{"identifier":"/us/usc/t21/s379k\u20131","title":21,"num":"\u00a7\u202f379k\u20131.","heading":"Electronic format for submissions","text":"\u00a7\u202f379k\u20131.\nElectronic format for submissions\n(a)\nDrugs and biologics\n(1)\nIn general\nBeginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of\nsection 355 of this title\nsection 262 of title 42\n(2)\nGuidance contents\nIn the guidance under paragraph (1), the Secretary may\u2014\n(A) provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and\n(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.\n(3)\nException\nThis subsection shall not apply to submissions described in\nsection 360bbb of this title\n(b)\nDevices\n(1)\nIn general\nBeginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb\u20133 of this title or\nsection 262 of title 42\n(2)\nGuidance contents\nIn the guidance under paragraph (1), the Secretary may\u2014\n(A) provide standards for the electronic copy required under such paragraph; and\n(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.\n(3)\nPresubmissions and submissions solely in electronic format\n(A)\nIn general\nBeginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.\n(B)\nDraft guidance\nThe Secretary shall, not later than\n(i) any further standards for the submission by electronic format required under subparagraph (A);\n(ii) a timetable for the establishment by the Secretary of such further standards; and\n(iii) criteria for waivers of and exemptions from the requirements of this subsection.\n(C)\nFinal guidance\nThe Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.","url":"https://projectusc.org/usc/t21/s379k\u20131.html","content":[{"t":"sec","id":"/us/usc/t21/s379k\u20131","children":[{"t":"num","text":"\u00a7\u202f379k\u20131."},{"t":"heading","text":"Electronic format for submissions"},{"t":"subsec","id":"/us/usc/t21/s379k\u20131/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"Drugs and biologics"},{"t":"para","id":"/us/usc/t21/s379k\u20131/a/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of ","children":[{"t":"ref","text":"section 355 of this title","href":"/us/usc/t21/s355","tail":" or subsection (a) or (k) of "},{"t":"ref","text":"section 262 of title 42","href":"/us/usc/t42/s262","tail":" shall be submitted in such electronic format as specified by the Secretary in such guidance."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s379k\u20131/a/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Guidance contents"},{"t":"chapeau","text":"In the guidance under paragraph (1), the Secretary may\u2014"},{"t":"subpara","id":"/us/usc/t21/s379k\u20131/a/2/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s379k\u20131/a/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" set forth criteria for waivers of and exemptions from the requirements of this subsection.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s379k\u20131/a/3","children":[{"t":"num","text":"(3)"},{"t":"heading","text":"Exception"},{"t":"content","children":[{"t":"p","text":"This subsection shall not apply to submissions described in ","children":[{"t":"ref","text":"section 360bbb of this title","href":"/us/usc/t21/s360bbb","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s379k\u20131/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Devices"},{"t":"para","id":"/us/usc/t21/s379k\u20131/b/1","children":[{"t":"num","text":"(1)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb\u20133 of this title or ","children":[{"t":"ref","text":"section 262 of title 42","href":"/us/usc/t42/s262","tail":", and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s379k\u20131/b/2","children":[{"t":"num","text":"(2)"},{"t":"heading","text":"Guidance contents"},{"t":"chapeau","text":"In the guidance under paragraph (1), the Secretary may\u2014"},{"t":"subpara","id":"/us/usc/t21/s379k\u20131/b/2/A","children":[{"t":"num","text":"(A)"},{"t":"content","text":" provide standards for the electronic copy required under such paragraph; and","tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s379k\u20131/b/2/B","children":[{"t":"num","text":"(B)"},{"t":"content","text":" set forth criteria for waivers of and exemptions from the requirements of this subsection.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s379k\u20131/b/3","children":[{"t":"num","text":"(3)"},{"t":"heading","text":"Presubmissions and submissions solely in electronic format"},{"t":"subpara","id":"/us/usc/t21/s379k\u20131/b/3/A","children":[{"t":"num","text":"(A)"},{"t":"heading","text":"In general"},{"t":"content","children":[{"t":"p","text":"Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s379k\u20131/b/3/B","children":[{"t":"num","text":"(B)"},{"t":"heading","text":"Draft guidance"},{"t":"chapeau","text":"The Secretary shall, not later than ","children":[{"t":"text","text":"October 1, 2019","tail":", issue draft guidance providing for\u2014"}]},{"t":"clause","id":"/us/usc/t21/s379k\u20131/b/3/B/i","children":[{"t":"num","text":"(i)"},{"t":"content","text":" any further standards for the submission by electronic format required under subparagraph (A);","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s379k\u20131/b/3/B/ii","children":[{"t":"num","text":"(ii)"},{"t":"content","text":" a timetable for the establishment by the Secretary of such further standards; and","tail":"\n"}],"tail":"\n"},{"t":"clause","id":"/us/usc/t21/s379k\u20131/b/3/B/iii","children":[{"t":"num","text":"(iii)"},{"t":"content","text":" criteria for waivers of and exemptions from the requirements of this subsection.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subpara","id":"/us/usc/t21/s379k\u20131/b/3/C","children":[{"t":"num","text":"(C)"},{"t":"heading","text":"Final guidance"},{"t":"content","children":[{"t":"p","text":"The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.","tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}