---
kind: "section"
citation: "21 U.S.C. § 360bb"
title: "21"
title_heading: "Food and Drugs"
number: "360bb"
heading: "Designation of drugs for rare diseases or conditions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360bb"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part B — Drugs for Rare Diseases or Conditions"
---

# §360bb. Designation of drugs for rare diseases or conditions

- (a) **Request by sponsor; preconditions; “rare disease or condition” defined—**
  - (1) The [manufacturer](/usc/21/360hh.md?p=3) or the [sponsor](/usc/21/360fff.md?p=8) of a [drug](/usc/21/321.md?p=g-1) may request the [Secretary](/usc/21/321.md?p=d) to designate the [drug](/usc/21/321.md?p=g-1) as a [drug](/usc/21/321.md?p=g-1) for a rare disease or condition. A request for designation of a [drug](/usc/21/321.md?p=g-1) shall be made before the submission of an application under [section 355(b) of this title](/usc/21/355.md?p=b) for the [drug](/usc/21/321.md?p=g-1), or the submission of an application for licensing of the [drug](/usc/21/321.md?p=g-1) under [section 262 of title 42](/usc/42/262.md). If the [Secretary](/usc/21/321.md?p=d) finds that a [drug](/usc/21/321.md?p=g-1) for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and—
    - (A) if an application for such [drug](/usc/21/321.md?p=g-1) is approved under [section 355 of this title](/usc/21/355.md), or
    - (B) if a license for such [drug](/usc/21/321.md?p=g-1) is issued under [section 262 of title 42](/usc/42/262.md),

    the approval, certification, or license would be for use for such disease or condition, the [Secretary](/usc/21/321.md?p=d) shall designate the [drug](/usc/21/321.md?p=g-1) as a [drug](/usc/21/321.md?p=g-1) for such disease or condition. A request for a designation of a [drug](/usc/21/321.md?p=g-1) under this subsection shall contain the consent of the applicant to notice being given by the [Secretary](/usc/21/321.md?p=d) under [subsection (b)](#b)[^1] respecting the designation of the [drug](/usc/21/321.md?p=g-1).

  - (2) For purposes of [paragraph (1)](#a-1), the term “rare disease or condition” means any disease or condition which (A) affects less than 200,000 [persons](/usc/21/321.md?p=e) 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](/usc/21/321.md?p=g-1) for such disease or condition will be recovered from sales in the United States of such [drug](/usc/21/321.md?p=g-1). Determinations under the preceding sentence with respect to any [drug](/usc/21/321.md?p=g-1) shall be made on the basis of the facts and circumstances as of the date the request for designation of the [drug](/usc/21/321.md?p=g-1) under this subsection is made.
- (b) **Notification of discontinuance of drug or application as condition—** A designation of a [drug](/usc/21/321.md?p=g-1) under [subsection (a)](#a) shall be subject to the condition that—
  - (1) if an application was approved for the [drug](/usc/21/321.md?p=g-1) under [section 355(b) of this title](/usc/21/355.md?p=b) or a license was issued for the [drug](/usc/21/321.md?p=g-1) under [section 262 of title 42](/usc/42/262.md), the [manufacturer](/usc/21/360hh.md?p=3) of the [drug](/usc/21/321.md?p=g-1) will notify the [Secretary](/usc/21/321.md?p=d) of any discontinuance of the production of the [drug](/usc/21/321.md?p=g-1) at least one year before discontinuance, and
  - (2) if an application has not been approved for the [drug](/usc/21/321.md?p=g-1) under [section 355(b) of this title](/usc/21/355.md?p=b) or a license has not been issued for the [drug](/usc/21/321.md?p=g-1) under [section 262 of title 42](/usc/42/262.md) and if preclinical investigations or investigations under [section 355(i) of this title](/usc/21/355.md?p=i) are being conducted with the [drug](/usc/21/321.md?p=g-1), the [manufacturer](/usc/21/360hh.md?p=3) or [sponsor](/usc/21/360fff.md?p=8) of the [drug](/usc/21/321.md?p=g-1) will notify the [Secretary](/usc/21/321.md?p=d) of any decision to discontinue active pursuit of approval of an application under [section 355(b) of this title](/usc/21/355.md?p=b) or approval of a license under [section 262 of title 42](/usc/42/262.md).
- (c) **Notice to public—** Notice respecting the designation of a [drug](/usc/21/321.md?p=g-1) under [subsection (a)](#a) shall be made available to the public.
- (d) **Regulations—** The [Secretary](/usc/21/321.md?p=d) shall by regulation promulgate procedures for the implementation of [subsection (a)](#a).

## Footnotes

[^1]: See References in Text note below.

## Source credit

(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.)

## Notes

### Editorial Notes

### References in Text

Subsection (b), referred to in subsec. (a)(1), was redesignated as subsec. (c) of this section by Pub. L. 100–290, § 2(b), Apr. 18, 1988, 102 Stat. 90.

### 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”.

### Statutory Notes and Related Subsidiaries

### 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.