The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before—
(1) it may be approved for such disease or condition under section 355 of this title, or
(2) if the drug is a biological product, it may be licensed for such disease or condition under section 262 of title 42.
The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).
(June 25, 1938, ch. 675, § 525, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2049; amended Pub. L. 99–91, § 3(a)(1), Aug. 15, 1985, 99 Stat. 387; Pub. L. 105–115, title I, § 125(b)(2)(F), (G), Nov. 21, 1997, 111 Stat. 2325, 2326.)
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