{"identifier":"/us/usc/t21/s356\u20131","title":21,"num":"\u00a7\u202f356\u20131.","heading":"Accelerated approval of priority countermeasures","text":"\u00a7\u202f356\u20131.\nAccelerated approval of priority countermeasures\n(a)\nIn general\nThe Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to\n(1) a request for designation by the sponsor or applicant; or\n(2) an application for the investigation of the drug under\nsection 355(i) of this title\nsection 262(a)(3) of title 42\nNothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.\n(b)\nUse of animal trials\nA drug for which approval is sought under\nsection 355(b) of this title\nsection 262 of title 42\n1\n(c)\nPriority review of drugs and biological products\nA priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.\n(d)\nDefinitions\nFor purposes of this title:\n(1) The term \u201cpriority countermeasure\u201d has the meaning given such term in section 247d\u20136(h)(4)\n1\n(2) The term \u201cpriority drugs or biological products\u201d means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.","url":"https://projectusc.org/usc/t21/s356\u20131.html","content":[{"t":"sec","id":"/us/usc/t21/s356\u20131","children":[{"t":"num","text":"\u00a7\u202f356\u20131."},{"t":"heading","text":"Accelerated approval of priority countermeasures"},{"t":"subsec","id":"/us/usc/t21/s356\u20131/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"In general"},{"t":"chapeau","text":"The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to ","children":[{"t":"ref","text":"section 356 of this title","href":"/us/usc/t21/s356","tail":" or as a device granted review priority pursuant to section 360e(d)(5)\u202f"},{"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":" of this title. Such a designation may be made prior to the submission of\u2014"}]},{"t":"para","id":"/us/usc/t21/s356\u20131/a/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" a request for designation by the sponsor or applicant; or","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356\u20131/a/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" an application for the investigation of the drug under ","children":[{"t":"ref","text":"section 355(i) of this title","href":"/us/usc/t21/s355/i","tail":" or "},{"t":"ref","text":"section 262(a)(3) of title 42","href":"/us/usc/t42/s262/a/3","tail":"."}],"tail":"\n"}],"tail":"\n\n"},{"t":"continuation","text":"Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.","tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s356\u20131/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Use of animal trials"},{"t":"content","children":[{"t":"p","text":"A drug for which approval is sought under ","children":[{"t":"ref","text":"section 355(b) of this title","href":"/us/usc/t21/s355/b","tail":" or "},{"t":"ref","text":"section 262 of title 42","href":"/us/usc/t42/s262","tail":" on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123\u202f"},{"t":"text","text":"1","tail":" may be designated as a fast track product for purposes of this section."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s356\u20131/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Priority review of drugs and biological products"},{"t":"content","children":[{"t":"p","text":"A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s356\u20131/d","children":[{"t":"num","text":"(d)"},{"t":"heading","text":"Definitions"},{"t":"chapeau","text":"For purposes of this title:\u202f","children":[{"t":"text","text":"1"}]},{"t":"para","id":"/us/usc/t21/s356\u20131/d/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" The term \u201cpriority countermeasure\u201d has the meaning given such term in section 247d\u20136(h)(4)\u202f","children":[{"t":"text","text":"1","tail":" of title 42."}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s356\u20131/d/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" The term \u201cpriority drugs or biological products\u201d means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}