Title 21, Food and DrugsRelease 119-102
§360bbb–1 Dispute Resolution
Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part E — General Provisions Relating to Drugs and Devices › § 360bbb–1
Summary
The Secretary must publish rules within 1 year after November 21, 1997, for prompt review when a scientific dispute arises between the Secretary and a sponsor/applicant/manufacturer about drugs or devices under this Act or section 351 and no review exists, including advisory bodies in 355(n) and 360e(g)(2)(B).
Full Legal Text
Title 21, §360bbb–1
Food and Drugs, Source: USLM XML via OLRC
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.
Legislative History
Notes & Related Subsidiaries
Editorial Notes
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, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.
Statutory Notes and Related Subsidiaries
Effective Date
Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an
Effective Date
of 1997 Amendment note under section 321 of this title.
Reference
Citations & Metadata
Citation
21 U.S.C. § 360bbb–1
Title 21, Food and Drugs
Last Updated
Aug 21, 2026
Release point: 119-102