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 provides’’ for ‘‘such holder provides’’. Subsecs. (c) to (e). Pub. L. 115–52, § 607(a)(3), added subsecs. (c) to (e). 2002—Subsec. (a). Pub. L. 107–281, in concluding provi- sions, struck out ‘‘, of such certification,’’ after ‘‘such approved application’’ and ‘‘, the issuance of the cer- tification,’’ after ‘‘approval of the approved applica- tion’’. 1997—Subsec. (a). Pub. L. 105–115, § 125(b)(2)(J), struck out ‘‘, issue another certification under section 357 of this title,’’ before ‘‘or issue another license’’ in closing provisions, inserted ‘‘or’’ at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: ‘‘issues a certification under section 357 of this title, or’’. Subsec. (b). Pub. L. 105–115, § 125(b)(2)(K), in introduc- tory provisions, struck out ‘‘, if a certification is issued under section 357 of this title for such a drug,’’ after ‘‘rare disease or condition’’, ‘‘, of the issuance of the certification under section 357 of this title,’’ after ‘‘application approval’’, ‘‘, issue another certification under section 357 of this title,’’ after ‘‘application under section 355 of this title’’, and ‘‘, of such certifi- cation,’’ after ‘‘approved application’’. Subsec. (b)(1). Pub. L. 105–115, § 125(b)(2)(K), struck out ‘‘, of the certification,’’ after ‘‘holder of the ap- proved application’’. Subsec. (b)(2). Pub. L. 105–115, § 125(b)(2)(K), struck out ‘‘, issuance of other certifications,’’ after ‘‘approval of other applications’’. 1993—Subsec. (b). Pub. L. 103–80 struck out extraneous comma before ‘‘or issue a license under section 262’’ in introductory provisions and substituted ‘‘the’’ for ‘‘The’’ at beginning of par. (1). 1985—Pub. L. 99–91, § 2(3), struck out ‘‘unpatented’’ be- fore ‘‘drugs’’ in section catchline. Subsec. (a). Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), struck out ‘‘or’’ at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out ‘‘and for which a United States Letter of Patent may not be issued’’ after ‘‘rare disease or condition’’, inserted in first sen- tence ‘‘, issue another certification under section 357 of this title,’’ after ‘‘section 355 of this title’’ the second time it appeared, inserted ‘‘, of such certification,’’ after ‘‘holder of such approved application’’, and in- serted ‘‘, the issuance of the certification,’’ after ‘‘ap- proval of the approved application’’. Subsec. (b). Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), struck out ‘‘and if a United States Letter of Patent may not be issued for the drug’’ after ‘‘such a drug’’, substituted ‘‘, if a certification is issued under section 357 of this title for such a drug, or if a license’’ for ‘‘or a license’’, inserted ‘‘, of the issuance of the certification under section 357 of this title,’’ after ‘‘application approval’’, struck out ‘‘, if the drug is a biological product,’’ be- fore ‘‘issue a license’’, inserted ‘‘, issue another certifi- cation under section 357 of this title,’’ after ‘‘section 355 of this title’’, inserted ‘‘, of such certification,’’ after ‘‘holder of such approved application’’, inserted ‘‘, of such certification,’’ after ‘‘application’’ in par. (1), and inserted ‘‘, issuance of other certifications,’’ after ‘‘other applications’’ in par. (2). 1984—Subsecs. (a), (b). Pub. L. 98–417 substituted ‘‘sec- tion 355’’ for ‘‘section 355(b)’’ wherever appearing. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1985 AMENDMENT Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title. CONSTRUCTION Pub. L. 115–52, title VI, § 607(b), Aug. 18, 2017, 131 Stat. 1050, provided that: ‘‘Nothing in the amendments made by subsection (a) [amending this section] shall affect any determination under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017 [Aug. 18, 2017].’’ § 360dd. Open protocols for investigations of drugs for rare diseases or conditions If a drug is designated under section 360bb of this title as a drug for a rare disease or condi- tion and if notice of a claimed exemption under section 355(i) of this title or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to de- sign protocols for clinical investigations of the drug which may be conducted under the exemp- tion 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. (June 25, 1938, ch. 675, § 528, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2051.) § 360ee. Grants and contracts for development of drugs for rare diseases and conditions (a) Authority of Secretary The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in (1) defraying the costs of developing drugs for rare diseases or conditions, including qualified testing expenses, (2) defraying the costs of developing medical de- vices for rare diseases or conditions, (3) defray- ing the costs of developing medical foods for rare diseases or conditions, and (4) developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions. (b) Definitions For purposes of subsection (a): (1) The term ‘‘qualified testing’’ means— (A) human clinical testing— (i) which is carried out under an exemp- tion for a drug for a rare disease or condi-