21 U.S. Code § 360bbb–1 - Dispute resolution

If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [42 U.S.C. 262], there is a scientific controversy between the Secretary and a person who is a sponsor, applicant, or manufacturer and no specific provision of the Act involved, including a regulation promulgated under such Act, provides a right of review of the matter in controversy, the Secretary shall, by regulation, establish a procedure under which such sponsor, applicant, or manufacturer may request a review of such controversy, including a review by an appropriate scientific advisory panel described in section 355 (n) of this title or an advisory committee described in section 360e (g)(2)(B) of this title. Any such review shall take place in a timely manner. The Secretary shall promulgate such regulations within 1 year after November 21, 1997.

Source

(June 25, 1938, ch. 675, § 562, as added Pub. L. 105–115, title IV, § 404,Nov. 21, 1997, 111 Stat. 2368.)
References in Text

This Act, referred to in text, is the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.
Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

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.


21 CFR - Food and Drugs

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

 

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