{"identifier":"/us/usc/t21/s360bb","title":21,"num":"\u00a7\u202f360bb.","heading":"Designation of drugs for rare diseases or conditions","text":"\u00a7\u202f360bb.\nDesignation of drugs for rare diseases or conditions\n(a)\nRequest by sponsor; preconditions; \u201crare disease or condition\u201d defined\n(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\n(A) if an application for such drug is approved under\nsection 355 of this title\n(B) if a license for such drug is issued under\nsection 262 of title 42\nthe 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)\n1\n1 See References in Text note below.\n(2) For purposes of paragraph (1), the term \u201crare disease or condition\u201d 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.\n(b)\nNotification of discontinuance of drug or application as condition\nA designation of a drug under subsection (a) shall be subject to the condition that\u2014\n(1) if an application was approved for the drug under\nsection 355(b) of this title\nsection 262 of title 42\n(2) if an application has not been approved for the drug under\nsection 355(b) of this title\nsection 262 of title 42\nsection 355(i) of this title\nsection 355(b) of this title\nsection 262 of title 42\n(c)\nNotice to public\nNotice respecting the designation of a drug under subsection (a) shall be made available to the public.\n(d)\nRegulations\nThe Secretary shall by regulation promulgate procedures for the implementation of subsection (a).","url":"https://projectusc.org/usc/t21/s360bb.html","content":[{"t":"sec","id":"/us/usc/t21/s360bb","children":[{"t":"num","text":"\u00a7\u202f360bb."},{"t":"heading","text":"Designation of drugs for rare diseases or conditions"},{"t":"subsec","id":"/us/usc/t21/s360bb/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"Request by sponsor; preconditions; \u201crare disease or condition\u201d defined"},{"t":"para","id":"/us/usc/t21/s360bb/a/1","children":[{"t":"num","text":"(1)"},{"t":"chapeau","text":" 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 ","children":[{"t":"ref","text":"section 355(b) of this title","href":"/us/usc/t21/s355/b","tail":" for the drug, or the submission of an application for licensing of the drug under "},{"t":"ref","text":"section 262 of title 42","href":"/us/usc/t42/s262","tail":". 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\u2014"}]},{"t":"subpara","id":"/us/usc/t21/s360bb/a/1/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" if an application for such drug is approved under ","children":[{"t":"ref","text":"section 355 of this title","href":"/us/usc/t21/s355","tail":", or"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s360bb/a/1/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" if a license for such drug is issued under ","children":[{"t":"ref","text":"section 262 of title 42","href":"/us/usc/t42/s262","tail":","}],"tail":"\n"}],"tail":"\n\n"},{"t":"continuation","text":"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)\u202f","children":[{"t":"ref","text":"1"},{"t":"num","text":"1","tail":"\u202fSee References in Text note below."},{"t":"text","text":"\u202fSee References in Text note below.","tail":" respecting the designation of the drug."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360bb/a/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" For purposes of paragraph (1), the term \u201crare disease or condition\u201d 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.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s360bb/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Notification of discontinuance of drug or application as condition"},{"t":"chapeau","text":"A designation of a drug under subsection (a) shall be subject to the condition that\u2014"},{"t":"para","id":"/us/usc/t21/s360bb/b/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" if an application was approved for the drug under ","children":[{"t":"ref","text":"section 355(b) of this title","href":"/us/usc/t21/s355/b","tail":" or a license was issued for the drug under "},{"t":"ref","text":"section 262 of title 42","href":"/us/usc/t42/s262","tail":", 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"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360bb/b/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" if an application has not been approved for the drug under ","children":[{"t":"ref","text":"section 355(b) of this title","href":"/us/usc/t21/s355/b","tail":" or a license has not been issued for the drug under "},{"t":"ref","text":"section 262 of title 42","href":"/us/usc/t42/s262","tail":" and if preclinical investigations or investigations under "},{"t":"ref","text":"section 355(i) of this title","href":"/us/usc/t21/s355/i","tail":" 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 "},{"t":"ref","text":"section 355(b) of this title","href":"/us/usc/t21/s355/b","tail":" or approval of a license under "},{"t":"ref","text":"section 262 of title 42","href":"/us/usc/t42/s262","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s360bb/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Notice to public"},{"t":"content","children":[{"t":"p","text":"Notice respecting the designation of a drug under subsection (a) shall be made available to the public.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s360bb/d","children":[{"t":"num","text":"(d)"},{"t":"heading","text":"Regulations"},{"t":"content","children":[{"t":"p","text":"The Secretary shall by regulation promulgate procedures for the implementation of subsection (a).","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}