TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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, the Assistant Secretary for
Health, and Public Health Service Officials.
- (a) The Assistant Secretary for Health has redelegated to the Commissioner
of Food and Drugs, with authority to redelegate except when specifically
prohibited, all authority delegated to the Assistant Secretary for Health
by the Secretary of Health and Human Services, as follows:
- (1) Functions vested in the Secretary under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Filled Milk
Act (21 U.S.C. 61-63), the Federal Import Milk Act (21 U.S.C. 141
et seq.), the Tea Importation Act (21 U.S.C. 41 et seq.), the Federal
Caustic Poison Act (44 Stat. 1406), and The Fair Packaging and
Labeling Act (15 U.S.C. 1451 et seq.), pursuant to 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 (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 sections 354 through
360F of the Public Health Service Act (42 U.S.C. 263b through 263n),
as amended, which relate to electronic product radiation control.
- (4) Functions vested in the Secretary under section 361 of the
Public Health Service 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 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.
- (5) Functions vested in the Secretary under sections 351 and
352 of part F, subpart 1 of the Public Health Service 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.
- (6) Functions vested in the Secretary under section 302(a) of
the Public Health Service 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.
- (7) Functions vested in the Secretary under section 303 of the
Public Health Service 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 Pub. L. 91-513 for which
an investigational new drug application is filed with the Food
and Drug Administration and with respect to all drugs not scheduled
under Pub. L. 91-513.
- (8) Functions vested in the Secretary pertaining to section 4
of the Comprehensive Drug Abuse Prevention and Control Act of 1970
(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.
- (9) 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 determination of the qualifications and competency of practitioners
wishing to conduct research with controlled substances listed in
Schedule I of the Act, and the merits of the research protocol.
- (10) 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.).
- (11) 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.
- (12) 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.
- (13) Functions vested in the Secretary under the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.).
- (14) Functions vested in the Secretary by amendments to the foregoing
statutes subsequent to Reorganization Plan No. 1 of 1953.
- (15) 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.
- (16) 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 promulgated
by the Federal Preparedness Agency of the General Services Administration;
Office of the Secretary, HHS; and Office of the Assistant Secretary
for Health.
- (17) Function vested in the Secretary of authorizing and approving
miscellaneous and emergency expenses of enforcement activities.
- (18) Functions vested in the Secretary under the Federal Advisory
Committee Act, Public Law 92-463, 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 for those committees
under the administrative jurisdiction of the Commissioner of Food
and Drugs. This authority may be redelegated to a single official
who reports directly to the Commissioner of Food and Drugs. This
authority is to be exercised in accordance with the requirements
of the Federal Advisory Committee Act and only with respect to
the following:
- (i) Meetings, to the extent that they directly involve
review, discussion or consideration of records of the Department
which are exempt from disclosure under 5 U.S.C. 552(b) (4),
(6), and (7), namely, (a) records containing trade secrets
and commercial or financial information obtained from a person
and privileged or confidential; (b) personnel, medical and
similar files the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy; and (c)
investigatory files compiled for law enforcement purposes;
- (ii) Meetings to the extent that they involve the review,
discussion, and evaluation of specific drugs and devices
regulated by FDA which are intended to result in recommendations
for regulatory decisions under the Federal Food, Drug, and
Cosmetic Act and which are concerned with matters listed
in 5 U.S.C. 552(b) (4), (5), and (7);
- (iii) Meetings held for the sole purpose of considering
and formulating advice which the committee will give or any
final report it will render, Provided:
- (a) The meetings will involve solely the internal
expression of views and judgments of the members
and it is essential to close the meeting or portions
thereof to protect the free exchange of such
views and avoid undue interference with agency
or committee operations, and such views if reduced
to writing would be protected from mandatory
disclosure under 5 U.S.C. 552(b);
- (b) The meeting is closed for the shortest
time necessary, summarizing the work of the committee
during the closed session, and a report, prepared
by the executive secretary will be made available
promptly to the public.
- (c) When feasible, the public is given a timely
opportunity to present relevant information and
views to the committee; and
- (d) Concurrence for closing the meetings for
such purpose is obtained from the Office of the
General Counsel and the Office of Public Affairs.
- (19) 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 Public Health Service
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.
- (20) Functions vested in the Secretary under section 2101 of
the Public Health Service Act (42 U.S.C. 219) 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.
- (21) Functions vested in the Secretary under section 362 of the
Public Health Service 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.
- (22) Functions vested in the Secretary under section 1003(b)(3),
title X, of the Public Works and Economic Development Act of 1965
(42 U.S.C. 3246b(b)(3)) to waive any matching requirements for
programs or projects of State and local governments funded under
title X of that act where it is determined that State or local
governments concerned cannot reasonably obtain any non-Federal
contributions.
- (23) Functions vested in the Secretary under section 401(a) of
the Lead-Based Paint Poisoning Prevention Act, as amended by Pub.
L. 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.
- (24) Functions vested in the Secretary for the health information
and health promotion program under title XVII of the Public Health
Service 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), (2), and (6). The delegation excludes the authority to
select all Senior Executive Service, supergrade and equivalent,
and Schedule C (GS-12 and above) positions; promulgate regulations;
and submit reports to the President.
- (25) 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 promulgate regulations,
establish advisory councils and committees, appoint members to
advisory councils and committees, and submit reports to Congress.
- (26) Functions vested in the Secretary under sections 982 and
983 of the Consumer-Patient Radiation Health and Safety Act of
1981 (42 U.S.C. 10007 and 10008), as amended. The delegation excludes
the authority to promulgate 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.
- (27) 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. 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.
- (28) Functions vested in the Secretary 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)), as amended, which provides for a registry
of all cardiac pacemaker devices and pacemaker leads for which
payment was made under this title. The approval and issuance of
regulations under that section are reserved to the Secretary, as
provided in 21 CFR 5.11.
- (29) Functions vested in the Secretary under the Stevenson-Wydler
Technology Innovation Act of 1980 (15 U.S.C. 3701 et seq.) (the
Act), as amended, and under Executive Order No. 12591 of April
10, 1987, as they pertain to the functions of the Food and Drug
Administration. The delegation excludes the authority to promulgate
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 of Food and Drugs 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) of the Act (15 U.S.C.
3710a(b)(3)) 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)(4) of the Act (15 U.S.C. 3710a(b)(4)) 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)(29) of this section
delegated by the Commissioner of Food and Drugs may not be
further redelegated.
- (30) 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) which relate to pesticide monitoring and enforcement
information, foreign pesticide information, and pesticide analytical
methods. The delegation excludes the authority to submit reports
to Congress.
- (31) Functions vested in the Secretary under the Government Patent
Policy Act of 1980 as amended by the Federal Court Reorganization
Act of 1984, as they pertain to the functions of the Food and Drug
Administration (FDA). The delegated authorities, to be exercised
in compliance with all existing rules and regulations regarding
patent and invention rights and responsibilities, are restricted
to the extent that 35 U.S.C. 203, as amended, may not be redelegated
and that under 35 U.S.C. 207(a), the Assistant Secretary for Health
is to be notified of any significant invention, patent, or license,
so that the Assistant Secretary for Health may decide whether or
not documentation concerning any such invention, patent, or license
should be submitted to the Assistant Secretary for Health for signature.
All other authorities may be redelegated to officials at the level
equivalent to bureau and institute directors.
- (i) Disposition of rights, 35 U.S.C. 202(c)(7), as amended:
The authority to permit a nonprofit organization to assign
the rights to a subject invention in the United States to
organizations which do not have as one of their primary functions
the management of inventions.
- (ii) Disposition of rights, 35 U.S.C. 202(d), as amended:
The authority to permit a contractor to grant requests for
retention of rights by the inventor.
- (iii) Disposition of rights, 35 U.S.C. 202(e), as amended:
The authority to transfer or assign whatever rights FDA may
acquire in the subject invention in any case when an agency
employee is a coinventor of any invention made under a funding
agreement with a nonprofit organization or small business
firm. Such rights may be transferred or assigned from the
FDA employee to the contractor subject to the conditions
set forth in this chapter.
- (iv) March-in-rights, 35 U.S.C. 203, as amended: The authority
to require the contractor to grant nonexclusive, partially exclusive,
or exclusive licenses to responsible applicant(s), or the authority
for FDA to grant such licenses, provided such action would be in
the best interest of FDA, in accordance with all provisions of
this section.
- (v) Preference for United States industry, 35 U.S.C. 204, as
amended: The authority to waive the preference for U.S. industry
requirement.
- (vi) Domestic and foreign protection of federally owned inventions,
35 U.S.C. 207(a) as amended, the authority to:
- (A) Apply for, obtain, and maintain patents or other forms
of protection in the United States and in foreign countries
on inventions in which the Federal Government owns a right,
title, or interest;
- (B) Grant nonexclusive, exclusive, or partially exclusive
licenses under federally owned patent applications, patents,
or other forms of protection obtained, royalty-free or for
royalties or other consideration, and on such terms and conditions,
including the grant to the licensee of the right of enforcement
pursuant to the provisions of chapter 29 of title 35 as determined
appropriate in the public interest;
- (C) Undertake all other suitable and necessary steps to
protect and administer rights to federally owned inventions
on behalf of the Federal Government either directly or through
contract; and
- (D) Transfer custody and administration, in whole or in
part, to another Federal agency, of the right, title, or
interest in any federally owned invention.
- (vii) Determination as to domestic rights and notice to employee
of determination, 45 CFR 7.3 and 7.7, as amended, authority to:
- (A) Leave title to invention in the FDA employee inventor
where the Government has insufficient interest in an invention
to obtain the entire domestic right, title, and interest
therein; and
- (B) Notify the FDA employee inventor of the determination
in writing.
- (32) 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 Public Health Service 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 promulgate regulations, submit reports to the Congress,
establish advisory committees or national commissions, and appoint members
to such committees or commissions.
- (33) 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 Public Health Service Act (42 U.S.C. 300ff
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 promulgate regulations, submit reports to the Congress,
establish advisory committees or national commissioners, and appoint
members to such committees or commissions.
- (34) 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.
- (35) Functions vested in the Secretary under part C, subtitle 2 of
title XXI of the Public Health Service 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 Public Health Service Act (42 U.S.C.
300aa- 25)--Recording and reporting of information.
- (ii) Section 2127 of the Public Health Service Act (42 U.S.C.
300aa- 27)--Mandate for safer childhood vaccines.
- (iii) Section 2128 of the Public Health Service 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.
- (v) Section 313 of the National Childhood Vaccine Injury Act
of 1986--Study of other vaccine risks.
- (vi) Section 314 of the National Childhood Vaccine Injury Act
of 1986--Review of warnings, use instructions, and precautionary
information.
- (vii) The delegation excludes the authority to issue regulations
and submit reports to Congress.
- (36) Functions vested in the Secretary under section 354(b) through
(l) and (n), (o), (q), and (r) of the Public Health Service Act (section
2 of the Mammography Quality Standards Act of 1992 (Pub. L. 102-539)),
as amended, which deal with the certification of mammography facilities.
The delegation excludes the authority to submit reports to Congress.
- (37) Functions vested in the Secretary under section 811(h)(4) of the
Controlled Substances Act (Title II of the Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended) to provide responses to the Drug
Enforcement Administration's temporary scheduling notices. The delegation
excludes the authority to submit reports to Congress.
- (b) The Chief Counsel of the Food and Drug Administration,
i.e., the Associate General Counsel in charge of the Food and Drug Division,
has been authorized to report apparent violations to the Department of
Justice for the institution of criminal proceedings, pursuant to section
305 of the Federal Food, Drug, and Cosmetic Act, section 4 of the Federal
Import Milk Act, and section 9(b) of the Federal Caustic Poison Act.
- (c) The Director, Office of Management, 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 of be affixed to such certifications
and to agreements, awards, citations, diplomas, and similar documents.
- (d) The Executive Officer, Public Health Service, has redelegated
to the Commissioner of Food and Drugs 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.
- (f) The Secretary of Health and Human Services 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. [42 FR 15560, Mar. 22, 1977]
Sec. 5.11 Reservation of authority.
- (a) Notwithstanding provisions of Sec. 5.10 or any previous
delegations of authority to the contrary, the 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 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. [47 FR 16318, Apr. 16, 1982]
