Fabio
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Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
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| LegalText | 21 U.S.C. § 360bbb–1 | Dispute resolution | us | united_states_code | code_section | 21 | FOOD AND DRUGS | 9 | FEDERAL FOOD, DRUG, AND COSMETIC ACT | 360bbb–1 | 21 U.S.C. § 360bbb–1 | current | 119-100 | 2026-06-26 | official | https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip | /us/usc/t21/s360bbb–1 | data/legal/raw/us/code/title-21/usc21.xml | 5b174f9190ab4b642fc3f5501be71c5ac02d607064cb279426b04b38d5e18fac | 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 | bc74df7ad2420b5fb75e9fdd88b00bc931014511ad1fd5f1863cd0eff526229c | 2026-07-04 | official |
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21 U.S.C. § 360bbb–1 - Dispute resolution
Text
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.)
Notes
Editorial Notes
References in TextThis 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 DateSection 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.