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Title 21 — Food and DrugsRelease 119-73

§360bbb–1 Dispute resolution

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER V— - DRUGS AND DEVICES › Part Part E— - General Provisions Relating to Drugs and Devices › § 360bbb–1

Last updated Apr 6, 2026|Official source

Summary

If the Secretary and a drug or device sponsor, applicant, or manufacturer disagree about a scientific issue tied to duties under this Act or section 351 of the Public Health Service Act (42 U.S.C. 262), and no law or rule already gives the company a review, the Secretary must create a review process by regulation. That process must let the sponsor ask for a review by an appropriate scientific advisory panel or advisory committee and must be done in a timely way. The Secretary had to issue those regulations within 1 year after November 21, 1997.

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

Apr 6, 2026

Release point: 119-73