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21 U.S. Code § 360bb. Designation of drugs for rare diseases or conditions
(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 for the drug, or the submission of an application for licensing of the drug under section 262 of title 42. 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, 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 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) [1] respecting the designation of the drug.