21 CFR 14.35 - Written submissions to an advisory committee.

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§ 14.35 Written submissions to an advisory committee.
(a) Ten copies of written submissions to a committee are to be sent to the Designated Federal Officer unless an applicable Federal Register notice or other regulations in this chapter specify otherwise. Submissions are subject to the provisions of § 10.20, except that it is not necessary to send copies to the Division of Dockets Management.
(b) At the request of a committee, or on the Commissioner's own initiative, the Commissioner may issue in the Federal Register a notice requesting the submission to the committee of written information and views pertinent to a matter being reviewed by the committee. The notice may specify the manner in which the submission should be made.
(c) At the request of a committee, or on the Commissioner's own initiative, the Commissioner may at any time request the applicant or sponsor of an application or petition about a specific product on which action is pending before FDA, and is being reviewed by an advisory committee, to present or discuss safety, effectiveness, or other data concerning the product during a regularly scheduled meeting of the committee. The request may be for an oral presentation or for a concise, well-organized written summary of pertinent information for review by the committee members before the meeting, or both. Unless specified otherwise, one copy of the written summary along with a proposed agenda outlining the topics to be covered and identifying the participating industry staff members or consultants that will present each topic is to be submitted to the Designated Federal Officer or other designated agency employee at least 3 weeks before the meeting.
(d) An interested person may submit to a committee written information or views on any matter being reviewed. Voluminous data is to be accompanied by a summary. A submission is to be made to the Designated Federal Officer and not directly to a committee member.
(1) FDA will distribute submissions to each member, either by mail or at the next meeting. Submissions will be considered by the committee in its review of the matter.
(2) A committee may establish, and give public notice of, a cutoff date after which submissions about a matter will no longer be received or considered.
(e) The Commissioner will provide the committee all information the Commissioner deems relevant. A member will, upon request, also be provided any material available to FDA which the member believes appropriate for an independent judgment on the matter, e.g., raw data underlying a summary or report, or a briefing on the legal aspects of the matter.

Title 21 published on 2014-04-01

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.

  • 2014-11-14; vol. 79 # 220 - Friday, November 14, 2014
    1. 79 FR 68114 - Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective November 14, 2014.
      21 CFR Parts 5, 10, 14, 20, 21, 314, 350, 516, and 814

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 2014-04-01

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

  • 2014-11-14; vol. 79 # 220 - Friday, November 14, 2014
    1. 79 FR 68114 - Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective November 14, 2014.
      21 CFR Parts 5, 10, 14, 20, 21, 314, 350, 516, and 814