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TITLE 21 > CHAPTER 9 > SUBCHAPTER V > Part B > § 360bb
NOTES:
Source
(June 25, 1938, ch. 675, § 526, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2050; amended Pub. L. 98–551, § 4(a), Oct. 30, 1984, 98 Stat. 2817; Pub. L. 99–91, § 3(a)(2), Aug. 15, 1985, 99 Stat. 387; Pub. L. 100–290, § 2, Apr. 18, 1988, 102 Stat. 90; Pub. L. 105–115, title I, § 125(b)(2)(H), (I), Nov. 21, 1997, 111 Stat. 2326.)
Amendments
1997—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”.
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.
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