21 U.S.C. § 360bb | Designation of drugs for rare diseases or conditions

(a)

Request by sponsor; preconditions; “rare disease or condition” defined

(1)

section 355(b) of this title section 262 of title 42 The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. A request for designation of a drug shall be made before the submission of an application under for the drug, or the submission of an application for licensing of the drug under . If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—

(A)

section 355 of this title if an application for such drug is approved under , or

(B)

section 262 of title 42 if a license for such drug is issued under ,

1 See References in Text note below.

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)  respecting the designation of the drug.

(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 condition

A designation of a drug under subsection (a) shall be subject to the condition that—

(1)

section 355(b) of this title section 262 of title 42 if an application was approved for the drug under or a license was issued for the drug under , the manufacturer of the drug will notify the Secretary of any discontinuance of the production of the drug at least one year before discontinuance, and

(2)

section 355(b) of this title section 262 of title 42 section 355(i) of this title section 355(b) of this title section 262 of title 42 if an application has not been approved for the drug under or a license has not been issued for the drug under and if preclinical investigations or investigations under are being conducted with the drug, the manufacturer or sponsor of the drug will notify the Secretary of any decision to discontinue active pursuit of approval of an application under or approval of a license under .

(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 Pub. L. 97–414, § 2(a)Jan. 4, 198396 Stat. 2050 Pub. L. 98–551, § 4(a)Oct. 30, 198498 Stat. 2817 Pub. L. 99–91, § 3(a)(2)Aug. 15, 198599 Stat. 387 Pub. L. 100–290, § 2Apr. 18, 1988102 Stat. 90 Pub. L. 105–115, title I, § 125(b)(2)(H)Nov. 21, 1997111 Stat. 2326(, as added , , ; amended , , ; , , ; , , ; , (I), , .)

Editorial Notes

References in Text

Pub. L. 100–290, § 2(b)Apr. 18, 1988102 Stat. 90Subsection (b), referred to in subsec. (a)(1), was redesignated as subsec. (c) of this section by , , .

Amendments

Pub. L. 105–115, § 125(b)(2)(H)section 357 of this title section 357 of this title1997—Subsec. (a)(1). , struck out “the submission of an application for certification of the drug under ,” 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 , or”.

Pub. L. 105–115, § 125(b)(2)(I)(i)section 357 of this titleSubsec. (b)(1). , struck out “, a certificate was issued for the drug under ,” before “or a license was issued”.

Pub. L. 105–115, § 125(b)(2)(I)(ii)section 357 of this title section 357 of this titleSubsec. (b)(2). , struck out “, a certificate has not been issued for the drug under ,” before “or a license has not been issued” and “, approval of an application for certification under ,” before “or approval of a license”.

Pub. L. 100–290, § 2(a)section 355(b) of this title section 357 of this title section 262 of title 421988—Subsec. (a)(1). , inserted after first sentence “A request for designation of a drug shall be made before the submission of an application under for the drug, the submission of an application for certification of the drug under , or the submission of an application for licensing of the drug under .”

Pub. L. 100–290, § 2(b)Subsecs. (b) to (d). , added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively.

Pub. L. 99–911985—Subsec. (a)(1). struck out “or” at end of subpar. (A), struck out subpar. (B) and substituted subpars. (B) and (C), and inserted “, certification,” after “approval”.

Pub. L. 98–5511984—Subsec. (a)(2). 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

Pub. L. 99–91Aug. 15, 1985section 8(b) of Pub. L. 99–91 section 360aa of this titleAmendment by effective , see , set out as a note under .