(a) Request by sponsor; preconditions; “rare disease or condition” defined
(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 200,000 in the United
States and for which there is no reasonable expectation that the cost of developing and making available in the United
States a
drug for such disease or condition will be recovered from sales in the United
States of such
drug. Determinations under the preceding sentence with respect to any
drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the
drug under this subsection is made.
(b) Notification of discontinuance of drug or application as conditionA designation of a drug under subsection (a) shall be subject to the condition that—
(c) Notice to public
Notice respecting the designation of a drug under subsection (a) shall be made available to the public.
(d) Regulations
The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
(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”.
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