**(a) Request by sponsor; preconditions; “rare disease or condition” defined**
(1) 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 [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for the drug, or the submission of an application for licensing of the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). 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) if an application for such drug is approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or
(B) if a license for such drug is issued under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim),
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) 11 See References in Text note below. 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 200,0
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Stable record: federal_law:legal_authorities:record_usc_0c69532610acaadaa06ea6a0 Source file: Laws/federal/codes/united-states-code/title-21/section-360bb-designation-of-drugs-for-rare-diseases-or-conditions--0053c60485.md Pages: Not recorded – Not recorded Passage SHA-256: 935388db0c89c64e915f4512e2517f79ff473c68f616b8c7f9cff809063e44da Retained source evidence SHA-256: 08dd015d2f9bc45945dda1c489d49531d6672512dec836c947272eb05fd69847
Source location: Title 21, Chapter 9, § 360bb; chapter-009-federal-food-drug-and-cosmetic-act.md
Stored source content
**(a) Request by sponsor; preconditions; “rare disease or condition” defined**
(1) 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 [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) for the drug, or the submission of an application for licensing of the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). 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) if an application for such drug is approved under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or
(B) if a license for such drug is issued under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim),
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) 11 See References in Text note below. 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) if an application was approved for the drug under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or a license was issued for the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), 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) if an application has not been approved for the drug under [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or a license has not been issued for the drug under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) and if preclinical investigations or investigations under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) 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 [section 355(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/b&num=0&edition=prelim) or approval of a license under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim).
**(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).
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Federal law — U.S. Code and appendices · legal_authorities
§ 360bb. Designation of drugs for rare diseases or
conditions
(a) Request by sponsor; preconditions; ‘‘rare dis-
ease or condition’’ defined
(1) 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 re-
quest for designation of a drug shall be made be-
fore the submission of an application under sec-
tion 355(b) of this title for the drug, or the sub-
mission of an application for licensing of the
drug under section 262 of title 42. If the Sec-
retary 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) if an application for such drug is ap-
proved under section 355 of this title, or
(B) if a license for such drug is issued under
section 262 of title 42,
the approval, certification, or license would be
for use for such disease or condition, the Sec-
retary shall designate the drug as a drug for
such disease or condition. A request for a des-
ignation of a drug under this subsection shall
contain the consent of the applicant to notice
being given by the Secretary under subsection
(b) 1 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 condi-
tion 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 a