{"identifier":"/us/usc/t21/s360fff\u20134","title":21,"num":"\u00a7\u202f360fff\u20134.","heading":"Guidance; other provisions","text":"\u00a7\u202f360fff\u20134.\nGuidance; other provisions\n(a)\nGuidance\n(1)\nIn general\n(A)\nDraft guidance\nNot later than 1 year after\n(i) the format and content of information submitted by a sponsor in support of a request under\nsection 360fff\u20131 of this title\n(ii) the data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded;\n(iii) the process by which a request under\nsection 360fff\u20131 of this title\n(iv) the process by which the Secretary will carry out\nsection 360fff\u20133(c) of this title\nsection 360fff\u20131 of this title\n(B)\nFinal guidance\nThe Secretary shall finalize the guidance described in subparagraph (A) not later than 2 years after\nNovember 26, 2014\n(C)\nInapplicability of Paperwork Reduction Act\nChapter 35 of title 44 shall not apply to collections of information made for purposes of guidance under this subsection.\n(2)\nSubmissions pending issuance of final guidance\nIrrespective of whether final guidance under paragraph (1) has been issued\u2014\n(A) persons may, beginning on\nNovember 26, 2014\n(B) the Secretary shall review and act upon such submissions in accordance with this part.\n(b)\nRules of construction\n(1)\nCurrently marketed sunscreens\nNothing in this part shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before\nNovember 26, 2014\n(2)\nEnsuring safety and effectiveness\nNothing in this part shall be construed to alter the authority of the Secretary with respect to prohibiting the marketing of a sunscreen that is not safe and effective or is misbranded, or with respect to imposing restrictions on the marketing of a sunscreen to ensure safety and effectiveness, except as otherwise provided in this part, including\nsection 360fff\u20133(e) of this title\n(3)\nOther drugs\nExcept as otherwise provided in\nsection 360fff\u20136 of this title\n42 U.S.C. 201\n(4)\nEffect on drugs otherwise approved\nNothing in this part shall affect the marketing of a drug approved under\nsection 355 of this title\n42 U.S.C. 262\n(c)\nTimelines\nThe timelines for the processes and procedures under paragraphs (1), (2), (5), and (6) of\nsection 360fff\u20133(a) of this title\nsection 360fff\u20131 of this title\nNovember 26, 2014","url":"https://projectusc.org/usc/t21/s360fff\u20134.html","content":[{"t":"sec","id":"/us/usc/t21/s360fff\u20134","children":[{"t":"num","text":"\u00a7\u202f360fff\u20134."},{"t":"heading","text":"Guidance; other provisions"},{"t":"subsec","id":"/us/usc/t21/s360fff\u20134/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"Guidance"},{"t":"para","id":"/us/usc/t21/s360fff\u20134/a/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"In general"},{"t":"subpara","id":"/us/usc/t21/s360fff\u20134/a/1/A","children":[{"t":"num","text":"(A)"},{"t":"heading","text":"Draft guidance"},{"t":"chapeau","text":"Not later than 1 year after ","children":[{"t":"text","text":"November 26, 2014","tail":", the Secretary shall issue draft guidance on the implementation of, and compliance with, the requirements with respect to sunscreen under this part, including guidance on\u2014"}]},{"t":"clause","id":"/us/usc/t21/s360fff\u20134/a/1/A/i","children":[{"t":"num","text":"(i)"},{"t":"content","text":" the format and content of information submitted by a sponsor in support of a request under ","children":[{"t":"ref","text":"section 360fff\u20131 of this title","href":"/us/usc/t21/s360fff\u20131","tail":" or a pending request;"}],"tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s360fff\u20134/a/1/A/ii","children":[{"t":"num","text":"(ii)"},{"t":"content","text":" the data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded;","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s360fff\u20134/a/1/A/iii","children":[{"t":"num","text":"(iii)"},{"t":"content","text":" the process by which a request under ","children":[{"t":"ref","text":"section 360fff\u20131 of this title","href":"/us/usc/t21/s360fff\u20131","tail":" or a pending request is withdrawn; and"}],"tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s360fff\u20134/a/1/A/iv","children":[{"t":"num","text":"(iv)"},{"t":"content","text":" the process by which the Secretary will carry out ","children":[{"t":"ref","text":"section 360fff\u20133(c) of this title","href":"/us/usc/t21/s360fff\u20133/c","tail":", including with respect to how the Secretary will address the total number of requests received under "},{"t":"ref","text":"section 360fff\u20131 of this title","href":"/us/usc/t21/s360fff\u20131","tail":" and pending requests."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s360fff\u20134/a/1/B","children":[{"t":"num","text":"(B)"},{"t":"heading","text":"Final guidance"},{"t":"content","children":[{"t":"p","text":"The Secretary shall finalize the guidance described in subparagraph (A) not later than 2 years after ","children":[{"t":"text","text":"November 26, 2014","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s360fff\u20134/a/1/C","children":[{"t":"num","text":"(C)"},{"t":"heading","text":"Inapplicability of Paperwork Reduction Act"},{"t":"content","children":[{"t":"p","text":"Chapter 35 of title 44 shall not apply to collections of information made for purposes of guidance under this subsection.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360fff\u20134/a/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Submissions pending issuance of final guidance"},{"t":"chapeau","text":"Irrespective of whether final guidance under paragraph (1) has been issued\u2014"},{"t":"subpara","id":"/us/usc/t21/s360fff\u20134/a/2/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" persons may, beginning on ","children":[{"t":"text","text":"November 26, 2014","tail":", make submissions under this part; and"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s360fff\u20134/a/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" the Secretary shall review and act upon such submissions in accordance with this part.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s360fff\u20134/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Rules of construction"},{"t":"para","id":"/us/usc/t21/s360fff\u20134/b/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"Currently marketed sunscreens"},{"t":"content","children":[{"t":"p","text":"Nothing in this part shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before ","children":[{"t":"text","text":"November 26, 2014","tail":", except as otherwise provided in this part."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360fff\u20134/b/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Ensuring safety and effectiveness"},{"t":"content","children":[{"t":"p","text":"Nothing in this part shall be construed to alter the authority of the Secretary with respect to prohibiting the marketing of a sunscreen that is not safe and effective or is misbranded, or with respect to imposing restrictions on the marketing of a sunscreen to ensure safety and effectiveness, except as otherwise provided in this part, including ","children":[{"t":"ref","text":"section 360fff\u20133(e) of this title","href":"/us/usc/t21/s360fff\u20133/e","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360fff\u20134/b/3","children":[{"t":"num","text":"(3)"},{"t":"heading","text":"Other drugs"},{"t":"content","children":[{"t":"p","text":"Except as otherwise provided in ","children":[{"t":"ref","text":"section 360fff\u20136 of this title","href":"/us/usc/t21/s360fff\u20136","tail":", nothing in this part shall be construed to affect the authority of the Secretary under this chapter or the Public Health Service Act ("},{"t":"ref","text":"42 U.S.C. 201","href":"/us/usc/t42/s201","tail":" et seq.) with respect to a drug other than a nonprescription sunscreen."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360fff\u20134/b/4","children":[{"t":"num","text":"(4)"},{"t":"heading","text":"Effect on drugs otherwise approved"},{"t":"content","children":[{"t":"p","text":"Nothing in this part shall affect the marketing of a drug approved under ","children":[{"t":"ref","text":"section 355 of this title","href":"/us/usc/t21/s355","tail":" or section 351 of the Public Health Service Act ["},{"t":"ref","text":"42 U.S.C. 262","href":"/us/usc/t42/s262","tail":"]."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s360fff\u20134/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Timelines"},{"t":"content","children":[{"t":"p","text":"The timelines for the processes and procedures under paragraphs (1), (2), (5), and (6) of ","children":[{"t":"ref","text":"section 360fff\u20133(a) of this title","href":"/us/usc/t21/s360fff\u20133/a","tail":" shall not apply to any requests submitted to the Secretary under "},{"t":"ref","text":"section 360fff\u20131 of this title","href":"/us/usc/t21/s360fff\u20131","tail":" after the date that is 6 years after "},{"t":"text","text":"November 26, 2014","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}