,,ii #aagth ,,congress #b;d ,session ,s4 #dcdh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #bf1 #bjbb,mrs4 ,murray 7for herself and ,mr4 ,burr7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to revise and extend the user-fee programs for prescription drugs1 medical devices1 generic drugs1 and biosimilar biological products1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb or the ,,fdasla ,act of #bjbb4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,fees relating to drugs,sec4 #aja4 ,short title2 finding4,sec4 #ajb4 ,definitions4,sec4 #ajc4 ,authority to assess and use drug fees4,sec4 #ajd4 ,reauthorization2 reporting requirement4,sec4 #aje4 ,sunset dates4,sec4 #ajf4 ,effective date4,sec4 #ajg4 ,savings clause4,,title ,,ii--,fees relating to devices,sec4 #bja4 ,short title2 finding4,sec4 #bjb4 ,definitions4,sec4 #bjc4 ,authority to assess and use device fees4,sec4 #bjd4 ,accreditation programs4,sec4 #bje4 ,sunset dates4,sec4 #bjf4 ,effective date4,sec4 #bjg4 ,savings clause4,,title ,,iii--,fees relating to generic drugs,sec4 #cja4 ,short title2 finding4,sec4 #cjb4 ,authority to assess and use human generic drug fees4,sec4 #cjc4 ,reauthorization2 reporting requirements4,sec4 #cjd4 ,sunset dates4,sec4 #cje4 ,effective date4,sec4 #cjf4 ,savings clause4,,title ,,iv--,fees relating to biosimilar biological products,sec4 #dja4 ,short title2 finding4,sec4 #djb4 ,definitions4,sec4 #djc4 ,authority to assess and use biosimilar biological product fees4,sec4 #djd4 ,reauthorization2 reporting requirements4,sec4 #dje4 ,sunset dates4,sec4 #djf4 ,effective date4,sec4 #djg4 ,savings clause4,,title ,v--,improving regulation of drugs and biological products,sec4 #eja4 ,alternatives to animal testing4,sec4 #ejb4 ,safer disposal of opioids4,sec4 #ejc4 ,clarifications to exclusivity provisions for first interchangeable biosimilar biological products4,sec4 #ejd4 ,improvements to the ,purple ,book4,sec4 #eje4 ,therapeutic equivalence evaluations4,sec4 #ejf4 ,modernizing accelerated approval4,,title ,,vi--,other reauthorizations,sec4 #fja4 ,reauthorization of the critical path public-private partnership4,sec4 #fjb4 ,reauthorization of the best pharmaceuticals for children program4,sec4 #fjc4 ,reauthorization of the humanitarian device exemption incentive4,sec4 #fjd4 ,reauthorization of the pediatric device consortia program4,sec4 #fje4 ,reauthorization of provision pertaining to drugs containing single enantiomers4,sec4 #fjf4 ,reauthorization of orphan drug grants4,sec4 #fjg4 ,reauthorization of certain device inspections4,,title ,,vii--,enhancing ,,fda hiring authorities,sec4 #gja4 ,enhancing ,,fda hiring authority for scientific1 technical1 and professional personnel4,sec4 #gjb4 ,strategic workforce plan and report4,,title ,,viii--,advancing regulation of cosmetics1 dietary supplements1 and laboratory developed tests,subtitle ,a--,cosmetics,sec4 #hja4 ,short title4,sec4 #hjb4 ,amendments to cosmetic requirements4,sec4 #hjc4 ,enforcement and conforming amendments4,sec4 #hjd4 ,records inspection4,sec4 #hje4 ,talc-containing cosmetics4,sec4 #hjf4 ,,pfas in cosmetics4,sec4 #hjg4 ,funding4,subtitle ,b--,dietary supplements,sec4 #haa4 ,regulation of dietary supplements4,subtitle ,c--,in vitro clinical tests,sec4 #hba4 ,short title2 table of contents4,sec4 #hbb4 ,definitions4,sec4 #hbc4 ,regulation of in vitro clinical tests4,sec4 #hbd4 ,enforcement and other provisions4,sec4 #hbe4 ,transition4,sec4 #hbf4 ,emergency use authorization4,sec4 #hbg4 ,antimicrobial susceptibility tests4,sec4 #hbh4 ,combination products4,sec4 #hbi4 ,resources4,sec4 #hcj4 ,authorization of appropriations4,,title ,,ix--,other provisions,sec4 #ija4 ,facilities management4,sec4 #ijb4 ,annual report on inspections4,sec4 #ijc4 ,user fee program transparency and accountability4,sec4 #ijd4 ,,otc hearing aids final rule4,sec4 #ije4 ,enhance intra-agency coordination and public health assessment with regard to compliance activities4 ,i ,fees relating to drugs #aja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,prescription ,drug ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications1 including postmarket drug safety activities1 as set forth in the goals identified for purposes of part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #ajb4 ,definitions ,section #gce of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is amended-- 7#a7 in paragraph 7#a71 in the matter following subparagraph 7,b71 by striking an allergenic extract product1 or and inserting does not include an application with respect to an allergenic extract product licensed before ,october #a1 #bjbb1 does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the ,secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before ,october #a1 #bjbb1 does not include an application with respect to2 7#b7 in paragraph 7#c71 in the matter following subparagraph 7,c7-- 7,a7 by inserting licensed before ,october #a1 #bjbb1 a standardized allergenic extract product submitted pursuant to a notification to the applicant from the ,secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before ,october #a1 #bjbb1 after an allergenic extract product2 7,b7 by adding at the end the following3 ,if a written request to place a product in the discontinued section of either of the lists described in subparagraph 7,c7 is submitted to the ,secretary on behalf of an applicant1 and the request identifies the date the product is1 or will be1 withdrawn from sale1 then1 for purposes of assessing the prescription drug program fee under section #gcf7;a77#b71 the ,secretary shall consider such product to have been included in the discontinued section on the later of 7i7 the date such request was received1 or 7ii7 if the product will be withdrawn from sale on a future date1 such future date when the product is withdrawn from sale4 ,for purposes of subparagraph 7,c71 a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product1 whether or not the applicant has ordered recall of all previously distributed lots of the product1 except that a routine1 temporary interruption in supply shall not render a product withdrawn from sale42 and 7,c7 by adding at the end the following3 7#ab7 ,the term skin-test diagnostic product-- 7,a7 means a product-- 7i7 for prick1 scratch1 intradermal1 or subcutaneous administration2 7ii7 expected to produce a limited1 local reaction at the site of administration 7if positive71 rather than a systemic effect2 7iii7 not intended to be a preventive or therapeutic intervention2 and 7iv7 intended to detect an immediate or delayed-type skin hypersensitivity reaction to aid in the diagnosis of-- 7,i7 an allergy to an antimicrobial agent2 7,,ii7 an allergy that is not to an antimicrobial agent1 if the diagnostic product was authorized for marketing prior to ,october #a1 #bjbb2 or 7,,iii7 infection with fungal or mycobacterial pathogens2 and 7,b7 includes positive and negative controls required to interpret the results of a product described in subparagraph 7,a74 4 #ajc4 ,authority to assess and use drug fees 7a7 ,types of fees ,section #gcf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking #bjah and inserting #bjbc2 7#b7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 by striking subsection 7c77#e7 each place it appears and inserting subsection 7c77#f72 7,b7 in subparagraph 7,c71 by inserting prior to approval after or was withdrawn2 and 7,c7 by adding at the end the following3 7,h7 ,exception for skin-test diagnostic products ,a human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph 7,a74 2 and 7#c7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking subsection 7c77#e7 and inserting subsection 7c77#f72 7ii7 by striking ,except as provided and inserting the following3 7i7 ,payment of fees ,except as provided 2 and 7iii7 by adding at the end the following3 7ii7 ,previously discontinued drug products ,if a drug product that is identified in a human drug application approved as of ,october #a of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list identified in section #gce7c71 and on any subsequent day during such fiscal year the drug product is a prescription drug product1 then except as provided in subparagraphs 7,b7 and 7,c71 each person who is named as the applicant in a human drug application with respect to such product1 and who1 after ,september #a1 #aiib1 had pending before the ,secretary a human drug application or supplement1 shall pay the annual prescription drug program fee established for a fiscal year under subsection 7c77#f7 for such prescription drug product4 ,such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for a fiscal year in which the fee is payable4 2 and 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,exception for certain prescription drug products ,a prescription drug program fee shall not be assessed for a prescription drug product under subparagraph 7,a7 if such product is-- 7i7 a large volume parenteral product 7a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to #ajj m,l1 not including powders for reconstitution or pharmacy bulk packages7 identified on the list compiled under section #eje7;j77#g72 7ii7 pharmaceutically equivalent 7as defined in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations771 to another product on the list of products compiled under section #eje7;j77#g7 7not including the discontinued section of such list72 or 7iii7 a skin-test diagnostic product4 4 7b7 ,fee revenue amounts ,section #gcf7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7,b7 by redesignating subparagraphs 7,c7 through 7,f7 as subparagraphs 7,d7 through 7,g71 respectively2 7,c7 by inserting after subparagraph 7,b7 the following3 7,c7 ,the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year 7as determined under subsection 7c77#b772 2 7,d7 in subparagraph 7,d71 as so redesignated1 by striking 7c77#b7 and inserting 7c77#c72 7,e7 in subparagraph 7,e71 as so redesignated1 by striking 7c77#c7 and inserting 7c77#d72 7,f7 in subparagraph 7,f71 as so redesignated1 by striking 7c77#d7 and inserting 7c77#e72 and 7,g7 in subparagraph 7,g71 as so redesignated1 by striking clauses 7i7 through 7v7 and inserting the following3 7i7 #fe1ggc1fic for fiscal year #bjbc4 7ii7 #be1jig1fga for fiscal year #bjbd4 7iii7 #ad1aed1afi for fiscal year #bjbe4 7iv7 #d1hfd1hfj for fiscal year #bjbf4 7v7 #a1cad1fbj for fiscal year #bjbg4 2 and 7#b7 in paragraph 7#c7-- 7,a7 in subparagraph 7,a71 by striking #bjah1 #hgh1eij1jjj and inserting #bjbc1 #a1aea1ebb1ieh2 and 7,b7 in subparagraph 7,b7-- 7i7 by striking #bjai through #bjbb and inserting #bjbd through #bjbg2 and 7ii7 by striking subsection 7c77#c7 or 7c77#d7 and inserting subsection 7c77#d7 or 7c77#e74 7c7 ,adjustments2 annual fee setting ,section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended-- 7#a7 in paragraph 7#a77;,b77ii71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 7#b7 by redesignating paragraphs 7#b7 through 7#f7 as paragraphs 7#c7 through 7#g71 respectively2 7#c7 by inserting after paragraph 7#a7 the following3 7#b7 ,strategic hiring and retention adjustment ,for each fiscal year1 after the annual base revenue established in subsection 7b77#a77;,a7 is adjusted for inflation in accordance with paragraph 7#a71 the ,secretary shall further increase the fee revenue and fees-- 7,a7 for fiscal year #bjbc1 by #i1jjj1jjj2 and 7,b7 for fiscal year #bjbd and each subsequent fiscal year1 by #d1jjj1jjj4 2 7#d7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraph 7,a7-- 7i7 by striking for inflation2 and 7ii7 by striking paragraph 7#a7 and inserting paragraphs 7#a7 and 7#b72 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,methodology ,for purposes of this paragraph1 the ,secretary shall employ the capacity planning methodology utilized by the ,secretary in setting fees for fiscal year #bjba1 as described in the notice titled ,prescription ,drug ,user ,fee ,rates for ,fiscal ,year #bjba 7#he ,fed4 ,reg4 #dffea2 ,august #c1 #bjbj74 ,the workload categories used in forecasting shall include only the activities described in such notice and1 as feasible1 additional activities that are directly related to the direct review of applications and supplements1 including additional formal meeting types1 the direct review of postmarketing commitments and requirements1 the direct review of risk evaluation and mitigation strategies1 and the direct review of annual reports for approved prescription drug products4 ,subject to the exceptions in the preceding sentence1 the ,secretary shall not include as workload categories in forecasting any non-core review activities1 including any activities that the ,secretary referenced for potential future use in such notice but did not utilize in the setting fees for fiscal year #bjba4 2 7,c7 by striking subparagraph 7,c72 7,d7 by redesignating subparagraphs 7,d7 and 7,e7 as subparagraphs 7,c7 and 7,d71 respectively2 7,e7 in subparagraph 7,c71 as so redesignated-- 7i7 by striking year7 and and inserting year712 and 7ii7 by inserting 1 and subsection 7b77#a77;,c7 7the dollar amount of the strategic hiring and retention adjustment742 and 7,f7 in subparagraph 7,d71 as so redesignated1 by striking paragraph 7#e7 and inserting paragraph 7#f72 7#e7 in paragraph 7#d71 as so redesignated-- 7,a7 by amending subparagraph 7,a7 to read as follows3 7,a7 ,increase ,for fiscal year #bjbc and subsequent fiscal years1 the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees if such an adjustment is necessary to provide for at least the following amounts of operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year1 as follows3 7i7 ,for fiscal year #bjbc1 at least #h weeks of operating reserves4 7ii7 ,for fiscal year #bjbd1 at least #i weeks of operating reserves4 7iii7 ,for fiscal year #bjbe and subsequent fiscal years1 at least #aj weeks of operating reserves4 2 and 7,b7 in subparagraph 7,c71 by striking paragraph 7#e7 and inserting paragraph 7#f72 7#f7 by amending paragraph 7#e71 as so redesignated1 to read as follows3 7#e7 ,additional direct cost adjustment ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 7#c71 and 7#d71 further increase the fee revenue and fees-- 7,a7 for fiscal year #bjbc1 by #dd1chf1aej2 and 7,b7 for fiscal years #bjbd through #bjbg1 by the amount set forth in clauses 7i7 through 7iv71 as applicable1 multiplied by the ,consumer ,price ,index for urban consumers 7,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 ,not ,seasonally ,adjusted2 ,all ,items2 ,annual ,index7 for the most recent year of available data1 divided by such ,index for #bjba-- 7i7 for fiscal year #bjbd1 #fj1ifg1iic2 7ii7 for fiscal year #bjbe1 #ce1gii1cad2 7iii7 for fiscal year #bjbf1 #ce1gii1cad2 and 7iv7 for fiscal year #bjbg1 #ce1gii1cad4 2 and 7#g7 in paragraph 7#f71 as so redesignated1 by striking #bjag and inserting #bjbb4 7d7 ,crediting and availability of fees ,section #gcf7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7e7 ,written requests for waivers1 reductions1 and refunds ,section #gcf7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7i77 is amended to read as follows3 7i7 ,written requests for waivers1 reductions1 exemptions1 and returns2 disputes concerning fees ,to qualify for consideration for a waiver or reduction under subsection 7d71 an exemption under subsection 7k71 or the return of any fee paid under this section1 including if the fee is claimed to have been paid in error1 a person shall submit to the ,secretary a written request justifying such waiver1 reduction1 exemption1 or return not later than #ahj days after such fee is due4 ,a request submitted under this paragraph shall include any legal authorities under which the request is made4 4 7f7 ,orphan drugs ,section #gcf7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is amended-- 7#a7 in paragraph 7#a77;,b71 by striking during the previous year and inserting 1 as determined under paragraph 7#b72 and 7#b7 in paragraph 7#b71 by striking that its gross annual revenues and all that follows through the period at the end and inserting supported by tax returns submitted to the ,internal ,revenue ,service1 or1 as necessary1 by other appropriate financial information1 that its gross annual revenues did not exceed #ej1jjj1jjj for the last calendar year ending prior to the fiscal year for which the exemption is requested44 #ajd4 ,reauthorization2 reporting requirement ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is amended-- 7#a7 by striking #bjah each place it appears and inserting #bjbc2 7#b7 by striking ,prescription ,drug ,user ,fee ,amendments of #bjag each place it appears and inserting ,prescription ,drug ,user ,fee ,amendments of #bjbb2 7#c7 in subsection 7a77#d71 by striking #bjbj and inserting #bjbc2 and 7#d7 in subsection 7f71 by striking #bjbb each place it appears and inserting #bjbg4 #aje4 ,sunset dates 7a7 ,authorization ,sections #gce and #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #ajd of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #ajf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq47 shall be assessed for all human drug applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #ajg4 ,savings clause ,notwithstanding the amendments made by this title1 part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to human drug applications and supplements 7as defined in such part as of such day7 that were accepted by the ,food and ,drug ,administration for filing on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,ii ,fees relating to devices #bja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,medical ,device ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices1 as set forth in the goals identified for purposes of part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #bjb4 ,definitions ,section #gcg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is amended-- 7#a7 in paragraph 7#i7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking and premarket notification submissions and inserting premarket notification submissions1 and de novo classification requests2 7,b7 in subparagraph 7,d71 by striking and submissions and inserting submissions1 and de novo classification requests2 7,c7 in subparagraph 7,f71 by striking and premarket notification submissions and inserting premarket notification submissions1 and de novo classification requests2 7,d7 in subparagraphs 7,g7 and 7,h71 by striking or submissions each place it appears and inserting submissions1 or requests2 and 7,e7 in subparagraph 7,k71 by striking or premarket notification submissions and inserting premarket notification submissions1 or de novo classification requests2 and 7#b7 in paragraph 7#aa71 by striking #bjaf and inserting #bjba4 #bjc4 ,authority to assess and use device fees 7a7 ,types of fees ,section #gch7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjah and inserting #bjbc2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking #bjag and inserting #bjbb2 7ii7 in clause 7iii71 by striking #ge percent and inserting #hj percent2 and 7iii7 in clause 7viii71 by striking #c4d percent and inserting #d4e percent2 7,b7 in subparagraph 7,b77iii71 by striking or premarket notification submission and inserting premarket notification submission1 or de novo classification request2 and 7,c7 in subparagraph 7,c71 by striking or periodic reporting concerning a class ,,iii device and inserting periodic reporting concerning a class ,,iii device1 or de novo classification request4 7b7 ,fee amounts ,section #gch7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#b7 by amending the table in paragraph 7#b7 to read as follows3 ,fee ,type,fiscal ,year #bjbc;,fiscal ,year #bjbd;,fiscal ,year #bjbe;,fiscal ,year #bjbf;,fiscal ,year #bjbg,premarket ,application#dbe1jjjdce1jjjdde1jjjdee1jj jdgj1jjj;,establishment ,registration#f1bejf1hgeg1ajjg1egeh1dfe 2 and 7#c7 in paragraph 7#c71 by amending subparagraphs 7,a7 through 7,e7 to read as follows3 7,a7 #cab1fjf1jjj for fiscal year #bjbc4 7,b7 #cce1gej1jjj for fiscal year #bjbd4 7,c7 #cej1gdf1djj for fiscal year #bjbe4 7,d7 #cff1dhf1cjj for fiscal year #bjbf4 7,e7 #dah1cdc1jjj for fiscal year #bjbg4 4 7c7 ,annual fee setting2 adjustments ,section #gch7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7c77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjag and inserting #bjbb2 7#b7 in paragraph 7#b7-- 7,a7 by striking #bjah each place it appears and inserting #bjbc2 7,b7 in subparagraph 7,b77ii71 by striking #bjaf and inserting #bjbb2 7,c7 in subparagraph 7,c77i77,,ii71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 and 7,d7 in subparagraph 7,d71 by striking #bjbb and inserting #bjbg2 7#c7 in paragraph 7#c71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#d7 by redesignating paragraphs 7#d7 and 7#e7 as paragraphs 7#g7 and 7#h71 respectively2 and 7#e7 by inserting after paragraph 7#c7 the following3 7#d7 ,performance improvement adjustment 7,a7 ,in general ,for each of fiscal years #bjbe through #bjbg1 after the adjustment under paragraph 7#c71 the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the ,secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb1 as the ,secretary determines necessary to achieve an increase in total fee collections for such fiscal year1 equal to the following amounts1 as applicable3 7i7 ,for fiscal year #bjbe1 the product of-- 7,i7 the amount determined under subparagraph 7,b77i77,i72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7ii7 ,for fiscal year #bjbf1 the product of-- 7,i7 the sum of the amounts determined under subparagraphs 7,b77i77,,ii71 7,b77ii77,i71 and 7,b77iii77,i72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7iii7 ,for fiscal year #bjbg1 the product of-- 7,i7 the sum of the amounts determined under subparagraphs 7,b77i77,,iii71 7,b77ii77,,ii71 and 7,b77iii77,,ii72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7,b7 ,amounts 7i7 ,presubmission amount ,for purposes of subparagraph 7,a71 with respect to the presubmission written feedback goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbe1 #ae1cif1fjj if the goal for fiscal year #bjbc is met4 7,,ii7 ,for fiscal year #bjbf-- 7aa7 #ae1cif1fjj if the goal for fiscal year #bjbc is met and the goal for fiscal year #bjbd is missed2 or 7bb7 #cf1gib1bjj if the goal for fiscal year #bjbd is met4 7,,iii7 ,for fiscal year #bjbg-- 7aa7 #ae1cif1fjj if the goal for fiscal year #bjbc is met and the goal for each of fiscal years #bjbd and #bjbe is missed2 7bb7 #cf1gib1bjj if the goal for fiscal year #bjbd is met and the goal for fiscal year #bjbe is missed2 or 7cc7 #dj1egb1fjj if the goal for fiscal year #bjbe is met4 7ii7 ,de novo classification request amount ,for purposes of subparagraph 7,a71 with respect to the de novo decision goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbf1 #f1cbc1ejj if the goal for fiscal year #bjbc is met4 7,,ii7 ,for fiscal year #bjbg-- 7aa7 #f1cbc1ejj if the goal for fiscal year #bjbc is met and the goal for fiscal year #bjbd is missed2 or 7bb7 #aa1gfe1djj if the goal for fiscal year #bjbd is met4 7iii7 ,premarket notification and premarket approval amount ,for purposes of subparagraph 7,a71 with respect to the #eaj7k7 decision goal1 #eaj7k7 shared outcome total time to decision goal1 ,,pma decision goal1 and ,,pma shared outcome total time to decision goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbf1 #a1jbj1jjj if the #d goals for fiscal year #bjbc are met4 7,,ii7 ,for fiscal year #bjbg-- 7aa7 #a1jbj1jjj if the #d goals for fiscal year #bjbc are met and one or more of the #d goals for fiscal year #bjbd is missed2 or 7bb7 #c1ijf1jjj if the #d goals for fiscal year #bjbd are met4 7,c7 ,performance calculation ,for purposes of this paragraph1 performance of the following goals shall be determined as specified in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb and based on data available as of the applicable dates as follows3 7i7 ,the performance of the presubmission written feedback goal-- 7,i7 for fiscal year #bjbc1 shall be based on data available as of ,march #ca1 #bjbd2 7,,ii7 for fiscal year #bjbd1 shall be based on data available as of ,march #ca1 #bjbe2 and 7,,iii7 for fiscal year #bjbe1 shall be based on data available as of ,march #ca1 #bjbf4 7ii7 ,the performance of the de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 shared outcome total time to decision goal1 ,,pma decision goal1 and ,,pma shared outcome total time to decision goal-- 7,i7 for fiscal year #bjbc1 shall be based on data available as of ,march #ca1 #bjbe2 and 7,,ii7 for fiscal year #bjbd1 shall be based on data available as of ,march #ca1 #bjbf4 7,d7 ,definitions ,for purposes of this paragraph1 the terms presubmission written feedback goal1 de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 shared outcome total time to decision goal1 ,,pma decision goal1 and ,,pma shared outcome total time to decision goal have the meanings given such terms in the goals identified in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb4 7#e7 ,hiring adjustment 7,a7 ,in general ,for each of fiscal years #bjbe through #bjbg1 after the adjustments under paragraphs 7#c7 and 7#d71 if applicable1 the base establishment registration fee amounts shall be decreased as the ,secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph 7,b71 if the number of hires to support the process for the review of device applications falls below the following thresholds for the applicable fiscal years3 7i7 ,for fiscal year #bjbe1 #he percent of the hiring goal specified in subparagraph 7,c7 for fiscal year #bjbc4 7ii7 ,for fiscal year #bjbf1 #ij percent of the hiring goal specified in subparagraph 7,c7 for fiscal year #bjbd4 7iii7 ,for fiscal year #bjbg1 #ij percent of the hiring goal specified in subparagraph 7,c7 for fiscal year #bjbe4 7,b7 ,hiring adjustment amount ,the hiring adjustment amount for fiscal year #bjbe and each subsequent fiscal year is the product of-- 7i7 the number of hires by which the hiring goal specified in subparagraph 7,c7 for the fiscal year before the prior fiscal year was missed2 7ii7 #gb1hgg2 and 7iii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for the fiscal year for which the hiring goal was missed4 7,c7 ,hiring goals 7i7 ,in general ,for purposes of subparagraph 7,b71 the hiring goals for each of fiscal years #bjbc through #bjbe are as follows3 7,i7 ,for fiscal year #bjbc1 #add hires4 7,,ii7 ,for fiscal year #bjbd1 #db hires4 7,,iii7 ,for fiscal year #bjbe-- 7aa7 #bd hires if the base establishment registration fees are not increased by the amount determined under paragraph 7#d77;,a77i72 or 7bb7 #hc hires if the base establishment registration fees are increased by the amount determined under paragraph 7#d77;,a77i74 7ii7 ,number of hires ,for purposes of this paragraph1 the number of hires for a fiscal year shall be determined by the ,secretary1 as set forth in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb4 7#f7 ,operating reserve adjustment 7,a7 ,in general ,for each of fiscal years #bjbc through #bjbg1 after the adjustments under paragraphs 7#c71 7#d71 and 7#e71 if applicable1 if the ,secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph 7,b71 the ,secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves4 7,b7 ,designated amount ,subject to subparagraph 7,c71 for each fiscal year1 the designated amount in this subparagraph is equal to the sum of-- 7i7 #ac weeks of operating reserves of carryover user fees2 and 7ii7 the #a month of operating reserves described in paragraph 7#h74 7,c7 ,excluded amount ,for the period of fiscal years #bjbc through #bjbf1 a total amount equal to #aah1jjj1jjj shall not be considered part of the designated amount under subparagraph 7,b7 and shall not be subject to the decrease under subparagraph 7,a74 4 7d7 ,small businesses ,section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended-- 7#a7 in subsection 7d77#b77;,b77iii71 by inserting 1 if extant1 after national taxing authority2 and 7#b7 in subsection 7e77#b77;,b77iii71 by inserting 1 if extant1 after national taxing authority4 7e7 ,conditions ,section #gch7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77 is amended-- 7#a7 in paragraph 7#a77;,a71 by striking #cbj1hbe1jjj and inserting #cih1eff1jjj2 and 7#b7 in paragraph 7#b71 by inserting de novo classification requests1 after class ,,iii device14 7f7 ,authorization of appropriations ,section #gch7;h77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77#c77 is amended to read as follows3 7#c7 ,authorization of appropriations 7,a7 ,in general ,for each of the fiscal years #bjbc through #bjbg1 there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined in subparagraph 7,b71 less the amount of reductions determined in subparagraph 7,c74 7,b7 ,revenue amount ,for purposes of this paragraph1 the revenue amount for each fiscal year is the sum of-- 7i7 the total revenue amount under subsection 7b77#c7 for the fiscal year1 as adjusted under subsection 7c77#b72 and 7ii7 the performance improvement adjustment amount for the fiscal year under subsection 7c77#d77;,a71 if applicable4 7,c7 ,amount of reductions ,for purposes of this paragraph1 the amount of reductions for each fiscal year is the sum of-- 7i7 the hiring adjustment amount for the fiscal year under subsection 7c77#e71 if applicable2 and 7ii7 the operating reserve adjustment amount for the fiscal year under subsection 7c77#f71 if applicable4 4 #bjd4 ,accreditation programs 7a7 ,accreditation scheme for conformity assessment ,section #ead7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is amended-- 7#a7 in the subsection heading1 by striking ,pilot2 7#b7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking pilot2 7,b7 in subparagraph 7,a7-- 7i7 by inserting meeting criteria specified by the ,secretary in guidance after testing laboratories2 7ii7 by inserting in guidance after by the ,secretary2 and 7iii7 by striking assess the conformance of a device with and inserting conduct testing to support the assessment of the conformance of a device to2 and 7,c7 in subparagraph 7,b7-- 7i7 by striking determinations and inserting results2 7ii7 by inserting to support after so accredited2 and 7iii7 by striking a particular such determination and inserting particular such results2 7#c7 in paragraph 7#b7-- 7,a7 in the paragraph heading1 by striking determinations and inserting results2 7,b7 in subparagraph 7,a7-- 7i7 by striking determinations by testing laboratories and all that follows through such determinations or and inserting results by testing laboratories accredited pursuant to this subsection1 including by conducting periodic audits of such results or of the2 7ii7 by inserting a comma after or testing laboratories2 7iii7 by inserting or recognition of an accreditation body after accreditation of such testing laboratory2 and 7iv7 by striking such device and inserting a device2 and 7,c7 in subparagraph 7,b7-- 7i7 by striking by a testing laboratory so accredited and inserting under this subsection2 and 7ii7 by inserting or recognition of an accreditation body before under paragraph 7#a77;,a72 7#d7 in paragraph 7#c77;,c7-- 7,a7 in the subparagraph heading1 by inserting and transition after initiation2 and 7,b7 by adding at the end the following3 ,after ,september #cj1 #bjbc1 such pilot program will be considered to be completed1 and the ,secretary shall have the authority to continue operating a program consistent with this subsection42 and 7#e7 by striking paragraph 7#d74 7b7 ,accredited persons ,section #ebc7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7c77 is amended by striking #bjbb and inserting #bjbg4 #bje4 ,sunset dates 7a7 ,authorization ,sections #gcg and #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;fj7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gch;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #baj of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #bjf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq47 shall be assessed for all submissions listed in section #gch7;a77#b77;,a7 of such ,act received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #bjg4 ,savings clause ,notwithstanding the amendments made by this title1 part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to the submissions listed in section #gch7;a77#b77;,a7 of such ,act 7as defined in such part as of such day7 that on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 were received by the ,food and ,drug ,administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,iii ,fees relating to generic drugs #cja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,generic ,drug ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities1 as set forth in the goals identified for purposes of part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #cjb4 ,authority to assess and use human generic drug fees 7a7 ,types of fees ,section #gdd;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking #bjah and inserting #bjbc2 7#b7 in paragraph 7#b77;,c71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg2 7#c7 in paragraph 7#c77;,b71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg2 7#d7 in paragraph 7#d77;,d71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg2 and 7#e7 in paragraph 7#e77;,d71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg4 7b7 ,fee revenue amounts ,section #gdd;,b7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in the heading1 by striking #bjah and inserting #bjbc2 7ii7 by striking #bjah and inserting #bjbc2 and 7iii7 by striking #dic1fjj1jjj and inserting #ehb1ejj1jjj2 and 7,b7 in subparagraph 7,b7-- 7i7 in the heading1 by striking #bjai through #bjbb and inserting #bjbd through #bjbg2 7ii7 by striking ,for each and inserting the following3 7i7 ,in general ,for each 2 7iii7 by striking #bjai through #bjbb and inserting #bjbd through #bjbg2 7iv7 by striking #dic1fjj1jjj and inserting the base revenue amount under clause 7ii72 and 7v7 by adding at the end the following3 7ii7 ,base revenue amount ,the base revenue amount for a fiscal year is the total revenue amount established under this paragraph for the previous fiscal year1 not including any adjustments made for such previous fiscal year under subsection 7c77#c74 2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,c71 by striking one-third the amount and inserting #bd percent2 7,b7 in subparagraph 7,d71 by striking ,seven and inserting ,six2 and 7,c7 in subparagraph 7,e77i71 by striking ,thirty-five and inserting ,thirty-six4 7c7 ,adjustments ,section #gdd;,b7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking #bjai and inserting #bjbd2 and 7ii7 by striking the product of the total revenues established in such notice for the prior fiscal year and inserting the base revenue amount for the fiscal year determined under subsection 7b77#a77;,b77ii72 and 7,b7 in subparagraph 7,c71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 and 7#b7 by striking paragraph 7#b7 and inserting the following3 7#b7 ,capacity planning adjustment 7,a7 ,in general ,beginning with fiscal year #bjbd1 the ,secretary shall1 in addition to the adjustment under paragraph 7#a71 further increase the fee revenue and fees under this section for a fiscal year1 in accordance with this paragraph1 to reflect changes in the resource capacity needs of the ,secretary for human generic drug activities4 7,b7 ,capacity planning methodology ,the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7i7 be derived from the methodology and recommendations made in the report titled ,independent ,evaluation of the ,,gdufa ,resource ,capacity ,planning ,adjustment ,methodology3 ,evaluation and ,recommendations as announced in the ,federal ,register on ,august #c1 #bjbj 7#he ,fed4 ,reg4 #dffeh72 and 7ii7 incorporate approaches and attributes determined appropriate by the ,secretary1 including those made in such report recommendations1 except the workload categories used in forecasting resources shall only be those specified in section ,,viii4,b4#b4;e4 of the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjbb4 7,c7 ,limitations 7i7 ,in general ,under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection 7b77#a77;,b77ii7 7the base revenue amount for the fiscal year7 and paragraph 7#a7 7the dollar amount of the inflation adjustment for the fiscal year74 7ii7 ,additional limitation ,an adjustment under this paragraph shall not exceed #c percent of the sum described in clause 7i7 for the fiscal year1 except that such limitation shall be #d percent if-- 7,i7 for purposes of an adjustment for fiscal year #bjbd1 the ,secretary determines that1 during the period from ,april #a1 #bjba1 through ,march #ca1 #bjbc-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1jjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as that term is defined in section ,,xi of the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjbb72 7,,ii7 for purposes of an adjustment for fiscal year #bjbe1 the ,secretary determines that1 during the period from ,april #a1 #bjbb1 through ,march #ca1 #bjbd-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined72 7,,iii7 for purposes of an adjustment for fiscal year #bjbf1 the ,secretary determines that1 during the period from ,april #a1 #bjbc1 through ,march #ca1 #bjbe-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined72 and 7,,iv7 for purposes of an adjustment for fiscal year #bjbg1 the ,secretary determines that1 during the period from ,april #a1 #bjbd1 through ,march #ca1 #bjbf-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined74 7,d7 ,publication in federal register ,the ,secretary shall publish in the ,federal ,register notice under subsection 7a71 the fee revenue and fees resulting from the adjustment and the methodology under this paragraph4 7#c7 ,operating reserve adjustment 7,a7 ,in general ,for fiscal year #bjbd and subsequent fiscal years1 the ,secretary may1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees under this section if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph 7,b74 7,b7 ,number of weeks ,the number of weeks specified in this subparagraph is-- 7i7 #h weeks for fiscal year #bjbd2 7ii7 #i weeks for fiscal year #bjbe2 and 7iii7 #aj weeks for each of fiscal year #bjbf and #bjbg4 7,c7 ,decrease ,if the ,secretary has carryover balances for human generic drug activities in excess of #ab weeks of the operating reserves referred to in subparagraph 7,a71 the ,secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than #ab weeks of such operating reserves4 7,d7 ,rationale for adjustment ,if an adjustment under this paragraph is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under subsection 7a7 publishing the fee revenue and fees for the fiscal year involved4 4 7d7 ,annual fee setting ,section #gdd;,b7d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77#a77 is amended-- 7#a7 in the heading1 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#b7 by striking more and inserting later2 and 7#c7 by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7e7 ,effect of failure ,to pay fees ,the heading of paragraph 7#c7 of section #gdd;,b7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is amended by striking and prior approval supplement fee4 7f7 ,crediting and availability of fees ,section #gdd;,b7i77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77#c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #cjc4 ,reauthorization2 reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking #bjah each place it appears and inserting #bjbc2 and 7,b7 by striking ,generic ,drug ,user ,fee ,amendments of #bjag each place it appears and inserting ,generic ,drug ,user ,fee ,amendments of #bjbb2 7#b7 in subsection 7b71 by striking #bjah and inserting #bjbc2 7#c7 in subsection 7c7-- 7,a7 by striking #bjah and inserting #bjbc2 and 7,b7 by striking ,generic ,drug ,user ,fee ,amendments of #bjag each place it appears and inserting ,generic ,drug ,user ,fee ,amendments of #bjbb2 and 7#d7 in subsection 7f7-- 7,a7 in paragraph 7#a71 by striking #bjbb and inserting #bjbg2 and 7,b7 in paragraph 7#e71 by striking ,january #ae1 #bjbb and inserting ,january #ae1 #bjbg4 #cjd4 ,sunset dates 7a7 ,authorization ,sections #gdd;,a and #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #cje of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #cje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be assessed for all abbreviated new drug applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #cjf4 ,savings clause ,notwithstanding the amendments made by this title1 part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to abbreviated new drug applications 7as defined in such part as of such day7 that were received by the ,food and ,drug ,administration within the meaning of section #eje7;j77#e77;,a7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,a771 prior approval supplements that were submitted1 and drug master files for ,type ,,ii active pharmaceutical ingredients that were first referenced on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,iv ,fees relating to biosimilar biological products #dja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,biosimilar ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications1 including postmarket safety activities1 as set forth in the goals identified for purposes of part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #djb4 ,definitions ,section #gdd;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 7,b7 by striking ,october of and inserting ,september of2 and 7,c7 by striking ,october #bjaa and inserting ,september #bjaa2 and 7#b7 in paragraph 7#d77;,b77iii7-- 7,a7 by striking subclause 7,,ii72 and 7,b7 by redesignating subclauses 7,,iii7 and 7,,iv7 as subclauses 7,,ii7 and 7,,iii71 respectively4 #djc4 ,authority to assess and use biosimilar biological product fees 7a7 ,types of fees ,section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking #bjah and inserting #bjbc2 7#b7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7iv77,i71 by striking #e days and inserting #g days2 and 7ii7 in clause 7v77,,ii71 by striking #e days and inserting #g days2 7,b7 in subparagraph 7,b7-- 7i7 in clause 7i71 by inserting except that1 in the case that such product 7including1 where applicable1 ownership of the relevant investigational new drug application7 is transferred to a licensee1 assignee1 or successor of such person1 and written notice of such transfer is provided to the ,secretary1 such licensee1 assignee or successor shall pay the annual biosimilar biological product development fee before the period2 7ii7 in clause 7iii7-- 7,i7 in subclause 7,i71 by striking 2 or and inserting a semicolon2 7,,ii7 in subclause 7,,ii71 by striking the period and inserting 2 or2 and 7,,iii7 by adding at the end the following3 7,,iii7 been administratively removed from the biosimilar biological product development program for the product under subparagraph 7,e77v74 2 and 7iii7 in clause 7iv71 by striking accepted for filing on or after ,october #a of such fiscal year and inserting subsequently accepted for filing2 7,c7 in subparagraph 7,d7-- 7i7 in clause 7i7-- 7,i7 in the matter preceding subclause 7,i71 by striking shall1 if the person seeks to resume participation in such program1 pay and inserting or who has been administratively removed from such program for a product under subparagraph 7,e77v7 shall1 if the person seeks to resume participation in such program1 pay all annual biosimilar biological product development fees previously assessed for such product and still owed and2 7,,ii7 in subclause 7,i7-- 7aa7 by striking #e days and inserting #g days2 and 7bb7 by inserting or the date of administrative removal1 as applicable after discontinued2 and 7,,iii7 in subclause 7,,ii71 by inserting or the date of administrative removal1 as applicable after discontinued2 and 7ii7 in clause 7ii71 by inserting except that1 in the case that such product 7including1 where applicable1 ownership of the relevant investigational new drug application7 is transferred to a licensee1 assignee1 or successor of such person1 and written notice of such transfer is provided to the ,secretary1 such licensee1 assignee or successor shall pay the annual biosimilar biological product development fee before the period at the end2 and 7,d7 in subparagraph 7,e71 by adding at the end the following3 7v7 ,administrative removal from the biosimilar biological product development program ,if a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph 7,b7 for a period of #b consecutive fiscal years1 the ,secretary may administratively remove such person from the biosimilar biological product development program for the product4 ,at least #cj days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause1 the ,secretary shall provide written notice to such person of the intended administrative removal4 2 7#c7 in paragraph 7#b77;,d71 by inserting prior to approval after withdrawn2 7#d7 in paragraph 7#c7-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7i71 by striking 2 and and inserting a semicolon2 7ii7 by redesignating clause 7ii7 as clause 7iii72 and 7iii7 by inserting the following after clause 7i73 7ii7 may be dispensed only under prescription pursuant to section #ejc7;b72 and 2 and 7,b7 by adding at the end the following3 7,e7 ,movement to discontinued list 7i7 ,written request to place on discontinued list 7,i7 ,in general ,if a written request to place a product on the list of discontinued biosimilar biological products referred to in subparagraph 7,a77iii7 is submitted to the ,secretary on behalf of an applicant1 and the request identifies the date the product is1 or will be1 withdrawn from sale1 then for purposes of assessing the biosimilar biological product program fee1 the ,secretary shall consider such product to have been included on such list on the later of-- 7aa7 the date such request was received2 or 7bb7 if the product will be withdrawn from sale on a future date1 such future date when the product is withdrawn from sale4 7,,ii7 ,withdrawn from sale defined ,for purposes of this clause1 a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product1 whether or not the applicant has ordered recall of all previously distributed lots of the product1 except that a routine1 temporary interruption in supply shall not render a product withdrawn from sale4 7ii7 ,products removed from discontinued list ,if a biosimilar biological product that is identified in a biosimilar biological product application approved as of ,october #a of a fiscal year appears1 as of ,october #a of such fiscal year1 on the list of discontinued biosimilar biological products referred to in subparagraph 7,a77iii71 and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list1 except as provided in subparagraph 7,d71 each person who is named as the applicant in the biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection 7c77#e7 for such biosimilar biological product4 ,notwithstanding subparagraph 7,b71 such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for each fiscal year4 2 and 7#e7 by striking paragraph 7#d74 7b7 ,fee revenue amounts ,section #gdd;,h7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;b77 is amended-- 7#a7 by striking paragraph 7#a72 7#b7 by redesignating paragraphs 7#b7 through 7#d7 as paragraphs 7#a7 through 7#c71 respectively2 7#c7 in paragraph 7#a71 as so redesignated-- 7,a7 in the paragraph heading1 by striking ,subsequent fiscal years and inserting ,in general2 7,b7 in the matter preceding subparagraph 7,a71 by striking #bjai through #bjbb and inserting #bjbc through #bjbg2 7,c7 in subparagraph 7,a71 by striking paragraph 7#d7 and inserting paragraph 7#c72 7,d7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,d7 and 7,e71 respectively2 7,e7 by inserting after subparagraph 7,b7 the following3 7,c7 the dollar amount equal to the strategic hiring and retention adjustment 7as determined under subsection 7c77#b772 2 7,f7 in subparagraph 7,d71 as so redesignated1 by striking subsection 7c77#b772 and and inserting subsection 7c77#c7722 7,g7 in subparagraph 7,e71 as so redesignated1 by striking subsection 7c77#c774 and inserting subsection 7c77#d772 and2 and 7,h7 by adding at the end the following3 7,f7 for fiscal years #bjbc and #bjbd1 additional dollar amounts equal to-- 7i7 #d1dbh1 #hhf for fiscal year #bjbc2 and 7ii7 #cbj1efi for fiscal year #bjbd4 2 7#d7 in paragraph 7#b71 as so redesignated-- 7,a7 in the paragraph heading1 by striking 2 limitations on fee amounts2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating subaparagraphs 7,c7 and 7,d7 as subparagraphs 7,b7 and 7,c71 respectively2 and 7#e7 by amending paragraph 7#c71 as so redesignated1 to read as follows3 7#c7 ,annual base revenue ,for purposes of paragraph 7#a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjbc1 #dc1cgf1ibb2 and 7,b7 for fiscal years #bjbd through #bjbg1 the dollar amount of the total revenue amount established under paragraph 7#a7 for the previous fiscal year1 excluding any adjustments to such revenue amount under subsection 7c77#d74 4 7c7 ,adjustments2 annual fee setting ,section #gdd;,h7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;c77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking subsection 7b77#b77;,b7 and inserting subsection 7b77#a77;,b72 and 7ii7 in clause 7i71 by striking subsection 7b7 and inserting subsection 7b77#a77;,a72 and 7,b7 in subparagraph 7,b77ii71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 7#b7 by striking paragraph 7#d72 7#c7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#c7 and 7#d71 respectively2 7#d7 by inserting after paragraph 7#a7 the following3 7#b7 ,strategic hiring and retention adjustment ,for each fiscal year beginning in fiscal year #bjbc1 after the annual base revenue under subsection 7b77#a77;,a7 is adjusted for inflation in accordance with paragraph 7#a71 the ,secretary shall further increase the fee revenue and fees by #aej1jjj4 2 7#e7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraph 7,a7-- 7i7 by striking ,beginning with the fiscal year described in subparagraph 7,b77ii77,,ii7 and inserting ,for each fiscal year2 and 7ii7 by striking adjustment under paragraph 7#a71 further increase and inserting adjustments under paragraphs 7#a7 and 7#b71 further adjust2 and 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,methodology ,for purposes of this paragraph1 the ,secretary shall employ the capacity planning methodology utilized by the ,secretary in setting fees for fiscal year #bjba1 as described in the notice titled ,biosimilar ,user ,fee ,rates for ,fiscal ,year #bjba 7#he ,fed4 ,reg4 #dgbbj2 ,august #d1 #bjbj74 ,the workload categories used in forecasting shall include only the activities described in such notice and1 as feasible1 additional activities that are also directly related to the direct review of biosimilar biological product applications and supplements1 including additional formal meeting types and the direct review of postmarketing commitments and requirements1 the direct review of risk evaluation and mitigation strategies1 and the direct review of annual reports for approved biosimilar biological products4 ,subject to the exceptions in the preceding sentence1 the ,secretary shall not include as workload categories in forecasting any non-core review activities1 including any activities that the ,secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year #bjba4 2 and 7,c7 in subparagraph 7,c7-- 7i7 by striking subsections 7b77#b77;,a7 and inserting subsections 7b77#a77;,a72 7ii7 by striking and 7b77#b77;,b7 and inserting 1 7b77#a77;,b72 and 7iii7 by inserting 1 and 7b77#a77;,c7 7the dollar amount of the strategic hiring and retention adjustment7 before the period at the end2 7#f7 by amending paragraph 7#d71 as so redesignated1 to read as follows3 7#d7 ,operating reserve adjustment 7,a7 ,increase ,for fiscal year #bjbc and subsequent fiscal years1 the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees if such an adjustment is necessary to provide for at least #aj weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications4 7,b7 ,decrease 7i7 ,fiscal year #bjbc ,for fiscal year #bjbc1 if the ,secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of #cc weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #cc weeks of such operating reserves4 7ii7 ,fiscal year #bjbd ,for fiscal year #bjbd1 if the ,secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of #bg weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #bg weeks of such operating reserves4 7iii7 ,fiscal year #bjbe and subsequent fiscal years ,for fiscal year #bjbe and subsequent fiscal years1 if the ,secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of #ba weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #ba weeks of such operating reserves4 7,c7 ,federal register notice ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e77;,b7 establishing fee revenue and fees for the fiscal year involved4 2 and 7#g7 in paragraph 7#e71 in the matter preceding subparagraph 7,a71 by striking #bjah and inserting #bjbc4 7d7 ,crediting and availability of fees ,section #gdd;,h7f77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7e7 ,written requests for waivers and refunds ,subsection 7h7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is amended to read as follows3 7h7 ,written requests for waivers and returns2 disputes concerning fees ,to qualify for consideration for a waiver under subsection 7d71 or the return of any fee paid under this section1 including if the fee is claimed to have been paid in error1 a person shall submit to the ,secretary a written request justifying such waiver or return and1 except as otherwise specified in this section1 such written request shall be submitted to the ,secretary not later than #ahj days after such fee is due4 ,a request submitted under this paragraph shall include any legal authorities under which the request is made4 4 #djd4 ,reauthorization2 reporting requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is amended-- 7#a7 by striking #bjah each place it appears and inserting #bjbc2 7#b7 by striking ,biosimilar ,user ,fee ,amendments of #bjag each place it appears and inserting ,biosimilar ,user ,fee ,amendments of #bjbb2 7#c7 in subsection 7a77#d71 by striking #bjbj and inserting #bjbc2 and 7#d7 in subsection 7f71 by striking #bjbb each place it appears and inserting #bjbg4 #dje4 ,sunset dates 7a7 ,authorization ,sections #gdd;,g and #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea1 #cgi;j-#eb 7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #dje of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #djf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq47 shall be assessed for all biosimilar biological product applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #djg4 ,savings clause ,notwithstanding the amendments made by this title1 part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to biosimilar biological product applications and supplements 7as defined in such part as of such day7 that were accepted by the ,food and ,drug ,administration for filing on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,v ,improving regulation of drugs and biological products #eja4 ,alternatives to animal testing 7a7 ,in general ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended-- 7#a7 in subsection 7i7-- 7,a7 in paragraph 7#a77;,a71 by striking preclinical tests 7including tests on animals7 and inserting nonclinical tests2 and 7,b7 in paragraph 7#b77;,b71 by striking animal and inserting nonclinical tests2 and 7#b7 after subsection 7y71 by inserting the following3 7z7 ,nonclinical test defined ,for purposes of this section1 the term nonclinical test means a test conducted in vitro1 in silico1 or in chemico1 or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug1 and may include animal tests1 or non-animal or human biology-based test methods1 such as cell-based assays1 microphysiological systems1 or computer models4 4 7b7 ,biosimilar biological product applications ,item 7bb7 of section #cea7k77#b77;,a77i77,i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77i77,i77 is amended to read as follows3 7bb7 an assessment of toxicity 7which may rely on1 or consist of1 a study or studies described in item 7aa7 or 7cc772 and 4 #ejb4 ,safer disposal of opioids ,section #eje-a7;e77#d77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;e77#d77;,b77 is amended by striking for purposes of rendering drugs nonretrievable 7as defined in section #acjj4je of title #ba1 ,code of ,federal ,regulations 7or any successor regulation774 #ejc4 ,clarifications to exclusivity provisions for first interchangeable biosimilar biological products ,section #cea7k77#f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#f77 is amended-- 7#a7 in the matter preceding subparagraph 7,a7-- 7,a7 by striking ,upon review of and inserting ,the ,secretary shall not make licensure as an interchangeable biological product effective with respect to2 7,b7 by striking relying on and inserting that relies on2 and 7,c7 by striking the ,secretary shall not make a determination under paragraph 7#d7 that the second or subsequent biological product is interchangeable for any condition of use2 and 7#b7 in the flush text that follows subparagraph 7,c71 by striking the period and inserting 1 and the term first interchangeable biosimilar biological product means any interchangeable biosimilar biological product that is approved on the first day on which such a product is approved as interchangeable with the reference product44 #ejd4 ,improvements to the ,purple ,book 7a7 ,in general ,section #ejf;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking ,the holder of an application approved under subsection 7c7 or 7j7 of section #eje and inserting ,the holder of an application approved under subsection 7c7 or 7j7 of section #eje of this ,act or subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act2 7,b7 in paragraph 7#b71 by inserting 7in the case of a biological product1 the proper name7 after established name2 and 7,c7 in paragraph 7#c71 by striking or abbreviated application number and inserting 1 abbreviated application number1 or biologics license application number2 and 7#b7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking ,the holder of an application approved under subsection 7c7 or 7j7 and inserting ,the holder of an application approved under subsection 7c7 or 7j7 of section #eje of this ,act or subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act2 7,b7 in paragraph 7#a71 by inserting 7in the case of a biological product1 the proper name7 after established name2 and 7,c7 in paragraph 7#b71 by striking or abbreviated application number and inserting 1 abbreviated application number1 or biologics license application number4 7b7 ,additional one-,time report ,subsection 7c7 of section #ejf;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is amended to read as follows3 7c7 ,additional one-,time report ,within #ahj days of the date of enactment of the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb1 all holders of applications approved under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act shall review the information in the list published under section #cea7k77#i77;,a7 and shall submit a written notice to the ,secretary-- 7#a7 stating that all of the application holder's biological products in the list published under section #cea7k77#i77;,a7 that are not listed as discontinued are available for sale2 or 7#b7 including the information required pursuant to subsection 7a7 or 7b71 as applicable1 for each of the application holder's biological products that are in the list published under section #cea7k77#i77;,a7 and not listed as discontinued1 but have been discontinued from sale or never have been available for sale4 4 7c7 ,purple book ,section #ejf;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7 is amended-- 7#a7 in subsection 7d7-- 7,a7 by striking or 7c71 the ,secretary and inserting 8or 7c7-- 7#a7 the ,secretary 2 7,b7 by striking the period at the end1 and inserting 2 and2 and 7,c7 by adding at the end the following3 7#b7 the ,secretary may identify the application holder's biological products as discontinued in the list published under section #cea7k77#i77;,a7 of the ,public ,health ,service ,act1 except that the ,secretary shall remove from the list in accordance with section #cea7k77#i77;,b7 of such ,act any biological product for which a license has been revoked or suspended for reasons of safety1 purity1 or potency4 2 and 7#b7 in subsection 7e7-- 7,a7 by inserting after the first sentence the following3 ,the ,secretary shall update the list published under section #cea7k77#i77;,a7 of the ,public ,health ,service ,act based on information provided under subsections 7a71 7b71 and 7c7 by identifying as discontinued biological products that are not available for sale1 except that any biological product for which the license has been revoked or suspended for reasons of safety1 purity1 or potency shall be removed from the list in accordance with section #cea7k77#i77;,b7 of the ,public ,health ,service ,act42 and 7,b7 in the last sentence-- 7i7 by striking updates to the list and inserting updates to the lists published under section #eje7;j77#g77;,a7 of this ,act and section #cea7k77#i77;,a7 of the ,public ,health ,service ,act2 and 7ii7 by striking update the list and inserting update such lists4 #eje4 ,therapeutic equivalence evaluations ,section #eje7;j77#g77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a77 is amended by adding at the end the following3 7v7 7,i7 ,with respect to an application submitted pursuant to subsection 7b77#b7 for a drug that is subject to section #ejc7;b7 for which the sole difference from a listed drug relied upon in the application is a difference in inactive ingredients not permitted under clause 7iii7 or 7iv7 of section #cad4id7;a77#i7 of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 the ,secretary shall make an evaluation with respect to whether such drug is a therapeutic equivalent 7as defined in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 to another approved drug product in the prescription drug product section of the list under this paragraph as follows3 7aa7 ,with respect to such an application submitted after the date of enactment of the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb1 the evaluation shall be made with respect to a listed drug relied upon in the application under subsection 7b77#b7 that is a pharmaceutical equivalent 7as defined in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 to the drug in the application under subsection 7b77#b7 at the time of approval of such application or not later than #ahj days after the date of such approval1 provided that the request for such a determination is made in the original application 7or in a resubmission to a complete response letter71 and all necessary data and information are submitted in the original application 7or in a resubmission in response to a complete response letter7 for the therapeutic equivalence evaluation1 including information to demonstrate bioequivalence1 in a form and manner prescribed by the ,secretary4 7bb7 ,with respect to such an application submitted prior to the date of enactment of the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb1 with respect to an application approved on or after the date of enactment of such ,act1 the evaluation shall be made not later than #ahj days after receipt of a request for a therapeutic equivalence evaluation submitted as part of a supplement to such application2 or with respect to an application that was not approved as of the date of enactment of such ,act1 the evaluation shall be made not later than #ahj days after the date of approval of such application if a request for such evaluation is submitted to the application1 provided that-- 7,,aa7 such request for a therapeutic equivalent evaluation is being sought with respect to a listed drug relied upon in the application1 and the relied upon listed drug is in the prescription drug product section of the list under this paragraph and is a pharmaceutical equivalent 7as defined in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 to the drug for which a therapeutic equivalence evaluation is sought2 and 7,,bb7 the initial submission containing such request1 or the relevant application1 includes all necessary data and information for the therapeutic equivalence evaluation1 including information to demonstrate bioequivalence1 in a form and manner prescribed by the ,secretary4 7,,ii7 ,when the ,secretary makes an evaluation under subclause 7,i71 the ,secretary shall1 in revisions made to the list pursuant to clause 7ii71 include such information for such drug4 4 #ejf4 ,modernizing accelerated approval 7a7 ,in general ,section #ejf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii71 respectively1 and adjusting the margins accordingly2 7,b7 by striking ,approval of a product and inserting the following3 7,a7 ,in general ,approval of a product 2 7,c7 in clause 7i7 of such subparagraph 7,a71 as so redesignated1 by striking appropriate postapproval studies and inserting an appropriate postapproval study or studies 7which may be augmented or supported by real world evidence72 and 7,d7 by adding at the end the following3 7,b7 ,studies not required ,if the ,secretary does not require that the sponsor of a product approved under accelerated approval conduct a postapproval study under this paragraph1 the ,secretary shall publish on the website of the ,food and ,drug ,administration the rationale for why such study is not appropriate or necessary4 7,c7 ,postapproval study conditions ,not later than the time of approval of a product under accelerated approval1 the ,secretary shall specify the conditions for a postapproval study or studies required to be conducted under this paragraph with respect to such product1 which may include enrollment targets1 the study protocol1 and milestones1 including the target date of study completion4 7,d7 ,studies ,begun ,before ,approval ,the ,secretary may require such study or studies to be underway prior to approval4 2 and 7#b7 in paragraph 7#c7-- 7,a7 by redesignating subparagraphs 7,a7 through 7,d7 as clauses 7i7 through 7iv71 respectively and adjusting the margins accordingly2 7,b7 by striking ,the ,secretary may and inserting the following3 7,a7 ,in general ,the ,secretary may 2 7,c7 in clause 7i7 of such subparagraph 7,a71 as so redesignated1 by striking drug with due diligence and inserting product with due diligence1 including with respect to conditions specified by the ,secretary under paragraph 7#b77;,c72 7,d7 in clause 7iii7 of such subparagraph 7,a71 as so redesignated1 by inserting shown to be after product is not2 and 7,e7 by adding at the end the following3 7,b7 ,expedited procedures described ,expedited procedures described in this subparagraph shall consist of1 prior to the withdrawal of accelerated approval-- 7i7 providing the sponsor with-- 7,i7 due notice2 7,,ii7 an explanation for the proposed withdrawal2 7,,iii7 an opportunity for a meeting with the ,commissioner or the ,commissioner's designee2 and 7,,iv7 an opportunity for written appeal to-- 7aa7 the ,commissioner2 or 7bb7 a designee of the ,commissioner who has not participated in the proposal withdrawal of approval 7other than a meeting pursuant to subclause 7,,iii77 and is not subordinate of an individual 7other than the ,commissioner7 who participated in such proposed withdrawal2 7ii7 providing an opportunity for public comment on the proposing to withdrawal approval2 7iii7 the publication of a summary of the public comments received1 and the ,secretary's response to such comments1 on the website of the ,food and ,drug ,administration2 and 7iv7 convening and consulting an advisory committee on issues related to the proposed withdrawal1 if requested by the sponsor and if no such advisory committee has previously advised the ,secretary on such issues with respect to the withdrawal of the product prior to the sponsor's request4 4 7b7 ,reports of postmarketing studies ,section #ejf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;b7a77 is amended-- 7#a7 by redesignating paragraph 7#b7 as paragraph 7#c72 and 7#b7 by inserting after paragraph 7#a7 the following3 7#b7 ,accelerated approval ,notwithstanding paragraph 7#a71 a sponsor of a drug approved under accelerated approval shall submit to the ,secretary a report of the progress of any study required under section #ejf7;c71 including progress toward enrollment targets1 milestones1 and other information as required by the ,secretary1 not later than #ahj days after the approval of such drug and not less frequently than every #ahj days thereafter1 until the study is completed or terminated4 4 7c7 ,enforcement ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 as amended by section #hbd1 is further amended by adding at the end the following3 7ll7 ,the failure of a sponsor of a product approved under accelerated approval pursuant to section #ejf7;c7-- 7#a7 to conduct with due diligence any postapproval study required under section #ejf7;c7 with respect to such product2 or 7#b7 to submit timely reports with respect to such product in accordance with section #ejf;,b7a77#b74 4 7d7 ,guidance 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall issue guidance describing-- 7,a7 how sponsor questions related to the identification of novel surrogate or intermediate clinical endpoints may be addressed in early-stage development meetings with the ,food and ,drug ,administration2 7,b7 the use of novel clinical trial designs that may be used to conduct appropriate post-approval studies as may be required under section #ejf7;c77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by subsection 7a72 7,c7 the expedited procedures described in section #ejf7;c77#c77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7,d7 considerations related to the use of surrogate or intermediate clinical endpoints that may support the accelerated approval of an application under #ejf7;c77#a77;,a71 including considerations in evaluating the evidence related to any such endpoints4 7#b7 ,final guidance ,the ,secretary shall issue-- 7,a7 a draft guidance under paragraph 7#a7 not later than #ah months after the date of enactment of this ,act2 and 7,b7 final guidance not later than #a year after the close of the public comment period on such draft guidance4 7e7 ,rare disease endpoint advancement pilot 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall establish a pilot program under which the ,secretary will establish procedures to provide increased interaction with sponsors of rare disease drug development programs for purposes of advancing the development of efficacy endpoints1 including surrogate and intermediate endpoints1 for drugs intended to treat rare diseases1 including through-- 7,a7 determining eligibility of participants for such program2 and 7,b7 developing and implementing a process for applying to1 and participating in1 such a program4 7#b7 ,public workshops ,the ,secretary shall conduct up to #c public workshops1 which shall be completed not later than ,september #cj1 #bjbf1 to discuss topics relevant to the development of endpoints for rare diseases1 which may include discussions about-- 7,a7 novel endpoints developed through the pilot program established under this subsection2 and 7,b7 as appropriate1 the use of real world evidence and real work data to support the validation of efficacy endpoints1 including surrogate and intermediate endpoints1 for rare diseases4 7#c7 ,report ,not later than ,september #cj1 #bjbg1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report describing the outcomes of the pilot program established under this subsection4 7#d7 ,guidance ,not later than ,september #cj1 #bjbg1 the ,secretary shall issue guidance describing best practices and strategies for development of efficacy endpoints1 including surrogate and intermediate endpoints1 for rare diseases4 7#e7 ,sunset ,the ,secretary may not accept any new application or request to participate in the program established by this subsection on or after ,october #a1 #bjbg4 7f7 ,accelerated approval council 7#a7 ,general ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall establish an intra-agency coordinating council within the ,food and ,drug ,administration to ensure the consistent and appropriate use of accelerated approval across the ,food and ,drug ,administration1 pursuant to section #ejf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c774 7#b7 ,membership ,the members of the ,council shall consist of the following senior officials1 or a designee of such official1 from the ,food and ,drug ,administration and relevant ,centers3 7,a7 ,the ,director of the ,center for ,drug ,evaluation and ,research4 7,b7 ,the ,director of the ,center for ,biologics ,evaluation and ,research4 7,c7 ,the ,director of the ,oncology ,center of ,excellence4 7,d7 ,the ,director of the ,office of ,new ,drugs4 7,e7 ,the ,director of the ,office of ,orphan ,products ,development4 7,f7 ,the ,director of the ,office of ,tissues and ,advanced ,therapies4 7,g7 ,the ,director of the ,office of ,medical ,policy4 7,h7 ,at least #c directors of review division overseeing products approved under accelerated approval1 including at least one director of a review division within the ,office of ,neuroscience4 7#c7 ,duties of the council 7,a7 ,meetings ,the ,council shall convene not fewer than #c times per calendar year to discuss issues related to accelerated approval1 including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval4 7,b7 ,policy development ,the ,council shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the ,food and ,drug ,administration4 ,such activities may include-- 7i7 developing guidance for ,food and ,drug ,administration staff and best practices for1 and across1 product review teams1 including with respect to communication between sponsors and the ,food and ,drug ,administration and the review of products under accelerated approval2 7ii7 providing training for product review teams2 and 7iii7 advising review divisions on product-specific development1 review1 and withdrawal of products under accelerated approval4 7#d7 ,publication of a report ,not later than #a year after the date of enactment of this ,act1 and annually thereafter1 the council shall publish on the public website of the ,food and ,drug ,administration a report on the activities of the council4 7g7 ,rule of construction ,nothing in this section 7including the amendments made by this section7 shall be construed to affect products approved under #ejf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 prior to the date of enactment of this ,act4 ,,vi ,other reauthorizations #fja4 ,reauthorization of the critical path public-private partnership ,section #eff7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #fjb4 ,reauthorization of the best pharmaceuticals for children program ,section #dji;,i7d77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #fjc4 ,reauthorization of the humanitarian device exemption incentive ,section #ebj7m77#f77;,a77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is amended by striking #bjbb and inserting #bjbg4 #fjd4 ,reauthorization of the pediatric device consortia program ,section #cje7;e7 of the ,food and ,drug ,administration ,amendments ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is amended by striking #e1bej1jjj for each of fiscal years #bjah through #bjbb and inserting #g1jjj1jjj for each of fiscal years #bjbc through #bjbg4 #fje4 ,reauthorization of provision pertaining to drugs containing single enantiomers ,section #eje7u7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7u77 is amended by-- 7#a7 in paragraph 7#a77;,a77ii77,,ii71 by adding 7other than bioavailability studies7 after any clinical investigations2 and 7#b7 in paragraph 7#d71 by striking ,october #a1 #bjbb and inserting ,october #a1 #bjbg4 #fjf4 ,reauthorization of orphan drug grants ,section #e7;c7 of the ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #fjg4 ,reauthorization of certain device inspections ,section #gjd7;g77#aa7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77#aa77 is amended by striking #bjbb and inserting #bjbg4 ,,vii ,enhancing ,,fda hiring authorities #gja4 ,enhancing ,,fda hiring authority for scientific1 technical1 and professional personnel ,section #gad;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c;a7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by inserting 1 including cross-cutting operational positions1 after professional positions2 and 7,b7 by inserting and the regulation of food after medical products2 and 7#b7 in subsection 7d77#a7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking the #bast ,century ,cures ,act and inserting the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb2 and 7ii7 by striking that examines the extent and all that follows through 1 including and inserting that addresses2 7,b7 in subparagraph 7,a7-- 7i7 by inserting updated before analysis2 and 7ii7 by striking 2 and and inserting a semicolon2 7,c7 by redesignating subparagraph 7,b7 as subparagraph 7,c72 7,d7 by inserting after subparagraph 7,a7 the following3 7,b7 an analysis of how the ,secretary has used the authorities provided under this section1 and a plan for how the ,secretary will use the authority under this section1 and other applicable hiring authorities1 for employees of the ,food and ,drug ,administration2 and 2 and 7,e7 in subparagraph 7,c71 as so redesignated1 by striking a recruitment and inserting an updated recruitment4 #gjb4 ,strategic workforce plan and report ,chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cga et seq47 is amended by inserting after section #gad;,a the following3 #gad;,b4 ,strategic workforce plan and report 7a7 ,in general ,not later than ,september #cj1 #bjbc1 and at least every #d years thereafter1 the ,secretary shall develop and submit to the appropriate committees of ,congress and post on the website of the ,food and ,drug ,administration1 a coordinated strategy and report to provide direction for the activities and programs of the ,secretary to recruit1 hire1 train1 develop1 and retain the workforce needed to fulfill the public health mission of the ,food and ,drug ,administration1 including to facilitate collaboration across centers1 to keep pace with new biomedical1 technological1 and scientific advancements1 and support the development1 review1 and regulation of medical products4 ,each such report shall be known as the ,food and ,drug ,administration ,strategic ,workforce ,plan4 7b7 ,use of the food and drug administration strategic workforce plan ,each center within the ,food and ,drug ,administration shall develop and update1 as appropriate1 a strategic plan that will be informed by the ,food and ,drug ,administration ,strategic ,workforce ,plan developed and updated under this subsection4 7c7 ,contents of the food and drug administration strategic workforce plan ,each ,food and ,drug ,administration ,strategic ,workforce ,plan under subsection 7a7 shall-- 7#a7 include agency-wide strategic goals and priorities for recruiting1 hiring1 training1 developing1 and retaining a qualified workforce for the ,food and ,drug ,administration2 7#b7 establish specific activities the ,secretary will take to achieve its strategic goals and priorities and address the workforce needs of the ,food and ,drug ,administration in the forthcoming fiscal years2 7#c7 identify challenges and risks the ,secretary will face in meeting its strategic goals and priorities1 and the activities the ,secretary will undertake to overcome those challenges and mitigate those risks2 7#d7 establish metrics and milestones that the ,secretary will use to measure progress in achieving its strategic goals and priorities2 and 7#e7 define functions1 capabilities1 and gaps in such workforce and identify strategies to recruit1 hire1 train1 develop1 and retain such workforce4 7d7 ,considerations ,in developing each ,food and ,drug ,administration ,strategic ,workforce ,plan under subsection 7a71 the ,secretary shall consider-- 7#a7 the number of employees1 employee expertise1 and employing center of employees1 including senior leadership and non-senior leadership employees1 eligible for retirement2 7#b7 the vacancy and turnover rates for employees with different types of expertise and from different centers1 including any changes or trends related to such rates2 7#c7 the results of the ,federal ,employee ,viewpoint ,survey for employees of the ,food and ,drug ,administration1 including any changes or trends related to such results2 7#d7 rates of pay for different types of positions1 including rates for different types of expertise within the same field 7such as differences in pay between different medical specialists71 and how such rates of pay impact the ability of the ,secretary to achieve strategic goals and priorities2 and 7#e7 the statutory hiring authorities used to hire ,food and ,drug ,administration employees1 and the time to hire across different hiring authorities4 7e7 ,evaluation of progress ,each ,food and ,drug ,administration ,strategic ,workforce ,plan issued pursuant to subsection 7a71 with the exception of the first such ,food and ,drug ,administration ,strategic ,workforce ,plan1 shall include an evaluation of the progress the ,secretary has made1 based on the metrics1 benchmarks1 and other milestones that measure successful recruitment1 hiring1 training1 development1 and retention activities2 and whether such actions improved the capacity of the ,food and ,drug ,administration to achieve the strategic goals and priorities set forth in the previous ,food and ,drug ,administration ,strategic ,workforce ,plan4 7f7 ,additional considerations ,the ,food and ,drug ,administration ,strategic ,workforce ,plan issued in fiscal year #bjbc shall address the effect of the ,,covid-#ai pandemic on hiring1 retention1 and other workforce challenges for the ,food and ,drug ,administration1 including protecting such workforce during public health emergencies4 4 ,,viii ,advancing regulation of cosmetics1 dietary supplements1 and laboratory developed tests ,a ,cosmetics #hja4 ,short title ,this subtitle may be cited as the ,modernization of ,cosmetics ,regulation ,act of #bjbb4 #hjb4 ,amendments to cosmetic requirements ,chapter ,,vi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa et seq47 is amended by adding at the end the following3 #fjd4 ,definitions ,in this chapter3 7#a7 ,adverse event ,the term adverse event means any health-related event associated with the use of a cosmetic product that is adverse4 7#b7 ,cosmetic product ,the term cosmetic product means a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product4 7#c7 ,facility 7,a7 ,in general ,the term facility includes any establishment 7including an establishment of an importer7 that manufactures or processes cosmetic products distributed in the ,united ,states4 7,b7 ,such term does not include any of the following3 7i7 ,beauty shops and salons1 unless such establishment manufactures or processes cosmetic products at that location4 7ii7 ,cosmetic product retailers1 including individual sales representatives1 direct sellers1 retail distribution facilities1 and pharmacies1 unless such establishment manufactures or processes cosmetic products that are not sold directly to consumers at that location4 7iii7 ,hospitals1 physicians' offices1 and health care clinics4 7iv7 ,public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer4 7v7 ,entities 7such as hotels and airlines7 that provide complimentary cosmetic products to customers incidental to other services4 7vi7 ,trade shows and other venues where cosmetic product samples are provided free of charge4 7vii7 ,an establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation1 including for production testing and not offered for retail sale4 7viii7 ,an establishment that solely performs one or more of the following with respect to cosmetic products3 7,i7 ,labeling4 7,,ii7 ,relabeling4 7,,iii7 ,packaging4 7,,iv7 ,repackaging4 7,v7 ,holding4 7,,vi7 ,distributing4 7,c7 ,clarification ,for the purposes of subparagraph 7,b77viii71 the terms packaging and repackaging do not include filling a product container with a cosmetic product4 7#d7 ,responsible person ,the term responsible person means the manufacturer1 packer1 or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section #fji7;a7 of this ,act or section #d7;a7 of the ,fair ,packaging and ,labeling ,act4 7#e7 ,serious adverse event ,the term serious adverse event means an adverse event that-- 7,a7 results in-- 7i7 death2 7ii7 a life-threatening experience2 7iii7 inpatient hospitalization2 7iv7 a persistent or significant disability or incapacity2 7v7 a congenital anomaly or birth defect2 or 7vi7 significant disfigurement 7including serious and persistent rashes or infections1 second- or third-degree burns1 significant hair loss1 or permanent or significant alteration of appearance71 other than as intended1 under conditions of use that are customary or usual2 or 7,b7 requires1 based on reasonable medical judgment1 a medical or surgical intervention to prevent an outcome described in subparagraph 7,a74 #fje4 ,adverse events 7a7 ,serious adverse event reporting requirements ,the responsible person shall submit to the ,secretary any report received of a serious adverse event associated with the use1 in the ,united ,states1 of a cosmetic product manufactured1 packed1 or distributed by such person4 7b7 ,submission of reports 7#a7 ,serious adverse event report ,the responsible person shall submit to the ,secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than #ae business days after the report is received by the responsible person4 7#b7 ,new medical information ,the responsible person shall submit to the ,secretary any new and material medical information1 related to a serious adverse event report submitted to the ,secretary in accordance with paragraph 7#a71 that is received by the responsible person within #a year of the initial report to the ,secretary1 no later than #ae business days after such information is received by such responsible person4 7#c7 ,consolidation of reports ,the ,secretary shall develop systems to enable responsible persons to submit a single report that includes duplicate reports of1 or new medical information related to1 a serious adverse event4 7c7 ,exemptions ,the ,secretary may establish by regulation an exemption to any of the requirements of this section if the ,secretary determines that such exemption would have no significant adverse effect on public health4 7d7 ,contact information ,the responsible person shall receive reports of adverse events through the domestic address1 domestic telephone number1 or electronic contact information included on the label in accordance with section #fji7;a74 7e7 ,maintenance and inspection of adverse event records 7#a7 ,maintenance ,the responsible person shall maintain records related to each report of an adverse event associated with the use1 in the ,united ,states1 of a cosmetic product manufactured or distributed by such person received by such person1 for a period of #f years4 7#b7 ,inspection 7,a7 ,in general ,the responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section #gjd4 7,b7 ,authorized person ,for purposes of this paragraph1 the term authorized person means an officer or employee of the ,department of ,health and ,human ,services who has-- 7i7 appropriate credentials1 as determined by the ,secretary2 and 7ii7 been duly designated by the ,secretary to have access to the records required under this section4 7f7 ,fragrance and flavor ingredients ,if the ,secretary has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event required to be reported under this section1 the ,secretary may request in writing a complete list of ingredients in the specific fragrances or flavors in the cosmetic product1 from the responsible person4 ,the responsible person shall ensure that the requested information is submitted to the ,secretary within #cj days of such request4 ,information submitted to the ,secretary under this subsection that is confidential commercial or trade secret information shall be exempt from disclosure under section #eeb of title #e1 ,united ,states ,code4 7g7 ,protected information ,a serious adverse event report submitted to the ,secretary under this section1 including any new medical information submitted under subsection 7a77#b71 or an adverse event report1 or any new information1 voluntarily submitted to the ,secretary shall be considered to be-- 7#a7 a safety report under section #gef and may be accompanied by a statement1 which shall be a part of any report that is released for public disclosure1 that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event2 and 7#b7 a record about an individual under section #eeb;a of title #e1 ,united ,states ,code 7commonly referred to as the ,privacy ,act of #aigd7 and a medical or similar file the disclosure of which would constitute a violation of section #eeb of such title #e 7commonly referred to as the ,freedom of ,information ,act71 and shall not be publicly disclosed unless all personally identifiable information is redacted4 7h7 ,effect of section 7#a7 ,in general ,nothing in this section shall affect the authority of the ,secretary to provide adverse event reports and information to any health1 food1 or drug officer or employee of any ,state1 territory1 or political subdivision of a ,state or territory1 under a memorandum of understanding between the ,secretary and such ,state1 territory1 or political subdivision4 7#b7 ,personally identifiable information ,notwithstanding any other provision of law1 personally identifiable information in adverse event reports provided by the ,secretary to any health1 food1 or drug officer or employee of any ,state1 territory1 or political subdivision of a ,state or territory1 shall not-- 7,a7 be made publicly available pursuant to any ,state or other law requiring disclosure of information or records2 or 7,b7 otherwise be disclosed or distributed to any party without the written consent of the ,secretary and the person submitting such information to the ,secretary4 7#c7 ,use of reports ,nothing in this section shall permit a ,state1 territory1 or political subdivision of a ,state or territory1 to use any safety report received from the ,secretary in a manner inconsistent with this section4 7#d7 ,rule of construction ,the submission of any report in compliance with this section shall not be construed as an admission that the cosmetic product involved caused or contributed to the relevant adverse event4 #fjf4 ,good manufacturing practice 7a7 ,in general ,the ,secretary shall by regulation establish good manufacturing practices for facilities that are consistent1 to the extent practicable1 and appropriate1 with national and international standards1 in accordance with section #fja4 ,any such regulations shall be intended to protect the public health and ensure that cosmetic products are not adulterated4 ,such regulations may allow for the ,secretary to inspect records necessary to demonstrate compliance with good manufacturing practices prescribed by the ,secretary under this paragraph during an inspection conducted under section #gjd4 7b7 ,considerations ,in establishing regulations for good manufacturing practices under this section1 the ,secretary shall take into account the size and scope of the businesses engaged in the manufacture of cosmetics1 and the risks to public health posed by such cosmetics1 and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply4 ,such regulations shall include simplified good manufacturing practice requirements for smaller businesses1 as appropriate1 to ensure that such regulations do not impose undue economic hardship for smaller businesses1 and may include longer compliance times for smaller businesses4 ,before issuing regulations to implement subsection 7a71 the ,secretary shall consult with cosmetics manufacturers1 including smaller businesses1 consumer organizations1 and other experts selected by the ,secretary4 7c7 ,timeframe ,the ,secretary shall publish a notice of proposed rulemaking not later than #b years after the date of enactment of the ,modernization of ,cosmetics ,regulation ,act of #bjbb and shall publish a final such rule not later than #c years after such date of enactment4 #fjg4 ,registration and product listing 7a7 ,submission of registration 7#a7 ,initial registration 7,a7 ,existing facilities ,every person that1 on the date of enactment of the ,modernization of ,cosmetics ,regulation ,act of #bjbb1 owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the ,united ,states shall register each facility with the ,secretary not later than #a year after date of enactment of such ,act4 7,b7 ,new facilities ,every person that owns or operates a facility that first engages1 after the date of enactment of the ,modernization of ,cosmetics ,regulation ,act of #bjbb1 in manufacturing or processing of a cosmetic product for distribution in the ,united ,states1 shall register with the ,secretary such facility within #fj days of first engaging in such activity or #fj days after the deadline for registration under subparagraph 7,a71 whichever is later4 7#b7 ,biennial renewal of registration ,a person required to register a facility under paragraph 7#a7 shall renew such registrations with the ,secretary biennially4 7#c7 ,contract manufacturers ,if a facility manufactures or processes cosmetic products on behalf of a responsible person1 the ,secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of more than one responsible person4 ,such single registration may be submitted to the ,secretary by such facility or any responsible person whose products are manufactured or processed at such facility4 7#d7 ,updates to content ,a person that is required to register under subsection 7a77#a7 shall notify the ,secretary within #fj days of any changes to information required under subsection 7b77#b74 7#e7 ,abbreviated renewal registrations ,the ,secretary shall provide for an abbreviated registration renewal process for any person that owns or operates a facility that has not been required to submit updates under paragraph 7#d7 for a registered facility since submission of the most recent registration of such facility under paragraph 7#a7 or 7#b74 7b7 ,format2 contents of registration 7#a7 ,in general ,registration information under this section may be submitted at such time and in such manner as the ,secretary may prescribe4 7#b7 ,contents ,the registration under subsection 7a7 shall contain-- 7,a7 the facility's name1 physical address1 email address1 and telephone number2 7,b7 with respect to any foreign facility1 the contact for the ,united ,states agent of the facility1 and1 if available1 the electronic contact information2 7,c7 the facility registration number1 if any1 previously assigned by the ,secretary under subsection 7d72 7,d7 all brand names under which cosmetic products manufactured or processed in the facility are sold2 and 7,e7 the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility4 7c7 ,cosmetic product listing 7#a7 ,in general ,for each cosmetic product1 the responsible person shall submit1 or ensure is submitted1 to the ,secretary a cosmetic product listing1 at such time and in such manner as the ,secretary may prescribe4 7#b7 ,cosmetic product listing ,the responsible person of a cosmetic product that is marketed on the date of enactment of the ,modernization of ,cosmetics ,regulation ,act of #bjbb shall submit to the ,secretary a cosmetic product listing not later than #a year after the date of enactment of the ,modernization of ,cosmetics ,regulation ,act of #bjbb1 or for a cosmetic product that is first marketed after the date of enactment of such ,act1 within #abj days of marketing such product in interstate commerce4 ,thereafter1 any updates to such listing shall be made annually1 consistent with paragraphs 7#d7 and 7#e74 7#c7 ,abbreviated renewal ,the ,secretary shall provide for an abbreviated process for the renewal of any cosmetic product listing under this subsection with respect to which there has been no change since the responsible person submitted the previous listing4 7#d7 ,contents of listing 7,a7 ,in general ,each such cosmetic product listing shall include-- 7i7 the facility registration number of each facility where the cosmetic product is manufactured or processed2 7ii7 the name and contact number of the responsible person and the name for the cosmetic product1 as such name appears on the label2 7iii7 the applicable cosmetic category or categories for the cosmetic product2 7iv7 a list of ingredients in the cosmetic product1 including any fragrances1 flavors1 or colors1 with each ingredient identified by the name adopted in regulations promulgated by the ,secretary1 if any1 or by the common or usual name of the ingredient2 and 7v7 the product listing number1 if any previously assigned by the ,secretary under subsection 7d74 7,b7 ,flexible listings ,a single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations1 or formulations that differ only with respect to colors1 fragrances or flavors1 or quantity of contents4 7#e7 ,updates to content ,a responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually4 7#f7 ,submission ,a responsible person may submit product listing information as part of a facility registration or separately4 7d7 ,facility registration and product listing numbers ,at the time of the initial registration of any facility under subsection 7a77#a7 or initial listing of any cosmetic product under 7c77#a71 the ,secretary shall assign a facility registration number to the facility and a product listing number to each cosmetic product4 ,the ,secretary shall not make such product listing number publicly available4 7e7 ,confidentiality ,information submitted to the ,secretary under this section that is confidential commercial or trade secret information shall be exempt from disclosure under section #eeb of title #e1 ,united ,states ,code1 including all information submitted under subsection 7b77#b77;,d7 or 7c77#d77;,a77i74 7f7 ,suspensions 7#a7 ,suspension of registration of a facility ,the ,secretary may suspend the registration of a facility if the ,secretary determines that a cosmetic product manufactured or processed by a registered facility and distributed in the ,united ,states has a reasonable probability of causing serious adverse health consequences or death to humans and the ,secretary has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products1 or is sufficiently pervasive to raise concerns about other products manufactured in the facility4 7#b7 ,notice of suspension ,before suspending a facility registration under this section1 the ,secretary shall provide-- 7,a7 notice to the facility registrant of the cosmetic product or other responsible person1 as appropriate1 of the intent to suspend the facility registration1 which shall specify the basis of the determination by the ,secretary that the facility should be suspended2 and 7,b7 an opportunity1 within #e business days of the notice provided under subparagraph 7,a71 for the responsible person to provide a plan for addressing the reasons for possible suspension of the facility registration4 7#c7 ,hearing on suspension ,the ,secretary shall provide the registrant subject to an order under paragraph 7#a7 or 7#b7 with an opportunity for an informal hearing1 to be held as soon as possible but not later than #e business days after the issuance of the order1 or such other time period agreed upon by the ,secretary and the registrant1 on the actions required for reinstatement of registration and why the registration that is subject to the suspension should be reinstated4 ,the ,secretary shall reinstate a registration if the ,secretary determines1 based on evidence presented1 that adequate grounds do not exist to continue the suspension of the registration4 7#d7 ,post-hearing corrective action plan ,if1 after providing opportunity for an informal hearing under paragraph 7#c71 the ,secretary determines that the suspension of registration remains necessary1 the ,secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the ,secretary4 ,the ,secretary shall review such plan not later than #ad business days after the submission of the corrective action plan or such other time period as determined by the ,secretary1 in consultation with the registrant4 7#e7 ,vacating of order2 reinstatement ,upon a determination by the ,secretary that adequate grounds do not exist to continue the suspension actions1 the ,secretary shall promptly vacate the suspension and reinstate the registration of the facility4 7#f7 ,effect of suspension ,if the registration of the facility is suspended under this section1 no person shall introduce or deliver for introduction into commerce in the ,united ,states cosmetic products from such facility4 7#g7 ,no delegation ,the authority conferred by this section to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the ,commissioner4 #fjh4 ,safety substantiation 7a7 ,substantiation of safety ,a responsible person for a cosmetic product shall ensure1 and maintain records supporting1 that there is adequate substantiation of safety of such cosmetic product4 7b7 ,coal-,tar hair dye ,subsection 7a7 shall not apply to coal-tar hair dye that otherwise complies with the requirements of section #fja7;a74 ,a responsible person for a coal-tar hair dye shall maintain records related to the safety of such product4 7c7 ,definitions ,for purposes of this section3 7#a7 ,adequate substantiation of safety ,the term adequate substantiation of safety means tests or studies1 research1 analyses1 or other evidence or information that is considered1 among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients1 sufficient to support a reasonable certainty that a cosmetic product is safe4 7#b7 ,safe ,the term safe means that the cosmetic product1 including any ingredient thereof1 is not injurious to users under the conditions of use prescribed in the labeling thereof1 or under such conditions of use as are customary or usual4 ,the ,secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users4 ,in determining for purposes of this section whether a cosmetic product is safe1 the ,secretary may consider1 as appropriate and available1 the cumulative or other relevant exposure to the cosmetic product1 including any ingredient thereof4 #fji4 ,labeling 7a7 ,general requirement ,each cosmetic product shall bear a label that includes a domestic address1 domestic phone number1 or electronic contact information1 which may include a website1 through which the responsible person can receive adverse event reports with respect to such cosmetic product4 7b7 ,fragrance allergens ,the responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product4 ,substances that are fragrance allergens for purposes of this subsection shall be determined by the ,secretary by regulation4 ,the ,secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than #ah months after the date of enactment of the ,modernization of ,cosmetics ,regulation ,act of #bjbb1 and not later than #ahj days after the date on which the public comment period on the proposed rulemaking closes1 shall issue a final rulemaking4 ,in promulgating regulations implementing this subsection1 the ,secretary shall consider international1 ,state1 and local requirements for allergen disclosure1 including the substance and format of requirements in the ,european ,union1 and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations4 7c7 ,cosmetic products for professional use 7#a7 ,definition of professional ,for purposes of this subsection1 the term professional means an individual who is licensed by an official ,state authority to practice in the field of cosmetology1 nail care1 barbering1 or esthetics4 7#b7 ,professional use labeling ,a cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that-- 7,a7 contains a clear and prominent statement that the product shall be administered or used only by licensed professionals2 and 7,b7 is in conformity with the requirements of the ,secretary for cosmetics labeling under this ,act and section #d7;a7 of the ,fair ,packaging and ,labeling ,act4 #faj4 ,records 7a7 ,in general ,if the ,secretary has a reasonable belief that a cosmetic product1 including an ingredient in such cosmetic product1 and any other cosmetic product that the ,secretary reasonably believes is likely to be affected in a similar manner1 is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans1 each responsible person and facility shall1 at the request of an officer or employee duly designated by the ,secretary1 permit such officer or employee1 upon presentation of appropriate credentials and a written notice to such person1 at reasonable times and within reasonable limits and in a reasonable manner1 to have access to and copy all records relating to such cosmetic product1 and to any other cosmetic product that the ,secretary reasonably believes is likely to be affected in a similar manner1 that are needed to assist the ,secretary in determining whether the cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans4 ,this subsection shall not be construed to extend to recipes or formulas for cosmetics1 financial data1 pricing data1 personnel data 7other than data as to qualification of technical and professional personnel performing functions subject to this ,act71 research data 7other than safety substantiation data for cosmetic products and their ingredients71 or sales data 7other than shipment data regarding sales74 7b7 ,protection of sensitive information ,the ,secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the ,secretary pursuant to this section4 7c7 ,rule of construction ,nothing in this section shall be construed to limit the authority of the ,secretary to inspect records or require establishment and maintenance of records under any other provision of this ,act1 including section #fje or #fjf4 #faa4 ,mandatory recall authority 7a7 ,in general ,if the ,secretary determines that there is a reasonable probability that a cosmetic is adulterated under section #fja or misbranded under section #fjb and the use of or exposure to such cosmetic will cause serious adverse health consequences or death1 the ,secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article4 ,if the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the ,secretary 7if so prescribed71 the ,secretary may1 by order1 require1 as the ,secretary deems necessary1 such person to immediately cease distribution of such article4 7b7 ,hearing ,the ,secretary shall provide the responsible person who is subject to an order under subsection 7a7 with an opportunity for an informal hearing1 to be held not later than #aj days after the date of issuance of the order1 on whether adequate evidence exists to justify the order4 7c7 ,order resolution ,after an order is issued according to the process under subsections 7a7 and 7b71 the ,secretary shall1 except as provided in subsection 7d7-- 7#a7 vacate the order1 if the ,secretary determines that inadequate grounds exist to support the actions required by the order2 7#b7 continue the order ceasing distribution of the cosmetic until a date specified in such order2 or 7#c7 amend the order to require a recall of the cosmetic1 including any requirements to notify appropriate persons1 a timetable for the recall to occur1 and a schedule for updates to be provided to the ,secretary regarding such recall4 7d7 ,action following order ,any person who is subject to an order pursuant to paragraph 7#b7 or 7#c7 of subsection 7c7 shall immediately cease distribution of or recall1 as applicable1 the cosmetic and provide notification as required by such order4 7e7 ,notice to persons affected ,if the ,secretary determines necessary1 the ,secretary may require the person subject to an order pursuant to subsection 7a7 or an amended order pursuant to paragraph 7#b7 or 7#c7 of subsection 7c7 to provide either a notice of a recall order for1 or an order to cease distribution of1 such cosmetic1 as applicable1 under this section to appropriate persons1 including persons who manufacture1 distribute1 import1 or offer for sale such product that is the subject of an order and to the public4 7f7 ,public notification ,in conducting a recall under this section1 the ,secretary shall-- 7#a7 ensure that a press release is published regarding the recall1 and that alerts and public notices are issued1 as appropriate1 in order to provide notification-- 7,a7 of the recall to consumers and retailers to whom such cosmetic was1 or may have been1 distributed2 and 7,b7 that includes1 at a minimum-- 7i7 the name of the cosmetic subject to the recall2 7ii7 a description of the risk associated with such article2 and 7iii7 to the extent practicable1 information for consumers about similar cosmetics that are not affected by the recall2 and 7#b7 ensure publication1 as appropriate1 on the website of the ,food and ,drug ,administration of an image of the cosmetic that is the subject of the press release described in paragraph 7#a71 if available4 7g7 ,no delegation ,the authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the ,commissioner4 7h7 ,effect ,nothing in this section shall affect the authority of the ,secretary to request or participate in a voluntary recall1 or to issue an order to cease distribution or to recall under any other provision of this chapter4 #fab4 ,small businesses 7a7 ,in general ,responsible persons1 and owners and operators of facilities1 whose average gross annual sales in the ,united ,states of cosmetic products for the previous #c-year period is less than #a1jjj1jjj1 adjusted for inflation1 and who do not engage in the manufacturing or processing of the cosmetic products described in subsection 7b71 shall be considered small businesses and not subject to the requirements of section #fjf or #fjg4 7b7 ,requirements applicable to all manufacturers and processors of cosmetics ,the exemptions under subsection 7a7 shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products3 7#a7 ,cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual4 7#b7 ,cosmetic products that are injected4 7#c7 ,cosmetic products that are intended for internal use4 7#d7 ,cosmetic products that are intended to alter appearance for more than #bd hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual4 #fac4 ,exemption for certain products and facilities 7a7 ,in general ,notwithstanding any other provision of law1 except as provided in subsection 7b71 a cosmetic product or facility that is also subject to the requirements of chapter ,v shall be exempt from the requirements of sections #fje1 #fjf1 #fjg1 #fjh1 #fji7;a71 #faj1 and #faa4 7b7 ,exception ,a facility described in subsection 7a7 that also manufactures or processes cosmetic products that are not subject to the requirements of chapter ,v shall not be exempt from the requirements of sections #fje1 #fjf1 #fjg1 #fjh1 #fji7;a71 #faj1 and #faa1 with respect to such cosmetic products4 #fad4 ,preemption 7a7 ,in general ,no ,state or political subdivision of a ,state may establish or continue in effect any law1 regulation1 order1 or other requirement for cosmetics that is different from or in addition to1 or otherwise not identical with1 any requirement applicable under this chapter with respect to registration and product listing1 good manufacturing practice1 recordkeeping1 recalls1 adverse event reporting1 or safety substantiation4 7b7 ,limitation ,nothing in the amendments to this ,act made by the ,modernization of ,cosmetics ,regulation ,act of #bjbb shall be construed to preempt any ,state statute1 public initiative1 referendum1 regulation1 or other ,state action1 except as expressly provided in subsection 7a74 ,notwithstanding subsection 7a71 nothing in this section shall be construed to prevent any ,state from prohibiting the use or limiting the amount of an ingredient in a cosmetic product1 or from continuing in effect a requirement of any ,state that is in effect at the time of enactment of the ,modernization of ,cosmetics ,regulation ,act of #bjbb for the reporting to the ,state of an ingredient in an cosmetic product4 7c7 ,savings ,nothing in the amendments to this ,act made by the ,modernization of ,cosmetics ,regulation ,act of #bjbb1 nor any standard1 rule1 requirement1 regulation1 or adverse event report shall be construed to modify1 preempt1 or displace any action for damages or the liability of any person under the law of any ,state1 whether statutory or based in common law4 7d7 ,rule of construction ,nothing in this section shall be construed to amend1 expand1 or limit the provisions under section #geb4 4 #hjc4 ,enforcement and conforming amendments 7a7 ,in general 7#a7 ,prohibited acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended-- 7,a7 by adding at the end the following3 7fff7 ,the failure to register or submit listing information in accordance with section #fjg4 7ggg7 ,the refusal or failure to follow an order under section #faa4 2 and 7,b7 in paragraph 7d71 by striking or #efd and inserting 1 #efd1 or #fjg4 7#b7 ,adulterated products ,section #fja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfa7 is amended by adding at the end the following3 7f7 ,if it has been manufactured or processed under conditions that do not meet good manufacturing practice regulations1 as prescribed by the ,food and ,drug ,administration in accordance with section #fjf4 7g7 ,if it is a cosmetic product1 and the cosmetic product1 including each ingredient in the cosmetic product1 does not have adequate substantiation for safety1 as defined in section #fjh7;c74 4 7#c7 ,misbranded cosmetics ,section #fjb7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfb7;b77 is amended-- 7,a7 by striking and 7#b7 and inserting 7#b72 and 7,b7 by inserting after numerical count the following3 2 and 7#c7 the information required under section #fji4 7#d7 ,adverse event reporting ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is amended-- 7,a7 in section #cja7;e7 7#ba ,u4,s4,c4 #cca7;e77-- 7i7 by striking #efd1 #gjc and inserting #efd1 #fje1 #gjc2 and 7ii7 by striking #efd1 #gfj and inserting #efd1 #fje1 #faa1 #gfj2 7,b7 in section #cja7;ii7 7#ba ,u4,s4,c4 #cca7;ii77-- 7i7 by striking #gfj or #gfa7 or and inserting #fjd1 #gfj1 or #gfa7 or2 and 7ii7 by inserting or required under section #fje7;a7 after report 7as defined under section #gfj or #gfa2 7,c7 in section #hja7;a7 7#ba ,u4,s4,c4 #cha7;a77-- 7i7 by striking under section #gfj or #gfa and inserting under section #fje1 #gfj1 or #gfa2 7ii7 by striking defined in such section #gfj or #gfa and inserting defined in section #fjd1 #gfj1 or #gfa2 7iii7 by striking of such section #gfj or #gfa and inserting of such section #fje1 #gfj1 or #gfa2 and 7iv7 by striking described in such section #gfj or #gfa and inserting described in such section #fje1 #gfj1 or #gfa2 and 7,d7 in section #hja7;b7 7#ba ,u4,s4,c4 #cha7;b77-- 7i7 by striking requirements of sections #gfj or #gfa1 and inserting requirements of section #fje1 #gfj1 or #gfa2 7ii7 by striking as defined in section #gfj or #gfa and inserting as defined in section #fjd1 #gfj1 or #gfa2 and 7iii7 by striking with section #gfj or #gfa and inserting with section #fje1 #gfj1 or #gfa4 7b7 ,effective date ,the amendments made by subsection 7a7 shall take effect on the date that is #a year after the date of enactment of this ,act4 #hjd4 ,records inspection ,section #gjd7;a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#a77 is amended by inserting after the second sentence the following3 ,in the case of a facility 7as defined in section #fjd7 that manufactures or processes cosmetic products1 the inspection shall extend to all records and other information described in sections #fje1 #fjf1 and #faj1 when the standard for records inspection under such section applies44 #hje4 ,talc-containing cosmetics ,the ,secretary of ,health and ,human ,services-- 7#a7 not later than one year after the date of enactment of this ,act1 shall promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products2 and 7#b7 not later than #ahj days after the date on which the public comment period on the proposed regulations closes1 shall issue such final regulations4 #hjf4 ,,pfas in cosmetics 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products1 including any risks associated with such use4 ,in conducting such assessment1 the ,secretary may1 as appropriate1 consult with the ,national ,center for ,toxicological ,research4 7b7 ,report ,not later than #b years after enactment of this ,act1 the ,secretary shall publish on the website of the ,food and ,drug ,administration a report summarizing the results of the assessment conducted under subsection 7a74 #hjg4 ,funding ,there is authorized to be appropriated #ad1bjj1jjj for fiscal year #bjbc1 #be1ifj1jjj for fiscal year #bjbd1 and #da1hij1jjj for each of the fiscal years #bjbe through #bjbg1 for purposes of conducting the activities under this subtitle 7including the amendments made by this subtitle7 and hiring personnel required to carry out this subtitle 7including the amendments made by this subtitle74 ,b ,dietary supplements #haa4 ,regulation of dietary supplements 7a7 ,in general ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is amended by adding after section #djc;,c of such ,act 7#ba ,u4,s4,c4 #cdc-c7 the following3 #djc;,d4 ,dietary supplement listing requirement 7a7 ,in general ,beginning on the date specified in subsection 7b77#d71 each dietary supplement shall be listed with the ,secretary in accordance with this section4 ,each such listing shall include1 with respect to the dietary supplement1 the information specified in subsection 7b77#a74 7b7 ,requirements 7#a7 ,in general ,the manufacturer1 packer1 or distributor of a dietary supplement whose name 7pursuant to section #djc7;e77#a77 appears on the label of a dietary supplement marketed in the ,united ,states 7referred to in this section as the responsible person71 or if the responsible person is a foreign entity1 the ,united ,states agent of such person1 shall submit to the ,secretary in accordance with this section the following information for a dietary supplement that is marketed3 7,a7 ,any name of the dietary supplement and the statement of identity1 including brand name and specified flavors1 if applicable4 7,b7 ,the name and address of the responsible person and the name and email address of the owner1 operator1 or agent in charge of the responsible person4 7,c7 ,the name1 domestic address1 and email address for the ,united ,states agent1 if the responsible person is a foreign entity4 7,d7 ,the business name and mailing address of all locations at which the responsible person manufactures1 packages1 labels1 or holds the dietary supplement4 7,e7 ,a list of all ingredients in each such dietary supplement required under sections #aja4d and #aja4cf1 title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 to appear on the label of a dietary supplement1 including-- 7i7 where applicable1 ingredients in a proprietary blend as described in section #aja4cf7;c7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 7ii7 the amount per serving of each listed dietary ingredient2 7iii7 if required by section #aja4cf of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 the percent of the daily value of each listed dietary ingredient2 and 7iv7 the amount per serving of dietary ingredients within a proprietary blend4 7,f7 ,the number of servings per container for each container size of the identical formulation4 7,g7 ,the directions for use4 7,h7 ,warnings1 notice1 and safe handling statements1 as required by section #aja4ag of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,i7 ,allergen statements for major food allergens 7pursuant to sections #djc7w7 and #djc7x774 7,j7 ,the form of the dietary supplement 7such as tablets1 capsules74 7,k7 ,any health claims or structure or function claims4 7,l7 ,the dietary supplement product listing number for the product provided by the ,secretary in accordance with subsection 7c7 for that product4 7#b7 ,format ,the ,secretary may require that a listing submitted under paragraph 7#a7 be submitted in an electronic format4 ,upon receipt of a complete listing under paragraph 7#a71 the ,secretary shall promptly notify the responsible person of the receipt of such listing4 7#c7 ,listing content ,a single listing submission for a dietary supplement under paragraph 7#a7 may include multiple dietary supplements with identical formulations1 or formulations that differ only with respect to color1 additives1 or flavorings1 whether offered in a single package size or in multiple package sizes4 7#d7 ,timing 7,a7 ,in general 7i7 ,dietary supplements on the market ,in the case of a dietary supplement that is being offered in interstate commerce on or before ,january #a1 #bjbd1 a listing for each such dietary supplement introduced or delivered for introduction into interstate commerce shall be submitted by the responsible person to the ,secretary under this subsection not later than #ah months after the date of enactment of the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb4 7ii7 ,new dietary supplements ,in the case of a dietary supplement that is not being offered in interstate commerce on or before ,january #a1 #bjbd1 a listing for each such dietary supplement introduced or delivered for introduction into interstate commerce that has not been included in any listing previously submitted by the responsible person to the ,secretary under this subsection shall be submitted to the ,secretary at the time of introduction into interstate commerce4 7,b7 ,discontinued dietary supplements ,the responsible person shall notify the ,secretary within one year of the date of discontinuance of a dietary supplement required to be listed with the ,secretary under paragraph 7#a7 for which the responsible person has discontinued commercial marketing4 7,c7 ,changes to existing listings ,the responsible person shall submit to the ,secretary a change or modification to listing information submitted under paragraph 7#a7 included on the label for a dietary supplement at the time the dietary supplement with the change or modification is introduced into interstate commerce4 7#e7 ,additional information ,the responsible person shall provide upon request from the ,secretary1 within #aj calendar days of such request1 the full business name and physical and mailing address from which the responsible person receives a dietary ingredient or combination of dietary ingredients that the responsible person uses in the manufacture of the dietary supplement or1 if applicable1 from which the responsible person receives the dietary supplement4 7c7 ,product listing number and dietary supplement electronic database 7#a7 ,dietary supplement product listing number ,the ,secretary shall provide each dietary supplement listed in accordance with subsection 7b77#a7 a dietary supplement product listing number1 which may apply to multiple dietary supplements with identical formulations1 or formulations that differ only with respect to color1 additives1 or flavorings1 including dietary supplements offered in a single package size or in multiple package sizes4 ,the ,secretary shall provide a process for a responsible person to reserve dietary supplement listing numbers in advance of listing under subsection 7b77#a74 7#b7 ,electronic database ,not later than #b years after the date of enactment of the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb1 the ,secretary shall establish and maintain an electronic database that is publicly available and contains information submitted under subsection 7b77#a7 7except for the information submitted under subparagraphs 7,d7 and 7,e77iv7 of such subsection74 ,the ,secretary shall make such information maintained in the electronic database publicly searchable1 including by dietary supplement product listing number1 and by any field of information or combination of fields of information provided under subsection 7b77#a74 7d7 ,rule of construction ,nothing in this section shall be construed-- 7#a7 to limit the authority of the ,secretary to inspect or copy records or to require the establishment and maintenance of records under any other provision of this ,act2 or 7#b7 to authorize the disclosure of trade secret or confidential commercial information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 as prohibited under section #cja7;j7 of this ,act or section #aije of title #ah1 ,united ,states ,code1 including information provided to the ,secretary under subsection 7b77#a77;,d7 or 7b77#a77;,e77iv74 7e7 ,authorization of appropriations ,there is authorized to be appropriated #g1dih1jhj for fiscal year #bjbc1 and #f1cjj1jjj for each of fiscal years #bjbd through #bjbg1 for purposes of conducting the activities under this section and hiring personnel required to carry out this section4 4 7b7 ,guidance ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall publish final guidance related to the draft guidance titled1 ,dietary ,supplements3 ,new ,dietary ,ingredient ,notifications and ,related ,issues2 ,revised ,draft ,guidance for ,industry2 ,availability 7#ha ,fed4 ,reg4 #ecdhf2 ,august #ab1 #bjaf71 consistent with section #djc;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 7c7 ,inspections for certain dietary supplements ,the ,secretary of ,health and ,human ,services shall direct resources to inspections of facilities1 suppliers1 and dietary supplement types that present a high risk to public health 7as identified by the ,secretary74 7d7 ,misbranding ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is amended by adding at the end the following3 7z7 ,if it is a dietary supplement for which a responsible person is required under section #djc;,d to file a listing1 file a change to an existing listing1 or provide additional information to the ,secretary1 and such person has failed to comply with any such requirements under section #djc;,d with respect to such dietary supplement4 4 7e7 ,new prohibited act ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 as amended by section #hjc7;a71 is further amended by adding at the end the following3 7hhh7 ,the introduction or delivery for introduction into interstate commerce of any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under section #bja7;ff74 7iii7 ,the introduction or delivery for introduction into interstate commerce of a dietary supplement that has been prepared1 packed1 or held using the assistance of1 or at the direction of1 a person debarred under section #cjf4 4 ,c ,in vitro clinical tests #hba4 ,short title2 table of contents 7a7 ,short title ,this subtitle may be cited as the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb or the ,,valid ,act of #bjbb4 7b7 ,table of contents ,the table of contents of this subtitle is as follows3 ,,subchapter ,c--,in ,vitro ,clinical ,tests,sec4 #hba4 ,short title2 table of contents4,sec4 #hbb4 ,definitions4,sec4 #hbc4 ,regulation of in vitro clinical tests4,,subchapter ,j--,in ,vitro ,clinical ,tests,s,u,b,c,h,a,p,t,e,r ,j4 ,in ,vitro ,clinical ,tests,sec4 #ehg4 ,definitions4,sec4 #ehg;,a4 ,regulation of in vitro clinical tests4,sec4 #ehg;,b4 ,premarket review4,sec4 #ehg;,c4 ,exemptions4,sec4 #ehg;,d4 ,technology certification4,sec4 #ehg;,e4 ,mitigating measures4,sec4 #ehg;,f4 ,regulatory pathway designation4,sec4 #ehg;,g4 ,grandfathered in vitro clinical tests4,sec4 #ehg;,h4 ,advisory committees4,sec4 #ehg;,i4 ,breakthrough in vitro clinical tests4,sec4 #ehg;,j4 ,registration and listing4,sec4 #ehg,k4 ,test design and quality requirements4,sec4 #ehg,l4 ,labeling requirements4,sec4 #ehg,m4 ,adverse event reporting4,sec4 #ehg,n4 ,corrections and removals4,sec4 #ehg,o4 ,restricted in vitro clinical tests4,sec4 #ehg,p4 ,appeals4,sec4 #ehg,q4 ,accredited persons4,sec4 #ehg,r4 ,recognized standards4,sec4 #ehg,s4 ,investigational use4,sec4 #ehg,t4 ,collaborative communities for in vitro clinical tests4,sec4 #ehg,u4 ,comprehensive test information system4,sec4 #ehg,v4 ,preemption4,sec4 #ehg,w4 ,adulteration4,sec4 #ehg,x4 ,misbranding4,sec4 #ehg,y4 ,postmarket surveillance4,sec4 #ehg,z4 ,electronic format for submissions4,sec4 #ehg;,,aa4 ,postmarket remedies4,sec4 #ehg;,,bb4 ,applicability4,sec4 #ehg;,,cc4 ,judicial review4,sec4 #hbd4 ,enforcement and other provisions4,sec4 #hbe4 ,transition4,sec4 #hbf4 ,emergency use authorization4,sec4 #hbg4 ,antimicrobial susceptibility tests4,sec4 #hbh4 ,combination products4,sec4 #hbi4 ,resources4 #hbb4 ,definitions 7a7 ,in general ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended-- 7#a7 by adding at the end the following3 7ss7 7#a7 ,the term in vitro clinical test means an article specified in subparagraph 7#b7 that is intended by its developer 7as defined in section #ehg7 to be used in the collection1 preparation1 analysis1 or in vitro clinical examination of specimens taken or derived from the human body for the purpose of-- 7,a7 identifying or diagnosing a disease or condition2 7,b7 providing information for diagnosing1 screening1 measuring1 detecting1 predicting1 prognosing1 analyzing1 or monitoring a disease or condition1 including by making a determination of an individual's state of health2 or 7,c7 selecting1 monitoring1 or informing therapy or treatment for a disease or condition4 7#b7 ,an article specified in this subparagraph is-- 7,a7 a test kit2 7,b7 a test system2 7,c7 a test protocol or laboratory test protocol2 7,d7 an instrument 7as defined in section #ehg7aa772 7,e7 a specimen receptacle 7as defined in section #ehg7ag772 7,f7 software1 excluding software that is excluded by section #ebj7o7 from the definition of a device under section #bja7;h71 that-- 7i7 is a component or part of another in vitro clinical test or analyzes1 processes1 or interprets a signal or pattern from another in vitro clinical test2 and 7ii7 does not analyze1 process1 or interpret a signal1 pattern1 or medical image from a device2 and 7,g7 subject to subparagraph 7#c71 a component or part of a test1 a test protocol1 an instrument1 an article1 or software described in any of clauses 7,a7 through 7,d7 of such subparagraph1 whether alone or in combination1 including reagents1 calibrators1 and controls4 7#c7 ,notwithstanding subparagraph 7#b77;,g71 an article intended to be used as a component or part of an in vitro clinical test described in subparagraph 7#a7 is excluded from the definition in subparagraph 7#a7 if the article consists of any of the following3 7,a7 ,blood1 blood components1 or human cells or tissues1 from the time of acquisition1 donation1 or recovery of such article1 including determination of donor eligibility1 as applicable1 until such time as the article is released as a component or part of an in vitro clinical test by the establishment that collected such article4 7,b7 ,an article used for invasive sampling1 a needle1 or a lancet1 except to the extent such article1 needle1 or lancet is an integral component of an article for holding1 storing1 or transporting a specimen4 7,c7 ,general purpose laboratory equipment1 including certain pre-analytical equipment1 as determined by the ,secretary4 7,d7 ,an article used solely for personal protection during the administering1 conducting1 or otherwise performing of test activities4 2 7#b7 by adding at the end of section #bja7;g7 the following3 7#c7 ,the term drug does not include an in vitro clinical test4 2 and 7#c7 in section #bja7;h77#a71 in the matter following clause 7,c71 by striking section #ebj7o7 and inserting section #ebj7o7 or an in vitro clinical test4 7b7 ,exclusion from definition of biological product ,section #cea7;i77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i77#a77 is amended-- 7#a7 by striking 7#a7 ,the term biological product means and inserting 7#a77;,a7 ,the term biological product means2 and 7#b7 by adding at the end the following3 7,b7 ,the term biological product does not include an in vitro clinical test as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 7c7 ,in vitro clinical test definition ,in this ,act1 the term in vitro clinical test has the meaning given such term in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 #hbc4 ,regulation of in vitro clinical tests ,the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 is amended-- 7#a7 by amending the heading of chapter ,v to read as follows3 ,drugs1 ,devices1 and ,in ,vitro ,clinical ,tests2 and 7#b7 by adding at the end of chapter ,v the following3 ,j ,in ,vitro ,clinical ,tests #ehg4 ,definitions ,in this subchapter3 7#a7 ,analytical validity ,the term analytical validity means1 with respect to an in vitro clinical test1 the ability of the in vitro clinical test1 to identify1 measure1 detect1 calculate1 or analyze 7or assist in such identification1 measurement1 detection1 calculation1 or analysis of7 one or more analytes1 biomarkers1 substances1 or other targets intended to be identified1 measured1 detected1 calculated1 or analyzed by the test4 7#b7 ,applicable standard ,the term applicable standard1 with respect to an in vitro clinical test1 means a reasonable assurance of analytical and clinical validity for its indications for use1 and a reasonable assurance of safety for individuals who come into contact with such in vitro clinical test1 except that such term1 with respect to specimen receptacles and test instruments1 means a reasonable assurance of analytical validity for its indications for use and safety for individuals who come into contact with such specimen receptacle or test instrument4 7#c7 ,clinical use ,the term clinical use means the operation1 application1 or functioning of an in vitro clinical test for the purpose for which it is intended as described in section #bja7ss77#a74 7#d7 ,clinical validity ,the term clinical validity means the ability of an in vitro clinical test to achieve the purpose for which it is intended as described in section #bja7ss77#a74 7#e7 ,component or part ,the term component or part means a substance1 piece1 part1 raw material1 software1 firmware1 labeling1 or assembly1 including reagents1 that is intended by the developer to be included as an aspect of an in vitro clinical test described in section #bja7ss77#a74 7#f7 ,develop ,the term develop1 with respect to an in vitro clinical test1 means-- 7,a7 designing1 validating1 producing1 manufacturing1 remanufacturing1 labeling1 advertising1 propagating1 or assembling an in vitro clinical test2 7,b7 modifying an in vitro clinical test1 including modifying the indications for use of the in vitro clinical test1 or modifying an article to be in an in vitro clinical test2 or 7,c7 establishing a test system as described or included in a test protocol developed by another entity unless such test protocol is listed as an in vitro clinical test in the comprehensive test information system established under section #ehg,t by that other entity4 7#g7 ,developer ,the term developer means a person who engages in development as described in paragraph 7#f71 except the term does not include a laboratory that-- 7,a7 is certified by the ,secretary under section #cec of the ,public ,health ,service ,act2 and 7,b7 assembles for use solely within that laboratory1 without otherwise developing1 an in vitro clinical test appropriately listed in the comprehensive test information system established under section #ehg,t by a different person4 7#h7 ,first-of-a-kind ,the term first-of-a-kind1 with respect to an in vitro clinical test1 means that such test has any novel combination of the elements specified in paragraph 7#aj7 that differs from in vitro clinical tests that already are legally available in the ,united ,states1 except for such tests offered under section #ehg;,c7a77#c71 #ehg;,c7a77#d71 or #ehg;,g4 7#i7 ,high-risk ,the term high-risk1 with respect to an in vitro clinical test or category of in vitro clinical tests1 means that an undetected inaccurate result from such test1 or such category of tests1 when used as intended-- 7,a7 7i7 has the substantial likelihood to result in serious or irreversible harm or death to a patient or patients1 or would otherwise cause serious harm to the public health2 or 7ii7 is reasonably likely to result in the absence1 significant delay1 or discontinuation of life-supporting or life-sustaining medical treatment2 and 7,b7 sufficient mitigating measures are not able to be established and applied to prevent1 mitigate1 or detect the inaccurate result1 or otherwise mitigate the risk resulting from an undetected inaccurate result described in subparagraph 7,a71 such that the test would be moderate-risk or low-risk4 7#aj7 ,indications for use ,the term indications for use1 with respect to an in vitro clinical test1 means the following elements3 7,a7 ,substance or substances measured by the in vitro clinical test1 such as an analyte1 protein1 or pathogen4 7,b7 ,test method4 7,c7 ,test purpose or purposes1 as described in section #bja7ss77#a74 7,d7 ,diseases or conditions for which the in vitro clinical test is intended for use1 including intended patient populations4 7,e7 ,context of use1 such as in a clinical laboratory1 in a health care facility1 prescription home use1 over-the-counter use1 or direct-to-consumer testing4 7#aa7 ,instrument 7,a7 ,in general ,the term instrument means an analytical or pre-analytical instrument4 7,b7 ,analytic instrument ,the term analytic instrument means an in vitro clinical test that is hardware intended by the hardware developer to be used with one or more other in vitro clinical tests to generate a clinical test result1 including software used to effectuate the functionality of the hardware4 7,c7 ,pre-analytical instrument ,the term pre-analytical instrument means an in vitro clinical test that is hardware intended by the hardware's developer solely to generate an output for use exclusively with one or more analytical instruments as defined in subparagraph 7,b7 and which does not itself generate a clinical test result4 ,such term may include software used to effectuate the hardware's functionality4 7#ab7 ,instrument family ,the term instrument family means more than one instrument developed by the same developer for which the developer demonstrates and documents1 with respect to all such instruments1 that all-- 7,a7 have the same basic architecture1 design1 and performance characteristics2 7,b7 have the same indications for use and capabilities2 7,c7 share the same measurement principles1 detection methods1 and reaction conditions1 as applicable2 and 7,d7 produce the same or similar analytical results from samples of the same specimen type or types4 7#ac7 ,low-risk ,the term low-risk1 with respect to an in vitro clinical test or category of in vitro clinical tests1 means that an undetected inaccurate result from such in vitro clinical test1 or such category of in vitro clinical tests1 when used as intended-- 7,a7 would cause only minimal or immediately reversible harm1 and would lead to only a remote risk of adverse patient impact or adverse public health impact2 or 7,b7 sufficient mitigating measures are able to be established and applied such that the in vitro clinical test meets the standard described in subparagraph 7,a74 7#ad7 ,mitigating measures ,the term mitigating measures-- 7,a7 means controls1 standards1 and other requirements that the ,secretary determines1 based on evidence1 are necessary-- 7i7 for an in vitro clinical test1 or a category of in vitro clinical tests1 to meet the applicable standard2 or 7ii7 to mitigate the risk of harm ensuing from an undetected inaccurate result or misinterpretation of a result2 and 7,b7 may include1 as required by the ,secretary1 as appropriate1 applicable requirements regarding labeling1 conformance to performance standards and consensus standards1 performance testing1 submission of clinical data1 advertising1 website posting of information1 clinical studies1 postmarket surveillance1 user comprehension studies1 training1 and confirmatory laboratory1 clinical findings1 or testing4 7#ae7 ,moderate-risk ,the term moderate-risk1 with respect to an in vitro clinical test or category of in vitro clinical tests1 means that1 when used as intended1 such test or category of tests-- 7,a7 meets the criteria specified in paragraph 7#i7 for classification as high-risk1 but one or more mitigating measures are able to be established and applied to prevent or detect an inaccurate result or otherwise sufficiently mitigate such risk1 but are not sufficient such that the test is low-risk2 or 7,b7 7i7 an undetected inaccurate result for the intended use of the test would cause only non-life-threatening harm1 harm that is medically reversible1 or the absence1 significant delay1 or discontinuation of necessary treatment that is not life-supporting or life-sustaining2 and 7ii7 mitigating measures are not able to be established and applied to prevent or detect such inaccurate result or otherwise sufficiently mitigate the risk of such inaccurate result such that the test would be low-risk4 7#af7 ,specimen receptacle ,the term specimen receptacle means an in vitro clinical test intended for taking1 collecting1 holding1 storing1 or transporting of specimens derived from the human body or for in vitro examination for purposes described in subparagraph 7,a7 or 7,b7 of section #bja7ss77#a74 7#ag7 ,technology ,the term technology-- 7,a7 means a set of control mechanisms1 energy sources1 or operating principles-- 7i7 that do not differ significantly among multiple in vitro clinical tests2 and 7ii7 for which design and development 7including analytical and clinical validation1 as applicable7 of the tests would be addressed in a similar manner or through similar procedures2 and 7,b7 may include clot detection1 colorimetric 7non-immunoassay71 electrochemical 7non-immunoassay71 enzymatic 7non-immunoassay71 flow cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or chromatography1 microbial culture1 next generation sequencing1 nephlometric or turbidimetric 7non-immunoassay71 singleplex or multiplex non-,,ngs nucleic acid analysis1 slide-based technology1 spectroscopy1 and any other technology1 as the ,secretary determines appropriate4 7#ah7 ,test ,the term test1 unless otherwise provided1 means an in vitro clinical test4 7#ai7 ,valid scientific evidence ,the term valid scientific evidence-- 7,a7 means1 with respect to an in vitro clinical test1 evidence that-- 7i7 has been generated and evaluated by persons qualified by training or experience to do so1 using procedures generally accepted by other persons so qualified2 and 7ii7 forms an appropriate basis for concluding by qualified experts whether the applicable standard has been met by the in vitro clinical test2 and 7,b7 may include evidence described in subparagraph 7,a7 consisting of-- 7i7 peer-reviewed literature2 7ii7 clinical guidelines2 7iii7 reports of significant human experience with an in vitro clinical test2 7iv7 bench studies2 7v7 case studies or histories2 7vi7 clinical data2 7vii7 consensus standards2 7viii7 reference standards2 7ix7 data registries2 7x7 postmarket data2 7xi7 real world data2 7xii7 clinical trials2 and 7xiii7 data collected in countries other than the ,united ,states if such data are demonstrated to be appropriate for the purpose of making a regulatory determination under this subchapter4 #ehg;,a4 ,regulation of in vitro clinical tests 7a7 ,in general ,no person shall introduce or deliver for introduction into interstate commerce any in vitro clinical test1 unless-- 7#a7 an approval of an application filed pursuant to subsection 7a7 or 7b7 of section #ehg;,b is effective with respect to such in vitro clinical test2 7#b7 a technology certification order is in effect under section #ehg;,d2 or 7#c7 the test is exempt under sections #ehg;,c or #ehg;,g from the requirements of section #ehg;,b4 7b7 ,transfer or sale of ,in vitro clinical tests 7#a7 ,transfer and assumption of regulatory obligations ,if ownership of an in vitro clinical test is sold or transferred in such manner that the developer transfers the regulatory submissions and obligations applicable under this subchapter with respect to the test1 the transferee or purchaser becomes the developer of the test and shall have all regulatory obligations applicable to such a test under this subchapter4 ,the transferee or purchaser shall update the registration and listing information under section #ehg;,j for the in vitro clinical test4 7#b7 ,transfer or sale of premarket approval 7,a7 ,notice required ,if a developer of an in vitro clinical test transfers or sells the approval of the in vitro clinical test1 the transferor or seller shall-- 7i7 submit a notice of the transfer or sale to the ,secretary and update the registration and listing information under section #ehg;,j for the in vitro clinical test2 and 7ii7 submit a supplement to an application if required under section #ehg;,b7h74 7,b7 ,effective date of approval transfer ,a transfer or sale described in subparagraph 7,a7 shall become effective upon completion of a transfer or sale described in paragraph 7#a7 or the approval of a supplement to an application under section #ehg;,b7h7 if required1 whichever is later4 ,the transferee or purchaser shall update the registration and listing information under section #ehg;,j for the in vitro clinical test within #ae calendar days of the effective date of the transfer or sale4 7#c7 ,transfer or sale of technology certification 7,a7 ,requirements for transfer or sale of technology certification ,an unexpired technology certification can be transferred or sold if the transferee or purchaser-- 7i7 is an eligible person under section #ehg;,d7a77#b72 and 7ii7 maintains1 upon such transfer or sale1 test design and quality requirements1 processes and procedures under the scope of technology certification1 and scope of the technology certification identified in the applicable technology certification order4 7,b7 ,notice required ,if a developer of an in vitro clinical test transfers or sells a technology certification order that has not expired1 the transferor or seller shall submit a notice of the transfer or sale to the ,secretary and shall update the registration and listing information under section #ehg;,j for all in vitro clinical tests covered by the technology certification4 7,c7 ,effective date of technology certification transfer ,the transfer of a technology certification shall become effective upon completion of a transfer or sale described in subparagraph 7,a74 ,the transferee or purchaser shall update the registration and listing information under section #ehg;,j for the in vitro clinical test within #cj calendar days of the effective date of the technology certification transfer4 7,d7 ,new technology certification required ,if the requirements of subparagraph 7,a77ii7 are not met1 the technology certification order may not be transferred and the transferee or purchaser of an in vitro clinical test is required to submit an application for technology certification and obtain a technology certification order prior to offering the test for clinical use4 7c7 ,regulations ,the ,secretary may issue regulations to implement this subchapter4 #ehg;,b4 ,premarket review 7a7 ,application 7#a7 ,filing ,any developer may file with the ,secretary an application for premarket approval of an in vitro clinical test under this subsection4 7#b7 ,transparency and predictability ,if a developer files a premarket application under this section and provides any additional documentation required under section #ehg;,d1 the in vitro clinical test that is the subject of the premarket application may be utilized as the representative in vitro clinical test reviewed by the ,secretary to support a technology certification order under section #ehg;,d4 7#c7 ,application content ,an application submitted under paragraph 7#a7 shall include the following1 in such format as the ,secretary specifies3 7,a7 ,general information regarding the in vitro clinical test1 including-- 7i7 the name and address of the applicant2 7ii7 the table of contents for the application and the identification of the information the applicant claims as trade secret or confidential commercial or financial information2 7iii7 a description of the test's design and intended use1 including the indications for use2 and 7iv7 a description regarding test function and performance characteristics4 7,b7 ,a summary of the data and information in the application for the in vitro clinical test1 including-- 7i7 a brief description of the foreign and domestic marketing history of the test1 if any1 including a list of all countries in which the test has been marketed and a list of all countries in which the test has been withdrawn from marketing for any reason related to the ability of the in vitro clinical test to meet the applicable standard1 if known by the applicant2 7ii7 a description of benefit and risk considerations related to the in vitro clinical test1 including a description of any applicable adverse effects of the test on health and how such adverse effects have been1 or will be1 mitigated2 7iii7 a risk assessment of the test2 and 7iv7 a description of how the data and information in the application constitute valid scientific evidence and support a showing that the test meets the applicable standard under section #ehg7b74 7,c7 ,the signature of the developer filing the premarket application or an authorized representative4 7,d7 ,a bibliography of applicable published reports relied upon by the applicant and a description of any studies conducted1 including any unpublished studies related to such test1 that are known or that should reasonably be known to the applicant1 and a description of data and information relevant to the evaluation of whether the test meets the applicable standard4 7,e7 ,applicable information regarding the methods used in1 and the facilities or controls used for1 the development of the test to demonstrate compliance with the applicable quality requirements under section #ehg,k4 7,f7 ,information demonstrating compliance with any relevant and applicable-- 7i7 mitigating measures under section #ehg;,e2 and 7ii7 standards established or recognized under section #ead prior to the date of enactment of the ,,valid ,act of #bjbb1 or1 after applicable standards are established or recognized under section #ehg,q1 with such standards4 7,g7 ,valid scientific evidence to support that the test meets the applicable standard1 which shall include-- 7i7 summary information for all supporting validation studies performed1 including a description of the objective of the study1 a description of the experimental design of the study1 a description of any limitations of the study1 a brief description of how the data were collected and analyzed1 a brief description of the results of each study1 and conclusions drawn from each study2 7ii7 new raw data for each study1 which may include1 as applicable1 tabulations of data and results as required under section #had4bj7;b77#f77;ii7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 and 7iii7 for nonclinical laboratory studies involving the test1 if applicable1 a statement that studies were conducted in compliance with applicable good laboratory practices4 7,h7 ,to the extent the application seeks authorization to make modifications to the test within the scope of the approval that are not otherwise permitted without premarket review under this subchapter1 a proposed change protocol that includes validation procedures and acceptance criteria for anticipated modifications that could be made to the test within the scope of the approval4 7,i7 ,proposed labeling1 in accordance with the requirements of section #ehg,l4 7,j7 ,such other data or information as the ,secretary may require in accordance with the least burdensome requirements under section #ehg;,,aa7c74 7#d7 ,guidance for premarket and abbreviated premarket applications ,in accordance with section #hbe of the ,,valid ,act of #bjbb1 the ,secretary shall issue draft guidance detailing the information to be provided in a premarket application and abbreviated premarket application under this section4 ,the ,secretary shall issue final guidance detailing the information to be provided in a premarket application and abbreviated premarket application under this section not later than #a year prior to the effective date of such ,act4 7#e7 ,refuse to file a premarket or abbreviated premarket application ,the ,secretary may refuse to file an application under this section only for lack of completeness or legibility of the application4 ,if1 after receipt of an application under this section1 the ,secretary refuses to file such an application1 the ,secretary shall provide to the developer1 within #fj calendar days of receipt of such application1 a description of the reason for such refusal1 and identify the information required1 if any1 to allow for the filing of the application4 7#f7 ,substantive review for deficient application ,if1 after receipt of an application under this section1 the ,secretary determines that any portion of such application is materially deficient1 the ,secretary shall provide to the applicant a description of such material deficiencies and the information required to resolve such deficiencies4 7#g7 ,inspections ,with respect to an application under paragraph 7#a71 preapproval inspections authorized by an employee of the ,food and ,drug ,administration or a person accredited under section #ehg,q need not occur unless requested by the ,secretary4 7b7 ,abbreviated premarket review 7#a7 ,in general ,any developer may file with the ,secretary an application for abbreviated premarket approval for-- 7,a7 an instrument2 7,b7 a specimen receptacle2 7,c7 an in vitro clinical test that is moderate-risk2 or 7,d7 an in vitro clinical test that is determined by the ,secretary to be eligible for abbreviated premarket review under section #ehg;,f7a77#a77;,b74 7#b7 ,application content ,an application under paragraph 7#a7 shall include-- 7,a7 the information required for applications submitted under subsection 7a77#b71 except that applications under paragraph 7#a7 need not include-- 7i7 quality requirement information2 or 7ii7 raw data1 unless explicitly requested by the ,secretary2 and 7,b7 data1 as applicable1 to support software validation1 electromagnetic compatibility1 and electrical safety1 and information demonstrating compliance with maintaining quality systems documentation4 7#c7 ,safety information ,the developer of an in vitro clinical test specimen receptacle reviewed under this subsection shall maintain safety information for such specimen receptacle4 7#d7 ,inspections ,with respect to an application under paragraph 7#a71 preapproval inspections authorized by an employee of the ,food and ,drug ,administration or a person accredited under section #ehg,q need not occur unless requested by the ,secretary4 7c7 ,instruments and instrument families 7#a7 ,in general ,a developer of an instrument family shall file with the ,secretary an application for premarket approval of one version of an instrument under this subsection4 ,any modified versions of the instrument that generate a new instrument within the same instrument family shall be exempt from premarket review requirements of this section1 provided that the developer of such instrument or instrument family-- 7,a7 maintains documentation that the new instrument is part of the instrument family1 as defined in section #ehg2 7,b7 performs1 documents1 and maintains a risk assessment 7as described in subsection 7a77#b77;,b77iv77 of the new instrument compared to the instrument approved under subsection 7b7 and no new risks are identified2 7,c7 performs1 documents1 and maintains validation and verification activities for the new instrument2 7,d7 makes such documentation available to the ,secretary upon request2 and 7,e7 registers and lists the new instrument in accordance with section #ehg;,j4 7#b7 ,test kits and test protocols ,a test kit or test protocol that is approved under this section for use on an approved instrument or an instrument exempt from premarket review1 including an instrument within an instrument family under this section1 a submission under this section shall not be required for such test kit or test protocol in order for it to be used on a new instrument within its instrument family1 provided that-- 7,a7 use of the test kit or test protocol with the new instrument does not-- 7i7 change the claims for the test kit or test protocol1 except as applicable1 claims regarding an instrument or instruments that can be used with such test kit or test protocol2 7ii7 adversely affect performance of the test kit or test protocol2 or 7iii7 cause the test kit or test protocol to no longer conform with performance standards required under section #ehg,r or comply with any applicable mitigating measures under section #ehg;,e1 conditions of approval under subsection 7e77#b77;,b71 or restrictions under section #ehg,o2 7,b7 the test developer does not identify any new risks for the test kit or test protocol when using the new instrument2 7,c7 the test developer validates the use of the new instrument with the test kit or test protocol and maintains validation documentation2 7,d7 the test kit or test protocol is not intended for use-- 7i7 at the point of care setting or in settings for which a certificate of waiver is in effect under section #cec of the ,public ,health ,service ,act2 7ii7 without a prescription2 7iii7 at home2 or 7iv7 in testing donors1 donations1 and recipients of blood1 blood components1 human cells1 tissues1 cellular-based products1 or tissue-based products2 7,e7 the test developer makes the documentation described under subparagraph 7,c7 available to the ,secretary upon request2 and 7,f7 the test developer updates the listing information for the test kit or test protocol1 as applicable4 7d7 ,amendments to an application ,an applicant shall amend an application submitted under subsection 7a71 7b71 or 7f7 if the applicant becomes aware of information that could reasonably affect an evaluation under subsection 7e7 of whether the approval standard has been met4 7e7 ,action on an application for premarket approval 7#a7 ,review 7,a7 ,disposition ,as promptly as possible1 but not later than #ij calendar days after an application under subsection 7a7 is accepted for submission 7unless the ,secretary determines that an extension is necessary to review one or more major amendments to the application71 or not later than #fj calendar days after an application under subsection 7b7 is accepted for submission or a supplemental application under subsection 7f7 is accepted for submission1 the ,secretary1 after considering any applicable report and recommendations pursuant to advisory committees under section #ehg;,h1 shall issue an order approving the application1 unless the ,secretary finds that the grounds for approval in paragraph 7#b7 are not met4 7,b7 ,reliance on proposed labeling ,in determining whether to approve or deny an application under paragraph 7#a71 the ,secretary shall rely on the indications for use included in the proposed labeling1 provided that such labeling is not false or misleading based on a fair evaluation of all material facts4 7#b7 ,approval of an application 7,a7 ,in general ,the ,secretary shall approve an application submitted under subsection 7a7 or 7b7 with respect to an in vitro clinical test if the ,secretary finds that the applicable standard is met1 and-- 7i7 the applicant is in compliance with applicable quality requirements in section #ehg,k2 7ii7 the application does not contain a false statement or misrepresentation of material fact2 7iii7 based on a fair evaluation of all material facts1 the proposed labeling is truthful and non-misleading and complies with the requirements of section #ehg,l2 7iv7 the applicant permits1 if requested1 authorized employees of the ,food and ,drug ,administration and persons accredited under section #ehg,q an opportunity to inspect pursuant to section #gjd2 7v7 the test conforms with any applicable performance standards required under section #ehg,r and any applicable mitigating measures under section #ehg;,e2 7vi7 all nonclinical laboratory studies and clinical investigations involving human subjects that are described in the application were conducted in a manner that meets the applicable requirements of this subchapter2 and 7vii7 other data and information the ,secretary may require under subsection 7a77#b77,k7 support approval4 7,b7 ,conditions of approval ,an order approving an application pursuant to this section may require reasonable conditions of approval for the in vitro clinical test1 which may include conformance with applicable mitigating measures under section #ehg;,e1 restrictions under section #ehg,o1 and performance standards under section #ehg,r4 7,c7 ,publication ,the ,secretary shall publish an order for each application approved pursuant to this paragraph on the public website of the ,food and ,drug ,administration and make publicly available a summary of the data used to approve such application1 except to the extent the ,secretary determines that such order-- 7i7 contains commercially confidential or trade secret information2 or 7ii7 if published1 would present a risk to national security4 7#c7 ,review of denials ,an applicant whose application submitted under this section has been denied approval under this subsection may1 by petition filed not more than #fj calendar days after the date on which the applicant receives notice of such denial1 obtain review of the denial in accordance with section #ehg,p4 7f7 ,supplements to an approved application 7#a7 ,risk analysis ,prior to implementing any modification to an in vitro clinical test1 the holder of the application approved under subsection 7a7 or 7b7 for such test shall perform risk analyses in accordance with this subsection1 unless such modification is included in the change protocol submitted by the applicant and approved under this section or exempt under section #ehg;,c4 7#b7 ,supplement requirement 7,a7 ,in general ,if the holder of an application of an approved in vitro clinical test makes a modification to such in vitro clinical test1 except as provided in subparagraph 7,c71 or otherwise specified by the ,secretary1 the holder of the application approved under subsection 7e7 for an in vitro clinical test shall submit a supplemental application to the ,secretary4 ,the holder of the application may not implement such modification to the in vitro clinical test until such supplemental application is approved4 ,the information required in a supplemental application is limited to what is needed to support the change4 7,b7 ,adjustments to change protocol ,the holder of an approved application may submit under this paragraph a supplemental application to modify the change protocol of the test at any time after the application is submitted under subsection 7a7 or 7b74 7,c7 ,exceptions ,notwithstanding subparagraphs 7,a7 and 7,b71 and so long as the holder of an approved application submitted under subsection 7a7 or 7b7 for an in vitro clinical test does not add a manufacturing site1 or change activities at an existing manufacturing site1 with respect to the test1 the holder of an approved application may1 without submission of a supplemental application1 implement the following modifications to the test3 7i7 ,modifications in accordance with an approved change protocol under subsection 7a77#c77;,h74 7ii7 ,modifications that are exempt under section #ehg;,c7b74 7iii7 ,labeling changes that are appropriate to address a safety concern1 except such labeling changes that include any of the following1 remain subject to subparagraph 7,a73 7,i7 ,a change to the indications for use of the test4 7,,ii7 ,a change to the performance claims made with respect to the test4 7,,iii7 ,a change that adversely affects performance of the test4 7,d7 ,reporting for certain modifications made pursuant to a change protocol ,the holder of an application approved under subsection 7e71 with an approved change protocol under subsection 7a77#b77;,h7 for such in vitro clinical test shall-- 7i7 report any modification to such test made pursuant to such change protocol approved under subsection 7a77#b77;,h7 in a submission under section #ehg;,j7c77#b77;,b72 and 7ii7 include in such report-- 7,i7 a description of the modification2 7,,ii7 the rationale for implementing such modification2 and 7,,iii7 as applicable1 a summary of the evidence supporting that the test1 as modified1 meets the applicable standard1 complies with performance standards required under section #ehg,q1 and complies with any mitigating measures established under section #ehg;,e and any restrictions under section #ehg,o4 7,e7 ,reporting for certain safety related labeling changes ,the holder of the application for an in vitro clinical test approved under subsection 7a7 or 7b7 pursuant to subsection 7e7 shall-- 7i7 report to the ,secretary any modification to the test described in subparagraph 7,c77iii7 not more than #cj days after the date on which the test1 with the modifications1 is introduced into interstate commerce2 and 7ii7 include in the report-- 7,i7 a description of the change or changes2 7,,ii7 the rationale for implementing such change or changes2 and 7,,iii7 a description of how the change or changes were evaluated4 7#c7 ,contents of supplement ,unless otherwise specified by the ,secretary1 a supplement under this subsection shall include-- 7,a7 for modifications other than manufacturing site changes requiring a supplement-- 7i7 a description of the modification2 7ii7 data relevant to the modification to demonstrate that the applicable standard is met1 not to exceed data requirements for the original submission2 7iii7 acceptance criteria2 and 7iv7 any revised labeling2 and 7,b7 for manufacturing site changes-- 7i7 the information listed in subparagraph 7,a72 and 7ii7 information regarding the methods used in1 or the facilities or controls used for1 the development of the test to demonstrate compliance with the applicable quality requirements under section #ehg,k4 7#d7 ,additional data ,the ,secretary may require1 when necessary1 data to evaluate a modification to an in vitro clinical test that is in addition to the data otherwise required under the preceding paragraphs if the data request is in accordance with the least burdensome requirements under section #ehg;,,aa7c74 7#e7 ,conditions of approval ,in an order approving a supplement under this subsection1 the ,secretary may require conditions of approval for the in vitro clinical test1 including compliance with restrictions under section #ehg,o and conformance to performance standards under section #ehg,r4 7#f7 ,approval ,the ,secretary shall approve a supplement under this subsection if-- 7,a7 the data demonstrate that the modified in vitro clinical test meets the applicable standard2 and 7,b7 the holder of the application approved under subsection 7e7 for the test has demonstrated compliance with applicable quality and inspection requirements1 as applicable and appropriate4 7#g7 ,publication ,the ,secretary shall publish on the public website of the ,food and ,drug ,administration notice of any order approving a supplement under this subsection1 except that such publication shall exclude-- 7,a7 commercial confidential or trade secret information2 and 7,b7 any other information that the ,secretary determines to relate to national security or countermeasures or to be restricted from disclosure pursuant to another provision of law4 7#h7 ,review of denial ,an applicant whose supplement under this subsection has been denied approval may1 by petition filed on or before the #fjth calendar day after the date upon which the applicant receives notice of such denial1 obtain review of the denial in accordance with section #ehg,p4 7g7 ,withdrawal and temporary suspension of approval 7#a7 ,order withdrawing approval 7,a7 ,in general ,the ,secretary may1 after providing due notice and an opportunity for an informal hearing to the holder of an approved application for an in vitro clinical test under this section1 issue an order withdrawing approval of the application if the ,secretary finds that-- 7i7 the grounds for approval under subsection 7e7 are no longer met2 7ii7 there is a reasonable likelihood that the test would cause death or serious adverse health consequences1 including by causing the absence1 significant delay1 or discontinuation of life-saving or life sustaining medical treatment2 7iii7 the holder of the approved application-- 7,i7 has failed to1 or repeatedly or deliberately failed to1 maintain records to make reports1 as required under section #ehg,m2 7,,ii7 has refused to permit access to1 or copying or verification of such records1 as required under section #gjd2 7,,iii7 has not complied with the requirements of section #ehg,k2 or 7,,iv7 has not complied with any mitigating measure required under section #ehg;,e or restriction under section #ehg,o2 or 7iv7 the labeling of such in vitro clinical test1 based on a fair evaluation of all material facts1 is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the ,secretary of such fact4 7,b7 ,content ,an order under subparagraph 7,a7 withdrawing approval of an application shall state each ground for withdrawal and shall notify the holder of such application #fj calendar days prior to issuing such order4 7,c7 ,publication ,the ,secretary shall publish any order under subparagraph 7,a7 on the public website of the ,food and ,drug ,administration1 except that such publication shall exclude-- 7i7 commercial confidential or trade secret information2 and 7ii7 any other information that the ,secretary determines1 if published1 would present a risk to national security4 7#b7 ,order of temporary suspension ,if1 after providing due notice and an opportunity for an informal hearing to the holder of an approved application for an in vitro clinical test under this section1 the ,secretary determines1 based on scientific evidence1 that there is a reasonable likelihood that the in vitro clinical test would cause death or serious adverse health consequences1 such as by causing the absence1 significant delay1 or discontinuation of life-saving or life-sustaining medical treatment1 the ,secretary shall1 by order1 temporarily suspend the approval of the application4 ,if the ,secretary issues such an order1 the ,secretary shall proceed expeditiously under paragraph 7#a7 to withdraw approval of such application4 7#c7 ,appeal withdrawing approval and orders of temporary suspensions ,an order of withdrawal or an order of temporary suspension may be appealed under #ehg,p4 #ehg;,c4 ,exemptions 7a7 ,in general ,the following in vitro clinical tests are exempt from premarket review under section #ehg;,b1 and may be lawfully marketed subject to other applicable requirements of this ,act3 7#a7 ,tests exempt from section #eaj7k7 7,a7 ,exemption ,an in vitro clinical test is exempt from premarket review under section #ehg;,b and may be lawfully marketed subject to the other applicable requirements of this ,act1 if the developer of the in vitro clinical test-- 7i7 maintains documentation demonstrating that the test meets and continues to meet the criteria set forth in subparagraph 7,b72 and 7ii7 makes such documentation available to the ,secretary upon request4 7,b7 ,criteria for exemption ,an in vitro clinical test is exempt as specified in subparagraph 7,a7 if such test-- 7i7 7,i7 was offered for clinical use prior to the date of enactment of the ,,valid ,act of #bjbb2 7,,ii7 immediately prior to such date of enactment was exempt pursuant to subsection 7l7 or 7m77#b7 of section #eaj from the requirements for submission of a report under section #eaj7k72 or 7,,iii7 7aa7 was not offered for clinical use prior to such date of enactment2 7bb7 is not an instrument2 and 7cc7 falls within a category of tests that was exempt from the requirements for submission of a report under section #eaj7k7 as of such date of enactment 7including class ,,ii devices and excluding class ,i devices described in section #eaj7l772 7ii7 meets the applicable standard as described in section #ehg7b72 7iii7 is not offered with labeling and advertising that is false or misleading2 and 7iv7 is not likely to cause or contribute to serious adverse health consequences4 7,c7 ,effect on special controls ,for any in vitro clinical test1 or category of in vitro clinical tests1 that is exempt from premarket review based on the criteria in subparagraph 7,b71 any special control that applied to a device within a predecessor category immediately prior to the date of enactment of the ,,valid ,act of #bjbb shall be deemed a mitigating measure applicable under section #ehg;,e to an in vitro clinical test within the successor category1 except to the extent such mitigating measure is withdrawn or changed in accordance with section #ehg;,e4 7,d7 ,near-patient testing ,not later than #a year after the date of enactment of the ,,valid ,act of #bjbb1 the ,secretary shall issue draft guidance indicating categories of tests that shall be exempt from premarket review under section #ehg;,b when offered for near-patient testing 7point of care71 which were not exempt from submission of a report under section #eaj7k7 pursuant to subsection 7l7 or 7m77#b7 of section #eaj and regulations imposing limitations on exemption for in vitro devices intended for near-patient testing 7point of care74 7#b7 ,low-risk tests 7,a7 ,exemption ,an in vitro clinical test is exempt from premarket review under section #ehg;,b and may be lawfully marketed subject to the other applicable requirements of this ,act1 including section #ehg;,j7b77#f71 if such test meets the definition of low-risk under section #ehg and if the developer of the test-- 7i7 maintains documentation demonstrating that the in vitro clinical test meets and continues to meet the criteria set forth in paragraph 7#b72 and 7ii7 makes such documentation available to the ,secretary upon request4 7,b7 ,criteria for exemption ,an in vitro clinical test is exempt as specified in subparagraph 7,a7 if-- 7i7 the in vitro clinical test meets the applicable standard as described in #ehg7b72 7ii7 the labeling and advertising are not false or misleading2 7iii7 the in vitro clinical test is not likely to cause or contribute to serious adverse health consequences2 and 7iv7 the in vitro clinical test is listed pursuant to section #ehg;,j or falls within a category of tests listed as described in subparagraph 7,c74 7,c7 ,list of low-risk tests 7i7 ,in general ,the ,secretary shall maintain1 and make publicly available on the website of the ,food and ,drug ,administration1 a list of in vitro clinical tests1 and categories of in vitro clinical tests1 that are low-risk in vitro clinical tests for purposes of the exemption under this paragraph4 7ii7 ,inclusion ,the list under clause 7i7 shall consist of-- 7,i7 all in vitro clinical tests and categories of in vitro clinical tests that are exempt from premarket review pursuant to subsection 7d77#a7 or 7d77#c72 and 7,,ii7 all in vitro clinical tests and categories of in vitro clinical tests that are designated by the ,secretary pursuant to subparagraph 7,c7 as low-risk for purposes of this paragraph4 7,d7 ,designation of tests and categories ,without regard to subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 the ,secretary may designate1 in addition to the tests and categories described in subparagraph 7,c77i71 additional in vitro clinical tests1 and categories of in vitro clinical tests1 as low-risk in vitro clinical tests for purposes of the exemption under this paragraph4 ,the ,secretary may make such a designation on the ,secretary's own initiative or in response to a request by a developer pursuant to subsection 7a7 or 7b7 of section #ehg;,f4 ,in making such a designation for a test or category of tests1 the ,secretary shall consider-- 7i7 whether the test1 or category of tests1 is low-risk2 7ii7 the existence of and ability to develop mitigating measures sufficient for such test category to meet the low-risk standard2 and 7iii7 such other factors as the ,secretary determines to be appropriate for the protection of the public health4 7#c7 ,humanitarian test exemption 7,a7 ,in general ,an in vitro clinical test that meets the criteria under subparagraph 7,b7 is exempt from premarket review under section #ehg;,b and may be lawfully offered subject to the other applicable requirements of this subchapter1 if the developer of the test-- 7i7 maintains documentation 7which may include literature citations in specialized medical journals1 textbooks1 specialized medical society proceedings1 and governmental statistics publications1 or1 if no such studies or literature citations exist1 credible conclusions from appropriate research or surveys7 demonstrating that such test meets and continues to meet the criteria described in this subsection2 and 7ii7 makes such documentation available to the ,secretary upon request4 7,b7 ,criteria for exemption ,an in vitro clinical test is exempt as described in subparagraph 7,a7 if-- 7i7 the in vitro clinical test is intended by the developer for use for a diagnostic purpose for a disease or condition that affects not more than #aj1jjj 7or such other higher number determined by the ,secretary7 individuals in the ,united ,states per year2 and 7ii7 the in vitro clinical test meets the applicable standard described in section #ehg7b72 7iii7 the labeling and advertising for the in vitro clinical test are not false or misleading2 7iv7 the in vitro clinical test is not likely to cause or contribute to serious health consequences2 and 7v7 the in vitro clinical test is not intended for screening4 7,c7 ,exception for certain tests ,an in vitro clinical test intended to inform the use of a specific individual or specific type of biological product1 drug1 or device shall be eligible for an exemption from premarket review under this subsection only if1 the developer submits a request under subsection 7m7 for informal feedback and the ,secretary determines that such in vitro clinical test is eligible for an exemption from premarket review under this subsection4 7#d7 ,custom tests and low-,volume tests ,an in vitro clinical test is exempt from premarket review under section #ehg;,b1 quality requirements under section #ehg,k1 and listing requirements under section #ehg;,j1 and may be lawfully marketed subject to the other applicable requirements of this ,act1 if-- 7,a7 such in vitro clinical test-- 7i7 is a test protocol performed for not more than #e patients per year 7or such other higher number determined by the ,secretary71 in a laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that-- 7,i7 meets the requirements to perform tests of high-complexity in which the test protocol was developed2 or 7,,ii7 meets the requirements to perform tests of high-complexity within the same corporate organization and having common ownership by the same parent corporation as the laboratory in which such test protocol was developed2 or 7ii7 is an in vitro clinical test developed or modified to diagnose a unique pathology or physical condition of a specific patient or patients1 upon order of a health professional or other specially qualified person designated under regulations1 for which no other in vitro clinical test is commercially available in the ,united ,states1 and is-- 7,i7 not intended for use with respect to more than #e 7or such other higher number determined by the ,secretary7 other patients2 and 7,,ii7 after the development of such test1 not included in any test menu or template test report or other promotional materials1 and is not otherwise advertised2 and 7,b7 the developer of the in vitro clinical test-- 7i7 maintains documentation demonstrating that such test meets the applicable criteria described in subparagraph 7,a72 7ii7 makes such documentation1 such as a prescription order requesting the custom test for an individual patient1 available to the ,secretary upon request2 and 7iii7 informs the ,secretary1 on an annual basis1 in a manner prescribed by the ,secretary by guidance1 that such test was offered4 7#e7 ,in vitro clinical tests under a technology certification order ,an in vitro clinical test that is within the scope of a technology certification order1 as described in section #ehg;,d7a71 is exempt from premarket review under section #ehg;,b4 4 7#f7 ,modified tests 7,a7 ,in general ,an in vitro clinical test that is modified is exempt from premarket review under section #ehg;,b if-- 7i7 7,i7 the modification is made by-- 7aa7 the developer that obtained premarket approval for the unmodified version of the test under section #ehg;,b2 or 7bb7 a clinical laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that meets the requirements for performing high complexity testing1 to a lawfully offered in vitro clinical test1 including another developer's lawfully offered in vitro clinical test1 excluding investigational in vitro clinical tests offered under section #ehg,s1 and the modified test is performed-- 7,,aa7 in the same clinical laboratory in which it was developed for which a certification is still in effect under section #cec that meets the requirements to perform tests of high complexity2 7,,bb7 by another clinical laboratory for which a certificate is in effect under section #cec that meets the requirements to perform tests of high complexity1 is within the same corporate organization1 and has common ownership by the same parent corporation as the laboratory in which the test was developed2 or 7,,cc7 by a clinical laboratory for which a certificate is in effect under section #cec that meets the requirements to perform tests of high complexity and is within a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention1 if the test was developed by the ,centers for ,disease ,control and ,prevention or another laboratory within such public health laboratory network2 or 7,,ii7 the modification does not-- 7aa7 constitute a significant change to the indications for use2 7bb7 cause the test to no longer comply with applicable mitigating measures under section #ehg;,e or restrictions under section #ehg,o2 7cc7 significantly change performance claims or significantly and adversely change performance1 unless provided for under an approved change protocol under section #ehg7;a77#b77;,h72 or 7dd7 constitute an adverse change in the safety of the in vitro clinical test for individuals who come in contact with the in vitro clinical test2 7ii7 the test meets the applicable standard as described in section #ehg7b72 7iii7 the labeling and advertising are not false or misleading2 and 7iv7 the test is not likely to cause or contribute to serious adverse health consequences4 7,b7 ,certain modifications ,a modification to extend specimen stability is exempt from premarket review under section #ehg;,b if the modified test meets the requirements in clauses 7iii7 through 7v7 of subparagraph 7,a74 7,c7 ,modifications under a change protocol ,notwithstanding subparagraph 7,a71 a modification made under a change protocol pursuant to subsection 7a77#b77;,h7 of section #ehg;,b is exempt from review under such section4 7,d7 ,documentation ,a person who modifies an in vitro clinical test in a manner that is a modification described in subparagraph 7,a7 shall-- 7i7 document the modification that was made and the basis for determining that the modification1 considering the changes individually and collectively1 is a type of modification described in subparagraph 7,a71 7,b71 or 7,c72 and 7ii7 provide such documentation to the ,secretary upon request or inspection4 7,e7 ,guidance ,not later than #cj months after the date of enactment of the ,,valid ,act of #bjbb1 the ,secretary shall issue guidance regarding the in vitro clinical tests that are modified and exempt from premarket review under section #ehg;,b pursuant to this paragraph4 7b7 ,manual tests 7#a7 ,exemption ,an in vitro clinical test is exempt from all requirements of this subchapter if the output of such in vitro clinical test is the result of direct1 manual observation1 without the use of automated instrumentation or software for intermediate or final interpretation1 by a qualified laboratory professional1 and such in vitro clinical test-- 7,a7 is designed1 developed1 and used within a single clinical laboratory for which a certificate is in effect under section #cec of the ,public ,health ,service ,act that meets the requirements under section #cec for performing high-complexity testing2 7,b7 is not a specimen receptacle1 instrument1 or an in vitro clinical test that includes an instrument or specimen receptacle that is not approved under or exempt from section #ehg;,b2 7,c7 is not a high-risk test1 or is a high-risk test that the ,secretary has determined meets at least one condition in paragraph 7#b7 and is otherwise appropriate for this exemption2 and 7,d7 is not intended for testing donors1 donations1 or recipients of blood1 blood components1 human cells1 tissues1 cellular-based products1 or tissue-based products4 7#b7 ,high-risk test limitation or condition ,a high-risk test may be exempt under paragraph 7#a7 from the requirements of this subchapter only if-- 7,a7 no component or part of such test1 including any reagent1 is introduced into interstate commerce under the exemption under paragraph 7#e71 and any article for taking or deriving specimens from the human body used in conjunction with the test remains subject to the requirements of this subchapter2 or 7,b7 the test has been developed in accordance with the applicable test design and quality requirements under section #ehg;,j4 7c7 ,public health surveillance activities 7#a7 ,in general ,the provisions of this subchapter shall not apply to a test intended by the developer to be used solely for public health surveillance activities4 7#b7 ,exclusion ,an in vitro clinical test used for public health surveillance activities is not excluded from the provisions of this subchapter pursuant to this subsection if such test is intended for use in making clinical decisions for individual patients4 7d7 ,general laboratory equipment ,any instrument that does not produce an analytical result1 and that functions as a component of pre-analytical procedures related to in vitro clinical tests1 is not subject to the requirements of this subchapter1 provided that the instrument is operating in a clinical laboratory that is certified under section #cec of the ,public ,health ,service ,act4 7e7 ,components and ,parts 7#a7 ,in general ,subject to paragraph 7#b71 a component or part described in section #bja7ss77#b77;,e7 is-- 7,a7 exempt from the requirements of this subchapter if it is intended for further development as described in paragraph 7#c72 or 7,b7 subject to the requirements of this subchapter and regulated based on its risk when used as intended by the developer1 notwithstanding its subsequent use by a developer as a component1 part1 or raw material of another in vitro clinical test4 7#b7 ,inapplicability to other tests ,notwithstanding paragraph 7#a71 an in vitro clinical test that is described in section #bja7ss77#a77;,b7 and that uses a component or part described in such subparagraph shall be subject to the requirements of this subchapter1 unless the test is otherwise exempt under this section4 7#c7 ,further development ,a component1 part1 or raw material 7as described in paragraph 7#a77 is intended for further development 7for purposes of such paragraph7 if-- 7,a7 it is intended solely for use in the development of another in vitro clinical test2 and 7,b7 in the case of such a test that is introduced or delivered for introduction into interstate commerce after the date of enactment of the ,,valid ,act of #bjbb1 the labeling of such test bears the following statement3 ,this product is intended solely for further development of an in vitro clinical test and is exempt from ,,fda regulation4 ,this product must be evaluated by the in vitro clinical test developer if it is used with or in the development of an in vitro clinical test44 7f7 ,general exemption authority ,the ,secretary may1 by order published in the ,federal ,register following notice and an opportunity for comment1 exempt a class of persons from any section under this subchapter upon a finding that such exemption is appropriate for the protection of the public health and other relevant considerations4 7g7 ,exemption ,an in vitro clinical test that is intended solely for use in forensic analysis or law enforcement activity is exempt from the requirements of this subchapter4 ,an in vitro clinical test that is intended for use in making clinical decisions for individual patients1 or whose individually identifiable results may be reported back to an individual patient or the patient's health care provider1 even if also intended for forensic analysis or law enforcement purposes1 is not intended solely for forensic analysis or law enforcement for purposes of this subsection4 7h7 ,revocation 7#a7 ,in general ,the ,secretary may revoke any exemption with respect to in vitro clinical tests with the same indications for use if new clinical information indicates that the exemption of an in vitro clinical test or tests from premarket review under section #ehg;,b has a reasonable probability of severe adverse health consequences1 including the absence1 delay1 or discontinuation of appropriate medical treatment4 7#b7 ,process ,any action under paragraph 7#a7 shall be made by publication of a notice of such proposed action on the website of the ,food and ,drug ,administration1 the consideration of comments to a public docket on such proposal1 and publication of a final action on such website within #fj calendar days of the close of the comment period posted to such public docket1 notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7i7 ,pre-,analytical instrument ,a pre-analytical instrument is exempt from premarket review under section #ehg;,b and may be lawfully offered subject to the other applicable requirements of this ,act1 if either of the following applies3 7#a7 ,such instrument provides additional information regarding the sample or performs an action on the sample but is not preparing or processing the sample and does not perform any function of an analytical instrument4 ,such types of pre-analytical instruments include barcode readers1 sample movers1 and sample identifiers4 7#b7 ,such instrument processes or prepares the sample prior to use on an analytical instrument1 does not perform any function of an analytical instrument1 and does not select1 isolate1 or prepare a part of a sample based on specific properties4 ,such types of pre-analytical instruments may include sample mixers1 ,,dna extractors and those used to dilute samples4 #ehg;,d4 ,technology certification 7a7 ,definitions ,in this section3 7#a7 ,eligible in vitro clinical test ,the term eligible in vitro clinical test means an in vitro clinical test that is not-- 7,a7 a component or part of an in vitro clinical test as described in section #bja7ss77#b77;,e72 7,b7 an instrument under section #bja7ss77#b77;,b7 or an in vitro clinical test that includes an instrument that is not approved under1 or exempt from1 section #ehg;,b2 7,c7 a specimen receptacle under section #bja7ss77#b77;,c7 or an in vitro clinical test that includes a specimen receptacle that is not approved under1 or exempt from1 section #ehg;,b2 7,d7 an in vitro clinical test1 including reagents used in such tests1 intended for use for testing donors1 donations1 and recipients of blood1 blood components1 human cells1 tissues1 cellular-based products1 or tissue-based products2 7,e7 high-risk2 7,f7 a combination product unless such test has been determined to be eligible to be introduced into interstate commerce under a technology certification order pursuant to the regulatory pathway designation process described in section #ehg;,f1 or as described in subsection 7k72 or 7,g7 a first-of-a-kind in vitro clinical test1 unless such test has been determined to be eligible to be introduced into interstate commerce under a technology certification order pursuant to the regulatory pathway designation process described in section #ehg;,f1 or as described in subsection 7k74 7#b7 ,eligible person ,the term eligible person means an in vitro clinical test developer unless such developer-- 7,a7 is a laboratory subject to section #cec of the ,public ,health ,service ,act and does not have in effect a certificate applicable to the category of laboratory examination or other procedure2 7,b7 was a laboratory1 or an owner or operator or any employee of a laboratory1 found to have committed a significant violation of section #cec of the ,public ,health ,service ,act that resulted in a suspended1 revoked1 or limited certificate within the #b-year period preceding the date of the submission of the application for a technology certificate under subsection 7c7 and such violation has not been resolved2 or 7,c7 has been found to have submitted information to the ,secretary1 or otherwise disseminated information1 that-- 7i7 made false or misleading statements relevant to the requirements of this subchapter2 or 7ii7 violated any requirement of this ,act1 where such violation exposed individuals to serious risk of illness1 injury1 or death1 unless-- 7,i7 such violation has been resolved2 or 7,,ii7 such violation is not pertinent to any in vitro clinical test within the scope of the technology certification that such developer seeks4 7b7 ,applicability 7#a7 ,in general ,an in vitro clinical test is not subject to section #ehg;,b and may be introduced into interstate commerce if the in vitro clinical test-- 7,a7 is an eligible in vitro clinical test2 7,b7 is developed by an eligible person2 7,c7 falls within the scope of a technology certification order issued under this section and that is in effect2 7,d7 complies with the conditions of the technology certification order1 including with applicable mitigating measures under section #ehg;,e1 restrictions under section #ehg,o1 and performance standards under section #ehg,r2 and 7,e7 meets the applicable standard described in section #ehg7b74 7#b7 ,scope 7,a7 ,in general ,subject to subparagraph 7,b71 the scope of a technology certification order issued under this section shall apply to multiple in vitro clinical tests utilizing the technology do not significantly differ in control mechanisms1 energy sources1 or operating principles and for which development1 including design1 and analytical and clinical validation1 of the in vitro clinical tests would be addressed through similar procedures1 and be no broader than-- 7i7 a single technology type2 or 7ii7 a fixed combination of technologies4 7,b7 ,technology type ,a technology type described in this paragraph may include clot detection1 colorimetric 7non-immunoassay71 electrochemical 7non-immunoassay71 enzymatic 7non-immunoassay71 flow cytometry1 fluorometry 7non-immunoassay71 immunoassay1 mass spectrometry or chromatography1 microbial culture1 next generation sequencing1 nephlometric or turbidimetric 7non-immunoassay71 singleplex or multiplex non-,,ngs nucleic acid analysis1 slide-based technology1 spectroscopy1 and any other technology1 as the ,secretary determines appropriate4 7c7 ,application for technology certification 7#a7 ,in general ,a developer seeking a technology certification order shall submit an application under this subsection1 which shall contain the information specified under paragraph 7#b74 7#b7 ,content of application ,a developer that submits an application for a technology certification shall include all necessary information to make a showing that all eligible in vitro clinical tests developed within the scope of the technology certification order will meet the applicable standard1 including-- 7,a7 the name and address of the developer2 7,b7 a table of contents for the application and the identification of the information the developer claims as trade secret or confidential commercial or financial information2 7,c7 the signature of the individual filing the application or an authorized representative2 7,d7 a statement identifying the scope of the proposed technology certification intended to be introduced into interstate commerce under the application2 7,e7 information establishing that the developer submitting the application is an eligible person2 7,f7 quality procedures showing that eligible in vitro clinical tests covered under the technology certification will conform to the applicable quality requirements of section #ehg,k with respect to-- 7i7 design controls1 including related purchasing controls and acceptance activities2 7ii7 complaint investigation1 adverse event reporting1 and corrections and removals2 and 7iii7 process validation1 as applicable2 7,g7 procedures for analytical and clinical validation1 including all procedures for validation1 verification1 and acceptance criteria1 and an explanation as to how such procedures1 when used1 provide a showing of analytical validity of eligible in vitro clinical tests within the proposed scope of the technology certification order that is analytically and clinically valid2 7,h7 procedures that provide a showing that in vitro clinical tests covered by the proposed scope of the technology certification order will be safe for individuals who come into contact with in vitro clinical tests covered by such order2 7,i7 a proposed listing submission under section #ehg;,j7b7 for in vitro clinical tests that the developer intends to introduce into interstate commerce upon receiving a technology certification order1 which shall not be construed to limit the developer from introducing additional tests not included in such submission under the same technology certification order2 7,j7 information concerning one or more representative in vitro clinical tests1 including-- 7i7 a test within the scope of the technology certification application with the appropriate analytical complexity at the time of the submission of the application under this section to serve as the representative test and validate and run within the developer's stated scope2 7ii7 the information specified in subsection 7a7 or 7b7 of section #ehg;,b1 as applicable1 for the representative in vitro clinical test or tests1 including information and data required pursuant to subsection 7a77#b77;,g7 of section #ehg;,b1 unless the ,secretary determines that such information is not necessary2 7iii7 a summary of a risk assessment of the in vitro clinical test2 7iv7 an explanation of the choice of the representative in vitro clinical test or tests for the technology certification application and how such test adequately demonstrates the range of procedures that the developer includes in the application under subparagraphs 7,f71 7,g71 7,h71 and 7,i72 and 7v7 a brief explanation of the ways in which the procedures included in the application under subparagraphs 7,f71 7,g71 7,h71 and 7,i7 have been applied to the representative in vitro clinical test or tests2 and 7,k7 such other information necessary to make a determination on a technology certification application as the ,secretary may determine necessary4 7#c7 ,reference to existing applications ,with respect to the content requirements in the technology certification application described in paragraph 7#b71 a developer may incorporate by reference any content of an application previously submitted by the developer4 7d7 ,action on an application for technology certification 7#a7 ,secretary response 7,a7 ,in general ,as promptly as practicable1 and not later than #ij days after receipt of an application under subsection 7c71 the ,secretary shall-- 7i7 issue a technology certification order granting the application1 which shall specify the scope of the technology certification1 if the ,secretary finds that all of the grounds in paragraph 7#c7 are met2 or 7ii7 deny the application if the ,secretary finds 7and sets forth the basis of such finding as part of or accompanying such denial7 that one or more grounds for granting the application specified in paragraph 7#c7 are not met4 7,b7 ,extension ,the timeline described in subparagraph 7,a7 may be extended by mutual agreement between the ,secretary and the applicant4 7#b7 ,deficient applications 7,a7 ,in general ,if1 after receipt of an application under this section1 the ,secretary determines that any portion of such application is deficient1 the ,secretary1 not later than #fj days after receipt of such application1 shall provide to the applicant a description of such deficiencies and identify the information required to resolve such deficiencies4 7,b7 ,converting to premarket applications ,when responding to the deficiency letter1 the developer may convert the application for technology certification under subsection 7c7 into a premarket application under section #ehg;,b4 7#c7 ,technology certification order ,the ,secretary shall issue an order granting a technology certification under this section if1 on the basis of the information submitted to the ,secretary as part of the application and any other information with respect to such applicant1 the ,secretary finds that-- 7,a7 there is a showing that in vitro clinical tests within the scope of the technology certification order will meet the applicable standard2 7,b7 the methods used in1 and the facilities or controls used for1 the development of eligible in vitro clinical tests covered by the proposed scope of the technology certification conform to the applicable requirements of section #ehg,k with respect to-- 7i7 design controls1 including related purchasing controls and acceptance activities2 7ii7 complaint investigation1 adverse event reporting1 and corrections and removals2 and 7iii7 process validation1 as applicable2 7,c7 based on a fair evaluation of all material facts1 the applicant's proposed labeling and advertising are not false or misleading in any particular2 7,d7 the application does not contain a false statement of material fact2 7,e7 there is a showing that the representative in vitro clinical test or tests-- 7i7 meet the applicable standard2 and 7ii7 reasonably represent the range of procedures required to be submitted in the application2 7,f7 the applicant has agreed to permit1 upon request1 authorized employees of the ,food and ,drug ,administration or persons accredited1 or recognized under this ,act1 an opportunity to inspect at a reasonable time and in a reasonable manner the facilities and all pertinent equipment1 finished and unfinished materials1 containers1 and labeling therein1 including all things 7including records1 files1 papers1 and controls7 bearing on whether an in vitro clinical test is adulterated1 misbranded1 or otherwise in violation of this ,act1 and permits such authorized employees or persons accredited under this ,act to view and to copy and verify all records pertinent to the application and the in vitro clinical test2 and 7,g7 based on other data and information the ,secretary may require under subsection 7c77#b77,k71 the ,secretary finds that such data and information support granting a technology certification order4 7#d7 ,review of denials ,an applicant whose application has been denied under this subsection may obtain review of such denial under section #ehg,p4 7e7 ,supplements 7#a7 ,supplemental applications 7,a7 ,in general ,with respect to any of the following changes related to an in vitro clinical test under a technology certification order1 a supplemental application to a technology certification order shall be submitted by the holder of the technology certification order describing such proposed changes1 prior to introducing the in vitro clinical test that is the subject of the technology certification order into interstate commerce-- 7i7 any significant change to the procedures provided in support of the application for technology certification submitted under subparagraph 7,g7 or 7,h7 of subsection 7c77#b72 or 7ii7 any significant change to the procedures provided in support of the application for technology certification submitted under subparagraph 7,f7 of subsection 7c77#b74 7,b7 ,secretary action on supplemental applications ,any action by the ,secretary on a supplemental application shall be in accordance with subsection 7d71 and any order resulting from such supplement shall be treated as an amendment to a technology certification order4 7#b7 ,content of application 7,a7 ,in general ,a supplemental application for a change to an in vitro clinical test under a technology certification order shall-- 7i7 contain all necessary information to make a showing that any in vitro clinical test affected by such change that is within the scope of the technology certification order will meet the applicable standard2 and 7ii7 be limited to such information that is needed to support the change4 7,b7 ,content ,unless otherwise specified by the ,secretary1 a supplemental application under this subsection shall include-- 7i7 a description of the change1 including a rationale for implementing such change2 7ii7 a description of how the change was evaluated2 7iii7 data from a representative in vitro clinical test or tests that supports a showing that1 in using the modified procedure or procedures1 all eligible in vitro clinical tests within the scope of the technology certification will meet the applicable standard2 7iv7 as applicable1 information to demonstrate that the modified procedure or procedures submitted under subsection 7c77#b77;,f7 continue to conform to applicable requirements under section #ehg,k2 and 7v7 any other information requested by the ,secretary4 7#c7 ,changes in response to a public health risk 7,a7 ,in general ,if the holder of a technology certification makes a change to an in vitro clinical test or tests to address a potential risk to public health by adding a new specification or test method1 such holder may immediately implement such change and shall submit a notification for such change to the ,secretary within #cj days4 7,b7 ,content ,any notification to the ,secretary under this paragraph shall include-- 7i7 a summary of the relevant change2 7ii7 the rationale for implementing such change2 7iii7 7,i7 if such a change necessitates a change to the procedures reviewed as part of the granted technology certification order1 the modified procedures2 or 7,,ii7 if the procedures were not changed1 an explanation as to why they were not changed2 and 7iv7 if such a change necessitates a change to the procedures reviewed as part of the granted technology certification order1 data from a representative in vitro clinical test or tests that support a showing that1 in using the modified procedures1 all eligible in vitro clinical tests within the scope of the technology certification will meet the applicable standard4 7f7 ,temporary hold 7#a7 ,in general ,subject to the process specified in paragraph 7#b71 and based on one or more findings under paragraph 7#d71 the ,secretary may issue a temporary hold prohibiting any holder of a technology certification order issued under this section from introducing into interstate commerce an in vitro clinical test that was not previously the subject of a listing under section #ehg;,j4 ,the temporary hold shall identify the grounds for the temporary hold under paragraph 7#d7 and the rationale for such finding4 7#b7 ,process for issuing a temporary hold ,if the ,secretary makes a finding that a temporary hold may be warranted based on one or more grounds specified in paragraph 7#d71 the ,secretary shall promptly notify the holder of the technology certification order of such finding and provide #cj calendar days for the developer to come into compliance with or otherwise resolve the finding4 7#c7 ,written requests ,any written request to the ,secretary from the holder of a technology certification order that a temporary hold under paragraph 7#a7 be removed shall receive a decision1 in writing and specifying the reasons therefore1 within #ij days after receipt of such request4 ,any such request shall include information to support the removal of the temporary hold4 7#d7 ,grounds for temporary hold ,the ,secretary may initiate a temporary hold under this subsection upon a finding that the holder of a technology certification order-- 7,a7 is not in compliance with the conditions of the technology certification order pursuant to subsection 7b77#a77;,d72 7,b7 offers one or more in vitro clinical tests with advertising or labeling that is false or misleading2 7,c7 has reported a correction or removal of an in vitro clinical test that is offered under a technology certification order under this section and has failed to demonstrate that the issue or issues causing the correction or removal does not adversely impact the ability of other in vitro clinical tests offered under the same technology certification order to meet the applicable standard2 or 7,d7 has introduced into interstate commerce an in vitro clinical test under a technology certification order and such test is adulterated or misbranded1 based on a determination by the ,secretary1 and has failed to demonstrate that the issue or issues causing the adulteration or misbranding does not adversely impact the ability of other in vitro clinical tests offered under the same technology certification granted under this section to meet the applicable standard4 7g7 ,withdrawal ,the ,secretary may1 after due notice and opportunity for an informal hearing1 issue an order withdrawing a technology certification order including all tests introduced into interstate commerce under the technology certification order if the ,secretary finds that-- 7#a7 the application1 supplement1 or report under subsection 7h7 contains false or misleading information or fails to reveal a material fact2 7#b7 such holder fails to correct false or misleading labeling or advertising upon the request of the ,secretary2 7#c7 in connection with a technology certification1 the holder provides false or misleading information to the ,secretary2 or 7#d7 the holder of such technology certification order fails to correct the grounds for a temporary hold within a timeframe specified in the temporary hold order4 7h7 ,reports to ,congress 7#a7 ,in general ,not later than #a year after the effective date of the ,,valid ,act of #bjbb1 and annually thereafter for the next #d years1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and make publicly available1 including through posting on the website of the ,food and ,drug ,administration1 a report containing the information described in paragraph 7#b74 7#b7 ,content 7,a7 ,in general ,each report under paragraph 7#a7 shall address1 at a minimum-- 7i7 the total number of applications for technology certifications filed1 granted1 withdrawn and denied2 7ii7 the total number of technology certification orders the ,secretary put on temporary hold under subsection 7h7 and the number of technology certification orders withdrawn under subsection 7i72 7iii7 the types of technologies for which the ,secretary granted technology certification orders2 7iv7 the total number of holders of technology certification orders that are in effect2 and 7v7 the total number of in vitro clinical test categories that required premarket review under section #ehg;,b that were redesignated as eligible in vitro clinical tests under this section4 7,b7 ,final report ,the fifth report submitted under paragraph 7#a7 shall include a summary of1 and responses to1 comments raised in the docket4 7,c7 ,performance reports ,the reports required under this section may be issued with performance reports as required under section #hbi of the ,,valid ,act of #bjbb4 7i7 ,public meeting and input 7#a7 ,public docket ,not later than #cj days after the date of enactment of the ,,valid ,act of #bjbb1 the ,secretary shall establish a public docket to receive comments concerning recommendations for implementation of this section1 including criteria and procedures for subsections 7c7 through 7h74 ,the public docket shall remain open for at least #a year after the establishment of the public docket4 7#b7 ,public meeting ,not later than #ahj days after the date of enactment of the ,,valid ,act of #bjbb1 the ,secretary shall convene a public meeting to which stakeholders from organizations representing patients and consumers1 academia1 and the in vitro clinical test industry are invited to discuss the technology certification process including application requirements1 inspections1 alignment with third-party accreditors1 and the definition of the term technology under section #ehg4 7j7 ,regulations ,the ,secretary shall issue regulations regarding the technology certification process1 including describing criteria or procedures relating to technology certification under this section1 which shall be subject to public comment for a minimum of #fj days from issuance prior to finalizing such regulations after considering the comments received4 ,the regulation shall include an outline of the application process1 opportunities to meet with officials of the ,food and ,drug ,administration1 and plans to streamline inspections4 7k7 ,notification 7#a7 ,in general ,notwithstanding subsection 7a77#a71 a first-of-a-kind in vitro clinical test or a combination product that meets the definition of a moderate-risk test under section #ehg;,a may be introduced into interstate commerce under a technology certification order that has been issued by the ,secretary1 subject to other applicable requirements if-- 7,a7 the developer provides notification to the ,secretary #fj days prior to introducing such tests into interstate commerce that includes information demonstrating that the test is moderate-risk and within the scope of the applicable technology certification order2 and 7,b7 the ,secretary has not issued a notification to the developer under paragraph 7#b7 before such time has elapsed4 7#b7 ,notification from ,secretary ,the ,secretary shall issue a notification to the developer that such test may not be introduced into interstate commerce under such order if the ,secretary determines that-- 7,a7 such test-- 7i7 does not meet the definition of a moderate-risk test under section #ehg;,a2 7ii7 is not eligible to be introduced into interstate commerce under the referenced technology certification order issued by the ,secretary2 or 7iii7 is not eligible for technology certification under subsection 7b77#b72 or 7,b7 based on the information included in the notification submitted by the developer pursuant to this subsection1 there is insufficient information for the ,secretary to make the determinations described in clauses 7i71 7ii71 and 7iii7 of subparagraph 7,a74 #ehg;,e4 ,mitigating measures 7a7 ,establishment of mitigating measures 7#a7 ,establishing1 changing1 or withdrawing 7,a7 ,establishment ,the ,secretary may establish and require1 on the basis of evidence1 mitigating measures for any in vitro clinical test or category of in vitro clinical tests with the same indications for use that is introduced or delivered for introduction into interstate commerce after the establishment of such mitigating measures4 7,b7 ,methods of establishment ,the ,secretary may establish mitigating measures-- 7i7 under the process set forth in subparagraph 7,d72 7ii7 as provided under section #ehg;,f2 or 7iii7 through a premarket approval or technology certification order1 which may establish mitigating measures for an individual in vitro clinical test or a category of in vitro clinical tests4 7,c7 ,methods of change or withdrawal ,the ,secretary may change or withdraw mitigating measures-- 7i7 under the process set forth in subparagraph 7,d72 or 7ii7 as provided under section #ehg;,f4 7,d7 ,process for establishment1 change1 or withdrawal ,notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 the ,secretary may1 upon the initiative of the ,secretary or upon petition of an interested person-- 7i7 establish1 change1 or withdraw mitigating measures for an in vitro clinical test or category of in vitro clinical tests by-- 7,i7 publishing a proposed order in the ,federal ,register2 7,,ii7 providing an opportunity for public comment for a period of not less than #cj #fj calendar days2 and 7,,iii7 after consideration of any comments submitted1 publishing a final order in the ,federal ,register that responds to the comments submitted1 and which shall include a reasonable transition period4 7,e7 ,effect of mitigating measures on grandfathered tests ,a mitigating measure shall not be required by the ,secretary for an in vitro clinical test subject to section #ehg;,g7a71 unless otherwise provided under section #ehg;,f4 7#b7 ,in vitro clinical tests previously cleared or exempt as devices with special controls 7,a7 ,in general ,any special controls applicable to an in vitro clinical test previously cleared or exempt under section #eaj7k71 or classified under section #eac7;f77#b7 prior to date of enactment of the ,,valid ,act of #bjbb1 including any such special controls established during the period beginning on the date of enactment of the ,,valid ,act of #bjbb and ending on the effective date of such ,act 7as described in section #e7;b7 of such ,act7-- 7i7 shall continue to apply to such in vitro clinical test after such effective date2 and 7ii7 are deemed to be mitigating measures as of the effective date specified in section #hbe7;a77#a77;,a7 of the ,,valid ,act of #bjbb4 7,b7 ,changes ,notwithstanding subparagraph 7,a71 the ,secretary may establish1 change1 or withdraw mitigating measures for such tests or category of tests using the procedures under paragraph 7#a74 7b7 ,documentation 7#a7 ,in vitro clinical tests subject to premarket review ,the developer of an in vitro clinical test subject to premarket review under section #ehg;,b and to which mitigating measures apply shall-- 7,a7 in accordance with section #ehg;,b7c77#b77;,g77i71 submit documentation to the ,secretary as part of the application for the test under subsection 7c7 or 7d7 of section #ehg;,b demonstrating that such mitigating measures have been met2 7,b7 if such application is approved1 maintain documentation demonstrating that such mitigating measures continue to be met following a test modification by the developer2 and 7,c7 make such documentation available to the ,secretary upon request or inspection4 7#b7 ,other tests ,the developer of an in vitro clinical test that is offered under a technology certification order or other exemption from premarket review under section #ehg;,b and to which mitigating measures apply shall-- 7,a7 maintain documentation in accordance with the applicable quality requirements under section #ehg;,j demonstrating that such mitigating measures continue to be met following a test modification by the developer2 7,b7 make such documentation available to the ,secretary upon request or inspection2 and 7,c7 include in the performance summary for such test a brief description of how such mitigating measures are met1 if applicable4 #ehg;,f4 ,regulatory pathway designation 7a7 ,pathway determinations 7#a7 ,in general ,after considering available evidence with respect to an in vitro clinical test or category of in vitro clinical tests with the same intended use1 including the identification1 establishment1 and implementation of mitigating measures under section #ehg;,e1 as appropriate1 the ,secretary may1 upon the initiative of the ,secretary or upon request of a developer1 determine that-- 7,a7 such in vitro clinical test is high-risk and subject to premarket review under section #ehg;,b2 7,b7 such in vitro clinical tests1 including a first of a kind test1 is moderate-risk and subject to abbreviated premarket review under section #ehg;,b7d7 or technology certification under section #ehg;,d7b77#b72 or 7,c7 such in vitro clinical test1 including a first of a kind test is low-risk or otherwise exempt from premarket review under section #ehg;,b4 7#b7 ,requests 7,a7 ,submissions by developers 7i7 ,special premarket review2 technology certification ,a developer submitting a request that the ,secretary make a determination as described in paragraph 7#a77;,b7 shall submit information to support that the in vitro clinical test is moderate-risk or propose mitigating measures1 if applicable1 that would support such a determination4 7ii7 ,low-risk2 exempt from premarket review ,a developer submitting a request that the ,secretary make a determination as described in paragraph 7#a77;,c7 shall submit information that the in vitro clinical test is low-risk1 or otherwise appropriate for exemption from premarket review under section #ehg;,b and propose mitigating measures1 if applicable1 that would support such a determination4 7,b7 ,response by the ,secretary ,after receiving a request under clause 7i7 or 7ii7 of subparagraph 7,a71 the ,secretary shall provide a timely response describing whether or not the ,secretary will initiate the process for making a determination under paragraph 7#a77;,b7 or 7#a77;,c7 as described in paragraph 7#d74 7#c7 ,sufficiency of mitigating measures ,when determining whether mitigating measures for an in vitro clinical test1 or category of in vitro clinical tests1 are sufficient to make such test moderate-risk or low-risk1 the ,secretary shall take into account the following3 7,a7 ,the degree to which the technology for the intended use of the in vitro clinical test is well-characterized1 taking into consideration factors that include one or more of the following3 7i7 ,peer-reviewed literature4 7ii7 ,practice guidelines4 7iii7 ,consensus standards4 7iv7 ,recognized standards of care4 7v7 ,use of such technology1 including historical use4 7vi7 ,multiple scientific publications by different authors4 7vii7 ,adoption by the scientific or clinical community4 7viii7 ,real world evidence4 7,b7 ,whether the criteria for performance of the test are well-established to be sufficient for the intended use4 7,c7 ,the clinical circumstances under which the in vitro clinical test is used1 including whether the in vitro clinical test is the sole determinate for the diagnosis or treatment of the targeted disease1 and the availability of other tests 7such as confirmatory or adjunctive tests7 or relevant material standards4 7,d7 ,whether such mitigating measures sufficiently mitigate the risk of harm such that the test or category of tests is moderate-risk or low-risk4 7#d7 ,process 7,a7 ,in general ,for a test that is not first-of-a-kind1 any action under paragraph 7#a7 shall be made by publication of a notice of such proposed action on the website of the ,food and ,drug ,administration1 the consideration of comments to a public docket on such proposal1 and publication of a final action on such website within #fj calendar days of the close of the comment period posted to such public docket1 notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7,b7 ,process for first-of-a-kind test ,in the case of an in vitro clinical test that is first-of-a-kind1 the process is as follows3 7i7 ,any determination that the test is subject to premarket approval or abbreviated premarket review under subparagraph 7,a7 or 7,b7 of paragraph 7#a7 shall be published on the website of the ,food and ,drug ,administration1 notwithstanding subclause ,,ii of chapter #e of title #e1 ,united ,states ,code1 only after the in vitro clinical test is approved under section #ehg;,b4 ,until that time1 the determination shall not be binding on other in vitro clinical tests4 7ii7 ,any determination other than those made under clause 7i7 shall be made by publication of a notice of final action on the website of the ,food and ,drug ,administration1 notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7b7 ,transition period ,upon a decision by the ,secretary to change a regulatory pathway designation1 or reclassifies an in vitro clinical test1 or category of in vitro clinical tests1 the ,secretary shall provide an appropriate transition period with respect to any new requirements4 7c7 ,appeals ,a decision by the ,secretary under this section shall be deemed a significant decision subject to appeal under section #ehg,p4 7d7 ,advisory committee ,the ,secretary may request recommendations from an advisory committee under section #ehg;,h pursuant to carrying out this section4 7e7 ,request for informal feedback ,before submitting a premarket application or technology certification application for an in vitro clinical test-- 7#a7 the developer of the test may submit to the ,secretary a written request for a meeting1 conference1 or written feedback to discuss and provide information relating to the regulation of such in vitro clinical test which may include-- 7,a7 the submission process and the type and amount of evidence expected to demonstrate the applicable standard2 7,b7 which regulatory pathway is appropriate for an in vitro clinical test2 and 7,c7 an investigation plan for an in vitro clinical test1 including a clinical protocol2 and 7#b7 upon receipt of such a request1 the ,secretary shall-- 7,a7 if a meeting is requested-- 7i7 within #fj calendar days after such receipt1 or within such time period as may be agreed to by the developer1 meet or confer with the developer submitting the request2 and 7ii7 within #ae calendar days after such meeting or conference1 provide to the developer a written record or response describing the issues discussed and conclusions reached in the meeting or conference2 and 7,b7 if written feedback is requested1 provide feedback to the requestor within #ge days after such receipt4 #ehg;,g4 ,grandfathered in vitro clinical tests 7a7 ,in general ,subject to subsection 7d71 an in vitro clinical test is exempt from the requirements of this subchapter specified in subsection 7b7 if-- 7#a7 the test was first offered for clinical use before the date of enactment of the ,,valid ,act of #bjbb2 7#b7 the was developed by a clinical laboratory for which a certificate was in effect under section #cec of the ,public ,health ,service ,act that meets the requirements for performing tests of high complexity2 7#c7 the test is performed-- 7,a7 in the same clinical laboratory in which the test was developed for which a certification is still in effect under section #cec of the ,public ,health ,service ,act that meets the requirements to perform tests of high complexity2 7,b7 by another clinical laboratory for which a certificate is in effect under section #cec of such ,act that meets the requirements to perform tests of high complexity1 and that is within the same corporate organization and having common ownership by the same parent corporation as the laboratory in which the test was developed2 or 7,c7 in the case of a test that was developed by the ,centers for ,disease ,control and ,prevention or another laboratory a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention1 by a clinical laboratory for which a certificate is in effect under section #cec of such ,act that meets the requirements to perform tests of high complexity1 and that is within a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention2 7#d7 the test does not have in effect an approval under section #eae1 a clearance under section #eaj7k71 an authorization under section #eac7;f77#b71 or an exemption under section #ebj7m71 or licensure under section #cea of the ,public ,health ,service ,act2 7#e7 any modification to the test on or after the date of enactment of the ,,valid ,act of #bjbb made by the initial developer and conform with section #ehg;,c7a77#f77;,a77ii7 and does not meet the criterial in subsection 7d77#a72 7#f7 the test is not for investigational use2 7#g7 the test is offered with an order from an authorized person as required under section #cec of the ,public ,health ,service ,act1 and was offered with a prescription required under section #hji4cj7;f7 of title #ba1 ,code of ,federal ,regulations prior to the effective date of this subchapter2 7#h7 the test is not for use with home specimen collection1 unless the specimen is collected with a collection container1 receptacle1 or kit that-- 7,a7 has been approved1 cleared1 or authorized by the ,secretary for home specimen collection and the collection is performed pursuant to the approved1 cleared1 or authorized labeling1 including any indication for use as prescription use or over-the-counter use1 or 7,b7 is exempt from premarket review and its use is consistent with applicable limitations on the exemption2 7#i7 is not a specimen receptacle or instrument 7#aj7 each test report template for the test bears a statement that reads as follows3 ,this in vitro clinical test has not been reviewed by the ,food and ,drug ,administration42 and 7#aa7 the developer of the test-- 7,a7 maintains documentation demonstrating that the test meets and continues to meet the criteria set forth in this subsection2 and 7,b7 makes such documentation available to the ,secretary upon request4 7b7 ,exemptions applicable to grandfathered tests ,an in vitro clinical test that meets the criteria specified in subsection 7a7 is exempt from premarket review under #ehg;,b1 labeling requirements under #ehg,l1 and test design requirements and quality requirements under #ehg,k1 and may be lawfully offered subject to the other applicable requirements of this ,act4 7c7 ,modifications ,in the case of an in vitro clinical test that meets the criteria specified in subsection 7a71 such test continues to qualify for the exemptions described in subsection 7b7 if the test is modified and the modification is not of a type described in subsection 7a77#e71 and the person modifying such in vitro clinical test-- 7#a7 documents each such modification and maintains documentation of the basis for such determination2 7#b7 provides such documentation relating to the change to the ,secretary upon request or inspection2 and 7#c7 does not modify the in vitro clinical test such that it no longer meets the criteria under subsection 7a74 7d7 ,request for information 7#a7 ,criteria ,the criteria described in this paragraph are any of the following3 7,a7 ,there is insufficient valid scientific evidence to support that the test is analytically valid or clinically valid4 7,b7 ,such in vitro clinical test is being offered by its developer with any false or misleading analytical or clinical claims4 7,c7 ,it is probable that such in vitro clinical test will cause serious adverse health consequences4 7#b7 ,process 7,a7 ,written request for information ,the ,secretary may issue a written request to a developer identifying specific scientific concerns1 based on credible information1 with an in vitro clinical test1 which indicate that one or more of the criteria described in paragraph 7#a7 apply to such in vitro clinical tests4 ,such written request shall include specific information requests pertaining to such criteria4 7,b7 ,deadline for submitting information ,not later than #de days after receiving a request for information under subparagraph 7,a7-- 7i7 the developer of an in vitro clinical test-- 7,i7 may seek a teleconference prior to the submission of information under clause 7ii7 to discuss the ,secretary's request2 and 7,,ii7 shall submit the information requested pursuant to subparagraph 7,a7 within #cj days of receipt of such request2 and 7ii7 the ,secretary shall-- 7,i7 schedule a teleconference requested under clause 7i77,i72 and 7,,ii7 hold a teleconference so requested within #aj days of the ,secretary's receipt of the information requested under clause 7i77,,ii74 7,c7 ,review deadline ,upon receiving a submission under subparagraph 7,b71 the ,secretary shall-- 7i7 review the submitted information within #de calendar days of such receipt1 which may include communication with the developer2 and 7ii7 determine whether the criteria listed in paragraph 7#a7 apply to the in vitro clinical test and communicate such determination to the developer as described in subparagraph 7,d74 7,d7 ,communication and results of determination ,the ,secretary shall notify the developer1 in writing1 of the ,secretary's determination under subparagraph 7,c71 as follows3 7i7 ,if the ,secretary determines that none of the criteria listed in paragraph 7#a7 apply to the in vitro clinical test1 such test shall be exempt from relevant requirements of this subchapter1 as set forth in subsection 7b71 subject to applicable limitation4 7ii7 ,if the ,secretary determines that one or more of the criteria listed in subparagraph 7#a7 apply to the test but such a determination may be resolved within a reasonable time1 and the test has not been previously subject to this subsection on the basis of the same or substantially similar scientific concerns identified in the written request issued under paragraph 7d77#b77;,a7-- 7,i7 the ,secretary shall notify the developer of such a determination and allow the developer to seek a teleconference to discuss the finding2 7,,ii7 the developer shall submit information demonstrating resolution of the determination within #ae days of receiving the notification2 and 7,,iii7 the ,secretary shall make a determination within #cj days of the submission of information as to whether the criteria under paragraph 7#a7 apply to the test4 7iii7 ,if the ,secretary determines that none of the criteria listed in paragraph 7#a7 apply to the test1 such test shall be exempt from relevant requirements of the subchapter as set forth in subsection 7b71 subject to applicable limitations4 7iv7 ,if the ,secretary determines that one or more of the criteria listed in paragraph 7#a7 apply to the in vitro clinical test1 such test is not exempt as set forth in this section and shall not be offered unless approved under section #ehg;,b1 offered under a technology certification order under section #ehg;,d1 or offered as a low-risk test4 upon a determination by the ,secretary pursuant to section #ehg;,f4 7v7 ,if the ,secretary determines that one or more of the criteria listed in paragraph 7#a7 apply to the in vitro clinical test and clause 7ii7 does not apply1 the in vitro clinical test is not exempt as set forth in section and shall not be offered unless approved under section #ehg;,b1 offered under a technology certification order under section #ehg;,d1 or offered as a low-risk test upon a determination by the ,secretary pursuant to section #ehg;,f4 #ehg;,h4 ,advisory committees 7a7 ,in general ,the ,secretary may establish advisory committees or use advisory committee panels of experts established before the date of enactment of the ,,valid ,act of #bjbb 7including a device classification panel under section #eac7 for the purposes of providing expert scientific advice and making recommendations related to-- 7#a7 the approval of an application for an in vitro clinical test submitted under this subchapter1 including for evaluating1 as applicable1 the analytical validity1 clinical validity1 and safety of in vitro clinical tests2 7#b7 the potential effectiveness of mitigating measures for a determination of the applicable regulatory pathway under section #ehg;,f7b7 or risk evaluation for an in vitro clinical test or tests2 7#c7 quality requirements under section #ehg,k or applying such requirements to in vitro clinical tests developed or imported by developers2 7#d7 appeals under section #ehg,p2 or 7#e7 such other purposes as the ,secretary determines appropriate4 7b7 ,appointments 7#a7 ,voting members ,the ,secretary shall appoint to each committee established under subsection 7a71 as voting members1 individuals who are qualified by training and experience to evaluate in vitro clinical tests referred to the committee for the purposes specified in subsection 7a71 including individuals with1 to the extent feasible1 scientific expertise in the development of such in vitro clinical tests1 laboratory operations1 and the use of in vitro clinical tests4 ,the ,secretary shall designate one member of each committee to serve as chair4 7#b7 ,nonvoting members ,in addition to the individuals appointed pursuant to paragraph 7#a71 the ,secretary shall appoint to each committee established under subsection 7a71 as nonvoting members-- 7,a7 a representative of consumer interests2 and 7,b7 a representative of interests of in vitro clinical test developers not directly affected by the matter to be brought before the committee4 7#c7 ,limitation ,no individual who is a regular full-time employee of the ,united ,states and engaged in the administration of this ,act may be a member of any advisory committee established under subsection 7a74 7#d7 ,education and training ,the ,secretary shall1 as appropriate1 provide education and training to each new committee member before such member participates in a committee's activities1 including education regarding requirements under this ,act and related regulations of the ,secretary1 and the administrative processes and procedures related to committee meetings4 7#e7 ,meetings ,the ,secretary shall ensure that scientific advisory committees meet regularly and at appropriate intervals so that any matter to be reviewed by such a committee can be presented to the committee not more than #fj calendar days after the matter is ready for such review4 ,meetings of the committee may be held using electronic or telephonic communication to convene the meetings4 7#f7 ,compensation ,members of an advisory committee established under subsection 7a71 while attending meetings or conferences or otherwise engaged in the business of the advisory committee-- 7,a7 shall be entitled to receive compensation at rates to be fixed by the ,secretary1 but not to exceed the daily equivalent of the rate in effect for positions classified above level ,,gs-#ae of the ,general ,schedule2 and 7,b7 may be allowed travel expenses as authorized by section #egjc of title #e1 ,united ,states ,code1 for employees serving intermittently in the ,government service4 7c7 ,guidance ,the ,secretary may issue guidance on the policies and procedures governing advisory committees established under subsection 7a74 #ehg;,i4 ,breakthrough in vitro clinical tests 7a7 ,in general ,the purpose of this section is to encourage the ,secretary1 and provide the ,secretary with sufficient authority1 to apply efficient and flexible approaches to expedite the development of1 and prioritize the review of1 in vitro clinical tests that represent breakthrough technologies4 7b7 ,establishment of program ,the ,secretary shall establish a program to expedite the development of1 and provide for the priority review of1 in vitro clinical tests4 7c7 ,eligibility ,the program developed under subsection 7b7 shall be available for any in vitro clinical test that-- 7#a7 provides or enables more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions compared to existing approved or cleared alternatives1 including an in vitro clinical test offered under a technology certification order2 and 7#b7 is a test-- 7,a7 that represents a breakthrough technology2 7,b7 for which no approved or cleared alternative in vitro clinical test exists1 including no in vitro clinical test offered under a technology certification order2 7,c7 that offers a clinically meaningful advantage over any existing alternative in vitro clinical test that is approved or cleared 7including any in vitro clinical test offered under a technology certification order71 including the potential to reduce or eliminate the need for hospitalization1 improve patient quality of life1 facilitate patients' ability to manage their own care 7such as through self-directed personal assistance71 or establish long-term clinical efficiencies2 or 7,d7 the availability of which is in the best interest of patients or public health4 7d7 ,designation 7#a7 ,request ,to receive breakthrough designation under this section1 an applicant may request that the ,secretary designate the in vitro clinical test for expedited development and priority review4 ,any such request for designation may be made at any time prior to1 or at the time of1 the submission of an application under section #ehg;,b or #ehg;,d1 and shall include information demonstrating that the test meets the criteria described in subsection 7c74 7#b7 ,determination ,not later than #fj calendar days after the receipt of a request under paragraph 7#a71 the ,secretary shall determine whether the in vitro clinical test that is the subject of the request meets the criteria described in subsection 7c74 ,if the ,secretary determines that the test meets the criteria1 the ,secretary shall designate the test for expedited development and priority review4 7#c7 ,review ,review of a request under paragraph 7#a7 shall be undertaken by a team that is composed of experienced staff and senior managers of the ,food and ,drug ,administration4 7#d7 ,withdrawal 7,a7 ,in general ,the designation of an in vitro clinical test under this subsection is deemed to be withdrawn1 and such in vitro clinical test shall no longer be eligible for designation under this section1 if an application for approval for such test under section #ehg;,b or #ehg;,d is denied4 ,such test shall be eligible for breakthrough designation upon a new request for such designation4 7,b7 ,exception ,the ,secretary may not withdraw a designation granted under this subsection based on the subsequent approval or technology certification of another in vitro clinical test that-- 7i7 is designated under this section2 or 7ii7 was given priority review under section #eae;,b4 7e7 ,actions ,for purposes of expediting the development and review of in vitro clinical tests under this section1 the ,secretary may take the actions and additional actions set forth in paragraphs 7#a7 and 7#b71 respectively1 of section #eae;,b7e7 when reviewing such tests4 ,any reference or authorization in section #eae;,b7e7 with respect to a device shall be deemed a reference or authorization with respect to an in vitro clinical test for purposes of this section4 7f7 ,guidance ,not later than the date specified for final guidance under section #hbe of the ,,valid ,act of #bjbb1 the ,secretary shall issue final guidance on the implementation of this section4 ,such guidance shall-- 7#a7 set forth the process by which a person may seek a designation under subsection 7d72 7#b7 provide a template for request under subsection 7d72 7#c7 identify the criteria the ,secretary will use in evaluating a request for designation2 and 7#d7 identify the criteria and processes the ,secretary will use to assign a team of staff1 including team leaders1 to review in vitro clinical tests designated for expedited development and priority review1 including any training required for such personnel to ensure effective and efficient review4 7g7 ,rules of construction ,nothing in this section shall be construed to affect-- 7#a7 the criteria and standards for evaluating an application pursuant to section #ehg;,b or #ehg;,d1 including the recognition of valid scientific evidence as described in section #ehg7ag7 and consideration and application of the least burdensome means described under section #ehg;,,aa7c72 7#b7 the authority of the ,secretary with respect to clinical holds under section #ehg,r2 7#c7 the authority of the ,secretary to act on an application pursuant to section #ehg;,b before completion of an establishment inspection1 as the ,secretary determines appropriate2 or 7#d7 the authority of the ,secretary with respect to postmarket surveillance under sections #ehg,l7d7 and #ehg,y4 #ehg;,j4 ,registration and listing 7a7 ,registration requirement 7#a7 ,in general ,each person described in subsection 7b77#a7 shall-- 7,a7 during the period beginning on ,october #a and ending on ,december #ca of each year1 register with the ,secretary the name of such person1 places of business of such person1 all establishments engaged in the activities specified under this paragraph1 the establishment registration number of each such establishment1 and a point of contact for each such establishment1 including an electronic point of contact2 and 7,b7 submit an initial registration containing the information required under subparagraph 7,a7 not later than-- 7i7 the effective date of this section if such establishment is engaged in any activity described in subsection 7b77#a7 on such effective date1 unless the ,secretary establishes by guidance a date later than such implementation date for all or a category of such establishments2 or 7ii7 #cj days prior to engaging in any activity described in subsection 7b77#a71 if such establishment is not engaged in any activity described in this paragraph on such effective date4 7#b7 ,registration numbers ,the ,secretary may assign a registration number to any person or an establishment registration number to any establishment registered in accordance with this section4 ,registration information shall be made publicly available by publication on the website maintained by the ,food and ,drug ,administration1 in accordance with subsection 7d74 7#c7 ,inspection ,each person or establishment that is required to be registered with the ,secretary under this section shall be subject to inspection pursuant to section #gjd4 7b7 ,listing ,information for ,in ,vitro ,clinical ,tests 7#a7 ,in general ,each person who-- 7,a7 is a developer2 and 7,b7 introduces or proposes to begin the introduction or delivery for introduction into interstate commerce through an exemption under subsection 7a77#a71 7a77#b71 7a77#c71 or 7g7 of section #ehg;,c or section #ehg;,g or through the filing of an application under section #ehg;,b or section #ehg;,d1 shall submit a listing to the ,secretary containing the information described in paragraph 7#b71 7#d71 or 7#e71 as applicable1 in accordance with the applicable schedule described under subsection 7c74 ,such listing shall be prepared in such form and manner as the ,secretary may specify in guidance4 ,listing information shall be submitted through the comprehensive test information system in accordance with section #ehg,t1 as appropriate4 7#b7 ,submissions ,each developer submitting a listing under paragraph 7#a7 shall electronically submit to the comprehensive test information system described in section #ehg,t the following information1 as applicable1 for each in vitro clinical test for which such person is a developer in the form and manner prescribed by the ,secretary1 taking into account least burdensome principles3 7,a7 ,name of the establishment and its establishment registration number4 7,b7 ,contact information for the official correspondent for the listing4 7,c7 ,name 7common name and trade name1 if applicable7 of the in vitro clinical test and its test listing number 7when available74 7,d7 ,the certificate number for any laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that meets the requirements to perform high-complexity testing and that is the developer of the in vitro clinical test1 and the certificate number under such section for any laboratory that is performing the test1 is within the same corporate organization1 and has common ownership by the same parent corporation4 7,e7 ,whether the in vitro clinical test is1 as applicable1 offered as a test approved under section #ehg;,b1 cleared to be offered under a granted technology certification order1 or offered as an exempt in vitro clinical test under section #ehg;,a4 7,f7 ,indications for use information under section #ehg7aj74 7,g7 ,a brief summary of the analytical and clinical performance of the in vitro clinical test1 and as applicable1 the lot release criteria4 7,h7 ,a brief description of conformance with any applicable mitigating measures1 restrictions1 and standards4 7,i7 ,representative labeling for the in vitro clinical test1 as appropriate4 7#c7 ,test listing number ,the ,secretary may assign a test listing number to each in vitro clinical test that is the subject of a listing under this section4 ,the process for assigning test listing numbers may be established through guidance1 and may include the recognition of standards1 formats1 or conventions developed by a third-party organization4 7#d7 ,abbreviated listing ,a person who is not a developer but is otherwise required to register pursuant to subsection 7a7 shall submit an abbreviated listing to the ,secretary containing the information described in subparagraphs 7,a7 through 7,c7 of paragraph 7#b71 and the name of the developer4 ,the information shall be submitted in accordance with the applicable schedule described under subsection 7c74 ,such abbreviated listing shall be prepared in such form and manner as the ,secretary may specify through guidance4 ,listing information shall be submitted to the comprehensive test information system in accordance with section #ehg,t1 as appropriate4 7#e7 ,grandfathered tests ,a developer offering a test that is a grandfathered in vitro clinical test under section #ehg;,g7a7 shall submit listing information required under subparagraphs 7,a7 through 7,f7 of paragraph 7#b71 and may submit a statement of the performance specifications for such in vitro clinical tests4 7#f7 ,exempt tests ,a developer of an in vitro clinical test who introduces or proposes to begin the introduction or delivery for introduction into interstate commerce that is otherwise exempt from the requirement to submit listing information pursuant to an exemption under section #ehg;,c may submit listing information under this subsection4 7c7 ,timelines for submission of listing information 7#a7 ,in general ,the timelines for submission of registration and listing under subsections 7a7 and 7b7 are as follows3 7,a7 ,for an in vitro clinical test that was listed as a device under section #eaj7;j7 prior to the effective date of this section1 a person shall maintain a device listing under section #eaj until such time as the system for submitting the listing information required under subsection 7b7 becomes available and thereafter shall submit the listing information not later than the later of #a year after the system for submitting the listing under this section becomes available or the effective date of this section4 7,b7 ,for an in vitro clinical test that is subject to grandfathering under section #ehg;,g7a7 a person shall submit the listing information required under subsection 7b77#e7 not later that the later of #a year after the system for submitting the listing under this section becomes available or the effective date of this section4 7,c7 ,for an in vitro clinical test that is not described in subparagraph 7,a7 or 7,b71 a person shall submit the required listing information as follows3 7i7 ,for an in vitro clinical test that is not exempt from premarket approval under section #ehg;,b1 a person shall submit the required listing information1 prior to offering the in vitro clinical test and not later than #cj business days after the date of approval of the premarket approval application4 7ii7 ,for an in vitro clinical test that is exempt from premarket review under section #ehg;,c1 the required listing information shall be submitted prior to offering the in vitro clinical test4 7#b7 ,updates 7,a7 ,updates after changes ,each developer required to submit listing information under this section shall update such information within #aj business days of any change that causes any previously listed information to be inaccurate or incomplete4 7,b7 ,annual updates ,each developer required to submit listing information under this section shall update its information annually during the period beginning on ,october #a and ending on ,december #ca of each year4 7d7 ,public availability of listing information 7#a7 ,in general ,listing information submitted pursuant to this section shall be made publicly available on the website of the ,food and ,drug ,administration in accordance with paragraph 7#c74 7#b7 ,confidentiality ,listing information for an in vitro clinical test that is subject to premarket approval or technology certification shall remain confidential until such date as the in vitro clinical test receives the applicable premarket approval or the developer receives a technology certification order and for subsequent tests introduced under a technology certification order until their introduction4 7#c7 ,exceptions from public availability requirements ,the public listing requirements of this subsection shall not apply to any registration and listing information submitted under subsection 7a7 or 7b71 if the ,secretary determines that such information-- 7,a7 is a trade secret or confidential commercial information2 or 7,b7 if posted1 would present a risk to national security4 7e7 ,submission of information by accredited persons ,if agreed upon by the developer1 the information required under this section may be submitted by a person accredited under section #ehg,q4 #ehg,k4 ,test design and quality requirements 7a7 ,applicability 7#a7 ,in general ,each developer and each other person required to register under section #ehg;,i7b77#a7 shall establish and maintain quality requirements in accordance with the applicable requirements set forth in subsection 7b74 7#b7 ,certified laboratory requirements ,a developer shall establish and maintain quality requirement under subsection 7b77#b7 or 7b77#c71 as applicable1 if such developer is a clinical laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that-- 7,a7 is certified to perform high-complexity testing2 7,b7 develops an in vitro clinical test that is for use only-- 7i7 within the laboratory certified by the ,secretary under such section #cec in which such test was developed2 or 7ii7 within another laboratory certified by the ,secretary under such section #cec if such laboratory is-- 7,i7 within the same corporate organization and has common ownership by the same parent corporation as the laboratory in which the test was developed2 or 7,,ii7 within a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention1 if the test is developed by a public health laboratory or the ,centers for ,disease ,control and ,prevention2 and 7,c7 does not manufacture1 produce1 or distribute in vitro clinical tests other than laboratory test protocols4 7#c7 ,regulations ,the ,secretary shall promulgate quality system regulations implementing this section4 ,in promulgating such regulations under this section1 the ,secretary shall consider whether1 and to what extent1 international harmonization is appropriate4 7#d7 ,quality systems for hybrid developers of both laboratory test protocols and other in vitro clinical tests ,an entity that develops both finished products and laboratory test protocols and other in vitro clinical tests shall comply with subsection 7b77#a7 for activities related to the development of any in vitro clinical test that is not a laboratory test protocol product and with subsection 7b77#b7 or 7b77#c71 as applicable1 for activities related to the development of any laboratory test protocol4 7b7 ,quality requirements 7#a7 ,in general ,the quality requirements applicable under this section shall-- 7,a7 avoid duplication of regulations under section #cec of the ,public ,health ,service ,act2 and 7,b7 shall include the following1 as applicable1 subject to subparagraph 7,a7 and paragraphs 7#b7 and 7#c7-- 7i7 management responsibilities2 7ii7 quality audits2 7iii7 personnel2 7iv7 design controls2 7v7 document controls2 7vi7 purchasing controls2 7vii7 identification and traceability2 7viii7 production and process controls2 7ix7 acceptance activities2 7x7 nonconforming in vitro clinical tests2 7xi7 corrective and preventive action2 7xii7 labeling and packaging controls2 7xiii7 handling1 storage1 distribution1 and installation2 7xiv7 complaints and records2 7xv7 servicing2 and 7xvi7 statistical techniques4 7#b7 ,exception for laboratory test protocols ,developers that are developing test protocols for use as described in subsection 7a77#b77;,b77i7 are exempt from the requirements under paragraph 7#a77;,b7 except for the requirements described in clauses 7iv71 7vi71 7ix71 7xi71 and 7xiv7 of such paragraph4 7#c7 ,quality requirements for certain laboratories distributing laboratory test protocols within organizations or public health networks ,quality requirements applicable to the developer who is distributing a laboratory test protocol as described in subsection 7a77#b77;,b77ii7 shall consist of the following3 7,a7 ,clauses 7iv71 7vi71 7ix71 7xi71 7xiv71 7xii7 of paragraph 7#a77;,b74 7,b7 ,the requirement to maintain records of the laboratories to which the laboratory test protocol is distributed4 7c7 ,regulations ,in implementing quality requirements for test developers that participate in international audit programs under this section1 the ,secretary shall-- 7#a7 for purposes of facilitating international harmonization1 consider whether the developer participates in an international audit program in which the ,united ,states participates and recognizes compliance with1 or conformance to1 such standards recognized by the ,secretary2 and 7#b7 ensure a least burdensome approach described in section #ehg;,,aa7c7 by leveraging1 to the extent applicable1 the quality assurance requirements applicable to developers certified by the ,secretary under section #cec of the ,public ,health ,service ,act4 #ehg,l4 ,labeling requirements 7a7 ,in general ,an in vitro clinical test shall bear or be accompanied by labeling1 as applicable1 that meets the requirements set forth in subsections 7b7 and 7c71 unless such test is exempt under subsection 7d7 or 7e74 7b7 ,labels 7#a7 ,in general ,the label of an in vitro clinical test1 shall meet the requirements set forth in paragraph 7#b7 if there is an immediate container to which the label is applied4 7#b7 ,regulations ,the label of an in vitro clinical test shall state the name and place of business of its developer and meet the requirements set forth in regulations promulgated in accordance with this section4 7c7 ,labeling 7#a7 ,in general ,labeling of an in vitro clinical test1 including labeling in the form of a package insert1 website1 standalone laboratory reference document1 or other similar document shall include-- 7,a7 adequate directions for use and shall meet the requirements set forth in regulations promulgated under this section1 except as provided in subsection 7d7 or 7e72 and 7,b7 the information described in paragraph 7#b71 as applicable4 7#b7 ,content ,labeling of an in vitro clinical test shall include-- 7,a7 the test listing number that was provided to the developer at the time of listing2 7,b7 information to facilitate reporting an adverse event2 7,c7 information regarding accessing the performance summary data displayed in the listing database for the test2 7,d7 the indications of use of the in vitro clinical test2 and 7,e7 any warnings1 contraindications1 or limitations4 7#c7 ,public availability of information ,the ,secretary shall make all of the information described in paragraph 7#b7 with respect to each in vitro clinical test available to the public1 as applicable1 in accordance with section #ehg,t1 except to the extent that the ,secretary determines that such information-- 7,a7 is trade secret or confidential commercial information2 or 7,b7 if posted1 would present a risk to national security4 7#d7 ,additional requirements ,labeling for an in vitro clinical test used for immunohematology testing shall meet the applicable requirements set forth in part #ffj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 related to the labeling of blood grouping reagents1 reagent red blood cells1 and anti-human globulin4 7d7 ,exemptions and alternative requirements 7#a7 ,in general 7,a7 ,in general ,with respect to an in vitro clinical test that meets the criteria of subparagraph 7,b71 the state in one place regulations under section #hji4aj7;b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 may be satisfied by the laboratory posting such information on its website or in multiple documents1 if such documents are maintained and accessible in one place4 7,b7 ,applicable tests ,an in vitro clinical test meets the criteria of this subparagraph if such test is-- 7i7 developed by a laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that meets the requirements to perform tests of high-complexity2 and 7ii7 performed in-- 7,i7 the same laboratory in which such test was developed2 or 7,,ii7 by another laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act that-- 7aa7 meets the requirements to perform tests of high complexity2 and 7bb7 is under common ownership and control as the laboratory that developed the test4 7#b7 ,test instrument labeling ,unless the instrument is the entire test system1 the labeling for an instrument is not required to bear the information indicated in paragraphs 7#c71 7#d71 7#e71 7#g71 7#h71 7#i71 7#aj71 7#aa71 7#ab71 and 7#ac7 of section #hji4aj7;b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7#c7 ,reagent labeling ,for purposes of compliance with subsection 7c77#a71 the labeling for a reagent intended for use as a replacement in an in vitro clinical test may be limited to that information necessary to identify the reagent adequately and to describe its proper use in the test4 7#d7 ,investigational use ,a shipment or other delivery of an in vitro clinical test for investigational use pursuant to section #ehg,s shall be exempt from the labeling requirements of subsections 7b7 and 7c77#a7 and from any standard promulgated through regulations1 except as required under section #cec of the ,public ,health ,service ,act or section #ehg,r of this ,act4 7#e7 ,general purpose laboratory reagents ,the labeling of general purpose laboratory reagents 7such as hydrochloric acid7 whose uses are generally known by persons trained in their use need not bear the directions for use required by subsection 7c77#a77;,a74 7#f7 ,over-the-counter test specimen receptacle labeling ,the labeling for over-the-counter test specimen receptacles for drugs of abuse testing shall bear the name and place of business of the developer included in the registration under section #ehg;,j and any information specified in applicable regulations promulgated under this section1 in language appropriate for the intended users4 7e7 ,tests in the strategic national stockpile 7#a7 ,in general ,the ,secretary may grant an exception or alternative to any provision listed in this section1 unless explicitly required by a statutory provision outside this subchapter1 for specified lots1 batches1 or other units of an in vitro clinical test1 if the ,secretary determines that compliance with such labeling requirement could adversely affect the availability of such products that are1 or will be1 included in the ,strategic ,national ,stockpile under section #cai;,f-#b of the ,public ,health ,service ,act4 7#b7 ,regulations ,the ,secretary may issue regulations amending section #hji4aa of title #ba1 ,code of ,federal ,regulations 7or any successor regulation7 to apply in full or in part to in vitro clinical tests and in vitro clinical test developers4 7f7 ,regulations ,the ,secretary shall issue or revise regulations related to standardized1 general content and format for in vitro clinical test labeling pursuant to this subsection4 #ehg,m4 ,adverse event reporting 7a7 ,in general ,each in vitro clinical test developer shall establish and maintain a system for establishing and maintaining records of adverse events and reporting adverse events in accordance with this section4 7b7 ,submission of individual reports ,a developer shall submit an individual adverse event not later than #e calendar days after the developer receives or becomes aware of an adverse event that reasonably suggests that an in vitro clinical test may-- 7#a7 have caused or contributed to a patient or user death2 or 7#b7 present an imminent threat to public health4 7c7 ,submission of quarterly reports ,as applicable1 a developer shall submit quarterly reports that include any in vitro clinical test errors and serious injuries that occurred during the applicable quarter4 ,such quarterly reports shall be submitted not later than the end of the quarter following the quarter in which the developer receives or becomes aware of such adverse events4 7d7 ,definitions ,for the purposes of this section-- 7#a7 the term in vitro clinical test error means a failure of an in vitro clinical test to meet its performance specifications1 or to otherwise perform as intended by the developer1 including an inaccurate result resulting from such failure2 and 7#b7 the term serious injury means-- 7,a7 a significant delay in a diagnosis that results in the absence1 delay1 or discontinuation of critical medical treatment or that irreversibly or seriously and negatively alters the course of a disease or condition2 or 7,b7 an injury that-- 7i7 is life threatening2 7ii7 results in permanent impairment of a body function or permanent damage to a body structure2 or 7iii7 necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure4 7e7 ,regulations ,the ,secretary shall promulgate regulations to implement this section4 #ehg,n4 ,corrections and removals 7a7 ,regulations ,the ,secretary shall promulgate regulations1 or amend existing regulations1 as appropriate1 to implement this section4 7b7 ,reports of corrections and removals 7#a7 ,in general ,each in vitro clinical test developer shall report to the ,secretary any correction or removal of an in vitro clinical test undertaken by such developer if the correction or removal was undertaken-- 7,a7 to reduce the risk to health posed by the in vitro clinical test2 or 7,b7 to remedy a violation of this ,act caused by the in vitro clinical test which may present a risk to health4 7#b7 ,exception for in vitro clinical tests offered under a technology certification order ,for any eligible test offered under a technology certification order under section #ehg;,d1 a correction and removal report for any correction or removal of an in vitro clinical test should demonstrate that the issue or issues causing the correction or removal do not adversely impact the ability of other in vitro clinical tests offered under the same technology certification order to meet the applicable standard4 7c7 ,timing ,a developer shall submit any report required under this subsection to the ,secretary within #ae business days of initiating such correction or removal4 7d7 ,recordkeeping ,a developer of an in vitro clinical test that undertakes a correction or removal of an in vitro clinical test which is not required to be reported under this subsection shall keep a record of such correction or removal4 7e7 ,recall communications ,upon the voluntary reporting of a correction or removal by the developer-- 7#a7 the ,secretary shall classify such correction or removal under this section within #ae calendar days2 and 7#b7 not later than #de calendar days after the developer or other responsible party notifies the ,secretary that it has completed a recall action1 the ,secretary shall provide the developer or other responsible party with a written statement closing the recall action or stating the reasons the ,secretary cannot close the recall at that time4 #ehg,o4 ,restricted in vitro clinical tests 7a7 ,applicability 7#a7 ,in general ,for the types of in vitro clinical tests described in paragraph 7#c7 the ,secretary may require1 in issuing an approval of an in vitro clinical test under section #ehg;,b1 granting a technology certification order under section #ehg;,d1 or in issuing a determination under section #ehg;,f7a71 or by issuing a regulation1 that such test1 or category of tests1 be restricted to sale1 distribution1 or use upon such conditions as the ,secretary may prescribe under paragraph 7#b74 7#b7 ,conditions ,the ,secretary may prescribe conditions under this section1 based on available evidence1 with respect to an in vitro clinical test described in paragraph 7#c71 that are determined to be needed due to the potential for harmful effect of such test 7including any resulting absence1 significant delay1 or discontinuation of appropriate medical treatment71 and are necessary to ensure that the test meets the applicable standard4 7#c7 ,in vitro clinical tests subject to restrictions ,the restrictions or conditions authorized under this section may be applied by the ,secretary to any high-risk or moderate-risk in vitro clinical test1 prescription home-use in vitro clinical test1 direct-to-consumer in vitro clinical test1 or over-the-counter in vitro clinical test4 7b7 ,labeling and advertising of a restricted in vitro clinical test ,the labeling and advertising of an in vitro clinical test to which restrictions apply under subsection 7a7 shall bear such appropriate statements of the restrictions as the ,secretary may prescribe in an approval under section #ehg;,b1 an order under section #ehg;,d1 a determination under section #ehg;,f7a71 or in regulation1 as applicable4 7c7 ,device restrictions ,an in vitro clinical test that was offered as a restricted device prior to the date of enactment of this subchapter-- 7#a7 shall continue to comply with the applicable restrictions under section #eae or section #ebj7;e7 until the this subchapter takes effect2 and 7#b7 except for in vitro clinical tests required to meet section #hji4cj of title #ba1 ,code of ,federal ,regulations prior to the effective date of this subchapter specified in section #hbe7;a77#a77;,a7 of the ,,valid ,act of #bjbb1 such restrictions shall be deemed to be restrictions under this ,act as of such effective date4 #ehg,p4 ,appeals 7a7 ,significant decision 7#a7 ,in general ,the ,secretary shall maintain a substantive summary of the scientific and regulatory rationale for any significant decision of the ,food and ,drug ,administration pursuant to section #ehg;,f1 regarding-- 7,a7 the submission of an application for1 or a review of1 an in vitro clinical test under section #ehg;,b or section #ehg;,d2 7,b7 an exemption under section #ehg;,c2 or 7,c7 any requirements for mitigation measures to an in vitro clinical test or category of in vitro clinical tests4 ,such summaries shall include documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion4 7#b7 ,provision of documentation ,upon request1 the ,secretary shall furnish a substantive summary described in paragraph 7#a7 to the person who has made1 or is seeking to make1 a submission described in such paragraph4 7#c7 ,application of least burdensome requirements ,the substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section #ehg;,,aa7c71 as applicable4 7b7 ,review of significant decisions 7#a7 ,request for supervisory review of significant decision ,a developer may request a supervisory review of the significant decision described in subsection 7a77#a74 ,such review may be conducted at the next supervisory level or higher above the agency official who made the significant decision4 7#b7 ,submission of request ,a developer requesting a supervisory review under paragraph 7#a7 shall submit such request to the ,secretary not later than #cj days after the decision for which the review is requested and shall indicate in the request whether such developer seeks an in-person meeting or a teleconference review4 7#c7 ,timeframe ,the ,secretary shall schedule an in-person or teleconference review1 if so requested1 not later than #cj days after such request is made4 ,the ,secretary shall issue a decision to the developer requesting a review under this subsection not later than #de days after the request is made under paragraph 7#a71 or1 in the case of a developer who requests an in-person meeting or teleconference1 #cj days after such meeting or teleconference4 7c7 ,advisory panels ,the process established under subsection 7a7 shall permit the appellant to request review by an advisory committee established under section #ehg;,g when there is a dispute involving substantial scientific fact4 ,if an advisory panel meeting is held1 the ,secretary shall make a determination under this subsection not later than #de days after the requested advisory committee meeting has concluded4 7d7 ,least burdensome review ,any developer who has submitted an application under section #ehg;,b or #ehg;,d may request a supervisory review of a request for additional information during an evaluation of such submission within #fj calendar days of receipt of the additional information request from the ,secretary4 7e7 ,availability of all remedies ,the procedures set forth in this section shall be in addition to1 and not in lieu of1 other remedies available to the developer4 #ehg,q4 ,accredited persons 7a7 ,in general 7#a7 ,authorization ,beginning on the date of enactment of the ,,valid ,act of #bjbb1 the ,secretary shall accredit persons for any of the following purposes3 7,a7 ,reviewing applications for premarket approval under section #ehg;,b and making findings with respect to such applications4 7,b7 ,reviewing applications for technology certification under section #ehg;,d and making recommendations to the ,secretary with respect to such applications4 7,c7 ,conducting inspections as specified in subsection 7c7 of in vitro clinical test developers and other persons required to register pursuant to section #ehg;,i4 7#b7 ,persons submitting applications ,a person submitting an application for premarket approval under section #ehg;,b or an application for technology certification under section #ehg;,d may submit such application to the ,secretary or to a person accredited pursuant to subparagraph 7,a7 or 7,b7 of paragraph 7#a74 7b7 ,accredited persons application reviews1 findings and recommendations 7#a7 ,requirements for premarket application 7,a7 ,review and finding requirements ,an accredited person receiving an application for premarket approval under section #ehg;,b shall either-- 7i7 provide to the ,secretary1 together with the application for premarket approval submitted by the applicant1 a finding that the criteria for approval of the application under section #ehg;,b7g77#b77;,a7 are met and issue a copy of such finding to the applicant1 which finding shall plainly state-- 7,i7 the basis for the accredited person's finding that the criteria under section #ehg;,b7g77#b77;,a7 are met2 and 7,,ii7 any proposed restrictions1 mitigating measures1 or conditions of approval under section #ehg;,b7g77#b77;,b71 as applicable2 or 7ii7 provide a notification to the applicant that the accredited person cannot find that the criteria for approval of the application under section #ehg;,b7g77#b77;,a7 are met and the reasons for such decision4 7,b7 ,requesting missing or clarifying information ,after receipt of an application under this section1 the ,secretary may request missing or clarifying information from the applicant concerning the application1 which the applicant shall promptly provide4 7,c7 ,secretary action on finding that approval criteria are met ,if the accredited person transmits a finding to the ,secretary under clause 7i7 of subparagraph 7,a71 then prior to the date that is #de calendar days after the transmittal date the ,secretary shall-- 7i7 approve the application for premarket approval under section #ehg;,b7g77#b7 with appropriate restrictions1 mitigating measures1 or conditions of approval1 as applicable2 or 7ii7 deny approval of the application by issuing a written notice that reflects appropriate management input and concurrence to the accredited person and the applicant detailing the scientific basis for the ,secretary's determination that the criteria for issuance of an approval under section #ehg;,b7g77#b77;,a7 have not been met4 7,d7 ,effect of inaction on finding ,if the ,secretary fails to take an action under subparagraph 7,c7 the ,secretary shall-- 7i7 within #de calendar days after the transmittal date1 provide written feedback to the applicant that-- 7,i7 includes all outstanding issues with the application preventing the ,secretary from taking an action under subparagraph 7,b72 7,,ii7 reflects appropriate management input and concurrence2 and 7,,iii7 includes action items for the ,secretary1 the applicant1 or both1 as appropriate1 with an estimated date of completion for the ,secretary and the applicant to complete their respective tasks1 as applicable2 and 7ii7 promptly schedule a meeting or teleconference to discuss the feedback provided under clause 7i71 unless the ,secretary and applicant agree that the outstanding issues are adequately presented through written correspondence and a meeting or teleconference is not necessary4 7#b7 ,requirements for technology certification 7,a7 ,review and recommendation requirements ,an accredited person receiving an application for technology certification under section #ehg;,d shall either-- 7i7 provide to the ,secretary1 together with the application for technology certification submitted by the applicant1 a recommendation that the criteria for issuance of a technology certification order under section #ehg;,d7f77#c7 are met and issue a copy of such recommendation to the applicant1 which recommendation shall plainly state the basis for the accredited person's recommendation that the criteria under section #ehg;,d7f77#c7 are met2 or 7ii7 provide a notification to the applicant that the accredited person cannot recommend that the criteria for issuance of a technology certification order under section #ehg;,d7f77#c7 are met and the reasons for such decision4 7,b7 ,requesting missing or clarifying information ,after receipt of an application under this section1 the ,secretary may request missing or clarifying information from the applicant concerning the application1 which the applicant shall promptly provide4 7,c7 ,secretary action on recommendation for issuance of a technology certification order ,if the accredited person transmits a recommendation to the ,secretary under clause 7i7 of subparagraph 7,a71 then prior to the date that is #fj calendar days after the transmittal date the ,secretary shall-- 7i7 issue the technology certification order under section #ehg;,d7f77#c71 consistent with such recommendation from the accredited person2 or 7ii7 deny approval of the application by issuing a written notice to the accredited person and the applicant detailing the scientific basis for a determination by the ,secretary that the criteria for issuance of a technology certification order under section #ehg;,d7f77#c7 have not been met4 7c7 ,requirements for inspections 7#a7 ,in general ,when conducting inspection1 persons accredited under subparagraph 7a77#a77;,b7 shall record in writing their specific observations and shall present their observations to the designated representative of the inspected establishment4 7#b7 ,inspection report requirements ,each person accredited under this subparagraph 7a77#a77;,c7 shall prepare and submit to the ,secretary an inspection report in a form and manner designated by the ,secretary for conducting inspections4 ,any statement or representation made by an employee or agent of an establishment to a person accredited to conduct inspections under subparagraph 7a77#a77;,c7 shall be subject to section #ajja of title #ah1 ,united ,states ,code4 7#c7 ,savings clause ,nothing in this section affects the authority of the ,secretary to inspect any in vitro clinical test developer or other person registered under section #ehg;,i or recognize inspections conducted by auditing organizations as described under section #gjd7;g77#ae74 7#d7 ,inspection limitations ,the ,secretary shall ensure that inspections carried out under this section are not duplicative of inspections carried out under section #cec of the ,public ,health ,service ,act4 ,inspections under this section shall be limited to the data and information necessary-- 7,a7 for routine surveillance activities of facilities associated with an approved application under section #ehg;,b or issuance of a technology certification order under section #ehg;,d2 or 7,b7 to meet the requirements for premarket approval under section #ehg;,b or issuance of a technology certification order under section #ehg;,d1 as applicable4 7d7 ,accreditation 7#a7 ,accreditation program ,the ,secretary may provide for accreditation under this section through programs administered by the ,food and ,drug ,administration1 by other non-,federal government agencies1 or by qualified nongovernmental organizations4 ,a person may be accredited for the review of applications submitted under sections #ehg;,b as described in subsection 7a77#a77;,a71 for the review of applications submitted under section #ehg;,d as described in subsection 7a77#a77;,b7 and to conduct inspection activities under subsection 7a77#a77;,c71 or for a subset of such reviews or activities4 7#b7 ,eligible persons 7,a7 ,minimum qualifications ,an accredited person1 at a minimum1 shall-- 7i7 not be an employee of the ,federal ,government2 7ii7 not engage in the activities of a developer1 as defined in section #ehg7g72 7iii7 not be a person required to register under section #ehg;,i1 unless such person has established sufficient processes and protocols to separate activities to develop in vitro clinical tests and the activities for which such person would be accredited under subsection 7a7 and discloses applicable information under this section2 7iv7 not be owned or controlled by1 and shall have no organizational1 material1 or financial affiliation with1 an in vitro clinical test developer or other person required to register under section #ehg;,i2 7v7 be a legally constituted entity permitted to conduct the activities for which it seeks accreditation2 7vi7 ensure that the operations of such person are in accordance with generally accepted professional and ethical business practices2 and 7vii7 include in its request for accreditation a commitment to1 at the time of accreditation and at any time it is performing activities pursuant to this section-- 7,i7 certify that the information reported to the ,secretary accurately reflects the data or protocol reviewed1 and the documented inspection findings1 as applicable2 7,,ii7 limit work to that for which competence and capacity are available2 7,,iii7 treat information received or learned1 records1 reports1 and recommendations as proprietary information of the person submitting such information2 and 7,,iv7 in conducting the activities for which the person is accredited in respect to a particular in vitro clinical test1 protect against the use of any employee or consultant who has a financial conflict of interest regarding that in vitro clinical test4 7,b7 ,waiver ,the ,secretary may waive any requirements in clauses 7i71 7ii71 7iii71 or 7iv7 of subparagraph 7,a7 upon making a determination that such person has implemented other appropriate controls sufficient to ensure a competent and impartial review4 7#c7 ,accreditation process 7,a7 ,accreditation process guidance and regulations ,not later than #ahj days after the date of enactment of the ,,valid ,act of #bjbb1 the ,secretary shall issue draft guidance specifying the process for submitting a request for accreditation and reaccreditation under this section1 including the form and content of information to be submitted1 including the criteria that the ,secretary will consider to accredit or deny accreditation and1 not later than #a year after the close of the comment period for the draft guidance1 issue final guidance4 7,b7 ,response to request ,the ,secretary shall respond to a request for accreditation or reaccreditation within #fj calendar days of the receipt of the request4 ,the ,secretary's response may be to accredit or reaccredit the person1 to deny accreditation1 or to request additional information in support of the request4 ,if the ,secretary requests additional information1 the ,secretary shall respond within #fj calendar days of receipt of such additional information to accredit or deny the accreditation4 7,c7 ,type of accreditation ,the accreditation or reaccreditation of a person shall specify the particular activity or activities under subsection 7a7 for which such person is accredited1 and shall include any limitation to certain eligible in vitro clinical tests4 7,d7 ,public list ,the ,secretary shall publish on the website of the ,food and ,drug ,administration a list of persons who are accredited under this section4 ,such list shall be updated on at least a monthly basis4 ,the list shall specify the particular activity or activities under this section for which the person is accredited4 7,e7 ,audit ,the ,secretary may audit the performance of persons accredited under this section for purposes of ensuring that such persons continue to meet the published criteria for accreditation1 and may modify the scope or particular activities for which a person is accredited if the ,secretary determines that such person fails to meet one or more criteria for accreditation4 7,f7 ,suspension or withdrawal ,the ,secretary may suspend or withdraw accreditation of any person accredited under this section1 after providing notice and an opportunity for an informal hearing1 when such person is substantially not in compliance with the requirements of this section or the published criteria for accreditation1 or poses a threat to public health1 or fails to act in a manner that is consistent with the purposes of this section4 7,g7 ,reaccreditation ,accredited persons may be initially accredited for up to #c years4 ,after expiration of such initial period1 persons may be reaccredited for unlimited additional #ce-year periods1 as determined by the ,secretary4 7e7 ,compensation of accredited persons ,compensation of an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person1 and shall be paid by the person who engages such services4 7f7 ,international harmonization ,notwithstanding any other provision of this section1 to facilitate international harmonization the ,secretary may recognize persons accredited or recognized by governments1 who have also entered into information sharing agreements1 including confidentiality commitments1 with the ,commissioner of ,food and ,drugs4 7g7 ,information sharing agreements ,an accredited person may enter into an agreement with a test developer to provide information to the comprehensive test information system under section #ehg,t1 including any requirements under section #ehg;,i4 7h7 ,reports ,not later than #b years after the effective date of the ,,valid ,act of #bjbb1 and annually thereafter for the next #d years1 the ,secretary shall post on the website of the ,food and ,drug ,administration1 a report describing the ,secretary's performance in implementing this section1 including the ,secretary's progress in minimizing duplicative reviews of applications for which an accredited person finds the criteria for approval are met4 ,such reports shall include1 for each period-- 7#a7 with regard to premarket approval applications-- 7,a7 the total number of findings transmitted to the ,secretary under subsection 7b77#a77;,a77i72 7,b7 the total number of determinations made by the ,secretary under subsection 7b77#a77;,b77i7 within #cj calendar days of the transmittal date to approve an application2 7,c7 the total number of determinations made by the ,secretary under subsection 7b77#a77;,b77ii7 within #cj calendar days of the transmittal date to deny approval of an application2 and 7,d7 the total number of applications that were approved and the total number of applications that were denied approval1 after the ,secretary failed to make a determination within #cj calendar days of the transmittal date under subsection 7b77#a77;,b72 and 7#b7 with regard to applications for technology certification-- 7,a7 the total number of recommendations transmitted to the ,secretary under subsection 7b77#b77;,a77i72 7,b7 the total number of determinations made by the ,secretary under subsection 7b77#b77;,b77i7 to issue a technology certification order1 including determinations made within #cj days of the transmittal date2 7,c7 the total number of determinations made by the ,secretary under subsection 7b77#b77;,b77ii7 to deny the application for technology certification1 including determinations made within #cj calendar days of the transmittal date2 and 7,d7 the total number of technology certification orders issued1 and the total number of applications for technology certification that were denied1 including applications denied after the ,secretary failed to make a determination within #cj calendar days of the transmittal date under subsection 7b77#b77;,b74 #ehg,r4 ,recognized standards 7a7 ,in general ,the ,secretary may recognize all or part of appropriate standards established by nationally or internationally recognized standards development organizations for which a person may submit a declaration of conformity in order to meet a requirement under this subchapter to which that standard is applicable4 ,standards for in vitro diagnostic devices previously recognized under section #ead7;c7 shall be considered recognized standards under this section4 ,recognized and proposed standards shall be accessible to the public at no charge4 ,the application of any such consensus standard shall only apply prospectively4 ,the ,secretary shall issue regulations establishing the criteria and process1 for such recognition and adoption4 7b7 ,amendment process ,the procedures established in this section or in regulation or guidance issued under this section shall apply to amendment of an existing standard4 #ehg,s4 ,investigational use 7a7 ,in general ,subject to the conditions prescribed in subsections 7c71 7d71 7e71 7f71 and 7g7 of this section1 an in vitro clinical test for investigational use shall be exempt from the requirements of this subchapter other than sections #ehg;,a1 #ehg,p1 #ehg,t1 and #ehg,v4 ,the ,secretary may amend parts #ej1 #ed1 and #ef of title #ba of the ,code of ,federal ,regulations1 or any successor regulations1 to apply to in vitro clinical tests to permit the investigational use of such tests by experts qualified by scientific training and experience4 7b7 ,regulations 7#a7 ,in general ,not later than #b years after the date of enactment of the ,,valid ,act of #bjbb1 the ,secretary shall promulgate regulations1 or amend existing regulations1 to implement this section4 7#b7 ,variation ,the requirements in the regulations promulgated under this section shall take into account variations based on-- 7,a7 the scope and duration of clinical testing to be conducted under investigation that is the subject of such application2 7,b7 the number of human subjects that are to be involved in such testing2 7,c7 the need to permit changes to be made to the in vitro clinical test involved during testing conducted in accordance with a plan required under subsection 7c77#e72 or 7,d7 whether the clinical testing of such in vitro clinical test is for the purpose of developing data to obtain approval to offer such test4 7c7 ,application for investigational use ,the following shall apply with respect to in vitro clinical tests for investigational use3 7#a7 ,significant risk and other studies ,in the case of an in vitro clinical test the investigational use of which poses a significant risk to the human subject1 a sponsor of an investigation of such a test seeking an investigational use exemption shall submit to the ,secretary an investigational use application with respect to the in vitro clinical test in accordance with paragraphs 7#c7 and 7#d74 ,for purposes of this subparagraph1 the term significant risk means1 with respect to an in vitro clinical test and that the use of such in vitro clinical test-- 7,a7 is of substantial importance in performing an activity or activities described in section #bja7ss77#a7 for1 a serious or life-threatening disease or condition without confirmation of the diagnosis by a medically established diagnostic product or procedure2 7,b7 requires an invasive sampling procedure that presents a significant risk to the human subject1 provided that routine venipuncture shall not be considered an invasive sampling procedure2 or 7,c7 otherwise presents a potential for serious risk to the health of a human subject4 7#b7 ,non-significant risk studies ,in the case of an in vitro clinical test1 the investigational use of which is not described in paragraph 7#a7-- 7,a7 the sponsor of such investigation shall-- 7i7 ensure such investigation is conducted in compliance with an investigational plan approved by an institutional review committee and the labeling of the in vitro clinical test involved clearly and conspicuously states1 ,for investigational use only1 as specified in paragraph 7#d77;,a77ii72 7ii7 ensure each investigator obtains informed consent as required under part #ej1 #ed1 and #ef of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 subject to the exceptions set forth in paragraph 7#f77;,c72 7iii7 establish and maintain records with respect to all requirements in this subparagraph2 7iv7 maintain records and make reports as established by the ,secretary in regulations issued under subsection 7b72 and 7v7 ensure that investigators monitor investigations1 maintain records and make reports as established by the ,secretary in regulations issued under subsection 7b72 and 7,b7 the sponsor may rely on any exception or exemption described in paragraph 7#e77;,b7 or as established by the ,secretary in regulations issued under subsection 7b74 7#c7 ,application ,an investigational use application shall be submitted in such time and manner and contain such information as the ,secretary may require in regulation1 and shall include an investigational plan for proposed clinical testing and assurances that the sponsor submitting the application will-- 7,a7 establish and maintain records relevant to the investigation of such in vitro clinical test2 and 7,b7 submit to the ,secretary annual reports of data obtained as a result of the investigational use of the in vitro clinical test during the period covered by the exemption that the ,secretary reasonably determines will enable the ,secretary-- 7i7 to ensure compliance with the conditions for the exemption specified in paragraph 7#d72 7ii7 to review the progress of the investigation involved2 and 7iii7 to evaluate the ability to meet the applicable standard4 7#d7 ,conditions for exemption 7,a7 ,in general ,an application for an investigational use exemption with respect to a significant risk study shall be granted if each of the following conditions is met3 7i7 ,the risks to the subjects of the in vitro clinical test are outweighed by the anticipated benefits of the test to the subjects and the importance of the knowledge to be gained1 and adequate assurance of informed consent is provided in accordance with paragraphs 7#f77;,a77iii7 and 7#f77;,b74 7ii7 ,the proposed labeling for the in vitro clinical test involved clearly and conspicuously states ,for investigational use only4 7iii7 ,such other requirements the ,secretary determines-- 7,i7 are necessary for the protection of the public health and safety2 and 7,,ii7 do not unduly delay investigation4 7,b7 ,certain significant risk studies of in vitro clinical tests for an unmet need ,the ,secretary shall not impose a limit on the sample size for a significant risk study of an in vitro clinical test that has received breakthrough designation under section #ehg;,i4 7#e7 ,coordination with investigational new drug applications ,any requirement for the submission of a report to the ,secretary pursuant to an application for an investigational new drug exemption involving an in vitro clinical test shall supersede the reporting requirement in paragraph 7#c77;,b71 but only to the extent the requirement with respect to the application for exemption with respect to the drug is duplicative of the reporting requirement under such paragraph4 7#f7 ,investigational plan1 procedures1 and conditions ,with respect to an investigational plan submitted under paragraph 7#c71 the sponsor submitting such plan shall-- 7,a7 promptly notify the ,secretary of the approval or the suspension or termination of the approval of such plan by an institutional review committee2 7,b7 in the case of an in vitro clinical test made available to investigators for clinical testing1 obtain agreements from each investigator that any testing of the in vitro clinical test involving human subjects will be under such investigator's supervision and in accordance with paragraph 7,c7 and submit such agreements to the ,secretary that ensure-- 7i7 all investigators will comply with this section1 regulations promulgated or revised under this section1 and applicable human subjects regulations2 and 7ii7 the investigator will ensure that-- 7,i7 informed consent is obtained as required under part #ej of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 amended to apply to in vitro clinical tests2 and 7,,ii7 the requirements for institutional review board under part #ef of title #ba of the ,code of ,federal ,regulations 7or successor regulations71 amended to apply to in vitro clinical tests1 are met2 and 7,c7 assure that informed consent will be obtained from each human subject 7or the representative of such subject7 of proposed clinical testing involving such in vitro clinical test1 except where1 subject to such other conditions as the ,secretary may prescribe-- 7i7 the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights1 safety1 and welfare of the human subject2 or 7ii7 the investigator conducting or supervising the clinical testing determines in writing that there exists a life-threatening situation involving the human subject of such testing which necessitates the use of such in vitro clinical test and it is not feasible to obtain informed consent from the subject and there is not sufficient time to obtain such consent from a representative of such subject4 7#g7 ,concurred by licensed physician ,the determination required by paragraph 7#f77;,c77ii7 shall be concurred in writing by a licensed physician who is not involved in the testing of the human subject with respect to which such determination is made unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence4 7d7 ,review of applications 7#a7 ,in general ,the ,secretary may issue an order approving an investigation as proposed1 approving it with conditions or modifications1 or disapproving it4 7#b7 ,failure to act ,unless the ,secretary1 not later than the date that is #cj calendar days after the date of the submission of an application for an investigational use exemption that meets the requirements of subsection 7c71 issues an order under paragraph 7#a7 and notifies the sponsor submitting the application1 the application shall be treated as approved as of such date without further action by the ,secretary4 7#c7 ,denial ,the ,secretary may deny an investigational use application submitted under this subsection if the ,secretary determines that the investigation with respect to which the application is submitted does not conform to the requirements of subsection 7c74 ,a notification of such denial submitted to the sponsor with respect to such a request shall contain the order of disapproval and a complete statement of the reasons for the ,secretary's denial of the application4 7e7 ,withdrawal of exemption 7#a7 ,in general ,the ,secretary may1 by administrative order1 withdraw an exemption approved under this section with respect to an in vitro clinical test1 including an exemption treated as approved based on the ,secretary's failure to act pursuant to subsection 7d77#b71 if the ,secretary determines that an investigation conducted under such an exemption does not meet the applicable conditions under subsection 7c77#c7 for such exemption4 7#b7 ,opportunity to be heard 7,a7 ,in general ,subject to subparagraph 7,b71 an order withdrawing an investigational use exemption granted under this section may be issued only after the ,secretary provides the sponsor of the in vitro clinical test with an opportunity for an informal hearing4 7,b7 ,exception ,an order referred to in subparagraph 7,a7 with respect to an investigational use exemption granted under this section may be issued on a preliminary basis before the provision of an opportunity for an informal hearing if the ,secretary determines that the continuation of testing under the exemption will result in an unreasonable risk to the public health4 ,the ,secretary will provide an opportunity for an informal hearing promptly following any preliminary action under this subparagraph4 7f7 ,changes 7#a7 ,in general ,the regulations promulgated under subsection 7b7 shall provide1 with respect to an in vitro clinical test for which an exemption under this subsection is in effect1 procedures and conditions under which changes are allowed without the additional approval of an application for an exemption or submission of a supplement to such an application4 ,such regulations shall provide that such a change may be made if-- 7,a7 the sponsor determines1 on the basis of credible information 7as defined in regulations7 that the change meets the conditions specified in paragraph 7#b72 and 7,b7 the sponsor submits to the ,secretary1 not later than #e calendar days after making the change1 a notice of the change4 7#b7 ,conditions ,the conditions specified in this paragraph are that-- 7,a7 in the case of developmental changes to an in vitro clinical test1 including manufacturing changes1 the changes-- 7i7 do not constitute a significant change in design or in basic principles of operation2 7ii7 do not affect the rights1 safety1 or welfare of the human subjects involved in the investigation2 and 7iii7 are made in response to information gathered during the course of an investigation2 and 7,b7 in the case of changes to clinical protocols applicable to the test1 the changes do not affect-- 7i7 the validity of data or information resulting from the completion of an approved clinical protocol1 or the relationship of likely patient risk to benefit relied upon to approve a product2 7ii7 the scientific soundness of a plan submitted under subsection 7c77#c72 or 7iii7 the rights1 safety1 or welfare of the human subjects involved in the investigation4 7g7 ,clinical hold 7#a7 ,in general ,at any time1 the ,secretary may impose a clinical hold with respect to an investigation of an in vitro clinical test if the ,secretary makes a written determination described in paragraph 7#b74 ,the ,secretary shall1 in imposing such clinical hold1 specify the basis for the clinical hold1 including the specific information available to the ,secretary which served as the basis for such clinical hold1 and confirm such determination in writing4 ,the applicant may immediately appeal any such determination pursuant to section #ehg,p4 7#b7 ,determination 7,a7 ,in general ,for purposes of paragraph 7#a71 a determination described in this subparagraph with respect to a clinical hold is a determination that1 based on credible evidence1 the in vitro clinical test involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation1 taking into account the qualifications of the clinical investigators1 information about the in vitro clinical test1 the design of the clinical investigation1 the condition for which the in vitro clinical test is to be investigated1 and the health status of the subjects involved4 7,b7 ,removal of clinical hold ,any written request to the ,secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision1 in writing and specifying the reasons therefor1 within #cj days after receipt of such request4 ,any such request shall include sufficient information to support the removal of such clinical hold4 #ehg,t4 ,comprehensive test information system 7a7 ,establishment ,not later than #b years after the date of enactment of the ,,valid ,act of #bjbb1 the ,secretary shall make available a comprehensive test information system for in vitro clinical tests that is designed to-- 7#a7 provide a transparent interface on the website of the ,food and ,drug ,administration for stakeholders1 to the extent permitted by applicable law1 which may include access to the-- 7,a7 regulatory pathway designation information for each in vitro clinical test or tests with the same indications for use2 7,b7 registration and listing information provided by developers under section #ehg;,j1 including the use of a link for labels2 7,c7 adverse event reports submitted under section #ehg,m1 as appropriate2 7,d7 reports of corrections and removals submitted under section #ehg,n2 and 7,e7 other information pertaining to an in vitro clinical test or tests with the same indications for use1 as the ,secretary determines appropriate2 and 7#b7 provide a secure portal for electronic submission1 including applications and other in vitro clinical test submissions1 registration and listing information1 and adverse event reports1 which provides protections from unauthorized disclosure of information1 including of-- 7,a7 trade secret or commercial confidential information2 and 7,b7 national security1 countermeasure1 or other information restricted from disclosure pursuant to any provision of law4 7b7 ,submission function ,the comprehensive test information system shall serve as the electronic submission service for test developers submitting information for applications under sections #ehg;,b and #ehg;,d4 #ehg,u4 ,preemption 7a7 ,in general ,except as provided in subsection 7b71 no ,state1 ,tribal1 or local government 7or political subdivision thereof7 may establish or continue in effect any requirement that-- 7#a7 is different from1 or in addition to1 any requirement applicable to an in vitro clinical test under this ,act2 or 7#b7 with respect to the analytical validity1 clinical validity1 or safety for individuals who come into contact with such an in vitro clinical test under this ,act4 7b7 ,exceptions ,subsection 7a7 shall not be construed to affect the authority of a ,state1 ,tribal1 or local government to do any of the following3 7#a7 ,to license laboratory personnel1 health care practitioners1 or health care facilities or to regulate any aspect of a health care practitioner-patient relationship4 7#b7 ,to enforce laws of general applicability1 such as zoning laws1 environmental laws1 labor laws1 and general business laws4 7#c7 ,to authorize laboratories to develop and perform an in vitro clinical test1 pursuant to a law enacted by a ,state prior to ,january #a1 #bjbb1 as long as such law does not impose requirements that are different from any requirement applicable to an in vitro clinical test under this ,act4 ,if a ,state has enacted such a law1 the ,secretary may exempt such laboratories in that ,state from compliance with this subchapter4 7c7 ,clarification ,nothing in this section shall be construed to-- 7#a7 modify any action for damages or the liability of any person under the law of any ,state2 or 7#b7 shift liability to health care practitioners or other users4 #ehg,v4 ,adulteration ,an in vitro clinical test shall be deemed to be adulterated3 7#a7 ,if it consists in whole or in part of any filthy1 putrid1 or decomposed substance4 7#b7 ,if it has been developed1 prepared1 packed1 or held under insanitary conditions whereby it may have been contaminated with filth1 or whereby it may have been rendered injurious to health4 7#c7 ,if its container or package is composed1 in whole or in part1 of any poisonous or deleterious substance which may render the contents injurious to health4 7#d7 ,if it bears or contains1 for purposes of coloring only1 a color additive which is unsafe within the meaning of section #gba7;a74 7#e7 ,if its analytical or clinical validity1 as applicable1 or with respect to a specimen receptacle1 its safety1 falls below that which it purports or is represented to possess4 7#f7 ,if it is required to be1 declared to be1 purports to be1 or is represented as being1 in conformity with any performance standard established or recognized under section #ehg,r and is not in conformity with such standard4 7#g7 ,if it is required to be in compliance with mitigating measures established under section #ehg;,e and is not in conformity with such mitigating measures4 7#h7 ,if it fails to have in effect an approved premarket application under section #ehg;,b unless such in vitro clinical test is in compliance with the requirements for-- 7,a7 offering without an approved premarket application under section #ehg;,d2 7,b7 an exemption from premarket approval under section #ehg;,c or #ehg;,g2 or 7,c7 investigational use pursuant to section #ehg,s4 7#i7 ,if it is not in conformity with any condition established under section #ehg;,b or #ehg;,d4 7#aj7 ,if it purports to be an in vitro clinical test subject to an exemption under section #ehg;,c and it fails to meet or maintain any criteria1 condition1 or requirement of such exemption4 7#aa7 ,if it has been granted an exemption under section #ehg,s for investigational use1 and the person granted such exemption or any investigator who uses such in vitro clinical test under such exemption fails to comply with a requirement prescribed by or under such section4 7#ab7 ,if it fails to meet the quality requirements prescribed in or established under section #ehg,k 7as applicable71 or the methods used in1 or facilities or controls used for1 its development1 packaging1 storage1 or installation are not in conformity with applicable requirements established under such section4 7#ac7 ,if it has been developed1 processed1 packaged1 or held in any establishment1 factory1 or warehouse and the owner1 operator or agent of such establishment1 factory1 or warehouse delays1 denies1 or limits an inspection1 or refuses to permit entry or inspection4 7#ad7 ,if it is not in compliance with any restriction required under section #ehg,o4 #ehg,w4 ,misbranding ,an in vitro clinical test shall be deemed to be misbranded3 7#a7 ,if its labeling is false or misleading in any particular4 7#b7 ,if in a package form unless it bears a label containing-- 7,a7 the name and place of business of the test developer1 packager1 or distributor2 and 7,b7 an accurate statement of the quantity of contents in terms of weight1 measure1 or numerical count with respect to small packages1 unless an exemption is granted by the ,secretary by the issuance of guidance4 7#c7 ,if any word1 statement1 or other information required by or under authority of this ,act to appear on the label or labeling1 including a test report1 is not prominently placed thereon with such conspicuousness 7as compared with other words1 statements1 designs1 or devices1 in the labeling7 and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use4 7#d7 ,unless its labeling bears adequate directions for use and such adequate warnings as are necessary for the protection of users of the in vitro clinical test and recipients of the results of such in vitro clinical test1 including patients1 consumers1 donors1 and related health care professionals4 ,required labeling for in vitro clinical tests intended for use in health care facilities1 blood establishments1 or by a health care professional may be made available solely by electronic means1 provided that the labeling complies with all applicable requirements of law1 and that the test developer1 or distributor affords such users the opportunity to request the labeling in paper form1 and after such request1 promptly provides the requested information without additional cost4 7#e7 ,if there is a reasonable probability that it could cause serious or adverse health consequences or death1 including through absence1 delay1 or discontinuation in diagnosis or treatment1 when used in the manner prescribed1 recommended1 or suggested in the labeling thereof4 7#f7 ,if it was developed1 sterilized1 packaged1 repackaged1 relabeled1 installed1 or imported in an establishment not duly registered under section #ehg;,j or it was not included in a listing under section #ehg;,j1 in accordance with timely reporting requirements under this subchapter4 7#g7 ,in the case of any in vitro clinical test subject to restrictions under section #ehg,o1 7#a7 if its advertising is false or misleading in any particular1 7#b7 if it is offered for clinical use1 sold1 distributed1 or used in violation of such restrictions1 or 7#c7 unless the test developer or distributor includes in all advertisements and other descriptive printed matter that such person issues or causes to be issued1 a brief statement of the indications for use of the in vitro clinical test and relevant warnings1 precautions1 side effects1 and contraindications4 ,this subsection shall not be applicable to any printed matter that the ,secretary determines to be labeling as defined in section #bja7m74 7#h7 ,if it is subject to a mitigating measure established under section #ehg;,e and does not bear such labeling as may be prescribed in such mitigating measure4 7#i7 ,if it is subject to a standard established under section #ehg,r and it does not bear such labeling as may be prescribed in such standard4 7#aj7 ,unless it bears such labeling as may be required by or established under an applicable labeling requirement under this ,act4 7#aa7 ,if there was a failure to comply with any requirement prescribed in or under section #ehg;,d1 #ehg;,j1 #ehg,k1 #ehg,l1 #ehg,m1 #ehg,n1 #ehg,x1 #ehg,y1 #ehg,z1 or to provide any report1 material1 or other information required with respect to in vitro clinical tests under this subchapter4 #ehg,x4 ,postmarket surveillance 7a7 ,in general 7#a7 ,in general ,in addition to other applicable requirements under this ,act1 the ,secretary may issue an order requiring a developer of a high-risk or moderate-risk in vitro clinical test to conduct postmarket surveillance of such in vitro clinical test1 if the failure of the in vitro clinical test is reasonably likely to result in serious adverse health consequences or death from use of such in vitro clinical test4 7#b7 ,consideration ,in determining whether to require a developer to conduct postmarket surveillance of an in vitro clinical test1 the ,secretary shall take into consideration the benefits and risks for the patient and the least burdensome principles under section #ehg;,b7j74 7b7 ,surveillance approval 7#a7 ,in general ,each developer required to conduct surveillance of an in vitro clinical test shall submit1 within #cj days of receiving an order from the ,secretary1 a plan for the required surveillance4 ,the ,secretary1 within #fj days of the receipt of such plan1 shall determine if the person designated to conduct the surveillance has the appropriate qualifications and experience to undertake such surveillance and if the plan will result in useful data that can reveal unforeseen adverse events or other information necessary to protect the health of patients or the public4 7#b7 ,timeline ,the developer shall commence surveillance under this section not later than #ae months after the day on which the ,secretary orders such postmarket surveillance1 unless the ,secretary determines more time is needed to commence surveillance4 7#c7 ,prospective surveillance ,the ,secretary may order a prospective surveillance period of up to #c years4 ,any determination by the ,secretary that a longer period is necessary shall be made by mutual agreement between the ,secretary and the developer or1 if no agreement can be reached1 upon the completion of a dispute resolution process pursuant to section #efb4 #ehg,y4 ,electronic format for submissions 7a7 ,in general ,all submissions to the ,food and ,drug ,administration with respect to an in vitro clinical test1 unless otherwise agreed to by the ,secretary1 shall-- 7#a7 be made electronically2 and 7#b7 with respect to the information required under sections #ehg;,b and #ehg;,d1 utilize the system described in section #ehg,u4 7b7 ,electronic format ,beginning on such date as the ,secretary specifies in final guidance issued under subsection 7c71 submissions for in vitro clinical tests1 including recommendations submitted by accredited and recognized persons under section #ehg,q1 and any appeals of action taken by the ,secretary with respect to such submissions1 shall be submitted in such electronic format as specified by the ,secretary in such guidance4 7c7 ,guidance ,the ,secretary shall issue guidance implementing this section4 ,such guidance may-- 7#a7 provide standards for the electronic submission required under subsection 7a7 or the submission in electronic format required under subsection 7b72 7#b7 set forth criteria for waivers of1 or exemptions from1 the requirements of subsection 7a7 or 7b72 and 7#c7 provide any other information for the efficient implementation and enforcement of this section4 #ehg,z4 ,postmarket remedies 7a7 ,safety ,notice 7#a7 ,in general ,if the ,secretary determines that an in vitro clinical test presents an unreasonable risk of substantial harm to the public health1 and notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this ,act 7other than this section7 to eliminate the risk1 the ,secretary may issue such order as may be necessary to ensure that adequate safety notice is provided in an appropriate form1 by the persons and means best suited under the circumstances1 to all health care professionals who prescribe1 order1 or use the in vitro clinical test and to any other person 7including developers1 importers1 distributors1 retailers1 and users7 who should properly receive such notice4 7#b7 ,notice to individuals ,an order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the ,secretary determines that notice to such individuals would present a greater danger to the health of such individuals than no such notice4 ,if the ,secretary makes such a determination with respect to such individuals1 the order shall require the health care professionals who prescribed1 ordered1 or used the in vitro clinical test provide notification to the individuals for whom the health professionals prescribed1 ordered1 or used such test1 of the risk presented by such in vitro clinical test and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk4 ,before issuing an order under this subsection1 the ,secretary shall consult with the persons required to give notice under the order4 7b7 ,repair1 ,replacement1 or ,refund 7#a7 ,determination after an informal hearing 7,a7 ,in general ,if1 after affording opportunity for an informal hearing1 the ,secretary determines that-- 7i7 an in vitro clinical test presents an unreasonable risk of substantial harm to the public health2 7ii7 there are reasonable grounds to believe that the in vitro clinical test was not properly developed or manufactured considering the state of the art as it existed at the time of its development2 7iii7 there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a developer1 importer1 distributor1 or retailer of the in vitro clinical test to exercise due care in the installation1 maintenance1 repair1 or use of the in vitro clinical test2 and 7iv7 the notice authorized by subsection 7a7 would not by itself be sufficient to eliminate the unreasonable risk and action described in paragraph 7#b7 of this subsection is necessary to eliminate such risk1 the ,secretary may order the developer1 importer1 or any distributor of such in vitro clinical test1 or any combination of such persons1 to submit to him within a reasonable time a plan for taking one or more of the actions described in paragraph 7#b74 ,an order issued under the preceding sentence which is directed to more than one person shall specify which person may decide which action shall be taken under such plan and the person specified shall be the person who the ,secretary determines bears the principal1 ultimate financial responsibility for action taken under the plan unless the ,secretary cannot determine who bears such responsibility or the ,secretary determines that the protection of the public health requires that such decision be made by a person 7including a health professional or user of the in vitro clinical test7 other than the person the ,secretary determines bears such responsibility4 7,b7 ,secretary approval of plan ,the ,secretary shall approve a plan submitted pursuant to an order issued under subparagraph 7,a7 unless the ,secretary determines 7after affording opportunity for an informal hearing7 that the action or actions to be taken under the plan or the manner in which such action or actions are to be taken under the plan will not assure that the unreasonable risk with respect to which such order was issued will be eliminated4 ,if the ,secretary disapproves a plan1 the ,secretary shall order a revised plan to be submitted within a reasonable time4 ,if the ,secretary determines 7after affording opportunity for an informal hearing7 that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the ,secretary within the prescribed time1 the ,secretary shall 7i7 prescribe a plan to be carried out by the person or persons to whom the order issued under subparagraph 7,a7 was directed1 or 7ii7 after affording an opportunity for an informal hearing1 by order prescribe a plan to be carried out by a person who is a developer1 importer1 distributor1 or retailer of the in vitro clinical test with respect to which the order was issued but to whom the order under subparagraph 7,a7 was not directed4 7#b7 ,actions on a plan ,the actions which may be taken under a plan submitted under an order issued under paragraph 7#a77;,a7 are as follows3 7,a7 ,to repair the in vitro clinical test so that it does not present the unreasonable risk of substantial harm with respect to which the order under paragraph 7#a77;,a7 was issued4 7,b7 ,to replace the in vitro clinical test with a like or equivalent test which is in conformity with all applicable requirements of this ,act4 7,c7 ,to refund the purchase price of the in vitro clinical test 7less a reasonable allowance for use if such in vitro clinical test has been in the possession of the user for one year or more at the time of notice ordered under subsection 7a71 or at the time the user receives actual notice of the unreasonable risk with respect to which the order was issued under paragraph 7#a77;,a71 whichever occurs first74 7#c7 ,no charge ,no charge shall be made to any person 7other than a developer1 importer1 distributor or retailer7 for using a remedy described in paragraph 7#b7 and provided under an order issued under paragraph 7#a71 and the person subject to the order shall reimburse each person 7other than a developer1 manufacturer1 importer1 distributor1 or retailer7 who is entitled to such a remedy for any reasonable and foreseeable expenses actually incurred by such person in using such remedy4 7c7 ,reimbursement ,an order issued under subsection 7b77#a77;,a7 with respect to an in vitro clinical test may require any person who is a developer1 importer1 distributor1 or retailer of the in vitro clinical test to reimburse any other person who is a developer1 importer1 distributor1 or retailer of such in vitro clinical test for such other person's expenses actually incurred in connection with carrying out the order if the ,secretary determines such reimbursement is required for the protection of the public health4 ,any such requirement shall not affect any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party4 7d7 ,recall ,authority 7#a7 ,in general ,if the ,secretary finds that there is a reasonable probability that an in vitro clinical test approved under section #ehg;,b or offered under a technology certification order under section #ehg;,d would cause serious1 adverse health consequences or death1 including by the absence1 significant delay1 or discontinuation of appropriate medical treatment1 the ,secretary shall issue an order requiring the appropriate person 7including the developers1 importers1 distributors1 or retailers of the in vitro clinical test7-- 7,a7 to immediately cease distribution of such in vitro clinical test2 and 7,b7 to immediately notify health professionals and applicable in vitro clinical test user facilities of the order and to instruct such professionals and facilities to cease use of such in vitro clinical test4 7#b7 ,informal hearing ,the order issued under paragraph 7#a77;,a71 shall provide the person subject to the order with an opportunity for an informal hearing1 to be held not later than #aj calendar days after the date of the issuance of the order1 on the actions required by the order and on whether the order should be amended to require a recall of such in vitro clinical test4 ,if1 after providing an opportunity for such a hearing1 the ,secretary determines that inadequate grounds exist to support the actions required by the order1 the ,secretary shall vacate the order4 7#c7 ,amended order 7,a7 ,in general ,if1 after providing an opportunity for an informal hearing under paragraph 7#b71 the ,secretary determines that the order should be amended to include a recall of the in vitro clinical test with respect to which the order was issued1 the ,secretary shall1 except as provided in subparagraph 7,b71 amend the order to require a recall4 ,the ,secretary shall specify a timetable in which the recall will occur and shall require periodic reports describing the progress of the recall4 7,b7 ,requirements ,an amended order under subparagraph 7,a7-- 7i7 shall not include recall of the in vitro clinical test from individuals2 7ii7 shall not include recall of an in vitro clinical test from test user facilities if the ,secretary determines that the risk of recalling such in vitro clinical test from the facilities presents a greater health risk than the health risk of not recalling the in vitro clinical test from use2 and 7iii7 shall provide for notice to individuals subject to the risks associated with the use of such in vitro clinical test4 ,in providing the notice required by this clause1 the ,secretary may use the assistance of health professionals who prescribed1 ordered1 or used such an in vitro clinical test for individuals4 7#d7 ,clarification ,the remedy provided by this subsection shall be in addition to remedies provided by subsections 7a71 7b71 and 7c74 #ehg;,,aa4 ,applicability 7a7 ,in general ,an in vitro clinical test shall be subject to the requirements of this subchapter1 except as otherwise provided in this subchapter4 7b7 ,interstate commerce ,any in vitro clinical test that is offered1 including by making available for clinical use in the ,united ,states is deemed to be an act that constitutes introduction into interstate commerce for purposes of enforcing the requirements of this ,act4 7c7 ,least burdensome requirements 7#a7 ,in general ,in carrying out this subchapter1 the ,secretary shall consider the least burdensome means necessary to meet the applicable standard1 and other regulatory requirements1 as determined by the ,secretary4 7#b7 ,necessary defined ,for purposes of paragraph 7#a7 and paragraph 7#c71 the term necessary means the minimum required information that would support a determination by the ,secretary that the application meet the applicable standard or regulatory requirement1 as determined by the ,secretary4 7d7 ,service of orders ,orders of the ,secretary under this section with respect to applications under subsection 7a7 or 7b7 of section #ehg;,b or supplements under subsection 7f7 of such section shall be served-- 7#a7 in person by any officer or employee of the ,department of ,health and ,human ,services designated by the ,secretary2 or 7#b7 by mailing the order by registered mail or certified mail or electronic equivalent addressed to the applicant at the last known address in the records of the ,secretary4 7e7 ,laboratories and blood and tissue establishments 7#a7 ,relation to laboratory certification pursuant to section #cec of the ,public ,health ,service ,act ,nothing in this subchapter shall be construed to modify the authority of the ,secretary with respect to laboratories or clinical laboratories under section #cec of the ,public ,health ,service ,act4 7#b7 ,avoiding duplication ,in implementing this subchapter1 the ,secretary shall avoid issuing or enforcing regulations or guidance that are duplicative of regulations or guidance under section #cec of the ,public ,health ,service ,act4 7#c7 ,blood and tissue ,nothing in this subchapter shall be construed to modify the authority of the ,secretary with respect to laboratories1 establishments1 or other facilities to the extent they are engaged in the propagation1 manufacture1 or preparation1 including filling1 labeling1 packaging1 and storage1 of blood1 blood components1 human cells1 tissues1 or tissue products pursuant to any requirements under this ,act or section #cea or #cfa of the ,public ,health ,service ,act4 7f7 ,not combination product ,a product constituted of a device and an in vitro clinical test is not a combination product and shall be regulated as a device4 7g7 ,practice of medicine ,nothing in this subchapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any lawfully offered in vitro clinical test for any condition or disease within a legitimate health care practitioner-patient relationship pursuant to applicable ,federal or ,state law4 7h7 ,rules of construction 7#a7 ,sale1 distribution1 labeling ,nothing in this paragraph shall be construed to limit the authority of the ,secretary to establish or enforce restrictions on the sale1 distribution1 or labeling of an in vitro clinical test under this ,act4 7#b7 ,promotion of unapproved uses ,nothing in this paragraph shall be construed to alter any prohibition on the promotion of unapproved uses of legally marketed in vitro clinical tests4 #ehg;,,bb4 ,judicial review 7a7 ,in general ,not later than #cj days after an order issued pursuant to sections #ehg;,b or #ehg;,d1 any person adversely affected by such order may file a petition with the ,united ,states ,court of ,appeals for the ,district of ,columbia or for the circuit wherein such person resides or has a principal place of business for judicial review of such order1 in accordance with the procedure set forth in section #eag7;a74 7b7 ,application of provisions ,subsections 7a7 through 7e7 of section #eag shall apply with respect to a petition under subsection 7a7 of this section in the same manner such subsections apply to a petition under section #eag4 ,subsection 7f7 of section #eag shall apply to an order issued under section #ehg;,b or #ehg;,d4 4 #hbd4 ,enforcement and other provisions 7a7 ,prohibited acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca71 as amended by section #haa1 is further amended-- 7#a7 in paragraphs 7a71 7b71 7c71 7g71 7h71 7k71 7q71 7r71 and 7y71 by inserting in vitro clinical test1 after device1 each place it appears2 7#b7 in paragraph 7g71 by inserting after misbranded1 1 and the development within any ,territory of any in vitro clinical test that is adulterated or misbranded2 7#c7 in paragraph 7y71 by inserting or #ehg,q after section #ebc each place it appears2 7#d7 in paragraph 7ff71 by striking or device and inserting 1 device1 or in vitro clinical test2 and 7#e7 by adding at the end1 the following3 7jjj7 7#a7 ,forging1 counterfeiting1 simulating1 or falsely representing1 or without proper authority using any mark1 stamp1 tag1 label1 or other identification upon any in vitro clinical test or container1 packaging1 or labeling thereof so as to render such in vitro clinical test a counterfeit in vitro clinical test4 7#b7 ,making1 selling1 disposing of1 or keeping in possession1 control1 or custody1 or concealing any punch1 die1 plate1 stone1 or other thing designed to print1 imprint1 or reproduce the trademark1 trade name1 or other identifying mark or imprint of another or any likeness of any of the foregoing upon any in vitro clinical test or container1 packaging1 or labeling thereof so as to render such in vitro clinical test a counterfeit in vitro clinical test4 7#c7 ,the doing of any act which causes an in vitro clinical test to be a counterfeit in vitro clinical test1 or the sale or dispensing1 or the holding for sale or dispensing1 of a counterfeit in vitro clinical test4 7kkk7 7#a7 ,the introduction or delivery for introduction into interstate commerce of an in vitro clinical test in violation of section #ehg;,b7a74 7#b7 ,the making of a false1 fraudulent1 or deceptive statement about an in vitro clinical test that is exempt from premarket review under section #ehg;,c4 7#c7 ,the failure to maintain complete and accurate documentation for an exemption as required under section #ehg;,c or the failure to provide labeling required under section #ehg,l4 7#d7 ,with respect to an in vitro clinical test1 the submission of any report or listing under this ,act that is false or misleading in any material respect4 7#e7 ,the failure to comply with a condition of approval1 or restriction required under an approved application under section #ehg;,b2 the failure to perform a risk analysis required by section #ehg;,b2 the failure to submit an annual update required under section #ehg;,j7c77#b77;,b72 or the failure to complete postmarket surveillance as required under section #ehg,x4 7#f7 ,the failure to comply with applicable requirements to submit an application or report under section #ehg;,d7e74 7#g7 ,the failure to comply with applicable mitigating measures established under section #ehg;,e or to submit1 maintain1 or make available the documentation required under section #ehg;,e7b72 or the failure to comply with applicable performance standards established under section #ehg,r4 7#h7 ,the failure to register in accordance with section #ehg;,j1 the failure to provide information required under section #ehg;,j7b71 or the failure to maintain or submit information required under section #ehg;,j7c74 7#i7 ,the failure to comply with requirements under section #ehg,m or #ehg,n1 the failure to comply with a restriction required under section #ehg,o1 or the failure to comply with labeling and advertising requirements under section #ehg,o7b74 7#aj7 ,the failure to comply with the requirements of section #ehg,q4 7#aa7 ,the failure to comply with any requirement of section #ehg,s2 the failure to furnish any notification1 information1 material1 or report required under section #ehg,s2 or the failure to comply with an order issued under section #ehg,s4 7#ab7 ,the failure to furnish information requested by the ,secretary under #ehg;,g7d77#b74 4 7b7 ,penalties ,section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended-- 7#a7 in subsection 7b77#h71 by inserting or counterfeit in vitro clinical test after counterfeit drug2 7#b7 in subsection 7c7-- 7,a7 by striking 2 or 7#e7 and inserting 2 7#e72 and 7,b7 by inserting before the period at the end the following3 2 or 7#f7 for having violated section #cja7;fff77#b7 if such person acted in good faith and had no reason to believe that use of the punch1 die1 plate1 stone1 or other thing involved would result in an in vitro clinical test being a counterfeit in vitro clinical test1 or for having violated section #cja7;fff77#c7 if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the in vitro clinical test was a counterfeit in vitro clinical test2 and 7#c7 in subsection 7f77#a7-- 7,a7 in subparagraph 7,a7-- 7i7 by inserting or in vitro clinical tests after which relates to devices2 7ii7 by inserting or section #ehg,q7a77#b7 after section #gjd7;g72 and 7iii7 by inserting or in vitro clinical tests1 as applicable before the period at the end of the second sentence2 and 7,b7 in subparagraph 7,b77i71 by striking or #ebj7;f7 and inserting 1 #ebj7;f71 #ehg,k1 or #ehg,m14 7c7 ,seizure ,section #cjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccd7 is amended-- 7#a7 in subsection 7a77#b7-- 7,a7 by striking 1 and 7,e7 and inserting 1 7,e72 and 7,b7 by inserting before the period at the end the following3 1 and 7,f7 ,any in vitro clinical test that is a counterfeit in vitro clinical test1 7,g7 ,any container1 packaging1 or labeling of a counterfeit in vitro clinical test1 and 7,h7 ,any punch1 die1 plate1 stone1 labeling1 container1 or other thing used or designed for use in making a counterfeit in vitro clinical test2 7#b7 in subsection 7d77#a71 by inserting in vitro clinical test1 after device12 and 7#c7 in subsection 7g7-- 7,a7 in paragraph 7#a71 by inserting 1 in vitro clinical test1 after device each place it appears2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting 1 in vitro clinical test1 after device2 and 7ii7 in subparagraph 7,b71 by inserting or in vitro clinical test after device each place it appears4 7d7 ,debarment1 temporary denial of approval1 and suspension ,section #cjf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cce;a7 is amended by adding at the end the following3 7n7 ,in vitro clinical tests2 mandatory debarment regarding third-,party inspections and reviews 7#a7 ,in general ,if the ,secretary finds that a person has been convicted of a felony for a violation of section #cja7;gg7 or #cja7;jjj77#a71 the ,secretary shall debar such person from being accredited under section #ehg,q and from carrying out activities under an agreement described in section #hjc7;b74 7#b7 ,debarment period ,the ,secretary shall debar a person under paragraph 7#a7 for the following periods3 7,a7 ,the period of debarment of a person 7other than an individual7 shall not be less than #a year or more than #aj years1 but if an act leading to a subsequent debarment under such paragraph occurs within #aj years after such person has been debarred under such paragraph1 the period of debarment shall be permanent4 7,b7 ,the debarment of an individual shall be permanent4 7#c7 ,termination of debarment2 judicial review2 other matters ,subsections 7c77#c71 7d71 7e71 7i71 7j71 and 7l77#a7 apply with respect to a person 7other than an individual7 or an individual who is debarred under paragraph 7#a7 to the same extent and in the same manner as such subsections apply with respect to a person who is debarred under subsection 7a77#a71 or an individual who is debarred under subsection 7a77#b71 respectively4 4 7e7 ,expanded access to unapproved therapies and diagnostics ,section #efa of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 is amended-- 7#a7 in subsections 7a7 through 7d7-- 7,a7 by striking or investigational devices each place it appears and inserting 1 investigational devices1 or investigational in vitro clinical tests2 and 7,b7 by striking or investigational device each place it appears 7other than the second such place in paragraph 7#c77;,a77 of subsection 7c77 and inserting 1 investigational device1 or investigational in vitro clinical test2 7#b7 in subsection 7b77#d7 by striking or #ebj7;g7 and inserting 1 #ebj7;g71 or #ehg,s each place it appears2 7#c7 in subsection 7c7-- 7,a7 by amending the subsection heading to read3 ,treatment ,investigational ,new ,drug ,applications1 ,treatment ,investigational ,device ,exemptions1 and ,treatment ,investigational in ,vitro ,clinical ,test ,exemptions4--2 7,b7 in paragraph 7#c77;,a71 by striking or investigational device exemption in effect under section #ebj7;g7 and inserting 1 investigational device exemption in effect under section #ebj7;g71 or investigational in vitro clinical test exemption under section #ehg,s2 7,c7 by striking or treatment investigational device exemption each place it appears and inserting 1 treatment investigational device exemption1 or treatment investigational in vitro clinical test exemption2 7,d7 in paragraph 7#e71 by striking or #ebj7;g7 and inserting 1 #ebj7;g71 or #ehg,s2 and 7,e7 in the matter following paragraph 7#g7 by striking or #ebj7;g7 each place it appears and inserting 1 #ebj7;g7 or #ehg,s2 and 7#d7 by amending subsection 7e7 to read as follows3 7e7 ,definitions ,in this section1 the terms investigational drug1 investigational device1 investigational in vitro clinical test1 treatment investigational new drug application1 treatment investigational device exemption1 and treatment investigational in vitro clinical test exemption shall have the meanings given the terms in regulations prescribed by the ,secretary4 4 7f7 ,optimizing global clinical trials ,section #efi;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;a7b77 is amended by inserting an in vitro clinical test1 as defined in subsection 7ss7 of such section1 before or a biological product4 7g7 ,patient participation in medical product discussion ,the heading of subsection 7a7 of section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is amended by striking ,drugs and ,devices and inserting ,drugs1 ,devices1 and ,in ,vitro ,clinical ,tests4 7h7 ,regulations and hearings ,section #gja7;h77#a77;,c77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cga7;h77#a77;,c77ii77 is amended by inserting and in vitro clinical tests after devices4 7i7 ,records ,section #gjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgc7 is amended-- 7#a7 by inserting in vitro clinical tests after devices each place such term appears2 and 7#b7 by inserting in vitro clinical test after device each place such term appears4 7j7 ,factory inspection ,section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 7other than subsection 7g77 is amended-- 7#a7 by striking drugs or devices each place it appears and inserting drugs1 devices1 or in vitro clinical tests2 7#b7 in subsection 7a77#a71 in the fourth sentence1 by striking or chapter ,,ix and inserting section #ehg,s1 section #ehg,m1 section #ehg,n1 or chapter ,,ix2 7#c7 after making the amendments in paragraphs 7#a7 and 7#b71 by inserting in vitro clinical tests1 after devices1 each place it appears2 7#d7 in subsection 7a77#b77;,b7-- 7,a7 by inserting or in vitro clinical tests after prescribe or use devices2 and 7,b7 by inserting or in vitro clinical tests after process devices2 7#e7 by inserting in vitro clinical test1 after device1 each place it appears2 7#f7 in subsection 7e71 by inserting 1 or section #ehg,m1 #ehg,n1 or #ehg,s1 after section #eai or #ebj7;g72 7#g7 in subsection 7f77#c7-- 7,a7 in subparagraph 7,a71 by striking or at the end2 7,b7 in subparagraph 7,b71 by striking the period at the end and inserting 2 or2 and 7,c7 after subparagraph 7,b71 by inserting the following3 7,c7 is accredited under section #ehg,q4 2 and 7#h7 by adding at the end the following3 7i7 ,for purposes of this section1 the term establishment includes a laboratory performing an in vitro clinical test4 4 7k7 ,publicity ,section #gje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cge7;b77 is amended by inserting in vitro clinical tests1 after devices14 7l7 ,presumption ,section #gji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;a7 is amended by inserting in vitro clinical test1 after device14 7m7 ,listing and certification of color additives for foods1 drugs1 and cosmetics ,section #gba7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;e7a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by inserting or in vitro clinical tests after or devices2 and 7#b7 in the flush text following paragraph 7#b7-- 7,a7 by inserting or an in vitro clinical test after a device2 and 7,b7 by inserting or in vitro clinical tests after devices4 7n7 ,imports and exports ,section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by inserting in vitro clinical tests1 after devices1 each place it appears2 and 7,b7 by inserting in the case of an in vitro clinical test1 the test does not conform to the applicable requirements of section #ehg,k1 or after requirements of section #ebj7;f71 or2 7#b7 in subsection 7d77#c7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by inserting and no component of an in vitro clinical test or other article of in vitro clinical test that requires further processing1 after health-related purposes2 7ii7 in clause 7i71 by striking drug or device and inserting drug1 device1 or in vitro clinical test2 and 7iii7 in clause 7i77,i71 by inserting in vitro clinical test1 after device12 and 7,b7 in subparagraph 7,b71 by inserting in vitro clinical test1 after device12 7#c7 in subsection 7e77#a71 by inserting in vitro clinical test1 after device12 and 7#d7 in subsection 7o7-- 7,a7 by inserting or in vitro clinical test after device2 and 7,b7 by inserting section #ehg;,j of each foreign establishment after section #eaj7;i7 of each establishment4 7o7 ,office of international relations ,section #hjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chc7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by inserting and in vitro clinical tests after devices2 and 7,b7 in paragraph 7#a71 by inserting quality requirements established under section #ehg,k2 and at the end2 and 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#b71 by inserting in vitro clinical tests1 after devices12 and 7,b7 in paragraph 7#d71 by inserting or in vitro clinical tests after devices4 7p7 ,recognition of foreign government inspections ,section #hji7;a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is amended by inserting 1 or of foreign establishments registered under section #ehg;,j after #eaj7;h74 7q7 ,food and drug administration ,section #ajjc7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;b77#b77 is amended-- 7#a7 in subparagraph 7,d71 by striking and at the end2 7#b7 in subparagraph 7,e71 by striking the semicolon at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7,f7 in vitro clinical tests are analytically and clinically valid2 4 7r7 ,office of women's health ,section #ajaa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;b7b77 is amended-- 7#a7 in paragraph 7#a71 by inserting in vitro clinical tests1 after devices12 and 7#b7 in paragraph 7#d71 by striking and device manufacturers and inserting device manufacturers1 and in vitro clinical test developers14 7s7 ,countermeasure provisions of the public health service act ,title ,,iii of the ,public ,health ,service ,act is amended-- 7#a7 in section #cai;,f-#a7;a77#b77;,a7 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b77;,a77-- 7,a7 in the matter preceding clause 7i7-- 7i7 by striking or device and inserting device2 and 7ii7 by inserting or an in vitro clinical tests 7as that term is defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 after ,act 7#ba ,u4,s4,c4 #cba7;h77712 and 7,b7 in each of clauses 7ii7 and 7iii71 by striking or device and inserting device1 or in vitro clinical test2 7#b7 in section #cai;,f-#b7;c77#a77;,b7 7#db ,u4,s4,c4 #bdg;d-#f;b7c77#a77;,b77-- 7,a7 by striking or device and inserting device2 and 7,b7 by inserting 1 or an in vitro clinical test 7as that term is defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss777 after ,act 7#ba ,u4,s4,c4 #cba7;h77712 and 7#c7 in section #cai;,f-#c7;i77#g7 7#db ,u4,s4,c4 #bdg;d-#f;d7i77#g77-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking or device and inserting device2 and 7ii7 by inserting or an in vitro clinical tests 7as that term is defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7ss7771 after ,act 7#ba ,u4,s4,c4 #cba7;h772 7,b7 in subparagraph 7,a7-- 7i7 by moving the margin of clause 7iii7 #b ems to the left2 and 7ii7 in clause 7iii71 by striking or device and inserting device1 or in vitro clinical test2 and 7,c7 in subparagraph 7,b7-- 7i7 in clause 7i71 by inserting or the subject of a technology certification order after approved or cleared2 and 7ii7 in clause 7ii71 by striking or #ebj7;g7 and inserting 1 #ebj7;g71 or #ehg,s4 #hbe4 ,transition 7a7 ,implementation 7#a7 ,effective date 7,a7 ,in general ,except as otherwise provided in this section1 the amendments made by this ,act shall take effect on ,october #a1 #bjbg 7in this section and in subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 referred to in this section as the effective date of this ,act74 7,b7 ,exceptions 7i7 ,in general ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 may take the actions described in paragraph 7#c71 and may expend such funds as the ,secretary determines necessary to ensure an orderly transition1 including prior to the effect date of this ,act4 7ii7 ,implementation of certain provisions ,the ,secretary may implement sections #ehg;,j and #ehg,u of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #c7 beginning on ,october #a1 #bjbd1 and such sections may take effect not earlier than ,october #a1 #bjbg1 to the extent and for the purposes indicated in such sections4 ,in the case of a developer who1 between ,october #a1 #bjbd1 and the effective date of this ,act specified in subparagraph 7,a71 registers under such section #ehg,k with respect to an article that is an in vitro clinical test1 such developer shall not be required to register with respect to such article under section #eaj of such ,act 7#ba ,u4,s4,c4 #cfj74 7#b7 ,actions ,the ,secretary-- 7,a7 shall-- 7i7 within #a year of the date of enactment of this ,act1 hold the public meetings described in section #ehg;,d7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #c72 7ii7 within #c years of the date of enactment of this ,act1 promulgate final regulations required under the amendments made by this ,act2 and 7iii7 within #cj months of the date of enactment of this ,act1 issue final guidance on applicability requirements under amendments made by this ,act2 and 7,b7 may take additional actions after the date of enactment that the ,secretary determines necessary to ensure an orderly transition1 which may not take effect until after the effective date1 including-- 7i7 establishment of mitigating measures for an in vitro clinical test or category of in vitro clinical tests2 and 7ii7 establishment of the comprehensive test information system under section #ehg,t4 7#c7 ,applicability of guidance and regulations ,notwithstanding the date on which guidance or regulations are issued under paragraph 7#c7 and section #ehg,k1 no guidance or regulations issued pursuant to the amendments made by this ,act shall be implemented or take effect until the effective date of this ,act1 as described in paragraph 7#a71 except as otherwise specified in this ,act 7including the amendments made by this ,act74 7b7 ,application of authorities to in vitro clinical tests under review on the effective date of this act ,for any in vitro clinical test1 as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #hbb1 for which a submission for approval under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e71 clearance under section #eaj7k7 of such ,act 7#ba ,u4,s4,c4 #cfj7k771 authorization under section #eac7;f77#b7 of such ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b771 or licensure under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is pending on the effective date of this ,act1 including transitional in vitro clinical tests as described in subsection 7c71 the ,secretary may review and take action on such submission after the effective date of this ,act according to the statutory provision under which such submission was submitted4 7c7 ,application of authorities to transitional ,in vitro clinical tests 7#a7 ,definition ,for purposes of this section1 the term transitional in vitro clinical test means an in vitro clinical test1 as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 that-- 7,a7 is first offered for clinical use during the period beginning on the date of enactment of this ,act and ending on the effective date of this ,act2 7,b7 is developed by a clinical laboratory certified by the ,secretary under section #cec of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a7 that meets the requirements for performing high-complexity testing and performed-- 7i7 in the same clinical laboratory in which the test was developed and for which a certification is still in effect under such section #cec that meets the requirements to perform tests of high complexity2 7ii7 by another laboratory for which a certificate is in effect under such section #cec that meets the requirements to perform tests of high complexity1 is within the same corporate organization1 and has common ownership by the same parent corporation as the laboratory in which the test was developed2 or 7iii7 in the case of a test that was developed by the ,centers for ,disease ,control and ,prevention or another laboratory a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention1 by a clinical laboratory for which a certificate is in effect under section #cec of such ,act that meets the requirements to perform tests of high complexity1 and that is within a public health laboratory network coordinated or managed by the ,centers for ,disease ,control and ,prevention2 and 7,c7 when first offered1 is not approved under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 cleared under section #eaj7k7 of such ,act1 authorized under section #eac7;f77#b7 of such ,act1 subject to a humanitarian device exemption under section #ebj7m7 of such ,act 7#ba ,u4,s4,c4 #cfj;j7m771 subject to an exemption for investigation use under section #ebj7;g7 of such ,act 7#ba ,u4,s4,c4 #cfj;j7g771 authorized under section #efd of such ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 or licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#b7 ,premarket review or technology certification ,a transitional in vitro clinical test that is the subject of an application for premarket review under section #ehg;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act or technology certification application under section #ehg;,d of such ,act1 as added by this ,act1 may continue to be offered1 sold1 or distributed until completion of the ,secretary's review of the premarket application or technology certification application1 if such application is submitted no later than #ij days after the effective date of this ,act4 7#c7 ,tests approved by new york state ,notwithstanding paragraph 7#b71 a transitional in vitro clinical test that has been approved by the ,new ,york ,state ,department of ,health may continue to be offered1 sold1 or distributed after the effective date if-- 7,a7 starting on the effective date of this ,act1 the in vitro clinical test complies with the requirements of subchapter ,j of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 except for sections #ehg;,b and design control provisions of section #ehg,k2 7,b7 each test report template for the test bears a statement of adequate prominence that reads as follows3 ,this in vitro clinical test was developed and first introduced prior to the effective date of the ,,valid ,act of #bjbb4 ,this test was approved by the ,new ,york ,state ,department of ,health1 but the test has not been reviewed by the ,food and ,drug ,administration42 7,c7 a premarket application under section #ehg;,b or technology certification application under section #ehg;,d is submitted no later than-- 7i7 #e years after the effective date of this ,act1 if the in vitro clinical test is approved by the ,new ,york ,state ,department of ,health as a genetic testing molecular test1 a microbiology molecular test1 an oncology molecular test1 or any other type of molecular test2 or 7ii7 #b years after the effective date of this ,act1 if the in vitro clinical test is approved by the ,new ,york ,state ,department of ,health as a type of test not described in clause 7i72 and 7,d7 a test in compliance with this paragraph 7#c7 may continue to be offered1 sold1 or distributed until the completion of the ,secretary's review of the premarket application or technology certification application referenced in subparagraph 7,c74 7d7 ,conversion 7#a7 ,deemed premarket approval ,beginning on the effective date of this ,act-- 7,a7 any in vitro clinical test 7as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #hbb7 with a premarket approval under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7 or a licensure under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is deemed to be approved pursuant to an application under section #ehg;,b7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act2 and 7,b7 any in vitro clinical test 7as so defined7 that was cleared under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 or authorized under section #eac7;f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7f77#b77 is deemed to be approved pursuant to an application under section #ehg;,b7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act4 7#b7 ,deemed investigational use exemption ,any in vitro clinical test 7as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #hbb7 that has an investigational device exemption in effect under section #ebj7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 is deemed to have an investigational use exemption in effect under section #ehg,s of such ,act1 as added by this ,act1 beginning on the effective date of this ,act4 7#c7 ,deemed humanitarian device exemption ,any in vitro clinical test 7as defined in section #bja7ss7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #hbb7 that has an approved humanitarian device exemption under section #ebj7m7 of such ,act is deemed to have a humanitarian test exemption under section #ehg;,a7g7 of such ,act1 as added by this ,act1 beginning on the effective date of this ,act4 7#d7 ,deemed designated breakthrough ,any in vitro clinical test 7as defined in section #bja7;gg7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #hbb7 that has received a breakthrough device designation under section #eae;,b7e77#a77;,d7 of such ,act 7#ba ,u4,s4,c4 #cfj;e-#c7;e77#a77;,d77 is deemed to have a breakthrough in vitro clinical test designation under section #ehg;,c of such ,act1 as added by this ,act1 beginning on the effective date of this ,act4 7#e7 ,deemed request for informal feedback ,with regard to any in vitro clinical test that is the subject of a pre-submission request described in the guidance1 ,requests for ,feedback and ,meetings for ,medical ,device ,submissions3 ,the ,q-,submission ,program1 issued by the ,food and ,drug ,administration on ,january #f1 #bjba1 such request is deemed to constitute a request for informal feedback under section #ehg;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #hbc1 beginning on the effective date of this ,act4 7e7 ,previously classified devices ,notwithstanding section #ehg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #hbc1 for purposes of subchapter ,j of chapter ,v of such ,act1 as added by section #hbc1 the following apply3 7#a7 ,in the case of an in vitro clinical test type that has been classified by the ,secretary as a class ,i device pursuant to section #eac of such ,act 7#ba ,u4,s4,c4 #cfj;c71 such in vitro clinical test shall be low-risk1 unless the in vitro clinical test is a test described in section #eaj7l7 or the test is redesignated by the ,secretary pursuant to section #ehg;,f of such ,act4 7#b7 ,in the case of an in vitro clinical test type that has been classified by the ,secretary as a class ,,ii device pursuant to section #eac of such ,act 7#ba ,u4,s4,c4 #cfj;c71 such in vitro clinical test shall be moderate-risk1 unless inaccurate results from the test would be immediately life threatening or the test is redesignated by the ,secretary pursuant to section #ehg;,f of such ,act4 7#c7 ,in the case of an in vitro clinical test type that is a class ,,iii device pursuant to section #eac of such ,act 7#ba ,u4,s4,c4 #cfj;c71 such in vitro clinical test shall be high-risk1 unless redesignated by the ,secretary pursuant to section #ehg;,f of such ,act4 #hbf4 ,emergency use authorization 7a7 ,in general ,section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraphs 7#a7 and 7#d77;,c71 by inserting in vitro clinical test1 before or biological product each place such term appears2 and 7,b7 in paragraph 7#b77;,a71 by striking or #eae and inserting #eae1 or #ehg;,b2 7#b7 in subsection 7e7-- 7,a7 in paragraph 7#c7-- 7i7 in subparagraph 7,b71 by striking and at the end2 7ii7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7,d7 quality requirements 7with respect to in vitro clinical tests7 under section #ehg,k4 2 and 7,b7 in paragraph 7#d7-- 7i7 in subparagraph 7,a71 by striking 2 or and inserting a semicolon2 7ii7 in subparagraph 7,b71 by striking the period and inserting 2 or2 and 7iii7 by adding at the end the following3 7,c7 with respect to in vitro clinical tests1 requirements applicable to restricted in vitro clinical tests pursuant to section #ehg,o4 2 7#c7 in subsection 7m7-- 7,a7 in the subsection heading1 by striking ,laboratory tests associated with devices inserting in vitro clinical tests after devices2 and 7,b7 in paragraph 7#a7-- 7i7 by striking to a device and inserting to an in vitro clinical test2 and 7ii7 by striking such device and inserting such in vitro clinical test4 7b7 ,emergency use of medical products ,section #efd;,a7a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;a7a77#b77 is amended by inserting in vitro clinical test1 after device14 7c7 ,products held for emergency use ,section #efd;,b7#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c;b7#b77 is amended-- 7#a7 in subparagraph 7,a71 by striking or #eae and inserting #eae1 or #ehg;,b2 and 7#b7 in subparagraph 7,b71 by striking or #ebj and inserting #ebj1 or #ehg,s4 #hbg4 ,antimicrobial susceptibility tests ,section #eaa;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;a-#b7 is amended-- 7#a7 in subsection 7a77#a77;,c7-- 7,a7 by striking clear under section #eaj7k71 classify under section #eac7;f77#b71 or approve under section #eae and inserting approve under section #ehg;,b1 exempt from premarket review under section #ehg;,c1 or grant a technology certification order under section #ehg;,d2 and 7,b7 by striking testing devices and inserting in vitro clinical tests2 7#b7 in subsection 7c77#e71 by striking drug or device each place it appears and inserting drug1 device1 or in vitro clinical test2 7#c7 in subsection 7e7-- 7,a7 in the heading1 by striking testing devices and inserting ,in vitro clinical tests2 7,b7 in paragraph 7#a7-- 7i7 by striking #eaj1 #eac1 and #eae1 and inserting #ehg;,b1 and #ehg;,d2 7ii7 by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test2 and 7iii7 by striking such device and inserting such in vitro clinical test2 and 7,c7 in paragraph 7#b7-- 7i7 in the heading1 by striking testing devices and inserting in vitro clinical tests2 7ii7 in subparagraphs 7,a7 and 7,b7 7other than clause 7iii7 of such subparagraph 7,b771 by striking device each place it appears and inserting in vitro clinical test2 7iii7 in subparagraph 7,b77iii71 by striking a device and inserting an in vitro clinical test2 and 7iv7 by amending subparagraph 7,c7 to read as follows3 7,c7 ,the antimicrobial susceptibility in vitro clinical test meets all other requirements to be approved under section #ehg;,b1 exempted from premarket review under section #ehg;,c1 or offered under a technology certification order under section #ehg;,d4 2 7#d7 in subsection 7f71 by amending paragraph 7#a7 to read as follows3 7#a7 ,the term antimicrobial susceptibility in vitro clinical test means an in vitro clinical test that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug 7or drugs74 2 and 7#e7 in subsection 7g77#b7-- 7,a7 by amending the matter preceding subparagraph 7,a7 to read as follows3 7#b7 with respect to approving an application under section #ehg;,b or granting a technology certification order under section #ehg;,d-- 2 and 7,b7 in subparagraph 7,a7-- 7i7 by striking device and inserting in vitro clinical test2 and 7ii7 by striking antimicrobial susceptibility testing device and inserting antimicrobial susceptibility in vitro clinical test4 #hbh4 ,combination products 7a7 ,in general ,section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 by striking or biological product and inserting in vitro clinical test1 or biological product 7except for a product constituted of a device and an in vitro clinical test72 7,b7 in subparagraph 7,b71 by adding at the end the following3 ,for purposes of this ,act1 a product that constitutes a combination of a drug and an in vitro clinical test is not a combination product within the meaning of this subsection42 and 7,c7 in subparagraph 7,d77ii7-- 7i7 by inserting or in vitro clinical test after device2 and 7ii7 by inserting and in vitro clinical tests before shall2 7#b7 in paragraph 7#c71 by striking safety and effectiveness or substantial equivalence and inserting safety and effectiveness1 substantial equivalence1 or analytical validity and clinical validity before for the approved constituent part2 7#c7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a71 by striking or #eac7;f77#b7 7submitted in accordance with paragraph 7#e77 and inserting #eac7;f77#b7 7submitted in accordance with paragraph 7#e771 #ehg;,b1 or #ehg;,d1 or an exempt test under section #ehg;,c1 as applicable2 and 7,b7 in subparagraph 7,b71 by inserting 1 #ehg;,b1 or #ehg;,d after section #eae2 7#d7 in paragraph 7#e77;,a71 by striking or #eaj7k7 and inserting 1 #eaj7k71 #ehg;,b1 or #ehg;,d2 7#e7 in paragraph 7#g71 by striking or substantial equivalence and inserting 1 substantial equivalence1 or analytical validity and clinical validity2 7#f7 in paragraph 7#h71 by adding at the end the following3 7,i7 ,this paragraph shall not apply to a product constituted of a device and an in vitro clinical test4 2 and 7#g7 in paragraph 7#i7-- 7,a7 in subparagraph 7,c77i71 by striking or #ebj7;g7 and inserting #ebj7;g71 #ehg;,b1 or #ehg;,d2 and 7,b7 in subparagraph 7,d71 by striking or #ebj and inserting #ebj1 #ehg;,b1 or #ehg;,d4 7b7 ,classification of products ,section #efc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#b7 is amended by adding at the end the following3 7d7 ,exemption ,this section shall not apply to a product constituted of a device and an in vitro clinical test4 4 #hbi4 ,resources 7a7 ,findings ,congress finds that the fees authorized by this section will be dedicated to meeting the goals identified in the letters from the ,secretary of ,health and ,human ,services to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 7b7 ,authorization of appropriations ,for purposes of funding implementation of subchapter ,j of title ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 including undertaking activities for the development of regulations and guidances1 hiring of necessary staff1 and the development of technology systems to implement this subchapter in a timely1 effective1 and efficient manner there is authorized to be appropriated #dhj1jjj1jjj4 7c7 ,establishment of user fee program 7#a7 ,development of user fees for in vitro clinical tests 7,a7 ,in general ,beginning not later than ,october #a1 #bjba1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall develop recommendations to present to ,congress with respect to the goals1 and plans for meeting the goals1 for the process for the review of in vitro clinical test submissions and applications under subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 for the first #e fiscal years after fiscal year #bjbb4 ,in developing such recommendations1 the ,secretary shall consult with-- 7i7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7ii7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7iii7 scientific and academic experts2 7iv7 health care professionals2 7v7 representatives of patient and consumer advocacy groups2 and 7vi7 the regulated industry4 7,b7 ,prior public input ,prior to beginning negotiations with the regulated industry on the authorization of such subchapter ,j1 the ,secretary shall-- 7i7 publish a notice in the ,federal ,register requesting public input on the authorization of user fees2 7ii7 hold a public meeting at which the public may present its views on the authorization1 including specific suggestions for the recommendations submitted under subparagraph 7,e72 7iii7 provide a period of #cj days after the public meeting to obtain written comments from the public suggesting changes to such subchapter ,j2 and 7iv7 publish any comments received under clause 7iii7 on the website of the ,food and ,drug ,administration4 7,c7 ,periodic consultation ,not less frequently than once every month during negotiations with the regulated industry1 the ,secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of the authorization under such subchapter ,j and to solicit suggestions to be included in the recommendations transmitted to ,congress under subparagraph 7,e74 7,d7 ,public review of recommendations ,after negotiations with the regulated industry1 the ,secretary shall-- 7i7 present the recommendations developed under subparagraph 7,a7 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7ii7 publish such recommendations in the ,federal ,register2 7iii7 provide for a period of #cj days for the public to provide written comments on such recommendations2 7iv7 hold a meeting at which the public may present its views on such recommendations2 and 7v7 after consideration of such public views and comments1 revise such recommendations as necessary4 7,e7 ,transmittal of recommendations 7i7 ,in general ,not later than ,january #ae1 #bjbg1 the ,secretary shall transmit to ,congress the revised recommendations under subparagraph 7,a71 a summary of the views and comments received under such subparagraph1 and any changes made to the recommendations in response to such views and comments4 7ii7 ,recommendation requirements ,the recommendations transmitted under this subparagraph shall-- 7,i7 include the number of full-time equivalent employees per fiscal year that are agreed to be hired to carry out the goals included in such recommendations for each year of the #e-year period2 7,,ii7 provide that the amount of operating reserve balance in the user fee program established under this section is not more than the equivalent of #aj weeks of operating reserve2 7,,iii7 require the development of a strategic plan for any surplus within the operating reserve account above the #aj-week operating reserve within #b years of the establishment of the program2 7,,iv7 include an operating reserve adjustment such that1 if the ,secretary has an operating reserve balance in excess of #aj weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #aj weeks of such operating reserves2 7,v7 if an adjustment is made as described in subclause 7,,iv71 provide the rationale for the amount of the decrease in fee revenue and fees shall be contained in the ,federal ,register2 and 7,,vi7 provide that the fees assessed and collected for the full-time equivalent employees at the ,center for ,devices and ,radiological ,health1 with respect to which the majority of time reporting data indicates are dedicated to the process for the review of in vitro clinical test submissions and applications under paragraph 7#e71 are not supported by the funds authorized to be collected and assessed under section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j74 7,f7 ,publication of recommendations ,the ,secretary shall publish on the website of the ,food and ,drug ,administration the revised recommendations under subparagraph 7,a71 a summary of the views and comments received under subparagraphs 7,b7 through 7,d71 and any changes made to the recommendations originally proposed by the ,secretary in response to such views and comments4 7,g7 ,minutes of negotiation meetings 7i7 ,public availability ,the ,secretary shall make publicly available1 on the website of the ,food and ,drug ,administration1 minutes of all negotiation meetings conducted under this subsection between the ,food and ,drug ,administration and the regulated industry not later than #cj days after such meeting4 7ii7 ,content ,the minutes described under clause 7i7 shall summarize any substantive proposal made by any party to the negotiations1 any significant controversies or differences of opinion during the negotiations1 and the resolution of any such controversy or difference of opinion4 7#b7 ,establishment of user fee program ,effective on ,october #a1 #bjbg1 provided that the ,secretary transmits the recommendations under paragraph 7#a77;,e71 the ,secretary is authorized to collect user fees relating to the review of in vitro clinical test submissions and applications under subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act4 ,fees under such program shall be assessed and collected only if the requirements under paragraph 7#d7 are met4 7#c7 ,audit 7,a7 ,in general ,on the date that is #b years after first receiving a user fee applicable to submission of an in vitro clinical test application submitted under subchapter ,j of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this ,act1 and on a biennial basis thereafter1 the ,secretary shall perform an audit of the costs of reviewing such applications under such subchapter ,j4 ,such an audit shall compare the costs of reviewing such applications under such subchapter ,j to the amount of the user fee applicable to such applications4 7,b7 ,alteration of user fee ,if the audit performed under subparagraph 7,a7 indicates that the user fees applicable to applications submitted under such subchapter ,j exceed #di percent of the costs of reviewing such applications1 the ,secretary shall alter the user fees applicable to applications submitted under such subchapter ,j such that the user fees do not exceed such percentage4 7,c7 ,accounting standards ,the ,secretary shall perform an audit under subparagraph 7,a7 in conformance with the accounting principles1 standards1 and requirements prescribed by the ,comptroller ,general of the ,united ,states under section #ceaa of title #ca1 ,united ,states ,code1 to ensure the validity of any potential variability4 7#d7 ,conditions ,the user fee program described in this subsection shall take effect only if the ,food and ,drug ,administration issues draft guidance related to the review requirements for in vitro diagnostic tests that would be subject to premarket review under section #ehg;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #hbc1 the review requirements for test categories eligible for technology certification under section #ehg;,d of such ,act1 as added by section #hbc1 and the parameters for the test categories that would be exempt from any review under subchapter ,j of chapter ,v of such ,act4 7#e7 ,user fee program definitions and resource requirements 7,a7 ,in general ,the term process for the review of in vitro clinical test submissions and applications means the following activities of the ,secretary with respect to the review of in vitro clinical test premarket and technology certification applications including supplements for such applications3 7i7 ,the activities necessary for the review of premarket applications1 premarket reports1 technology certification applications1 and supplements to such applications4 7ii7 ,actions related to submissions in connection with in vitro clinical test development1 the issuance of action letters that allow the marketing of in vitro clinical tests or which set forth in detail the specific deficiencies in such applications1 reports1 supplements1 or submissions and1 where appropriate1 the actions necessary to support the development of in vitro clinical tests4 7iii7 ,the inspection of manufacturing establishments and other facilities undertaken as part of the ,secretary's review of pending premarket applications1 technology certifications1 and supplements4 7iv7 ,monitoring of research conducted in connection with the review of such applications1 supplements1 and submissions4 7v7 ,review of in vitro clinical test applications subject to section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 and activities conducted in anticipation of the submission of such applications for investigational use under section #ehg,s of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #hbc74 7vi7 ,the development of guidance1 policy documents1 or regulations to improve the process for the review of premarket applications1 technology certification applications1 and supplements4 7vii7 ,the development of voluntary test methods1 consensus standards1 or mandatory performance standards in connection with the review of such applications1 supplements1 or submissions and related activities4 7viii7 ,the provision of technical assistance to in vitro clinical test developers in connection with the submission of such applications1 reports1 supplements1 or submissions4 7ix7 ,any activity undertaken in connection with the initial classification or reclassification of an in vitro clinical test in connection with any requirement for approval or eligibility for an exemption from premarket review of an in vitro clinical test4 7x7 ,any activity undertaken in connection with making a pathway determination of an in vitro clinical test1 including the identification1 establishment1 and implementation of mitigation measures4 7xi7 ,evaluation of postmarket studies required as a condition of an approval of a premarket application of an in vitro clinical test and ensuring such studies are conducted as required4 7xii7 ,any activity undertaken in connection with ensuring in vitro clinical tests marketed under an exemption from premarket review pursuant to section #ehg;,c or #ehg;,g meet the criteria for such exemption and the applicable standard4 7xiii7 ,compiling1 developing1 and reviewing information on in vitro clinical tests necessary to identify issues with the ability of in vitro clinical tests to meet the applicable standard1 as applicable4 7,b7 ,resource requirements ,fees collected and assessed under this section shall be used for the process for the review of in vitro clinical test applications1 as described in subparagraph 7,a71 and shall-- 7i7 be subject to the limitation under section #gch7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77#c771 in the same manner that fees collected and assessed under section #gcg7i77;,c7 of such ,act 7#ba ,u4,s4,c4 #cgi;i7#i77;,c77 are subject to such limitation2 7ii7 include travel expenses for officers and employees of the ,food and ,drug ,administration only if the ,secretary determines that such travel is directly related to an activity described in subparagraph 7,a72 and 7iii7 not be allocated to purposes described under section #gbb7;a7 of the ,consolidated ,appropriations ,act1 #bjah 7,public ,law #aae-ada74 7d7 ,reports 7#a7 ,performance report 7,a7 ,in general 7i7 ,general requirements ,beginning with fiscal year #bjbg1 for each fiscal year for which fees are collected under this section1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives annual reports concerning the progress of the ,food and ,drug ,administration in achieving the goals identified in the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e7 during such fiscal year and the future plans of the ,food and ,drug ,administration for meeting the goals4 7ii7 ,additional information ,beginning with fiscal year #bjba1 the annual report under this subparagraph shall include the progress of the ,food and ,drug ,administration in achieving the goals1 and future plans for meeting the goals1 including-- 7,i7 the number of premarket applications filed under section #ehg;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act during the applicable fiscal year2 7,,ii7 the number of technology certification applications submitted under section #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act during the applicable fiscal year for each review division2 7,,iii7 the number of breakthrough designations under section #ehg;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act during the applicable fiscal year2 and 7,,iv7 the number of information requests requested by the ,secretary pursuant to section #ehg;,g7d7 of such ,act4 7iii7 ,real-time reporting 7,i7 ,in general ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjbg1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter1 the ,secretary shall post the data described in subclause 7,,ii7 on the website of the ,food and ,drug ,administration for such quarter and on a cumulative basis for such fiscal year1 and may remove duplicative data from the annual report under this subparagraph4 7,,ii7 ,data ,the ,secretary shall post the following data in accordance with subclause 7,i73 7aa7 ,the number and titles of draft and final regulations on topics related to the process for the review of in vitro clinical test submissions and applications1 and whether such guidances were required by statute or pursuant to the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7bb7 ,the number and titles of draft and final guidance on topics related to the process for the review of in vitro clinical test submissions and applications1 and whether such guidances were issued as required by statute or pursuant to the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7c77#a77;,e74 7cc7 ,the number and titles of public meetings held on topics related to the process for the review of in vitro clinical tests1 and if such meetings were required by statute or pursuant to the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7c77#a77;,e74 7iv7 ,rationale for ,,ivct user fee program changes ,beginning with fiscal year #bjbg1 the ,secretary shall include in the annual performance report under paragraph 7#a7-- 7,i7 data1 analysis1 and discussion of the changes in the number of full-time equivalents hired as agreed upon in the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e7 and the number of full-time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,devices and ,radiological ,health1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,,ii7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of in vitro clinical test submissions and applications1 including identifying drivers of such changes2 and 7,,iii7 for each of the ,center for ,devices and ,radiological ,health1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required4 7v7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report under clause 7i7 an analysis of the following3 7,i7 ,the difference between the aggregate number of premarket applications filed under section #ehg;,b or section #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act and the aggregate number of major deficiency letters1 not approvable letters1 and denials for such applications issued by the agency1 accounting for-- 7aa7 the number of applications filed under each of sections #ehg;,b and #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 and 7bb7 the aggregate number of applications under each of sections #ehg;,b and #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act for each fiscal year that did not meet the goals as identified by the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7,,ii7 ,relevant data to determine whether the ,center for ,devices and ,radiological ,health has met performance enhancement goals identified by the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7,,iii7 ,the most common causes and trends for external or other circumstances affecting the ability of the ,food and ,drug ,administration to meet review time and performance enhancement goals identified by the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e74 7,b7 ,publication ,with regard to information to be reported by the ,food and ,drug ,administration to industry on a quarterly and annual basis pursuant to recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e71 the ,secretary shall make such information publicly available on the website of the ,food and ,drug ,administration not later than #fj days after the end of each quarter or #abj days after the end of each fiscal year1 respectively1 to which such information applies4 7,c7 ,updates ,the ,secretary shall include in each report under subparagraph 7,a7 information on all previous cohorts for which the ,secretary has not given a complete response on all in vitro clinical test premarket applications and technology certification orders and supplements1 premarket1 and technology certification notifications in the cohort4 7#b7 ,corrective action report ,beginning with fiscal year #bjbb1 for each fiscal year for which fees are collected under this section1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives4 ,the report shall include the following information1 as applicable3 7,a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under paragraph 7#a77;,a77v71 that each of the goals identified by the recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e7 for the applicable fiscal year have been met1 the corrective action report shall include recommendations on ways in which the ,secretary can improve and streamline the in vitro clinical test premarket application and technology certification review process4 7,b7 ,goals missed ,for each of the goals identified by the letters described in recommendations transmitted to ,congress by the ,secretary pursuant to subsection 7b77#a77;,e7 for the applicable fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include-- 7i7 a justification for such determination2 7ii7 a description of the types of circumstances1 in the aggregate1 under which applications or reports submitted under sections #ehg;,b and #ehg;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act missed the review goal times but were approved during the first cycle review1 as applicable2 7iii7 a summary and any trends with regard to the circumstances for which a review goal was missed2 and 7iv7 the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the ,food and ,drug ,administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year4 7#c7 ,fiscal report ,for fiscal years #bjbg and annually thereafter1 not later than #abj days after the end of each fiscal year during which fees are collected under this subpart1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report on the implementation of the authority for such fees during such fiscal year and the use1 by the ,food and ,drug ,administration1 of the fees collected during such fiscal year for which the report is made4 7,a7 ,contents ,such report shall include expenditures delineated by budget authority and user fee dollars related to administrative expenses and information technology infrastructure contracts and expenditures4 7,b7 ,operating reserve ,such report shall provide the amount of operating reserve balance available each year1 and any planned allocations or obligations of such balance that is above #aj weeks of operating reserve for the program4 7#d7 ,public availability ,the ,secretary shall make the reports required under paragraphs 7#a7 through 7#c7 available to the public on the website of the ,food and ,drug ,administration4 7#e7 ,enhanced communication 7,a7 ,communications with ,congress ,each fiscal year1 as applicable and requested1 representatives from the ,centers with expertise in the review of in vitro clinical tests shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7,b7 ,participation in congressional hearing ,each fiscal year1 as applicable and requested1 representatives from the ,food and ,drug ,administration shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this section4 #hcj4 ,authorization of appropriations ,for purposes of funding implementation of this subtitle 7including the amendments made by this subtitle71 including undertaking activities for the development of regulations and guidances1 hiring of necessary staff1 and the development of technology systems to implement this subtitle 7including the amendments made by this subtitle7 in a timely1 effective1 and efficient manner1 there is authorized to be appropriated not more than #dhj1jjj1jjj1 to remain available through the end of fiscal year #bjbg4 ,,ix ,other provisions #ija4 ,facilities management 7a7 ,,pdufa authority ,section #gcf7;g77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#b77-- 7#a7 in subparagraph 7,a77ii7-- 7,a7 by striking shall be available to defray and inserting the following3 8shall be available-- 7,i7 for fiscal year #bjbc1 to defray 2 7,b7 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7,,ii7 for fiscal year #bjbd and each subsequent fiscal year1 to defray the costs of the resources allocated for the process for the review of human drug applications 7including such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such process71 only if the sum of the amounts allocated by the ,secretary for such costs1 excluding costs paid from fees collected under this section1 plus other costs for the maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 and other necessary materials and supplies in connection with the process for the review of human drug applications1 is no less than the amount allocated for such costs1 excluding any such costs paid from fees collected under this section1 for fiscal year #aiig1 multiplied by the adjustment factor4 2 and 7#b7 in subparagraph 7,b71 by striking for the process for the review of human drug applications and inserting as described in subclause 7,i7 or 7,,ii7 of such subparagraph1 as applicable4 7b7 ,bs,u,f,a authority ,section #gdd;,h7f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;f77#b77 is amended-- 7#a7 in subparagraph 7,b77i7-- 7,a7 by striking available for a fiscal year beginning after fiscal year #bjab and inserting the following3 8available-- 7,i7 for fiscal year #bjbc 2 7,b7 by striking the fiscal year involved4 and inserting such fiscal year2 and2 and 7,c7 by adding at the end the following3 7,,ii7 for fiscal year #bjbd and each subsequent fiscal year1 to defray the costs of the process for the review of biosimilar biological product applications 7including such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such process71 only if the sum of the amounts allocated by the ,secretary for such costs1 excluding costs paid from fees collected under this section1 plus other costs for the maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications1 is no less than #bj1jjj1jjj1 multiplied by the adjustment factor applicable to the fiscal year involved4 2 and 7#b7 in subparagraph 7,c71 by striking subparagraph 7,b7 in any fiscal year if the costs described in such subparagraph and inserting subparagraph 7,b77i7 in any fiscal year if the costs allocated as described in subclause 7,i7 or 7,,ii7 of such subparagraph1 as applicable14 7c7 ,,gdufa authority ,section #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7 is amended-- 7#a7 in subsection 7e77#b71 by striking #gdd;,a7#aa77;,c7 and inserting #gdd;,a7#ab77;,c72 and 7#b7 in subsection 7i77#b7-- 7,a7 in subparagraph 7,a77ii7-- 7i7 by striking available for a fiscal year beginning after fiscal year #bjab and inserting the following3 8available-- 7,i7 for fiscal year #bjbc2 and 2 7ii7 by striking the fiscal year involved4 and inserting such fiscal year2 and2 and 7iii7 by adding at the end the following3 7,,ii7 for fiscal year #bjbd and each subsequent fiscal year1 to defray the costs of human generic drug activities 7including such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such activities71 only if the sum of the amounts allocated by the ,secretary for such costs1 excluding costs paid from fees collected under this section1 plus other costs for the maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 and other necessary materials and supplies in connection with human generic drug activities1 is no less than #ig1jjj1jjj multiplied by the adjustment factor defined in section #gdd;,a7#c7 applicable to the fiscal year involved4 2 and 7,b7 in subparagraph 7,b71 by striking for human generic activities and inserting as described in subclause 7,i7 or 7,,ii7 of such subparagraph1 as applicable4 7d7 ,,mdufa authority ,section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended-- 7#a7 in subsection 7h77#b7-- 7,a7 in subparagraph 7,a77ii7-- 7i7 by striking shall be available to defray and inserting the following3 8shall be available-- 7,i7 for fiscal year #bjbc1 to defray 2 7ii7 by striking the period and inserting 2 and2 and 7iii7 by adding at the end the following3 7,,ii7 for fiscal year #bjbd and each subsequent fiscal year1 to defray the costs of the resources allocated for the process for the review of device applications 7including such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such process71 only if the sum of the amounts allocated by the ,secretary for such costs1 excluding costs paid from fees collected under this section1 plus other costs for the maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture and other necessary materials and supplies in connection with the process for the review of device applications1 is no less than the amount allocated for such costs1 excluding any such costs paid from fees collected under this section1 for fiscal year #bjji multiplied by the adjustment factor4 2 and 7,b7 in subparagraph 7,b77i71 in the matter preceding subclause 7,i71 by striking for the process for the review of device applications and inserting as described in subclause 7,i7 or 7,,ii7 of such subparagraph1 as applicable2 and 7#b7 in subsection 7g77#c71 by striking #gcg7i77;,c7 and inserting #gcg7aj77;,c74 7e7 ,technical correction 7#a7 ,in general ,section #ije7;b77#b7 of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 is amended by striking ,section #gch7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77 is amended and inserting ,subsection 7g7 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j71 as so redesignated by section #bjc7;f77#b77;,b77i71 is amended4 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall take effect as though included in the enactment of section #ije of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb74 #ijb4 ,annual report on inspections ,section #ijb of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 is amended1 in the matter preceding paragraph 7#a7-- 7#a7 by striking ,march #a of each year and inserting #abj days after the end of each fiscal year2 and 7#b7 by striking previous calendar year and inserting previous fiscal year4 #ijc4 ,user fee program transparency and accountability 7a7 ,,pdufa 7#a7 ,reauthorization2 reporting requirements 7,a7 ,performance report ,section #gcf;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a77 is amended-- 7i7 in paragraph 7#a7-- 7,i7 in subparagraph 7,b7-- 7aa7 in clause 7vii71 by striking 2 and and inserting a semicolon2 7bb7 in clause 7viii71 by striking the period and inserting 2 and2 and 7cc7 by adding at the end the following3 7ix7 the number of investigational new drug applications submitted per fiscal year1 including for each review division4 2 and 7,,ii7 by adding at the end the following flush text3 ,nothing in subparagraph 7,b7 shall be construed to authorize the disclosure of confidential commercial information or other information considered proprietary or trade secret1 as prohibited under section #cja7;j7 of this ,act of section #aije of title #ah1 ,united ,states ,code4 2 and 7ii7 in paragraph 7#d7-- 7,i7 by amending subparagraph 7,a7 to read as follows3 7,a7 data1 analysis1 and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjbb and the number of remaining vacancies1 the number of full-time equivalents funded by fees collected pursuant to section #gcf1 and the number of full-time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 2 7,,ii7 by amending subparagraph 7,b7 to read as follows3 7,b7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications1 including identifying-- 7i7 drivers of such changes2 and 7ii7 changes in the average total cost per full-time equivalent in the prescription drug review program2 2 7,,iii7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7,d7 data1 analysis1 and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application4 4 7#b7 ,reauthorization ,section #gcf;,b7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;f77 is amended-- 7,a7 by redesignating paragraphs 7#d7 through 7#f7 as paragraphs 7#e7 through 7#g71 respectively2 7,b7 by inserting after paragraph 7#c7 the following3 7#d7 ,updates to ,congress ,the ,secretary1 in consultation with regulated industry1 shall provide regular updates on negotiations on the reauthorization of this part to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 2 and 7,c7 in paragraph 7#g71 as so redesignated-- 7i7 in subparagraph 7,a7-- 7,i7 by striking ,before presenting the recommendations developed under paragraphs 7#a7 through 7#e7 to the ,congress1 the and inserting ,the2 and 7,,ii7 by inserting 1 not later than #cj days after each such negotiation meeting before the period at the end2 and 7ii7 in subparagraph 7,b71 by inserting 1 in sufficient detail1 after shall summarize4 7b7 ,,mdufa 7#a7 ,reauthorization2 reporting requirements 7,a7 ,reports ,section #gch;,a7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a77 is amended-- 7i7 in clause 7ii7-- 7,i7 in subclause 7,,ii71 by striking 2 and and inserting a semicolon2 7,,ii7 in subclause 7,,iii71 by striking the period and inserting a semicolon2 7,,iii7 by adding at the end the following3 7,,iv7 the number of investigational device exemption applications submitted under section #ebj7;g7 per fiscal year1 including for each review division2 and 7,v7 the number of expedited development and priority review requests and designations under section #eae;,b per fiscal year1 including for each review division4 2 and 7,,iv7 by adding at the end the following flush text3 ,nothing in this clause shall be construed to authorize the disclosure of confidential commercial information or other information considered proprietary or trade secret1 as prohibited under section #cja7;j7 of this ,act or section #aije of title #ah1 ,united ,states ,code4 2 7ii7 in the first clause 7iv7 7relating to rationale for ,,mdufa program changes7-- 7,i7 by amending subclause 7,i7 to read as follows3 7,i7 data1 analysis1 and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb and the number of remaining vacancies1 the number of full-time equivalents funded by fees collected pursuant to section #gch1 and the number of full time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,devices and ,radiological ,health1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 2 7,,ii7 by amending subclause 7,,ii7 to read as follows3 7,,ii7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications1 including identifying-- 7aa7 drivers of such changes2 and 7bb7 changes in the average total cost per full-time equivalent in the medical device review program2 2 7,,iii7 in subclause 7,,iii71 by striking the period and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7,,iv7 data1 analysis1 and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types4 2 and 7iii7 by redesignating the second clause 7iv7 7relating to analysis7 as clause 7v74 7#b7 ,reauthorization ,section #gch;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is amended-- 7,a7 by redesignating paragraphs 7#d7 through 7#f7 as paragraphs 7#e7 through 7#g71 respectively2 7,b7 by inserting after paragraph 7#c7 the following3 7#d7 ,updates to ,congress ,the ,secretary1 in consultation with regulated industry1 shall provide regular updates on negotiations on the reauthorization of this part to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 2 and 7,c7 in paragraph 7#g71 as so redesignated-- 7i7 in subparagraph 7,a7-- 7,i7 by striking ,before presenting the recommendations developed under paragraphs 7#a7 through 7#e7 to the ,congress1 the and inserting ,the2 and 7,,ii7 by inserting 1 not later than #cj days after each such negotiation meeting before the period at the end2 and 7ii7 in subparagraph 7,b71 by inserting 1 in sufficient detail1 after shall summarize4 7c7 ,,gdufa 7#a7 ,reauthorization2 reporting requirements 7,a7 ,performance report ,section #gdd;,c7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a77#c77 is amended-- 7i7 by amending subparagraph 7,a7 to read as follows3 7,a7 data1 analysis1 and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjbb and the number of remaining vacancies1 the number of full-time equivalents funded by fees collected pursuant to section #gdd;,b1 and the number of full time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 2 7ii7 by amending subparagraph 7,b7 to read as follows3 7,b7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for human generic drug activities1 including-- 7i7 identifying drivers of such changes2 and 7ii7 changes in the total average cost per full-time equivalent in the generic drug review program2 2 7iii7 in subparagraph 7,c71 by striking the period at the end and inserting 2 and2 and 7iv7 by adding at the end the following3 7,d7 data1 analysis1 and discussion of the changes in the average full-time equivalent hours required to complete review of each type of abbreviated new drug application4 4 7#b7 ,reauthorization ,section #gdd;,c7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;f77 is amended-- 7,a7 by redesignating paragraphs 7#d7 through 7#f7 as paragraphs 7#e7 through 7#g71 respectively2 7,b7 by inserting after paragraph 7#c7 the following3 7#d7 ,updates to ,congress ,the ,secretary1 in consultation with regulated industry1 shall provide regular updates on negotiations on the reauthorization of this part to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 2 and 7,c7 in paragraph 7#g71 as so redesignated-- 7i7 in subparagraph 7,a7-- 7,i7 by striking ,before presenting the recommendations developed under paragraphs 7#a7 through 7#e7 to the ,congress1 the and inserting ,the2 and 7,,ii7 by inserting 1 not later than #cj days after each such negotiation meeting before the period at the end2 and 7ii7 in subparagraph 7,b71 by inserting 1 in sufficient detail1 after shall summarize4 7d7 ,,bsufa 7#a7 ,reauthorization2 reporting requirements ,section #gdd;,i7a77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77#d77 is amended-- 7,a7 by amending subparagraph 7,a7 to read as follows3 7,a7 data1 analysis1 and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjbb and the number of remaining vacancies1 the number of full-time equivalents funded by fees collected pursuant to section #gdd;,h1 and the number of full time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 2 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications1 including identifying-- 7i7 drivers of such changes2 and 7ii7 changes in the average total cost per full-time equivalent in the biosimilar biological product review program2 2 7,c7 in subparagraph 7,c71 by striking the period at the end and inserting 2 and2 and 7,d7 by adding at the end the following3 7,d7 data1 analysis1 and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application4 4 7#b7 ,reauthorization ,section #gdd;,i7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;f77 is amended-- 7,a7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#e7 and 7#f71 respectively2 7,b7 by inserting after paragraph 7#a7 the following3 7#b7 ,prior public input ,prior to beginning negotiations with the regulated industry on the reauthorization of this part1 the ,secretary shall-- 7,a7 publish a notice in the ,federal ,register requesting public input on the reauthorization2 7,b7 hold a public meeting at which the public may present its views on the reauthorization2 7,c7 provide a period of #cj days after the public meeting to obtain written comments from the public suggesting changes to this part2 and 7,d7 publish the comments on the ,food and ,drug ,administration's website4 7#c7 ,periodic consultation ,not less frequently than once every month during negotiations with the regulated industry1 the ,secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph 7#b74 7#d7 ,updates to ,congress ,the ,secretary1 in consultation with regulated industry1 shall provide regular updates on negotiations on the reauthorization of this part to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 2 and 7,c7 by adding at the end the following3 7#g7 ,minutes of negotiation meetings 7,a7 ,public availability ,the ,secretary shall make publicly available1 on the public website of the ,food and ,drug ,administration1 minutes of all negotiation meetings conducted under this subsection between the ,food and ,drug ,administration and the regulated industry1 not later than #cj days after each such negotiation meeting4 7,b7 ,content ,the minutes described under subparagraph 7,a7 shall summarize1 in sufficient detail1 any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution4 4 #ijd4 ,,otc hearing aids final rule ,not later than #cj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue a final rule to establish a category of over-the-counter hearing aids1 as defined in subsection 7q7 of section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as described in section #gji7;b7 of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb74 #ije4 ,enhance intra-agency coordination and public health assessment with regard to compliance activities 7a7 ,coordination ,section #ejf;,d of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;d7 is amended-- 7#a7 by adding at the end the following3 7g7 ,coordination ,the ,secretary shall ensure timely and effective internal coordination and alignment among the field investigators of the ,food and ,drug ,administration and the staff of the ,center for ,drug ,evaluation and ,research's ,office of ,compliance and ,drug ,shortage ,program regarding the reviews of reports shared pursuant to section #gjd7;b77#b71 and any feedback or corrective or preventive actions in response to such reports4 2 and 7#b7 by amending subsection 7f7 to read as follows3 7f7 ,temporary sunset ,subsection 7a7 shall cease to be effective on the date that is #e years after the date of enactment of the ,food and ,drug ,administration ,safety and ,innovation ,act4 ,subsections 7b71 7c71 and 7e7 shall not be in effect during the period beginning #e years after the date of enactment of the ,food and ,drug ,administration ,safety and ,innovation ,act and ending on the date of enactment of the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb4 ,subsections 7b71 7c71 and 7e7 shall be in effect beginning on the date of enactment of the ,food and ,drug ,administration ,safety and ,landmark ,advancements ,act of #bjbb4 4 7b7 ,reporting ,section #ejf;,c-#a7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c-#a7;a77 is amended-- 7#a7 by redesignating paragraphs 7#c7 through 7#g7 as paragraphs 7#d7 through 7#h71 respectively2 7#b7 by inserting after paragraph 7#b7 the following3 7#c7 provides the number of reports that were required under section #gjd7;b77#b7 to be sent to the appropriate offices of the ,food and ,drug ,administration with expertise regarding drug shortages1 and the number of such reports that were sent2 2 and 7#c7 in paragraph 7#c77;,a71 by striking paragraph 7#g7 and inserting paragraph 7#h74 7c7 ,applicability 7#a7 ,subsection 7a7 ,the amendments made by subsection 7a7 shall apply beginning on the date of enactment of this ,act4 7#b7 ,subsection 7b7 ,the amendments made by subsection 7b7 shall apply beginning on the date that is #a year after the date of enactment of this ,act4 7d7 ,reporting of mutual recognition agreements for inspections and review activities ,section #eaj7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77 is amended-- 7#a7 in paragraph 7#f7-- 7,a7 in subparagraph 7,a71 by striking clause 7ii7 and inserting the following3 7ii7 the number of such registered establishments in each region of interest2 7iii7 the number of such domestic establishments and the number of such foreign establishments1 including the number of establishments in each region of interest1 that the ,secretary inspected in the previous calendar year2 7iv7 the number of inspections to support actions by the ,secretary on applications under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 including the number of inspections to support actions by the ,secretary on supplemental applications1 including changes to manufacturing processes1 the ,secretary conducted in the previous fiscal year2 7v7 the number of routine surveillance inspections the ,secretary conducted in the previous fiscal year2 7vi7 the number of for-cause inspections the ,secretary conducted in the previous fiscal year1 not including inspections described in clause 7iv72 and 7vii7 the number of inspections the ,secretary has recognized pursuant to an agreement entered into pursuant to section #hji1 or otherwise recognized1 for each of the types of inspections described in clauses 7v7 and 7vi72 2 7,b7 in subparagraph 7,b71 by striking 2 and and inserting a semicolon2 7,c7 in subparagraph 7,c71 by striking the period and inserting 2 and2 and 7,d7 by adding at the end the following3 7,d7 the status of the efforts of the ,food and ,drug ,administration to expand its recognition of inspections conducted or recognized by foreign regulatory authorities under section #hji1 including any obstacles to expanding the use of such recognition4 2 and 7#b7 by adding at the end the following3 7#g7 ,region of interest ,for purposes of paragraph 7#f77;,a71 the term region of interest means a foreign geographic region or country1 including the ,people's ,republic of ,china1 ,india1 the ,european ,union1 the ,united ,kingdom1 and any other country or geographic region1 as the ,secretary determines appropriate4 4 7e7 ,enhancing transparency of drug facility inspection timelines ,section #ijb of the ,,fda ,reauthorization ,act of #bjag 7#ba ,u4,s4,c4 #cee note7 is amended to read as follows3 #ijb4 ,annual report on inspections ,not later than ,march #a of each year1 the ,secretary of ,health and ,human ,services shall post on the website of the ,food and ,drug ,administration information related to inspections of facilities necessary for approval of a drug under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 approval of a device under section #eae of such ,act 7#ba ,u4,s4,c4 #cfj;e71 or clearance of a device under section #eaj7k7 of such ,act 7#ba ,u4,s4,c4 #cfj7k77 that were conducted during the previous calendar year4 ,such information shall include the following3 7#a7 ,the median time following a request from staff of the ,food and ,drug ,administration reviewing an application or report to the beginning of the inspection1 including-- 7,a7 the median time for drugs described in #eje7;j77#aa77;,a77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#aa77;,a77i772 7,b7 the median time for drugs described in section #ejf;,c7a7 of such ,act 7#ba ,u4,s4,c4 #cef;c7a77 only2 and 7,c7 the median time for drugs on the drug shortage list in effect under section #ejf;,e of such ,act 7#ba ,u4,s4,c4 #cef;f74 7#b7 ,the median time from the issuance of a report pursuant to section #gjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b77 to the sending of a warning letter1 issuance of an import alert1 or holding of a regulatory meeting for inspections for which the ,secretary concluded that regulatory or enforcement action was indicated1 including the median time for each category of drugs listed in subparagraphs 7,a7 through 7,c7 of paragraph 7#a74 7#c7 ,the median time from the sending of a warning letter1 issuance of an import alert1 or holding of a regulatory meeting related to conditions observed by the ,secretary during an inspection1 to the time at which the ,secretary concludes that corrective actions to resolve such conditions have been taken4 7#d7 ,the median time spent by staff of the ,food and ,drug ,administration at a facility during an inspection1 including-- 7,a7 the median time when records were provided remotely in accordance with a request under section #gjd7;a77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77 in advance of the inspection2 and 7,b7 the median time when a request for records pursuant to such section #gjd7;a77#d7 was not issued1 or complied with1 in advance of the inspection4 7#e7 ,the number and type of violations identified during inspections when a request for records pursuant to such section #gjd7;a77#d7 was issued and complied with in advance of the inspection1 versus when a request for records pursuant to such section #gjd7;a77#d7 was not issued or complied with4 7#f7 ,the number of facilities that did not implement requested corrective or preventive actions following a report issued pursuant to such section #gjd7;b71 resulting in a withhold recommendation1 including the number of such times for each category of drugs listed in subparagraphs 7,a7 through 7,c7 of paragraph 7#a74 4