21 U.S.C. § 360aa Recommendations For Investigations of Drugs For Rare Diseases Or Conditions

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 360aa

(a) Request by sponsor; response by Secretary

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.

If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such drug for such disease or condition under section 355 of this title or licensing of such drug for such disease or condition under section 262 of title 42.

(b) Regulations

The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).

Cite as 21 U.S.C. § 360aa

Source: 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.

Notes from the Office of Law Revision Counsel

current through 5/22/2023

EDITORIAL NOTES

AMENDMENTS

1997-Subsec. (a). Pub. L. 105-115, §125(b)(2)(G), struck out ", certification of such drug for such disease or condition under section 357 of this title," before "or licensing of such drug" in closing provisions.

Subsec. (a)(1) to (3). Pub. L. 105-115, §125(b)(2)(F), inserted "or" at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2), which read as follows: "if the drug is an antibiotic, it may be certified for such disease or condition under section 357 of this title, or".

1985-Subsec. (a). Pub. L. 99-91 struck out "or" at end of par. (1), inserted par. (2), redesignated former par. (2) as (3) and struck out "before" after "product,", and in last sentence inserted provisions relating to certification of such drug for disease or condition under section 357 of this title and substituted "licensing of such drug for such disease or condition under section 262 of title 42" for "licensing under section 262 of title 42 for such disease or condition".