[Federal Register Volume 66, Number 111 (Friday, June 8, 2001)]
[Rules and Regulations]
[Pages 30992-31025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14294]



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Part II





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 5



Delegations of Authority and Organization; Reorganization and 
Republication; Final Rule

  Federal Register / Vol. 66, No. 111 / Friday, June 8, 2001 / Rules 
and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Reorganization and 
Republication

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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 Sec. 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correct or remove outdated statutory citations.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 
Sec. 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 Sec. 5.10(c), (d), and (f) into Sec. 5.10(a).
    In this revision, we have also removed or corrected obsolete 
citations to legislation in Sec. 5.10 and in the agency delegations. 
Following are the legal citations that we removed or corrected, as 
appropriate:
    (1) In Sec. 5.10(a)(1) and in Sec. 5.32 (formerly Sec. 5.35), we 
removed references to the Tea Importation Act, which Congress repealed 
by Public Law 104-128, section 2.
    (2) We removed Sec. 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 Secs. 5.800, 5.601, 5.602, 5.603, 5.604, 5.605, and 
5.606 (formerly Secs. 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 Sec. 5.10(a)(19) (formerly Sec. 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 Sec.  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 Sec. 5.10(a)(22) (formerly Sec. 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 Sec. 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 
Sec. 5.28, regarding payments for cardiac pacemaker devices and 
pacemaker leads, because Congress repealed the statutory provision.
    (7) In Sec. 5.10(a)(26) (formerly Sec. 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 Secs. 5.20 through 
5.1000, we have added the appropriate redelegation statements. Although 
the officials under Sec. 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 Secs. 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

[[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

Sec.
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
Sec.
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
Sec.
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
Sec.
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
Sec.
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
Sec.
5.400  Issuance of Federal Register documents to recognize or to 
withdraw recognition of a standard to meet premarket submission 
requirements.

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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.
Sec.
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
Sec.
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
Sec.
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
Sec.
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
Sec.
5.1000   Authority to ensure that mammography facilities meet 
quality standards.
Subpart M--Organization
Sec.
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


Sec. 5.10  Delegations from the Secretary of Health and Human Services 
to the Commissioner of Food and Drugs.

    (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

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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 Sec. 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

[[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

[[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   Sec. 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.


Sec. 5.11   Reservation of authority.

    (a) Notwithstanding provisions of Sec. 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


Sec. 5.20  General redelegations of authority from the Commissioner to 
other officers of the Food and Drug Administration.

    (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

[[Page 30998]]

may not further redelegate this authority:
    (i) Requests for waiver, suspension, or modification of procedural 
requirements under Sec. 10.19 of this chapter;
    (ii) Citizen petitions under Sec. 10.30 of this chapter;
    (iii) Petitions for reconsideration under Sec. 10.33 of this 
chapter;
    (iv) Petitions for stay under Sec. 10.35 of this chapter; or
    (v) Requests for advisory opinions under Sec. 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 Secs. 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 Sec. 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, Sec. 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.


Sec. 5.21  Emergency functions.

    (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.


Sec. 5.22  Certification of true copies and use of Department seal.

    (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

[[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.

[[Page 31000]]

Sec.  5.23  Disclosure of official records and authorization of 
testimony.

    (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 Sec.  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 Sec.  
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 Sec. 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 
Sec. 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 Secs. 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 Secs. 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 
Sec. 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.

[[Page 31001]]

    (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.


Sec. 5.24  Authority relating to technology transfer.

    (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 
Sec. 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.


Sec. 5.25  Research, investigation, and testing programs and health 
information and promotion programs.

    (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.


Sec. 5.26  Service fellowships.

    (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

[[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.


Sec.  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.

    (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.


Sec. 5.28  Hearings.

    (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 Sec. 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,

[[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.


Sec. 5.29  Petitions under part 10.

    (a) For drugs assigned to their organizations, the following 
officials are authorized to grant or deny citizen petitions submitted 
under Sec. 10.30 of this chapter for a stay of an effective date in 
Sec. 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 Sec. 10.30 of this chapter requesting in 
vitro test modifications under Sec. 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 Sec. 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 Secs. 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 Sec. 10.30 of this chapter requesting 
exemption from the general pregnancy-nursing warning for over-the-
counter (OTC) drugs required under Sec. 201.63 of this chapter, 
requesting exemption from a general overdose warning required under 
Sec. 330.1(g) of this chapter, and requesting exemption from OTC drug 
administrative procedures under Sec. 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 Sec. 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 
Sec. 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 Sec. 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 
Sec. 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 
Sec. 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 Sec. 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

[[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 
Sec. 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 Sec. 314.440(b) of this chapter, are authorized to issue 
responses to citizen petitions submitted under Sec. 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 Sec. 314.440(b) of this 
chapter, are authorized to issue responses to citizen petitions 
submitted under Sec. 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 Sec. 10.30 of this chapter from sponsors of an 
investigational new drug application who request approval to ship in 
interstate commerce, in accordance with Sec. 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 Sec. 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 
Sec. 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 Sec. 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 Sec. 10.30 of this chapter 
concerning actions they are authorized to take under Sec. 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 
Secs. 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.


Sec. 5.30  Authority to select temporary voting members for advisory 
committees and authority to sign conflict of interest waivers.

    (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.


Sec. 5.31  Enforcement activities.

    (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;

[[Page 31005]]

    (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.


Sec. 5.32  Certification following inspections.

    Regional Food and Drug Directors and District Directors are 
authorized to issue certificates of sanitation under Sec. 1240.20 of 
this chapter. These officials may not further redelegate this 
authority.


Sec. 5.33  Issuance of reports of minor violations.

    (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 
Sec. 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 Sec. 1040.20(b) 
of this chapter.
    (c) These officials may not further redelegate these authorities.


Sec. 5.34  Issuance of notices relating to proposals and orders for 
debarment and denial of an application to terminate debarment.

    (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

[[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.


Sec. 5.35  Officials authorized to make certification under 5 U.S.C. 
605(b) for any proposed and final rules.

    (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


Sec. 5.100  Issuance of notices implementing the provisions of the Drug 
Amendments of 1962.

    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.


Sec. 5.101  Termination of exemptions for new drugs for investigational 
use in human beings.

    (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 Sec. 312.44 of this chapter and in animals under 
Sec. 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 Sec. 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 Sec. 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.


Sec. 5.102  Authority to approve and to withdraw approval of a charge 
for investigational new drugs.

    (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 Sec. 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.


Sec. 5.103  Approval of new drug applications and their supplements.

    (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 Sec. 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

[[Page 31007]]

Research, for drugs listed in Sec. 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 Sec. 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 Sec. 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 Sec. 5.10(a) and paragraph 
(a) of this section.
    (1) For drugs submitted under Secs. 314.50, 314.70, and 314.94 of 
this chapter, except for those drug products listed in Sec. 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 Sec. 314.440(b) of this chapter and 
submitted under Secs. 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 Secs. 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 Secs. 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 Secs. 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 
Sec. 5.10(a) and paragraphs (a) and (b) of this section.
    (g) These officials may not further redelegate these authorities.


Sec. 5.104  Responses to Drug Enforcement Administration temporary 
scheduling notices.

    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.


Sec. 5.105  Issuance of notices relating to proposals to refuse 
approval or to withdraw approval of new drug applications and their 
supplements.

    (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 Sec. 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 Sec. 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.

[[Page 31008]]

Sec. 5.106  Submission of and effective approval dates for abbreviated 
new drug applications and certain new drug applications.

    (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.


Sec. 5.107  Extensions or stays of effective dates for compliance with 
certain labeling requirements for human prescription drugs.

    (a) The following officials are authorized to extend or stay an 
effective date in Sec. 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.


Sec. 5.108  Authority relating to waivers or reductions of prescription 
drug user fees.

    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 Sec. 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.


Sec. 5.109  Issuance of written notices concerning patent information, 
current good manufacturing practices and false or misleading labeling 
of new drugs.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under Sec. 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


Sec. 5.200  Functions pertaining to safer vaccines.

    (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

[[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.


Sec. 5.201  Redelegation of the Center for Biologics Evaluation and 
Research Director's program authorities.

    (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.


Sec. 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.

    (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 
Sec. 601.4(b) of this chapter.
    (2) Notices of opportunity for a hearing on proposals to revoke 
biologics licenses under Sec. 601.5(b) of this chapter.
    (3) Notices of revocation, at the manufacturer's request, of 
biologics licenses under Secs. 601.5(a) and 601.8 of this chapter.
    (4) Notices of revocation when the manufacturer has waived the 
opportunity for hearing under Sec. 601.7(a) of this chapter.
    (5) Notice of biologics license suspensions under Sec. 601.6 of 
this chapter.
    (b) These officials may not further redelegate these authorities.


Sec. 5.203  Issuance and revocation of licenses for the propagation or 
manufacture and preparation of biological products.

    (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.


Sec. 5.204  Notification of release for distribution of biological 
products.

    (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


Sec. 5.300  Food standards, food additives, generally recognized as 
safe (GRAS) substances, color additives, nutrient content claims, and 
health claims.

    (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 Sec.  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.

[[Page 31010]]

    (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 Sec.  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 Secs.  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 Sec.  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.


Sec. 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.

    (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 Sec. 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.


Sec. 5.302  Detention of meat, poultry, eggs, and related products.

    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.).


Sec. 5.303  Establishing standards and approving accrediting bodies 
under the National Laboratory Accreditation Program.

    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.

[[Page 31011]]

Sec. 5.304  Approval of schools providing food-processing instruction.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs (Commissioner) under 
Sec. 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


Sec. 5.400  Issuance of Federal Register documents to recognize or to 
withdraw recognition of a standard to meet premarket submission 
requirements.

    (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.


Sec. 5.401  Issuance of Federal Register documents pertaining to 
exemptions from premarket notification.

    (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 Sec. 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.


Sec. 5.402  Detention of adulterated or misbranded medical devices.

    (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 Sec. 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.


Sec. 5.403  Authorization to use alternative evidence for determination 
of the effectiveness of medical devices.

    (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.


Sec. 5.404  Notification to petitioners of determinations made on 
petitions for reclassification of medical devices.

    (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 Sec. 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.


Sec. 5.405  Determination of classification of devices.

    (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

[[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.


Sec. 5.406  Notification to sponsors of deficiencies in petitions for 
reclassification of medical devices.

    (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.


Sec. 5.407  Approval, disapproval, or withdrawal of approval of product 
development protocols and applications for premarket approval for 
medical devices.

    (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.


Sec. 5.408  Determinations concerning the type of valid scientific 
evidence submitted in a premarket approval application.

    (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.


Sec. 5.409  Determinations that medical devices present unreasonable 
risk of substantial harm.

    (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.


Sec. 5.410  Orders to repair or replace, or make refunds for, medical 
devices.

    (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

[[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.


Sec. 5.411  Medical device recall authority.

    (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.


Sec. 5.412  Temporary suspension of a medical device application.

    (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.


Sec. 5.413  Approval, disapproval, or withdrawal of approval of 
applications and entering into agreements for investigational device 
exemptions.

    (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.


Sec. 5.414  Postmarket surveillance.

    (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).

[[Page 31014]]

    (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.


Sec. 5.415  Authority relating to medical device reporting procedures.

    (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 Sec. 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 
Sec. 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 Sec. 803.19 of this chapter.
    (d) These officials may not further redelegate these authorities.


Sec. 5.416  Medical device tracking.

    (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.


Sec. 5.417  Authority pertaining to accreditation functions for medical 
devices.

    (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


Sec. 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.

    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.


Sec. 5.501  Approval of new animal drug applications, medicated feed 
mill license applications and their supplements.

    (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

[[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.


Sec. 5.502  Issuance of notices, proposals, and orders relating to new 
animal drugs and medicated feed mill license applications.

    (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.


Sec. 5.503  Submission of and effective approval dates for abbreviated 
new animal drug applications and certain new animal drug applications.

    (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.


Sec. 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.

    (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.


Sec. 5.505  Termination of exemptions for new drugs for investigational 
use in animals.

    (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 Sec. 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


Sec. 5.600  Variances from performance standards for electronic 
products.

    (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.


Sec. 5.601  Exemption of electronic products from performance standards 
and prohibited acts.

    (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.


Sec. 5.602  Testing programs and methods of certification and 
identification for electronic products.

    (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

[[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.


Sec. 5.603  Notification of defects in, and repair or replacement of, 
electronic products.

    (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 Secs. 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 
Sec. 1020.30(b) of this chapter.
    (2) Manufacturers of sunlamp products and ultraviolet lamps 
intended for use in any sunlamp product, as defined in Sec. 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 
Sec. 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 
Sec. 1020.30(b) of this chapter.
    (2) Manufacturers of sunlamp products and ultraviolet lamps 
intended for use in any sunlamp products, as defined in Sec. 1040.20(b) 
of this chapter.
    (c) These officials may not further redelegate these authorities.


Sec. 5.604  Manufacturers requirement to provide data to ultimate 
purchasers of electronic products.

    (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.


Sec. 5.605  Dealer and distributor direction to provide data to 
manufacturers of electronic products.

    (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.


Sec. 5.606  Acceptance of assistance from State and Local authorities 
for enforcement of radiation control legislation and regulations.

    (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


Sec. 5.700  Authority relating to determination of product primary 
jurisdiction.

    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.


Sec. 5.701  Premarket approval of a product that is or contains a 
biologic, a device, or a drug.

    (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


Sec. 5.800  Imports and exports.

    (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

[[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.


Sec. 5.801  Export of unapproved drugs.

    (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.


Sec. 5.802  Manufacturer's resident import agents.

    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 
Sec.  1005.25(b) of this chapter. These officials may not further 
redelegate this authority.

Subpart K--Orphan Products; Redelegations of Authority


Sec. 5.900  Orphan products.

    (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;

[[Page 31018]]

    (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


Sec. 5.1000  Authority to ensure that mammography facilities meet 
quality standards.

    (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.

[[Page 31019]]

    (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


Sec.  5.1100  Headquarters.

    The central organization of the Food and Drug Administration 
consists of the following:
Office of the Commissioner.\1\
---------------------------------------------------------------------------

    \1\ Mailing address: 5600 Fishers Lane, Rockville, MD 20857.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \2\ Mailing address: 5630 Fishers Lane, Rockville, MD 20857.
---------------------------------------------------------------------------

Center for Biologics Evaluation and Research.\3\
---------------------------------------------------------------------------

    \3\ Mailing address: 1401 Rockville Pike, Rockville, MD 20852-
1448.
---------------------------------------------------------------------------

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.

[[Page 31020]]

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\
---------------------------------------------------------------------------

    \4\ Mailing address: 200 C St. SW., Washington, DC 20204.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \5\ Mailing address: 7500 Standish Pl., Rockville, MD 20855.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \6\ Mailing address: 7520 Standish Pl., Rockville, MD 20855.
---------------------------------------------------------------------------

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.

[[Page 31021]]

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\
---------------------------------------------------------------------------

    \7\ Mailing address: 8301 Muirkirk Rd., Laurel, MD 20708.
---------------------------------------------------------------------------

Division of Pharmaceutical Analysis.\8\
---------------------------------------------------------------------------

    \8\ Mailing address: 1114 Market St., St. Louis, MO 63101.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \9\ Mailing address: 900 U.S. Customhouse, Second Chestnut St., 
Philadelphia, PA 19106.
---------------------------------------------------------------------------

Midwest Area Office. \10\
---------------------------------------------------------------------------

    \10\ Mailing address: 901 Warrenville Rd., suite 360, Lisle, IL 
60532.
---------------------------------------------------------------------------

Northeast Area Office.\11\
---------------------------------------------------------------------------

    \11\ Mailing address: 158-15 Liberty Ave., Jamaica, NY 11433.
---------------------------------------------------------------------------

Pacific Area Office.\12\
---------------------------------------------------------------------------

    \12\ Mailing address: 13301 Clay St., Oakland CA 94512.
---------------------------------------------------------------------------

Southeast Area Office.\13\
---------------------------------------------------------------------------

    \13\ Mailing address: 60 Eighth St. NE, Atlanta, GA 30309.
---------------------------------------------------------------------------

Southwest Area Office.\14\
---------------------------------------------------------------------------

    \14\ Mailing address: 7920 Elmbrook Rd., Dallas, TX 75247.
---------------------------------------------------------------------------

Center for Veterinary Medicine.\15\
---------------------------------------------------------------------------

    \15\ Mailing address: 7500 Standish Pl., MPN-2, Rockville, MD 
20855.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \16\ Mailing address: 9200 Corporate Blvd., Rockville, MD 20850.
---------------------------------------------------------------------------

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.

[[Page 31022]]

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\
---------------------------------------------------------------------------

    \17\ Mailing address: 3900 NCTR Dr., Jefferson, AR 72079.
---------------------------------------------------------------------------

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.


Sec.  5.1105  Chief Counsel, Food and Drug Administration.

    The Office of the Chief Counsel's mailing address is 5600 Fishers 
Lane, rm. 6-57, Rockville, MD 20857.


Sec.  5.1110  Food and Drug Administration Public Information Offices.

    (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.


Sec.  5.1115  Field structure.

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.

[[Page 31023]]



   Appendix A--Part 5; Corresponding Former and New Subparts, Section
                          Numbers, and Subjects
------------------------------------------------------------------------
  Former CFR Subpart, Section No.,    New CFR Subpart, Section No., and
            and Subject                            Subject
------------------------------------------------------------------------
Subpart A, Sec.  5.10-Delegations    Subpart A, Sec.  5.10-Delegations
 from the Secretary, the Assistant    from the Secretary for Health and
 Secretary for Health, and Public     Human Services to the Commissioner
 Health Service Officials.            of Food and Drugs
Subpart A, Sec.  5.11-Reservation    Subpart A, Sec.  5.11-(same
 of Authority.                        subject)
Subpart B, Sec.  5.20-General        Subpart B, Sec.  5.20-(same
 Redelegations of Authority from      subject)
 the Commissioner to other officers
 of FDA..
Subpart B, Sec.  5.21-Emergency      Subpart B, Sec.  5.21-(same
 functions.                           subject)
Subpart B, Sec.  5.22-Certification  Subpart B, Sec.  5.22-(same
 of true copies and use of            subject)
 Department seal.
Subpart B, Sec.  5.23-Disclosure of  Subpart B, Sec.  5.23-Disclosure of
 official records.                    official records and authorization
                                      of testimony
Subpart B, Sec.  5.24-Authority      Subpart B, Sec.  5.24-(same
 relating to technology transfer.     subject)
Subpart B, Sec.  5.25-Research,      Subpart B, Sec.  5.25-Research,
 investigation, and testing           investigation, and testing
 programs and health information      programs and health information
 and health promotion programs.       and promotion programs
Subpart B, Sec.  5.26-Service        Subpart B, Sec.  5.26-(same
 fellowships.                         subject)
Subpart B, Sec.  5.27-Patent term    Subpart B, Sec.  5.27-Patent term
 extensions for human drug            extensions for human drug
 products, medical devices, and       products, medical devices, and
 food and color additives.            food and color additives; and
                                      authority to perform due diligence
                                      determinations and informal
                                      hearings
Subpart B, Sec.  5.28-Cardiac        Deleted because the Social Security
 pacemaker devices and pacemaker      Act was repealed.
 leads.
Subpart B, Sec.  5.29-Functions      Subpart D, Sec.  5.200-(same
 pertaining to safer vaccines.        subject)
Subpart B, Sec.  5.30-Hearings.....  Subpart B, Sec.  5.28-(same
                                      subject)
Subpart B, Sec.  5.31-Petitions      Subpart B, Sec.  5.29-(same
 under part 10.                       subject)
Subpart B, Sec.  5.32-Authority      Subpart I, Sec.  5.700-(same
 relating to determination of         subject)
 product primary jurisdiction.
Subpart B, Sec.  5.33-Premarket      Subpart I, Sec.  5.701-(same
 approval of a product that is or     subject)
 contains a biologic, a device, or
 a drug.
Subpart B, Sec.  5.34-Authority to   Subpart B, Sec.  5.30-(same
 select temporary voting members      subject)
 for advisory committees and
 authority to sign conflict of
 interest waivers.
Subpart B, Sec.  5.35-Enforcement    Subpart B, Sec.  5.31-(same
 activities.                          subject)
Subpart B, Sec.  5.36-Certification  Subpart B, Sec.  5.32-(same
 following inspections.               subject)
Subpart B, Sec.  5.37-Issuance of    Subpart B, Sec.  5.33-(same
 reports of minor violations.         subject)
Subpart B, Sec.  5.38-Issuance of    Subpart C, Sec.  5.109-Issuance of
 written notices concerning patent    written notices concerning patent
 information, current good            information, current good
 manufacturing practices and false    manufacturing practices and false
 or misleading labeling of new        or misleading labeling of new
 drugs, new animal drugs, and feeds   drugs.
 bearing or containing new animal
 drugs.
                                     Subpart G, Sec.  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, Sec.  5.39-Redelegation   Subpart D, Sec.  5.201-(same
 of the Center for Biologics          subject)
 Evaluation and Research Director's
 program authorities.
Subpart B, Sec.  5.40-Issuance of    Subpart G, Sec.  5.500-(same
 Federal Register documents           subject)
 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 B, Sec.  5.44-Export of      Subpart J, Sec.  5.801-(same
 unapproved drugs.                    subject)
Subpart B, Sec.  5.45-Imports and    Subpart J, Sec.  5.800-(same
 exports.                             subject)
Subpart B, Sec.  5.46-               Subpart J, Sec.  5.802-(same
 Manufacturer's resident import       subject)
 agents.
Subpart B, Sec.  5.47-Detention of   Subpart F, Sec.  5.402-(same
 adulterated or misbranded medical    subject)
 devices.
Subpart B, Sec.  5.49-Authorization  Subpart F, Sec.  5.403-(same
 to use alternative evidence for      subject)
 determination of the effectiveness
 of medical devices.
Subpart B, Sec.  5.50-Notification   Subpart F, Sec.  5.404-(same
 to petitioners of determinations     subject)
 made on petitions for
 reclassification of medical
 devices.
Subpart B, Sec.  5.51-Determination  Subpart F, Sec.  5.405-(same
 of classification of devices.        subject)
Subpart B, Sec.  5.52-Notification   Subpart F, Sec.  5.406-(same
 to sponsors of deficiencies in       subject)
 petitions for reclassification of
 medical devices.
Subpart B, Sec.  5.53-Approval,      Subpart F, Sec.  5.407-(same
 disapproval, or withdrawal of        subject)
 approval of product development
 protocols and applications for
 premarket approval for medical
 devices.
Subpart B, Sec.  5.54-               Subpart F, Sec.  5.409-(same
 Determinations that medical          subject)
 devices present unreasonable risk
 of substantial harm.
Subpart B, Sec.  5.55-Orders to      Subpart F, Sec.  5.410-(same
 repair or replace, or make refunds   subject)
 for, medical devices.
Subpart B, Sec.  5.56-Recall         Subpart F, Sec.  5.411-Medical
 authority.                           device recall authority
Subpart B, Sec.  5.57-Temporary      Subpart F, Sec.  5.412-(same
 suspension of a medical device       subject)
 application.
Subpart B, Sec.  5.58-Orphan         Subpart K, Sec.  5.900-(same
 products.                            subject)
Subpart B, Sec.  5.59-Approval,      Subpart F, Sec.  5.413-Approval,
 disapproval, or withdrawal of        disapproval, or withdrawal of
 approval of applications for         approval of applications and
 investigational device exemptions.   entering into agreements for
                                      investigational device exemptions
Subpart B, Sec.  5.60-Required and   Subpart F, Sec.  5.414-Postmarket
 discretionary postmarket             surveillance (proposed subject)
 surveillance.

[[Page 31024]]

 
Subpart B, Sec.  5.61-Food           Subpart E, Sec.  5.300-(same
 standards, food additives,           subject)
 generally recognized as safe
 (GRAS) substances, color
 additives, nutrient content
 claims, and health claims.
Subpart B, Sec.  5.62-Issuance of    Subpart E, Sec.  5.301-(same
 initial emergency permit orders      subject)
 and notices of confirmation of
 effective date of final
 regulations on food for human and
 animal consumption.
Subpart B, Sec.  5.63-Detention of   Subpart E, Sec.  5.302-(same
 meat, poultry, eggs, and related     subject)
 products.
Subpart B, Sec.  5.64-Establishing   Subpart E, Sec.  5.303-(same
 standards and approving              subject)
 accrediting bodies under the
 National Laboratory Accreditation
 Program.
Subpart B, Sec.  5.66-Approval of    Subpart E, Sec.  5.304-(same
 schools providing food-processing    subject)
 instruction.
Subpart B, Sec.  5.67-Issuance of    Subpart D, Sec.  5.202-(same
 notices of opportunity for a         subject)
 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 B, Sec.  5.68-Issuance and   Subpart D, Sec.  5.203-(same
 revocation of licenses for the       subject)
 propagation or manufacture and
 preparation of biological products.
Subpart B, Sec.  5.69-Notification   Subpart D, Sec.  5.204-(same
 of release for distribution of       subject)
 biological products.
Subpart B, Sec.  5.70-Issuance of    Subpart C, Sec.  5.100-(same
 notices implementing the             subject)
 provisions of the Drug Amendments
 of 1962.
Subpart B, Sec.  5.71-Termination    Subpart C, Sec.  5.101-(same
 of exemptions for new drugs for      subject)
 investigational use in human
 beings and in animals (Note: Sec.
 5.71(d) is under animal drugs).
                                     Subpart G, Sec.  5.505-(same
                                      subject)
Subpart B, Sec.  5.72-Authority to   Subpart C, Sec.  5.102-(same
 approve and to withdraw approval     subject)
 of a charge for investigational
 new drugs.
Subpart B, Sec.  5.75-Removed,       None
 effective 5/20/99.
Subpart B, 5.76-Removed, effective   None
 5/20/99.
Subpart B, Sec.  5.78-Removed,       None
 effective 5/20/99.
Subpart B, Sec.  5.80-Approval of    Subpart C, Sec.  5.103-(same
 new drug applications and their      subject)
 supplements.
Subpart B, Sec.  5.81-Responses to   Subpart C, Sec.  5.104-(same
 Drug Enforcement Administration      subject)
 temporary scheduling notices.
Subpart B, Sec.  5.82-Issuance of    Subpart C, Sec.  5.105-(same
 notices relating to proposals to     subject)
 refuse approval or to withdraw
 approval of new drug applications
 and their supplements.
Subpart B, Sec.  5.83-Approval of    Subpart G, Sec.  5.501-(same
 new animal drug applications,        subject)
 medicated feed mill license
 applications and their supplements.
Subpart B, Sec.  5.84-Issuance of    Subpart G, Sec.  5.502-(same
 notices, proposals, and orders       subject)
 relating to new animal drugs and
 medicated feed mill license
 applications.
Subpart B, Sec.  5.85-Authority to   Subpart L, Sec.  5.1000-(same
 ensure that mammography facilities   subject)
 meet quality standards.
Subpart B, Sec.  5.86-Variances      Subpart H, Sec.  5.600-(same
 from performance standards for       subject)
 electronic products.
Subpart B, Sec.  5.87-Exemption of   Subpart H, Sec.  5.601-(same
 electronic products from             subject)
 performance standards and
 prohibited acts.
Subpart B, Sec.  5.88-Testing        Subpart H, Sec.  5.602-(same
 programs and methods of              subject)
 certification and identification
 for electronic products.
Subpart B, Sec.  5.89-Notification   Subpart H, Sec.  5.603-(same
 of defects in, and repair or         subject)
 replacement of, electronic
 products.
Subpart B, Sec.  5.90-Manufacturers  Subpart H, Sec.  5.604-(same
 requirement to provide data to       subject)
 ultimate purchasers of electronic
 products.
Subpart B, Sec.  5.91-Dealer and     Subpart H, Sec.  5.605-(same
 distributor direction to provide     subject)
 data to manufacturers of
 electronic products.
Subpart B, Sec.  5.92-Acceptance of  Subpart H, Sec.  5.606-(same
 assistance from State and Local      subject)
 authorities for enforcement of
 radiation control legislation and
 regulations.
Subpart B, Sec.  5.93-Submission of  Subpart C, Sec.  5.106-(same
 and effective approval dates for     subject)
 abbreviated new drug applications
 and certain new drug applications.
Subpart B, Sec.  5.94-Extensions or  Subpart C, Sec.  5.107-(same
 stays of effective dates for         subject)
 compliance wit certain labeling
 requirements for human
 prescription drugs.
Subpart B, Sec.  5.95-Submission of  Subpart G, Sec.  5.503-(same
 and effective approval dates for     subject)
 abbreviated new animal drug
 applications and certain new
 animal drug applications.
Subpart B, Sec.  5.98-Authority      Subpart F, Sec.  5.415-(same
 relating to medical device           subject)
 reporting procedures.
Subpart B, Sec.  5.99-Issuance of    Subpart B, Sec.  5.34-(same
 notices relating to proposals and    subject)
 orders for debarment and denial of
 an application to terminate
 debarment.
Subpart B, Sec.  5.100-Officials     Subpart B, Sec.  5.35-(same
 authorized to make certification     subject)
 under 5 U.S.C. 605(b) for any
 proposed and final rules.

[[Page 31025]]

 
Subpart B, Sec.  5.101-Authority     Subpart C, Sec.  5.108-(same
 relating to waivers or reductions    subject)
 of prescription drug user fees.
Subpart C, Sec.  5.200 through Sec.  Subpart M, Sec.  5.1100-(same
  5.215-Organization.                 subject)
New-Not previously codified........  Subpart F, Sec.  5.416-Medical
                                      device tracking
New-Not previously codified........  Subpart F, Sec.  5.400-Issuance of
                                      Federal Register documents to
                                      recognize or to withdraw
                                      recognition of a standard to meet
                                      premarket submission requirements
New-Not previously codified........  Subpart F, Sec.  5.401-Issuance of
                                      Federal Register documents
                                      pertaining to exemptions from
                                      premarket notification.
New-Not previously codified........  Subpart F, Sec.  5.408-
                                      Determinations concerning the type
                                      of valid scientific evidence
                                      submitted in a premarket approval
                                      application.
New-Not previously codified........  Subpart F, Sec.  5.417-Authority
                                      pertaining to accreditation
                                      functions for medical devices.
------------------------------------------------------------------------

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