21 CFR 13.10 - Members of a Board.

§ 13.10 Members of a Board.
(a) All members of a Board are to have medical, technical, scientific, or other qualifications relevant to the issues to be considered, are subject to the conflict of interest rules applicable to special Government employees, and are to be free from bias or prejudice concerning the issues involved. A member of a Board may be a full-time or part-time Federal Government employee or may serve on an FDA advisory committee but, except with the agreement of all parties, may not currently be a full-time or part-time employee of FDA or otherwise act as a special Government employee of FDA.
(b) Within 30 days of publication of the notice of hearing, the director of the center of FDA responsible for a matter before a Board, the other parties to the proceeding, and any person whose petition was granted and is the subject of the hearing, shall each submit to the Division of Dockets Management the names and full curricula vitae of five nominees for members of the Board. Nominations are to state that the nominee is aware of the nomination, is interested in becoming a member of the Board, and appears to have no conflict of interest.
(1) Any two or more persons entitled to nominate members may agree upon a joint list of five qualified nominees.
(2) The lists of nominees must be submitted to the persons entitled to submit a list of nominees under this paragraph but not to all participants. Within 10 days of receipt of the lists of nominees, such persons may submit comments to the Division of Dockets Management on whether the nominees of the other persons meet the criteria established in paragraph (a) of this section. A person submitting comments to the Division of Dockets Management shall submit them to all persons entitled to submit a list of nominees.
(3) The lists of nominees and comments on them are to be held in confidence by the Division of Dockets Management as part of the administrative record of the proceeding and are not to be made available for public disclosure, and all persons who submit or receive them shall similarly hold them in confidence. This portion of the administrative record remains confidential but is available for judicial review in the event that it becomes relevant to any issue before a court.
(c) After reviewing the lists of nominees and any comments, the Commissioner will choose three qualified persons as members of a Board. One member will be from the lists of nominees submitted by the director of the center and by any person whose petition was granted and is the subject of the hearing. The second will be from the lists of nominees submitted by the other parties. The Commissioner may choose the third member from any source. That member is the Chairman of the Board.
(1) If the Commissioner is unable to find a qualified person with no conflict of interest from among a list of nominees or if additional information is needed, the Commissioner will request the submission of the required additional nominees or information.
(2) If a person fails to submit a list of nominees as required by paragraph (b) of this section, the Commissioner may choose a qualified member without further consultation with that person.
(3) The Commissioner will announce the members of a Board by filing a memorandum in the record of the proceeding and sending a copy to all participants.
(d) Instead of using the selection method in paragraphs (b) and (c) of this section, the director of the center, the other parties to the proceeding, and any person whose petition was granted and is the subject of the hearing, may, with the approval of the Commissioner, agree that a standing advisory committee listed in § 14.80 constitutes the Board for a particular proceeding, or that another procedure is to be used for selection of the members of the Board, or that the Board consists of a larger number of members.
(e) The members of a Board serve as consultants to the Commissioner and are special Government employees or Government employees. A Board functions as an administrative law tribunal in the proceeding and is not an advisory committee subject to the requirements of the Federal Advisory Committee Act or part 14.
(f) The Chairman of the Board has the authority of a presiding officer set out in § 12.70.
[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985]
Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 13.10 Members of a Board.

(a) All members of a Board are to have medical, technical, scientific, or other qualifications relevant to the issues to be considered, are subject to the conflict of interest rules applicable to special Government employees, and are to be free from bias or prejudice concerning the issues involved. A member of a Board may be a full-time or part-time Federal Government employee or may serve on an FDA advisory committee but, except with the agreement of all parties, may not currently be a full-time or part-time employee of FDA or otherwise act as a special Government employee of FDA.

(b) Within 30 days of publication of the notice of hearing, the director of the center of FDA responsible for a matter before a Board, the other parties to the proceeding, and any person whose petition was granted and is the subject of the hearing, shall each submit to the Division of Dockets Management the names and full curricula vitae of five nominees for members of the Board. Nominations are to state that the nominee is aware of the nomination, is interested in becoming a member of the Board, and appears to have no conflict of interest.

(1) Any two or more persons entitled to nominate members may agree upon a joint list of five qualified nominees.

(2) The lists of nominees must be submitted to the persons entitled to submit a list of nominees under this paragraph but not to all participants. Within 10 days of receipt of the lists of nominees, such persons may submit comments to the Division of Dockets Management on whether the nominees of the other persons meet the criteria established in paragraph (a) of this section. A person submitting comments to the Division of Dockets Management shall submit them to all persons entitled to submit a list of nominees.

(3) The lists of nominees and comments on them are to be held in confidence by the Division of Dockets Management as part of the administrative record of the proceeding and are not to be made available for public disclosure, and all persons who submit or receive them shall similarly hold them in confidence. This portion of the administrative record remains confidential but is available for judicial review in the event that it becomes relevant to any issue before a court.

(c) After reviewing the lists of nominees and any comments, the Commissioner will choose three qualified persons as members of a Board. One member will be from the lists of nominees submitted by the director of the center and by any person whose petition was granted and is the subject of the hearing. The second will be from the lists of nominees submitted by the other parties. The Commissioner may choose the third member from any source. That member is the Chairman of the Board.

(1) If the Commissioner is unable to find a qualified person with no conflict of interest from among a list of nominees or if additional information is needed, the Commissioner will request the submission of the required additional nominees or information.

(2) If a person fails to submit a list of nominees as required by paragraph (b) of this section, the Commissioner may choose a qualified member without further consultation with that person.

(3) The Commissioner will announce the members of a Board by filing a memorandum in the record of the proceeding and sending a copy to all participants.

(d) Instead of using the selection method in paragraphs (b) and (c) of this section, the director of the center, the other parties to the proceeding, and any person whose petition was granted and is the subject of the hearing, may, with the approval of the Commissioner, agree that a standing advisory committee listed in § 14.80 constitutes the Board for a particular proceeding, or that another procedure is to be used for selection of the members of the Board, or that the Board consists of a larger number of members.

(e) The members of a Board serve as consultants to the Commissioner and are special Government employees or Government employees. A Board functions as an administrative law tribunal in the proceeding and is not an advisory committee subject to the requirements of the Federal Advisory Committee Act or part 14.

(f) The Chairman of the Board has the authority of a presiding officer set out in § 12.70.

[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985]

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
U.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES
U.S. Code: Title 15 - COMMERCE AND TRADE
U.S. Code: Title 21 - FOOD AND DRUGS

§ 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 section 142; regulations; suspension and revocation of permits

§ 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. Pub. L. 101–647, title XIX, § 1905, Nov. 29, 1990, 104 Stat. 4853

§ 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

§ 343-1

§ 343-2

§ 343-3

§ 343a - Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73

§ 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

§ 350l - Mandatory recall authority

§ 350l-1

§ 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

§ 355-1

§ 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

§ 356-1

§ 356a - Manufacturing changes

§ 356b - Reports of postmarketing studies

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

§ 357 - Repealed. Pub. L. 105–115, title I, § 125(b)(1), Nov. 21, 1997, 111 Stat. 2325

§ 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

§ 360e-1

§ 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

§ 360l - Postmarket surveillance

§ 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

§ 360ll - Notification of defects in and repair or replacement of electronic products

§ 360mm - Imports

§ 360nn - Inspection, records, and reports

§ 360oo - Prohibited acts

§ 360pp - Enforcement

§ 360qq - Repealed. Pub. L. 105–362, title VI, § 601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285

§ 360rr - Federal-State cooperation

§ 360ss - State standards

§ 360aaa to 360aaa–6 - Omitted

§ 360bbb - Expanded access to unapproved therapies and diagnostics

§ 360bbb-1

§ 360bbb-2

§ 360bbb-3

§ 360bbb-4

§ 360bbb-5

§ 360bbb-6

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

§ 360ccc-1

§ 360ccc-2

§ 361 - Adulterated cosmetics

§ 362 - Misbranded cosmetics

§ 363 - Regulations making exemptions

§ 364 - Repealed. Pub. L. 86–618, title I, § 103(a)(3), July 12, 1960, 74 Stat. 398

§ 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

§ 379d-1

§ 379d-2

§ 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

§ 379h-1

§ 379h-2

§ 379i - Definitions

§ 379j - Authority to assess and use device fees

§ 379j-1

§ 379j-11

§ 379j-12

§ 379j-13

§ 379j-21

§ 379j-22

§ 379j-31

§ 379k - Information system

§ 379l - Education

§ 379o - Environmental impact

§ 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

§ 379aa-1

§ 379dd - Establishment and functions of the Foundation

§ 379dd-1

§ 379dd-2

§ 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

§ 387a-1

§ 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

§ 387f-1

§ 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

§ 387l - Judicial review

§ 387m - Equal treatment of retail outlets

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

§ 387o - Regulation requirement

§ 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

§ 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