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)1 respecting the designation of the drug.
A designation of a drug under subsection (a) shall be subject to the condition that-
Notice respecting the designation of a drug under subsection (a) shall be made available to the public.
The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
1See References in Text note below.
21 U.S.C. § 360bb
EDITORIAL NOTES
REFERENCES IN TEXTSubsection (b), referred to in subsec. (a)(1), was redesignated as subsec. (c) of this section by Pub. L. 100-290, §2(b), Apr. 18, 1988, 102 Stat. 90.
AMENDMENTS1997-Subsec. (a)(1). Pub. L. 105-115, §125(b)(2)(H), struck out "the submission of an application for certification of the drug under section 357 of this title," before "or the submission of an application for licensing of the drug" in introductory provisions, inserted "or" at end of subpar. (A), redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: "if a certification for such drug is issued under section 357 of this title, or".Subsec. (b)(1). Pub. L. 105-115, §125(b)(2)(I)(i), struck out ",a certificate was issued for the drug under section 357 of this title," before "or a license was issued".Subsec. (b)(2). Pub. L. 105-115, §125(b)(2)(I)(ii), struck out ",a certificate has not been issued for the drug under section 357 of this title," before "or a license has not been issued" and ",approval of an application for certification under section 357 of this title," before "or approval of a license". 1988-Subsec. (a)(1). Pub. L. 100-290, §2(a), inserted after first sentence "A request for designation of a drug shall be made before the submission of an application under section 355(b) of this title for the drug, the submission of an application for certification of the drug under section 357 of this title, or the submission of an application for licensing of the drug under section 262 of title 42."Subsecs. (b) to (d). Pub. L. 100-290, §2(b), added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively. 1985-Subsec. (a)(1). Pub. L. 99-91 struck out "or" at end of subpar. (A), struck out subpar. (B) and substituted subpars. (B) and (C), and inserted ",certification," after "approval". 1984-Subsec. (a)(2). Pub. L. 98-551 substituted "which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which" for "which occurs so infrequently in the United States that".
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.