Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration 21 CFR Part 5
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Final rule.
 SUMMARY: The Food and Drug Administration (FDA) is revising its regulation for its delegations of authority, to improve information retrieval, ensure consistency, clarify redelegation statements, update the legal citations and position and organizational titles, and, in some instances, redelegate authorities to additional agency officials and employees.  This action is necessary to ensure the continued accuracy of the regulations.
 DATES: This rule is effective April 2, 2001.
 FOR FURTHER INFORMATION CONTACT: Donna Page or Robin Phipps, Division of Management Programs (HFA-340), Food and Drug Administration, 301-827-4816 or 301-827-4806, respectively.


SUPPLEMENTARY INFORMATION: FDA is revising its regulations for delegation of authority and organization in part 5 (21 CFR part 5) to improve information retrieval by agency officials and employees, the public, and affected industries; to ensure the accuracy of the regulation by removing or correcting obsolete references to legislation, organizational and position titles; and to improve consistency in the display of the information.  This regulation includes revisions to § 5.10 to clarify that the authority of the Secretary of Health and Human Services (the Secretary) is delegated directly to the Commissioner of Food and Drugs (the Commissioner), as well as to correct or remove outdated statutory citations.  In 21 CFR, subpart B has been substantially reorganized, made into additional subparts, and updated. Prior to November 1995, the Commissioner had reported to the Assistant Secretary for Health (ASH), and the Commissioner exercised authority delegated from the Secretary through the ASH.  In November 1995, the Secretary designated U.S. Public Health Service agencies, including FDA, as Operating Divisions within the Department of Health and Human Services that report directly to the Secretary, and deleted the Office of the ASH (60 FR 56605, November 9, 1995).  In this revision, we have therefore modified the introductory language of § 5.10(a) to indicate that the delegations are from the Secretary directly to the Commissioner, and we have moved the delegations formerly listed in § 5.10(c), (d), and (f) into § 5.10(a). In this revision, we have also removed or corrected obsolete citations to legislation in § 5.10 and in the agency delegations.  Following are the legal citations that we removed or corrected, as appropriate: (1) In § 5.10(a)(1) and in § 5.32 (formerly § 5.35), we removed references to the Tea Importation Act, which Congress repealed by Public Law 104-128, section 2. (2) We removed § 5.10(a)(3), which pertained to electronic product radiation control under the PHS Act (PHS Act), because Congress transferred these provisions from the PHS Act to the Federal Food, Drug and Cosmetic Act (the act) by Public Law 101-629, section 19(a).  Additionally in §§ 5.800, 5.601, 5.602, 5.603, 5.604, 5.605, and 5.606 (formerly §§ 5.45, 5.87, 5.88, 5.89, 5.90, 5.91, and 5.92), we revised citations for electronic product radiation control to the act instead of the PHS Act. (3) In § 5.10(a)(19) (formerly § 5.10(a)(20)), we updated the reference to the acceptance of gifts, which was formerly codified under the PHS Act (at 42 U.S.C. 219) and is now codified at 42 U.S.C. 238 by Public Law 103-43, title XX, section  2010(a)(1)-(3). (4) We removed § 5.10(a)(22), which pertained to waiving matching requirements on state and local governments under title X of the Public Works and Economic Development Act of 1965 (42 U.S.C. 3246b(b)(3)), because Congress repealed section 1003(b)(3), title X, of that act by Public Law 105-393, title I, section 102(c). (5) In § 5.10(a)(22) (formerly § 5.10(a)(24)), we removed the reference to section 1704(6) of the PHS Act, because Congress repealed it by Public Law 98-551, section 2(b). (6) We removed § 5.10(a)(28), which pertained to a registry for cardiac pacemaker devices and leads under section 1862(h)(1), (2)(A), and (3) of the Social Security Act (42 U.S.C.  1395y(h)(1), (2)(A), and (3)) because Congress repealed section 1862(h) (42 U.S.C. 1395y(h)) by Public Law 104-224, section 1.   Additionally, we removed former § 5.28, regarding payments for cardiac pacemaker devices and pacemaker leads, because Congress repealed the statutory provision. (7) In § 5.10(a)(26) (formerly § 5.10(a)(29)), we updated citations under the Stevenson-Wydler Technology Innovation Act of 1980, because Congress placed what had been section 11(b)(3) into 11(b)(3)(D) and what had been section 11(b)(4) into 11(b)(3)(C) by Public Law 104-113, section 4. At the end of each section of the reorganized §§ 5.20 through 5.1000, we have added the appropriate redelegation statements.  Although the officials under § 5.20(b) (the Deputy Commissioner; Senior Associate Commissioner; Deputy Commissioner for International and Constituent Relations; Senior Associate Commissioner for Management and Systems; Senior Associate Commissioner for Policy, Planning, and Legislation; and the Associate Commissioner for Regulatory Affairs) have all the authorities of the Commissioner, their titles appear in other sections of the reorganized §§ 5.21 through 5.1000, generally to indicate that they are the agency officials who would principally exercise the authority.  Further, in some instances, the Commissioner has delegated authorities to additional agency officials to ensure more efficient operations. For the convenience of the user, we have established additional subparts to categorize the information about delegations within FDA by functional areas.  In this revision, the subparts are Subpart B, General Redelegations of Authority; Subpart C, Human Drugs, Redelegations of Authority; Subpart D, Biologics, Redelegations of Authority; Subpart E, Food and Cosmetics, Redelegations of Authority; Subpart F, Medical Devices, Redelegations of Authority; Subpart G, Animal Drugs, Redelegations of Authority; Subpart H, Radiation Control, Redelegations of Authority; Subpart I, Product Designation, Redelegations of Authority; Subpart J, Imports and Exports, Redelegations of Authority; Subpart K, Orphan Products, Redelegations of Authority; Subpart L, Mammography Facilities, Redelegations of Authority; and Subpart M, Organization.  We have cross-referenced (in the attached Appendix) the former subparts and sections to the new subparts and sections; and we are displaying the entire text of the revised part 5. The agency is issuing this rule as a final rule without publishing a general notice of proposed rulemaking because such notice is not required for this rule of agency organization, procedure, or practice under 5 U.S.C. 533(b)(A). The agency has determined under 21 CFR 25.30 that this action is of a type that does not individually or 
                        ( print page 30993)
                        cumulatively have a significant effect on the human environment.  Therefore, neither an environmental assessment nor an environmental impact statement is required. FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132.  FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.  Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required. FDA has examined the impacts of this final rule under Executive Order 12866.  Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).  Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million or more, or adversely affecting in a material way a sector of the economy, competition, or jobs, or if it raises novel legal or policy issues.   The agency finds that this final rule, which reorganizes, updates, and clarifies the agency’s internal delegations, is not a significant rule as defined by Executive Order 12866.  No analysis is required under the Regulatory Flexibility Act (5 U.S.C. 601-612) because the agency is issuing it without publishing a general notice of proposed rulemaking, as explained previously in this document. This final rule contains no collections of information.  Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. The agency plans to migrate to an Intra/Internet-based system for publishing the delegations of authority and eventually remove them from part 5.   The agency will publish a notice to make that change effective and provide the Internet website address. The Commissioner hereby ratifies and affirms any actions taken by the delegates and their subordinates, which in effect, involved the exercise of the authorities delegated herein prior to the effective date of this notice. List of Subjects in 21 CFR Part 5 Authority delegations (Government agencies)
Imports
Organization and functions (Government agencies)
 Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, title 21 CFR part 5 is revised to read as follows: PART 5—DELEGATIONS OF AUTHORITY AND ORGANIZATION
 1. Part 5 is revised in its entirety to read as follows: PART 5—DELEGATIONS OF AUTHORITY AND ORGANIZATION
 Subpart A—Delegations of Authority to the Commissioner of Food and Drugs
 5.10
                        Delegations from the Secretary for Health and Human Services to the Commissioner of Food and Drugs.
                        5.11
                        Reservation of authority.
                        Subpart B—General Redelegations of Authority
 5.20
                        General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration.
                        5.21
                        Emergency functions.
                        5.22
                        Certification of true copies and use of Department seal.
                        5.23
                        Disclosure of official records and authorization of testimony.
                        5.24
                        Authority relating to technology transfer.
                        5.25
                        Research, investigation, and testing programs and health information and promotion programs.
                        5.26
                        Service fellowships.
                        5.27
                        Patent term extensions for human drug products, medical devices, and food and color additives; and authority to perform due diligence determinations and informal hearings.
                        5.28
                        Hearings.
                        5.29
                        Petitions under part 10.
                        5.30
                        Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers.
                        5.31
                        Enforcement activities.
                        5.32
                        Certification following inspections.
                        5.33
                        Issuance of reports of minor violations.
                        5.34
                        Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.
                        5.35
                        Officials authorized to make certification under 5  U.S.C. 605(b) for any proposed and final rules.
                        Subpart  C—Human  Drugs;  Redelegations  of  Authority
 5.100
                        Issuance  of  notices  implementing  the  provisions  of  the  Drug  Amendments  of  1962.
                        5.101
                        Termination  of  exemptions  for  new  drugs  for  investigational  use  in  human  beings.
                        5.102
                        Authority  to  approve  and  to  withdraw  approval  of  a  charge  for  investigational  new  drugs.
                        5.103
                        Approval  of  new  drug  applications  and  their  supplements.
                        5.104
                        Responses  to  Drug  Enforcement  Administration  temporary  scheduling  notices.
                        5.105
                        Issuance  of  notices  relating  to  proposals  to  refuse  approval  or  to  withdraw  approval  of  new  drug  applications  and  their  supplements.
                        5.106
                        Submission of and effective approval dates for abbreviated new drug applications  and certain new drug applications.
                        5.107
                        Extensions  or  stays  of  effective  dates  for  compliance  with  certain  labeling  requirements  for  human  prescription  drugs.
                        5.108
                        Authority  relating  to  waivers  or  reductions  of  prescription  drug  user  fees.
                        5.109
                        Issuance  of  written  notices  concerning  patent  information,  current  good  manufacturing  practices  and  false  or  misleading  labeling  of  new  drugs.
                        Subpart  D—Biologics;  Redelegations  of  Authority
 5.200
                        Functions  pertaining  to  safer  vaccines.
                        5.201
                        Redelegation  of  the  Center  for  Biologics  Evaluation  and  Research  Director’s  program  authorities.
                        5.202
                        Issuance  of  notices  of  opportunity  for  a  hearing  on  proposals  for  denial  of  approval  of  applications  for  licenses,  suspension  of  licenses,  or  revocation  of  licenses  and  certain  notices  of  revocation  of  licenses.
                        5.203
                        Issuance  and  revocation  of  licenses  for  the  propagation  or  manufacture  and  preparation  of  biological  products.
                        5.204
                        Notification  of  release  for  distribution  of  biological  products.
                        Subpart  E—Foods  and  Cosmetics;  Redelegations  of  Authority
 5.300
                        Food  standards,  food  additives,  generally  recognized  as  safe  (GRAS)  substances,  color  additives,  nutrient  content  claims,  and  health  claims.
                        5.301
                        Issuance  of  initial  emergency  permit  orders  and  notices  of  confirmation  of  effective  date  of  final  regulations  on  food  for  human  and  animal  consumption.
                        5.302
                        Detention  of  meat,  poultry,  eggs,  and  related  products.
                        5.303
                        Establishing  standards  and  approving  accrediting  bodies  under  the  National  Laboratory  Accreditation  Program.
                        5.304
                        Approval  of  schools  providing  food-processing  instruction.
                        Subpart F—Medical  Devices and Radiological Health; Redelegations  of Authority
 5.400
                        Issuance  of 
                            **Federal Register**
                             documents to recognize or to withdraw recognition of a standard to meet premarket submission requirements.
                        ( print page 30994)
                        5.401
                        Issuance of 
                            **Federal Register**
                             documents pertaining to exemptions from premarket notification.
                        5.402
                        Detention of adulterated or misbranded medical devices.
                        5.403
                        Authorization to use alternative evidence for determination of the effectiveness of medical devices.
                        5.404
                        Notification of petitioners of determinations made on petitions for reclassification of medical devices.
                        5.405
                        Determination of classification of devices.
                        5.406
                          
                        Notification to sponsors of deficiencies in petitions for reclassification of medical devices.
                        5.407
                          
                        Approval, disapproval, or withdrawal of approval of product development protocols and applications for  premarket approval for medical devices.
                        5.408
                          
                        Determinations concerning the type of valid scientific evidence submitted in a premarket approval application.
                        5.409
                          
                        Determinations that medical devices present unreasonable risk of substantial harm.
                        5.410
                        Orders  to  repair  or  replace,  or  make  refunds  for,  medical  devices.
                        5.411
                        Medical  device  recall  authority.
                        5.412
                        Temporary  suspension  of  a  medical  device  application.
                        5.413
                        Approval,  disapproval,  or  withdrawal  of  approval  of  applications  and  entering  into  agreements  for  investigational  device  exemptions.
                        5.414
                        Postmarket  surveillance.
                        5.415
                        Authority  relating  to  medical  device  reporting  procedures.
                        5.416
                        Medical  device  tracking.
                        5.417
                        Authority  pertaining  to  accreditation  functions  for  medical  devices.
                        Subpart  G—Animal  Drugs;  Redelegations  of  Authority.
 5.500
                        Issuance  of 
                            **Federal Register**
                             documents  pertaining  to  the  determination  of  safe  levels,  notice  of  need  for  development  of  an  analytical  method,  notice  of  availability  of  a  developed  analytical  method,  and  prohibition  of  certain  extralabel  drug  use.
                        5.501
                        Approval  of  new  animal  drug  applications,  medicated  feed  mill  license  applications  and  their  supplements.
                        5.502
                        Issuance  of  notices,  proposals,  and  orders  relating  to  new  animal  drugs  and  medicated  feed  mill  license  applications.
                        5.503
                        Submission  of  and  effective  approval  dates  for  abbreviated  new  animal  drug  applications  and  certain  new  animal  drug  applications.
                        5.504
                        Issuance  of  written  notices  concerning  patent  information,  current  good  manufacturing  practices  and  false  or  misleading  labeling  of  new  animal  drugs  and  feeds  bearing  or  containing  new  animal  drugs.
                        5.505
                        Termination  of  exemptions  for  new  drugs  for  investigational  use  in  animals.
                        Subpart  H—Radiation  Control;  Redelegations  of  Authority
 5.600
                        Variances  from  performance  standards  for  electronic  products.
                        5.601
                        Exemption  of  electronic  products  from  performance  standards  and  prohibited  acts.
                        5.602
                        Testing  programs  and  methods  of  certification  and  identification  for  electronic  products.
                        5.603
                        Notification  of  defects  in,  and  repair  or  replacement  of,  electronic  products.
                        5.604
                        Manufacturers  requirement  to  provide  date  to  ultimate  purchasers  of  electronic  products.
                        5.605
                        Dealer  and  distributor  direction  to  provide  data  to  manufacturers  of  electronic  products.
                        5.606
                        Acceptance  of  assistance  from  State  and  Local  authorities  for  enforcement  of  radiation  control  legislation  and  regulations.
                        Subpart  I—Product  Designation;  Redelegations  of  Authority
 5.700
                        Authority  relating  to  determination  of  product  primary  jurisdiction.
                        5.701
                        Premarket  approval  of  a  product  that  is  or  contains  a  biologic,  a  device,  or  a  drug.
                        Subpart  J—Imports and Exports;  Redelegations  of  Authority
 5.800
                        Imports  and  exports.
                        5.801
                        Export  of  unapproved  drugs.
                        5.802
                        Manufacturer’s  resident  import  agents.
                        Subpart  K—Orphan  Products;  Redelegations  of  Authority
 Sec.
                        5.900  Orphan  products.
                        Subpart  L—Mammography  Facilities;  Redelegations  of  Authority
 5.1000
                        Authority  to  ensure  that  mammography  facilities  meet  quality  standards.
                        Subpart  M—Organization
 5.1100
                        Headquarters.
                        5.1105
                        Chief  Counsel,  Food  and  Drug  Administration.
                        5.1110
                        Food and Drug Administration  Public  Information  Offices.
                        5.1115
                        Field  Structure.
 Authority:
                        5 U.S.C. 504, 552, App. 2 605; 7 U.S.C. 138a, 2217; 15 U.S.C. 638, 1261-1282, 1451-1461, 3701-3711a; 21 U.S.C., 61-63, 141-149, 301-394, 467f, 679(b), 801-886, 1031-1309, 1401-1403; 35 U.S.C. 156; 42 U.S.C. 238, 241, 242, 242a, 242l, 242n, 242o, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1, 300ar-25-28, 300cc, 300ff, 1395y, 4332, 4831(a), 10007-10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223. Subpart  A—Delegations  of  Authority  to  the  Commissioner  of  Food  and  Drugs
 § 5.10
 (a)  The  Secretary  of  Health  and  Human  Services  (the  Secretary)  has  redelegated  to  the  Commissioner  of  Food  and  Drugs  (Commissioner),  with  authority  to  redelegate  (except  when  specifically  prohibited),  all  authority  as  follows: (1)  Functions  vested  in  the  Secretary  under  the  Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.  301 
                        *et  seq*.),  as  amended,  the  Filled  Milk  Act  (21  U.S.C.  61-63),  the  Federal  Import  Milk  Act  (21  U.S.C.  141 
                        *et  seq*.),  the  Federal  Caustic  Poison  Act  (44  Stat.  1406;  see  also  Public  Law  86-613,  section  19,  formerly  section   18)  and  The  Fair  Packaging  and  Labeling  Act  (15  U.S.C.  1451 
                        *et  seq*.),  under  section  12  of  Reorganization  Plan  No.  IV  and  Reorganization  Plan  No.  1  of  1953,  including  authority  to  administer  oaths  vested  in  the  Secretary  of  Agriculture  by  7  U.S.C.  2217. (2)  Functions  vested  in  the  Secretary  under  section  301  (Research  and  Investigations);  section  307  (International  Cooperation);  and  section  311  (Federal-State  Cooperation)  of  the  Public  Health  Service  Act  (the  PHS  Act)  (42  U.S.C.  241,  242l,  243),  as  amended,  which  relate  to  the  functions  of  the  Food  and  Drug  Administration. (3)  Functions  vested  in  the  Secretary  under  section  361  of  the  PHS  Act  (42  U.S.C.  264),  as  amended,  which  relate  to  the  law  enforcement  functions  of  the  Food  and  Drug  Administration  concerning  the  following  products  and  activities:   Biologicals  (including  blood  and  blood  products);  interstate  travel  sanitation  (except  interstate  transportation  of  etiologic  agents  under  42  CFR  part  72);  food  (including  milk  and  food  service  sanitation  and  shellfish  sanitation);  and  drugs,  devices,  cosmetics,  electronic  products,  and  other  items  or  products  regulated  by  the  Food  and  Drug  Administration. (4)  Functions  vested  in  the  Secretary  under  sections  351  and  352  of  part  F,  subpart  1  of  the  PHS  Act  (42  U.S.C.  262  and  263),  as  amended  (Biological  Products),  insofar  as  they  relate  to  the  functions  assigned  to  the  Food  and  Drug  Administration. (5)  Functions  vested  in  the  Secretary  under  section  302(a)  of  the  PHS  Act  (42  U.S.C.  242(a)),  as  amended,  which  relate  to  the  determination  and  reporting  requirements  with  respect  to  the  medicinal  and  scientific  requirements  of  the  United  States  for  controlled  substances. (6)  Functions  vested  in  the  Secretary  under  section  303  of  the  PHS  Act  (42  U.S.C.  242a),  as  amended,  which  relate  to  the  authorization  of  persons  engaged  in  research  on  the  use  and  effect  of  drugs  to  protect  the  identity  of  their  research  subjects  with  respect  to  drugs  scheduled  under  Public  Law  91-513  for  which  an  investigational  new  drug 
                        ( print page 30995)
                        application  is  filed  with  the  Food  and  Drug  Administration  and  with  respect  to  all  drugs  not  scheduled  under  Public  Law  91-513. (7)  Functions  vested  in  the  Secretary  pertaining  to  section  4  of  the  Comprehensive  Drug  Abuse  Prevention  and  Control  Act  of  1970  (Public  Law  91-513,  84  Stat.  1241)  which  relate  to  the  determination  of  the  safety  and  effectiveness  of  drugs  or  to  approve  new  drugs  to  be  used  in  the  treatment  of  narcotic  addicts. (8)  Functions  vested  in  the  Secretary  pertaining  to  section  303(f)  of  the  Controlled  Substances  Act  (21  U.S.C.  823(f)),  which  relate  to  the  merits  of  the  research  protocol  and  to  the  determination  of  the  qualifications  and  competency  of  practitioners  wishing  to  conduct  research  with  controlled  substances  listed  in  Schedule  I  of  the  Act. (9)  Functions  vested  in  the  Secretary  pertaining  to  provisions  of  the  Controlled  Substances  Act  (21  U.S.C.  801 
                        *et  seq*.),  which  relate  to  administration  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.  301 
                        *et  seq*.). (10)  Functions  vested  in  the  Secretary  under  section  409(b)  of  the  Federal  Meat  Inspection  Act  (21  U.S.C.  679(b)),  which  relate  to  the  detention  of  any  carcass,  part  thereof,  meat,  or  meat  product  of  cattle,  sheep,  swine,  goats,  or  equines. (11)  Functions  vested  in  the  Secretary  under  section  24(b)  of  the  Poultry  Products  Inspection  Act  (21  U.S.C.  467f(b)),  which  relate  to  the  detention  of  any  poultry  carcass,  part  thereof,  or  poultry  product. (12)  Functions  vested  in  the  Secretary  under  the  Egg  Products  Inspection  Act  (21  U.S.C.  1031 
                        *et  seq*.). (13)  Functions  vested  in  the  Secretary  by  amendments  to  the  foregoing  statutes  subsequent  to  Reorganization  Plan  No.  1  of  1953. (14)  Function  of  issuing  all  regulations  of  the  Food  and  Drug  Administration,  except  as  provided  in  § 5.11.  The  reservation  of  authority  contained  in  Chapter  2-000  of  the  Department  Organization  Manual  shall  not  apply. (15)  Functions  vested  in  the  Secretary  under  section  1103  of  Executive  Order  11490,  as  amended  by  Executive  Order  11921,  which  relate  to  emergency  health  functions  as  they  pertain  to  the  operations  and  functional  responsibilities  assigned  to  the  agency.   This  authority  shall  be  exercised  in  accordance  with  section  102  and  pertinent  sections  of  part  30  of  Executive  Order  11490  and  guidelines  issued  by  the  Federal  Preparedness  Agency  of  the  General  Services  Administration  and  the  Office  of  the  Secretary. (16)  Function  vested  in  the  Secretary  of  authorizing  and  approving  miscellaneous  and  emergency  expenses  of  enforcement  activities. (17)  Functions  vested  in  the  Secretary  under  the  Federal  Advisory  Committee  Act,  Public  Law  92-463,  to: (i)  Renew,  recharter,  amend  and  terminate  established  Federal  Advisory  Committees; (ii)  Authority  to  approve  waivers  to  appoint  committee  members  to  established  Federal  Advisory  Committees; (iii)  Authority  to  close  review  meetings  following  approval  by  the  Office  of  the  General  Counsel  based  on  a  determination  that  the  Advisory  Committee  meeting  or  a  portion  thereof  may  be  closed  to  the  public  under the  provisions  of  5  U.S.C.  552b(c)  and  section  10(d)  of  the  Federal  Advisory  Committee  Act.   These  authorities  are  to  be  exercised  in  accordance  with  the  requirements  of  5  U.S.C.  552b;  the  Federal  Advisory  Committee  Act  (Public  Law  92-463);  Departmental  regulations  (45  CFR  part  11,  superseded  by  41  CFR  part  101-6);  and  any  other  applicable  statutes  and  regulations.   These  authorities  may  be  redelegated. (18)  Functions  vested  in  the  Secretary  under  the  second  sentence  of  section  310(a)  and  under  section  310(b)  (Health  Conferences  and  Health  Education  Information)  of  the  PHS  Act  (42  U.S.C.  242o),  as  amended,  to  call  for  a  conference  and  invite  as  many  health  authorities  and  officials  of  State  or  local  public  or  private  agencies  or  organizations  as  deemed  necessary  or  proper  on  subjects  related  to  the  functions  of  the  Food  and  Drug  Administration,  and  to  issue  information  related  to  health  for  the  use  of  the  public  and  other  pertinent  health  information  for  the  use  of  persons  and  institutions  concerned  with  health  services  when  such  information  is  related  to  the  functions  of  the  Food  and  Drug  Administration. (19)  Functions  vested  in  the  Secretary  under  section  2701  of  the  PHS  Act  (42  U.S.C.  238),  as  amended,  to  accept  offers  of  gifts,  excluding  the  acceptance  of  gifts  of  real  property.   Only  the  authority  to  accept  unconditional  gifts  of  personal  property  valued  at  $5,000  or  less  may  be  redelegated. (20)  Functions  vested  in  the  Secretary  under  section  362  of  the  PHS  Act  (42  U.S.C.  265),  as  amended,  which  relate  to  the  prohibition  of  the  introduction  of  foods,  drugs,  devices,  cosmetics,  electronic  products,  and  other  items  or  products  regulated  by  the  Food  and  Drug  Administration  into  the  United  States  when  it  is  determined  that  it  is  required  in  the  interest  of  public  health  when  such  functions  relate  to  the  law  enforcement  functions  of  the  Food  and  Drug  Administration. (21)  Functions  vested  in  the  Secretary  under  section  401(a)  of  the  Lead-Based  Paint  Poisoning  Prevention  Act,  as  amended  by  Public  Law  94-317  (42  U.S.C.  4831(a)),  relating  to the  prohibition  of  the  application  of  lead-based  paint  to  cooking,  drinking,  or  eating  utensils. (22)  Functions  vested  in  the  Secretary  for  the  health  information  and  health  promotion  program  under  title  XVII  of  the  PHS  Act  (42  U.S.C.  300u 
                        *et  seq*.),  as  amended,  insofar  as  the  authorities  pertain  to  functions  assigned  to  the  Food  and  Drug  Administration.  The  delegation  includes,  but  is  not  limited  to,  the  authorities  under:   Section  1702(a)(1)  and  (3)  and  section  1704(1)  and  (2)  (42  U.S.C.  300u-1(a)  and  (3)  and  300u-3(1)  and  (2)).  The  delegation  excludes  the  authority  to  select  all  Senior  Executive  Service,  supergrade  and  equivalent,  and  Schedule  C  (GS-12  and  above)  positions;  issue  regulations;  and  submit  reports  to  the  President. (23)  To  administer  a  Small  Business  Innovation  Research  Program  under  section  9  of  the  Small  Business  Act  (15  U.S.C.  638),  as  amended.  The  delegation  excludes  the  authority  to  issue  regulations,  establish  advisory  councils  and  committees,  appoint  members  to  advisory  councils  and  committees,  and  submit  reports  to  Congress. (24)  Functions  vested  in  the  Secretary  under  sections  982  and  983  of  the  Consumer-Patient  Radiation  Health  and  Safety  Act  of  1981  (the  Act)   (42  U.S.C.  10007  and  10008),  as  amended.  The  delegation  excludes  the  authority  to  issue  regulations  and  submit  reports  to  Congress.  The  authority  delegated  under  section  983  of  the  Act  may  only  be  exercised  as  it  relates  to  functions  assigned  to  the  Food  and  Drug  Administration. (25)  Functions  vested  in  the  Secretary  under  section  156  of  title  35  of  the  U.S.  Code  (35  U.S.C.  156),  as  amended,  which  allows  for  the  extension  of  patent  terms  for  human  drug  products,  medical  devices,  food  additives,  and  color  additives  subject  to  the  Federal  Food,  Drug,  and  Cosmetic  Act  (the  act).  These  authorities  may  be  redelegated,  except  the  authority  to  make  due  diligence  determinations  under  section  156(d)(2)(B),  which  may  not  be  redelegated  to  an  Office  below  the  Office  of  the  Commissioner  of  Food  and  Drugs. (26)  Functions  vested  in  the  Secretary  under  the  Stevenson-Wydler  Technology  Innovation  Act  of  1980  (15 
                        ( print page 30996)
                        U.S.C.  3701 
                        *et  seq*.)  (the  Act),  as  amended,  and  under  Executive  Order  12591  of  April  10,  1987,  as  they  pertain  to  the  functions  of  the  Food  and  Drug  Administration.   The  delegation  excludes  the  authority  to  issue  regulations  and  submit  reports  to  Congress;  under  section  11(a)(2)  of  the  Act  (15  U.S.C.  3710a(a)(2))  to  approve  agreements  and  contracts  with  invention  management  organizations;  and  under  section  11(c)(3)(B)  of  the  Act  (15  U.S.C.  3710a(c)(3)(B))  to  propose  necessary  statutory  changes  regarding  conflict  of  interest. (i)  The  authorities  under  sections  11(c)(5)  (A)  and  (B)  of  the  Act  (15  U.S.C.  3710a  (c)(5)  (A)  and  (B))  to  disapprove  or  require  the  modification  of  cooperative  research  and  development  agreements  and  licensing  agreements  after  the  agreement  is  presented  to  the  Commissioner  by  the  head  of  the  laboratory  concerned,  and  to  transmit  written  explanation  of  such  disapproval  or  modification  to  the  head  of  the  laboratory  concerned,  may  be  redelegated  only  to  a  senior  official  in  the  immediate  Office  of  the  Commissioner. (ii)  The  following  authorities  may  not  be  redelegated:   The  authority  under  section  11(b)(3)(D)  of  the  Act  (15  U.S.C.  3710a(b)(3)(D))  to  waive  a  right  of  ownership  which  the  Federal  Government  may  have  to  an  invention  made  under  a  cooperative  research  and  development  agreement;  the  authority  under  section  11(b)(3)(C)  of  the  Act  (15  U.S.C.  3710a(b)(3)(C))  to  permit  employees  or  former  employees  to  participate  in  efforts  to  commercialize  inventions  they  made  while  in  the  service  of  the  United  States;  the  authority  under  section  11(c)(3)(A)  of  the  Act  (15  U.S.C.  3710a(c)(3)(A))  to  review  employee  standards  of  conduct  for  resolving  potential  conflicts  of  interest;  the  authority  under  section  13(a)(1)  of  the  Act  (15  U.S.C.  3710c(a)(1))  to  retain  any  royalties  or  other  income,  except  as  provided  in  section  13(a)(2)  of  the  Act  (15  U.S.C.  3710c(a)2));  and  the  authority  under  section  13(a)(1)(A)(i)  of  the  Act  (15  U.S.C.  3710c(a)(1)(A)(i))  to  pay  royalties  or  other  income  the  agency  receives  on  account  of  an  invention  to  the  inventor  if  the  inventor  was  an  employee  of  the  agency  at  the  time  the  invention  was  made. (iii)  Any  authorities  under  paragraph  (a)(26)  of  this  section  delegated  by  the  Commissioner  may  not  be  further  redelegated. (27)  Functions  vested  in  the  Secretary  under  sections  4702,  4703,  and  4704  of  the  Pesticide  Monitoring  Improvements  Act  of  1988  (21  U.S.C.  1401-1403)  that  relate  to  pesticide  monitoring  and  enforcement  information,  foreign  pesticide  information,  and  pesticide  analytical  methods.  The  delegation  excludes  the  authority  to  submit  reports  to  Congress. (28)  Functions  vested  in  the  Secretary  under  sections  2312(a)(1)  and  (2)(B),  (b),  and  (c)  (Use  of  Investigational  New  Drugs  with  Respect  to  Acquired  Immunodeficiency  Syndrome);  2314(c)  (Scientific  and  Ethical  Guidelines  for  Certain  Treatments);  and  2317(d)  and  (e)  (Information  Services)  of  title  XXIII  of  the  PHS  Act  (42  U.S.C.  300cc-12(a)(1)  and  (2)(B),  (b)  and  (c),  300cc-14(c)  and  300cc-17  (d)  and  (e)),  as  amended,  insofar  as  these  authorities  pertain  to  the  functions  assigned  to  the  Food  and  Drug  Administration.  The  delegation  excludes  the  authority  to  issue  regulations,  submit  reports  to  the  Congress,  establish  advisory  committees  or  national  commissions,  and  appoint  members  to  such  committees  or  commissions. (29)  Functions  vested  in  the  Secretary  under  section  2672(a)(1)  (A)  and  (B)  (Provisions  Relating  to  Blood  Banks)  and  section  2672(a)(2)  (Information  and  Training  Programs)  of  the  PHS  Act  (42  U.S.C.  300ff-72(a)(1)(A)  and  (B)  and  (a)(2) 
                        *et  seq*.),  as  amended,  insofar  as  these  authorities  pertain  to  the  functions  assigned  to  the  Food  and  Drug  Administration.  The  delegations  exclude  the  authority  to  issue  regulations,  submit  reports  to  the  Congress,  establish  advisory  committees  or  national  commissioners,  and  appoint  members  to  such  committees  or  commissions. (30)  Functions  vested  in  the  Secretary  under  sections  1322(b)  and  (c)  of  the  Food,  Agriculture,  Conservation,  and  Trade  Act  of  1990  (the  National  Laboratory  Accreditation  Program)  (7  U.S.C.  138a),  as  amended  hereafter,  which  relate  to  setting  standards  for  the  National  Laboratory  Accreditation  Program  and  approving  State  agencies  or  private,  nonprofit  entities  as  accrediting  bodies  to  implement  certification  and  quality  assurance  programs  in  accordance  with  the  requirements  of  this  section.   The  delegation  excludes  the  authority  to  submit  reports  to  Congress. (31)  Functions  vested  in  the  Secretary  under  part  C,  subtitle  2  of  title  XXI  of  the  PHS  Act  (42  U.S.C.  300aa-25 
                        *et  seq*.),  as  amended,  and  the  National  Childhood  Vaccine  Injury  Act  of  1986  (42  U.S.C.  300aa-1  note),  as  amended  hereafter,  as  follows: (i)  Section  2125  of  the  PHS  Act  (42  U.S.C.  300aa-25)—Recording  and  reporting  of  information. (ii)  Section  2127  of  the  PHS  Act  (42  U.S.C.  300aa-27)—-Mandate  for  safer  childhood  vaccines. (iii)  Section  2128  of  the  PHS  Act  (42  U.S.C.  300aa-28)—Manufacturer  recordkeeping  and  reporting. (iv)  Section  312  of  the  National  Childhood  Vaccine  Injury  Act  of  1986—Related  studies  (42  U.S.C.  300aa-1  note). (v)  Section  313  of  the  National  Childhood  Vaccine  Injury  Act  of  1986—Study  of  other  vaccine  risks  (42  U.S.C.  300aa-1  note). (vi)  Section  314  of  the  National  Childhood  Vaccine  Injury  Act  of  1986—Review  of  warnings,  use  instructions,  and  precautionary  information  (42  U.S.C.  300aa-1  note). (vii)  The  delegation  excludes  the  authority  to  issue  regulations  and  submit  reports  to  Congress. (32)  Functions  vested  in  the  Secretary  under  section  201(h)(4)  of  the  Controlled  Substances  Act  (Title  II  of  the  Comprehensive  Drug  Abuse  Prevention  and  Control  Act  of  1970,  as  amended)  (21  U.S.C. 811(h)(4))  to  provide  responses  to  the  Drug  Enforcement  Administration's  temporary  scheduling  notices.  The  delegation  excludes  the  authority  to  submit  reports  to  Congress. (33)  Functions  vested  in  the  Secretary  under  the  Safe  Medical  Devices  Act  of  1990  (Pub.  L.  101-629),  as  amended  hereafter  (e.g.,  21  U.S.C.  360c  note,  360i  note,  and  360j  note).   The  delegation  excludes  the  authority  to  submit  reports  to  Congress. (34)  Functions  vested  in  the  Secretary  under  section  601  of  Effective  Medication  Guides  of  the  Agriculture,  Rural  Development,  Food  and  Drug  Administration,  and  Related  Agencies  Appropriations  Act  of  1997  (Public  Law  104-180),  as  amended  hereafter.  The  delegation  excludes  the  authority  to  issue  reports  to  Congress. (35)  The  Secretary  has  redelegated  to  the  Commissioner  of  Food  and  Drugs,  or  his  designee,  the  authority  to  take  final  action  on  matters  pertaining  to  section  203  of  the  Equal  Access  to  Justice  Act  (5  U.S.C.  504),  and  to  develop  procedures  and  regulations  where  necessary  to  supplement  the  Department's  regulations,  45  CFR  part  13. (36)  The  Secretary  has  delegated  to  the  Commissioner,  the  authority  to  administer  and  make  decisions  regarding  the  invention  and  patent  program  as  they  pertain  to  the  functions  of  the  Food  and  Drug  Administration  and  to  make  determinations  of  rights  in  inventions  and  patents  in  which  the  Department  has  an  interest.   This  delegation  excludes  the  authority  to 
                        ( print page 30997)
                        submit  reports  to  Congress  and  further,  it  excludes  those  authorities  under  the  Stevenson-Wydler  Technology  Innovation  Act  of  1980,  as  amended  by  the  Federal  Technology  Transfer  Act  of  1986  and  the  National  Technology  Transfer  and  Advancement  Act  of  1995,  which  are  governed  by  a  separate  delegation (under   § 5.10(a)(26)).   All  authorities  other  than  the  authority  under  35  U.S.C.  section  203  (March-In  Rights)  may  be  redelegated. (37)  Functions  vested  in  the  Secretary  under  title  III,  Section  354,  of  the  PHS  Act  (42  U.S.C.  262 
                        *et  seq*.),  as  amended.   The  authority  pertains  to  the  Food  and  Drug  Administration’s  oversight  of  mammography  facilities. (38)  The  Deputy  Assistant  Secretary  for  Health  Management  Operations,  Public  Health  Service,  has  redelegated  to  the  Commissioner  of  Food  and  Drugs,  with  authority  to  redelegate,  the  authority  to  certify  true  copies  of  any  books,  records,  or  other  documents  on  file  within  the  Food  and  Drug  Administration,  or  extracts  from  such;  to  certify  that  true  copies  are  true  copies  of  the  entire  file  of  the  Administration;  to  certify  the  complete  original  record  or  to  certify  the  nonexistence  of  records  on  file  within  the  Administration;  and  to  cause  the  Seal  of  the  Department  to  be  affixed  to  such  certifications  and  to  agreements,  awards,  citations,  diplomas,  and  similar  documents. (39)  The  Secretary  of  Health  and  Human  Services  has  redelegated  to  the  Commissioner,  of  Food  and  Drugs,  under  45  CFR 5b.8  regulations,  appeal  authority  to  take  final  action  upon  an  individual's  appeal  of  a  refusal  to  correct  or  amend  the  individual's  record  when  the  appeal  has  been  made  by  the  individual  under  Privacy  Act  regulations  (part  21  of  this  chapter  and  45  CFR  part  5b).  The  authority  may  not  be  redelegated. (b)  The  Chief  Counsel  of  the  Food  and  Drug  Administration  has  been  authorized  to  report  apparent  violations  to  the  Department  of  Justice  for  the  institution  of  criminal  proceedings,  under  section  305  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.  335),  section  4  of  the  Federal  Import  Milk  Act  (21  U.S.C.  144),  and  section  9(b)  of  the  Federal  Caustic  Poison  Act. § 5.11
 (a)  Notwithstanding  provisions  of  § 5.10  or  any  previous  delegations  of  authority  to  the  contrary,  the  Secretary  of  Health  and  Human  Services   (Secretary)  reserves  the  authority  to  approve  regulations  of  the  Food  and  Drug  Administration,  except  regulations  to  which  sections  556  and  557  of  title  5  U.S.C.  apply,  which: (1)  Establish  procedural  rules  applicable  to  a  general  class  of  foods,  drugs,  cosmetics,  medical  devices,  or  other  subjects  of  regulation;  or (2)  Present  highly  significant  public  issues  involving  the  quality,  availability,  marketability,  or  cost  of  one  or  more  foods,  drugs,  cosmetics,  medical  devices,  or  other  subjects  of  regulation. (b)  Nothing  in  this  section  precludes  the  Secretary  from  approving  a  regulation,  or  being  notified  in  advance  of  an  action,  to  which  sections  556  and  557  of  title  5  U.S.C.  apply,  which  meets  one  of  the  criteria  in  paragraph (a)  of  this  section. (c)  This  reservation  of  authority  is  intended  only  to  improve  the  internal  management  of  the  Department  of  Health  and  Human  Services,  and  it  is  not  intended  to  create  any  right  or  benefit,  substantive  or  procedural,  enforceable  at  law  by  a  party  against  the  United  States,  the  Department  of  Health  and  Human  Services,  the  Food  and  Drug  Administration,  any  agency,  officer,  or  employee  of  the  United  States,  or  any  person.   Regulations  issued  by  the  Food  and  Drug  Administration  without  the  approval  of  the  Secretary  are  to  be  conclusively  viewed  as  falling  outside  the  scope  of  this  reservation  of  authority. Subpart  B—General  Redelegations  of  Authority
 § 5.20
 (a)  Final  authority  of  the  Commissioner  of  Food  and  Drugs  (Commissioner)  is  redelegated  as  set  forth  in  these  subparts.   The  Commissioner  may  continue  to  exercise  all  authority  delegated  in  subparts  B  through  L. (b)  The  following  officials  are  authorized  to  perform  all  of  the  functions  of  the  Commissioner.  These  officials  may  not  further  redelegate  this  authority,  or  any  part  of  this  authority,  except  as  elsewhere  specified: (1)  Deputy  Commissioner; (2)  Associate  Commissioner  for  Regulatory  Affairs; (3)  Senior  Associate  Commissioner; (4)  Senior  Associate  Commissioner  for  Management  and  Systems; (5)  Senior  Associate  Commissioner  for  Policy,  Planning,  and  Legislation;  and (6)  Deputy  Commissioner  for  International  and  Constituent  Relations. (c)(1)  During  the  absence  or  disability  of  the  Commissioner  or  in  the  event  of  a  vacancy  in  that  position,  the  first  official  who  is  available  in  the  following  positions,  or  who  has  been  designated  by  the  Commissioner  to  act  in  such  position,  shall  act  as  Commissioner: (i)  Deputy  Commissioner; (ii)  Associate  Commissioner  for  Regulatory  Affairs;  or (iii)  Senior  Associate  Commissioner. (2)  These  officials  may  not  further  redelegate  this  authority.   However,  for  a  planned  period  of  absence,  the  Commissioner  (or  someone  “acting”  on  his/her  behalf)  may  specify  a  different  order  of  succession. (d)  Authority  delegated  to  a  position  by  title  may  be  exercised  by  a  person  officially  designated  to  serve  in  that  position  in  an  acting  capacity  or  on  a  temporary  basis,  unless  prohibited  by  a  restriction  in  the  document  designating  him/her  as  “acting”  or  unless  not  legally  permissible. (e)(1)  The  Senior  Associate  Commissioner  is  authorized  to  make  determinations  that  advisory  committee  meetings  are  concerned  with  matters  listed  in  5  U.S.C.  552(b)  and  therefore  may  be  closed  to  the  public  in  accordance  with  5.10(a)(17). (2)  The  Senior  Associate  Commissioner  is  authorized  to  perform  other  associated  advisory  committee  functions  (e.g.,  establishing  technical  and  scientific  review  groups  (advisory  committees));  appointing  and  paying  members;  approving  waivers  to  appoint  members  to  established  advisory  committees;  renewing  and  rechartering  of  established  advisory  committees;  amending  charters  of  established  advisory  committees;  and  terminating  established  advisory  committees. (3)  The  Senior  Associate  Commissioner  is  authorized  to  approve  conflict  of  interest  waivers  for  special  Government  employees  serving  on  advisory  committees  in  accordance  with  18  U.S.C.  208(b)(3),  as  amended. (4)  The  Senior  Associate  Commissioner  is  authorized  to  select  temporary  members  to  advisory  committees  if  such  voting  members  are  serving  on  an  advisory  committee  managed  by  another  center. (5)  The  Senior  Associate  Commissioner  may  not  further  redelegate  these  authorities. (f)(1)  The  Senior  Associate  Commissioner  for  Policy,  Planning,  and  Legislation   (SACPPL)  and  the  Associate  Commissioner  for  Policy  (ACP)  are  authorized  to  perform  any  of  the  functions  of  the  Commissioner  with  respect  to  the  issuance  of 
                        **Federal Register**
                         notices  and  proposed  and  final  regulations  of  the  Food  and  Drug  Administration.   These  officials  may  not  further  redelegate  this  authority. (2)  The  SACPPL  and  the  ACP  are  authorized  to  issue  responses  to  the  following  matters  under  part  10  of  this  chapter  as  follows  and  these  officials 
                        ( print page 30998)
                        may  not  further  redelegate  this  authority: (i)  Requests  for  waiver,  suspension,  or  modification  of  procedural  requirements  under  § 10.19  of  this  chapter; (ii)  Citizen  petitions  under  § 10.30  of  this  chapter; (iii)  Petitions  for  reconsideration  under  § 10.33  of  this  chapter; (iv)  Petitions  for  stay  under  § 10.35  of  this  chapter;  or (v)  Requests  for  advisory  opinions  under  § 10.85  of  this  chapter. (3)  With  respect  to  any  matter  delegated  to  the  SACPPL  and  the  ACP  under  this  paragraph,  the  SACPPL  and  the  ACP  are  authorized  to  perform  the  function  of  the  Commissioner  under §§ 10.40,  10.45,  10.50,  10.55,  10.60,  10.65,  10.80,  10.90,  and  10.95  of  this  chapter  and  of  the  Deputy  Commissioner  under  § 10.206(g)  and  (h)  of  this  chapter.   These  officials  may  not  further  redelegate  this  authority. (4)  The  SACPPL  and  the  ACP  are  authorized  under  the  Regulatory  Flexibility  Act  (5  U.S.C.  605(b))  to  certify  that  a  proposed  or  final  rule,  if  issued,  will  not  have  a  significant  economic  impact  on  a  substantial  number  of  small  entities.   The  SACPPL  and  the  ACP  may  further  redelegate  this  authority. (g)  The  following  officials  are  authorized  to  perform  all  the  functions  of  the  officials  under  them  in  their  respective  offices  and  they  may  not  further  redelegate  this  authority: (1)  Senior  Associate  Commissioner; (2)  Deputy  Commissioner  for  International  and  Constituent  Relations; (3)  Senior  Associate  Commissioner  for  Management  and  Systems;  or (4)  Senior  Associate  Commissioner  for  Policy,  Planning,  and  Legislation. (h)(1)  The  Chief  Mediator  and  Ombudsman  and  the  Deputy  Chief  Mediator  and  Ombudsman  are  authorized  to  act  upon  requests  for  reconsideration  of  any  user  fee  decisions  under  section  735  of  the  Federal  Food,  Drug  and  Cosmetic  Act  (the  act)  (21  U.S.C.  379h)  made  by  such  officers  and  the  former  Deputy  User  Fee  Waiver  Officer  prior  to  July  1,  1999.   These  officials  may  not  further  redelegate  this  authority.   (See  subpart  C,  § 5.108  for  the  user  fee-related  redelegation  to  officials  within  the  Center  for  Drug  Evaluation  and  Research.) (2)  The  Senior  Associate  Commissioner  for  Management  and  Systems  and  the  Director,  Office  of  Financial  Management,  are  authorized  to  perform  the  functions  of  the  Commissioner  under  section  736(d)(1)(c)  of  the  act  (21  U.S.C.  379h(d)(1)(C)),  as  amended,  to  waive  or  reduce  prescription  drug  user  fees  in  situation  where  he  or  she  finds  that  “the  fees  will  exceed  the  anticipated  present  and  future  costs.”   These  officials  may  not  further  redelegate  this  authority. (3)  The  Deputy  Commissioner,  or  in  the  event  of  a  vacancy  in  that  position,  the  Senior  Associate  Commissioner,  Office  of  the  Commissioner,  is  designated  as  the  User  Fee  Appeals  Officer.   The  User  Fee  Appeals  Officer  is  authorized  to  hear  and  decide  user  fee  waiver  appeals.   The  decision  of  the  User  Fee  Appeals  Officer  will  constitute  final  agency  action  on  such  matters.  The  User  Fee  Appeals  Officer  may  not  further  redelegate  this  authority. (i)  The  Senior  Associate  Commissioner  for  Management  and  Systems  is  authorized  to  perform  all  of  the  administrative  authorities  (i.e.,  financial,  personnel,  facilities  management,  property  management,  etc.)  of  the  Commissioner.   These  authorities  may  be  further  redelegated,  except  when  specifically  prohibited. (j)  Unless  specifically  noted,  the  persons  to  whom  the  Commissioner  has  delegated  authority  in  subparts  B  through  L  of  this  part  may  not  further  redelegate  that  authority. § 5.21
 (a)  Each  Regional  Food  and  Drug  Director  is  authorized,  during  any  period  when  normal  channels  of  direction  are  disrupted  between  the  Food  and  Drug  Administration  headquarters  and  his  or  her  region  to: (1)  Fully  represent  the  Food  and  Drug  Administration  within  his  or  her  region  in  cooperation  with  the  Department  of  Health  and  Human  Services  regional  emergency  plans,  and (2)  Exercise  the  authority  of  the  Commissioner  of  Food  and  Drugs  for  supervision  of  and  direction  to  all  Food  and  Drug  Administration  activities  and  use  of  resources  within  his  or  her  region  for  continuity  and  for  Federal  Emergency  Health  Service  operations. (b)  These  same  officials  are  authorized  to  provide  in  Regional  Emergency  Plans  for  the  delegation  of  Food  and  Drug  Administration  regional  authorities  to  heads  of  field  activities  when  such  activities  are  cut  off  from  national  and  regional  headquarters.   These  officials  may  not  further  redelegate  this  authority. § 5.22
 (a)  The  following  officials  are  authorized  to  certify  true  copies  of,  or  extracts  from,  any  books,  records,  papers,  or  other  documents  on  file  within  the  Food  and  Drug  Administration,  to  certify  that  copies  are  true  copies  of  the  entire  file,  to  certify  the  complete  original  record,  or  to  certify  the  nonexistence  of  records  on  file  within  the  Food  and  Drug  Administration,  and  to  cause  the  seal  of  the  Department  to  be  affixed  to  such  certifications: (1)  The  Deputy  Commissioner,  the  Senior  Associate  Commissioner,  the  Deputy  Commissioner  for  International  and  Constituent  Relations,  the  Senior  Associate  Commissioner  for  Management  and  Systems,  and  the  Senior  Associate  Commissioner  for  Policy,  Planning,  and  Legislation. (2)  The  Associate  and  Deputy  Associate  Commissioners  and  the  Chief  Counsel  and  Deputy  Chief  Counsels. (3)  The  Director,  Office  of  the  Executive  Secretariat,  Office  of  the  Senior  Associate  Commissioner,  Office  of  the  Commissioner  (OC). (4)  The  Director,  Office  of  Executive  Operations,  Office  of  the  Senior  Associate  Commissioner,  OC. (5)(i)  The  Director  and  Deputy  Director,  Office  of  Enforcement,  Office  of  Regulatory  Affairs  (ORA). (ii)  The  Director  and  Deputy  Director,  Office  of  Regional  Operations,  ORA. (iii)  The  Director  and  Deputy  Director,  Office  of  Resource  Management  (ORM),  ORA. (iv)  The  Director,  Division  of  Management  Operations,  ORM,  ORA. (v)  Team  Leader,  FDA  History  Staff,  ORM,  ORA. (6)(i)  The  Director,  Office  of  Human  Resources  and  Management  Services  (OHRMS),  Office  of  Management  and  Systems  (OMS),  OC. (ii)  The  Director,  Division  of  Management  Programs  (DMP),  OHRMS,  OMS,  OC. (iii)  The  Chief,  Dockets  Management  Branch,  DMP,  OHRMS,  OMS,  OC. (7)  The  Associate  Commissioner  for  Public  Affairs,  Office  of  Public  Affairs  (OPA),  Office  of  the  Senior  Associate  Commissioner  (OSAC),  OC. (8)(i)  The  Chief  Information  Officer,  Office  of  Information  Resources  Management  (OIRM),  Office  of  Management  and  Systems  (OMS),  OC. (ii)  The  Director,  Freedom  of  Information  Staff,  OIRM,  OMS,  OC. (9)(i)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER). (ii)  The  Director,  Office  of  Management,  CBER. (iii)  The  Director  and  Deputy  Directors  of  the  Office  of  Compliance  and  Biologics  Quality,  CBER. (iv)  The  Director  and  Deputy  Director,  Office  of  Communication,  Training,  and  Manufacturer’s  Assistance,  CBER. (v)  The  Director  and  Branch  Chiefs,  Division  of  Case  Management,  Office  of 
                        ( print page 30999)
                        Compliance  and  Biologics  Quality  (OCBQ),  CBER;  and  the  Consumer  Safety  Officers,  OCBQ,  CBER. (10)(i)  The  Director  and  Deputy  Director,  Center  for  Food  Safety  and  Applied  Nutrition  (CFSAN). (ii)  The  Director  of  Regulations  and  Policy,  CFSAN. (iii)  The  Director,  Office  of  Management  Systems,  CFSAN. (iv)  The  Director,  Office  of  Cosmetics  and  Colors,  CFSAN. (v)  The  Director,  Office  of  Plant  and  Dairy  Foods  and  Beverages,  CFSAN. (vi)  The  Director,  Office  of  Seafood,  CFSAN. (vii)  The  Director,  Office  of  Nutritional  Products,  Labeling,  and  Dietary  Supplements,  CFSAN. (viii)  The  Director,  Office  of  Special  Research  Skills,  CFSAN. (ix)  The  Director,  Office  of  Constituent  Operations,  CFSAN. (x)  The  Director,  Office  of  Field  Programs,  CFSAN. (xi)  The  Director,  Office  of  Premarket  Approval,  CFSAN. (xii)  The  Director,  Office  of  Scientific  Analysis  and  Support,  CFSAN. (11)(i)  The  Director  and  Deputy  Directors,  Center  for  Devices  and  Radiological  Health  (CDRH). (ii)  The  Associate  Director  and  Deputy  Associate  Director  for  Management  and  Systems,  CDRH. (iii)  The  Director  and  Deputy  Director,  Office  of  Compliance,  CDRH. (iv)  For  medical  devices  assigned  to  their  respective  divisions,  the  Division  Directors,  Office  of  Compliance,  CDRH. (v)  The  Director  and  Deputy  Director,  Office  of  Surveillance  and  Biometrics  (OSB),  CDRH,  and  the  Director  and  Deputy  Director,  Division  of  Surveillance  Systems  (DSS),  OSB,  CDRH. (vi)  The  Director,  Office  of  Systems  and  Management,  CDRH. (vii)  Freedom  of  Information  Officers,  CDRH. (12)(i)  The  Director  and  Deputy  Director,  Center  for  Veterinary  Medicine  (CVM). (ii)  The  Director  and  Deputy  Director,  Office  of  Management  and  Communications,  CVM. (iii)  The  Director  and  Deputy  Director,  Office  of  Surveillance  and  Compliance,  CVM. (iv)  The  Director,  Division  of  Compliance,  Office  of  Surveillance  and  Compliance,  CVM. (13)(i)  The  Director  and  Deputy  Director  for  Washington  Operations,  National  Center  for  Toxicological  Research  (NCTR). (ii)  The  Deputy  Center  Director,  Office  of  Management  (OM),  NCTR,  and  the  Associate  Director,  Office  of  Management  Services,  OM,  NCTR. (iii)  The  Deputy  Center  Director,  Office  of  Research,  NCTR. (14)(i)  The  Director  and  Deputy  Director,  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  the  Associate  Director  for Regulatory Policy,  and  the  Associate  Director  for  Medical  Policy,  Center  for  Drug  Evaluation  and  Research  (CDER). (ii)  The  Director  and  Deputy  Director,  Office  of  Management,  CDER. (iii)  The  Director  and  Deputy  Director,  Office  of  Compliance,  CDER. (iv)  The  Directors  and  Deputy  Directors  of  the  Offices  of  Drug  Evaluation  I,  II,  III,  IV,  and  V,  and  the  Director  and  Deputy  Director  of  the  Office  of  Biostatistics,  Office  of  Review  Management,  CDER. (v)  The  Directors  and  Deputy  Directors  of  the  Offices  of  Testing  and  Research,  Generic  Drugs,  New  Drug  Chemistry,  and  Clinical  Pharmacology  and  Biopharmaceutics,  Office  of  Pharmaceutical  Science,  CDER. (vi)  The  Director,  Office  of  Training  and  Communications  (OTCOM),  and  the  Director,  Division  of  Information  Disclosure  Policy,  Office  of  Regulatory Policy,  CDER. (vii)  The  Directors  of  the  Divisions  of  Labeling  and  Non-prescription  Drug  Compliance,  Prescription  Drug  Compliance  and  Surveillance,  and  Manufacturing  and  Product  Quality,  Office  of  Compliance,  CDER. (15)(i)  Regional  Food  and  Drug  Directors. (ii)  District  Directors. (iii)  The  Director,  St.  Louis  Branch. (iv)  The  Director,  Northeast  Regional  Laboratory,  Northeast  Region. (v)  The  Director,  Southeast  Regional  Laboratory,  Southeast  Region. (vi)  The  Director,  National  Forensic  Chemistry  Center. (vii)  The  Director,  Arkansas  Regional  Laboratory. (viii)  The  Director,  Winchester  Engineering  Analytical  Center. (b)  The  following  officials  are  authorized  to  cause  the  seal  of  the  Department  to  be  affixed  to  agreements,  awards,  citations,  diplomas,  and  similar  documents: (1)  Deputy  Commissioner;  the  Senior  Associate  Commissioner;  the  Deputy  Commissioner  for  International  and  Constituent  Relations;  the  Senior  Associate  Commissioner  for  Management  and  Systems;  and  the  Senior  Associate  Commissioner  for  Policy,  Planning,  and  Legislation. (2)  The  Associate  and  Deputy  Associate  Commissioners  and  the  Chief  Counsel  and  Deputies. (3)  The  Director  and  Deputy  Directors,  CBER;  the  Director  and  Deputy  Director,  CFSAN;  the  Director  and  Deputy  Directors,  CDRH;  the  Director  and  Deputy  Director,  CVM;  the  Director  and  Deputy  Directors,  CDER;  and  the  Director,  NCTR,  the  Deputy  Director  for  Washington  Operations,  NCTR,  and  the  Deputy  Center  Directors,  Offices  of  Management  and  Research,  respectively,  NCTR. (4)  The  Director,  Office  of  Executive  Operations,  Office  of  the  Senior  Associate  Commissioner  (OSAC),  OC;  Director,  Office  of  Management,  CBER;  Director,  Office  of  Management,  CDER;  Director,  Office  of  Management  Systems,  CFSAN;  Director,  Office  of  Systems  and  Management,  CDRH;  Director,  Office  of  Management  and  Communications,  CVM;  Associate  Director,  Office  of  Management  Services,  NCTR;  and  the  Director,  Office  of  Resource  Management,  ORA. (5)  The  Director,  Office  of  Human  Resources  and  Management  Services  (OHRMS),  Office  of  Management  and  Systems  (OMS),  OC. (c)  The  following  officials  may  further  redelegate  the  authorities  under  paragraphs  (a)  and  (b)  of  this  section  the  Deputy  Commissioner;  the  Senior  Associate  Commissioner;  the  Deputy  Commissioner  for  International  and  Constituent  Relations;  the  Senior  Associate  Commissioner  for  Management  and  Systems;  the  Senior  Associate  Commissioner  for  Policy,  Planning,  and  Legislation;  the  Associate  and  Deputy  Associate  Commissioners;  the  Chief  Counsel  and  Deputy  Chief  Counsels;  the  Directors  and  Deputy  Directors  for  CBER,  CFSAN,  CDRH,  CVM,  CDER,  and  NCTR;  the  Director,  Office  of  Executive  Operations,  OSAC,  OC;  the  Directors  of  the  Offices  of  Management,  CBER  and  CDER;  the  Director,  Office  of  Management  Systems,  CFSAN;  the  Director,  Office  of  Systems  and  Management,  CDRH;  the  Director,  Office  of  Management  and  Communications,  CVM;  the  Associate  Director,  Office  of  Management  Services,  NCTR;  the  Director,  Office  of  Resource  Management,  ORA;  and  the  Director,  OHRMS,  OMS,  OC.   The  other  officials  delegated  authority  by  this  section  may  not  further  redelegate  it. (d)  The  Chief,  Regulations  Editorial  Section  (RES),  Regulations  Policy  and  Management  Staff  (RPMS),  Office  of  Policy,  Planning,  and  Legislation  (OPPL),  OC,  and  his  or  her  alternates  are  authorized  to  certify  true  copies  of 
                        **Federal Register**
                         documents.   The  Chief,  RES,  RPMS,  OPPL,  OC  may  designate  alternates  as  required. 
 
 §  5.23
 (a)  The  following  officials  are  authorized  to  make  determinations  to  disclose  official  records  and  information  under  part  20  of  this  chapter,  except  that  only  the  officials,  listed  in  paragraphs  (a)(2)  through  (a)(8)  of  this  section,  have  the  authority  under  specific  sections  of  part  20  of  this  chapter. (1)(i)  Deputy  Commissioner,  the  Senior  Associate  Commissioner,  the  Deputy  Commissioner  for  International  and  Constituent  Relations,  the  Senior  Associate  Commissioner  for  Management  and  Systems,  the  Senior  Associate  Commissioner  for  Policy,  Planning,  and  Legislation,  and  the  Associate  and  Deputy  Associate  Commissioners. (ii)  The  Director,  Office  of  Executive  Operations,  Office  of  the  Senior  Associate  Commissioner,  Office  of  the  Commissioner  (OC). (iii)  The  Director,  Office  of  the  Executive  Secretariat,  Office  of  the  Senior  Associate  Commissioner,  OC. (iv)  The  Director,  Office  of  Human  Resources  and  Management  Services  (OHRMS),  Office  of  Management  and  Systems  (OMS),  OC;  the  Director,  Division  of  Management  Programs  (DMP),  OHRMS,  OMS,  OC;  and  the  Chief,  Dockets  Management  Branch,  DMP,  OHRMS,  OMS,  OC. (v)  Program  officials  at  all  organizational  levels  down  to  and  including  branch  level  for  all  Headquarters  organizations. (vi)  Regional  Food  and  Drug  Directors  and  District  Directors. (vii)  Director,  Winchester  Engineering  and  Analytical  Center. (viii)  Chiefs  of  branches  Field/District  Offices  and  Centers. (ix)  Freedom  of  Information  Officers  and  other  employees  engaged  in  Freedom  of  Information  activities. (x)  The  Director,  Office  of  Enforcement  (OE),  Office  of  Regulatory  Affairs  (ORA);  Deputy  Director,  OE,  ORA;  and  Director,  Division  of  Compliance  Policy,  OE,  ORA. (xi)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER);  and  the  Director  and  Deputy  Director,  Office  of  Communication,  Training,  and  Manufacturer’s  Assistance  (OCTMA),  CBER. (xii)  The  Director  and  Deputy  Director,  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  the  Associate  Director  for  Medical  Policy,  and  the  Associate  Director  for  Regulatory Policy,  Center  for  Drug  Evaluation  and  Research  (CDER). (xiii)  The  Director,  Center  for  Devices  and  Radiological  Health  (CDRH),  the  Deputy  Director  for  Regulations  and  Policy,  and  the  Deputy  Director  for  Science,  CDRH. (xiv)  The  Director  and  Deputy  Director,  Center  for  Food  Safety  and  Applied  Nutrition  (CFSAN). (xv)  The  Director  and  Deputy  Director,  Center  for  Veterinary  Medicine  (CVM). (xvi)  The  Director,  National  Center  for  Toxicological  Research  (NCTR);  the  Deputy  Center  Directors,  Offices  of  Research  and  Management,  respectively,  NCTR;  and  the  Deputy  Director  for  Washington  Operations,  NCTR. (xvii)  These  officials  may  not  further  redelegate  this  authority. (2)  The  Deputy  Associate  Commissioner  for  Regulatory  Affairs  (Deputy  ACRA),  ORA;  the  Director  and  Deputy  Director,  Office  of  Enforcement  OE,  ORA;  and  the  Director,  Division  of  Compliance  Policy,  OE,  ORA  are  delegated  the  authority  to  grant  requests  for  testimony  or  to  authorize  the  giving  of  testimony  under  §  20.1  of  this  chapter.   These  officials  may  not  further  redelegate  this  authority. (3)  The  Associate  and  Deputy  Associate  Commissioners  are  delegated  the  authority  to  disclose  official  records  and  information  under  §  20.82  of  this  chapter.   These  officials  may  not  further  redelegate  this  authority. (4)  The  Associate  and  Deputy  Associate  Commissioners;  the  Director  and  Deputy  Director,  OE,  ORA;  and  the  Director,  Division  of  Compliance  Policy,  OE,  ORA  are  delegated  the  authority  to  disclose  official  records  and  information  under § 20.85  of  this  chapter.   These  officials  may  not  further  redelegate  this  authority (5)  The  following  officials  are  delegated  the  authority  to  disclose  confidential  commercial  information  to  State  government  officials  under  § 20.88(d)  of  this  chapter  and  the  ACRA  and  the  Center  Directors  may  further  redelegate  this  authority. (i)  The  ACRA,  the  Deputy  ACRA,  ORA  and  the  Director,  OE,  ORA. (ii)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER);  and  the  Director  and  Deputy  Director,  Office  of  Communication,  Training,  and  Manufacturer’s  Assistance  (OCTMA),  CBER. (iii)  The  Director  and  Deputy  Director,  CDER;  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  CDER;  the  Associate  Director  for  Regulatory Policy,  CDER. (iv)  The  Director,  CDRH,  the  Deputy  Director  for  Regulations  and  Policy,  the  Deputy  Director  for  Science,  and  the  Director,  Office  of  Health  and  Industry  Programs,  CDRH. (v)  The  Director  and  Deputy  Director,  CFSAN. (vi)  The  Director  and  Deputy  Director,  CVM. (vii)  The  Director,  the  Deputy  Center  Directors,  Offices  of  Research  and  Management,  respectively,  NCTR,  and  the  Deputy  Director  for  Washington  Operations,  NCTR. (6)  The  following  officials  are  delegated  the  authority  to  disclose  nonpublic,  predecisional  documents  to  State  and  foreign  government  officials  under  §§ 20.88(e)  and  20.89(d)  of  this  chapter  and  they  may  not  further  redelegate  this  authority. (i)  The  Associate  Commissioner  for  Policy,  Office  of  Policy,  Planning  and  Legislation  (OPPL);  and  the  Director,  Office  of  International  Programs,  Office  of  International  and  Constituent  Relations   (OICR). (ii)  For  level  2  nonpublic,  predecisional  guidance  documents,  any  Center  Director  or  Deputy  Director,  and  any  Director  for  an  OC  office  having  program  responsibilities. (7)  The  Associate  Commissioner  for  Policy,  OPPL;  and  the  Director,  Office  of  International  Programs,  OICR  are  delegated  the  authority  to  receive  nonpublic,  predecisional  documents  from  State  and  foreign  government  officials  under  §§ 20.88(e)  and  20.89(d)  of  this  chapter.   These  officials  may  not  further  redelegate  this  authority. (8)  The  following  officials  are  authorized  to  disclose  confidential  commercial  information  to  foreign  government  officials  under  § 20.89(c)  of  this  chapter;  and  they  may  not  further  redelegate  it: (i)  The  Deputy ACRA,  ORA;  and  the  Director,  OE,  ORA. (ii)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER);  and  the  Director  and  Deputy  Director,  Office  of  Communication,  Training,  and  Manufacturer’s  Assistance  (OCTMA),  CBER. (iii)  The  Director  and  Deputy  Director,  CDER;  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  CDER;  the  Associate  Director  for  Medical  Policy,  CDER;  the  Associate  Director  for  Regulatory Policy,  CDER,  and  the  Director,  Division  of  Information  Disclosure  Policy,  Office  of   Regulatory Policy,  CDER. (iv)  The  Director,  CDRH,  the  Deputy  Director  for  Regulations  and  Policy  and  the  Deputy  Director  for  Science,  CDRH. (v)  The  Director  and  Deputy  Director,  CFSAN. 
 
 (vi)  The  Director  and  Deputy  Director,  CVM. (vii)  The  Director,  the  Deputy  Center  Directors,  Offices  of  Research  and  Management,  respectively,  and  the  Deputy  Director  for  Washington  Operations,  NCTR. (b)  The  Chief,  Information  Management  Team,  Division  of  Data  Management  and  Services,  Office  of  Information  Technology,  CDER,  is  authorized  to  sign  affidavits  regarding  the  presence  or  absence  of  records  of  Registration  of  Drug  Establishments.    This  official  may  not  further  redelegate  this  authority. (c)  The  following  officials  are  authorized  to  sign  affidavits  regarding  the  presence  or  absence  of  medical  device  establishment  registration  records  and  these  officials  may  not  further  redelegate  this  authority: (1)  The  Director,  the  Deputy  Director  for  Regulations  and  Policy,  and  the  Deputy  Director  for  Science,  CDRH. (2)  The  Director  and  Deputy  Director,  Office  of  Compliance,  CDRH. (3)  The  Director  and  Deputy  Director,  Division  of  Program  Operations,  Office  of  Compliance,  CDRH. (4)  The  Chief,  Information  Processing  and  Office  Automation  Branch,  Division  of  Program  Operations,  Office  of  Compliance,  CDRH. (d)  The  Director,  Office  of  Resource  Management,  Office  of  Regulatory  Affairs  is  authorized  to  sign  affidavits  regarding  the  presence  or  absence  of  records  in  the  files  of  that  office  and  this  official  may  not  further  redelegate  this  authority (e)  The  Director  and  Deputy  Directors,  CBER,  the  Director  and  Deputy  Director,  Office  of  Blood  Research  and  Review  (OBRR),  and  the  Director  and  Deputy  Director,  Division  of  Blood  Applications,  OBRR,  CBER,  are  authorized  to  sign  affidavits  regarding  the  presence  or  absence  of  records  of  registration  of  blood  product  establishments.   These  officials  may  not  further  redelegate  this  authority. § 5.24
 (a)  The  Associate  Commissioner  for  Regulatory  Affairs  is  authorized  to  perform  the  functions  of  the  Commissioner  of  Food  and  Drugs  as  requested  by  the  Commissioner  regarding  the  authority  to  disapprove  or  require  modification  of  cooperative  research  and  development  agreements  and  licensing  agreements  and  transmit  written  explanation  of  such  approval  or  disapproval  to  the  head  of  the  laboratory  concerned  under  section  11(c)(5)  (A)  and  (B)  of  the  Stevenson-Wydler  Technology  Innovation  Act  of  1980  (the  Act)  (15  U.S.C.  3710a(c)(5)  (A)  and  (B)),  as  amended. (b)  The  following  officials  are  authorized  to  perform  the  functions  of  the  Commissioner  of  Food  and  Drugs  (Commissioner)  requested  by  the  Commissioner  under  the  Act   (15  U.S.C.  3701 
                        *et  seq*.),  as  amended,  and  Executive  Order  12591  of  April  10,  1987  (except  to  the  extent  that  redelegation  of  those  functions  is  specifically  limited  in  § 5.10(a)(26)),  as  they  pertain  to  the  functions  of  their  respective  organizations,  including  the  authority  to  perform  the  functions  of  laboratory  directors  under  the  Act  as  the  heads  of  their  respective  Federal  laboratories,  subject  to  the  discretion  of  the  Commissioner  to  require  that  agreements  entered  into  under  section  11(a)  of  the  Act  (15  U.S.C.  3710a(a))  include  provisions  in  accordance  with  section  11(c)(5)(A)  of  the  Act  (15  U.S.C.  3710a(c)(5)(A): (1)  The  Director,  Center  for  Biologics  Evaluation  and  Research. (2)  The  Director,  Center  for  Devices  and  Radiological  Health. (3)  The  Director,  Center  for  Drug  Evaluation  and  Research. (4)  The  Director,  Center  for  Food  Safety  and  Applied  Nutrition. (5)  The  Director,  Center  for  Veterinary  Medicine. (6)  The  Director,  National  Center  for  Toxicological  Research. (7)  The  Associate  Commissioner  for  Regulatory  Affairs. (c)  These  officials  may  not  further  redelegate  these  authorities. § 5.25
 (a)  The  following  officials  are  authorized  under  sections  301,  307,  311,  1701,  1702,  1703,  and  1704  of  the  Public  Health  Service  Act  (the  PHS  Act)   (42  U.S.C.  241,  242l,  243,  300u,  300u-1,  300u-2,  300u-3)  to  establish  research,  investigation,  and  testing  programs  and  health  information  and  health  promotion  programs,  which  relate  to  their  assigned  functions,  and  to  approve  grants  for  conducting  such  programs: (1)  The  Director,  the  Deputy  Director  for  Washington  Operations,  and  the  Deputy  Center  Directors,  Offices  of  Research  and  Management,  respectively,  National  Center  for  Toxicological  Research  (NCTR). (2)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  Centers  for  Devices  and  Radiological  Health  (CDRH). (3)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER). (4)  The  Director  and  Deputy  Director,  Center  for  Food  Safety  and  Applied  Nutrition  (CFSAN). (5)  The  Director  and  Deputy  Director,  Center  for  Veterinary  Medicine  (CVM). (6)  The  Director  and  Deputy  Director,  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  Center  for  Drug  Evaluation  and  Research  (CDER). (7)  The  Director,  Office  of  Orphan  Products  Development  (OPD),  Office  of  the  Senior  Associate  Commissioner  (OSAC),  Office  of  the  Commissioner  (OC). (b)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  CDRH,  are  authorized  to  establish  an  electronic  product  radiation  control  program  and  to  approve  grants  for  conducting  the  program  under  section  532  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.  360ii). (c)  The  Senior  Associate  Commissioner  for  Management  and  Systems,  Office  of  Management  and  Systems  (OMS),  OC;  the  Director  and  Deputy  Director,  Office  of  Facilities,  Acquisitions,  and  Central  Services  (OFACS),  OMS,  OC;  the  Director,  Division  of  Contracts  and  Procurement  Management  (DCPM),  OFACS,  OMS,  OC;  and  the  Chief  Grants  Management  Officer  and  the  Grants  Management  Officer,  DCPM,  OFACS,  OMS,  OC  are  authorized  to  sign  and  issue  all  notices  of  grant  awards  and  amendments  thereto  and  sign  and  issue  notices  of  suspension  and  termination  thereof  for  grants  approved  under  the  authority  delegated  in  paragraphs  (a)  and  (b)  of  this  section. (d)  The  Director,  NCTR,  is  authorized  under  section  301  of  the  PHS  Act  (42  U.S.C.  241),  as  amended  by  Public  Law  95-622,  to  make  available  to  educational  institutions,  for  biomedical  and  behavioral  research,  laboratory  animals  bred  for  research  purposes  of  the  Center  that  are  not  required  to  support  Center  research  programs. (e)  The  Senior  Associate  Commissioner  for  Management  and  Systems  may  further  redelegate  the  authorities  in  paragraph  (c)  of  this  section.   With  the  exception  for  paragraph  (c)  of  this  section,  these  officials  may  not  further  redelegate  these  authorities. § 5.26
 (a)  Under  authority  of  sections  207(g)  and  208(f)  of  the  PHS  Act  (42  U.S.C.  209(g)  and  210(f)),  and  within  the  limits  of  an  approved  service  fellowship  plan,  the  following  officials  are  authorized  to  designate  persons  to  receive  service  fellowships,  appoint  service  fellows,  and  determine  specific  stipend  rates  for 
                        ( print page 31002)
                        individual  actions  within  the  ranges  established  under  an  approved  service  fellowship  plan: (1)  The  Deputy  Commissioner;  the  Senior  Associate  Commissioner;  the  Deputy  Commissioner  for  International  and  Constituent  Relations;  the  Senior  Associate  Commissioner  for  Management  and  Systems;  the  Senior  Associate  Commissioner  for  Policy,  Planning,  and  Legislation;  the  Chief  Counsel  and  Deputy  Chief  Counsels;  and  the  Associate  Commissioners  and  their  Deputies. (2)  The  Director,  the  Deputy  Director  for  Washington  Operations,  the  Deputy  Center  Directors  for  Research  and  Management,  respectively,  and  the  Associate  Director,  Office  of  Management  Services,  National  Center  for  Toxicological  Research  (NCTR). (3)  The  Director,  the  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  and  the  Director,  Office  of  Systems  and  Management,  Center  for  Devices  and  Radiological  Health  (CDRH). (4)  The  Director,  the  Deputy  Directors,  the  Associate  Director  for  Research,  the  Office  Directors,  and  the  Director,  Office  of  Management,  Center  for  Biologics  Evaluation  and  Research  (CBER). (5)  The  Director,  the  Deputy  Director,  and  Director,  Office  of  Management  Systems,  Center  for  Food  Safety  and  Applied  Nutrition  (CFSAN). (6)  The  Director,  the  Deputy  Director,  and  the  Director,  Office  of  Management  and  Communications,  Center  for  Veterinary  Medicine  (CVM). (7)  The  Director  and  Deputy  Director,  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  and  the  Director  and  Deputy  Director,  Office  of  Management,  Center  for  Drug  Evaluation  and  Research  (CDER). (8)  The  Director,  Office  of  Executive  Operations,  Office  of  the  Senior  Associate  Commissioner,  Office  of  the  Commissioner  and  the  Director,  Office  of  Resource  Management,  ORA. (9)  Director,  Office  of  Human  Resources  and  Management  Services,  Office  of  Management  and  Systems,  Office  of  the  Commissioner. (b)  These  officials  may  further  redelegate  this  authority, with the limitation that the Director,  Office  of  Human  Resources  and  Management  Services,  OMS,  OC,  is  delegated  the  authority  to  approve  service  fellowship  plans  and  exceptions  to  the  approved  plans,  and  this  official  may  not  further  redelegate  this  authority. §  5.27
 (a)  The  Deputy  Commissioner  is  authorized  to  perform  the  due  diligence  determinations  and  informal  hearings  functions  under  section  156(d)(2)(B)(ii)  of  title  35  U.S.C.  (35  U.S.C.  156),  as  amended,  relative  to  patent  term  extensions. (b)  The  Director,  Center  for  Drug  Evaluation  and  Research  (CDER)  and  the  Associate  Director  for  Regulatory Policy,  CDER,  are  authorized  to  perform  the  functions  delegated  to  the  Commissioner  under  title  35  U.S.C.  156,  as  amended,  except  for  making  due  diligence  determinations  and  holding  of  informal  hearings  under  title  35  U.S.C.  156(d)(2)(B). (c)  The  Chief  Mediator  and  Ombudsman,  Office  of  the  Ombudsman,  Office  of  the  Senior  Associate  Commissioner,  Office  of  the  Commissioner,  is  authorized  to  perform  the  functions  delegated  to  the  Commissioner  to  make  due  diligence  determinations  under  title  35  U.S.C.  156  (d)(2)(B),  as  amended,  except  for  holding  of  informal  hearings  under  title  35  U.S.C.   156(d)(2)(B)(ii). (d)  These  officials  may  not  further  redelegate  this  authority. § 5.28
 (a)  The  following  officials  are  authorized  to  designate  officials  to  hold  informal  hearings  that  relate  to  their  assigned  functions  under  sections  305,  404(b),  and  801(a)  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.   335,  344(b),  and  381(a));  section  6  of  the  Fair  Packaging  and  Labeling  Act  (15  U.S.C.  1455)  (21  U.S.C.  145);  section  9(b)  of  the  Federal  Caustic  Poison  Act  (44  Stat.  1406;  see  also  Public  Law  86-613,  section  19  formerly  section  18);  and  section  5  of  the  Federal  Import  Milk  Act.   Officials  so  designated  are  delegated  authority  vested  in  the  Secretary  of  Agriculture  by  7  U.S.C.  2217  (43  Stat.  803)  to  administer  to  take  from  any  person  an  oath,  affirmation,  affidavit,  or  deposition  for  use  in  any  prosecution  or  proceeding  under,  or  in  enforcement  of,  any  law  as  cited  in  this  part: (1)  The  Director  and  Deputy  Director,  Center  for  Food  Safety  and  Applied  Nutrition  (CFSAN);  and  the  Director  of  Regulations  and  Policy,  CFSAN. (2)  The  Director  and  Deputy  Director,  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  Center  for  Drug  Evaluation  and  Research  (CDER);  the  Associate  Director  for  Regulatory Policy  and  the  Associate  Director  for  Medical  Policy,  CDER;  the  Directors  of  the  Offices  of  Drug  Evaluation  I,  II,  III,  IV,  and  V,  Office  of  Review  Management,  CDER;  and  the  Director  and  Deputy  Director,  Office  of  Compliance,  CDER. (3)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  Center  for  Devices  and  Radiological  Health  (CDRH). (4)  The  Director  and  Deputy  Director,  Center  for  Veterinary  Medicine  (CVM). (5)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER),  and  the  Directors  and  Deputy  Directors,  Office  of  Blood  Research  and  Review,  Office  of  Vaccines  Research  and  Review,  Office  of  Therapeutics  Research  and  Review,  and    Office  of  Compliance  and  Biologics  Quality,  CBER. (6)  Regional  Food  and  Drug  Directors. (7)  District  Directors. (8)  The  Director,  St.  Louis  Branch. (b)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  Policy,  CDRH,  are  authorized  to  hold  hearings,  and  to  designate  other  officials  to  hold  informal  hearings,  under  section  360(a)  of  the  PHS  Act. (c)  The  following  officials  are  authorized  to  serve  as  the  presiding  officer,  and  to  designate  other  Food  and  Drug  Administration  employees  to  serve  as  the  presiding  officer,  at  a  regulatory  hearing  and  to  conduct  such  a  hearing  under  the  provisions  of  part  16  of  this  chapter.   An  official  can  serve  as  the  presiding  officer  in  a  particular  hearing  only  if  he  or  she  satisfies  the  requirements  of  § 16.42(b)  of  this  chapter  with  respect  to  the  action  that  is  the  subject  of  the  hearing.   Such  officials  are  delegated  authority  vested  in  the  Secretary  of  Agriculture  by  7  U.S.C.  2217  (43  Stat.  803)  to  administer  or  to  take  from  any  person  an  oath,  affirmation,  or  deposition  for  use  in  any  prosecution  or  proceeding  under,  or  in  enforcement  of,  any  law  as  cited  in  this  part: (1)  The  Chief  Mediator  and  Ombudsman,  Office  of  the  Ombudsman,  Office  of  the  Senior  Associate  Commissioner,  Office  of  the  Commissioner  of  Food  and  Drugs  (Commissioner). (2)  The  Director  and  Deputy  Director,  CFSAN. (3)  The  Director  and  Deputy  Director,  Center  for  Drug  Evaluation  and  Research  (CDER);  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  CDER;  the  Associate  Director  for Regulatory Policy  and  the  Associate  Director  for  Medical  Policy,  CDER,  the  Directors  of  the  Offices  of  Drug  Evaluation  I,  II,  III,  IV,  and  V,  Office  of  Review  Management, 
                        ( print page 31003)
                        CDER;  and  the  Director  and  Deputy  Director,  Office  of  Compliance,  CDER. (4)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  Policy,  CDRH. (5)  The  Director  and  Deputy  Director,  CVM. (6)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER),  and  the  Directors  and  Deputy  Directors,  Office  of  Blood  Research  and  Review,  Office  of  Vaccines  Research  and  Review,  Office  of  Therapeutics  Research  and  Review,  and  Office  of  Compliance  and  Biologics  Quality,  CBER. (7)  Regional  Food  and  Drug  Directors. (8)  District  Directors. (9)  The  Director,  St.  Louis  Branch. (10)  Such  other  FDA  official  as  is  designated  by  the  Commissioner  by  memorandum  in  the  proceeding. (d)  These  officials  may  not  further  redelegate  this  authority. § 5.29
 (a)  For  drugs  assigned  to  their  organizations,  the  following  officials  are  authorized  to  grant  or  deny  citizen  petitions  submitted  under  § 10.30  of  this  chapter  for  a  stay  of  an  effective  date  in  § 201.59  of  this  chapter  for  compliance  with  certain  labeling  requirements  for  human  prescription  drugs: (1)(i)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER). (ii)  The  Directors  and  Deputy  Directors,  Office  of  Blood  Research  and  Review  (OBRR),  Office  of  Vaccines  Research  and  Review  (OVRR),  and  Office  of  Therapeutics  Research  and  Review  (OTRR),  CBER. (iii)  The  Directors  and  Deputy  Directors  of  the  Divisions  in  OBRR,  OVRR,  and  OTRR,  CBER. (2)(i)  The  Director,  the  Deputy  Director,  and  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  Center  for  Drug  Evaluation  and  Research  (CDER). (ii)  The  Directors  and  Deputy  Directors  of  the  Offices  of  Drug  Evaluation  I,  II,  III,  IV,  and  V,  Office  of  Review  Management,  CDER. (iii)  The  Directors  and  Deputy  Directors  of  the  divisions  in  the  Offices  of  Drug  Evaluation  I,  II,  III,  IV,  and  V,  Office  of  Review  Management,  CDER. (b)  The  following  officials  are  authorized  to  grant  or  deny  citizen  petitions  submitted  under  § 10.30  of  this  chapter  requesting  in  vitro  test  modifications  under  § 331.29  of  this  chapter: (1)  The  Director,  the  Deputy  Director,  and  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  CDER. (2)  The  Director,  Office  of  Drug  Evaluation  V,  Office  of  Review  Management,  CDER. (3)  The  Director  and  Deputy  Director,  Division  of  Over-the-Counter  Drug  Products,  Office  of  Drug  Evaluation  V,  Office  of  Review  Management,  CDER. (c)  The  following  officials  are  authorized  to  grant  or  deny  citizen  petitions  submitted  under  § 10.30  of  this  chapter  for  a  stay  of  an  effective  date  or  for  an  exemption  from  the  tamper-resistant  packaging  and  labeling  requirements  set  forth  in  §§ 211.132,  700.25,  or   800.12  of  this  chapter  for  certain  over-the-counter  human  drug  and  cosmetic  products  and  medical  devices  which  relate  to  the  assigned  functions  of  the  respective  organizations: (1)  The  Director,  the  Deputy  Director,  and  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  CDER. (2)  The  Director  and  Deputy  Director,  Center  for  Food  Safety  and  Applied  Nutrition  (CFSAN);  and  the  Director  of  Regulations  and  Policy,  CFSAN. (3)  The  Director  and  the  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  Center  for  Devices  and  Radiological  Health  (CDRH). (d)  The  following  officials  are  authorized  to  grant  or  deny  citizen  petitions  submitted  under  § 10.30  of  this  chapter  requesting  exemption  from  the  general  pregnancy-nursing  warning  for  over-the-counter  (OTC)  drugs  required  under  § 201.63  of  this  chapter,  requesting  exemption  from  a  general  overdose  warning  required  under  § 330.1(g)  of  this  chapter,  and  requesting  exemption  from  OTC  drug  administrative  procedures  under  § 330.10  of  this  chapter: (1)  The  Director,  the  Deputy  Director,  and  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  CDER. (2)  The  Director,  Office  of  Drug  Evaluation  V,  Office  of  Review  Management,  CDER. (3)  The  Director  and  Deputy  Director,  Division  of  Over-the-Counter  Drug  Products,  Office  of  Drug  Evaluation  V,  Office  of  Review  Management,  CDER. (e)(1)  The  following  officials  are  authorized  to  issue  180-day  tentative  responses  to  citizen  petitions  on  food  and  cosmetic  matters  under  § 10.30(e)(2)(iii)  of  this  chapter  that  relate  to  the  assigned  functions  of  that  Center: (i)  The  Director  and  Deputy  Director,  CFSAN. (ii)  The  Director  of  Regulations  and  Policy,  CFSAN. (iii)  The  Director,  Office  of  Cosmetics  and  Colors,  CFSAN. (iv)  The  Director,  Office  of  Nutritional  Products,  Labeling  and  Dietary  Supplements,  CFSAN. (v)  The  Director,  Office  of  Premarket  Approval,  CFSAN. (vi)  The  Director,  Office  of  Plant  and  Dairy  Foods  and  Beverages,  CFSAN. (vii)  The  Director,  Office  of  Seafood,  CFSAN. (viii)  The  Director,  Office  of  Field  Programs,  CFSAN. (2)  The  Director  and  Deputy  Director,  Center  for  Veterinary  Medicine  (CVM),  are  authorized  to  issue  180-day  tentative  responses  to  citizen  petitions  on  animal  food  and  drug  matters  under  § 10.30(e)(2)(iii)  of  this  chapter  that  relate  to  the  assigned  functions  of  that  Center. (3)  The  Director  and  Deputy  Directors,  CBER,  are  authorized  to  issue  180-day  tentative  responses  to  citizen  petitions  on  biological  product  matters  under  § 10.30(e)(2)(iii)  of  this  chapter  that  relate  to  the  assigned  functions  of  that  Center. (4)  The  Director,  the  Deputy  Director,  and  the  Associate  Director  for Regulatory Policy,  CDER,  are  authorized  to  issue  180-day  tentative  responses  to  citizen  petitions  on  drug  product  matters  under  § 10.30(e)(2)(iii)  of  this  chapter  that  relate  to  the  assigned  functions  of  that  Center. (5)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  CDRH,  are  authorized  to  issue  180-day  tentative  responses  to  citizen  petitions  on  medical  device  matters  under  § 10.30(e)(2)(iii)  of  this  chapter  that  relate  to  the  assigned  functions  of  that  Center. (f)(1)  The  Director  and  Deputy  Directors,  CBER,  are  authorized  to  grant  or  deny  citizen  petitions  submitted  under  § 10.30  of  this  chapter  on  drug  and  biological  product  matters  in  program  areas  where  they  have  been  delegated  final  approval  authority  in  the  following  sections  of  this  chapter: (i)  Section  5.203 
                        *Issuance  and  revocation  of  licenses  for  the  propagation  or  manufacture  and  preparation  of  biological  products*; (ii)  Section  5.204 
                        *Notification  of  release  for  distribution  of  biological  products*; (iii)  Section  5.101 
                        *Termination  of  exemptions  for  new  drugs  for  investigational  use  in  human  beings  or  in  animals*; (iv)  Section  5.103 
                        *Approval  of  new  drug  applications  and  their  supplements*. (v)  Section  5.105 
                        *Issuance  of  notices  relating  to  proposals  to  refuse  approval 
                            ( print page 31004)
                            or  to  withdraw  approval  of  new  drug  applications  and  their  supplements*. (vi)  Section  5.34 
                        *Issuance  of  notices  relating  to  proposals  and  orders  for  debarment  and  denial  of  an  application  to  terminate  debarment*. (2)  The  Director,  the  Deputy  Director,  and  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  CDER,  are  authorized  to  grant  or  deny  citizen  petitions  submitted  under  § 10.30  of  this  chapter  on  drug  product  matters  in  program  areas  where  they  have  been  delegated  final  approval  authority  in  the  following  sections  of  this  chapter: (i)  Section  5.100 
                        *Issuance  of  notices  implementing  the  provisions  of  the  Drug  Amendments  of  1962*; (ii)  Section  5.101 
                        *Termination  of  exemptions  for  new  drugs  for  investigational  use  in  human  beings  or  in  animals*; (iii)  Section  5.103 
                        *Approval  of  new  drug  applications  and  their  supplements*. (iv)  Section  5.105 
                        *Issuance  of  notices  relating  to  proposals  to  refuse  approval  or  to  withdraw  approval  of  new  drug  applications  and  their  supplements*. (v)  Section  5.34 
                        *Issuance  of  notices  relating  to  proposals  and  orders  for  debarment  and  denial  of  an  application  to  terminate  debarment*. (3)  The  Director  and  Deputy  Director,  Office  of  Generic  Drugs,  Office  of  Pharmaceutical  Science,  CDER,  except  for  those  drug  products  listed  in  § 314.440(b)  of  this  chapter,  are  authorized  to  issue  responses  to  citizen  petitions  submitted  under  § 10.30  of  this  chapter  seeking  a  determination  of  the  suitability  of  an  abbreviated  new  drug  application  for  a  drug  product. (4)  The  Directors  and  Deputy  Directors  of  OBRR,  OVRR,  and  OTRR,  CBER,  for  those  drug  products  listed  in  § 314.440(b)  of  this  chapter,  are  authorized  to  issue  responses  to  citizen  petitions  submitted  under  § 10.30  of  this  chapter  seeking  a  determination  of  the  suitability  of  an  abbreviated  new  drug  application  for  a  drug  product. (5)  For  drugs  assigned  to  their  organization,  the  following  officials  are  authorized  to  issue  responses  to  citizen  petitions  submitted  under  § 10.30  of  this  chapter  from  sponsors  of  an  investigational  new  drug  application  who  request  approval  to  ship  in  interstate  commerce,  in  accordance  with  § 2.125(j)  of  this  chapter,  an  investigational  new  drug  for  human  use  containing  a  chlorofluorocarbon. (i)  The  Director  and  Deputy  Directors,  CBER. (ii)  The  Director,  the  Deputy  Director,  and  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  CDER. (6)  The  Director  and  Deputy  Director,  CVM,  are  authorized  to  issue  responses  to  citizen  petitions  submitted  under  § 10.30  of  this  chapter  from  sponsors  of  an  investigational  new  animal  drug  application  who  request  approval  to  ship  in  interstate  commerce,  in  accordance  with  § 21.125(j)  of  this  chapter,  an  investigational  new  animal  drug  for  animal  use  containing  a  chlorofluorocarbon. (7)  The  Director  and  Deputy  Director,  Office  of  New  Animal  Drug  Evaluation,  CVM,  are  authorized  to  issue  responses  to  citizen  petitions  submitted  under  § 10.30  of  this  chapter,  seeking  a  determination  of  the  suitability  of  an  abbreviated  new  animal  drug  application  for  an  animal  drug  product. (8)  The  Director  and  Deputy  Director,  CVM,  are  authorized  to  grant  or  deny  citizen  petitions  submitted  under  § 10.30  of  this  chapter  concerning  actions  they  are  authorized  to  take  under  § 5.34 
                        *Issuance  of  notices  relating  to  proposals  and  orders  for  debarment  and  denial  of  an  application  to  terminate  debarment*. (g)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  CDRH,  and  the  Director,  Office  of  Compliance,  CDRH,  are  authorized  to  grant  or  deny  citizen  petitions  submitted  under  §§ 10.30  and  821.2(b)  of  this  chapter,  requesting  an  exemption  or  variance  from  medical  device  tracking  requirements  in  part  821  of  this  chapter. (h)  These  officials  may  not  further  redelegate  this  authority. § 5.30
 (a)  Each  Center  director  is  authorized  to  select  members  of,  and  consultants  to,  scientific  and  technical  FDA  advisory  committees  under  that  Center's  management  to  serve  temporarily  as  voting  members  on  another  advisory  committee  under  that  Center's  management  when  expertise  is  required  that  is  not  available  among  current  voting  standing  members  of  a  committee  or  to  comprise  a  quorum  when,  because  of  unforeseen  circumstances,  a  quorum  is  or  will  be  lacking.  When  additional  voting  members  are  added  to  a  committee  to  provide  needed  expertise  not  available  among  current  voting  standing  members  of  a  committee,  a  quorum  will  be  based  on  the  total  of  regular  and  added  members.   Authority  to  select  temporary  voting  members  to  advisory  committees,  if  such  voting  members  are  serving  on  an  advisory  committee  managed  by  another  Center,  has  not  been  redelegated.  This  authority  will  continue  to  be  exercised  by  the  Commissioner  of  Food  and  Drugs  (Commissioner)  or  the  Senior  Associate  Commissioner,  Office  of  the  Commissioner. (b)  Each  Center  director  is  authorized,  under  18  U.S.C.  208(b)(1),  to  sign  conflict  of  interest  waivers  for  special  Government  employees  without  substantial  interest  to  serve  as  consultants  to  advisory  committees  or  in  any  other  capacity  within  the  Centers  except  as  advisory  committee  members. (c)  These  officials  may  not  further  redelegate  this  authority. § 5.31
 (a)  Designated  officers  and  employees  of  the  Food  and  Drug  Administration  who  have  been  issued  the  Food  and  Drug  Administration  official  credentials  consisting  of  Form  FDA-200A,  Identification  Record,  and  Form  FDA-200B,  Specification  of  General  Authority,  are  authorized: (1)  To  conduct  examinations,  inspections,  and  investigations;  to  collect  and  obtain  samples;  to  have  access  to  and  to  copy  and  verify  records  as  authorized  by  law;  to  make  seizures  of  items  under  section  702(e)(5)  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  (the  act)  (21  U.S.C.  372  (e)  (5));  and  to  supervise  compliance  operations  for  the  enforcement  of  the  act,  the  Fair  Packaging  and  Labeling  Act  (15  U.S.C.  1451-1461),  the  Federal  Caustic  Poison  Act  (44  Stat.  140b;  see  also  Public  Law  86-613,  section  19,  formerly  section  18),  the  Import  Milk  Act  (21  U.S.C.  141-149),  the  Filled  Milk  Act  (21  U.S.C.  61-64),  and  sections  351  and  361  of  the  PHS  Act  (42  U.S.C.  262  and  264). (2)  To  administer  oaths  and  affirmations  under  section  1  of  the  act  of  January  31,  1925  (Ch.  124,  43  Stat.  803);  sections  12  to  15  of  Reorganization  Plan  No.  IV,  effective  June  30,  1940;  and  Reorganization  Plan  No.  1  of  1953,  effective  April  11,  1953. (b)  Any  officer  or  employee  of  the  Food  and  Drug  Administration  who  has  been  designated  by  the  Commissioner  of  Food  and  Drugs  (Commissioner)  to  conduct  examinations,  investigations,  or  inspections  under  the  act  relating  to  counterfeit  drugs  and  issued  the  Food  and  Drug  Administration  Official  Credential  consisting  of  Form  FDA-200D,  Special  Authority  for  Criminal  Investigators,  is  authorized  to  do  the  following: (1)  As  set  forth  under  section  702(e)(1)  through  (e)(5)  of  the  act  (21  U.S.C.  372  (e)(1)-(e)(5)): (i)  Carry  firearms; (ii)  Serve  and  execute  search  warrants  and  arrest  warrants; 
 
 (iii)  Execute  seizure  by  process  issued  under  libel  under  section  304  of  the  act  (21  U.S.C.  334); (iv)  Make  arrests  without  warrant  for  an  offense  under  the  act  with  respect  to  counterfeit  drugs  if  the  offense  is  committed  in  the  presence  of  the  criminal  investigator  or,  in  the  case  of  a  felony,  if  the  investigator  has  probable  cause  to  believe  that  the  person  so  arrested  has  committed,  or  is  committing,  such  offense;  and (v)  Make,  prior  to  the  institution  of  libel  proceedings  under  section  304(a)(2)  of  the  act  (21  U.S.C.  334(a)(2)),  seizures  of  drugs  or  containers  or  of  equipment,  punches,  dies,  plates,  stones,  labeling,  or  other  things,  if  they  are,  or  the  criminal  investigator  has  reasonable  grounds  to  believe  that  they  are,  subject  to  seizure  and  condemnation  under  section  304(a)(2)  of  the  act. (2)  Perform  such  other  functions  under  the  act,  or  any  other  law,  as  the  Commissioner  may  prescribe. (3)  To  administer  oaths  and  affirmations  under  section  1  of  the  act  of  January  31,  1925  (Ch.  124,  43  Stat.  803);  sections  12  to  15  of  Reorganization  Plan  No.  IV,  effective  June  30,  1940;  and  Reorganization  Plan  No.  1  of  1953,  effective  April  11,  1953. (c)  Any  officer  or  employee  of  the  Food  and  Drug  Administration  who  has  been  designated  by  the  Commissioner  to  provide  specialized  law  enforcement  support  involving  criminal  investigations  under  the  act,  and  other  duties  as  assigned  by  the  Commissioner,  and  issued  the  Food  and  Drug  Administration  Official  Credential  consisting  of  Form  FDA-200E,  Special  Authority  for  Criminal  Investigative  Specialists,  is  authorized  to  receive  information  as  to  all  matters  relating  to  such  act  and  regulations  issued  under  the  act. (d)  These  officials  may  not  further  redelegate  these  authorities. § 5.32
 Regional  Food  and  Drug  Directors  and  District  Directors  are  authorized  to  issue  certificates  of  sanitation  under  § 1240.20  of  this  chapter.   These  officials  may  not  further  redelegate  this  authority. § 5.33
 (a)  The  following  officials  are  authorized  to  perform  all  the  functions  of  the  Commissioner  of  Food  and  Drugs  (Commissioner)  under  section  309  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.  336)  (the  act)  regarding  the  issuance  of  written  notices  or  warnings: (1)(i)  The  Director  and  Deputy  Directors,  Center  for  Biologics  Evaluation  and  Research  (CBER). (ii)  The  Director  and  Deputy  Directors,  Office  of  Compliance  and  Biologics  Quality,  CBER. (2)(i)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  Center  for  Devices  and  Radiological  Health  (CDRH). (ii)  The  Director  and  Deputy  Director,  Office  of  Compliance,  CDRH. (iii)  For  medical  devices  assigned  to  their  respective  divisions,  the  Division  Directors,  Office  of  Compliance,  CDRH. (iv)  The  Director  and  Deputy  Director,  Office  of  Surveillance  and  Biometrics  (OSB),  CDRH,  and  the  Director  and  Deputy  Director,  Division  of  Surveillance  Systems  (DSS),  OSB,  CDRH. (3)(i)  The  Director  and  Deputy  Director,  Center  for  Food  Safety  and  Applied  Nutrition,  (CFSAN). (ii)  The  Director  of  Regulations  and  Policy,  CFSAN. (iii)  The  Director,  Office  of  Field  Programs,  CFSAN. (iv)  The  Director,  Division  of  Enforcement  and  Programs,  Office  of  Field  Programs,  CFSAN. (4)(i)  The  Director  and  Deputy  Director,  Center  for  Veterinary  Medicine  (CVM). (ii)  The  Director  and  Deputy  Director,  Office  of  Surveillance  and  Compliance,  CVM. (iii)  The  Director,  Division  of  Compliance,  Office  of  Surveillance  and  Compliance,  CVM. (5)(i)  The  Director,  the  Deputy  Director,  the  Associate  Director  for  Regulatory Policy,  and  the  Directors,  Office  of  Review  Management  and  Office  of  Pharmaceutical  Science,  Center  for  Drug  Evaluation  and  Research  (CDER). (ii)  The  Director  and  Deputy  Director,  Office  of  Compliance,  CDER. (iii)  The  Associate  Director  for  Medical  Policy,  CDER. (iv)  The  Director,  Division  of  Drug  Marketing,  Advertising,  and  Communications,  Office  of  Medical  Policy,  CDER. (6)(i)  Regional  Food  and  Drug  Directors. (ii)  District  Directors. (iii)  Chiefs  of  District  Compliance  Branches. (iv)  The  Director,  St.  Louis  Branch. (v)  The  Director,  Northeast  Regional  Laboratory,  Northeast  Region. (vi)  The  Director,  Southeast  Regional  Laboratory,  Southeast  Region. (vii)  The  Director,  Winchester  Engineering  and  Analytical  Center. (viii)  The  Director,  National  Forensic  Chemistry  Center. (ix)  The  Director,  Arkansas  Regional  Laboratory. (b)  The  following  officials  are  authorized  to  perform  all  the  functions  of  the  Commissioner   under  section  539(d)  of  the  act  (21  U.S.C.  360pp(d))  regarding  the  issuance  of  written  notices  or  warnings: (1)  The  Director  and  Deputy  Directors  for  Science  and  for  Regulations  and  Policy,  Center  for  Devices  and  Radiological  Health  (CDRH). (2)  The  Director  and  Deputy  Director,  Office  of  Compliance,  CDRH. (3)  For  medical  devices  assigned  to  their  respective  divisions,  the  Division  Directors,  Office  of  Compliance,  CDRH. (4)  The  Director  and  Deputy  Director,  Office  of  Surveillance  and  Biometrics  (OSB),  CDRH,  and  the  Director  and  Deputy  Director,  Division  of  Surveillance  Systems  (DSS),  OSB,  CDRH. (5)  Regional  Food  and  Drug  Directors;  District  Directors;  the  Director,  St.  Louis  Branch;  the  Director,  Northeast  Regional  Laboratory,  Northeast  Region;  the  Director,  Southeast  Regional  Laboratory,  Southeast  Region;  the  Director,  Winchester  Engineering  and  Analytical  Center;  the  Director,  National  Forensic  Chemistry  Center,  and  the  Director,  Arkansas  Regional  Laboratory  when  such  functions  relate  to: (i)  Assemblers  of  diagnostic  x-ray  systems,  as  defined  in  § 1020.30(b)  of  this  chapter;  and (ii)  Manufacturers  of  sunlamp  products  and  ultraviolet  lamps  intended  for  use  in  any  sunlamp  product  as  defined  in  § 1040.20(b)  of  this  chapter. (c)  These  officials  may  not  further  redelegate  these  authorities. § 5.34
 (a) The Director, the Deputy Director, and the Associate Director for Regulatory Policy, Center for Drug Evaluation and Research, the Director and Deputy Director, Center for Veterinary Medicine, and the Director and Deputy Directors, Center for Biologics Evaluation and Research are authorized to issue the following notices and make all findings required in relation to these notices under section 306 of the Federal Food, Drug, and Cosmetic Act (the act)  (21 U.S.C. 335a) which relate to the assigned functions of their organizations: (1) Notices of opportunity for hearing on proposals for mandatory or permissive debarment. (2) Notices ordering debarment when opportunity for a hearing has been waived. (3) Notices ordering debarment where the person notifies the agency that the 
                        ( print page 31006)
                        person consents to debarment under section 306(c)(2)(B) of the act (21 U.S.C. 335a(c)(2)(B)). (4) Notices of opportunity for hearing on proposals denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)). (5) Orders denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)) when opportunity for a hearing has been waived. (b) These officials may not further redelegate these authorities. § 5.35
 5 U.S.C. 605(b)
 (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to decisions made under the Regulatory Flexibility Act (5 U.S.C. 605(b)), to certify that a proposed or final rule, if issued, will not have a significant economic impact on a substantial number of small entities: (1) The Associate Commissioner for Regulatory Affairs. (2) The Director, Center for Biologics Evaluation and Research. (3) The Director, Center for Drug Evaluation and Research. (4) The Director, Center for Devices and Radiological Health. (5) The Director, Center for Food Safety and Applied Nutrition. (6) The Director, Center for Veterinary Medicine. (7) Other Food and Drug Administration Officials authorized to issue 
                        **Federal Register**
                         documents. (b) These officials may not further redelegate this authority. Subpart C—Human Drugs; Redelegations of Authority
 § 5.100
 The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research; and the Director, the Deputy Directors for Regulations and Policy and for Science, and the Director and Deputy Directors, Office of Device Evaluation, Center for Devices and Radiological Health, are authorized to issue notices and amendments thereto implementing section 107(c)(3) of the Drug Amendments of 1962 (Pub. L. 87-781) by announcing new or revised efficacy findings on human drugs that are or were subject to the provisions of section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).  These officials may not further redelegate this authority. § 5.101
 (a) The following officials, for drugs under their jurisdiction, are authorized to perform all the functions of the Commissioner of Food and Drugs on the termination of exemptions for new drugs (including those that are biological products which are subject to the licensing provisions of the Public Health Service Act) for investigational use in human beings under § 312.44 of this chapter and in animals under § 312.160 of this chapter: (1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (2) The Director, the Deputy Director, and the Directors, Office of Review Management and Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (3) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (b) The following officials, for drugs under their jurisdiction, are authorized to terminate exemptions for new drugs for investigational use when sponsors fail to submit an annual progress report under § 312.44(b)(1)(viii) of this chapter: (1) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (2) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (3) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), OVRR, and Office of Therapeutics Research and Review (OTRR), CBER. (4) The Directors and Deputy Directors of the Division of Blood Applications, OBRR, the Division of Vaccines and Related Products Applications, OVRR, and the Division of Application Review and Policy, OTRR, CBER. (5) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH. (c) The following officials, for drugs under their jurisdiction, are authorized to make the findings set forth in § 312.44(b) of this chapter and to notify sponsors and invite correction before termination action on such exemptions: (1) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (2) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (3) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER. (4) The Directors and Deputy Directors of the Division of Blood Applications, OBRR, the Division of Vaccines and Related Products Applications, OVRR, and the Division of Application Review and Policy, OTRR, CBER. (5) The Director and Deputy Directors, ODE, CDRH. (d) These officials may not further redelegate these authorities. § 5.102
 (a) The following officials, for drugs under their jurisdiction, are authorized to perform all the functions of the Commissioner of Food and Drugs to approve a charge and to withdraw approval to charge for investigational drugs in a clinical trial under an investigational new drug application under § 312.7(d)(1) of this chapter: (1) The Director, the Deputy Director, and the Directors, Office of Review Management and the Office of Pharmaceutical Science, Center for Drug Evaluation and Research. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research. (b) These officials may not further redelegate this authority. § 5.103
 (a)(1) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to approval of new drug applications and supplements thereto on drugs for human use, except for those drugs listed in § 314.440(b) of this chapter, that have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355): (i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER, for drugs under their jurisdiction. (2) The Director and Deputy Directors, Center for Biologics Evaluation and 
                        ( print page 31007)
                        Research, for drugs listed in § 314.440(b) of this chapter, are authorized to perform all the functions of the Commissioner with regard to approval of new drug applications and supplements thereto on drugs for human use that have been submitted under section 505 of the act. (b) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER, for drugs under their jurisdiction, are authorized to perform all functions of the Commissioner with regard to approval of supplemental applications to approved new drug applications for drugs for human use that have been submitted under § 314.70 of this chapter and of new drug applications for drug products other than those that contain new molecular entities (new chemical entities). The applications to which this authorization applies may, in appropriate circumstances, continue to be acted upon by the officials so authorized in § 5.10(a) and paragraph (a) of this section. (c) The following officials are authorized to perform all the functions of the Commissioner with regard to approval of abbreviated new drug applications and supplements thereto for drugs for human use and new drug applications for drugs with a 5S classification whose clinical safety and efficacy may be supported by appropriate literature citations in lieu of submission of data from original proprietary studies, or section 505(b)(2) of the act (21 U.S.C. 355 (b)(2)) applications under their jurisdiction. The applications to which this authorization applies may, in appropriate circumstances, continue to be acted upon by the officials so authorized in § 5.10(a) and paragraph (a) of this section. (1) For drugs submitted under §§ 314.50, 314.70, and 314.94 of this chapter, except for those drug products listed in § 314.440(b): (i) The Director and Deputy Director, Office of Generic Drugs (OGD), Office of Pharmaceutical Science, CDER, except that the Director and Deputy Director, OGD are not authorized to approve new drug applications with a 5S classification if clinical studies are needed. (ii) The Directors and Deputy Directors of the divisions in Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (2) For drug products listed in § 314.440(b) of this chapter and submitted under §§ 314.50, 314.70, and 314.94 of this chapter:  The Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER. (d) The following officials are authorized to perform all functions of the Commissioner with respect to approval of supplemental applications to abbreviated new drug applications, 5S applications, or section 505(b)(2) applications for drugs for human use that are described in §§ 314.70(b)(1), (b)(2)(ii) through (b)(2)(x), (c)(1), and (c)(3) of this chapter.  (Authority to approve supplements that require in vivo bioavailability studies or that include in vivo bioavailability study waiver requests are not included in this paragraph.) (1) The Director and Deputy Director, Division of Chemistry I, Office of Generic Drugs, Office of Pharmaceutical Science, CDER. (2) The Director and Deputy Director, Division of Chemistry II, Office of Generic Drugs, Office of Pharmaceutical Science, CDER. (3) Associate Director for Chemistry, Office of New Drug Chemistry, Office of Pharmaceutical Science, CDER. (e) The Director, Division of Labeling and Program Support, Office of Generic Drugs, Office of Pharmaceutical Science, CDER, are authorized to perform all the functions of the Commissioner with respect to approval of supplemental applications to abbreviated new drug applications, 5S applications, or section 505(b)(2) applications for drugs for human use that are described in §§ 314.70(b)(3) and (c)(2)(i) through (c)(2)(iv) of this chapter.  Authority to approve supplements that require in vivo bioavailability studies or in vivo study waiver requests is not included in this paragraph. (f) The supervisory and team leader chemists in the Divisions of New Drug Chemistry I, II, and III, Office of New Drug Chemistry, Office of Pharmaceutical Science, CDER, are authorized to perform all functions of the Commissioner with respect to approval of supplemental applications to new drug applications for drugs for human use that are described in §§ 314(b)(1), (b)(2)(ii) through (b)(2)(x), (c)(1), and (c)(3) of this chapter.  Authority to approve supplements that require in vivo bioavailability information or that require a change in the labeling of the drug, except changes that reflect only the use of a different facility or establishment, are not included in this paragraph. The supplemental applications to which this authorization applies may continue to be acted upon by the officials so authorized in § 5.10(a) and paragraphs (a) and (b) of this section. (g) These officials may not further redelegate these authorities. § 5.104
 The Director, Center for Drug Evaluation and Research (CDER) and the Director, Executive Operations Staff, Office of the Center Director, CDER, are authorized to provide responses to the Drug Enforcement Administration's temporary scheduling notices under section 201(h)(4) of the Controlled Substances Act, as amended  (21 U.S.C. 811(h)(4)).  The delegation excludes the authority to submit reports to Congress.  These officials may not further redelegate this authority. § 5.105
 (a) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER), are authorized to issue notices of an opportunity for a hearing on proposals to refuse approval or to withdraw approval of new drug applications and abbreviated new drug applications and supplements thereto on drugs for human use, except for those drugs listed in § 314.440(b) of this chapter, that have been submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) and subpart B of part 314 of this chapter and to issue notices refusing approval or withdrawing approval when opportunity for hearing has been waived. (b) The Director and Deputy Directors, Center for Biologics Evaluation and Research, for those drugs listed in § 314.440(b) of this chapter, are authorized to issue notices of an opportunity for a hearing on proposals to refuse approval or to withdraw approval of new drug applications and abbreviated new drug applications and supplements thereto on drugs for human use that have been submitted under section 505 of the act and subpart B of part 314 of this chapter and to issue notices refusing approval or withdrawing approval when opportunity for hearing has been waived. (c) These officials may not further redelegate these authorities. 
 
 § 5.106
 (a) The following officials are authorized to perform all of the functions of the Commissioner of Food and Drugs with regard to decisions made under section 505 (c)(3)(D), (j)(4)(B)(iv), and (j)(4)(D) and section 505A of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 355(c)(3)(D), (j)(4)(B)(ii) and (j)(4)(D) and 355a) concerning the date of submission or the date of effective approval of abbreviated new drug applications including supplements thereto submitted under section 505(j) of the act (21 U.S.C. 355(j)) and of new drug applications including supplements thereto submitted under section 505(b)(1)  (21 U.S.C. 355 (b)(1)) of the act and described under section 505(b)(2) of the act (21 U.S.C. 355(b)(2)): (1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (2) The Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER. (b) These officials may not further redelegate this authority. § 5.107
 (a) The following officials are authorized to extend or stay an effective date in § 201.59 of this chapter for compliance with certain labeling requirements for human prescription drugs. (1) For drugs assigned to their organizations: (i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (ii) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER. (iii) The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OTRR, CBER. (2) For drugs assigned to their organizations: (i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (b) These officials may not further redelegate this authority. § 5.108
 The Director, Center for Drug Evaluation and Research (CDER), and the Associate Director for Regulatory Policy, CDER, are authorized to perform all the functions of the Commissioner of Food and Drugs relating to waivers or reductions of prescription drug user fees under the Prescription Drug User Fee Act of 1992, as originally enacted and as reauthorized by the Food and Drug Administration Modernization Act of 1997, except for the functions under section 736(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h(d)(1)(C)) that pertain to situations where “the fees will exceed the anticipated present and future costs,” on behalf of CDER, the Center for Biologics Evaluation and Research, and any other Food and Drug Administration Center.  This authority pertains to waivers requested under the public health waiver provision (21 U.S.C. 379h(d)(1)(A)); the barrier to innovation waiver provision (21 U.S.C. 379h(d)(1)(B)); the applications submitted under section 505(b)(1) and (b)(2) of the Federal Food, Drug, and Cosmetic Act waiver provision (21 U.S.C.  379h(d)(1)(D)); the small business waiver provision (21 U.S.C. 379h(d)(1)(E)); and to requests for refunds of fees if an application or supplement is withdrawn after filing (21 U.S.C. 379h(a)(1)(G)); as well as waivers, reductions, or refunds requested on any other basis except fees exceeding the cost.  (See § 5.20(h)(1) for the authority to reconsider any user fee decisions made by the Chief Mediator and Ombudsman, the Deputy Chief Mediator and Ombudsman, and/or the former Deputy User Fee Waiver Officer prior to July 1, 1999.)  These officials may not further redelegate this authority. § 5.109
 (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under § 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) regarding the issuance of written notices. (1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (2) The Director and Deputy Director, Office of Compliance, CDER. (3) The Director and Deputy Director, Division of Labeling and Nonprescription Drug Compliance, Office of Compliance, CDER. (4) The Director and Deputy Director, Division of Manufacturing and Product Quality, Office of Compliance, CDER. (5) The Director and Deputy Director, Division of Prescription Drug Compliance and Surveillance, Office of Compliance, CDER. (6) The Associate Director for Medical Policy, and the Director and Deputy Director, Division of Scientific Investigations, Office of Medical Policy, CDER. (7) The Director and Deputy Directors, Center for Biologics  Evaluation and Research (CBER), the Director and Deputy Directors, Office of Compliance and Biologics Quality (OCBQ), CBER, and the Directors, Division of Case Management, Division of Inspections and Surveillance, and Division of Manufacturing and Product Quality, OCBQ, CBER. (8) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Directors of the Office of Device Evaluation, CDRH. (9) Regional Food and Drug Directors. (10) District Directors. (b) These officials may not further redelegate this authority. Subpart D—Biologics; Redelegations of Authority
 § 5.200
 (a) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER) are authorized to perform the functions of the Commissioner of Food and Drugs (Commissioner) under part C, subtitle 2 of title XXI of the PHS Act (42 U.S.C. 300aa-25 
                        *et seq*.), as amended, and the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 note), as amended hereafter, as follows: (1) Section 2125 of the PHS Act (42 U.S.C. 300aa-25)-Recording and reporting of information. (2) Section 2127 of the PHS Act (42 U.S.C. 300aa-27)-Mandate for safer childhood vaccines. (3) Section 2128 of the PHS Act (42 U.S.C. 300aa-28)-Manufacturer recordkeeping and reporting. (4) Section 312 of the National Childhood Vaccine Injury Act of 1986-Related studies (42 U.S.C. 300aa-1 
                        ( print page 31009)
                        note), except that the authority to provide for notice and opportunity for public hearing on the review of vaccines and related illnesses and conditions under sections 312(a) and (d) of the National Childhood Vaccine Injury Act of 1986 is not redelegated by the Commissioner. (5) Section 313 of the National Childhood Vaccine Injury Act of 1986-Study of other vaccine risks (42 U.S.C. 300aa-1 note), except that the authority to provide for notice and opportunity for public hearing on the establishment of guidelines regarding the risks to children of certain vaccines under section 313(a)(1)(B) and (b) of the National Childhood Vaccine Injury Act of 1986 is not redelegated by the Commissioner. (6) Section 314 of the National Childhood Vaccine Injury Act of 1986-Review of warnings, use instructions, and precautionary information (42 U.S.C. 300aa-1 note). (b) These officials may not further redelegate these authorities. § 5.201
 (a) The following officials are authorized to perform all the functions of the Director, Center for Biologics Evaluation and Research (CBER) with regard to program authorities for their respective areas: (1) Deputy Directors, CBER. (2) Associate Directors, CBER. (3) Office Directors, CBER. (4) Division Directors, CBER. (b) These officials may not further redelegate these authorities. § 5.202
 (a) The Director and Deputy Directors, Center for Biologics Evaluation and Research are authorized to issue: (1) Notices of opportunity for a hearing on proposals to deny approval or filing of applications for biologics licenses under § 601.4(b) of this chapter. (2) Notices of opportunity for a hearing on proposals to revoke biologics licenses under § 601.5(b) of this chapter. (3) Notices of revocation, at the manufacturer's request, of biologics licenses under §§ 601.5(a) and 601.8 of this chapter. (4) Notices of revocation when the manufacturer has waived the opportunity for hearing under § 601.7(a) of this chapter. (5) Notice of biologics license suspensions under § 601.6 of this chapter. (b) These officials may not further redelegate these authorities. § 5.203
 (a) The following officials are authorized to issue licenses under section 351 of the PHS Act (42 U.S.C. 262) for the propagation or manufacture and preparation of biological products as specified in the PHS Act, and to revoke such licenses at the manufacturer's request: (1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (2) Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER. (b) These officials may not further redelegate this authority. § 5.204
 (a) The following officials are authorized to issue written notices of release for distribution of licensed biological products under subchapter F (parts 600 through 680.31) of this chapter: (1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (2) The Director and Deputy Directors, Office of Compliance and Biologics Quality (OCBQ), CBER. (3) The Director and Deputy Director, Division of Manufacturing and Product Quality, OCBQ, CBER. (b) These officials may not further redelegate this authority. Subpart E—Food and Cosmetics; Redelegations of Authority
 § 5.300
 (a)(1) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under sections 409 and 721 of the act (21 U.S.C. 348 and 379e) regarding the issuance of notices of filing (including notices of extension of, or reopening of, the comment period), and of voluntary withdrawal, of petitions on food additives, generally recognized as safe (GRAS) substances, and color additives that relate to the assigned functions of the respective Center: (i) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN). (ii) The Director of Regulations and Policy, CFSAN. (iii) The Director, Office of Premarket Approval, CFSAN. (iv) The Director and Deputy Director, Center for Veterinary Medicine (CVM). (2) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN are authorized to perform all the functions of the Commissioner under section 401 of the act (21 U.S.C. 341) regarding the issuance of proposed rulemaking (including notices of extension of, or reopening of, the comment period) pertaining to food standards. (b)(1) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN are authorized to perform all of the functions of the Commissioner under section 409 and 721 of the act (21 U.S.C. 348 and 379e) regarding the approval of the use of food additives under section 409(e) of the act (21 U.S.C. 348(e)) and the listing of color additives under section 721(d)(1) of the act (21 U.S.C. 379e) where the listing does not involve novel or controversial issues and does not involve any questions about the applicability of the Delaney Anti-Cancer Clause. (2) The following officials are authorized to perform all of the functions of the Commissioner under section 401 of the act (21 U.S.C. 341) regarding the issuance of notices of temporary permits for foods varying from standards of identity under § 130.17 of this chapter: (i) The Director and Deputy Director, CFSAN. (ii) The Director of Regulations and Policy, CFSAN. (iii) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN. (3) The Director and Deputy Director, CVM, are authorized to perform all the functions of the Commissioner regarding approvals of the use of food additives under section 409(e) of the act (21 U.S.C. 348(e)), where these approvals do not involve novel or controversial issues, including any question about the applicability of the Delaney Anti-Cancer Clause. (c)(1) The following officials are authorized to issue 90-day letters to food additive petitioners under section 409(c)(2) of the act (21 U.S.C. 348(c)(2)) or to color additive petitions under section 721e(d)(1) (21 U.S.C. 379e(d)(1)) of the act that relate to the assigned functions of the Center: (i) The Director and Deputy Director, CFSAN. (ii) The Director of Regulations and Policy, CFSAN. 
 
 (iii) The Director, Office of Premarket Approval, CFSAN. (iv) The Director, Division of Product Policy, Office of Premarket Approval, CFSAN. (v) The Director, Division of Petition Control, Office of Premarket Approval, CFSAN. (2) The following officials are authorized to issue 90-day letters to food additive petitioners under section 409(c)(2) of the act (21 U.S.C. 348(c)(2)) that relate to the assigned functions of the Center: (i) The Director and Deputy Director, CVM. (ii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM. (iii) The Director and Deputy Director, Division of Animal Feeds, Office of Surveillance and Compliance, CVM. (d) The following officials are authorized to certify batches of color additives under section 721 of the act (21 U.S.C. 379e): (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Cosmetics and Colors, CFSAN. (e) The following officials are authorized to issue advance notices of proposed rulemaking pertaining to Codex Alimentarius food standards and notices terminating consideration of such standards when comments fail to support the desirability and need for proposing their adoption, under § 130.6 of this chapter: (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN. (f) The following officials are authorized to issue notices of proposed rulemaking and issue or amend regulations affirming GRAS status of food substances under §§ 170.35 or  570.35 of this chapter where the affirmations relate to the assigned functions of the respective Center and do not involve novel or controversial issues: (1) The Director, Deputy Director, and Director of Regulations and Policy, CFSAN. (2) The Director and Deputy Director, CVM. (g)(1) The following officials are authorized to perform all of the functions of the Commissioner  under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) regarding the issuance of decisions to grant or deny petitions for nutrient content claims and health claims that do not present controversial issues and regarding the issuance of any notices of proposed rulemaking that result from such action: (i) The Director and Deputy Director, CFSAN. (ii) The Director of Regulations and Policy, CFSAN. (2) The following officials are authorized to perform all of the functions of the Commissioner under section 403(r)(4) of the act (21 U.S.C. 343(r)(4)) regarding the issuing of letters of filing in response to petitions for nutrient content claims and health claims: (i) The Director and Deputy Director, CFSAN. (ii) The Director of Regulations and Policy, CFSAN. (iii) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN. (h) The following officials are authorized to issue letters concerning substances determined to be below the “threshold of regulation” under § 170.39 of this chapter: (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Premarket Approval, CFSAN. (4) The Directors of the Divisions of Petition Control and Product Policy, Office of Premarket Approval, CFSAN. (i) The following officials are authorized to perform all of the functions of the Commissioner under section 409(h) of the act (21 U.S.C. 348(h)), excluding the duties to set out in section 409(h)(5) of the act (21 U.S.C. 348(h)(5)), regarding premarket notification of food-contact substances: (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Premarket Approval, CFSAN. (j) These officials may not further redelegate these authorities. § 5.301
 (a) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN), the Director, Office of Field Programs, CFSAN, and the Director, Division of Enforcement and Programs, Office of Field Programs, CFSAN, are authorized to issue initial emergency permit orders under § 108.5 of this chapter. (b) The following officials are authorized to issue notices of confirmation of effective date of final regulations on food matters issued under section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)): (1) The Director and Deputy Director, CFSAN. (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN. (4) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN. (5) The Director, Office of Seafood, CFSAN. 6) The Director, Office of Field Programs, CFSAN. (7) The Director, Office of Premarket Approval, CFSAN. (c) These officials may not further redelegate these authorities. § 5.302
 The Regional Food and Drug Directors and District Directors are authorized to perform and to designate other officials to perform all of the functions of the Commissioner of Food and Drugs under: (a) Section 409(b) of the Federal Meat Inspection Act (21 U.S.C. 679(b)), that relates to the detention of any carcass, part thereof, meat, or meat product of cattle, sheep, swine, goats, or equines. (b) Section 24(b) of the Poultry Products Inspection Act (21 U.S.C. 467f (b)) that relates to the detention of any poultry carcass, part thereof, or poultry product. (c) The Egg Products Inspection Act (21 U.S.C. 1031 
                        *et seq*.). § 5.303
 The Director, Deputy Director, and Director of Regulations and Policy, Center for Food Safety and Applied Nutrition, are authorized to perform all the functions of the Commissioner of Food and Drugs under sections 1322(b) and (c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended hereafter, which relate to setting standards for the National Laboratory Accreditation Program and approving State agencies or private, nonprofit entities as accrediting bodies to implement certification and quality assurance programs in accordance with the requirements of these sections. The delegation excludes the authority to submit reports to the Congress.  These officials may not further redelegate this authority. 
 
 § 5.304
 (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under § 113.10 of this chapter regarding the approval of schools giving instruction in retort operations, processing systems operations, aseptic processing and packaging system operations, and container closure inspections: (1) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN). (2) The Director of Regulations and Policy, CFSAN. (3) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN. (b) These officials may not further redelegate this authority. Subpart F—Medical Devices and Radiological Health;  Redelegations of Authority
 § 5.400
 (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health; and the Director and Deputy Directors, Center for Biologics Evaluation and Research, are authorized to issue 
                        **Federal Register**
                         documents under section 514(c) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360d(c)) recognizing or withdrawing recognition of a standard for which a person may submit a declaration of conformity in order to meet a premarket submission requirement. (b) These officials may not further redelegate this authority. § 5.401
 (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health; and the Directors and Deputy Directors, Center for Biologics Evaluation and Research, are authorized to make determinations and issue 
                        **Federal Register**
                         notices and rules under § 510(m) of the act (21 U.S.C. 360(m)) concerning exemptions from premarket notification. (b) These officials may not further redelegate this authority. § 5.402
 (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs pertaining to detention, under section 304(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(g)) and in accordance with § 800.55 of this chapter, of medical devices that may be adulterated or misbranded: (1) For medical devices assigned to their respective organizations: (i) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (ii) The Director and Deputy Director, Office of Compliance, CDRH. (iii) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (iv) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (2) Regional Food and Drug Directors. (3) District Directors. (4) The Director, St. Louis Branch. (b) These officials may not further redelegate this authority. § 5.403
 (a) The following officials, for medical devices assigned to their respective organizations, may authorize under section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (the act)  (21 U.S.C. 360c(a)(3)(B)) the use of valid scientific evidence (other than that prescribed by section 513(a)(3)(A) of the act) for determining the effectiveness of medical devices for the purposes of sections 513, 514, and 515 of the act (21 U.S.C. 360c, 360d, and 360e): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Directors, Office of Device Evaluation, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Director, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER. (b) These officials may not further redelegate this authority. § 5.404
 (a) The following officials, for medical devices assigned to their respective organizations, are authorized to notify petitioners of determinations made on petitions for reclassification of medical devices that are classified in class III (premarket approval) by sections 513(f) and 520(l) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f) and 360 j(1)) and denials of petitions for reclassification of medical devices that are submitted under section 513(e) of the act (21 U.S.C. 360c(e)) (except for petitions submitted in response to 
                        **Federal Register**
                         notices initiating standard-setting under § 514(b) of the act (21 U.S.C. 360d(b)) or premarket approval under section 515(b) of the act (21 U.S.C. 360e(b)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH) and the Director and Deputy Directors, Office of Device Evaluation. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Therapeutics Research and Review, CBER. (b) These officials may not further redelegate this authority. § 5.405
 (a) The following officials, for devices assigned to their respective organizations, are authorized to determine the classification of a medical device in commercial distribution prior to May 28, 1976, under section 513(d) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(d)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH) and the Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors of the Office of Blood Research and Review (OBRR), the Office of Vaccines Research and Review (OVRR), and the Office of Therapeutics Research and Review (OTRR), CBER. (b) The following officials, for devices assigned to their respective organizations, are authorized to determine the classification of a medical device first intended for commercial distribution after May 28, 1976, under section 513 (f)(1)(A) of the act (21 U.S.C. 360c(f)(1)(A)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, and the Director, Deputy Directors, Division and Deputy Division Directors, Associate Division Directors, Branch Chiefs, and Chief, Premarket Notification Section, ODE, CDRH. (2) The Director and Deputy Directors, CBER, and the Directors and Deputy 
                        ( print page 31012)
                        Directors of the OBRR, OVRR, and OTRR, CBER. (c) The following officials are authorized to make determinations and issue orders classifying devices under section 513(f)(2)(b): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Directors, ODE, CDRH. (3) The Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and OTRR, CBER. (d) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, and the Director and Deputy Directors, CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and OTRR, CBER, are authorized to issue 
                        **Federal Register**
                         notices under section 513(f)(2)(C) of the act (21 U.S.C. 360c(f)(2)(C)) announcing classification of devices under section 513(f)(2)(B) of the act (21 U.S.C. 360c(f)(2)(B)). (e) These officials may not further redelegate those authorities. § 5.406
 (a) The following officials, for medical devices assigned to their respective organizations, are authorized to notify sponsors of deficiencies in petitions for reclassification of medical devices submitted under sections 513(f) and 520(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f) and 360j(l)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Directors, Office of Device Evaluation, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors of the Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Therapeutics Research and Review, CBER. (b) These officials may not further redelegate this authority. § 5.407
 (a) The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, declare as complete or incomplete, or revoke product development protocols for medical devices submitted under section 515(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(f)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH, and the Division Directors, ODE, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER. (b)(1) The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, or withdraw approval of applications for premarket approval for medical devices submitted under sections 515 and 520(l) of the act (21 U.S.C. 360e and 360j(l)): (i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Directors, ODE, CDRH, and the Division Directors, ODE, CDRH. (ii) The Director and Deputy Directors, CBER, and the Directors and Deputy Directors, OBRR, OVRR, and OTRR, CBER. (2) For medical devices assigned to their respective division, the Division Directors, Office of Device Evaluation, CDRH, are authorized to approve, disapprove, or withdraw approval of supplemental premarket applications. (c) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, for medical devices assigned to their organization, are authorized to issue notices to announce the approval, disapproval, or withdrawal of approval of a device, and to make publicly available a detailed summary of the information on which the decision was based, under sections 515(d), (e), and (g) and 520(h)(1) of the act (21 U.S.C. (d), (e), and (g) and 360j(h)(1)). (d) These officials may not further redelegate these authorities. § 5.408
 (a) The following officials are authorized to make determinations under section 513(a)(3)(D) of the act (21 U.S.C. 360c(a)(3)(D)) concerning the type of valid scientific evidence to be submitted in a premarket approval application that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person: (i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (ii) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH. (iii) The Director, Program Operations Staff, ODE, CDRH. (iv) For devices assigned to their respective Divisions:  the Division Directors and Deputy Division Directors, ODE, CDRH. (b) These officials may may not further redelegate this authority. § 5.409
 (a) The following officials, for medical devices assigned to their respective organizations, are authorized to determine that medical devices present an unreasonable risk of substantial harm to the public health, and to order adequate notification thereof, under section 518(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(a)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Director, Office of Compliance and Biologics Quality, CBER. (3) The Director, the Deputy Director, and the Directors, Office of Review Management and Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER. (b) These officials may not further redelegate this authority. § 5.410
 (a) The following officials, for medical devices assigned to their respective organizations, are authorized to order repair or replacement of, or refund for, medical devices under section 518(b) and (c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(b) and (c)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and 
                        ( print page 31013)
                        Deputy Directors, Office of Compliance and Biologics Quality, CBER. (3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER. (b) These officials may not further redelegate this authority. § 5.411
 (a) The following officials, for medical devices assigned to their respective organizations, are authorized to perform all of the recall functions under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)), which have been delegated to the Commissioner of Food and Drugs: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Director and Deputy Director, Office of Compliance, CDER. (4) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (b) These officials may not further redelegate this authority. § 5.412
 (a) The following officials for medical devices assigned to their respective organizations are authorized under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)), to determine that there is reasonable probability that continuation of the distribution of a device under an approved application would cause serious adverse health consequences or death, and upon making such a determination, to issue an order to temporarily suspend the approval of an application: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (3) The Director and Deputy Directors, Office of Device Evaluation, CDRH. (4) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER; the Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER; and the Director and Deputy Director, Office of Compliance, CDER. (5) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (b) These officials may not further redelegate this authority. § 5.413
 (a) For medical devices assigned to their respective organizations, the following officials are authorized to approve, disapprove, or withdraw approval of applications for investigational device exemptions submitted under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) ( 21 U.S.C. 360j(g)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Directors, Office of Device Evaluation, CDRH, and the Director and Deputy Director, Office of Compliance, CDRH. (2) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER. (b) For medical devices assigned to their respective divisions, the Division Directors, Office of Device Evaluation, CDRH, are authorized to approve, disapprove, or withdraw approval of applications for investigational device exemptions submitted under section 520(g) of the act (21 U.S.C. 360j(y)). (c) The following officials are authorized to enter into written agreements concerning investigational device exemption protocols under section 520(g)(7) of the act (21 U.S.C. 360j(g)(7)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH. (3) The Director, Program Operations Staff, ODE, CDRH. (4) The Chief, Investigational Device Exemption Section, ODE, CDRH. (5) For medical devices assigned to their respective Divisions:  The Division Directors and Deputy Division Directors, ODE, CDRH. (6) The Director and Deputy Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OTRR, CBER. (d) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH and the Director and Deputy Directors, ODE, CDRH, the Director and Deputy Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OTRR, CBER, are authorized to make decisions under section 520(g)(7) of the act (21 U.S.C. 360j(g)(7)) with respect to an agreement on an investigational plan, that a substantial scientific issue essential to determining the safety and effectiveness of the device involved has been identified. (e) These officials may not further redelegate these authorities. § 5.414
 (a) For any class II or class III device (including any device that is or contains a drug or biologic), the failure of which would be reasonably likely to have serious adverse health consequences, or which is intended to be implanted in the human body for more than 1 year, or a life supporting or life sustaining device used outside a user facility, any of the following officials is authorized to require a manufacturer of such device to conduct postmarket surveillance: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Surveillance and Biometrics, CDRH. (3) The Director and Deputy Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics (OSB), and the Director, Issues Management Staff, OSB, CDRH. (4) The Director and Deputy Directors, Office of Device Evaluation, CDRH. (5) The Director and Deputy Director, Office of Science and Technology, CDRH. (6) The Director and Deputy Director, Office of Health and Industry Programs, CDRH. (7) The Director and Deputy Director, Office of Compliance, CDRH. (8) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). 
 
 (9) The Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (10) The Director and Deputy Director, Office of Compliance, CDER. (11) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (12) The Director and Deputy Director, Office of Compliance and Biologics Quality, CBER. (13) The Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Therapeutics Research and Review, CBER. (b) These officials may not further redelegate these authorities. § 5.415
 (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH, are authorized to approve electronic reporting under § 803.14 of this chapter. (b) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are authorized to request the submission of additional information under § 803.15 of this chapter. (c) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, the Director and Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, OSB, CDRH are authorized to grant or revoke exemptions and variances from reporting requirements under § 803.19 of this chapter. (d) These officials may not further redelegate these authorities. § 5.416
 (a) The following officials are authorized to issue orders under section 519(e) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360i(e)) requiring manufacturers to adopt methods of tracking devices: (1) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (b) These officials may not further redelegate this authority. § 5.417
 (a) The following officials are authorized under section 523(a)(1) and (b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m(a)(1) and (b)(2)(A)) to respond to a request for accreditation and to accredit persons for the purpose of reviewing reports submitted under section 510(k) of the act (21 U.S.C. 360(k)) and making recommendations regarding the initial classification of devices: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Health and Industry Programs (OHIP), CDRH. (3) The Director and Deputy Director, Division of Small Manufacturers Assistance (DSMA), OHIP, CDRH. (b) The following officials are authorized under section 523(a)(2)(B) and (C) of the act (21 U.S.C. 360m(a)(2)(B) and (C)) to make a determination with respect to the recommendation of an initial classification of a device; and to change the initial classification under section 513(f)(1) of the act (21 U.S.C. 360c(f)(1)) that is recommended by an accredited person to provide to such person, and the person who submitted the report under section 510(k) of the act (21 U.S.C. 360(k)) for the device, a statement explaining in detail the reasons for the change: (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH. (3) The Division Directors and Deputy Division Directors, ODE, CDRH. (c) The following officials are authorized under section 523(b)(2)(B) of the act (21 U.S.C. 360m(b)(2)(B)) to suspend or withdraw accreditation of any person accredited to review reports and to make recommendations under section 523 of the act (21 U.S.C. 360m): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DSMA, OHIP, CDRH. (d) The following officials are authorized under section 523(b)(2)(C) of the act (21 U.S.C. 360m(b)(2)(c)) to implement the measures described in that section to ensure that persons accredited under section 523 of the act (21 U.S.C. 360m) will continue to meet the standards of accreditation: (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, Office of Compliance, CDRH. (e) These officials may not further redelegate these authorities. Subpart G—Animal Drugs; Redelegations of Authority
 § 5.500
 Federal Register
 The Director and Deputy Director, Center for Veterinary Medicine (CVM) are authorized to issue 
                        **Federal Register**
                         documents pertaining to the determination of safe levels, notice of need for development of an analytical method, notice of availability of a developed analytical method, and prohibition of certain extralabel drug use related to implementation of section 512(a)(4) and (5) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b(a)(4) and (5)). These officials may further redelegate this authority. § 5.501
 (a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to the approval of new animal drug applications, and supplements thereto, for new animal drugs submitted under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b). (b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to the approval of supplemental applications to approved new animal drugs submitted under section 512 of the act (21 U.S.C. 360b): (1) The Director, the Deputy Director for Human Food Safety and Consultative Services, and the Deputy Director for Therapeutic and Production Drug Review, Office of New Animal Drug Evaluation, CVM. (2) The Director and Deputy Director, Office of Surveillance and Compliance, CVM. (c) The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of supplemental applications to new animal drug applications that are 
                        ( print page 31015)
                        described by section 514.8(a)(4)(iii), (iv), and (v), and (d)(3) of this chapter. (1) The Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM. (2) The Director, Division of Epidemiology and Surveillance, Office of Surveillance and Compliance, CVM. (d) The following officials are authorized to perform all the functions of the Commissioner  with regard to the approval of medicated feed mill license applications for the manufacture of animal feeds containing new animal drugs under section 512(m) of the act (21 U.S.C. 360b(m), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250): (1) The Director and Deputy Director, CVM. (2) The Director, Division of Animal Feeds, Office of Surveillance and Compliance, CVM. (3) The Leader, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM. (4) The Medicated Feeds Specialist, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM. (e) These officials may not further redelegate these authorities. § 5.502
 (a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to: (1) Issue notices of opportunity for a hearing on proposals to refuse approval or to withdraw approval of new animal drug applications, and supplements thereto, for drugs for animal use and proposals to refuse approval or to revoke approval of medicated feed mill license applications, and supplements thereto, submitted under section 512(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(m)), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250); (2) Issue notices refusing or withdrawing approval when opportunity for hearing has been waived; and (3) Issue proposals and orders to revoke and amend regulations for new animal drugs for drugs for animal use and medicated feed mill licenses, corresponding to said act on such applications. (b) The Director and Deputy Director, CVM, are authorized to issue notices of availability of Public Master Files containing data acceptable for use in applications for new animal drugs for drugs for animal use and feeds bearing or containing new animal drugs. (c) These officials may not further redelegate these authorities. § 5.503
 (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to decisions made under section 512(c)(2)(D)(iv) and (c)(2)(F) of the Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(D)(iv) and (c)(2)(F) concerning the date of submission and the date of effective approval of abbreviated new animal drug applications including supplements thereto, submitted under section 512(b)(2) of the act (21 U.S.C. 360b(b)(2)), and of new animal drug applications including supplements thereto, submitted under section 512(b)(1) of the act (21 U.S.C. 360b(b)(1)): (1) The Director and Deputy Director, Center for Veterinary Medicine (CVM). (2) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM. (b) These officials may not further redelegate this authority. § 5.504
 (a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under sections 512(e) and 512 (m)(4)(B)(ii) and (m)(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e), (m)(4)(B)(ii), and (m)(4)(B)(iii)) regarding the issuance of written notices: (1) The Director and Deputy Director, Center for Veterinary Medicine (CVM). (2) The Director and Deputy Director, Office of Surveillance and Compliance, CVM. (3) The Director, Division of Compliance, Office of Surveillance and Compliance, CVM. (4) Regional Food and Drug Directors. (5) District Directors. (b) These officials may not further redelegate this authority. § 5.505
 (a) The following officials are authorized to perform all functions of the Commissioner of Food and Drugs with regard to the termination of new animal drugs for investigational use in animals under § 511.1 of this chapter: (1) The Director and Deputy Director, Center for Veterinary Medicine (CVM). (2) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM. (b) These officials may not further redelegate this authority. Subpart H—Radiation Control; Redelegations of Authority
 § 5.600
 (a) The following officials are authorized to grant and withdraw variances and issue notices of availability of any approved variance or any amendment or extension thereof, from the provisions of performance standards for electronic products established in subchapter J of this chapter: (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (b) These officials may not further redelegate this authority. § 5.601
 (a) The following officials are authorized to exempt from performance standards any electronic product intended for use by departments or agencies of the United States under section 534 (a)(5) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360kk(a)(5)) and to exempt an electronic product or class of products from all or part of the provisions of section 538(a) of the act (21 U.S.C. 360oo(a)) under section 538(b) of the act (21 U.S.C. 360oo(b)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Compliance, CDRH. (b) These officials may not further redelegate this authority. § 5.602
 (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH, are authorized to review and evaluate industry testing programs under section 534(g) of the Federal Food, Drug and Cosmetic Act the act (21 U.S.C. 360kk(g)) and to approve or disapprove alternate 
                        ( print page 31016)
                        methods of certification and identification and to disapprove testing programs upon which certification is based under section 534(h) of the act (21 U.S.C. 360kk(h)). (b) These officials may not further redelegate this authority. § 5.603
 (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director and Deputy Director, Office of Compliance, CDRH, are authorized to perform all functions of the Commissioner of Food and Drugs (Commissioner), relating to notification of defects in, noncompliance of, and repair or replacement of or refund for, electronic products under section 534 of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360kk) and under §§ 1003.11, 1003.22, 1003.31, 1004.2, 1004.3, 1004.4, and 1004.6 of this chapter; and Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized to perform all such functions relating to: (1) Assemblers of diagnostic x-ray systems, as defined in § 1020.30(b) of this chapter. (2) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product, as defined in § 1040.20(b) of this chapter. (b) The Director and Deputy Director, Office of Compliance, CDRH, and the Division Directors, Office of Compliance, CDRH, are authorized to notify manufacturers of defects in, and noncompliance of, electronic products under section 535(e) of the act (21 U.S.C. 360ll(e)) and under § 1003.11(a) of this chapter; and the chiefs of District Compliance Branches are authorized to perform all such functions relating to: (1) Assemblers of diagnostic x-ray systems, as defined in § 1020.30(b) of this chapter. (2) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp products, as defined in § 1040.20(b) of this chapter. (c) These officials may not further redelegate these authorities. § 5.604
 (a) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health, are authorized to require manufacturers to provide performance and technical data to the ultimate purchaser of electronic products under section 537(c) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360nn(c)). (b) These officials may not further redelegate these authorities. § 5.605
 (a) The Director and Deputy Director for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Director, Office of Compliance, CDRH, and the Division Directors, Office of Compliance, CDRH, are authorized to direct dealers and distributors of electronic products to furnish information on first purchasers of such products to the manufacturer of the product under section 537(f) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360nn(f)). (b) These officials may not further redelegate these authorities. § 5.606
 (a) The Director and Deputy Directors, Center for Devices and Radiological Health, are authorized to accept assistance from State and Local authorities engaged in activities related to health or safety or consumer protection on a reimbursable basis or otherwise, under section 541 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360rr). (b) These officials may not further redelegate these authorities. Subpart I—Product Designation; Redelegations of Authority
 § 5.700
 The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of the Senior Associate Commissioner, Office of the Commissioner, as product jurisdiction officer is authorized to make a determination under section 563 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-2) respecting the classification of a product as a drug, biological product, device, or a combination product subject to section 503(g) of the act (21 U.S.C. 353(g)), and to assign primary responsibility respecting the organizational component of the Food and Drug Administration that will regulate the product.  This official may not further redelegate this authority. § 5.701
 (a) For a product that is or contains a biologic, a device, or a drug, the following officials in the Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, or Center for Drug Evaluation and Research who currently hold delegated premarket approval authority for biologics, devices, or drugs, respectively, are hereby delegated all the authorities necessary for premarket approval of any product that is a biologic, a device, or a drug, or any combination of two or more of these products: (1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER) and the Directors of the Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER. (2) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), and the Director, Office of Device Evaluation, CDRH. (3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); and the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (b) These officials may not further redelegate this authority. Subpart J—Imports and Exports; Redelegations of Authority
 § 5.800
 (a) The Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized, under section 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381), to perform the following functions or to designate officials to: (1) Request from the Secretary of the Treasury samples of food, drugs (including biological products), devices, or cosmetics imported or offered for import. (2) Determine whether such articles are in compliance with the act. (3) Authorize relabeling or other compliance actions to bring articles into compliance under the Act. (4) Supervise such compliance actions. (b) The Director and Deputy Directors for Science and for Regulations and 
                        ( print page 31017)
                        Policy, Center for Devices and Radiological Health (CDRH); the Director and Deputy Director, Office of Compliance, CDRH; Regional Food and Drug Directors; District Directors; and the Director, St. Louis Branch, are authorized, under section 536 of the act (21 U.S.C. 360mm), to perform the following functions or to designate officials to: (1) Request from the Secretary of the Treasury samples of electronic products imported or offered for import to determine whether such products are in compliance with section 534 of the act (21 U.S.C. 360kk). (2) Refuse admission of noncomplying products and notify the Secretary of the Treasury of such refusal. (3) Supervise operations to bring noncomplying products into compliance under section 534 of the act (21 U.S.C. 360kk). (4) Refuse or grant permission and time extensions to bring noncomplying products into compliance with section 534 of the act (21 U.S.C. 360kk) in accordance with a corrective action plan approved by the Directors, Offices of Compliance Surveillance and Biometrics, CDRH. (c) The following officials are authorized, under section 538(b) of the act (21 U.S.C. 360oo(b)), to exempt persons from issuing a certification, as required by section 534(h) of the act (21 U.S.C. 360kk(h)) for electronic products imported into the United States for testing, evaluation, demonstrations, or training, which will not be introduced into commerce and upon completion of their function will be destroyed or exported in accord with U.S. Customs Service's regulations: (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, Office of Compliance, CDRH. (3) Regional Food and Drug Directors. (4) District Directors. (5) The Director, St. Louis Branch. (d) The Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized to exercise all of the functions of the Commissioner of Food and Drugs (Commissioner) under section 362 of the Public Health Service Act (42 U.S.C. 265) that relate to the prohibition of the introduction of foods, drugs, devices, cosmetics, and electronic products, and other items or products regulated by the Food and Drug Administration into the United States when it is determined that it is required in the interest of public health, and such functions relate to the law enforcement functions of the Food and Drug Administration. (e) The following officials are authorized to perform all the functions of the Commissioner pertaining to exportation of medical devices under section 801(e) of the act (21 U.S.C. 381(e)): (1) For medical devices assigned to their respective organization: (i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (ii) The Director and Deputy Director, Office of Compliance, CDRH. (iii) The Director and Deputy Director, Division of Program Operations, Office of Compliance, CDRH. (iv) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (v) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (2) Regional Food and Drug Directors. (3) District Directors. (4) The Director, St. Louis Branch. (f) The following officials are authorized to perform the functions of the Commissioner for drugs under their jurisdiction, pertaining to authorizing the reimportation of prescription drugs under section 801(d)(2) of the act (21 U.S.C. 381(d)(2)) for emergency medical care: (1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER) and the Director, Office of Compliance and Biologics Quality, CBER. (2) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER) and the Director and Deputy Director, Office of Compliance, CDER. (g) These officials may not further redelegate these authorities. § 5.801
 (a) The following officials are authorized, under section 802(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382(b)(2) and (b)(3)), to grant or deny petitions to export unapproved new drugs and biological products and to issue notices of receipt of such petitions for human drugs assigned to their respective organizations: (1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (2) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (3) The Director, the Deputy Director, and the Directors, Office Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (4) The Director and Deputy Director, Office of Compliance, CDER. (b) The following officials are authorized, under section 802(e) of the act (21 U.S.C. 382(e)), to approve or disapprove an application to export a drug (including a biological product) to be used in the prevention or treatment of a tropical disease or another disease as described in section 802(e) for human drugs assigned to their respective organizations: (1) The Director and Deputy Directors, CBER. (2) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (3) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER. (4) The Director and Deputy Director, Office of Compliance, CDER. (c) The following officials are authorized, under section 351(h) of the Public Health Service Act (42 U.S.C. 262(h)), to approve or disapprove an application to export a partially processed biological product: (1) The Director and Deputy Directors, CBER. (2) The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER. (d) These officials may not further redelegate these authorities. § 5.802
 The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH) and the Director and Deputy Director, Office of Compliance, CDRH, are authorized to reject manufacturer's designation of import agents under § 1005.25(b) of this chapter.  These officials may not further redelegate this authority. Subpart K—Orphan Products; Redelegations of Authority
 § 5.900
 (a) The Director, Office of Orphan Products Development (OPD), Office of the Senior Associate Commissioner (OSAC), Office of the Commissioner (OC), is authorized to issue notices, and amendments thereto, inviting sponsorship for orphan products (human and animal drugs, biological products, and medical devices) and submission of: (1) Notices of claimed investigational exemption for a new drug or new drug applications; 
 
 (2) Notices of claimed investigational exemption for a new animal drug or new animal drug applications; (3) Applications for biologics licenses for biological products; or (4) Applications for an investigational device exemption or premarket approval applications for medical devices, as appropriate. (b) The Director, OPD, OSAC, OC, is authorized: (1) To determine whether there is reason to believe that a drug is a drug for a disease or condition that is rare in the United States under section 525(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aa(a)) and to designate such drug as a drug for a rare disease or condition under section 526(a) of the act (21 U.S.C. 360bb(a)). (2) To issue holders of approved applications or licenses notice and opportunity for the submission of views under section 527(b)(1) of the act (921 U.S.C. 360cc(b)(1)). (3) To encourage sponsors of an investigational new drug for a rare disease or condition to design protocols for clinical investigations to permit the addition to the investigation of persons with the disease or condition under section 528 of the act (21 U.S.C. 360dd). (c) The following officials are authorized to provide sponsors, under section 525(a) of the act (21 U.S.C. 360aa(a)), with recommendations for nonclinical or clinical investigations believed to be necessary for a drug for a rare disease or condition to be approved or licensed: (1) For drugs under their jurisdiction: (i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER). (ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER. (2) For biological products under their jurisdiction: (i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER). (ii) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), Office of Therapeutics Research and Review (OTRR), CBER. (iii) The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OTRR, CBER. (d) These officials may not further redelegate these authorities. Subpart L—Mammography Facilities; Redelegations of Authority
 § 5.1000
 (a) The following officials are authorized to ensure mammography facilities obtain certificates under section 354(b) of the Public Health Service Act (the PHS Act) (42 U.S.C. 263b(b)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH). (2) The Director and Deputy Director, Office of Health and Industry Programs (OHIP), CDRH. (3) The Director and Deputy Director, Division of Mammography Quality and Radiation Programs (DMQRP), OHIP, CDRH. (b) The following officials are authorized to issue, renew and extend certificates to mammography facilities under section 354(c) of the PHS Act (42 U.S.C. 263b(c)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (c) The following officials are authorized to accept an application for a certificate under section 354(d)(1) of the PHS Act (42 U.S.C. 263b(d)(1)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (d) The following officials are authorized to approve accreditation bodies to accredit mammography facilities under section 354(e)(1)(A) of the PHS Act (42 U.S.C. 263b(e)(1)(A)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (e) The following officials are authorized to ensure accreditation bodies provide satisfactory assurances of compliance under section 354(e)(1)(C) of the PHS Act (42 U.S.C. 263b(e)(1)(c)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (f) The Director, CDRH is authorized to issue regulations under which the Director may withdraw approval of accreditation bodies under section 354(e)(2)(A) of the PHS Act (42 U.S.C. 263b(e)(2)(A)). (g) The following officials are authorized to determine the expiration date of a certificate of a facility accredited by an accreditation body after the body’s approval is withdrawn, or a State’s certification authority has been withdrawn, or a facility’s accreditation has been revoked by an accreditation body under sections 354(e)(2)(B) and 354(e)(5) of the PHS Act (42 U.S.C. 263b(e)(2)(B) and (e)(5)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (h) The following officials are authorized to determine the applicable standards for a facility for accreditation under section 354(e)(3) of the PHS Act (42 U.S.C. 263b(e)(3)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (i) The following officials are authorized to ensure accreditation bodies make on site visits and to determine whether other measures are appropriate under section 354(e)(4) of the PHS Act (42 U.S.C. 263b(e)(4)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (j) The following officials are authorized to evaluate annually the performance of each approved accreditation body as provided by section 354(e)(6)(A) of the PHS Act (41 U.S.C. 263b(e)(6)(A)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (k) The following officials are authorized to determine the compliance of certified facilities with established standards through annual facility inspections as provided by section 354(g) of the PHS Act (42 U.S.C. 263b(g)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. 
 
 (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (l) The following officials are authorized to promote voluntary compliance with established standards instead of taking actions under section 354(i) of the PHS Act (42 U.S.C. 263b(i)) by imposing directed plans of correction and/or payment of the cost of onsite monitoring under section 354(h)(1) of the PHS Act (42 U.S.C. 263b(h)(l)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (m) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH are authorized to impose sanctions under section 354(h)(2) of the PHS Act (42 U.S.C. 263b(h)(2)). (n) The following officials are authorized to develop and implement the procedures for determining when and how to impose sanctions as provided by section 354(h)(3) of the PHS Act (42 U.S.C. 263b(h)(3)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (o) The following officials are authorized to suspend or revoke individual facility certificates under section 354(i)(1) and (i)(2) of the PHS Act (42 U.S.C. 263b(i)(1) and (i)(2)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (p) The following officials are authorized under section 354(i)(3) of the PHS Act (42 U.S.C. 263b(i)(3)) to ensure that no person who owned or operated a facility at the time the cause of revocation occurred may, within 2 years of the revocation of the certificate, own or operate a mammography facility: (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (q) The following officials are authorized to compile and make available to physicians and the general public information determined to be useful in evaluating the performance of mammography facilities as provided by section 354(l) of the PHS Act (42 U.S.C. 263b(l): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (r) The following officials are authorized to ensure that appropriate Federal agencies are consulted in the development of standards, regulations, evaluations, procedures for compliance and oversight as provided by section 354(o) of the PHS Act (42 U.S.C. 263b(o)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (3) The Director and Deputy Director, DMQRP, OHIP, CDRH. (s) The following officials may authorize a State to carry out certification program requirements and implement quality standards under sections 354(q)(1) and (q)(2) of the PHS Act (42 U.S.C. 263b(g)(1) and (g)(2)): (1) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH. (2) The Director and Deputy Director, OHIP, CDRH. (t) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH are authorized, after providing notice and opportunity for corrective action, to withdraw the approval of a State’s authority to carry out certification requirements and implement quality standards under section 354(q)(4) of the PHS Act (42 U.S.C. 263b(g)(4)). (u) These officials may not further redelegate these authorities. Subpart M—Organization
 § 5.1100
 The central organization of the Food and Drug Administration consists of the following: **Office of the Commissioner.**[1] Office of the Chief Counsel. Office of Equal Opportunity. Office of the Administrative Law Judge. *Office of the Senior Associate Commissioner.* Office of Executive Secretariat. Office of Public Affairs. Office of the Ombudsman. Office of Orphan Products Development. Office of Internal Affairs. Office of Executive Operations. Office of Science Coordination and Communication. Office of Human Research Trials. *Office of International and Constituent Relations.* Office of International Programs. Office of Consumer Affairs. Office of Women's Health. Office of Special Health Issues. *Office of Policy, Planning, and Legislation.* Office of Policy. Office of Planning. Office of Legislation. *Office of Management and Systems.* Office of Human Resources and Management Services. Office of Information Resources Management. Office of Financial Management. Office of Facilities, Acquisitions, and Central Services.[2] **Center for Biologics Evaluation and Research.**[3] *Office of the Center Director.* Scientific Advisors and Consultants Staff. Equal Employment Opportunity and Workforce Diversity Staff. Quality Assurance Staff. Regulations and Policy Staff. Veterinary Services Staff. *Office of Management.* Regulatory Information Management Staff. Division of Planning, Evaluation, and Budget. Division of Management Services. *Office of Information Technology Management.* Division of Information Technology Operations. Division of Information Technology Development. Division of Information Technology Infrastructure. *Office of Compliance and Biologics Quality.* Division of Case Management. Division of Manufacturing and Product Quality. Division of Inspections and Surveillance. *Office of Blood Research and Review.* Human Tissue Staff. 
 
 Policy and Publications Staff. Division of Emerging and Transfusion Transmitted Diseases. Division of Hematology. Division of Blood Applications. *Office of Therapeutics Research and Review.* Division of Cellular and Gene Therapies. Division of Therapeutic Proteins. Division of Monoclonal Antibodies. Division of Clinical Trial Design and Analysis. Division of Application Review and Policy. *Office of Vaccines Research and Review.* Division of Bacterial, Parasitic, and Allergenic Products. Division of Viral Products. Division of Vaccines and Related Products Applications. *Office of Communication, Training, and Manufacturers Assistance*. Division of Disclosure and Oversight Management. Division of Manufacturers Assistance and Training. Division of Communication and Consumer Affairs. *Office of Biostatistics and Epidemiology.* Division of Biostatistics. Division of Epidemiology. **Center for Food Safety and Applied Nutrition.**[4] *Office of the Center Director.* Food Safety Initiatives Staff. *Office of Science* Quality Assurance Staff. CFSAN Staff College. Microbial Research and Risk Assessment Staff. JIFSAN Liaison Staff. CFSAN Food Advisory Committee Staff. *Office of Applied Research and Safety Assessment.* Muirkirk Technical Operations Staff. Division of Molecular Biology. Division of Virulence Assessment. Division of Toxicology and Nutritional Product Studies. Division of In Vitro and Biochemical Toxicology. *Office of Regulations and Policy.* Regulations Coordination Staff. *Office of Constituent Operations.* Consumer Education Staff. Industry Activities Staff. International Activities Staff. *Office of Management Systems.* Safety Management Systems. Division of Information Resources Management. Division of Planning and Financial Resources Management. Division of Management Operations. Division of Administrative Services Management. *Office of Operations.* Equal Employment Opportunity Staff. Executive Operations Staff. *Office of Cosmetics and Colors.* Division of Programs and Enforcement Policy. Division of Science and Applied Technology. *Office of Nutritional Products, Labeling and Dietary Supplements.* Division of Compliance and Enforcement. Division of Standards and Labeling Regulations. Division of Nutrition Science Policy. *Office of Premarket Approval.* Division of Product Policy. Division of Petition Control. Division of Health Effects Evaluation. Division of Product Manufacture and Use. *Office of Plant and Dairy Foods and Beverages.* Division of Pesticides and Industrial Chemicals. Division of Natural Products. Division of Food Processing and Packaging. Division of Plant Product Safety. Division of Dairy and Egg Safety. Division of Risk Assessment. Division of Microbiological Studies. *Office of Seafood.* Division of Special Programs. Division of Programs and Enforcement Policy. Division of Science and Applied Technology. *Office of Field Programs.* Division of Enforcement and Programs. Division of HACCP Programs. Division of Cooperative Programs. *Office of Scientific Analysis and Support.* Division of General Scientific Support. Division of Mathematics. Division of Market Studies. **Center for Drug Evaluation and Research.**1 *Office of the Center Director.* Equal Employment Opportunity Staff. Executive Operations Staff. *Office of Regulatory Policy*. Division of Regulatory Policy I. Division of Regulatory Policy II. Division of Information Disclosure Policy. *Office of Management.*1 Strategic Planning Staff.1 *Division of Management and Budget*
                        .[5] Division of Management Services.1 *Office of Training and Communication.*1 Medwatch Staff. Division of Library and Information Services. Division of Training and Development. Division of Public Affairs. Division of Drug Information. Office of Compliance.[6] Division of Manufacturing and Product Quality. Division of Prescription Drug Compliance and Surveillance. Division of Labeling and Non-Prescription Drug Compliance. *Office of Information Technology.*1 Quality Assurance Staff. Technology Support Services Staff. Division of Data Management and Services. Division of Applications Development and Services. Division of Infrastructure Management and Services. *Office of Medical Policy.*1 Division of Drug Marketing, Advertising and Communication.1 Division of Scientific Investigations.5 *Office of Review Management.*1 Advisors and Consultants Staff.2 *Office of Drug Evaluation I.*1 Division of Cardio-Renal Drug Products. Division of Neuropharmacological Drug Products. Division of Oncology Drug Products. *Office of Drug Evaluation II.*1 Division of Metabolic and Endocrine Drug Products. Division of Pulmonary and Allergy Drug Products. Division of Anesthetic, Critical Care and Addiction Drug Products. *Office of Drug Evaluation III.*1 Division of Gastrointestinal and Coagulation Drug Products. Division of Medical Imaging and Radiopharmaceutical Drug Products. 
 
 Division of Reproductive and Urologic Drug Products. *Office of Drug Evaluation IV.*1 Division of Anti-Infective Drug Products. Division of Anti-Viral Drug Products. Division of Special Pathogen and Immunologic Drug Products. *Office of Drug Evaluation V.*1 Division of Anti-Inflammatory, Analgesic and Opthalmologic Drug Products. Division of Dermatologic and Dental Drug Products. Division of Over-The-Counter Drug Products. *Office of Biostatistics.*1 Quantitative Methods Research Staff. Division of Biometrics I. Division of Biometrics II. Division of Biometrics III. *Office of Post-Marketing Drug Risk Assessment*
                        .1 Extramural Programs Staff. Information Technology Staff. Division of Drug Risk Evaluation I. Division of Drug Risk Evaluation II. *Office of Pharmaceutical Science.*1 Quality Implementation Staff.1 Operations Staff.1 *Office of Clinical Pharmacology and Biopharmaceutics.* Pharmacometrics Staff. Division of Pharmaceutical Evaluation I.1 Division of Pharmaceutical Evaluation II.1 Division of Pharmaceutical Evaluation III.1 *Office of Generic Drugs.*6 Division of Bioequivalence. Division of Chemistry I. Division of Chemistry II. Division of Labeling and Program Support. *Office of New Drug Chemistry.*1 Division of New Drug Chemistry I.1 Division of New Drug Chemistry II.1 Division of New Drug Chemistry III.1 *Office of Testing and Research*
                        .1 Informatics and Computational Safety Analysis Staff. Laboratory of Clinical Pharmacology.1 Division of Applied Pharmacology Research.[7] Division of Pharmaceutical Analysis.[8] Division of Product Quality Research.1 **Office of Regulatory Affairs.**1 Equal Employment Opportunity Staff. *Office of Resource Management*. Strategic Initiatives Staff. Division of Planning, Evaluation, and Management. Division of Information Systems. Division of Human Resource Development. Division of Management Operations. Division of Personnel Operations. *Office of Enforcement*. Division of Compliance Management and Operations. Division of Compliance Policy. Division of Compliance Information and Quality Assurance. *Office of Regional Operations*. Division of Federal-State Relations. Division of Field Science. Division of Emergency and Investigational Operations. Division of Import Operations and Policy. *Office of Criminal Investigations.* Mid-Atlantic Area Office.[9] Midwest Area Office.[10] Northeast Area Office.[11] Pacific Area Office.[12] Southeast Area Office.[13] Southwest Area Office.[14] **Center for Veterinary Medicine.**[15] *Office of the Center Director.* *Office of Management and Communications.* Administrative Staff. Communications Staff. Information Resources Management Staff. *Office of New Animal Drug Evaluation.* Division of Therapeutic Drugs for Food Animals. Division of Biometics and Production Drugs Division of Therapeutic Drugs for Nonfood Animals. Division of Manufacturing Technologies. Division of Human Food Safety. *Office of Surveillance and Compliance.* Division of Surveillance. Division of Animal Feeds. Division of Compliance. Division of Epidemiology. *Office of Research.* Administrative Staff. Division of Residue Chemistry. Division of Animal Research. Division of Animal and Food Microbiology. **Center for Devices and Radiological Health.**[16] *Office of the Center Director.* Equal Employment Opportunity Staff. *Office of Systems and Management.* Integrity Committee and Conference Management Staff. Division of Management Operations. Division of Information Dissemination. Division of Information Technology Management. Division of Planning, Analysis and Finance. *Office of Compliance.* Promotion and Advertising Policy Staff. Division of Bioresearch Monitoring. Division of Program Operations. Division of Enforcement I. Division of Enforcement II. Division of Enforcement III. *Office of Device Evaluation.* Program Management Staff. Program Operations Staff. Division of Cardiovascular and Respiratory Devices. Division of Reproductive, Abdominal and Radiological Devices. Division of General, Restorative and Neurological Devices. Division of Clinical Laboratory Devices. Division of Ophthalmic, Ear, Nose, and Throat Devices. Division of Dental, Infection Control, and General Hospital Devices. *Office of Science and Technology.* Division of Mechanics and Materials Science. Division of Life Sciences. Division of Physical Sciences. Division of Electronics and Computer Sciences. Division of Management Information and Support Services. *Office of Health and Industry Programs.* Program Operations Staff. 
 
 Regulations Staff. Staff College. Division of Device User Programs and Systems Analysis. Division of Small Manufacturers Assistance. Division of Mammography Quality and Radiation Programs. Division of Communication Media. *Office of Surveillance and Biometrics.* Issues Management Staff. Division of Biostatistics. Division of Postmarket Surveillance. Division of Surveillance Systems. **National Center for Toxicological Research.**[17] *Office of the Center Director.* Environmental Health and Program Assurance Staff. *Office of Research.* Technology Advancement Staff. Division of Biochemical Toxicology. Division of Genetic and Reproductive Toxicology. Division of Biometry and Risk Assessment. Division of Microbiology. Division of Chemistry. Division of Neurotoxicology. Division of Veterinary Services. Division of Molecular Epidemiology. *Office of Management.* Office of Management Services. Division of Facilities, Engineering and Maintenance. Division of Administrative Services. Division of Contracts and Acquisitions. *Office of Planning, Finance and Information Technology.* Division of Planning. Division of Financial Management. Division of Information Technology. § 5.1105
 The Office of the Chief Counsel's mailing address is 5600 Fishers Lane, rm. 6-57, Rockville, MD  20857. § 5.1110
 (a) 
                        *Dockets Management Branch (HFA-305)*.  The Dockets Management Branch Public Room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD  20852.  Telephone: 301-827-6860. (b) 
                        *Freedom of Information Staff (HFI-35)*.  The Freedom of Information Public Room is located in rm. 12A-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD  20857.  Telephone: 301-827-6567. (c) 
                        *Press Relations Staff (HFI-40)*.  Press Offices are located in rm. 15-05, Parklawn Bldg, 5600 Fishers Lane, Rockville, MD  20857.  Telephone: 301-827-6242; and in rm. 3807, FB-8, 200 C  St. SW., Washington, DC  20204.  Telephone 202-205-4144. § 5.1115
 NORTHEAST REGION *Regional Field Office*:  158-15 Liberty Ave., Jamaica, NY  11433. *Northeast Regional Laboratory*:  158-15 Liberty Ave., Jamaica, NY   11433. *New York District Office*:  158-15 Liberty Ave., Jamaica, NY   11433. *New England District Office*:  One Montvale Ave., Stoneham, MA  02180. *Winchester Engineering and Analytical Center*:  109 Holton St., Winchester, MA  01890 CENTRAL REGION *Regional Field Office*:  U.S. Customhouse, Second and Chestnut Sts., rm. 900, Philadelphia, PA  19106. *Philadelphia District Office*:  U.S. Customhouse, Second and Chestnut Sts., rm. 900, Philadelphia, PA  19106. *Baltimore District Office*:  900 Madison Ave., Baltimore, MD   21201-2199. *Cincinnati District Office*:  6751 Steger Dr., Cincinnati, OH   45237-3097. *Forensic Chemistry Center*:  6751 Steger Dr., Cincinnati, OH   45237-3097. *New Jersey District Office*:  Waterview Corporate Center, 10 Waterview Blvd., 3d Floor, Parsippany, NJ  07054. *Chicago District Office*:  300 South Riverside Plaza, suite 550, South Chicago, IL  60606. *Detroit District Office*:  1560 East Jefferson Ave., Detroit, MI   48207-3179. *Minneapolis District Office*:  240 Hennepin Ave., Minneapolis, MN   55401-1912. SOUTHEAST REGION *Regional Field Office*:  60 Eighth St. NE., Atlanta, GA  30309. *Southeast Regional Laboratory*:  60 Eighth St. NE., Atlanta, GA   30309. *Atlanta District Office*:  60 Eighth St. NE., Atlanta, GA  30309. *New Orleans District Office*:  Textron Bldg., 6600 Plaza Dr., suite 400, New Orleans, LA  70127. *Nashville Branch of NOL-DO*:  297 Plus Park Blvd., Nashville, TN   37217. *Florida District Office*:  555 Winderley, suite 200, Maitland, FL   32751. *San Juan District Office*:  466 Fernandez Juncos Ave., San Juan, PR  00901-3223. SOUTHWEST REGION *Regional Field Office*:  7920 Elmwood Rd., suite 102, Dallas, TX  75247-4982. *Dallas District Office*:  3310 Live Oak St., Dallas, TX  75204. *Denver District Office*:  Bldg. 20, Denver Federal Center, Sixth and Kipling Sts., P.O. Box 25087, Denver, CO  80225-0087. *Kansas City District Office*:  11630 West 80th St., Lenexa, KS   66214-3338. *St. Louis Branch*:  12 Sunnen Dr., suite 122, St. Louis, MO   63143-3800. *Arkansas Regional Laboratory*:  3900 NCTR Rd., Bldg. 14-T, rm.  104, Jefferson, AR  72079-9502. PACIFIC REGION *Regional Field Office*:  1301 Clay St., suite 1180-N, Oakland, CA   94612-5217. *San Francisco District Office*:  1431 Harbor Bay Pkwy., Alameda, CA   94502-7070. *Los Angeles District Office*:  19900 Mac Arthur Blvd., suite 300, Irvine, CA  92715. *Seattle District Office*:  P.O. Box 3012, Bothell, WA  98021-3012. *Pacific Regional Laboratory*, SW:  1521 West Pico Blvd., Los Angeles, CA  90015-2488. *Pacific Regional Laboratory*, NW:  22201 23rd Dr. SE., Bothell, WA   98021-4421. Dated: May 30, 2001. Margaret M. Dotzel, Associate Commissioner for Policy.
 Note: This appendix will not appear in the Code of Federal Regulations. 
 
 **Appendix A—Part 5; Corresponding Former and New Subparts, Section Numbers, and Subjects**
Former CFR Subpart, Section No., and Subject
New CFR Subpart, Section No., and SubjectSubpart A, § 5.10-Delegations from the Secretary, the Assistant ­Secretary for Health, and Public Health Service Officials
Subpart A, § 5.10-Delegations from the Secretary for Health and Human Services to the Commissioner of Food and DrugsSubpart A, § 5.11-Reservation of Authority
Subpart A, § 5.11-(same subject)Subpart B, § 5.20-General Redelegations of Authority from the ­Commissioner to other officers of FDA.
Subpart B, § 5.20-(same subject)Subpart B, § 5.21-Emergency functions
Subpart B, § 5.21-(same subject)Subpart B, § 5.22-Certification of true copies and use of Department seal
Subpart B, § 5.22-(same subject)Subpart B, § 5.23-Disclosure of official records
Subpart B, § 5.23-Disclosure of official records and authorization of testimonySubpart B, § 5.24-Authority relating to technology transfer
Subpart B, § 5.24-(same subject)Subpart B, § 5.25-Research, investigation, and testing programs and health information and health promotion programs
Subpart B, § 5.25-Research, investigation, and testing programs and health information and promotion programsSubpart B, § 5.26-Service fellowships
Subpart B, § 5.26-(same subject)Subpart B, § 5.27-Patent term extensions for human drug products, medical devices, and food and color additives
Subpart B, § 5.27-Patent term extensions for human drug products, medical devices, and food and color additives; and authority to ­perform  due diligence determinations and informal hearingsSubpart B, § 5.28-Cardiac pacemaker devices and pacemaker leads
Deleted because the Social Security Act was repealed.Subpart B, § 5.29-Functions pertaining to safer vaccines
Subpart D, § 5.200-(same subject)Subpart B, § 5.30-Hearings
Subpart B, § 5.28-(same subject)Subpart B, § 5.31-Petitions under part 10
Subpart B, § 5.29-(same subject)Subpart B, § 5.32-Authority relating to determination of product primary jurisdiction
Subpart I, § 5.700-(same subject)Subpart B, § 5.33-Premarket approval of a product that is or contains a biologic, a device, or a drug
Subpart I, § 5.701-(same subject)Subpart B, § 5.34-Authority to select temporary voting members for ­advisory committees and authority to sign conflict of interest waivers
Subpart B, § 5.30-(same subject)Subpart B, § 5.35-Enforcement activities
Subpart B, § 5.31-(same subject)Subpart B, § 5.36-Certification following inspections
Subpart B, § 5.32-(same subject)Subpart B, § 5.37-Issuance of reports of minor violations
Subpart B, § 5.33-(same subject)Subpart B, § 5.38-Issuance of written notices concerning patent ­information, current good manufacturing practices and false or ­misleading labeling of new drugs, new animal drugs, and feeds ­bearing or containing new animal drugs
Subpart C, § 5.109-Issuance of written notices concerning patent ­information, current good manufacturing practices and false or ­misleading labeling of new drugs.Subpart G, § 5.504-Issuance of written notices concerning patent information, current good ­manufacturing practices and false or misleading labeling of new ­animal drugs and feeds bearing or containing new animal drugs.Subpart B, § 5.39-Redelegation of the Center for Biologics Evaluation and Research Director’s program authorities
Subpart D, § 5.201-(same subject)Subpart B, § 5.40-Issuance of 
                                **Federal Register**
                                 documents pertaining to the ­determination of safe levels, notice of need for development of an ­analytical method, notice of availability of a developed ­analytical method, and prohibition of certain extralabel drug use
Subpart G, § 5.500-(same subject)Subpart B, § 5.44-Export of unapproved drugs
Subpart J, § 5.801-(same subject)Subpart B, § 5.45-Imports and exports
Subpart J, § 5.800-(same subject)Subpart B, § 5.46-Manufacturer’s resident import agents
Subpart J, § 5.802-(same subject)Subpart B, § 5.47-Detention of adulterated or misbranded medical ­devices
Subpart F, § 5.402-(same subject)Subpart B, § 5.49-Authorization to use alternative evidence for ­determination of the effectiveness of medical devices
Subpart F, § 5.403-(same subject)Subpart B, § 5.50-Notification to petitioners of determinations made on petitions for reclassification of medical devices
Subpart F, § 5.404-(same subject)Subpart B, § 5.51-Determination of classification of devices
Subpart F, § 5.405-(same subject)Subpart B, § 5.52-Notification to sponsors of deficiencies in petitions for reclassification of medical devices
Subpart F, § 5.406-(same subject)Subpart B, § 5.53-Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket ­approval for medical devices
Subpart F, § 5.407-(same subject)Subpart B, § 5.54-Determinations that medical devices present ­unreasonable risk of substantial harm
Subpart F, § 5.409-(same subject)Subpart B, § 5.55-Orders to repair or replace, or make refunds for, medical devices
Subpart F, § 5.410-(same subject)Subpart B, § 5.56-Recall authority
Subpart F, § 5.411-Medical device recall authoritySubpart B, § 5.57-Temporary suspension of a medical device ­application
Subpart F, § 5.412-(same subject)Subpart B, § 5.58-Orphan products
Subpart K, § 5.900-(same subject)Subpart B, § 5.59-Approval, disapproval, or withdrawal of approval of applications for investigational device exemptions
Subpart F, § 5.413-Approval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptionsSubpart B, § 5.60-Required and discretionary postmarket surveillance
Subpart F, § 5.414-Postmarket surveillance  (proposed subject)Subpart B, § 5.61-Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims
Subpart E, § 5.300-(same subject)Subpart B, § 5.62-Issuance of initial emergency permit orders and ­notices of confirmation of effective date of final regulations on food for human and animal consumption
Subpart E, § 5.301-(same subject)Subpart B, § 5.63-Detention of meat, poultry, eggs, and related ­products
Subpart E, § 5.302-(same subject)Subpart B, § 5.64-Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program
Subpart E, § 5.303-(same subject)Subpart B, § 5.66-Approval of schools providing food-processing ­instruction
Subpart E, § 5.304-(same subject)Subpart B, § 5.67-Issuance of notices of opportunity for a hearing on proposals for denial of approval of applications for licenses, ­suspension of licenses, or revocation of licenses and certain notices of revocation of licenses
Subpart D, § 5.202-(same subject)Subpart B, § 5.68-Issuance and revocation of licenses for the ­propagation or manufacture and preparation of biological products
Subpart D, § 5.203-(same subject)Subpart B, § 5.69-Notification of release for distribution of biological products
Subpart D, § 5.204-(same subject)Subpart B, § 5.70-Issuance of notices implementing the provisions of the Drug Amendments of 1962
Subpart C, § 5.100-(same subject)Subpart B, § 5.71-Termination of exemptions for new drugs for ­investigational use in human beings and in animals (Note:  § 5.71(d) is under animal drugs)
Subpart C, § 5.101-(same subject)Subpart G, § 5.505-(same ­subject)Subpart B, § 5.72-Authority to approve and to withdraw approval of a charge for investigational new drugs
Subpart C, § 5.102-(same subject)Subpart B, § 5.75-Removed, effective 5/20/99
NoneSubpart B, 5.76-Removed,  effective 5/20/99
NoneSubpart B, § 5.78-Removed, effective 5/20/99
NoneSubpart B, § 5.80-Approval of new drug applications and their ­supplements
Subpart C, § 5.103-(same subject)Subpart B, § 5.81-Responses to Drug Enforcement Administration ­temporary scheduling notices
Subpart C, § 5.104-(same subject)Subpart B, § 5.82-Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements
Subpart C, § 5.105-(same subject)Subpart B, § 5.83-Approval of new animal drug applications, medicated feed mill license applications and their supplements
Subpart G, § 5.501-(same subject)Subpart B, § 5.84-Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications
Subpart G, § 5.502-(same subject)Subpart B, § 5.85-Authority to ensure that mammography facilities meet quality standards
Subpart L, § 5.1000-(same subject)Subpart B, § 5.86-Variances from performance standards for electronic products
Subpart H, § 5.600-(same subject)Subpart B, § 5.87-Exemption of electronic products from performance standards and prohibited acts
Subpart H, § 5.601-(same subject)Subpart B, § 5.88-Testing programs and methods of certification and identification for electronic products
Subpart H, § 5.602-(same subject)Subpart B, § 5.89-Notification of defects in, and repair or replacement of, electronic products
Subpart H, § 5.603-(same subject)Subpart B, § 5.90-Manufacturers requirement to provide data to ­ultimate purchasers of electronic products
Subpart H, § 5.604-(same subject)Subpart B, § 5.91-Dealer and distributor direction to provide data to manufacturers of electronic products
Subpart H, § 5.605-(same subject)Subpart B, § 5.92-Acceptance of assistance from State and Local ­authorities for enforcement of radiation control legislation and ­regulations
Subpart H, § 5.606-(same subject)Subpart B, § 5.93-Submission of and effective approval dates for ­abbreviated new drug applications and certain new drug applications
Subpart C, § 5.106-(same subject)Subpart B, § 5.94-Extensions or stays of effective dates for compliance wit  certain labeling requirements for human prescription drugs
Subpart C, § 5.107-(same subject)Subpart B, § 5.95-Submission of and effective approval dates for ­abbreviated new animal drug applications and certain new animal drug applications
Subpart G, § 5.503-(same subject)Subpart B, § 5.98-Authority relating to medical device reporting ­procedures
Subpart F, § 5.415-(same subject)Subpart B, § 5.99-Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment
Subpart B, § 5.34-(same subject)Subpart B, § 5.100-Officials authorized to make certification under ­5 U.S.C. 605(b) for any proposed and final rules
Subpart B, § 5.35-(same subject)Subpart B, § 5.101-Authority relating to waivers or reductions of ­prescription drug user fees
Subpart C, § 5.108-(same subject)Subpart C, § 5.200 through § 5.215-Organization
Subpart M, § 5.1100-(same subject)New-Not previously codified
Subpart F, § 5.416-Medical device trackingNew-Not previously codified
Subpart F, § 5.400-Issuance of 
                                **Federal Register**
                                 documents to ­recognize or to withdraw ­recognition of a standard to meet premarket submission requirementsNew-Not previously codified
Subpart F, § 5.401-Issuance of 
                                **Federal Register**
                                 documents pertaining to exemptions from premarket notification.New-Not previously codified
Subpart F, § 5.408-Determinations concerning the type of valid ­scientific evidence submitted in a premarket approval application.New-Not previously codified
Subpart F, § 5.417-Authority pertaining to accreditation functions for medical devices.


# Footnotes

1.
    
                             Mailing address: 5600 Fishers Lane, Rockville, MD 20857. Back to Citation
 2.
    
                             Mailing address:  5630 Fishers Lane, Rockville, MD 20857. Back to Citation
 3.
    
                             Mailing address: 1401 Rockville Pike, Rockville, MD  20852-1448. Back to Citation
 4.
    
                             Mailing address:  200 C St. SW., Washington, DC 20204. Back to Citation
 5.
    
                             Mailing address:  7500 Standish Pl., Rockville, MD  20855. Back to Citation
 6.
    
                             Mailing address:  7520 Standish Pl., Rockville, MD  20855. Back to Citation
 7.
    
                             Mailing address:  8301 Muirkirk Rd., Laurel, MD 20708. Back to Citation
 8.
    
                             Mailing address:  1114 Market St., St. Louis, MO  63101. Back to Citation
 9.
    
                             Mailing address:  900 U.S. Customhouse, Second Chestnut St., Philadelphia, PA  19106. Back to Citation
 10.
    
                             Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL   60532. Back to Citation
 11.
    
                             Mailing address:  158-15 Liberty Ave., Jamaica, NY  11433. Back to Citation
 12.
    
                             Mailing address:  13301 Clay St., Oakland CA  94512. Back to Citation
 13.
    
                             Mailing address:  60 Eighth St. NE, Atlanta, GA 30309. Back to Citation
 14.
    
                             Mailing address:  7920 Elmbrook Rd., Dallas, TX  75247. Back to Citation
 15.
    
                             Mailing address:  7500 Standish Pl., MPN-2, Rockville, MD  20855. Back to Citation
 16.
    
                             Mailing address:  9200 Corporate Blvd., Rockville, MD  20850. Back to Citation
 17.
    
                             Mailing address:  3900 NCTR Dr., Jefferson, AR  72079. Back to Citation


[FR Doc. 01-14294 Filed 6-7-01; 8:45 am] BILLING CODE 4160-01-S