21 U.S.C. § 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 .

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