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

if an application for such drug is approved under section 355 of this title , or if a license for such drug is issued under section 262 of title 42 , 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. if an application was approved for the drug under section 355(b) of this title or a license was issued for the drug under section 262 of title 42 , 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 if an application has not been approved for the drug under section 355(b) of this title or a license has not been issued for the drug under section 262 of title 42 and if preclinical investigations or investigations under section 355(i) of this title 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 or approval of a license under section 262 of title 42 . Notice respecting the designation of a drug under subsection (a) shall be made available to the public. The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).