVERTISEMENTS.—Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

352), as amended by section 901(d)(6), is further amended by 

inserting ‘‘and in the case of published direct-to-consumer 

advertisements the following statement printed in conspicuous text: 

‘You are encouraged to report negative side effects of prescription 

21 USC 355 note. 


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drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800- 

FDA-1088.’,’’ after ‘‘section 701(a),’’. 

(b) STUDY.— (1) IN GENERAL.—In the case of direct-to-consumer television advertisements, the Secretary of Health and Human 

Services, in consultation with the Advisory Committee on Risk 

Communication under section 567 of the Federal Food, Drug, 

and Cosmetic Act (as added by section 917), shall, not later 

than 6 months after the date of the enactment of this Act, 

conduct a study to determine if the statement in section 502(n) 

of such Act (as added by subsection (a)) required with respect 

to published direct-to-consumer advertisements is appropriate 

for inclusion in such television advertisements. 

(2) CONTENT.—As part of the study under paragraph (1), 

such Secretary shall consider whether the information in the 

statement described in paragraph (1) would detract from the 

presentation of risk information in a direct-to-consumer television advertisement. If such Secretary determines the inclusion 

of such statement is appropriate in direct-to-consumer television advertisements, such Secretary shall issue regulations 

requiring the implementation of such statement in direct-toconsumer television advertisements, including determining a 

reasonable length of time for displaying the statement in such 

advertisements. The Secretary shall report to the appropriate 

committees of Congress the findings of such study and any 

plans to issue regulations under this paragraph. 

SEC. 907. NO EFFECT ON VETERINARY MEDICINE. 

This subtitle, and the amendments made by this subtitle, shall 

have no effect on the use of drugs approved under section 505 

of the Federal Food, Drug, and Cosmetic Act by, or on the lawful 

written or oral order of, a licensed veterinarian within the context 

of a veterinarian-client-patient relationship, as provided for under 

section 512(a)(5) of such Act. 

SEC. 908. AUTHORIZATION OF APPROPRIATIONS. 

(a) IN GENERAL.—For carrying out this subtitle and the amendments made by this subtitle, there is authorized to be appropriated 

$25,000,000 for each of fiscal years 2008 through 2012. 

(b) RELATION TO OTHER FUNDING.—The authorization of appropriations under subsection (a) is in addition to any other funds 

available for carrying out this subtitle and the amendments made 

by this subtitle. 

SEC. 909. EFFECTIVE DATE AND APPLICABILITY. 

(a) EFFECTIVE DATE.—This subtitle takes effect 180 days after 

the date of the enactment of this Act. 

(b) DRUGS DEEMED TO HAVE RISK EVALUATION AND MITIGATION

STRATEGIES.— 

(1) IN GENERAL.—A drug that was approved before the 

effective date of this Act is, in accordance with paragraph 

(2), deemed to have in effect an approved risk evaluation and 

mitigation strategy under section 505–1 of the Federal Food, 

Drug, and Cosmetic Act (as added by section 901) (referred 

to in this section as the ‘‘Act’’) if there are in effect on the 

effective date of this Act elements to assure safe use— 

(A) required under section 314.520 or section 601.42 

of title 21, Code of Federal Regulations; or 

21 USC 331 note. 

21 USC 355 note. 

Reports. 

Deadline. 

21 USC 352 note. 


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(B) otherwise agreed to by the applicant and the Secretary for such drug. 

(2) ELEMENTS OF STRATEGY; ENFORCEMENT.—The approved 

risk evaluation and mitigation strategy in effect for a drug 

under paragraph (1)— 

(A) is deemed to consist of the timetable required under 

section 505–1(d) and any additional elements under subsections (e) and (f) of such section in effect for such drug 

on the effective date of this Act; and 

(B) is subject to enforcement by the Secretary to the 

same extent as any other risk evaluation and mitigation 

strategy under section 505–1 of the Act, except that sections 

303(f)(4) and 502(y) and (z) of the Act (as added by section 

902) shall not apply to such strategy before the Secretary 

has completed review of, and acted on, the first assessment 

of such strategy under such section 505–1. 

(3) SUBMISSION.—Not later than 180 days after the effective 

date of this Act, the holder of an approved application for 

which a risk evaluation and mitigation strategy is deemed 

to be in effect under paragraph (1) shall submit to the Secretary 

a proposed risk evaluation and mitigation strategy. Such proposed strategy is subject to section 505–1 of the Act as if 

included in such application at the time of submission of the 

application to the Secretary. 

Subtitle B—Other Provisions to Ensure 

Drug Safety and Surveillance 

SEC. 911. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS. 

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 351 et seq.) is amended by inserting after section 510 the 

following: 

‘‘SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS. 

‘‘(a) IN GENERAL.—Not later than 1 year after the date of 

the enactment of this section, the Secretary shall issue guidance 

for the conduct of clinical trials with respect to antibiotic drugs, 

including antimicrobials to treat acute bacterial sinusitis, acute 

bacterial otitis media, and acute bacterial exacerbation of chronic 

bronchitis. Such guidance shall indicate the appropriate models 

and valid surrogate markers. 

‘‘(b) REVIEW.—Not later than 5 years after the date of the 

enactment of this section, the Secretary shall review and update 

the guidance described under subsection (a) to reflect developments 

in scientific and medical information and technology.’’. 

SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR 

BIOLOGICAL PRODUCTS HAVE BEEN ADDED. 

(a) PROHIBITION.—Section 301 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331), as amended by section 901(d), is 

amended by adding at the end the following: 

‘‘(ll) The introduction or delivery for introduction into interstate 

commerce of any food to which has been added a drug approved 

under section 505, a biological product licensed under section 351 

of the Public Health Service Act, or a drug or a biological product 

for which substantial clinical investigations have been instituted 

Deadlines. 

21 USC 360a. 

Deadline. 


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and for which the existence of such investigations has been made 

public, unless— 

‘‘(1) such drug or such biological product was marketed 

in food before any approval of the drug under section 505, 

before licensure of the biological product under such section 

351, and before any substantial clinical investigations involving 

the drug or the biological product have been instituted; 

‘‘(2) the Secretary, in the Secretary’s discretion, has issued 

a regulation, after notice and comment, approving the use 

of such drug or such biological product in the food; 

‘‘(3) the use of the drug or the biological product in the 

food is to enhance the safety of the food to which the drug 

or the biological product is added or applied and not to have 

independent biological or therapeutic effects on humans, and 

the use is in conformity with— 

‘‘(A) a regulation issued under section 409 prescribing 

conditions of safe use in food; 

‘‘(B) a regulation listing or affirming conditions under 

which the use of the drug or the biological product in 

food is generally recognized as safe; 

‘‘(C) the conditions of use identified in a notification 

to the Secretary of a claim of exemption from the premarket 

approval requirements for food additives based on the notifier’s determination that the use of the drug or the 

biological product in food is generally recognized as safe, 

provided that the Secretary has not questioned the general 

recognition of safety determination in a letter to the notifier; 

‘‘(D) a food contact substance notification that is effective under section 409(h); or 

‘‘(E) such drug or biological product had been marketed 

for smoking cessation prior to the date of the enactment 

of the Food and Drug Administration Amendments Act 

of 2007; or 

‘‘(4) the drug is a new animal drug whose use is not 

unsafe under section 512.’’. 

(b) CONFORMING CHANGES.—The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended— 

(1) in section 304(a)(1), by striking ‘‘section 404 or 505’’ 

and inserting ‘‘section 301(ll), 404, or 505’’; and 

(2) in section 801(a), by striking ‘‘is adulterated, misbranded, or in violation of section 505,’’ and inserting ‘‘is 

adulterated, misbranded, or in violation of section 505, or 

prohibited from introduction or delivery for introduction into 

interstate commerce under section 301(ll),’’. 

SEC. 913. ASSURING PHARMACEUTICAL SAFETY. 

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 351 et seq.), as amended in section 403, is amended by 

inserting after section 505C the following: 

‘‘SEC. 505D. PHARMACEUTICAL SECURITY. 

‘‘(a) IN GENERAL.—The Secretary shall develop standards and 

identify and validate effective technologies for the purpose of 

securing the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs. 

‘‘(b) STANDARDS DEVELOPMENT.— 

Standards. 

21 USC 355e. 

21 USC 381. 

21 USC 334. 


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‘‘(1) IN GENERAL.—The Secretary shall, in consultation with 

the agencies specified in paragraph (4), manufacturers, distributors, pharmacies, and other supply chain stakeholders, 

prioritize and develop standards for the identification, validation, authentication, and tracking and tracing of prescription 

drugs. 

‘‘(2) STANDARDIZED NUMERAL IDENTIFIER.—Not later than 

30 months after the date of the enactment of the Food and 

Drug Administration Amendments Act of 2007, the Secretary 

shall develop a standardized numerical identifier (which, to 

the extent practicable, shall be harmonized with international 

consensus standards for such an identifier) to be applied to 

a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked 

to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate 

the identification, validation, authentication, and tracking and 

tracing of the prescription drug. 

‘‘(3) PROMISING TECHNOLOGIES.—The standards developed 

under this subsection shall address promising technologies, 

which may include— 

‘‘(A) radio frequency identification technology; 

‘‘(B) nanotechnology; 

‘‘(C) encryption technologies; and 

‘‘(D) other track-and-trace or authentication technologies. 

‘‘(4) INTERAGENCY COLLABORATION.—In carrying out this 

subsection, the Secretary shall consult with Federal health 

and security agencies, including— 

‘‘(A) the Department of Justice; 

‘‘(B) the Department of Homeland Security; 

‘‘(C) the Department of Commerce; and 

‘‘(D) other appropriate Federal and State agencies. 

‘‘(c) INSPECTION AND ENFORCEMENT.— 

‘‘(1) IN GENERAL.—The Secretary shall expand and enhance 

the resources and facilities of agency components of the Food 

and Drug Administration involved with regulatory and criminal 

enforcement of this Act to secure the drug supply chain against 

counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs including biological products and 

active pharmaceutical ingredients from domestic and foreign 

sources. 

‘‘(2) ACTIVITIES.—The Secretary shall undertake enhanced 

and joint enforcement activities with other Federal and State 

agencies, and establish regional capacities for the validation 

of prescription drugs and the inspection of the prescription 

drug supply chain. 

‘‘(d) DEFINITION.—In this section, the term ‘prescription drug’ 

means a drug subject to section 503(b)(1).’’. 

SEC. 914. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY 

ACTION. 

(a) IN GENERAL.—Section 505 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355), as amended by section 901(a), is 

amended by adding at the end the following: 

‘‘(q) PETITIONS AND CIVIL ACTIONS REGARDING APPROVAL OF

CERTAIN APPLICATIONS.— 

Deadline. 


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‘‘(1) IN GENERAL.— 

‘‘(A) DETERMINATION.—The Secretary shall not delay 

approval of a pending application submitted under subsection (b)(2) or (j) because of any request to take any 

form of action relating to the application, either before 

or during consideration of the request, unless— 

‘‘(i) the request is in writing and is a petition 

submitted to the Secretary pursuant to section 10.30 

or 10.35 of title 21, Code of Federal Regulations (or 

any successor regulations); and 

‘‘(ii) the Secretary determines, upon reviewing the 

petition, that a delay is necessary to protect the public 

health. 

‘‘(B) NOTIFICATION.—If the Secretary determines under 

subparagraph (A) that a delay is necessary with respect 

to an application, the Secretary shall provide to the 

applicant, not later than 30 days after making such determination, the following information: 

‘‘(i) Notification of the fact that a determination 

under subparagraph (A) has been made. 

‘‘(ii) If applicable, any clarification or additional 

data that the applicant should submit to the docket 

on the petition to allow the Secretary to review the 

petition promptly. 

‘‘(iii) A brief summary of the specific substantive 

issues raised in the petition which form the basis of 

the determination. 

‘‘(C) FORMAT.—The information described in subparagraph (B) shall be conveyed via either, at the discretion 

of the Secretary— 

‘‘(i) a document; or 

‘‘(ii) a meeting with the applicant involved. 

‘‘(D) PUBLIC DISCLOSURE.—Any information conveyed 

by the Secretary under subparagraph (C) shall be considered part of the application and shall be subject to the 

disclosure requirements applicable to information in such 

application. 

‘‘(E) DENIAL BASED ON INTENT TO DELAY.—If the Secretary determines that a petition or a supplement to the 

petition was submitted with the primary purpose of 

delaying the approval of an application and the petition 

does not on its face raise valid scientific or regulatory 

issues, the Secretary may deny the petition at any point 

based on such determination. The Secretary may issue 

guidance to describe the factors that will be used to determine under this subparagraph whether a petition is submitted with the primary purpose of delaying the approval 

of an application. 

‘‘(F) FINAL AGENCY ACTION.—The Secretary shall take 

final agency action on a petition not later than 180 days 

after the date on which the petition is submitted. The 

Secretary shall not extend such period for any reason, 

including— 

‘‘(i) any determination made under subparagraph 

(A); 

Deadline. 

Deadline. 


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‘‘(ii) the submission of comments relating to the 

petition or supplemental information supplied by the 

petitioner; or 

‘‘(iii) the consent of the petitioner. 

‘‘(G) EXTENSION OF 30-MONTH PERIOD.—If the filing of 

an application resulted in first-applicant status under subsection (j)(5)(D)(i)(IV) and approval of the application was 

delayed because of a petition, the 30-month period under 

such subsection is deemed to be extended by a period 

of time equal to the period beginning on the date on which 

the Secretary received the petition and ending on the date 

of final agency action on the petition (inclusive of such 

beginning and ending dates), without regard to whether 

the Secretary grants, in whole or in part, or denies, in 

whole or in part, the petition. 

‘‘(H) CERTIFICATION.—The Secretary shall not consider 

a petition for review unless the party submitting such 

petition does so in written form and the subject document 

is signed and contains the following certification: ‘I certify 

that, to my best knowledge and belief: (a) this petition 

includes all information and views upon which the petition 

relies; (b) this petition includes representative data and/ 

or information known to the petitioner which are unfavorable to the petition; and (c) I have taken reasonable steps 

to ensure that any representative data and/or information 

which are unfavorable to the petition were disclosed to 

me. I further certify that the information upon which I 

have based the action requested herein first became known 

to the party on whose behalf this petition is submitted 

on or about the following date: llllllllll. If 

I received or expect to receive payments, including cash 

and other forms of consideration, to file this information 

or its contents, I received or expect to receive those payments from the following persons or organizations: 

lllllllllllll. I verify under penalty of perjury that the foregoing is true and correct as of the date 

of the submission of this petition.’, with the date on which 

such information first became known to such party and 

the names of such persons or organizations inserted in 

the first and second blank space, respectively. 

‘‘(I) VERIFICATION.—The Secretary shall not accept for 

review any supplemental information or comments on a 

petition unless the party submitting such information or 

comments does so in written form and the subject document 

is signed and contains the following verification: ‘I certify 

that, to my best knowledge and belief: (a) I have not 

intentionally delayed submission of this document or its 

contents; and (b) the information upon which I have based 

the action requested herein first became known to me 

on or about llllllllll. If I received or expect 

to receive payments, including cash and other forms of 

consideration, to file this information or its contents, I 

received or expect to receive those payments from the following persons or organizations: lllll. I verify under 

penalty of perjury that the foregoing is true and correct 

as of the date of the submission of this petition.’, with 

the date on which such information first became known 


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to the party and the names of such persons or organizations 

inserted in the first and second blank space, respectively. 

‘‘(2) EXHAUSTION OF ADMINISTRATIVE REMEDIES.— 

‘‘(A) FINAL AGENCY ACTION WITHIN 180 DAYS.—The Secretary shall be considered to have taken final agency action 

on a petition if— 

‘‘(i) during the 180-day period referred to in paragraph (1)(F), the Secretary makes a final decision 

within the meaning of section 10.45(d) of title 21, Code 

of Federal Regulations (or any successor regulation); 

or 

‘‘(ii) such period expires without the Secretary 

having made such a final decision. 

‘‘(B) DISMISSAL OF CERTAIN CIVIL ACTIONS.—If a civil 

action is filed against the Secretary with respect to any 

issue raised in the petition before the Secretary has taken 

final agency action on the petition within the meaning 

of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies. 

‘‘(C) ADMINISTRATIVE RECORD.—For purposes of judicial 

review related to the approval of an application for which 

a petition under paragraph (1) was submitted, the administrative record regarding any issue raised by the petition 

shall include— 

‘‘(i) the petition filed under paragraph (1) and any 

supplements and comments thereto; 

‘‘(ii) the Secretary’s response to such petition, if 

issued; and 

‘‘(iii) other information, as designated by the Secretary, related to the Secretary’s determinations 

regarding the issues raised in such petition, as long 

as the information was considered by the agency no 

later than the date of final agency action as defined 

under subparagraph (2)(A), and regardless of whether 

the Secretary responded to the petition at or before 

the approval of the application at issue in the petition. 

‘‘(3) ANNUAL REPORT ON DELAYS IN APPROVALS PER PETITIONS.—The Secretary shall annually submit to the Congress 

a report that specifies— 

‘‘(A) the number of applications that were approved 

during the preceding 12-month period; 

‘‘(B) the number of such applications whose effective 

dates were delayed by petitions referred to in paragraph 

(1) during such period; 

‘‘(C) the number of days by which such applications 

were so delayed; and 

‘‘(D) the number of such petitions that were submitted 

during such period. 

‘‘(4) EXCEPTIONS.—This subsection does not apply to— 

‘‘(A) a petition that relates solely to the timing of 

the approval of an application pursuant to subsection 

(j)(5)(B)(iv); or 

‘‘(B) a petition that is made by the sponsor of an 

application and that seeks only to have the Secretary take 

or refrain from taking any form of action with respect 

to that application. 

Courts. 


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‘‘(5) DEFINITIONS.— ‘‘(A) APPLICATION.—For purposes of this subsection, the 

term ‘application’ means an application submitted under 

subsection (b)(2) or (j). 

‘‘(B) PETITION.—For purposes of this subsection, other 

than paragraph (1)(A)(i), the term ‘petition’ means a 

request described in paragraph (1)(A)(i).’’. 

(b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services 

shall submit a report to the Congress on ways to encourage the 

early submission of petitions under section 505(q), as added by 

subsection (a). 

SEC. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS 

AND PROVIDERS. 

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 355), as amended by section 914(a), is amended by adding 

at the end the following: 

‘‘(r) POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS

AND PROVIDERS.— 

‘‘(1) ESTABLISHMENT.—Not later than 1 year after the date 

of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall improve the transparency 

of information about drugs and allow patients and health care 

providers better access to information about drugs by developing and maintaining an Internet Web site that— 

‘‘(A) provides links to drug safety information listed 

in paragraph (2) for prescription drugs that are approved 

under this section or licensed under section 351 of the 

Public Health Service Act; and 

‘‘(B) improves communication of drug safety information to patients and providers. 

‘‘(2) INTERNET WEB SITE.—The Secretary shall carry out 

paragraph (1) by— 

‘‘(A) developing and maintaining an accessible, consolidated Internet Web site with easily searchable drug safety 

information, including the information found on United 

States Government Internet Web sites, such as the United 

States National Library of Medicine’s Daily Med and 

Medline Plus Web sites, in addition to other such Web 

sites maintained by the Secretary; 

‘‘(B) ensuring that the information provided on the 

Internet Web site is comprehensive and includes, when 

available and appropriate— 

‘‘(i) patient labeling and patient packaging inserts; 

‘‘(ii) a link to a list of each drug, whether approved 

under this section or licensed under such section 351, 

for which a Medication Guide, as provided for under 

part 208 of title 21, Code of Federal Regulations (or 

any successor regulations), is required; 

‘‘(iii) a link to the registry and results data bank 

provided for under subsections (i) and (j) of section 

402 of the Public Health Service Act; 

‘‘(iv) the most recent safety information and alerts 

issued by the Food and Drug Administration for drugs 

approved by the Secretary under this section, such 

as product recalls, warning letters, and import alerts; 

Deadline. 

Website. 


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‘‘(v) publicly available information about implemented RiskMAPs and risk evaluation and mitigation 

strategies under subsection (o); 

‘‘(vi) guidance documents and regulations related 

to drug safety; and 

‘‘(vii) other material determined appropriate by the 

Secretary; 

‘‘(C) providing access to summaries of the assessed 

and aggregated data collected from the active surveillance 

infrastructure under subsection (k)(3) to provide information of known and serious side-effects for drugs approved 

under this section or licensed under such section 351; 

‘‘(D) preparing, by 18 months after approval of a drug 

or after use of the drug by 10,000 individuals, whichever 

is later, a summary analysis of the adverse drug reaction 

reports received for the drug, including identification of 

any new risks not previously identified, potential new risks, 

or known risks reported in unusual number; 

‘‘(E) enabling patients, providers, and drug sponsors 

to submit adverse event reports through the Internet Web 

site; 

‘‘(F) providing educational materials for patients and 

providers about the appropriate means of disposing of 

expired, damaged, or unusable medications; and 

‘‘(G) supporting initiatives that the Secretary determines to be useful to fulfill the purposes of the Internet 

Web site. 

‘‘(3) POSTING OF DRUG LABELING.—The Secretary shall post 

on the Internet Web site established under paragraph (1) the 

approved professional labeling and any required patient 

labeling of a drug approved under this section or licensed 

under such section 351 not later than 21 days after the date 

the drug is approved or licensed, including in a supplemental 

application with respect to a labeling change. 

‘‘(4) PRIVATE SECTOR RESOURCES.—To ensure development 

of the Internet Web site by the date described in paragraph 

(1), the Secretary may, on a temporary or permanent basis, 

implement systems or products developed by private entities. 

‘‘(5) AUTHORITY FOR CONTRACTS.—The Secretary may enter 

into contracts with public and private entities to fulfill the 

requirements of this subsection. 

‘‘(6) REVIEW.—The Advisory Committee on Risk Communication under section 567 shall, on a regular basis, perform 

a comprehensive review and evaluation of the types of risk 

communication information provided on the Internet Web site 

established under paragraph (1) and, through other means, 

shall identify, clarify, and define the purposes and types of 

information available to facilitate the efficient flow of information to patients and providers, and shall recommend ways 

for the Food and Drug Administration to work with outside 

entities to help facilitate the dispensing of risk communication 

information to patients and providers.’’. 

SEC. 916. ACTION PACKAGE FOR APPROVAL. 

Section 505(l) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(l)) is amended by— 

Deadline. 

Reports. 

Reports. 


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(1) redesignating paragraphs (1), (2), (3), (4), and (5) as 

subparagraphs (A), (B), (C), (D), and (E), respectively; 

(2) striking ‘‘(l) Safety and’’ and inserting ‘‘(l)(1) Safety 

and’’; and 

(3) adding at the end the following: 

‘‘(2) ACTION PACKAGE FOR APPROVAL.— 

‘‘(A) ACTION PACKAGE.—The Secretary shall publish the 

action package for approval of an application under subsection 

(b) or section 351 of the Public Health Service Act on the 

Internet Web site of the Food and Drug Administration— 

‘‘(i) not later than 30 days after the date of approval 

of such application 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 

this section or section 351 of the Public Health Service 

Act; and 

‘‘(ii) not later than 30 days after the third request 

for such action package for approval received under section 

552 of title 5, United States Code, for any other drug. 

‘‘(B) IMMEDIATE PUBLICATION OF SUMMARY REVIEW.—Notwithstanding subparagraph (A), the Secretary shall publish, 

on the Internet Web site of the Food and Drug Administration, 

the materials described in subparagraph (C)(iv) not later than 

48 hours after the date of approval of the drug, except where 

such materials require redaction by the Secretary. 

‘‘(C) CONTENTS.—An action package for approval of an 

application under subparagraph (A) shall be dated and shall 

include the following: 

‘‘(i) Documents generated by the Food and Drug 

Administration related to review of the application. 

‘‘(ii) Documents pertaining to the format and content 

of the application generated during drug development. 

‘‘(iii) Labeling submitted by the applicant. 

‘‘(iv) A summary review that documents conclusions 

from all reviewing disciplines about the drug, noting any 

critical issues and disagreements with the applicant and 

within the review team and how they were resolved, recommendations for action, and an explanation of any nonconcurrence with review conclusions. 

‘‘(v) The Division Director and Office Director’s decision 

document which includes— 

‘‘(I) a brief statement of concurrence with the summary review; 

‘‘(II) a separate review or addendum to the review 

if disagreeing with the summary review; and 

‘‘(III) a separate review or addendum to the review 

to add further analysis. 

‘‘(vi) Identification by name of each officer or employee 

of the Food and Drug Administration who— 

‘‘(I) participated in the decision to approve the 

application; and 

‘‘(II) consents to have his or her name included 

in the package. 

‘‘(D) REVIEW.—A scientific review of an application is 

considered the work of the reviewer and shall not be altered 

by management or the reviewer once final. 

Publication. 

Website. 

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‘‘(E) CONFIDENTIAL INFORMATION.—This paragraph does not 

authorize the disclosure of any trade secret, confidential 

commercial or financial information, or other matter listed in 

section 552(b) of title 5, United States Code.’’. 

SEC. 917. RISK COMMUNICATION. 

Subchapter E of chapter V of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended by section 

603, is amended by adding at the end the following: 

‘‘SEC. 567. RISK COMMUNICATION. 

‘‘(a) ADVISORY COMMITTEE ON RISK COMMUNICATION.— ‘‘(1) IN GENERAL.—The Secretary shall establish an advisory 

committee to be known as the ‘Advisory Committee on Risk 

Communication’ (referred to in this section as the ‘Committee’). 

‘‘(2) DUTIES OF COMMITTEE.—The Committee shall advise 

the Commissioner on methods to effectively communicate risks 

associated with the products regulated by the Food and Drug 

Administration. 

‘‘(3) MEMBERS.—The Secretary shall ensure that the Committee is composed of experts on risk communication, experts 

on the risks described in subsection (b), and representatives 

of patient, consumer, and health professional organizations. 

‘‘(4) PERMANENCE OF COMMITTEE.—Section 14 of the Federal Advisory Committee Act shall not apply to the Committee 

established under this subsection. 

‘‘(b) PARTNERSHIPS FOR RISK COMMUNICATION.— 

‘‘(1) IN GENERAL.—The Secretary shall partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted 

systems for communication to health care providers about 

emerging postmarket drug risks. 

‘‘(2) PARTNERSHIPS.—The systems developed under paragraph (1) shall— 

‘‘(A) account for the diversity among physicians in 

terms of practice, willingness to adopt technology, and medical specialty; and 

‘‘(B) include the use of existing communication channels, including electronic communications, in place at the 

Food and Drug Administration.’’. 

SEC. 918. REFERRAL TO ADVISORY COMMITTEE. 

Section 505 of the Federal Food, Drug, and Cosmetic Act, 

as amended by section 915, is further amended by adding at the 

end the following: 

‘‘(s) REFERRAL TO ADVISORY COMMITTEE.—Prior to the approval 

of a drug no active ingredient (including any ester or salt of the 

active ingredient) of which has been approved in any other application under this section or section 351 of the Public Health Service 

Act, the Secretary shall— 

‘‘(1) refer such drug to a Food and Drug Administration 

advisory committee for review at a meeting of such advisory 

committee; or 

‘‘(2) if the Secretary does not refer such a drug to a Food 

and Drug Administration advisory committee prior to the 

approval of the drug, provide in the action letter on the application for the drug a summary of the reasons why the Secretary 

21 USC 355. 

Establishment. 

21 USC 

360bbb–6. 


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did not refer the drug to an advisory committee prior to 

approval.’’. 

SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE. 

(a) IN GENERAL.—Not later than 1 year after the date of the 

enactment of this title, the Secretary shall issue a report responding 

to the 2006 report of the Institute of Medicine entitled ‘‘The Future 

of Drug Safety—Promoting and Protecting the Health of the Public’’. 

(b) CONTENT OF REPORT.—The report issued by the Secretary 

under subsection (a) shall include— 

(1) an update on the implementation by the Food and 

Drug Administration of its plan to respond to the Institute 

of Medicine report described under such subsection; and 

(2) an assessment of how the Food and Drug Administration has implemented— 

(A) the recommendations described in such Institute 

of Medicine report; and 

(B) the requirement under section 505–1(c)(2) of the 

Federal Food, Drug, and Cosmetic Act (as added by this 

title), that the appropriate office responsible for reviewing 

a drug and the office responsible for postapproval safety 

with respect to the drug work together to assess, implement, and ensure compliance with the requirements of 

such section 505–1. 

SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS. 

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 355), as amended by section 918, is further amended by 

adding at the end the following: 

‘‘(t) DATABASE FOR AUTHORIZED GENERIC DRUGS.— ‘‘(1) IN GENERAL.— ‘‘(A) PUBLICATION.—The Commissioner shall— 

‘‘(i) not later than 9 months after the date of the 

enactment of the Food and Drug Administration 

Amendments Act of 2007, publish a complete list on 

the Internet Web site of the Food and Drug Administration of all authorized generic drugs (including drug 

trade name, brand company manufacturer, and the 

date the authorized generic drug entered the market); 

and 

‘‘(ii) update the list quarterly to include each 

authorized generic drug included in an annual report 

submitted to the Secretary by the sponsor of a listed 

drug during the preceding 3-month period. 

‘‘(B) NOTIFICATION.—The Commissioner shall notify 

relevant Federal agencies, including the Centers for Medicare & Medicaid Services and the Federal Trade Commission, when the Commissioner first publishes the information described in subparagraph (A) that the information 

has been published and that the information will be 

updated quarterly. 

‘‘(2) INCLUSION.—The Commissioner shall include in the 

list described in paragraph (1) each authorized generic drug 

included in an annual report submitted to the Secretary by 

the sponsor of a listed drug after January 1, 1999. 

‘‘(3) AUTHORIZED GENERIC DRUG.—In this section, the term 

‘authorized generic drug’ means a listed drug (as that term 

is used in subsection (j)) that— 

Deadlines. 

Deadline. 

Reports. 


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‘‘(A) has been approved under subsection (c); and 

‘‘(B) is marketed, sold, or distributed directly or 

indirectly to retail class of trade under a different labeling, 

packaging (other than repackaging as the listed drug in 

blister packs, unit doses, or similar packaging for use in 

institutions), product code, labeler code, trade name, or 

trade mark than the listed drug.’’. 

SEC. 921. ADVERSE DRUG REACTION REPORTS AND POSTMARKET 

SAFETY. 

Subsection (k) of section 505 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355), as amended by section 905, is 

amended by adding at the end the following: 

‘‘(5) The Secretary shall— 

‘‘(A) conduct regular, bi-weekly screening of the 

Adverse Event Reporting System database and post a quarterly report on the Adverse Event Reporting System Web 

site of any new safety information or potential signal of 

a serious risk identified by Adverse Event Reporting 

System within the last quarter; 

‘‘(B) report to Congress not later than 2 year after 

the date of the enactment of the Food and Drug Administration Amendments Act of 2007 on procedures and processes 

of the Food and Drug Administration for addressing 

ongoing post market safety issues identified by the Office 

of Surveillance and Epidemiology and how recommendations of the Office of Surveillance and Epidemiology are 

handled within the agency; and 

‘‘(C) on an annual basis, review the entire backlog 

of postmarket safety commitments to determine which 

commitments require revision or should be eliminated, 

report to the Congress on these determinations, and assign 

start dates and estimated completion dates for such 

commitments.’’. 

TITLE X—FOOD SAFETY 

SEC. 1001. FINDINGS. 

Congress finds that— 

(1) the safety and integrity of the United States food supply 

are vital to public health, to public confidence in the food 

supply, and to the success of the food sector of the Nation’s 

economy; 

(2) illnesses and deaths of individuals and companion animals caused by contaminated food— 

(A) have contributed to a loss of public confidence 

in food safety; and 

(B) have caused significant economic losses to manufacturers and producers not responsible for contaminated food 

items; 

(3) the task of preserving the safety of the food supply 

of the United States faces tremendous pressures with regard 

to— 

(A) emerging pathogens and other contaminants and 

the ability to detect all forms of contamination; 

21 USC 2101. 


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(B) an increasing volume of imported food from a wide 

variety of countries; and 

(C) a shortage of adequate resources for monitoring 

and inspection; 

(4) according to the Economic Research Service of the 

Department of Agriculture, the United States is increasing 

the amount of food that it imports such that— 

(A) from 2003 to 2007, the value of food imports has 

increased from $45,600,000,000 to $64,000,000,000; and 

(B) imported food accounts for 13 percent of the average 

American diet including 31 percent of fruits, juices, and 

nuts, 9.5 percent of red meat, and 78.6 percent of fish 

and shellfish; and 

(5) the number of full-time equivalent Food and Drug 

Administration employees conducting inspections has decreased 

from 2003 to 2007. 

SEC. 1002. ENSURING THE SAFETY OF PET FOOD. 

(a) PROCESSING AND INGREDIENT STANDARDS.—Not later than 

2 years after the date of the enactment of this Act, the Secretary 

of Health and Human Services (referred to in this title as the 

‘‘Secretary’’), in consultation with the Association of American Feed 

Control Officials and other relevant stakeholder groups, including 

veterinary medical associations, animal health organizations, and 

pet food manufacturers, shall by regulation establish— 

(1) ingredient standards and definitions with respect to 

pet food; 

(2) processing standards for pet food; and 

(3) updated standards for the labeling of pet food that 

include nutritional and ingredient information. 

(b) EARLY WARNING SURVEILLANCE SYSTEMS AND NOTIFICATION

DURING PET FOOD RECALLS.—Not later than 1 year after the date 

of the enactment of this Act, the Secretary shall establish an 

early warning and surveillance system to identify adulteration of 

the pet food supply and outbreaks of illness associated with pet 

food. In establishing such system, the Secretary shall— 

(1) consider using surveillance and monitoring mechanisms 

similar to, or in coordination with, those used to monitor human 

or animal health, such as the Foodborne Diseases Active 

Surveillance Network (FoodNet) and PulseNet of the Centers 

for Disease Control and Prevention, the Food Emergency 

Response Network of the Food and Drug Administration and 

the Department of Agriculture, and the National Animal Health 

Laboratory Network of the Department of Agriculture; 

(2) consult with relevant professional associations and private sector veterinary hospitals; 

(3) work with the National Companion Animal Surveillance 

Program, the Health Alert Network, or other notification networks as appropriate to inform veterinarians and relevant 

stakeholders during any recall of pet food; and 

(4) use such information and conduct such other activities 

as the Secretary deems appropriate. 

SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS 

DURING A RECALL. 

The Secretary shall, during an ongoing recall of human or 

pet food regulated by the Secretary— 

21 USC 2103. 

Deadline. 

Deadline. 

Regulations. 

21 USC 2102. 


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(1) work with companies, relevant professional associations, 

and other organizations to collect and aggregate information 

pertaining to the recall; 

(2) use existing networks of communication, including electronic forms of information dissemination, to enhance the 

quality and speed of communication with the public; and 

(3) post information regarding recalled human and pet 

foods on the Internet Web site of the Food and Drug Administration in a single location, which shall include a searchable 

database of recalled human foods and a searchable database 

of recalled pet foods, that is easily accessed and understood 

by the public. 

SEC. 1004. STATE AND FEDERAL COOPERATION. 

(a) IN GENERAL.—The Secretary shall work with the States 

in undertaking activities and programs that assist in improving 

the safety of food, including fresh and processed produce, so that 

State food safety programs and activities conducted by the Secretary 

function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage 

States to— 

(1) establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail 

commercial food establishments; and 

(2) establish procedures and requirements for ensuring that 

processed produce under the jurisdiction of State food safety 

programs is not unsafe for human consumption. 

(b) ASSISTANCE.—The Secretary may provide to a State, for 

planning, developing, and implementing such a food safety program— 

(1) advisory assistance; 

(2) technical assistance, training, and laboratory assistance 

(including necessary materials and equipment); and 

(3) financial and other assistance. 

(c) SERVICE AGREEMENTS.—The Secretary may, under an agreement entered into with a Federal, State, or local agency, use, 

on a reimbursable basis or otherwise, the personnel, services, and 

facilities of the agency to carry out the responsibilities of the agency 

under this section. An agreement entered into with a State agency 

under this subsection may provide for training of State employees. 

SEC. 1005. REPORTABLE FOOD REGISTRY. 

(a) FINDINGS.—Congress makes the following findings: 

(1) In 1994, Congress passed the Dietary Supplement 

Health and Education Act of 1994 (Public Law 103–417) to 

provide the Food and Drug Administration the legal framework 

which is intended to ensure that dietary supplements are safe 

and properly labeled foods. 

(2) In 2006, Congress passed the Dietary Supplement and 

Nonprescription Drug Consumer Protection Act (Public Law 

109–462) to establish a mandatory reporting system of serious 

adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States. 

(3) The adverse event reporting system created under the 

Dietary Supplement and Nonprescription Drug Consumer 

Protection Act is intended to serve as an early warning system 

for potential public health issues associated with the use of 

these products. 

21 USC 350f 

note. 

21 USC 2104. 

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(4) A reliable mechanism to track patterns of adulteration 

in food would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public 

health. 

(b) IN GENERAL.—Chapter IV of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at 

the end the following: 

‘‘SEC. 417. REPORTABLE FOOD REGISTRY. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) RESPONSIBLE PARTY.—The term ‘responsible party’, 

with respect to an article of food, means a person that submits 

the registration under section 415(a) for a food facility that 

is required to register under section 415(a), at which such 

article of food is manufactured, processed, packed, or held. 

‘‘(2) REPORTABLE FOOD.—The term ‘reportable food’ means 

an article of food (other than infant formula) for which there 

is a reasonable probability that the use of, or exposure to, 

such article of food will cause serious adverse health consequences or death to humans or animals. 

‘‘(b) ESTABLISHMENT.— 

‘‘(1) IN GENERAL.—Not later than 1 year after the date 

of the enactment of this section, the Secretary shall establish 

within the Food and Drug Administration a Reportable Food 

Registry to which instances of reportable food may be submitted 

by the Food and Drug Administration after receipt of reports 

under subsection (d), via an electronic portal, from— 

‘‘(A) Federal, State, and local public health officials; 

or 

‘‘(B) responsible parties. 

‘‘(2) REVIEW BY SECRETARY.—The Secretary shall promptly 

review and assess the information submitted under paragraph 

(1) for the purposes of identifying reportable food, submitting 

entries to the Reportable Food Registry, acting under subsection 

(c), and exercising other existing food safety authorities under 

this Act to protect the public health. 

‘‘(c) ISSUANCE OF AN ALERT BY THE SECRETARY.— 

‘‘(1) IN GENERAL.—The Secretary shall issue, or cause to 

be issued, an alert or a notification with respect to a reportable 

food using information from the Reportable Food Registry as 

the Secretary deems necessary to protect the public health. 

‘‘(2) EFFECT.—Paragraph (1) shall not affect the authority 

of the Secretary to issue an alert or a notification under any 

other provision of this Act. 

‘‘(d) REPORTING AND NOTIFICATION.— 

‘‘(1) IN GENERAL.—Except as provided in paragraph (2), 

as soon as practicable, but in no case later than 24 hours 

after a responsible party determines that an article of food 

is a reportable food, the responsible party shall— 

‘‘(A) submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes the data elements described in 

subsection (e) (except the elements described in paragraphs 

(8), (9), and (10) of such subsection); and 

‘‘(B) investigate the cause of the adulteration if the 

adulteration of the article of food may have originated 

with the responsible party. 

Deadline. 

Deadline. 

21 USC 350f. 


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‘‘(2) NO REPORT REQUIRED.—A responsible party is not 

required to submit a report under paragraph (1) if— 

‘‘(A) the adulteration originated with the responsible 

party; 

‘‘(B) the responsible party detected the adulteration 

prior to any transfer to another person of such article 

of food; and 

‘‘(C) the responsible party— 

‘‘(i) corrected such adulteration; or 

‘‘(ii) destroyed or caused the destruction of such 

article of food. 

‘‘(3) REPORTS BY PUBLIC HEALTH OFFICIALS.—A Federal, 

State, or local public health official may submit a report about 

a reportable food to the Food and Drug Administration through 

the electronic portal established under subsection (b) that 

includes the data elements described in subsection (e) that 

the official is able to provide. 

‘‘(4) REPORT NUMBER.—The Secretary shall ensure that, 

upon submission of a report under paragraph (1) or (3), a 

unique number is issued through the electronic portal established under subsection (b) to the person submitting such 

report, by which the Secretary is able to link reports about 

the reportable food submitted and amended under this subsection and identify the supply chain for such reportable food. 

‘‘(5) REVIEW.—The Secretary shall promptly review a report 

submitted under paragraph (1) or (3). 

‘‘(6) RESPONSE TO REPORT SUBMITTED BY A RESPONSIBLE

PARTY.—After consultation with the responsible party that submitted a report under paragraph (1), the Secretary may require 

such responsible party to perform, as soon as practicable, but 

in no case later than a time specified by the Secretary, 1 

or more of the following: 

‘‘(A) Amend the report submitted by the responsible 

party under paragraph (1) to include the data element 

described in subsection (e)(9). 

‘‘(B) Provide a notification— 

‘‘(i) to the immediate previous source of the article 

of food, if the Secretary deems necessary; 

‘‘(ii) to the immediate subsequent recipient of the 

article of food, if the Secretary deems necessary; and 

‘‘(iii) that includes— 

‘‘(I) the data elements described in subsection 

(e) that the Secretary deems necessary; 

‘‘(II) the actions described under paragraph 

(7) that the recipient of the notification shall perform, as required by the Secretary; and 

‘‘(III) any other information that the Secretary 

may require. 

‘‘(7) SUBSEQUENT REPORTS AND NOTIFICATIONS.—Except as 

provided in paragraph (8), the Secretary may require a responsible party to perform, as soon as practicable, but in no case 

later than a time specified by the Secretary, after the responsible party receives a notification under subparagraph (C) or 

paragraph (6)(B), 1 or more of the following: 

‘‘(A) Submit a report to the Food and Drug Administration through the electronic portal established under subsection (b) that includes those data elements described 


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in subsection (e) and other information that the Secretary 

deems necessary. 

‘‘(B) Investigate the cause of the adulteration if the 

adulteration of the article of food may have originated 

with the responsible party. 

‘‘(C) Provide a notification— 

‘‘(i) to the immediate previous source of the article 

of food, if the Secretary deems necessary; 

‘‘(ii) to the immediate subsequent recipient of the 

article of food, if the Secretary deems necessary; and 

‘‘(iii) that includes— 

‘‘(I) the data elements described in subsection 

(e) that the Secretary deems necessary; 

‘‘(II) the actions described under this paragraph that the recipient of the notification shall 

perform, as required by the Secretary; and 

‘‘(III) any other information that the Secretary 

may require. 

‘‘(8) AMENDED REPORT.—If a responsible party receives a 

notification under paragraph (6)(B) or paragraph (7)(C) with 

respect to an article of food after the responsible party has 

submitted a report to the Food and Drug Administration under 

paragraph (1) with respect to such article of food— 

‘‘(A) the responsible party is not required to submit 

an additional report or make a notification under paragraph (7); and 

‘‘(B) the responsible party shall amend the report submitted by the responsible party under paragraph (1) to 

include the data elements described in paragraph (9), and, 

with respect to both such notification and such report, 

paragraph (11) of subsection (e). 

‘‘(e) DATA ELEMENTS.—The data elements described in this 

subsection are the following: 

‘‘(1) The registration numbers of the responsible party 

under section 415(a)(3). 

‘‘(2) The date on which an article of food was determined 

to be a reportable food. 

‘‘(3) A description of the article of food including the 

quantity or amount. 

‘‘(4) The extent and nature of the adulteration. 

‘‘(5) If the adulteration of the article of food may have 

originated with the responsible party, the results of the investigation required under paragraph (1)(B) or (7)(B) of subsection 

(d), as applicable and when known. 

‘‘(6) The disposition of the article of food, when known. 

‘‘(7) Product information typically found on packaging 

including product codes, use-by dates, and names of manufacturers, packers, or distributors sufficient to identify the article 

of food. 

‘‘(8) Contact information for the responsible party. 

‘‘(9) The contact information for parties directly linked in 

the supply chain and notified under paragraph (6)(B) or (7)(C) 

of subsection (d), as applicable. 

‘‘(10) The information required by the Secretary to be 

included in a notification provided by the responsible party 

involved under paragraph (6)(B) or (7)(C) of subsection (d) 

or required in a report under subsection (d)(7)(A). 


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‘‘(11) The unique number described in subsection (d)(4). 

‘‘(f) COORDINATION OF FEDERAL, STATE, AND LOCAL EFFORTS.— 

‘‘(1) DEPARTMENT OF AGRICULTURE.—In implementing this 

section, the Secretary shall— 

‘‘(A) share information and coordinate regulatory 

efforts with the Department of Agriculture; and 

‘‘(B) if the Secretary receives a report submitted about 

a food within the jurisdiction of the Department of Agriculture, promptly provide such report to the Department 

of Agriculture. 

‘‘(2) STATES AND LOCALITIES.—In implementing this section, 

the Secretary shall work with the State and local public health 

officials to share information and coordinate regulatory efforts, 

in order to— 

‘‘(A) help to ensure coverage of the safety of the food 

supply chain, including those food establishments regulated 

by the States and localities that are not required to register 

under section 415; and 

‘‘(B) reduce duplicative regulatory efforts. 

‘‘(g) MAINTENANCE AND INSPECTION OF RECORDS.—The responsible party shall maintain records related to each report received, 

notification made, and report submitted to the Food and Drug 

Administration under this section for 2 years. A responsible party 

shall, at the request of the Secretary, permit inspection of such 

records as provided for section 414. 

‘‘(h) REQUEST FOR INFORMATION.—Except as provided by section 

415(a)(4), section 552 of title 5, United States Code, shall apply 

to any request for information regarding a record in the Reportable 

Food Registry. 

‘‘(i) SAFETY REPORT.—A report or notification under subsection 

(d) shall be considered to be a safety report under section 756 

and may be accompanied by a statement, which shall be part 

of any report released for public disclosure, that denies that the 

report or the notification constitutes an admission that the product 

involved caused or contributed to a death, serious injury, or serious 

illness. 

‘‘(j) ADMISSION.—A report or notification under this section 

shall not be considered an admission that the article of food involved 

is adulterated or caused or contributed to a death, serious injury, 

or serious illness. 

‘‘(k) HOMELAND SECURITY NOTIFICATION.—If, after receiving a 

report under subsection (d), the Secretary believes such food may 

have been deliberately adulterated, the Secretary shall immediately 

notify the Secretary of Homeland Security. The Secretary shall 

make relevant information from the Reportable Food Registry available to the Secretary of Homeland Security.’’. 

(c) DEFINITION.—Section 201(ff) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking ‘‘section 

201(g)’’ and inserting ‘‘sections 201(g) and 417’’. 

(d) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 331), as amended by section 912, 

is further amended— 

(1) in subsection (e), by— 

(A) striking ‘‘414,’’ and inserting ‘‘414, 417(g),’’; and 

(B) striking ‘‘414(b)’’ and inserting ‘‘414(b), 417’’; and 

(2) by adding at the end the following: 

Applicability. 


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‘‘(mm) The failure to submit a report or provide a notification 

required under section 417(d). 

‘‘(nn) The falsification of a report or notification required under 

section 417(d).’’. 

(e) EFFECTIVE DATE.—The requirements of section 417(d) of 

the Federal Food, Drug, and Cosmetic Act, as added by subsection 

(a), shall become effective 1 year after the date of the enactment 

of this Act. 

(f) GUIDANCE.—Not later than 9 months after the date of the 

enactment of this Act, the Secretary shall issue a guidance to 

industry about submitting reports to the electronic portal established under section 417 of the Federal Food, Drug, and Cosmetic 

Act (as added by this section) and providing notifications to other 

persons in the supply chain of an article of food under such section 

417. 

(g) EFFECT.—Nothing in 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. 

SEC. 1006. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION. 

(a) FINDINGS.—Congress finds the following: 

(1) In 2007, there has been an overwhelming increase in 

the volume of aquaculture and seafood that has been found 

to contain substances that are not approved for use in food 

in the United States. 

(2) As of May 2007, inspection programs are not able to 

satisfactorily accomplish the goals of ensuring the food safety 

of the United States. 

(3) To protect the health and safety of consumers in the 

United States, the ability of the Secretary to perform inspection 

functions must be enhanced. 

(b) HEIGHTENED INSPECTIONS.—The Secretary is authorized to 

enhance, as necessary, the inspection regime of the Food and Drug 

Administration for aquaculture and seafood, consistent with obligations of the United States under international agreements and 

United States law. 

(c) REPORT TO CONGRESS.—Not later than 180 days after the 

date of the enactment of this Act, the Secretary shall submit to 

Congress a report that— 

(1) describes the specifics of the aquaculture and seafood 

inspection program; 

(2) describes the feasibility of developing a traceability 

system for all catfish and seafood products, both domestic and 

imported, for the purpose of identifying the processing plant 

of origin of such products; and 

(3) provides for an assessment of the risks associated with 

particular contaminants and banned substances. 

(d) PARTNERSHIPS WITH STATES.—Upon the request by any 

State, the Secretary may enter into partnership agreements, as 

soon as practicable after the request is made, to implement inspection programs to Federal standards regarding the importation of 

aquaculture and seafood. 

SEC. 1007. CONSULTATION REGARDING GENETICALLY ENGINEERED 

SEAFOOD PRODUCTS. 

The Commissioner of Food and Drugs shall consult with the 

Assistant Administrator of the National Marine Fisheries Service 

Reports. 

21 USC 2106. 

21 USC 2105. 

21 USC 2110 

note. 

Deadline. 

21 USC 350f 

note. 

21 USC 350f 

note. 


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of the National Oceanic and Atmospheric Administration to produce 

a report on any environmental risks associated with genetically 

engineered seafood products, including the impact on wild fish 

stocks. 

SEC. 1008. SENSE OF CONGRESS. 

It is the sense of Congress that— 

(1) it is vital for Congress to provide the Food and Drug 

Administration with additional resources, authorities, and 

direction with respect to ensuring the safety of the food supply 

of the United States; 

(2) additional inspectors are required to improve the Food 

and Drug Administration’s ability to safeguard the food supply 

of the United States; 

(3) because of the increasing volume of international trade 

in food products the Secretary should make it a priority to 

enter into agreements with the trading partners of the United 

States with respect to food safety; and 

(4) Congress should work to develop a comprehensive 

response to the issue of food safety. 

SEC. 1009. ANNUAL REPORT TO CONGRESS. 

The Secretary shall, on an annual basis, submit 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 a report that includes, with respect 

to the preceding 1-year period— 

(1) the number and amount of food products regulated 

by the Food and Drug Administration imported into the United 

States, aggregated by country and type of food; 

(2) a listing of the number of Food and Drug Administration 

inspectors of imported food products referenced in paragraph 

(1) and the number of Food and Drug Administration inspections performed on such products; and 

(3) aggregated data on the findings of such inspections, 

including data related to violations of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 201 et seq.), and enforcement 

actions used to follow-up on such findings and violations. 

SEC. 1010. PUBLICATION OF ANNUAL REPORTS. 

(a) IN GENERAL.—The Commissioner of Food and Drugs shall 

annually submit to Congress and publish on the Internet Web 

site of the Food and Drug Administration, a report concerning 

the results of the Administration’s pesticide residue monitoring 

program, that includes— 

(1) information and analysis similar to that contained in 

the report entitled ‘‘Food and Drug Administration Pesticide 

Program Residue Monitoring 2003’’ as released in June of 2005; 

(2) based on an analysis of previous samples, an identification of products or countries (for imports) that require special 

attention and additional study based on a comparison with 

equivalent products manufactured, distributed, or sold in the 

United States (including details on the plans for such additional 

studies), including in the initial report (and subsequent reports 

as determined necessary) the results and analysis of the Ginseng Dietary Supplements Special Survey as described on page 

Website. 

21 USC 2109. 

21 USC 2108. 

21 USC 2107. 


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13 of the report entitled ‘‘Food and Drug Administration Pesticide Program Residue Monitoring 2003’’; 

(3) information on the relative number of interstate and 

imported shipments of each tested commodity that were sampled, including recommendations on whether sampling is statistically significant, provides confidence intervals or other related 

statistical information, and whether the number of samples 

should be increased and the details of any plans to provide 

for such increase; and 

(4) a description of whether certain commodities are being 

improperly imported as another commodity, including a description of additional steps that are being planned to prevent 

such smuggling. 

(b) INITIAL REPORTS.—Annual reports under subsection (a) for 

fiscal years 2004 through 2006 may be combined into a single 

report, by not later than June 1, 2008, for purposes of publication 

under subsection (a). Thereafter such reports shall be completed 

by June 1 of each year for the data collected for the year that 

was 2-years prior to the year in which the report is published. 

(c) MEMORANDUM OF UNDERSTANDING.—The Commissioner of 

Food and Drugs, the Administrator of the Food Safety and Inspection Service, the Department of Commerce, and the head of the 

Agricultural Marketing Service shall enter into a memorandum 

of understanding to permit inclusion of data in the reports under 

subsection (a) relating to testing carried out by the Food Safety 

and Inspection Service and the Agricultural Marketing Service on 

meat, poultry, eggs, and certain raw agricultural products, respectively. 

SEC. 1011. RULE OF CONSTRUCTION. 

Nothing in this title (or an amendment made by this title) 

shall be construed to affect— 

(1) the regulation of dietary supplements under the Dietary 

Supplement Health and Education Act of 1994 (Public Law 

103–417); or 

(2) the adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462). 

TITLE XI—OTHER PROVISIONS 

Subtitle A—In General 

SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC 

ARTICLES PUBLISHED BY FDA EMPLOYEES. 

Subchapter A of chapter VII of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 371 et seq.), as amended by section 701, 

is further amended by adding at the end the following: 

‘‘SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC 

ARTICLES PUBLISHED BY FDA EMPLOYEES. 

‘‘(a) DEFINITION.—In this section, the term ‘article’ means a 

paper, poster, abstract, book, book chapter, or other published 

writing. 

‘‘(b) POLICIES.—The Secretary, through the Commissioner of 

Food and Drugs, shall establish and make publicly available clear 

Public 

information. 

21 USC 379d–2. 

21 USC 2110. 


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written policies to implement this section and govern the timely 

submission, review, clearance, and disclaimer requirements for articles. 

‘‘(c) TIMING OF SUBMISSION FOR REVIEW.—If an officer or 

employee, including a Staff Fellow and a contractor who performs 

staff work, of the Food and Drug Administration is directed by 

the policies established under subsection (b) to submit an article 

to the supervisor of such officer or employee, or to some other 

official of the Food and Drug Administration, for review and clearance before such officer or employee may seek to publish or present 

such an article at a conference, such officer or employee shall 

submit such article for such review and clearance not less than 

30 days before submitting the article for publication or presentation. 

‘‘(d) TIMING FOR REVIEW AND CLEARANCE.—The supervisor or 

other reviewing official shall review such article and provide written 

clearance, or written clearance on the condition of specified changes 

being made, to such officer or employee not later than 30 days 

after such officer or employee submitted such article for review. 

‘‘(e) NON-TIMELY REVIEW.—If, 31 days after such submission 

under subsection (c), the supervisor or other reviewing official has 

not cleared or has not reviewed such article and provided written 

clearance, such officer or employee may consider such article not 

to have been cleared and may submit the article for publication 

or presentation with an appropriate disclaimer as specified in the 

policies established under subsection (b). 

‘‘(f) EFFECT.—Nothing in this section shall be construed as 

affecting any restrictions on such publication or presentation provided by other provisions of law.’’. 

SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES. 

Subchapter A of chapter V of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 

the end the following: 

‘‘SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) PRIORITY REVIEW.—The term ‘priority review’, with 

respect to a human drug application as defined in section 

735(1), means review and action by the Secretary on such 

application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies 

and Procedures of the Food and Drug Administration and goals 

identified in the letters described in section 101(c) of the Food 

and Drug Administration Amendments Act of 2007. 

‘‘(2) PRIORITY REVIEW VOUCHER.—The term ‘priority review 

voucher’ means a voucher issued by the Secretary to the sponsor 

of a tropical disease product application that entitles the holder 

of such voucher to priority review of a single human drug 

application submitted under section 505(b)(1) or section 351 

of the Public Health Service Act after the date of approval 

of the tropical disease product application. 

‘‘(3) TROPICAL DISEASE.—The term ‘tropical disease’ means 

any of the following: 

‘‘(A) Tuberculosis. 

‘‘(B) Malaria. 

‘‘(C) Blinding trachoma. 

21 USC 360n. 


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‘‘(D) Buruli Ulcer. 

‘‘(E) Cholera. 

‘‘(F) Dengue/dengue haemorrhagic fever. 

‘‘(G) Dracunculiasis (guinea-worm disease). 

‘‘(H) Fascioliasis. 

‘‘(I) Human African trypanosomiasis. 

‘‘(J) Leishmaniasis. 

‘‘(K) Leprosy. 

‘‘(L) Lymphatic filariasis. 

‘‘(M) Onchocerciasis. 

‘‘(N) Schistosomiasis. 

‘‘(O) Soil transmitted helmithiasis. 

‘‘(P) Yaws. 

‘‘(Q) Any other infectious disease for which there is 

no significant market in developed nations and that disproportionately affects poor and marginalized populations, 

designated by regulation by the Secretary. 

‘‘(4) TROPICAL DISEASE PRODUCT APPLICATION.—The term 

‘tropical disease product application’ means an application 

that— 

‘‘(A) is a human drug application as defined in section 

735(1)— 

‘‘(i) for prevention or treatment of a tropical disease; and 

‘‘(ii) the Secretary deems eligible for priority 

review; 

‘‘(B) is approved after the date of the enactment of 

the Food and Drug Administration Amendments Act of 

2007, by the Secretary for use in the prevention, detection, 

or treatment of a tropical disease; and 

‘‘(C) is for a human drug, no active ingredient 

(including any ester or salt of the active ingredient) of 

which has been approved in any other application under 

section 505(b)(1) or section 351 of the Public Health Service 

Act. 

‘‘(b) PRIORITY REVIEW VOUCHER.— 

‘‘(1) IN GENERAL.—The Secretary shall award a priority 

review voucher to the sponsor of a tropical disease product 

application upon approval by the Secretary of such tropical 

disease product application. 

‘‘(2) TRANSFERABILITY.—The sponsor of a tropical disease 

product that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such 

voucher to a sponsor of a human drug for which an application 

under section 505(b)(1) or section 351 of the Public Health 

Service Act will be submitted after the date of the approval 

of the tropical disease product application. 

‘‘(3) LIMITATION.— 

‘‘(A) NO AWARD FOR PRIOR APPROVED APPLICATION.— 

A sponsor of a tropical disease product may not receive 

a priority review voucher under this section if the tropical 

disease product application was submitted to the Secretary 

prior to the date of the enactment of this section. 

‘‘(B) ONE-YEAR WAITING PERIOD.—The Secretary shall 

issue a priority review voucher to the sponsor of a tropical 

disease product no earlier than the date that is 1 year 


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after the date of the enactment of the Food and Drug 

Administration Amendments Act of 2007. 

‘‘(4) NOTIFICATION.—The sponsor of a human drug application shall notify the Secretary not later than 365 days prior 

to submission of the human drug application that is the subject 

of a priority review voucher of an intent to submit the human 

drug application, including the date on which the sponsor 

intends to submit the application. Such notification shall be 

a legally binding commitment to pay for the user fee to be 

assessed in accordance with this section. 

‘‘(c) PRIORITY REVIEW USER FEE.— ‘‘(1) IN GENERAL.—The Secretary shall establish a user 

fee program under which a sponsor of a human drug application 

that is the subject of a priority review voucher shall pay to 

the Secretary a fee determined under paragraph (2). Such fee 

shall be in addition to any fee required to be submitted by 

the sponsor under chapter VII. 

‘‘(2) FEE AMOUNT.—The amount of the priority review user 

fee shall be determined each fiscal year by the Secretary and 

based on the average cost incurred by the agency in the review 

of a human drug application subject to priority review in the 

previous fiscal year. 

‘‘(3) ANNUAL FEE SETTING.—The Secretary shall establish, 

before the beginning of each fiscal year beginning after September 30, 2007, for that fiscal year, the amount of the priority 

review user fee. 

‘‘(4) PAYMENT.— 

‘‘(A) IN GENERAL.—The priority review user fee 

required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) 

or section 351 of the Public Health Services Act for which 

the priority review voucher is used. 

‘‘(B) COMPLETE APPLICATION.—An application described 

under subparagraph (A) for which the sponsor requests 

the use of a priority review voucher shall be considered 

incomplete if the fee required by this subsection and all 

other applicable user fees are not paid in accordance with 

the Secretary’s procedures for paying such fees. 

‘‘(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR

REFUNDS.—The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable 

under this section. 

‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to 

this subsection for any fiscal year— 

‘‘(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food 

and Drug Administration; and 

‘‘(B) shall not be collected for any fiscal year except 

to the extent provided in advance in appropriation Acts.’’. 

SEC. 1103. IMPROVING GENETIC TEST SAFETY AND QUALITY. 

(a) REPORT.—If the Secretary’s Advisory Committee on 

Genetics, Health, and Society does not complete and submit the 

Regulatory Oversight of Genetic/Genomic Testing Report & Action 

Recommendations to the Secretary of Health and Human Services 

(referred to in this section as the ‘‘Secretary’’) by July of 2008, 

the Secretary shall enter into a contract with the Institute of 

Contracts. 

Study. 

Deadline. 


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Medicine to conduct a study to assess the overall safety and quality 

of genetic tests and prepare a report that includes recommendations 

to improve Federal oversight and regulation of genetic tests. Such 

study shall take into consideration relevant reports by the Secretary’s Advisory Committee on Genetics, Health, and Society and 

other groups and shall be completed not later than 1 year after 

the date on which the Secretary entered into such contract. 

(b) RULE OF CONSTRUCTION.—Nothing in this section shall be 

construed as requiring Federal efforts with respect to regulatory 

oversight of genetic tests to cease or be limited or delayed pending 

completion of the report by the Secretary’s Advisory Committee 

on Genetics, Health, and Society or the Institute of Medicine. 

SEC. 1104. NIH TECHNICAL AMENDMENTS. 

The Public Health Service Act (42 U.S.C. 201 et seq.) is 

amended— 

(1) in section 319C–2(j)(3)(B), by striking ‘‘section 319C– 

1(h)’’ and inserting ‘‘section 319C–1(i)’’; 

(2) in section 402(b)(4), by inserting ‘‘minority and other’’ 

after ‘‘reducing’’; 

(3) in section 403(a)(4)(C)(iv)(III), by inserting ‘‘and 

postdoctoral training funded through research grants’’ before 

the semicolon; 

(4) by designating the second section 403C (relating to 

the drug diethylstilbestrol) as section 403D; and 

(5) in section 403C(a)— 

(A) in the matter preceding paragraph (1)— 

(i) by inserting ‘‘graduate students supported by 

the National Institutes of Health’’ after ‘‘with respect 

to’’; and 

(ii) by deleting ‘‘each degree-granting program’’; 

(B) in paragraph (1), by inserting ‘‘such’’ after ‘‘percentage of’’; and 

(C) in paragraph (2), by inserting ‘‘(not including any 

leaves of absence)’’ after ‘‘average time’’. 

SEC. 1105. SEVERABILITY CLAUSE. 

If any provision of this Act, an amendment made this Act, 

or the application of such provision or amendment to any person 

or circumstance is held to be unconstitutional, the remainder of 

this Act, the amendments made by this Act, and the application 

of the provisions of such to any person or circumstances shall 

not be affected thereby. 

Subtitle B—Antibiotic Access and 

Innovation 

SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CONCENTRATIONS OF ANTIMICROBIALS. 

(a) DEFINITION.—In this section, the term ‘‘clinically susceptible 

concentrations’’ means specific values which characterize bacteria 

as clinically susceptible, intermediate, or resistant to the drug (or 

drugs) tested. 

(b) IDENTIFICATION.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), through the 

Commissioner of Food and Drugs, shall identify (where such 

42 USC 247d–5a. 

21 USC 301 note. 

42 USC 283a–2. 

42 USC 283a–3. 

42 USC 283. 

42 USC 282. 

42 USC 247d–3b. 


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information is reasonably available) and periodically update clinically susceptible concentrations. 

(c) PUBLIC AVAILABILITY.—The Secretary, through the Commissioner of Food and Drugs, shall make such clinically susceptible 

concentrations publicly available, such as by posting on the Internet, 

not later than 30 days after the date of identification and any 

update under this section. 

(d) EFFECT.—Nothing in this section shall be construed to 

restrict, in any manner, the prescribing of antibiotics by physicians, 

or to limit the practice of medicine, including for diseases such 

as Lyme and tick-borne diseases. 

SEC. 1112. ORPHAN ANTIBIOTIC DRUGS. 

(a) PUBLIC MEETING.—The Commissioner of Food and Drugs 

shall convene a public meeting regarding which serious and life 

threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antibiotic-resistant bacteria, 

potentially qualify for available grants and contracts under section 

5(a) of the Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives 

for development. 

(b) GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN

DRUGS.—Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) 

is amended to read as follows: 

‘‘(c) For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000 for each of fiscal years 

2008 through 2012.’’. 

SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 

ENANTIOMERS. 

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 355), as amended by section 920, is further amended by 

adding at the end the following: 

‘‘(u) CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.— ‘‘(1) IN GENERAL.—For purposes of subsections (c)(3)(E)(ii) 

and (j)(5)(F)(ii), if an application is submitted under subsection 

(b) for a non-racemic drug containing as an active ingredient 

(including any ester or salt of the active ingredient) a single 

enantiomer that is contained in a racemic drug approved in 

another application under subsection (b), the applicant may, 

in the application for such non-racemic drug, elect to have 

the single enantiomer not be considered the same active ingredient as that contained in the approved racemic drug, if— 

‘‘(A)(i) the single enantiomer has not been previously 

approved except in the approved racemic drug; and 

‘‘(ii) the application submitted under subsection (b) 

for such non-racemic drug— 

‘‘(I) includes full reports of new clinical investigations (other than bioavailability studies)— 

‘‘(aa) necessary for the approval of the application under subsections (c) and (d); and 

‘‘(bb) conducted or sponsored by the applicant; 

and 

‘‘(II) does not rely on any investigations that are 

part of an application submitted under subsection (b) 

for approval of the approved racemic drug; and 

‘‘(B) the application submitted under subsection (b) 

for such non-racemic drug is not submitted for approval 

of a condition of use— 

Appropriation 

authorization. 

Deadline. 


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‘‘(i) in a therapeutic category in which the approved 

racemic drug has been approved; or 

‘‘(ii) for which any other enantiomer of the racemic 

drug has been approved. 

‘‘(2) LIMITATION.— ‘‘(A) NO APPROVAL IN CERTAIN THERAPEUTIC CAT- EGORIES.—Until the date that is 10 years after the date 

of approval of a non-racemic drug described in paragraph 

(1) and with respect to which the applicant has made 

the election provided for by such paragraph, the Secretary 

shall not approve such non-racemic drug for any condition 

of use in the therapeutic category in which the racemic 

drug has been approved. 

‘‘(B) LABELING.—If applicable, the labeling of a nonracemic drug described in paragraph (1) and with respect 

to which the applicant has made the election provided 

for by such paragraph shall include a statement that the 

non-racemic drug is not approved, and has not been shown 

to be safe and effective, for any condition of use of the 

racemic drug. 

‘‘(3) DEFINITION.— 

‘‘(A) IN GENERAL.—For purposes of this subsection, the 

term ‘therapeutic category’ means a therapeutic category 

identified in the list developed by the United States 

Pharmacopeia pursuant to section 1860D–4(b)(3)(C)(ii) of 

the Social Security Act and as in effect on the date of 

the enactment of this subsection. 

‘‘(B) PUBLICATION BY SECRETARY.—The Secretary shall 

publish the list described in subparagraph (A) and may 

amend such list by regulation. 

‘‘(4) AVAILABILITY.—The election referred to in paragraph 

(1) may be made only in an application that is submitted 

to the Secretary after the date of the enactment of this subsection and before October 1, 2012.’’. 

SEC. 1114. REPORT. 

Not later than January 1, 2012, the Comptroller General of 

the United States shall submit a report to the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives that 

examines whether and how this subtitle has— 

(1) encouraged the development of new antibiotics and 

other drugs; and 

Deadline. 


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LEGISLATIVE HISTORY—H.R. 3580: 

CONGRESSIONAL RECORD, Vol. 153 (2007): 

Sept. 19, considered and passed House. 

Sept. 20, considered and passed Senate. 

Æ 

(2) prevented or delayed timely generic drug entry into 

the market. 

Approved September 27, 2007. 


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