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21 U.S.C. § 360dd — Open protocols for investigations of drugs for rare diseases or conditions

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360dd — Open protocols for investigations of drugs for rare diseases or conditions

If a drug is designated under [section 360bb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bb&num=0&edition=prelim) as a drug for a rare disease or condition and if notice of a claimed exemption under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.

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Source file: Laws/federal/codes/united-states-code/title-21/section-360dd-open-protocols-for-investigations-of-drugs-for-rare-diseases-or-conditio--86bec2c238.md
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Source location: Title 21, Chapter 9, § 360dd; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360bb — Designation of drugs for rare diseases or conditions

**(a) Request by sponsor; preconditions; “rare disease or condition” defined** (1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for the drug, or the submission of an application for licensing of the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and— (A) if an application for such drug is approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or (B) if a license for such drug is issued under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), the approval, certification, or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) 11 See References in Text note below. respecting the designation of the drug. (2) For purposes of paragraph (1), the term “rare disease or condition” means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,0

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360dd — Open protocols for investigations of

Page 396 TITLE 21—FOOD AND DRUGS § 360dd 2017—Subsec. (a). Pub. L. 115–52, § 607(a)(1), sub- stituted ‘‘the same drug for the same disease or condi- tion’’ for ‘‘such drug for such disease or condition’’ in concluding provisions. Subsec. (b). Pub. L. 115–52, § 607(a)(2)(A), in introduc- tory provisions, substituted ‘‘During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an applica- tion or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if’’ for ‘‘If an application filed pursuant to section 355 of this title is approved for a drug designated under sec- tion 360bb of this title for a rare disease or condition or if a license is issued under section 262 of title 42 for such a drug, the Secretary may, during the seven-year period beginning on the date of the application ap- proval or of the issuance of the license, approve an- other application under section 355 of this title or issue a license under section 262 of title 42, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if’’. Subsec. (b)(1). Pub. L. 115–52, § 607(a)(2)(B), substituted ‘‘of exclusive approval or licensure notice and oppor- tunity for the submission of views, that during such pe- riod the holder of the exclusive approval or licensure cannot ensure’’ for ‘‘notice and opportunity for the sub- mission of views, that in such period the holder of the approved application or of the license cannot assure’’. Subsec. (b)(2). Pub. L. 115–52, § 607(a)(2)(C), substituted ‘‘the holder prov

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