21 CFR 14.171 - Utilization of an advisory committee on the initiative of FDA.

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§ 14.171 Utilization of an advisory committee on the initiative of FDA.
(a) Any matter involving a human prescription drug under review within the agency may, in the discretion of the Commissioner, be the subject of a public hearing and continuing or periodic review by the appropriate standing technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda of the committee are based upon the priorities of the various matters pending before the agency which fall within the pharmacologic class covered by that committee.
(b) High priority for such hearing and review by the appropriate standing technical advisory committee for human prescription drugs are given to the following types of human prescription drugs:
(1) Investigational drugs which are potential therapeutic advances over currently marketed products from the standpoint of safety or effectiveness, or which pose significant safety hazards, or which present narrow benefit-risk considerations requiring a close judgmental decision on approval for marketing, or which have a novel delivery system or formulation, or which are the subject of major scientific or public controversy, or which may be subject to special regulatory requirements such as a limitation on clinical trials, a patient followup requirement, postmarketing Phase IV studies, distributional controls, or boxed warnings.
(2) Marketed drugs for which an important new use has been discovered or which pose newly discovered safety hazards, or which are the subject of major scientific or public controversy, or which may be subject to important regulatory actions such as withdrawal of approval for marketing, boxed warnings, distributional controls, or newly required scientific studies.
(c) The committee may request the Commissioner for an opportunity to hold a public hearing and to review any matter involving a human prescription drug which falls within the pharmacologic class covered by the committee. The Commissioner may, after consulting with the committee on such request, grant or deny the request in light of the priorities of the other matters pending before the committee. Whenever feasible, consistent with the other work of the committee, the request will be granted.
(d) For a drug that meets any of the criteria established in paragraph (b) of this section, one or more members of or consultants to the appropriate advisory committee may be selected for more detailed monitoring of the matter and consultation with FDA on behalf of the committee. The member or consultant may be invited to attend appropriate meetings and shall assist the center in any briefing of the committee on that matter.
(e) An advisory committee may obtain advice and recommendations from other agency advisory committees, consultants, and experts which the advisory committee and the center conclude would facilitate the work of the advisory committee.
(f) Presentation of all relevant information about the matter will be made in open session unless it relates to an IND the existence of which has not previously been disclosed to the public as defined in § 20.81 or is otherwise prohibited from public disclosure under part 20 and the regulations referenced therein. Sections 314.430 and 601.51 determine whether, and the extent to which, relevant information may be made available for public disclosure, summarized and discussed in open session but not otherwise made available for public disclosure, or not in any way discussed or disclosed in open session or otherwise disclosed to the public.
[44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-04-11; vol. 79 # 70 - Friday, April 11, 2014
    1. 79 FR 20094 - Advisory Committee: Bone, Reproductive and Urologic Drugs Advisory Committee
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 11, 2014.
      21 CFR Part 14

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
USC: Title 5a
U.S. Code: Title 15 - COMMERCE AND TRADE
U.S. Code: Title 21 - FOOD AND DRUGS

§ 41 to 50 - Repealed.

§ 50 - Repealed.

§ 141 - Prohibition of importation without permit

§ 142 - Milk or cream when unfit for importation

§ 143 - Inspection; certified statement in lieu thereof; waiver of requirements of

§ 144 - Unlawful receiving of imported milk or cream

§ 145 - Penalties

§ 146 - Authorization of appropriations

§ 147 - Repeal of inconsistent laws

§ 148 - Powers of State with respect to milk or cream lawfully imported

§ 149 - Definitions

§ 321 - Definitions; generally

§ 321a - “Butter” defined

§ 321b - “Package” defined

§ 321c - Nonfat dry milk; “milk” defined

§ 321d - Market names for catfish and ginseng

§ 331 - Prohibited acts

§ 332 - Injunction proceedings

§ 333 - Penalties

§ 333a - Repealed.

§ 334 - Seizure

§ 335 - Hearing before report of criminal violation

§ 335a - Debarment, temporary denial of approval, and suspension

§ 335b - Civil penalties

§ 335c - Authority to withdraw approval of abbreviated drug applications

§ 336 - Report of minor violations

§ 337 - Proceedings in name of United States; provision as to subpoenas

§ 341 - Definitions and standards for food

§ 342 - Adulterated food

§ 343 - Misbranded food

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 343a - Repealed.

§ 344 - Emergency permit control

§ 345 - Regulations making exemptions

§ 346 - Tolerances for poisonous or deleterious substances in food; regulations

§ 346a - Tolerances and exemptions for pesticide chemical residues

§ 346b - Authorization of appropriations

§ 347 - Intrastate sales of colored oleomargarine

§ 347a - Congressional declaration of policy regarding oleomargarine sales

§ 347b - Contravention of State laws

§ 348 - Food additives

§ 349 - Bottled drinking water standards; publication in Federal Register

§ 350 - Vitamins and minerals

§ 350a - Infant formulas

§ 350b - New dietary ingredients

§ 350c - Maintenance and inspection of records

§ 350d - Registration of food facilities

§ 350e - Sanitary transportation practices

§ 350f - Reportable food registry

§ 350g - Hazard analysis and risk-based preventive controls

§ 350h - Standards for produce safety

§ 350i - Protection against intentional adulteration

§ 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

§ 350k - Laboratory accreditation for analyses of foods

21 U.S. Code § -

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 353a - Pharmacy compounding

§ 353b - Outsourcing facilities

§ 354 - Veterinary feed directive drugs

§ 355 - New drugs

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 355a - Pediatric studies of drugs

§ 355b - Adverse-event reporting

§ 355c - Research into pediatric uses for drugs and biological products

§ 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers

§ 355e - Pharmaceutical security

§ 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 356a - Manufacturing changes

§ 356b - Reports of postmarketing studies

§ 356c - Discontinuance or interruption in the production of life-saving drugs

§ 357 - Repealed.

§ 358 - Authority to designate official names

§ 359 - Nonapplicability of subchapter to cosmetics

§ 360 - Registration of producers of drugs or devices

§ 360a - Clinical trial guidance for antibiotic drugs

§ 360b - New animal drugs

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

§ 360f - Banned devices

§ 360g - Judicial review

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 360k - State and local requirements respecting devices

21 U.S. Code § -

§ 360m - Accredited persons

§ 360n - Priority review to encourage treatments for tropical diseases

§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions

§ 360bb - Designation of drugs for rare diseases or conditions

§ 360cc - Protection for drugs for rare diseases or conditions

§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions

§ 360ee - Grants and contracts for development of drugs for rare diseases and conditions

§ 360hh - Definitions

§ 360ii - Program of control

§ 360jj - Studies by Secretary

§ 360kk - Performance standards for electronic products

21 U.S. Code § -

§ 360mm - Imports

§ 360nn - Inspection, records, and reports

21 U.S. Code § -

§ 360pp - Enforcement

§ 360qq - Repealed.

§ 360rr - Federal-State cooperation

§ 360ss - State standards

§ 360aaa to 360aaa–6 - Omitted

§ 360bbb - Expanded access to unapproved therapies and diagnostics

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 360ccc - Conditional approval of new animal drugs for minor use and minor species

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 361 - Adulterated cosmetics

§ 362 - Misbranded cosmetics

§ 363 - Regulations making exemptions

§ 364 - Repealed.

§ 371 - Regulations and hearings

§ 372 - Examinations and investigations

§ 372a - Transferred

§ 373 - Records

§ 374 - Inspection

§ 374a - Inspections relating to food allergens

§ 375 - Publicity

§ 376 - Examination of sea food on request of packer; marking food with results; fees; penalties

§ 377 - Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests

§ 378 - Advertising of foods

§ 379 - Confidential information

§ 379a - Presumption of existence of jurisdiction

§ 379b - Consolidated administrative and laboratory facility

§ 379c - Transferred

§ 379d - Automation of Food and Drug Administration

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

§ 379f - Recovery and retention of fees for freedom of information requests

§ 379g - Definitions

§ 379h - Authority to assess and use drug fees

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 379i - Definitions

§ 379j - Authority to assess and use device fees

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 379k - Information system

21 U.S. Code § -

21 U.S. Code § -

§ 379r - National uniformity for nonprescription drugs

§ 379s - Preemption for labeling or packaging of cosmetics

§ 379v - Safety report disclaimers

§ 379aa - Serious adverse event reporting for nonprescription drugs

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 379dd - Establishment and functions of the Foundation

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 381 - Imports and exports

§ 382 - Exports of certain unapproved products

§ 383 - Office of International Relations

§ 384 - Importation of prescription drugs

§ 384a - Foreign supplier verification program

§ 384b - Voluntary qualified importer program

§ 384c - Inspection of foreign food facilities

§ 384d - Accreditation of third-party auditors

§ 387 - Definitions

§ 387a - FDA authority over tobacco products

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 387b - Adulterated tobacco products

§ 387c - Misbranded tobacco products

§ 387d - Submission of health information to the Secretary

§ 387e - Annual registration

§ 387f - General provisions respecting control of tobacco products

21 U.S. Code § 360aaa to 360aaa–6 - Omitted

§ 387g - Tobacco product standards

§ 387h - Notification and other remedies

§ 387i - Records and reports on tobacco products

§ 387j - Application for review of certain tobacco products

§ 387k - Modified risk tobacco products

21 U.S. Code § -

§ 387m - Equal treatment of retail outlets

§ 387n - Jurisdiction of and coordination with the Federal Trade Commission

21 U.S. Code § -

§ 387p - Preservation of State and local authority

§ 387q - Tobacco Products Scientific Advisory Committee

§ 387r - Drug products used to treat tobacco dependence

§ 387s - User fees

§ 387t - Labeling, recordkeeping, records inspection

§ 387u - Studies of progress and effectiveness

§ 391 - Separability clause

§ 392 - Exemption of meats and meat food products

§ 393 - Food and Drug Administration

§ 393a - Office of Pediatric Therapeutics

§ 394 - Scientific review groups

§ 467f - Federal Food, Drug, and Cosmetic Act applications

§ 679 - Application of Federal Food, Drug, and Cosmetic Act

§ 821 - Rules and regulations

§ 1034 - Inspection of egg products

U.S. Code: Title 28 - JUDICIARY AND JUDICIAL PROCEDURE
U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
Public Laws

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 14 after this date.

  • 2014-04-11; vol. 79 # 70 - Friday, April 11, 2014
    1. 79 FR 20094 - Advisory Committee: Bone, Reproductive and Urologic Drugs Advisory Committee
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 11, 2014.
      21 CFR Part 14