---
kind: "section"
citation: "21 U.S.C. § 360bbb–1"
title: "21"
title_heading: "Food and Drugs"
number: "360bbb–1"
heading: "Dispute resolution"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bbb-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part E — General Provisions Relating to Drugs and Devices"
---

# §360bbb–1. Dispute resolution


If, regarding an obligation concerning [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) under this Act or section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)], there is a scientific controversy between the [Secretary](/usc/21/321.md?p=d) and a [person](/usc/21/321.md?p=e) who is a [sponsor](/usc/21/360fff.md?p=8), applicant, or [manufacturer](/usc/21/360hh.md?p=3) 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](/usc/21/321.md?p=d) shall, by regulation, establish a procedure under which such [sponsor](/usc/21/360fff.md?p=8), applicant, or [manufacturer](/usc/21/360hh.md?p=3) may request a review of such controversy, including a review by an appropriate scientific advisory panel described in [section 355(n) of this title](/usc/21/355.md?p=n) or an [advisory committee](/usc/21/360fff.md?p=1) described in [section 360e(g)(2)(B) of this title](/usc/21/360e.md?p=g-2-B). Any such review shall take place in a timely manner. The [Secretary](/usc/21/321.md?p=d) shall promulgate such regulations within 1 year after November 21, 1997.


## Source credit

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

## Notes

### 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.