,,ii #aagth ,,congress #b;d ,session ,h4 ,r4 #gffg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #i1 #bjbb,received ,,an ,,act ,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 title ,this ,act may be cited as the ,food and ,drug ,amendments of #bjbb4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,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 requirements4,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 ,reauthorization2 reporting requirements4,sec4 #bje4 ,conformity assessment pilot program4,sec4 #bjf4 ,reauthorization of third-party review program4,sec4 #bjg4 ,sunset dates4,sec4 #bjh4 ,effective date4,sec4 #bji4 ,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 fees4,sec4 #djd4 ,reauthorization2 reporting requirements4,sec4 #dje4 ,sunset dates4,sec4 #djf4 ,effective date4,sec4 #djg4 ,savings clause4,title ,v--,improving ,diversity in ,clinical ,studies,sec4 #eja4 ,diversity action plans for clinical studies4,sec4 #ejb4 ,evaluation of the need for ,,fda authority to mandate postapproval studies or postmarket surveillance due to insufficient demographic subgroup data4,sec4 #ejc4 ,public workshops to enhance clinical study diversity4,sec4 #ejd4 ,annual summary report on progress to increase diversity in clinical studies4,sec4 #eje4 ,public meeting on clinical study flexibilities initiated in response to ,,covid-#ai pandemic4,sec4 #ejf4 ,decentralized clinical studies4,title ,,vi--,generic ,drug ,competition,sec4 #fja4 ,increasing transparency in generic drug applications4,sec4 #fjb4 ,enhancing access to affordable medicines4,title ,,vii--,research1 ,development1 and ,supply ,chain ,improvements,subtitle ,a--,in ,general,sec4 #gja4 ,animal testing alternatives4,sec4 #gjb4 ,emerging technology program4,sec4 #gjc4 ,improving the treatment of rare diseases and conditions4,sec4 #gjd4 ,antifungal research and development4,sec4 #gje4 ,advancing qualified infectious disease product innovation4,sec4 #gjf4 ,national ,centers of ,excellence in ,advanced and ,continuous ,pharmaceutical ,manufacturing4,sec4 #gjg4 ,advanced manufacturing technologies designation pilot program4,sec4 #gjh4 ,public workshop on cell therapies4,sec4 #gji4 ,reauthorization of best pharmaceuticals for children4,sec4 #gaj4 ,reauthorization for humanitarian device exemption and demonstration grants for improving pediatric availability4,sec4 #gaa4 ,reauthorization of provision related to exclusivity of certain drugs containing single enantiomers4,sec4 #gab4 ,reauthorization of the critical path public-private partnership program4,sec4 #gac4 ,reauthorization of orphan drug grants4,sec4 #gad4 ,research into pediatric uses of drugs2 additional authorities of ,food and ,drug ,administration regarding molecularly targeted cancer drugs4,subtitle ,b--,inspections,sec4 #gba4 ,factory inspection4,sec4 #gbb4 ,uses of certain evidence4,sec4 #gbc4 ,improving ,,fda inspections4,sec4 #gbd4 ,,gao report on inspections of foreign establishments manufacturing drugs4,sec4 #gbe4 ,unannounced foreign facility inspections pilot program4,sec4 #gbf4 ,reauthorization of inspection program4,sec4 #gbg4 ,enhancing intra-agency coordination and public health assessment with regard to compliance activities4,sec4 #gbh4 ,reporting of mutual recognition agreements for inspections and review activities4,sec4 #gbi4 ,enhancing transparency of drug facility inspection timelines4,title ,,viii--,transparency1 ,program ,integrity1 and ,regulatory ,improvements,sec4 #hja4 ,prompt reports of marketing status by holders of approved applications for biological products4,sec4 #hjb4 ,encouraging blood donation4,sec4 #hjc4 ,regulation of certain products as drugs4,sec4 #hjd4 ,postapproval studies and program integrity for accelerated approval drugs4,sec4 #hje4 ,facilitating the use of real world evidence4,sec4 #hjf4 ,dual ,submission for ,certain ,devices4,sec4 #hjg4 ,medical ,devices ,advisory ,committee meetings4,sec4 #hjh4 ,ensuring cybersecurity of medical devices4,sec4 #hji4 ,public docket on proposed changes to third-party vendors4,sec4 #haj4 ,facilitating exchange of product information prior to approval4,sec4 #haa4 ,bans of devices for one or more intended uses4,sec4 #hab4 ,clarifying application of exclusive approval1 certification1 or licensure for drugs designated for rare diseases or conditions4,sec4 #hac4 ,,gao report on third-party review4,sec4 #had4 ,reporting on pending generic drug applications and priority review applications4,sec4 #hae4 ,,fda ,workforce ,improvements4,title ,,ix--,miscellaneous,sec4 #ija4 ,determination of budgetary effects4,sec4 #ijb4 ,medicaid ,improvement ,fund4 ,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 ,the ,congress finds that the fees authorized by the amendments made by 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 7a7 ,human drug application ,section #gce7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#a77 is amended 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 to4 7b7 ,prescription drug product ,section #gce7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#c77 is amended-- 7#a7 by redesignating subparagraphs 7,a71 7,b71 and 7,c7 as clauses 7i71 7ii71 and 7iii71 respectively2 7#b7 by striking 7#c7 ,the term and inserting 7#c77;,a7 ,the term2 7#c7 by striking ,such term does not include whole blood and inserting the following3 7,b7 ,such term does not include whole blood 2 7#d7 by striking an allergenic extract product1 and inserting an allergenic extract product 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 #bjbb12 and 7#e7 by adding at the end the following3 7,c7 7i7 ,if a written request to place a product in the discontinued section of either of the lists referenced in subparagraph 7,a77iii7 is submitted to the ,secretary on behalf of an applicant1 and the request identifies the date the product is withdrawn from sale1 then 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-- 7,i7 the date such request was received2 or 7,,ii7 if the product will be withdrawn from sale on a future date1 such future date when the product is withdrawn from sale4 7ii7 ,for purposes of this subparagraph1 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 4 7c7 ,skin-,test diagnostic product ,section #gce of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is amended 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 7#a7 ,human drug application fee ,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 fiscal year #bjah and inserting fiscal year #bjbc2 7,b7 in paragraph 7#a77;,a71 by striking 7c77#e7 each place it appears and inserting 7c77#f72 7,c7 in paragraph 7#a77;,c71 by inserting prior to approval after or was withdrawn2 and 7,d7 in paragraph 7#a71 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 4 7#b7 ,prescription drug program fee ,section #gcf7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77#b77 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 by striking ,except as provided in subparagraphs 7,b7 and 7,c7 and inserting the following3 7i7 ,fee ,except as provided in subparagraphs 7,b7 and 7,c7 2 7ii7 by striking subsection 7c77#e7 and inserting subsection 7c77#f72 and 7iii7 by adding at the end the following3 7ii7 ,special rule ,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 referenced in section #gce7c77;,a77iii71 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 such 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 regulation77 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 7#a7 ,in general ,paragraph 7#a7 of section #gcf7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is amended to read as follows3 7#a7 ,in general ,for each of the fiscal years #bjbc through #bjbg1 fees under subsection 7a7 shall1 except as provided in subsections 7c71 7d71 7f71 and 7g71 be established to generate a total revenue amount under such subsection that is equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year 7as determined under subsection 7c77#b772 7,d7 the dollar amount equal to the capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#c772 7,e7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#d772 7,f7 the dollar amount equal to the additional direct cost adjustment for the fiscal year 7as determined under subsection 7c77#e772 and 7,g7 additional dollar amounts for each fiscal year as follows3 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 4 7#b7 ,annual base revenue ,paragraph 7#c7 of section #gcf7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is amended 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 #a1aea1ebb1ieh2 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 not including any adjustments made under subsection 7c77#d7 or 7c77#e74 4 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment ,section #gcf7;c77#a77;,b77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77#a77;,b77ii77 is amended by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv4 7#b7 ,strategic hiring and retention adjustment ,section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended-- 7,a7 by redesignating paragraphs 7#b7 through 7#f7 as paragraphs 7#c7 through 7#g71 respectively2 and 7,b7 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 by the following amounts3 7,a7 ,for fiscal year #bjbc1 #i1jjj1jjj4 7,b7 ,for each of fiscal years #bjbd through #bjbg1 #d1jjj1jjj4 4 7#c7 ,capacity planning adjustment ,paragraph 7#c71 as redesignated1 of section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended to read as follows3 7#c7 ,capacity planning adjustment 7,a7 ,in general ,for each fiscal year1 after the annual base revenue established in subsection 7b77#a77;,a7 is adjusted in accordance with paragraphs 7#a7 and 7#b71 such revenue shall be adjusted further for such fiscal year1 in accordance with this paragraph1 to reflect changes in the resource capacity needs of the ,secretary for the process for the review of human drug applications4 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 published in the ,federal ,register on ,august #c1 #bjbj 7#he ,fed4 ,reg4 #dffea74 ,the workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and1 as feasible1 additional activities that are also 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 applying such methodology in forecasting any non-core review activities1 including those activities that the ,secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year #bjba4 7,c7 ,limitation ,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 subsections 7b77#a77;,a7 7the annual base revenue for the fiscal year71 7b77#a77;,b7 7the dollar amount of the inflation adjustment for the fiscal year71 and 7b77#a77;,c7 7the dollar amount of the strategic hiring and retention adjustment for the fiscal year74 7,d7 ,publication in ,federal ,register ,the ,secretary shall publish in the ,federal ,register notice under paragraph 7#f7 of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph4 4 7#d7 ,operating reserve adjustment ,paragraph 7#d71 as redesignated1 of section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended-- 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 operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts3 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#f74 7#e7 ,additional direct cost adjustment ,paragraph 7#e71 as redesignated1 of section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended to read as follows3 7#e7 ,additional direct cost adjustment 7,a7 ,increase ,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-- 7i7 for fiscal year #bjbc1 by #dd1chf1aej2 and 7ii7 for each of fiscal years #bjbd through #bjbg1 by the amount set forth in clauses 7i7 through 7iv7 of subparagraph 7,b71 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 #bjba4 7,b7 ,applicable amounts ,the amounts referred to in subparagraph 7,a77ii7 are the following3 7i7 ,for fiscal year #bjbd1 #fj1ifg1iic4 7ii7 ,for fiscal year #bjbe1 #ce1gii1cad4 7iii7 ,for fiscal year #bjbf1 #ce1gii1 #cad4 7iv7 ,for fiscal year #bjbg1 #ce1gii1cad4 4 7#f7 ,annual fee setting ,paragraph 7#f71 as redesignated1 of section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended by striking ,september #cj1 #bjag and inserting ,september #cj1 #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 fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg4 7e7 ,written requests for waivers1 reductions1 exemptions1 and returns2 disputes concerning fees ,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-- 7#a7 not later than #ahj days after such fee is due1 submit to the ,secretary a written request justifying such waiver1 reduction1 exemption1 or return2 and 7#b7 include in the request 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 as determined under paragraph 7#b72 and 7#b7 by amending paragraph 7#b7 to read as follows3 7#b7 ,evidence of qualification ,an exemption under paragraph 7#a7 applies with respect to a drug only if the applicant involved submits a certification that the applicant's gross annual revenues did not exceed #ej1jjj1jjj for the last calendar year ending prior to the fiscal year for which the exemption is requested4 ,such certification shall be supported by-- 7,a7 tax returns submitted to the ,united ,states ,internal ,revenue ,service2 or 7,b7 as necessary1 other appropriate financial information4 4 #ajd4 ,reauthorization2 reporting requirements ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is amended-- 7#a7 in subsection 7a77#a71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 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#c77;,a71 by striking ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter and inserting ,not later than #cj calendar days after the end of each quarter of each fiscal year for which fees are collected under this part2 7#d7 in subsection 7a77#c77;,b71 by adding at the end the following3 7v7 ,for fiscal years #bjbc and #bjbd1 of the meeting requests from sponsors for which the ,secretary has determined that a face-to-face meeting is appropriate1 the number of face-to-face meetings requested by sponsors to be conducted in person 7in such manner as the ,secretary shall prescribe on the internet website of the ,food and ,drug ,administration71 and the number of such in-person meetings granted by the ,secretary4 2 7#e7 in subsection 7a77#d71 by striking ,beginning with fiscal year #bjbj1 the and inserting ,the2 7#f7 in subsection 7b71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 7#g7 in subsection 7c71 by striking ,beginning with fiscal year #bjah1 for and inserting ,for2 and 7#h7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking fiscal year #bjbb and inserting fiscal year #bjbg2 and 7,b7 in paragraph 7#e71 by striking ,january #ae1 #bjbb and inserting ,january #ae1 #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 on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 were accepted by the ,food and ,drug ,administration for filing 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 ,the ,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 7#ba ,u4,s4,c4 #cgi;i 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 #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 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 each of subparagraphs 7,g7 and 7,h71 by striking or submissions 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 fiscal year #bjah and inserting fiscal year #bjbc2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking ,october #a1 #bjag and inserting ,october #a1 #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 paragraph 7#b7 to read as follows3 7#b7 ,base fee amounts specified ,for purposes of paragraph 7#a71 the base fee amounts specified in this paragraph are 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 by amending paragraph 7#c7 to read as follows3 7#c7 ,total revenue amounts specified ,for purposes of paragraph 7#a71 the total revenue amounts specified in this paragraph are 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 in subparagraph 7,a71 by striking #bjah and inserting #bjbc2 7,b7 in subparagraph 7,b7-- 7i7 in the matter preceding clause 7i71 by striking fiscal year #bjah and inserting fiscal year #bjbc2 and 7ii7 in clause 7ii71 by striking fiscal year #bjaf and inserting fiscal year #bjbb2 7,c7 in subparagraph 7,c71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 and 7,d7 in subparagraph 7,d71 in the matter preceding clause 7i71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #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 adjustments under paragraphs 7#b7 and 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 year equal to the following amounts3 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 ,pre-submission amount ,for purposes of subparagraph 7,a71 with respect to the pre-submission written feedback goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbe1 #ae1cif1fjj if such goal for fiscal year #bjbc is met4 7,,ii7 ,for fiscal year #bjbf3 7aa7 #ae1cif1fjj if such goal for fiscal year #bjbc is met and such goal for fiscal year #bjbd is not met4 7bb7 #cf1gib1bjj if such goal for fiscal year #bjbd is met4 7,,iii7 ,for fiscal year #bjbg3 7aa7 #ae1cif1fjj if such goal for fiscal year #bjbc is met and such goal for each of fiscal years #bjbd and #bjbe is not met4 7bb7 #cf1gib1bjj if such goal for fiscal year #bjbd is met and such goal for fiscal year #bjbe is not met4 7cc7 #dj1egb1fjj if such goal for fiscal year #bjbe is met4 7ii7 ,de novo classification 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 such goal for fiscal year #bjbc is met4 7,,ii7 ,for fiscal year #bjbg3 7aa7 #f1cbc1ejj if such goal for fiscal year #bjbc is met and such goal for fiscal year #bjbd is not met4 7bb7 #aa1gfe1djj if such 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 four goals for fiscal year #bjbc are met4 7,,ii7 ,for fiscal year #bjbg3 7aa7 #a1jbj1jjj if the four goals for fiscal year #bjbc are met and one or more of the four goals for fiscal year #bjbd are not met4 7bb7 #c1ijf1jjj if the four goals for fiscal year #bjbd are met4 7,c7 ,performance calculation ,for purposes of this paragraph1 performance of the goals listed in subparagraph 7,d7 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 following dates3 7i7 ,the performance of the pre-submission written feedback goal shall be based on data available as of-- 7,i7 for fiscal year #bjbc1 ,march #ca1 #bjbd2 7,,ii7 for fiscal year #bjbd1 ,march #ca1 #bjbe2 and 7,,iii7 for fiscal year #bjbe1 ,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 shall be based on data available as of-- 7,i7 for fiscal year #bjbc1 ,march #ca1 #bjbe2 and 7,,ii7 for fiscal year #bjbd1 ,march #ca1 #bjbf4 7,d7 ,goals defined ,for purposes of this paragraph1 the terms pre-submission 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 refer to the goals identified by the same names 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#b71 7#c71 and 7#d71 if applicable1 if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph 7,b7 for the applicable fiscal years1 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,c74 7,b7 ,thresholds ,the thresholds specified in this subparagraph are as follows3 7i7 ,for fiscal year #bjbe1 the threshold is #abc hires for fiscal year #bjbc4 7ii7 ,for fiscal year #bjbf1 the threshold is #ch hires for fiscal year #bjbd4 7iii7 ,for fiscal year #bjbg1 the threshold is-- 7,i7 #bb hires for fiscal year #bjbe if the base establishment registration fees are not increased by the amount determined under paragraph 7#d77;,a77i72 or 7,,ii7 #ge hires for fiscal year #bjbe if such fees are so increased4 7,c7 ,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,d7 for the fiscal year before the prior fiscal year was not met2 7ii7 #gb1hgg2 and 7iii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for the fiscal year for which the hiring goal was not met4 7,d7 ,hiring goals ,the hiring goals for each of fiscal years #bjbc through #bjbe are as follows3 7i7 ,for fiscal year #bjbc1 #add hires4 7ii7 ,for fiscal year #bjbd1 #db hires4 7iii7 ,for fiscal year #bjbe3 7,i7 #bd hires if the base establishment registration fees are not increased by the amount determined under paragraph 7#d77;,a77i74 7,,ii7 #hc hires if the base establishment registration fees are increased by the amount determined under paragraph 7#d77;,a77i74 7,e7 ,number of hires ,for purposes of this paragraph1 the number of hires shall be determined by the ,secretary 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#b71 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 #a month of operating reserves maintained pursuant to 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 in each of subsections 7d77#b77;,b77iii7 and 7e77#b77;,b77iii7 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 ,crediting and ,availability of ,fees ,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 fiscal years #bjbc through #bjbg1 there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph 7,b71 less the amount of reductions determined under 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 paragraphs 7#b7 and 7#c7 of subsection 7c72 and 7ii7 the performance improvement adjustment amount for the fiscal year under subsection 7c77#d71 if applicable4 7,c7 ,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 ,reauthorization2 reporting requirements 7a7 ,performance reports ,section #gch;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is amended-- 7#a7 by striking fiscal year #bjah each place it appears and inserting fiscal year #bjbc2 7#b7 by striking ,medical ,device ,user ,fee ,amendments of #bjag each place it appears and inserting ,medical ,device ,user ,fee ,amendments of #bjbb2 7#c7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 by redesignating the second clause 7iv7 7relating to analysis7 as clause 7v72 and 7,b7 in subparagraph 7,a77iv71 by striking fiscal year #bjbj and inserting fiscal year #bjbc2 and 7#d7 in paragraph 7#d71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7b7 ,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 in paragraph 7#a71 by striking #bjbb and inserting #bjbg2 and 7#b7 in paragraph 7#e71 by striking #bjbb and inserting #bjbg4 #bje4 ,conformity assessment pilot program ,section #ead7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is amended to read as follows3 7d7 ,accreditation scheme for conformity assessment 7#a7 ,in general ,the ,secretary shall establish a program under which-- 7,a7 testing laboratories meeting criteria specified in guidance by the ,secretary may be accredited by accreditation bodies meeting criteria specified in guidance by the ,secretary1 to conduct testing to support the assessment of the conformity of a device to certain standards recognized under this section2 and 7,b7 subject to paragraph 7#b71 results from tests conducted to support the assessment of conformity of devices as described in subparagraph 7,a7 conducted by testing laboratories accredited pursuant to this subsection shall be accepted by the ,secretary for purposes of demonstrating such conformity unless the ,secretary finds that certain results of such tests should not be so accepted4 7#b7 ,secretarial review of accredited laboratory results ,the ,secretary may-- 7,a7 review the results of tests conducted by testing laboratories accredited pursuant to this subsection1 including by conducting periodic audits of such results or of the processes of accredited bodies or testing laboratories2 7,b7 following such review1 take additional measures under this ,act1 as the ,secretary determines appropriate1 such as-- 7i7 suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph 7#a77;,a72 or 7ii7 requesting additional information with respect to a device2 and 7,c7 if the ,secretary becomes aware of information materially bearing on the safety or effectiveness of a device for which an assessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection1 take such additional measures under this ,act1 as the ,secretary determines appropriate1 such as-- 7i7 suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph 7#a77;,a72 or 7ii7 requesting additional information with regard to such device4 7#c7 ,implementation and reporting 7,a7 ,pilot program transition ,after ,september #cj1 #bjbc1 the pilot program previously initiated under this subsection1 as in effect prior to the date of enactment of the ,medical ,device ,user ,fee ,amendments of #bjbb1 shall be considered to be completed1 and the ,secretary may continue operating a program consistent with this subsection4 7,b7 ,report ,the ,secretary shall make available on the internet website of the ,food and ,drug ,administration an annual report on the progress of the pilot program under this subsection4 4 #bjf4 ,reauthorization of third-party review program ,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 #bjg4 ,sunset dates 7a7 ,authorization ,sections #gcg and #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;j7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gch;,a 7#ba ,u4,s4,c4 #cgi;j- #a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7regarding reauthorization and reporting requirements7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provisions ,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 #bjh4 ,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 #bji4 ,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 by 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 ,act 7#ba ,u4,s4,c4 #cgi;j-#da 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 #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 fiscal year #bjah and inserting fiscal year #bjbc2 7#b7 in paragraph 7#b77;,c71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#c7 in paragraph 7#c77;,b71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#d7 in paragraph 7#d77;,d71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 and 7#e7 in paragraph 7#e77;,d71 by striking #bjah through #bjbb and inserting #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 by amending subparagraph 7,b7 to read as follows3 7,b7 ,fiscal years #bjbd through #bjbg 7i7 ,in general ,for each of the fiscal years #bjbd through #bjbg1 fees under paragraphs 7#b7 through 7#e7 of subsection 7a7 shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause 7ii71 as adjusted pursuant to subsection 7c74 7ii7 ,base revenue amount ,the base revenue amount for a fiscal year referred to in clause 7i7 is equal to 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 twenty-four percent2 7,b7 in subparagraph 7,d71 by striking ,seven percent and inserting ,six percent2 and 7,c7 in subparagraph 7,e77i71 by striking ,thirty-five percent and inserting ,thirty-six percent4 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 to equal the product of the total revenues established in such notice for the prior fiscal year multiplied and inserting to equal the base revenue amount for the fiscal year 7as specified in subsection 7b77#a77;,b77 multiplied2 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 announced in the ,federal ,register on ,august #c1 #bjbj2 7ii7 incorporate approaches and attributes determined appropriate by the ,secretary1 including approaches and attributes made in such report1 except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section ,,viii4,b4#b4;e4 of the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjbb2 and 7iii7 be effective beginning with fiscal year #bjbd4 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 ,percentage limitation ,an adjustment under this paragraph shall not exceed three percent of the sum described in clause 7i7 for the fiscal year1 except that such limitation shall be four percent if-- 7,i7 for purposes of a fiscal year #bjbd adjustment1 the ,secretary determines that 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 a fiscal year #bjbe adjustment1 the ,secretary determines that 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 a fiscal year #bjbf adjustment1 the ,secretary determines that 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 a fiscal year #bjbg adjustment1 the ,secretary determines that 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 referred to in subsection 7a7 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 each subsequent fiscal year1 the ,secretary may1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees under this section for such fiscal year 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,b7 with respect to that fiscal year4 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 paragraph heading1 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 and 7#b7 by striking more than #fj days before the first day of each of fiscal years #bjah through #bjbb and inserting later than #fj days before the first day of each of fiscal years #bjbc through #bjbg4 7e7 ,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 fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg4 7f7 ,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 #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 7a77#a71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 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#c7 in subsection 7a77#b71 by striking ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter and inserting ,not later than #cj calendar days after the end of each quarter of each fiscal year for which fees are collected under this part2 7#d7 in subsection 7a77#c71 by striking ,beginning with fiscal year #bjbj1 the and inserting ,the2 7#e7 in subsection 7b71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 7#f7 in subsection 7c71 by striking ,beginning with fiscal year #bjah1 for and inserting ,for2 and 7#g7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking fiscal year #bjbb and inserting fiscal year #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 7#ba ,u4,s4,c4 #cgi;j-#da et seq47 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 ,act 7#ba ,u4,s4,c4 #cgi;j-#da 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 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 ,the ,congress finds that the fees authorized by the amendments made by 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 7a7 ,adjustment factor ,section #gdd;,g7#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7a77 is amended to read as follows3 7#a7 ,the term adjustment factor applicable to a fiscal year is the ,consumer ,price ,index for urban consumers 7,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for ,september of the preceding fiscal year divided by such ,index for ,september #bjaa4 4 7b7 ,biosimilar biological product application ,section #gdd;,g7#d77;,b77iii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7d77;,b77iii77 is amended-- 7#a7 by striking subclause 7,,ii7 7relating to an allergenic extract product72 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 fees 7a7 ,types of fees 7#a7 ,in general ,the matter preceding paragraph 7#a7 in section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended by striking fiscal year #bjah and inserting fiscal year #bjbc4 7#b7 ,initial biosimilar biological product development fee ,clauses 7iv77,i7 and 7v77,,ii7 of section #gdd;,h7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,a77 are each amended by striking #e days and inserting #g days4 7#c7 ,annual biosimilar biological product development fee ,section #gdd;,h7a77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,b77 is amended-- 7,a7 in clause 7i71 by inserting before the period at the end the following3 1 except where 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 in which case such licensee1 assignee1 or successor shall pay the annual biosimilar biological product development fee2 7,b7 in clause 7iii7-- 7i7 in subclause 7,i71 by striking or at the end2 7ii7 in subclause 7,,ii71 by striking the period at the end and inserting 2 or2 and 7iii7 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 7,c7 in clause 7iv71 by striking is accepted for filing on or after ,october #a of such fiscal year and inserting is subsequently accepted for filing4 7#d7 ,reactivation fee ,section #gdd;,h7a77#a77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,d77 is amended to read as follows3 7,d7 ,reactivation fee 7i7 ,in general ,a person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph 7,c71 or who has been administratively removed from the biosimilar biological product development program for a product under subparagraph 7,e77v71 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 and a fee 7referred to in this section as reactivation fee7 by the earlier of the following3 7,i7 ,not later than #g days after the ,secretary grants a request by such person for a biosimilar biological product development meeting for the product 7after the date on which such participation was discontinued or the date of administrative removal1 as applicable74 7,,ii7 ,upon the date of submission 7after the date on which such participation was discontinued or the date of administrative removal1 as applicable7 by such person of an investigational new drug application describing an investigation that the ,secretary determines is intended to support a biosimilar biological product application for that product4 7ii7 ,application of annual fee ,a person that pays a reactivation fee for a product shall pay for such product1 beginning in the next fiscal year1 the annual biosimilar biological product development fee under subparagraph 7,b71 except where 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 in which case such licensee1 assignee1 or successor shall pay the annual biosimilar biological product development fee4 4 7#e7 ,effect of failure to pay fees ,section #gdd;,h7a77#a77;,e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#a77;,e77 is amended 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 two 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 4 7#f7 ,biosimilar biological product application fee ,section #gdd;,h7a77#b77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#b77;,d77 is amended by inserting after or was withdrawn the following3 prior to approval4 7#g7 ,biosimilar biological product program fee ,section #gdd;,h7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77#c77 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7i71 by striking and at the end2 7ii7 by redesignating clause 7ii7 as clause 7iii72 and 7iii7 by inserting after clause 7i7 the following3 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 ,date of inclusion ,if a written request to place a product on the list referenced in subparagraph 7,a7 of discontinued biosimilar biological products is submitted to the ,secretary on behalf of an applicant1 and the request identifies the date the product is 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-- 7,i7 the date such request was received2 or 7,,ii7 if the product will be withdrawn from sale on a future date1 such future date when the product is withdrawn from sale4 7ii7 ,treatment as withdrawn from sale ,for purposes of clause 7i71 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 7iii7 ,special rule ,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 referenced in subparagraph 7,a7 of discontinued biosimilar biological products1 and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list1 then except as provided in subparagraph 7,d71 each person who is named as the applicant in a biosimilar biological product application with respect to such product 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 such product for each fiscal year4 4 7#h7 ,biosimilar biological product fee ,section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended by striking paragraph 7#d74 7c7 ,fee revenue amounts ,subsection 7b7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 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 by amending paragraph 7#a7 7as so redesignated7 to read as follows3 7#a7 ,in general ,for each of the fiscal years #bjbc through #bjbg1 fees under subsection 7a7 shall1 except as provided in subsection 7c71 be established to generate a total revenue amount equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the strategic hiring and retention adjustment 7as determined under subsection 7c77#b772 7,d7 the dollar amount equal to the capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#c772 7,e7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#d772 7,f7 for fiscal year #bjbc an additional amount of #d1dbh1hhf2 and 7,g7 for fiscal year #bjbd an additional amount of #cbj1efi4 2 7#d7 in paragraph 7#b7 7as so redesignated7-- 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 subparagraphs 7,c7 and 7,d7 as subparagraphs 7,b7 and 7,c71 respectively2 and 7#e7 by amending paragraph 7#c7 7as so redesignated7 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 7d7 ,adjustments2 annual fee setting ,section #gdd;,h7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#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 paragraphs 7#b7 through 7#d7 and inserting the following3 7#b7 ,strategic hiring and retention adjustment ,for each fiscal year1 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 7#c7 ,capacity planning adjustment 7,a7 ,in general ,for each fiscal year1 the ,secretary shall1 in addition to the adjustments under paragraphs 7#a7 and 7#b71 further adjust the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the ,secretary for the process for the review of biosimilar biological product applications4 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 published in the ,federal ,register on ,august #d1 #bjbj 7#he ,fed4 ,reg4 #dgbbj74 ,the workload categories used in applying such methodology in forecasting shall include only the activities described in that 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 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 biosimilar biological products4 ,subject to the exceptions in the preceding sentence1 the ,secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities1 including those activities that the ,secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year #bjba4 7,c7 ,limitations ,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 subsections 7b77#a77;,a7 7the annual base revenue for the fiscal year71 7b77#a77;,b7 7the dollar amount of the inflation adjustment for the fiscal year71 and 7b77#a77;,c7 7the dollar amount of the strategic hiring and retention adjustment74 7,d7 ,publication in ,federal ,register ,the ,secretary shall publish in the ,federal ,register notice under paragraph 7#e7 the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph4 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 such process 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 such process 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 such process 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 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#c7 in paragraph 7#e71 in the matter preceding subparagraph 7,a71 by striking #bjah and inserting #bjbc4 7e7 ,crediting and availability of fees ,subsection 7f77#c7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7f7 ,written requests for waivers and returns2 disputes concerning fees ,section #gdd;,h7h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;h77 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 for 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 in subsection 7a77#a71 by striking ,beginning with fiscal year #bjah1 not and inserting ,not2 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#b71 by striking ,beginning with fiscal year #bjah1 the and inserting ,the2 7#d7 in subsection 7a77#c77;,a71 by striking ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter and inserting ,not later than #cj calendar days after the end of each quarter of each fiscal year for which fees are collected under this part2 7#e7 in subsection 7b71 by striking ,not later than #abj days after the end of fiscal year #bjah and each subsequent fiscal year for which fees are collected under this part and inserting ,not later than #abj days after the end of each fiscal year for which fees are collected under this part2 7#f7 in subsection 7c71 by striking ,beginning with fiscal year #bjah1 and for and inserting ,for2 and 7#g7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking fiscal year #bjbb and inserting fiscal year #bjbg2 and 7,b7 in paragraph 7#c71 by striking ,january #ae1 #bjbb and inserting ,january #ae1 #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-#eb7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting ,requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 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 ,diversity in ,clinical ,studies #eja4 ,diversity action plans for clinical studies 7a7 ,drugs ,section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 is amended by adding at the end the following3 7#e7 7,a7 ,in order for a new drug that is being studied in a phase #c study1 as defined in section #cab4ba7;c7 of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 or other pivotal study 7other than bioavailability or bioequivalence studies71 to be exempt pursuant to this subsection1 the sponsor of a clinical investigation of such new drug shall submit to the ,secretary a diversity action plan4 7,b7 ,such diversity action plan shall include-- 7i7 the sponsor's goals for enrollment in such clinical study2 7ii7 the sponsor's rationale for such goals2 and 7iii7 an explanation of how the sponsor intends to meet such goals4 7,c7 ,the sponsor shall submit such diversity action plan in the form and manner specified in the guidance required by section #ebd;,b as soon as practicable but no later than when the sponsor seeks feedback regarding such a phase #c study or other pivotal study of the drug4 7,d7 ,the ,secretary may waive the requirement in subparagraph 7,a7 if the ,secretary determines that a waiver is necessary based on what is known about the prevalence of the disease in terms of the patient population that may use the new drug4 7,e7 ,no diversity action plan shall be required for a submission described in section #efa4 4 7b7 ,devices ,section #ebj7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g77 is amended by adding at the end the following3 7#i7 7,a7 7i7 ,in order for a device in a clinical study for which submission of an application for an investigational device exemption is required to be exempt under this subsection1 the sponsor of such study shall submit to the ,secretary in such application a diversity action plan in the form and manner specified in the guidance required by section #ebd;,b4 7ii7 ,in order for a device in a clinical study for which submission of an application for an investigational device exemption is not required1 except for a device being studied as described in section #hab4b7;c7 of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 to be exempt under this subsection1 the sponsor of such study shall develop and implement a diversity action plan4 ,such diversity action plan shall be submitted to the ,secretary in any premarket notification under section #eaj7k71 request for classification under section #eac7;f77#b71 or application for premarket approval under section #eae for such device4 7,b7 ,a diversity action plan under clause 7i7 or 7ii7 of subparagraph 7,a7 shall include-- 7i7 the sponsor's goals for enrollment in the clinical study2 7ii7 the sponsor's rationale for such goals2 and 7iii7 an explanation of how the sponsor intends to meet such goals4 7,c7 ,the ,secretary may waive the requirement in subparagraph 7,a7 or 7,b7 if the ,secretary determines that a waiver is necessary based on what is known about the prevalence of the disease in terms of the patient population that may use the device4 7,d7 ,no diversity action plan shall be required for a submission described in section #efa4 4 7c7 ,guidance ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 #ebd;,b4 ,guidance on diversity action plans for clinical studies 7a7 ,in general ,the ,secretary shall issue guidance relating to-- 7#a7 the format and content of the diversity action plans required by sections #eje7;i77#e7 and #ebj7;g77#i7 pertaining to the sponsor's goals for clinical study enrollment1 disaggregated by age group1 sex1 race1 geographic location1 socioeconomic status1 and ethnicity1 including with respect to-- 7,a7 the rationale for the sponsor's enrollment goals1 which may include-- 7i7 the estimated prevalence or incidence in the ,united ,states of the disease or condition for which the drug or device is being developed or investigated1 if such estimated prevalence or incidence is known or can be determined based on available data2 7ii7 what is known about the disease or condition for which the drug or device is being developed or investigated2 7iii7 any relevant pharmacokinetic or pharmacogenomic data2 7iv7 what is known about the patient population for such disease or condition1 including1 to the extent data is available-- 7,i7 demographic information1 including age group1 sex1 race1 geographic location1 socioeconomic status1 and ethnicity2 7,,ii7 non-demographic factors1 including co-morbidities affecting the patient population2 and 7,,iii7 potential barriers to enrolling diverse participants1 such as patient population size1 geographic location1 and socioeconomic status2 and 7v7 any other data or information relevant to selecting appropriate enrollment goals1 disaggregated by demographic subgroup1 such as the inclusion of pregnant and lactating women2 7,b7 an explanation for how the sponsor intends to meet such goals1 including demographic-specific outreach and enrollment strategies1 study-site selection1 clinical study inclusion and exclusion practices1 and any diversity training for study personnel2 and 7,c7 procedures for the public posting of key information from the diversity action plan that would be useful to patients and providers on the sponsor's website1 as appropriate2 and 7#b7 how sponsors should include in regular reports to the ,secretary-- 7,a7 the sponsor's progress in meeting the goals referred to in paragraph 7#a77;,a72 and 7,b7 if the sponsor does not expect to meet such goals-- 7i7 any updates needed to be made to a diversity action plan referred to in paragraph 7#a7 to help meet such goals2 and 7ii7 the sponsor's reasons for why the sponsor does not expect to meet such goals4 7b7 ,issuance ,the ,secretary shall-- 7#a7 not later than #ab months after the date of enactment of this section1 issue new draft guidance or update existing draft guidance described in subsection 7a72 and 7#b7 not later than #i months after closing the comment period on such draft guidance1 finalize such guidance4 4 7d7 ,applicability ,sections #eje7;i77#e7 and #ebj7;g77#i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsections 7a7 and 7b7 of this section1 apply only with respect to clinical investigations with respect to which enrollment commences after the date that is #ahj days after the publication of final guidance under section #ebd;,b7b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7c74 #ejb4 ,evaluation of the need for ,,fda authority to mandate postapproval studies or postmarket surveillance due to insufficient demographic subgroup data 7a7 ,in general ,not later than #b years after the date of publication of final guidance pursuant to section #ebd;,b7b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #eja7;c7 of this ,act1 the ,secretary of ,health and ,human ,services shall commence an evaluation to assess whether additions or changes to statutes or regulations are warranted to ensure that sponsors conduct post-approval studies or postmarket surveillance where-- 7#a7 premarket studies collected insufficient data for underrepresented subgroups according to the goals specified in the diversity action plans of such sponsors2 and 7#b7 the ,secretary has requested additional studies be conducted4 7b7 ,determination and reporting ,not later than #ahj days after the commencement of the evaluation under subsection 7a71 the ,secretary of ,health and ,human ,services shall submit a report to the ,congress on the outcome of such evaluation1 including any recommendations related to additional needed authorities4 #ejc4 ,public workshops to enhance clinical study diversity 7a7 ,in general ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with drug sponsors1 medical device manufacturers1 patients1 and other stakeholders1 shall convene one or more public workshops to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups1 where appropriate1 and other topics1 including-- 7#a7 how and when to collect and present the prevalence or incidence data on a disease or condition by demographic subgroup1 including possible sources for such data and methodologies for assessing such data2 7#b7 considerations for the dissemination1 after approval1 of information to the public on clinical study enrollment demographic data2 7#c7 the establishment of goals for enrollment in clinical trials1 including the relevance of the estimated prevalence or incidence1 as applicable1 in the ,united ,states of the disease or condition for which the drug or device is being developed2 and 7#d7 approaches to support inclusion of underrepresented populations and to encourage clinical study participation that reflects the population expected to use the drug or device under study1 including with respect to-- 7,a7 the establishment of inclusion and exclusion criteria for certain subgroups1 such as pregnant and lactating women and individuals with disabilities1 including intellectual or developmental disabilities or mental illness2 7,b7 considerations regarding informed consent with respect to individuals with intellectual or developmental disabilities or mental illness1 including ethical and scientific considerations2 7,c7 the appropriate use of decentralized trials or digital health tools2 7,d7 clinical endpoints2 7,e7 biomarker selection2 and 7,f7 studying analysis4 7b7 ,public docket ,the ,secretary of ,health and ,human ,services shall establish a public comment period to receive written comments related to the topics addressed during each public workshop convened under this section4 ,the public comment period shall remain open for #fj days following the date on which each public workshop is convened4 7c7 ,report ,not later than #ahj days after the close of the public comment period for each public workshop convened under this section1 the ,secretary of ,health and ,human ,services shall make available on the public website of the ,food and ,drug ,administration a report on the topics discussed at such workshop4 ,the report shall include a summary of1 and response to1 recommendations raised in such workshop4 #ejd4 ,annual summary report on progress to increase diversity in clinical studies 7a7 ,in general ,beginning not later than #b years after the date of enactment of this ,act1 and each year thereafter1 the ,secretary of ,health and ,human ,services shall submit to the ,congress1 and publish on the public website of the ,food and ,drug ,administration1 a report that-- 7#a7 summarizes1 in aggregate1 the diversity action plans received pursuant to section #eje7;i77#e7 or #ebj7;g77#i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a7 or 7b7 of section #eja of this ,act2 and 7#b7 contains information on-- 7,a7 for drugs1 biological products1 and devices approved1 licensed1 cleared1 or classified under section #eje1 #eae1 #eaj7k71 or #eac7;f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee2 #cfj;e2 #cfj7k72 and #cfj7;f77#b771 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 whether the clinical studies conducted with respect to such applications met the demographic subgroup enrollment goals from the diversity action plan submitted for such applications2 7,b7 the reasons provided for why enrollment goals from submitted diversity action plans were not met2 and 7,c7 any postmarket studies of a drug or device in a demographic subgroup or subgroups required or recommended by the ,secretary based on inadequate premarket clinical study diversity or based on other reasons where a premarket study lacked adequate diversity1 including the status and completion date of any such study4 7b7 ,confidentiality ,nothing in this section shall be construed as authorizing the ,secretary of ,health and ,human ,services to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 #eje4 ,public meeting on clinical study flexibilities initiated in response to ,,covid-#ai pandemic 7a7 ,in general ,not later than #ahj days after the date on which the ,,covid-#ai emergency period ends1 the ,secretary of ,health and ,human ,services shall convene a public meeting to discuss the recommendations provided by the ,food and ,drug ,administration during the ,,covid-#ai emergency period to mitigate disruption of clinical studies1 including recommendations detailed in the guidance entitled ,conduct of ,clinical ,trials of ,medical ,products ,during the ,,covid-#ai ,public ,health ,emergency1 ,guidance for ,industry1 ,investigators1 and ,institutional ,review ,boards1 as updated on ,august #h1 #bjba1 and by any subsequent updates to such guidance4 ,the ,secretary of ,health and ,human ,services shall invite to such meeting representatives from the pharmaceutical and medical device industries who sponsored clinical studies during the ,,covid-#ai emergency period and organizations representing patients4 7b7 ,topics ,not later than #ij days after the date on which the public meeting under subsection 7a7 is convened1 the ,secretary of ,health and ,human ,services shall make available on the public website of the ,food and ,drug ,administration a report on the topics discussed at such meeting4 ,such topics shall include discussion of-- 7#a7 the actions drug sponsors took to utilize such recommendations and the frequency at which such recommendations were employed2 7#b7 the characteristics of the sponsors1 studies1 and patient populations impacted by such recommendations2 7#c7 a consideration of how recommendations intended to mitigate disruption of clinical studies during the ,,covid-#ai emergency period1 including any recommendations to consider decentralized clinical studies when appropriate1 may have affected access to clinical studies for certain patient populations1 especially unrepresented or underrepresented racial and ethnic minorities2 and 7#d7 recommendations for incorporating certain clinical study disruption mitigation recommendations into current or additional guidance to improve clinical study access and enrollment of diverse patient populations4 7c7 ,,covid-#ai emergency period defined ,in this section1 the term ,,covid-#ai emergency period has the meaning given the term emergency period in section #aace7;g77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#e7;g77#a77;,b774 #ejf4 ,decentralized clinical studies 7a7 ,guidance ,the ,secretary of ,health and ,human ,services shall-- 7#a7 not later than #ab months after the date of enactment of this ,act1 issue draft guidance that addresses considerations for decentralized clinical studies1 including considerations regarding the engagement1 enrollment1 and retention of a meaningfully diverse clinical population1 with respect to race1 ethnicity1 age1 sex1 and geographic location1 when appropriate2 and 7#b7 not later than #a year after closing the comment period on such draft guidance1 finalize such guidance4 7b7 ,content of guidance ,the guidance under subsection 7a7 shall address the following3 7#a7 ,recommendations for how digital health technology or other remote assessment options1 such as telehealth1 could support decentralized clinical studies1 including guidance on considerations for selecting technological platforms and mediums1 data collection and use1 data integrity and security1 and communication to study participants through digital technology4 7#b7 ,recommendations for subject recruitment and retention1 including considerations for sponsors to minimize or reduce burdens for clinical study participants through the use of digital health technology1 telehealth1 local health care providers and laboratories1 or other means4 7#c7 ,recommendations with respect to the evaluation of data collected within a decentralized clinical study setting4 7c7 ,definition ,in this section1 the term decentralized clinical study means a clinical study in which some or all of the study-related activities occur at a location separate from the investigator's location4 ,,vi ,generic ,drug ,competition #fja4 ,increasing transparency in generic drug applications 7a7 ,in general ,section #eje7;j77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#c77 is amended by adding at the end the following3 7,h7 7i7 ,upon request 7in controlled correspondence or otherwise7 by a person that has submitted or intends to submit an abbreviated application for a new drug under this subsection for which the ,secretary has specified in regulation1 including in section #cad4id7;a77#i7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 or recommended in applicable guidance1 certain qualitative or quantitative criteria with respect to an inactive ingredient1 or on the ,secretary's own initiative during the review of such abbreviated application1 the ,secretary shall inform the person whether such new drug is qualitatively and quantitatively the same as the listed drug4 7ii7 ,notwithstanding section #cja7;j71 if the ,secretary determines that such new drug is not qualitatively or quantitatively the same as the listed drug1 the ,secretary shall identify and disclose to the person-- 7,i7 the ingredient or ingredients that cause the new drug not to be qualitatively or quantitatively the same as the listed drug2 and 7,,ii7 for any ingredient for which there is an identified quantitative deviation1 the amount of such deviation4 7iii7 ,if the ,secretary determines that such new drug is qualitatively and quantitatively the same as the listed drug1 the ,secretary shall not change or rescind such determination after the submission of an abbreviated application for such new drug under this subsection unless-- 7,i7 the formulation of the listed drug has been changed and the ,secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness2 or 7,,ii7 the ,secretary makes a written determination that the prior determination must be changed because an error has been identified4 7iv7 ,if the ,secretary makes a written determination described in clause 7iii77,,ii71 the ,secretary shall provide notice and a copy of the written determination to the person making the request under clause 7i74 7v7 ,the disclosures required by this subparagraph are disclosures authorized by law including for purposes of section #aije of title #ah1 ,united ,states ,code4 4 7b7 ,guidance 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue draft guidance1 or update guidance1 describing how the ,secretary will determine whether a new drug is qualitatively and quantitatively the same as the listed drug 7as such terms are used in section #eje7;j77#c77;,h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a771 including with respect to assessing p,h adjusters4 7#b7 ,process ,in issuing guidance as required by paragraph 7#a71 the ,secretary of ,health and ,human ,services shall-- 7,a7 publish draft guidance2 7,b7 provide a period of at least #fj days for comment on the draft guidance2 and 7,c7 after considering any comments received1 and not later than one year after the close of the comment period on the draft guidance1 publish final guidance4 7c7 ,applicability ,section #eje7;j77#c77;,h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 applies beginning on the date of enactment of this ,act1 irrespective of the date on which the guidance required by subsection 7b7 is finalized4 #fjb4 ,enhancing access to affordable medicines ,section #eje7;j77#aj77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#aj77;,a77 is amended by striking clauses 7i7 through 7iii7 and inserting the following3 7i7 a revision to the labeling of the listed drug has been approved by the ,secretary within #ij days of when the application is otherwise eligible for approval under this subsection2 7ii7 the sponsor of the application agrees to submit revised labeling for the drug that is the subject of the application not later than #fj days after approval under this subsection of the application2 7iii7 the labeling revision described under clause 7i7 does not include a change to the ,warnings section of the labeling2 and 4 ,,vii ,research1 ,development1 and ,supply ,chain ,improvements ,a ,in ,general #gja4 ,animal testing alternatives ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended-- 7#a7 in subsection 7b77#e77;,b77i77,,ii71 by striking animal and inserting nonclinical tests2 7#b7 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#c7 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 nonhuman in vivo test1 that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug4 ,such test may include the following3 7#a7 ,cell-based assays4 7#b7 ,organ chips and microphysiological systems4 7#c7 ,computer modeling4 7#d7 ,other nonhuman or human biology-based test methods4 7#e7 ,animal tests4 4 #gjb4 ,emerging technology program ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #bja et seq47 is amended by inserting after section #eff of such ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7 the following3 #eff;,a4 ,emerging technology program 7a7 ,program establishment 7#a7 ,in general ,the ,secretary shall establish a program to support the adoption of1 and improve the development of1 innovative approaches to drug product design and manufacturing4 7#b7 ,actions ,in carrying out the program under paragraph 7#a71 the ,secretary may-- 7,a7 facilitate and increase communication between public and private entities1 consortia1 and individuals with respect to innovative drug product design and manufacturing2 7,b7 solicit information regarding1 and conduct or support research on1 innovative approaches to drug product design and manufacturing2 7,c7 convene meetings with representatives of industry1 academia1 other ,federal agencies1 international agencies1 and other interested persons1 as appropriate2 7,d7 convene working groups to support drug product design and manufacturing research and development2 7,e7 support education and training for regulatory staff and scientists related to innovative approaches to drug product design and manufacturing2 7,f7 advance regulatory science related to the development and review of innovative approaches to drug product design and manufacturing2 7,g7 convene or participate in working groups to support the harmonization of international regulatory requirements related to innovative approaches to drug product design and manufacturing2 and 7,h7 award grants or contracts to carry out or support the program under paragraph 7#a74 7#c7 ,grants and contracts ,to seek a grant or contract under this section1 an entity shall submit an application-- 7,a7 in such form and manner as the ,secretary may require2 and 7,b7 containing such information as the ,secretary may require1 including a description of-- 7i7 how the entity will conduct the activities to be supported through the grant or contract2 and 7ii7 how such activities will further research and development related to1 or adoption of1 innovative approaches to drug product design and manufacturing4 7b7 ,guidance ,the ,secretary shall-- 7#a7 issue or update guidance to help facilitate the adoption of1 and advance the development of1 innovative approaches to drug product design and manufacturing2 and 7#b7 include in such guidance descriptions of-- 7,a7 any regulatory requirements related to the development or review of technologies related to innovative approaches to drug product design and manufacturing1 including updates and improvements to such technologies after product approval2 and 7,b7 data that can be used to demonstrate the identity1 safety1 purity1 and potency of drugs manufactured using such technologies4 7c7 ,report to ,congress ,not later than #d years after the date of enactment of this section1 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 containing-- 7#a7 an annual accounting of the allocation of funds made available to carry out this section2 7#b7 a description of how ,food and ,drug ,administration staff were utilized to carry out this section and1 as applicable1 any challenges or limitations related to staffing2 7#c7 the number of public meetings held or participated in by the ,food and ,drug ,administration pursuant to this section1 including meetings convened as part of a working group described in subparagraph 7,d7 or 7,g7 of subsection 7a77#b71 and the topics of each such meeting2 and 7#d7 the number of drug products approved or licensed1 after the date of enactment of this section1 using an innovative approach to drug product design and manufacturing4 7d7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #bj1jjj1jjj for each fiscal year #bjbc through #bjbg4 4 #gjc4 ,improving the treatment of rare diseases and conditions 7a7 ,report on orphan drug program 7#a7 ,in general ,not later than ,september #cj1 #bjbf1 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 summarizing the activities of the ,food and ,drug ,administration related to designating drugs under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7 for a rare disease or condition and approving such drugs under section #eje of such ,act 7#ba ,u4,s4,c4 #cee7 or licensing such drugs under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 including-- 7,a7 the number of applications for such drugs under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 received by the ,food and ,drug ,administration1 the number of such applications accepted and rejected for filing1 and the number of such applications pending1 approved1 and disapproved by the ,food and ,drug ,administration2 7,b7 a description of trends in drug approvals for rare diseases and conditions across review divisions at the ,food and ,drug ,administration2 7,c7 the extent to which the ,food and ,drug ,administration is consulting with external experts pursuant to section #efi7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h7;a77#b77 on topics pertaining to drugs for a rare disease or condition1 including how and when any such consultation is occurring2 and 7,d7 the ,food and ,drug ,administration's efforts to promote best practices in the development of novel treatments for rare diseases1 including-- 7i7 reviewer training on rare disease-related policies1 methods1 and tools2 and 7ii7 new regulatory science and coordinated support for patient and stakeholder engagement4 7#b7 ,public availability ,the ,secretary shall make the report under paragraph 7#a7 available to the public1 including by posting the report on the website of the ,food and ,drug ,administration4 7#c7 ,information disclosure ,nothing in this subsection shall be construed to authorize the disclosure of information that is prohibited from disclosure under section #aije of title #ah1 ,united ,states ,code1 or subject to withholding under paragraph 7#d7 of section #eeb7;b7 of title #e1 ,united ,states ,code 7commonly referred to as the ,freedom of ,information ,act74 7b7 ,study on ,european ,union safety and efficacy reviews of drugs for rare diseases and conditions 7#a7 ,in general ,the ,secretary of ,health and ,human ,services shall enter into a contract with an appropriate entity to conduct a study on processes for evaluating the safety and efficacy of drugs for rare diseases or conditions in the ,united ,states and the ,european ,union1 including-- 7,a7 flexibilities1 authorities1 or mechanisms available to regulators in the ,united ,states and the ,european ,union specific to rare diseases or conditions2 7,b7 the consideration and use of supplemental data submitted during review processes in the ,united ,states and the ,european ,union1 including data associated with open label extension studies and expanded access programs specific to rare diseases or conditions2 7,c7 an assessment of collaborative efforts between ,united ,states and ,european ,union regulators related to-- 7i7 product development programs under review2 7ii7 policies under development recently issued2 and 7iii7 scientific information related to product development or regulation2 and 7,d7 recommendations for how ,congress can support collaborative efforts described in subparagraph 7,c74 7#b7 ,consultation ,the contract under paragraph 7#a7 shall provide for consultation with relevant stakeholders1 including-- 7,a7 representatives from the ,food and ,drug ,administration and the ,european ,medicines ,agency2 7,b7 rare disease or condition patients2 and 7,c7 patient groups that-- 7i7 represent rare disease or condition patients2 and 7ii7 have international patient outreach4 7#c7 ,report ,the contract under paragraph 7#a7 shall provide for1 not later than #b years after the date of entering into such contract-- 7,a7 the completion of the study under paragraph 7#a72 and 7,b7 the submission of a report on the results of such study to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7#d7 ,public availability ,the contract under paragraph 7#a7 shall provide for the appropriate entity referred to in paragraph 7#a7 to make the report under paragraph 7#c7 available to the public1 including by posting the report on the website of the appropriate entity4 7c7 ,public meeting 7#a7 ,in general ,not later than ,december #ca1 #bjbc1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall convene one or more public meetings to solicit input from stakeholders regarding the approaches described in paragraph 7#b74 7#b7 ,approaches ,the public meeting or meetings under paragraph 7#a7 shall address approaches to increasing and improving engagement with rare disease or condition patients1 groups representing such patients1 rare disease or condition experts1 and experts on small population studies1 in order to improve the understanding with respect to rare diseases or conditions of-- 7,a7 patient burden2 7,b7 treatment options2 and 7,c7 side effects of treatments1 including-- 7i7 comparing the side effects of treatments2 and 7ii7 understanding the risks of side effects relative to the health status of the patient and the progression of the disease or condition4 7#c7 ,public docket ,the ,secretary of ,health and ,human ,services shall establish a public docket to receive written comments related to the approaches addressed during each public meeting under paragraph 7#a74 ,such public docket shall remain open for #fj days following the date of each such public meeting4 7#d7 ,reports ,not later than #ahj days after each public meeting under paragraph 7#a71 the ,commissioner of ,food and ,drugs shall develop and publish on the website of the ,food and ,drug ,administration a report on-- 7,a7 the approaches discussed at the public meeting2 and 7,b7 any related recommendations4 7d7 ,consultation on the science of small population studies ,section #efi7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h7;a77#b77 is amended by adding at the end the following3 7,c7 ,small population studies ,the external experts on the list maintained pursuant to subparagraph 7,a7 may include experts on the science of small population studies4 4 7e7 ,study on sufficiency and use of ,,fda mechanisms for incorporating the patient and clinician perspective in ,,fda processes related to applications concerning drugs for rare diseases or conditions 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study on the use of ,food and ,drug ,administration mechanisms and tools to ensure that patient and physician perspectives are considered and incorporated throughout the processes of the ,food and ,drug ,administration-- 7,a7 for approving or licensing under section #eje of the ,federal ,food1 ,drug1 or ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 a drug designated as a drug for a rare disease or condition under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb72 and 7,b7 in making any determination related to such a drug's approval1 including assessment of the drug's-- 7i7 safety or effectiveness2 or 7ii7 postapproval safety monitoring4 7#b7 ,topics ,the study under paragraph 7#a7 shall-- 7,a7 identify and compare the processes that the ,food and ,drug ,administration has formally put in place and utilized to gather external expertise 7including patients1 patient groups1 and physicians7 related to applications for rare diseases or conditions2 7,b7 examine tools or mechanisms to improve efforts and initiatives of the ,food and ,drug ,administration to collect and consider such external expertise with respect to applications for rare diseases or conditions throughout the application review and approval or licensure processes1 including within internal benefit-risk assessments1 advisory committee processes1 and postapproval safety monitoring2 and 7,c7 examine processes or alternatives to address or resolve conflicts of interest that impede the ,food and ,drug ,administration in gaining external expert input on rare diseases or conditions with a limited set of clinical and research experts4 7#c7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall-- 7,a7 complete the study under paragraph 7#a72 7,b7 submit a report on the results of such study to the ,congress2 and 7,c7 include in such report recommendations1 if appropriate1 for changes to the processes and authorities of the ,food and ,drug ,administration to improve the collection and consideration of external expert opinions of patients1 patient groups1 and physicians with expertise in rare diseases or conditions4 7f7 ,definition ,in this section1 the term rare disease or condition has the meaning given such term in section #ebf7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7a77#b774 #gjd4 ,antifungal research and development 7a7 ,draft guidance ,not later than #c years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue draft guidance for industry for the purposes of assisting entities seeking approval under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or licensure under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 of antifungal therapies designed to treat coccidioidomycosis 7commonly known as ,valley ,fever74 7b7 ,final guidance ,not later than #ah months after the close of the public comment period on the draft guidance issued pursuant to subsection 7a71 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall finalize the draft guidance4 7c7 ,workshop ,to assist entities developing preventive vaccines for fungal infections and coccidioidomycosis1 the ,secretary of ,health and ,human ,services shall hold a public workshop4 #gje4 ,advancing qualified infectious disease product innovation 7a7 ,in general ,section #eje;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#b71 by striking or at the end2 7,b7 in paragraph 7#c71 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7#d7 an application pursuant to section #cea7;a7 of the ,public ,health ,service ,act4 2 7#b7 in subsection 7d77#a71 by inserting of this ,act or section #cea7;a7 of the ,public ,health ,service ,act after section #eje7;b72 and 7#c7 by amending subsection 7g7 to read as follows3 7g7 ,qualified infectious disease product ,the term qualified infectious disease product means a drug1 including an antibacterial or antifungal drug or a biological product1 for human use that-- 7#a7 acts directly on bacteria or fungi or on substances produced by such bacteria or fungi2 and 7#b7 is intended to treat a serious or life-threatening infection1 including such an infection caused by-- 7,a7 an antibacterial or antifungal resistant pathogen1 including novel or emerging infectious pathogens2 or 7,b7 qualifying pathogens listed by the ,secretary under subsection 7f74 4 7b7 ,priority review ,section #ebd;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn-#a7;a77 is amended by inserting of this ,act or section #cea7;a7 of the ,public ,health ,service ,act that requires clinical data 7other than bioavailability studies7 to demonstrate safety or effectiveness before the period at the end4 #gjf4 ,national ,centers of ,excellence in ,advanced and ,continuous ,pharmaceutical ,manufacturing 7a7 ,in general ,section #cjaf of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cii;h7 is amended to read as follows3 #cjaf4 ,national ,centers of ,excellence in ,advanced and ,continuous ,pharmaceutical ,manufacturing 7a7 ,in general ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs-- 7#a7 shall solicit and1 beginning not later than one year after the date of enactment of the ,prescription ,drug ,user ,fee ,amendments of #bjbb1 receive requests from institutions of higher education1 or consortia of institutions of higher education1 to be designated as a ,national ,center of ,excellence in ,advanced and ,continuous ,pharmaceutical ,manufacturing 7in this section referred to as a ,national ,center of ,excellence7 to support the advancement1 development1 and implementation of advanced and continuous pharmaceutical manufacturing2 and 7#b7 shall so designate not more than #e institutions of higher education or consortia of such institutions that-- 7,a7 request such designation2 and 7,b7 meet the criteria specified in subsection 7c74 7b7 ,request for designation ,a request for designation under subsection 7a7 shall be made to the ,secretary at such time1 in such manner1 and containing such information as the ,secretary may require4 ,any such request shall include a description of how the institution of higher education1 or consortium of institutions of higher education1 meets or plans to meet each of the criteria specified in subsection 7c74 7c7 ,criteria for designation described ,the criteria specified in this subsection with respect to an institution of higher education1 or consortium of institutions of higher education1 are that the institution or consortium has1 as of the date of the submission of a request under subsection 7a7 by such institution or consortium-- 7#a7 physical and technical capacity for research1 development1 implementation1 and demonstration of advanced and continuous pharmaceutical manufacturing2 7#b7 manufacturing knowledge-sharing networks with other institutions of higher education1 large and small pharmaceutical manufacturers1 generic and nonprescription manufacturers1 contract manufacturers1 and other relevant entities2 7#c7 proven capacity to design1 develop1 implement1 and demonstrate new1 highly effective technologies for use in advanced and continuous pharmaceutical manufacturing2 7#d7 a track record for creating1 preserving1 and transferring knowledge with respect to advanced and continuous pharmaceutical manufacturing2 7#e7 the proven ability to facilitate training of an adequate future workforce for research on1 and implementation of1 advanced and continuous pharmaceutical manufacturing2 and 7#f7 experience in participating in and leading advanced and continuous pharmaceutical manufacturing technology partnerships with other institutions of higher education1 large and small pharmaceutical manufacturers1 generic and nonprescription manufacturers1 contract manufacturers1 and other relevant entities-- 7,a7 to support companies seeking to implement advanced and continuous pharmaceutical manufacturing in the ,united ,states2 7,b7 to support ,federal agencies with technical assistance and employee training1 which may include regulatory and quality metric guidance as applicable1 and hands-on training1 for advanced and continuous pharmaceutical manufacturing2 7,c7 with respect to advanced and continuous pharmaceutical manufacturing1 to organize and conduct research and development activities needed to create new and more effective technology1 develop and share knowledge1 create intellectual property1 and maintain technological leadership2 7,d7 to develop best practices for designing and implementing advanced and continuous pharmaceutical manufacturing processes2 and 7,e7 to assess and respond to the national workforce needs for advanced and continuous pharmaceutical manufacturing1 including the development and implementing of training programs4 7d7 ,termination of designation ,the ,secretary may terminate the designation of any ,national ,center of ,excellence designated under this section if the ,secretary determines such ,national ,center of ,excellence no longer meets the criteria specified in subsection 7c74 ,not later than #ij days before the effective date of such a termination1 the ,secretary shall provide written notice to the ,national ,center of ,excellence1 including the rationale for such termination4 7e7 ,conditions for designation ,as a condition of designation as a ,national ,center of ,excellence under this section1 the ,secretary shall require that an institution of higher education or consortium of institutions of higher education enter into an agreement with the ,secretary under which the institution or consortium agrees-- 7#a7 to collaborate directly with the ,food and ,drug ,administration to publish the reports required by subsection 7g72 7#b7 to share data with the ,food and ,drug ,administration regarding best practices and research generated through the funding under subsection 7f72 7#c7 to develop1 along with industry partners 7which may include large and small biopharmaceutical manufacturers1 generic and nonprescription manufacturers1 and contract research organizations or contract manufacturers that carry out drug development and manufacturing activities7 and another institution or consortium designated under this section1 if any1 a roadmap for developing an advanced and continuous pharmaceutical manufacturing workforce2 7#d7 to develop1 along with industry partners and other institutions or consortia of such institutions designated under this section1 a roadmap for strengthening existing1 and developing new1 relationships with other institutions of higher education or consortia thereof2 and 7#e7 to provide an annual report to the ,food and ,drug ,administration regarding the institution's or consortium's activities under this section1 including a description of how the institution or consortium continues to meet and make progress on the criteria specified in subsection 7c74 7f7 ,funding 7#a7 ,in general ,the ,secretary shall award funding1 through grants1 contracts1 or cooperative agreements1 to the ,national ,centers of ,excellence designated under this section for the purpose of studying and recommending improvements to advanced and continuous pharmaceutical manufacturing1 including such improvements as may enable the ,centers-- 7,a7 to continue to meet the conditions specified in subsection 7e72 7,b7 to expand capacity for research on1 and development of1 advanced and continuous pharmaceutical manufacturing2 and 7,c7 to implement research infrastructure in advanced and continuous pharmaceutical manufacturing suitable for accelerating the development of drug products needed to respond to emerging medical threats1 such as emerging drug shortages1 quality issues disrupting the supply chain1 epidemics and pandemics1 and other such situations requiring the rapid development of new products or new manufacturing processes4 7#b7 ,consistency with ,,fda mission ,as a condition on receipt of funding under this subsection1 a ,national ,center of ,excellence shall agree to consider any input from the ,secretary regarding the use of funding that would-- 7,a7 help to further the advancement of advanced and continuous pharmaceutical manufacturing through the ,national ,center of ,excellence2 and 7,b7 be relevant to the mission of the ,food and ,drug ,administration4 7#c7 ,rule of construction ,nothing in this section shall be construed as precluding a ,national ,center for ,excellence designated under this section from receiving funds under any other provision of this ,act or any other ,federal law4 7g7 ,annual review and reports 7#a7 ,annual report ,beginning not later than one year after the date on which the first designation is made under subsection 7a71 and annually thereafter1 the ,secretary shall-- 7,a7 submit to ,congress a report describing the activities1 partnerships and collaborations1 ,federal policy recommendations1 previous and continuing funding1 and findings of1 and any other applicable information from1 the ,national ,centers of ,excellence designated under this section2 7,b7 include in such report an accounting of the ,federal administrative expenses described in subsection 7i77#b7 over the reporting period2 and 7,c7 make such report available to the public in an easily accessible electronic format on the website of the ,food and ,drug ,administration4 7#b7 ,review of ,national ,centers of ,excellence and potential designees ,the ,secretary shall periodically review the ,national ,centers of ,excellence designated under this section to ensure that such ,national ,centers of ,excellence continue to meet the criteria for designation under this section4 7#c7 ,report on long-term vision of ,,fda role ,not later than #b years after the date on which the first designation is made under subsection 7a71 the ,secretary1 in consultation with the ,national ,centers of ,excellence designated under this section1 shall submit a report to the ,congress on the long-term vision of the ,department of ,health and ,human ,services on the role of the ,food and ,drug ,administration in supporting advanced and continuous pharmaceutical manufacturing1 including-- 7,a7 a national framework of principles related to the implementation and regulation of advanced and continuous pharmaceutical manufacturing2 7,b7 a plan for the development of ,federal regulations and guidance for how advanced and continuous pharmaceutical manufacturing can be incorporated into the development of pharmaceuticals and regulatory responsibilities of the ,food and ,drug ,administration2 7,c7 a plan for development of ,federal regulations or guidance for how advanced and continuous pharmaceutical manufacturing will be reviewed by the ,food and ,drug ,administration2 and 7,d7 appropriate feedback solicited from the public1 which may include other institutions of higher education1 large and small biopharmaceutical manufacturers1 generic and nonprescription manufacturers1 and contract manufacturers4 7h7 ,definitions ,in this section3 7#a7 ,advanced ,the term advanced1 with respect to pharmaceutical manufacturing1 refers to an approach that incorporates novel technology1 or uses an established technique or technology in a new or innovative way1 that enhances drug quality or improves the performance of a manufacturing process4 7#b7 ,continuous ,the term continuous1 with respect to pharmaceutical manufacturing1 refers to a process-- 7,a7 where the input materials are continuously fed into and transformed within the process1 and the processed output materials are continuously removed from the system2 and 7,b7 that consists of an integrated process that consists of a series of two or more simultaneous unit operations4 7#c7 ,institution of higher education ,the term institution of higher education has the meaning given such term in section #aja7;a7 of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja7;a774 7#d7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs4 7i7 ,authorization of appropriations 7#a7 ,in general ,there is authorized to be appropriated to carry out this section #ajj1jjj1jjj for the period of fiscal years #bjbc through #bjbg4 7#b7 ,federal administrative expenses ,of the amounts made available to carry out this section for a fiscal year1 the ,secretary shall not use more than eight percent for ,federal administrative expenses1 including training1 technical assistance1 reporting1 and evaluation4 4 7b7 ,transition rule ,section #cjaf of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cii;h71 as in effect on the day before the date of the enactment of this section1 shall apply with respect to grants awarded under such section before such date of enactment4 7c7 ,clerical amendment ,the item relating to section #cjaf in the table of contents in section #a7;b7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended to read as follows3 ,sec4 #cjaf4 ,national ,centers of ,excellence in ,advanced and ,continuous ,pharmaceutical ,manufacturing4 4 #gjg4 ,advanced manufacturing technologies designation pilot program ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejf;,j 7#ba ,u4,s4,c4 #cef;j7 the following3 #ejf,k4 ,advanced manufacturing technologies designation pilot program 7a7 ,in general ,not later than #a year after the date of enactment of this section1 the ,secretary shall initiate a pilot program under which persons may request designation of an advanced manufacturing technology as described in subsection 7b74 7b7 ,designation process ,the ,secretary shall establish a process for the designation under this section of methods of manufacturing drugs1 including biological products1 and active pharmaceutical ingredients of such drugs1 as advanced manufacturing technologies4 ,a method of manufacturing1 or a combination of manufacturing methods1 is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology1 or uses an established technique or technology in a novel way1 that will substantially improve the manufacturing process for a drug and maintain equivalent or provide superior drug quality1 including by-- 7#a7 reducing development time for a drug using the designated manufacturing method2 or 7#b7 increasing or maintaining the supply of-- 7,a7 a drug that is described in section #ejf;,c7a7 and is intended to treat a serious or life-threatening condition2 or 7,b7 a drug that is on the drug shortage list under section #ejf;,e4 7c7 ,evaluation and designation of an advanced manufacturing technology 7#a7 ,submission ,a person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the ,secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection 7b7 in a particular context of use4 ,the ,secretary may facilitate the development and review of such data or information by-- 7,a7 providing timely advice to1 and interactive communication with1 such person regarding the development of the method of manufacturing2 and 7,b7 involving senior managers and experienced staff of the ,food and ,drug ,administration1 as appropriate1 in a collaborative1 cross-disciplinary review of the method of manufacturing1 as applicable4 7#b7 ,evaluation and designation ,not later than #ahj calendar days after the receipt of a request under paragraph 7#a71 the ,secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology1 in a particular context of use1 based on the data and information submitted under paragraph 7#a7 and the criteria described in subsection 7b74 7d7 ,review of advanced manufacturing technologies ,if the ,secretary designates a method of manufacturing as an advanced manufacturing technology1 the ,secretary shall-- 7#a7 expedite the development and review of an application submitted under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 including supplemental applications1 for drugs that are manufactured using a designated advanced manufacturing technology and could help mitigate or prevent a shortage or substantially improve manufacturing processes for a drug and maintain equivalent or provide superior drug quality1 as described in subsection 7b72 and 7#b7 allow the holder of an advanced technology designation1 or a person authorized by the advanced manufacturing technology designation holder1 to reference or rely upon1 in an application submitted under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 including a supplemental application1 data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted4 7e7 ,implementation and evaluation of advanced manufacturing technologies pilot 7#a7 ,public meeting ,the ,secretary shall publish in the ,federal ,register a notice of a public meeting1 to be held not later than #ahj days after the date of enactment of this section1 to discuss and obtain input and recommendations from relevant stakeholders regarding-- 7,a7 the goals and scope of the pilot program1 and a suitable framework1 procedures1 and requirements for such program2 and 7,b7 ways in which the ,food and ,drug ,administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs4 7#b7 ,pilot program guidance 7,a7 ,in general ,the ,secretary shall-- 7i7 not later than #ahj days after the public meeting under paragraph 7#a71 issue draft guidance regarding the goals and implementation of the pilot program under this section2 and 7ii7 not later than #b years after the date of enactment of this section1 issue final guidance regarding the implementation of such program4 7,b7 ,content ,the guidance described in subparagraph 7,a7 shall address-- 7i7 the process by which a person may request a designation under subsection 7b72 7ii7 the data and information that a person requesting such a designation is required to submit under subsection 7c71 and how the ,secretary intends to evaluate such submissions2 7iii7 the process to expedite the development and review of applications under subsection 7d72 and 7iv7 the criteria described in subsection 7b7 for eligibility for such a designation4 7#c7 ,report ,not later than #c years after the date of enactment of this section and annually thereafter1 the ,secretary shall publish on the website of the ,food and ,drug ,administration 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 a report containing a description and evaluation of the pilot program being conducted under this section1 including the types of innovative manufacturing approaches supported under the program4 ,such report shall include the following3 7,a7 ,the number of persons that have requested designations and that have been granted designations4 7,b7 ,the number of methods of manufacturing that have been the subject of designation requests and that have been granted designations4 7,c7 ,the average number of calendar days for completion of evaluations under subsection 7c77#b74 7,d7 ,an analysis of the factors in data submissions that are relevant to determinations to designate and not to designate after evaluation under subsection 7c77#b74 7,e7 ,the number of applications received under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 including supplemental applications1 that have included an advanced manufacturing technology designated under this section1 and the number of such applications approved4 7f7 ,sunset ,the ,secretary-- 7#a7 may not consider any requests for designation submitted under subsection 7c7 after ,october #a1 #bjbi2 and 7#b7 may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection 7d7 prior to such date1 if the ,secretary determines such activities are in the interest of the public health4 4 #gjh4 ,public workshop on cell therapies ,not later than #c years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall convene a public workshop with relevant stakeholders to discuss best practices on generating scientific data necessary to further facilitate the development of certain human cell-1 tissue-1 and cellular-based medical products 7and the latest scientific information about such products7 that are regulated as drugs under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 and biological products under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 namely1 stem-cell and other cellular therapies4 #gji4 ,reauthorization of best pharmaceuticals for children ,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 #gaj4 ,reauthorization for humanitarian device exemption and demonstration grants for improving pediatric availability 7a7 ,humanitarian device exemption ,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 7b7 ,pediatric ,medical ,device ,safety and ,improvement ,act ,section #cje7;e7 of the ,pediatric ,medical ,device ,safety and ,improvement ,act of #bjjg 7,public ,law #aaj-he7 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #gaa4 ,reauthorization of provision related to exclusivity of certain drugs containing single enantiomers ,section #eje7u77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7u77#d77 is amended by striking #bjbb and inserting #bjbg4 #gab4 ,reauthorization of the critical path public-private partnership program ,section #eff7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is amended by striking #f1jjj1jjj for each of fiscal years #bjah through #bjbb and inserting #aj1jjj1jjj for each of fiscal years #bjbc through #bjbg4 #gac4 ,reauthorization of orphan drug grants ,section #e of the ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking and 7#c7 and inserting 7#c72 and 7,b7 by inserting before the period at the end the following3 1 and 7#d7 developing regulatory science pertaining to the chemistry1 manufacturing1 and controls of individualized medical products to treat individuals with rare diseases or conditions2 and 7#b7 in subsection 7c71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #gad4 ,research into pediatric uses of drugs2 additional authorities of ,food and ,drug ,administration regarding molecularly targeted cancer drugs 7a7 ,in general 7#a7 ,additional active ingredient for application drug2 limitation regarding novel-combination application drug ,section #eje;,b7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c77 is amended-- 7,a7 by redesignating subparagraphs 7,b7 and 7,c7 as subparagraphs 7,c7 and 7,d71 respectively2 and 7,b7 by striking subparagraph 7,a7 and inserting the following3 7,a7 ,in general ,for purposes of paragraph 7#a77;,b71 the investigation described in this paragraph is 7as determined by the ,secretary7 a molecularly targeted pediatric cancer investigation of-- 7i7 the drug or biological product for which the application referred to in such paragraph is submitted2 or 7ii7 such drug or biological product in combination with-- 7,i7 an active ingredient of a drug or biological product-- 7aa7 for which an approved application under section #eje7;j7 under this ,act or under section #cea7k7 of the ,public ,health ,service ,act is in effect2 and 7bb7 that is determined by the ,secretary to be the standard of care for treating a pediatric cancer2 or 7,,ii7 an active ingredient of a drug or biological product-- 7aa7 for which an approved application under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph 7#a77;,b72 and 7bb7 that is directed at a molecular target that the ,secretary determines to be substantially relevant to the growth or progression of a pediatric cancer4 7,b7 ,additional requirements 7i7 ,design of investigation ,a molecularly targeted pediatric cancer investigation referred to in subparagraph 7,a7 shall be designed to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required1 regarding dosing1 safety1 and preliminary efficacy to inform potential pediatric labeling4 7ii7 ,limitation ,an investigation described in subparagraph 7,a77ii7 may be required only if the drug or biological product for which the application referred to in paragraph 7#a77;,b7 contains either-- 7,i7 a single new active ingredient2 or 7,,ii7 more than one active ingredient1 if an application for the combination of active ingredients has not previously been approved but each active ingredient has been previously approved to treat an adult cancer4 7iii7 ,results of already-completed preclinical studies of application drug ,the ,secretary may require that reports on an investigation required pursuant to paragraph 7#a77;,b7 include the results of all preclinical studies on which the decision to conduct such investigation was based4 7iv7 ,rule of construction regarding inactive ingredients ,with respect to a combination of active ingredients referred to in subparagraph 7,a77ii71 such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination4 4 7#b7 ,determination of applicable requirements ,section #eje;,b7e77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#a77 is amended by adding at the end the following3 ,the ,secretary shall determine whether subparagraph 7,a7 or 7,b7 of subsection 7a77#a7 shall apply with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph 7#b77;,a744 7#c7 ,clarifying applicability ,section #eje;,b7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77 is amended by adding at the end the following3 7,c7 ,rule of construction ,no application that is subject to the requirements of subparagraph 7,b7 shall be subject to the requirements of subparagraph 7,a71 and no application 7or supplement to an application7 that is subject to the requirements of subparagraph 7,a7 shall be subject to the requirements of subparagraph 7,b74 4 7#d7 ,conforming amendments ,section #eje;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77 is amended-- 7,a7 in paragraph 7#c77;,c71 as redesignated by paragraph 7#a77;,a7 of this subsection1 by striking investigations described in this paragraph and inserting investigations referred to in subparagraph 7,a72 and 7,b7 in paragraph 7#c77;,d71 as redesignated by paragraph 7#a77;,a7 of this subsection1 by striking the assessments under paragraph 7#b77;,b7 and inserting the assessments required under paragraph 7#a77;,a74 7b7 ,guidance ,the ,secretary shall-- 7#a7 not later than #ab months after the date of enactment of this ,act1 issue draft guidance on the implementation of the requirements in subsection 7a72 and 7#b7 not later than #ab months after closing the comment period on such draft guidance1 finalize such guidance4 7c7 ,applicability ,the amendments made by this section apply with respect to any application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 and any application under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 that is submitted on or after the date that is #c years after the date of enactment of this ,act4 7d7 ,reports to ,congress 7#a7 ,secretary of ,health and ,human ,services ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 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 on the ,secretary's efforts1 in coordination with industry1 to ensure implementation of the amendments made by subsection 7a74 7#b7 ,,gao study and report 7,a7 ,study ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of requiring assessments and investigations described in section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4#cee;c71 as amended by subsection 7a71 in the development of drugs and biological products for pediatric cancer indications4 7,b7 ,findings ,not later than #g years after the date of enactment of this ,act1 the ,comptroller ,general 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 containing the findings of the study conducted under subparagraph 7,a74 ,b ,inspections #gba4 ,factory inspection 7a7 ,in general ,section #gjd7;a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#a77 is amended by striking restricted devices each place it appears and inserting devices4 7b7 ,records or other information 7#a7 ,establishments ,section #gjd7;a77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77;,a77 is amended-- 7,a7 by striking an establishment that is engaged in the manufacture1 preparation1 propagation1 compounding1 or processing of a drug and inserting an establishment that is engaged in the manufacture1 preparation1 propagation1 compounding1 or processing of a drug or device1 or that is subject to inspection under paragraph 7#e77;,c712 and 7,b7 by inserting after a sufficient description of the records requested the following3 and a rationale for requesting such records or other information in advance of1 or in lieu of1 an inspection4 7#b7 ,guidance 7,a7 ,in general ,the ,secretary of ,health and ,human ,services shall issue or update guidance describing-- 7i7 circumstances in which the ,secretary intends to issue requests for records or other information in advance of1 or in lieu of1 an inspection under section #gjd7;a77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by paragraph 7#a72 7ii7 processes for responding to such requests electronically or in physical form2 and 7iii7 factors the ,secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe1 within reasonable limits1 and in a reasonable manner1 accounting for resource and other limitations that may exist1 including for small businesses4 7,b7 ,timing ,the ,secretary of ,health and ,human ,services shall-- 7i7 not later than #a year after the date of enactment of this ,act1 issue draft guidance under subparagraph 7,a72 and 7ii7 not later than #a year after the close of the comment period for such draft guidance1 issue final guidance under subparagraph 7,a74 7c7 ,bioresearch monitoring inspections 7#a7 ,in general ,section #gjd7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77 is amended by adding at the end the following3 7#e7 ,bioresearch monitoring inspections 7,a7 ,in general ,the ,secretary may1 to ensure the accuracy and reliability of studies and records or other information described in subparagraph 7,b7 and to assess compliance with applicable requirements under this ,act or the ,public ,health ,service ,act1 enter sites and facilities specified in subparagraph 7,c7 in order to inspect such records or other information4 7,b7 ,information subject to inspection ,an inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph 7,e71 including records and information related to the conduct1 results1 and analyses of1 and the protection of human and animal trial participants participating in1 such studies4 7,c7 ,sites and facilities subject to inspection 7i7 ,sites and facilities described ,the sites and facilities subject to inspection by the ,secretary under this paragraph are those owned or operated by a person described in clause 7ii7 and which are 7or were7 utilized by such person in connection with-- 7,i7 developing an application or other submission to the ,secretary under this ,act or the ,public ,health ,service ,act related to marketing authorization for a product described in paragraph 7#a72 7,,ii7 preparing1 conducting1 or analyzing the results of a study described in subparagraph 7,e72 or 7,,iii7 holding any records or other information described in subparagraph 7,b74 7ii7 ,persons described ,a person described in this clause is-- 7,i7 the sponsor of an application or submission specified in subparagraph 7,e72 7,,ii7 a person engaged in any activity described in clause 7i7 on behalf of such a sponsor1 through a contract1 grant1 or other business arrangement with such sponsor2 7,,iii7 an institutional review board1 or other individual or entity1 engaged by contract1 grant1 or other business arrangement with a nonsponsor in preparing1 collecting1 or analyzing records or other information described in subparagraph 7,b72 or 7,,iv7 any person not otherwise described in this clause that conducts1 or has conducted1 a study described in subparagraph 7,e7 yielding records or other information described in subparagraph 7,b74 7,d7 ,conditions of inspection 7i7 ,access to information subject to inspection ,subject to clause 7ii71 an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the ,secretary with access to records and other information described in subparagraph 7,b7 that is held by or under the control of such entity1 including-- 7,i7 permitting the ,secretary to record or copy such information for purposes of this paragraph2 7,,ii7 providing the ,secretary with access to any electronic information system utilized by such entity to hold1 process1 analyze1 or transfer any records or other information described in subparagraph 7,b72 and 7,,iii7 permitting the ,secretary to inspect the facilities1 equipment1 written procedures1 processes1 and conditions through which records or other information described in subparagraph 7,b7 is or was generated1 held1 processed1 analyzed1 or transferred4 7ii7 ,no effect on applicability of provisions for protection of proprietary information or trade secrets ,nothing in clause 7i7 shall negate1 supersede1 or otherwise affect the applicability of provisions1 under this or any other ,act1 preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret4 7iii7 ,reasonableness of inspections ,an inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner4 7,e7 ,studies and submissions described ,the studies and submissions described in this subparagraph are each of the following3 7i7 ,clinical and nonclinical studies submitted to the ,secretary in support of1 or otherwise related to1 applications and other submissions to the ,secretary under this ,act or the ,public ,health ,service ,act for marketing authorization of a product described in paragraph 7#a74 7ii7 ,postmarket safety activities conducted under this ,act or the ,public ,health ,service ,act4 7iii7 ,any other clinical investigation of-- 7,i7 a drug subject to section #eje or #eab of this ,act or section #cea of the ,public ,health ,service ,act2 or 7,,ii7 a device subject to section #ebj7;g74 7iv7 ,any other submissions made under this ,act or the ,public ,health ,service ,act with respect to which the ,secretary determines an inspection under this paragraph is warranted in the interest of public health4 7,f7 ,clarification ,this paragraph clarifies the authority of the ,secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that1 prior to the date of enactment of this paragraph1 the ,secretary lacked the authority to conduct such inspections1 including under this ,act or the ,public ,health ,service ,act4 4 7#b7 ,review of processes and practices2 guidance for industry 7,a7 ,in general ,the ,secretary of ,health and ,human ,services shall-- 7i7 review processes and practices in effect as of the date of enactment of this ,act applicable to inspections of foreign and domestic sites and facilities described in subparagraph 7,c77i7 of section #gjd7;a77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by paragraph 7#a72 and 7ii7 evaluate whether any updates are needed to facilitate the consistency of such processes and practices4 7,b7 ,guidance 7i7 ,in general ,the ,secretary of ,health and ,human ,services shall issue guidance describing the processes and practices applicable to inspections of sites and facilities described in subparagraph 7,c77i7 of section #gjd7;a77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by paragraph 7#a71 including with respect to the types of records and information required to be provided1 best practices for communication between the ,food and ,drug ,administration and industry in advance of or during an inspection or request for records or other information1 and other inspections-related conduct1 to the extent not specified in existing publicly available ,food and ,drug ,administration guides and manuals for such inspections4 7ii7 ,timing ,the ,secretary of ,health and ,human ,services shall-- 7,i7 not later than #ah months after the date of enactment of this ,act1 issue draft guidance under clause 7i72 and 7,,ii7 not later than #a year after the close of the public comment period for such draft guidance1 issue final guidance under clause 7i74 #gbb4 ,uses of certain evidence ,section #gjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgc7 is amended by adding at the end the following3 7c7 ,applicability ,the limitations on the ,secretary's use of evidence obtained under this section1 or any evidence which is directly or indirectly derived from such evidence1 in a criminal prosecution of the person from whom such evidence was obtained shall not apply to evidence1 including records or other information1 obtained under authorities other than this section1 unless such limitations are specifically incorporated by reference in such other authorities4 4 #gbc4 ,improving ,,fda inspections 7a7 ,risk factors for establishments ,section #eaj7;h77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77#d77 is amended-- 7#a7 by redesignating subparagraph 7,f7 as subparagraph 7,g72 and 7#b7 by inserting after subparagraph 7,e7 the following3 7,f7 ,the compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this ,act1 including the history of violations related to products exported from such country or region that are subject to such regulation4 4 7b7 ,use of records ,section #gjd7;a77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77 is amended-- 7#a7 by redesignating subparagraph 7,c7 as subparagraph 7,d72 and 7#b7 by inserting after subparagraph 7,b7 the following3 7,c7 ,the ,secretary may rely on any records or other information that the ,secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection1 or to resolve deficiencies identified during such inspections1 if applicable and appropriate4 4 7c7 ,recognition of foreign government inspections ,section #hji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7 is amended-- 7#a7 in subsection 7a77#a71 by inserting preapproval or before risk-based inspections2 and 7#b7 by adding at the end the following3 7c7 ,periodic review 7#a7 ,in general ,beginning not later than #a year after the date of the enactment of the ,food and ,drug ,amendments of #bjbb1 the ,secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government1 as allowed under this section1 are appropriate4 7#b7 ,reports to ,congress ,beginning not later than #d years after the date of the enactment of the ,food and ,drug ,amendments of #bjbb1 and every #d years thereafter1 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 findings and conclusions of each review conducted under paragraph 7#a74 4 #gbd4 ,,gao report on inspections of foreign establishments manufacturing drugs 7a7 ,in general ,not later than #ah months after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states 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 on inspections conducted by-- 7#a7 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 of foreign establishments pursuant to subsections 7h7 and 7i7 of section #eaj and section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj2 #cgd72 or 7#b7 a foreign government or an agency of a foreign government pursuant to section #hji of such ,act 7#ba ,u4,s4,c4 #chd;e74 7b7 ,contents ,the report conducted under subsection 7a7 shall include-- 7#a7 what alternative tools1 including remote inspections or remote evaluations1 other countries are utilizing to facilitate inspections of foreign establishments2 7#b7 how frequently trusted foreign regulators conduct inspections of foreign facilities that could be useful to the ,food and ,drug ,administration to review in lieu of its own inspections2 7#c7 how frequently and under what circumstances1 including for what types of inspections1 the ,secretary utilizes existing agreements or arrangements under section #hji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7 and whether the use of such agreements could be appropriately expanded2 7#d7 whether the ,secretary has accepted reports of inspections of facilities in ,china and ,india conducted by entities with which they have entered into such an agreement or arrangement2 7#e7 what additional foreign governments or agencies of foreign governments the ,secretary has considered entering into a mutual recognition agreement with and1 if applicable1 reasons why the ,secretary declined to enter into a mutual recognition agreement with such foreign governments or agencies2 7#f7 what tools1 if any1 the ,secretary used to facilitate inspections of domestic facilities that could also be effectively utilized to appropriately inspect foreign facilities2 7#g7 what steps the ,secretary has taken to identify and evaluate tools and strategies the ,secretary may use to continue oversight with respect to inspections when in-person inspections are disrupted2 7#h7 how the ,secretary is considering incorporating alternative tools into the inspection activities conducted pursuant to the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq472 and 7#i7 what steps the ,secretary has taken to identify and evaluate how the ,secretary may use alternative tools to address workforce shortages to carry out such inspection activities4 #gbe4 ,unannounced foreign facility inspections pilot program 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall conduct a pilot program under which the ,secretary increases the conduct of unannounced surveillance inspections of foreign human drug establishments and evaluates the differences between such inspections of domestic and foreign human drug establishments1 including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection4 ,such pilot program shall evaluate-- 7#a7 differences in the number and type of violations of section #eja7;a77#b77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7;a77#b77;,b77 identified as a result of unannounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection2 7#b7 costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments2 7#c7 barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections2 and 7#d7 approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments4 7b7 ,pilot program scope ,the inspections evaluated under the pilot program under this section shall be routine surveillance inspections and shall not include inspections conducted as part of the ,secretary's evaluation of a request for approval to market a drug submitted under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 or the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq474 7c7 ,pilot program initiation ,the ,secretary shall initiate the pilot program under this section not later than #ahj days after the date of enactment of this ,act4 7d7 ,report ,the ,secretary shall1 not later than #ahj days following the completion of the pilot program under this section1 make available on the website of the ,food and ,drug ,administration a final report on the pilot program under this section1 including-- 7#a7 findings and any associated recommendations with respect to the evaluation under subsection 7a71 including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments2 7#b7 findings and any associated recommendations regarding how the ,secretary may achieve parity between domestic and foreign human drug inspections2 and 7#c7 the number of unannounced inspections during the pilot program that would not be unannounced under existing practices4 #gbf4 ,reauthorization of inspection program ,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 #gbg4 ,enhancing 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 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-- 7#a7 the reviews of reports shared pursuant to section #gjd7;b77#b72 and 7#b7 any feedback or corrective or preventive actions in response to such reports4 4 7b7 ,reporting 7#a7 ,in general ,section #ejf;,c-#a7;a77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c-#a7;a77#b77 is amended to read as follows3 7#b7 7,a7 describes the communication between 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 ,program1 including the ,food and ,drug ,administration's procedures for enabling and ensuring such communication2 7,b7 provides the number of reports described in section #gjd7;b77#b7 that were required to be sent to the appropriate offices of the ,food and ,drug ,administration and the number of such reports that were sent2 and 7,c7 describes the coordination and alignment activities undertaken pursuant to section #ejf;,d7g72 4 7#b7 ,applicability ,the amendment made by paragraph 7#a7 shall apply with respect to reports submitted on or after ,march #ca1 #bjbc4 #gbh4 ,reporting of mutual recognition agreements for inspections and review activities 7a7 ,in general ,not later than ,december #ca1 #bjbb1 and annually thereafter1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall publish a report on the public website of the ,food and ,drug ,administration on the utilization of agreements entered into pursuant to section #hji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7 or otherwise entered into by the ,secretary in the previous fiscal year to recognize inspections between drug regulatory authorities across countries and international regions with analogous review criteria to the ,food and ,drug ,administration1 such as the ,pharmaceutical ,inspection ,co-,operation ,scheme1 the ,mutual ,recognition ,agreement with the ,european ,union1 and the ,australia-,canada-,singapore-,switzerla nd-,united ,kingdom ,consortium4 7b7 ,content ,the report under subsection 7a7 shall include each of the following3 7#a7 ,the total number of establishments that are registered under section #eaj7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;i771 and the number of such establishments in each region of interest4 7#b7 ,the total number of inspections conducted at establishments described in paragraph 7#a71 disaggregated by inspections conducted-- 7,a7 pursuant to an agreement or other recognition described in subsection 7a72 and 7,b7 by employees or contractors of the ,food and ,drug ,administration4 7#c7 ,of the inspections described in paragraph 7#b71 the total number of inspections in each region of interest4 7#d7 ,of the inspections in each region of interest reported pursuant to paragraph 7#c71 the number of inspections in each ,,fda inspection category4 7#e7 ,of the number of inspections reported under each of paragraphs 7#c7 and 7#d7-- 7,a7 the number of inspections which have been conducted pursuant to an agreement or other recognition described in subsection 7a72 and 7,b7 the number of inspections which have been conducted by employees or contractors of the ,food and ,drug ,administration4 7c7 ,definitions ,in this section3 7#a7 ,,fda inspection category ,the term ,,fda inspection category means the following inspection categories3 7,a7 ,inspections to support approvals of changes to the manufacturing process of drugs approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7,b7 ,surveillance inspections4 7,c7 ,for-cause inspections4 7#b7 ,region of interest ,the term region of interest means ,china1 ,india1 the ,european ,union1 and any other geographic region as the ,secretary determines appropriate4 #gbi4 ,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 #abj days after the end of each fiscal year1 the ,secretary of ,health and ,human ,services shall post on the public 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 fiscal 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 section #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;e74 7#b7 ,the median time from the issuance of a report pursuant to section #gjd7;b7 of such ,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 to resolution of the actions indicated to address the conditions or practices observed during an inspection4 7#d7 ,the number of facilities that failed to implement adequate corrective or preventive actions following a report 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 ,,viii ,transparency1 ,program ,integrity1 and ,regulatory ,improvements #hja4 ,prompt reports of marketing status by holders of approved applications for biological products 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 in the matter preceding paragraph 7#a71 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 striking established name and inserting established name 7for biological products1 by proper name72 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 striking established name and inserting established name 7for biological products1 by proper name72 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 ,amendments 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 by striking subsection 7d7 and inserting the following3 7d7 ,failure ,to meet requirements ,if a holder of an approved application fails to submit the information required under subsection 7a71 7b71 or 7c71 the ,secretary may-- 7#a7 move the application holder's drugs from the active section of the list published under section #eje7;j77#g77;,a7 to the discontinued section of the list1 except that the ,secretary shall remove from the list in accordance with section #eje7;j77#g77;,c7 drugs the ,secretary determines have been withdrawn from sale for reasons of safety or effectiveness2 and 7#b7 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 biological products for which the 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 biological products for which the license has been revoked or suspended for safety1 purity1 or potency reasons shall be removed from the list in accordance with section #cea7k77#i77;,b7 of the ,public ,health ,service ,act42 7,b7 by striking monthly updates to the list and inserting monthly updates to the lists referred to in the preceding sentences2 and 7,c7 by striking and shall update the list based on and inserting and shall update such lists based on4 7d7 ,technical corrections ,section #ejf;,i7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;i7e77 is amended-- 7#a7 by striking subsection #eje7;j77#g77;,a7 and inserting section #eje7;j77#g77;,a72 and 7#b7 by striking subsection #eje7;j77#g77;,c7 and inserting section #eje7;j77#g77;,c74 #hjb4 ,encouraging blood donation 7a7 ,streamlining patient and blood donor input ,section #cjjc of the #bast ,century ,cures ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c note7 is amended to read as follows3 #cjjc4 ,streamlining patient and blood donor input ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the collection of information to which a response is voluntary1 to solicit-- 7#a7 the views and perspectives of patients under section #efi;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 7as amended by section #cjja7 or section #cjjb2 or 7#b7 information from blood donors or potential blood donors to support the development of recommendations by the ,secretary of ,health and ,human ,services acting through the ,commissioner of ,food and ,drugs concerning blood donation4 4 7b7 ,clerical amendment ,the table of contents in section #a7;b7 of the #bast ,century ,cures ,act is amended by striking the item relating to section #cjjc and inserting the following3 ,sec4 #cjjc4 ,streamlining patient and blood donor input4 4 #hjc4 ,regulation of certain products as drugs ,section #ejc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 is amended by adding at the end the following3 7h7 7#a7 ,any contrast agent1 radioactive drug1 or ,,otc monograph drug shall be deemed to be a drug under section #bja7;g7 and not a device under section #bja7;h74 7#b7 ,for purposes of this subsection3 7,a7 ,the term contrast agent means an article that is intended for use in conjunction with a medical imaging device1 and-- 7i7 is a diagnostic radiopharmaceutical1 as defined in sections #cae4b and #fja4ca of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 or 7ii7 is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue1 structure1 or fluid4 7,b7 ,the term #8radioactive drug' has the meaning given such term in section #caj4c7n7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations71 except that such term does not include-- 7i7 an implant or article similar to an implant2 7ii7 an article that applies radiation from outside of the body2 or 7iii7 the radiation source of an article described in clause 7i7 or 7ii74 7,c7 ,the term #8,,otc monograph drug' has the meaning given such term in section #gdd,l4 7#c7 ,nothing in this subsection shall be construed as allowing for the classification of a product as a drug 7as defined in section #bja7;g77 if such product-- 7,a7 is not described in paragraph 7#a72 and 7,b7 meets the definition of a device under section #bja7;h71 unless another provision of this ,act otherwise indicates a different classification4 4 #hjd4 ,postapproval studies and program integrity for accelerated approval drugs 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 by striking paragraph 7#b7 and inserting the following3 7#b7 ,limitation 7,a7 ,in general ,approval of a product under this subsection may be subject to #a or both of the following requirements3 7i7 ,that the sponsor conduct an appropriate postapproval study or studies 7which may be augmented or supported by real world evidence7 to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit4 7ii7 ,that the sponsor submit copies of all promotional materials related to the product during the preapproval review period and1 following approval and for such period thereafter as the ,secretary determines to be appropriate1 at least #cj days prior to dissemination of the materials4 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 by striking paragraph 7#c7 and inserting the following3 7#c7 ,expedited withdrawal of approval 7,a7 ,in general ,the ,secretary may withdraw approval of a product approved under accelerated approval using expedited procedures described in subparagraph 7,b71 if-- 7i7 the sponsor fails to conduct any required postapproval study of the product with due diligence1 including with respect to conditions specified by the ,secretary under paragraph 7#b77;,c72 7ii7 a study required to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit of the product fails to verify and describe such effect or benefit2 7iii7 other evidence demonstrates that the product is not shown to be safe or effective under the conditions of use2 or 7iv7 the sponsor disseminates false or misleading promotional materials with respect to the product4 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 of ,food and ,drugs or the ,commissioner's designee2 and 7,,iv7 an opportunity for written appeal to-- 7aa7 the ,commissioner of ,food and ,drugs2 or 7bb7 a designee of the ,commissioner who has not participated in the proposed withdrawal of approval 7other than a meeting pursuant to subclause 7,,iii77 and is not a subordinate of an individual 7other than the ,commissioner7 who participated in such proposed withdrawal2 7ii7 providing an opportunity for public comment on the notice proposing to withdraw 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 7#d7 ,labeling 7,a7 ,in general ,subject to subparagraph 7,b71 the labeling for a product approved under accelerated approval shall include-- 7i7 a statement indicating that the product was approved under accelerated approval2 7ii7 a statement indicating that continued approval of the product is subject to postmarketing studies to verify clinical benefit2 7iii7 identification of the surrogate or intermediate endpoint or endpoints that supported approval and any known limitations of such surrogate or intermediate endpoint or endpoints in determining clinical benefit2 and 7iv7 a succinct description of the product and any uncertainty about anticipated clinical benefit and a discussion of available evidence with respect to such clinical benefit4 7,b7 ,applicability ,the labeling requirements of subparagraph 7,a7 shall apply only to products approved under accelerated approval for which the predicted effect on irreversible morbidity or mortality or other clinical benefit has not been verified4 7,c7 ,rule of construction ,with respect to any application pending before the ,secretary on the date of enactment of the ,food and ,drug ,amendments of #bjbb1 the ,secretary shall allow any applicable changes to the product labeling required to comply with subparagraph 7,a7 to be made by supplement after the approval of such application4 7#e7 ,reporting ,not later than ,september #cj1 #bjbe1 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 circumstances in which the ,secretary considered real world evidence submitted to support postapproval studies required under this subsection that were completed after the date of enactment of the ,food and ,drug ,amendments of #bjbb4 4 7b7 ,reports of postmarketing studies ,section #ejf;,b7a7 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 ,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 postapproval studies as may be required under section #ejf7;c77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77#b77;,a771 as amended by subsection 7a72 and 7,c7 the expedited procedures described in section #ejf7;c77#c77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77#c77;,b774 7#b7 ,final guidance ,the ,secretary shall issue-- 7,a7 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 7d7 ,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 a 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 world 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 #hje4 ,facilitating the use of real world evidence 7a7 ,guidance ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue1 or revise existing1 guidance on considerations for the use of real world data and real world evidence to support regulatory decisionmaking1 as follows3 7#a7 ,with respect to drugs1 such guidance shall address-- 7,a7 the use of such data and evidence to support the approval of a drug application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or a biological product application under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 or to support an investigational use exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a77#c7 of the ,public ,health ,service ,act2 and 7,b7 the use of such data and evidence obtained as a result of the use of drugs authorized for emergency use under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 in such applications1 submissions1 or requests2 and 7,c7 standards and methodologies which may be used for collection and analysis of real world evidence included in such applications1 submissions1 or requests1 as appropriate4 7#b7 ,with respect to devices1 such guidance shall address-- 7,a7 the use of such data and evidence to support the approval1 clearance1 or classification of a device pursuant to an application or submission submitted under section #eaj7k71 #eac7;f77#b71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c7f77#b71 #cfj;e71 or to support an investigational use exemption under section #ebj7;g7 of such ,act 7#ba ,u4,s4,c4 #cfj;j7g772 7,b7 the use of such data and evidence obtained as a result of the use of devices authorized for emergency use under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c71 in such applications1 submissions1 or requests2 and 7,c7 standards and methodologies which may be used for collection and analysis of real world evidence included in such applications1 submissions1 or requests1 as appropriate4 7b7 ,report to ,congress ,not later than #b years after the termination of the public health emergency determination by the ,secretary of ,health and ,human ,services under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 on ,february #d1 #bjbj1 with respect to the ,coronavirus ,disease #bjai 7,,covid-#ai71 the ,secretary shall submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate on-- 7#a7 the number of applications1 submissions1 or requests submitted for clearance or approval under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee1 #cfj7k71 #cfj;c7f77#b71 #cfj;e7 or section #cea of the ,public ,health ,service ,act1 for which an authorization under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 was previously granted2 7#b7 of the number of applications so submitted1 the number of such applications-- 7,a7 for which real world evidence was submitted and used to support a regulatory decision2 and 7,b7 for which real world evidence was submitted and determined to be insufficient to support a regulatory decision2 and 7#c7 a summary explanation of why1 in the case of applications described in paragraph 7#b77;,b71 real world evidence could not be used to support regulatory decisions4 7c7 ,information disclosure ,nothing in this section shall be construed to authorize the disclosure of information that is prohibited from disclosure under section #aije of title #ah1 ,united ,states ,code1 or subject to withholding under subsection 7b77#d7 of section #eeb of title #e1 ,united ,states ,code 7commonly referred to as the ,freedom of ,information ,act74 #hjf4 ,dual ,submission for ,certain ,devices ,section #eac of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is amended by adding at the end the following3 7k7 ,for a device authorized for emergency use under section #efd for which1 in accordance with section #efd7m71 the ,secretary has deemed a laboratory examination or procedure associated with such device to be in the category of examinations and procedures described in section #cec7;d77#c7 of the ,public ,health ,service ,act1 the sponsor of such device may1 when submitting a request for classification under section #eac7;f77#b71 submit a single submission containing-- 7#a7 the information needed for such a request2 and 7#b7 sufficient information to enable the ,secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized under section #cec7;d77#c7 of the ,public ,health ,service ,act4 4 #hjg4 ,medical ,devices ,advisory ,committee meetings 7a7 ,in general ,the ,secretary shall convene one or more panels of the ,medical ,devices ,advisory ,committee not less than once per year for the purpose of providing advice to the ,secretary on topics related to medical devices used in pandemic preparedness and response1 including topics related to in vitro diagnostics4 7b7 ,required panel member ,a panel convened under subsection 7a7 shall include at least #a population health-specific representative4 7c7 ,sunset ,this section shall cease to be effective on ,october #a1 #bjbg4 #hjh4 ,ensuring cybersecurity of medical devices 7a7 ,in general ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq471 as amended by section #eja1 is further amended by adding at the end the following3 #ebd;,c4 ,ensuring cybersecurity of devices 7a7 ,in general ,for purposes of ensuring cybersecurity throughout the lifecycle of a cyber device1 any person who submits a premarket submission for the cyber device shall include such information as the ,secretary may require to ensure that the cyber device meets such cybersecurity requirements as the ,secretary determines to be appropriate to demonstrate a reasonable assurance of safety and effectiveness1 including at a minimum the cybersecurity requirements under subsection 7b74 7b7 ,cybersecurity requirements ,at a minimum1 the manufacturer of a cyber device shall meet the following cybersecurity requirements3 7#a7 ,the manufacturer shall have a plan to appropriately monitor1 identify1 and address in a reasonable time postmarket cybersecurity vulnerabilities and exploits1 including coordinated vulnerability disclosure and procedures4 7#b7 ,the manufacturer shall design1 develop1 and maintain processes and procedures to ensure the device and related systems are cybersecure1 and shall make available updates and patches to the cyber device and related systems throughout the lifecycle of the cyber device to address-- 7,a7 on a reasonably justified regular cycle1 known unacceptable vulnerabilities2 and 7,b7 as soon as possible out of cycle1 critical vulnerabilities that could cause uncontrolled risks4 7#c7 ,the manufacturer shall provide in the labeling of the cyber device a software bill of materials1 including commercial1 open-source1 and off-the-shelf software components4 7#d7 ,the manufacturer shall comply with such other requirements as the ,secretary may require to demonstrate reasonable assurance of the safety and effectiveness of the device for purposes of cybersecurity1 which the ,secretary may require by an order published in the ,federal ,register4 7c7 ,substantial equivalence ,in making a determination of substantial equivalence under section #eac7;i7 for a cyber device1 the ,secretary may-- 7#a7 find that cybersecurity information for the cyber device described in the relevant premarket submission in the cyber device's use environment is inadequate2 and 7#b7 issue a nonsubstantial equivalence determination based on this finding4 7d7 ,definition ,in this section3 7#a7 ,cyber device ,the term cyber device means a device that-- 7,a7 includes software1 including software as or in a device2 7,b7 has the ability to connect to the internet2 or 7,c7 contains any such technological characteristics that could be vulnerable to cybersecurity threats4 7#b7 ,lifecycle of the cyber device ,the term lifecycle of the cyber device includes the postmarket lifecycle of the cyber device4 7#c7 ,premarket submission ,the term premarket submission means any submission under section #eaj7k71 #eac1 #eae7;c71 #eae7;f71 or #ebj7m74 7e7 ,exemption ,the ,secretary may identify devices or types of devices that are exempt from meeting the cybersecurity requirements established by this section and regulations promulgated pursuant to this section4 ,the ,secretary shall publish in the ,federal ,register1 and update1 as appropriate1 a list of the devices and types of devices so identified by the ,secretary4 4 7b7 ,prohibited act ,section #cja7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7q77 is amended by adding at the end the following3 7#c7 ,the failure to comply with any requirement under section #ebd;,c 7relating to ensuring device cybersecurity74 4 7c7 ,adulteration ,section #eja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is amended by inserting after paragraph 7j7 the following3 7k7 ,if it is a device subject to the requirements set forth in section #ebd;,c 7relating to ensuring device cybersecurity7 and fails to comply with any requirement under that section4 4 7d7 ,misbranding ,section #ejb7t7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7t77 is amended-- 7#a7 by striking or 7#c7 and inserting 7#c72 and 7#b7 by inserting before the period at the end the following3 1 or 7#d7 to furnish a software bill of materials as required under section #ebd;,c 7relating to ensuring device cybersecurity74 #hji4 ,public docket on proposed changes to third-party vendors 7a7 ,in general 7#a7 ,opening public docket ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall open a single public docket to solicit comments on factors that generally should be considered by the ,secretary when reviewing requests from sponsors of drugs subject to risk evaluation and mitigation strategies to change third-party vendors engaged by sponsors to aid in implementation and management of the strategies4 7#b7 ,factors ,such factors include the potential effects of changes in third-party vendors on-- 7,a7 patient access2 and 7,b7 prescribing and administration of the drugs by health care providers4 7#c7 ,closing public docket ,the ,secretary of ,health and ,human ,services may close such public docket not earlier than #ij days after such docket is opened4 7#d7 ,no delay ,nothing in this section shall delay agency action on any modification to a risk evaluation and mitigation strategy4 7b7 ,,gao report ,not later than ,december #ca1 #bjbf1 the ,comptroller ,general of the ,united ,states 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 on-- 7#a7 the number of changes in third-party vendors 7engaged by sponsors to aid implementation and management of risk evaluation and mitigation strategies7 for an approved risk evaluation and mitigation strategy the ,secretary of ,health and ,human ,services has approved under section #eje-a7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;h772 7#b7 any issues affecting patient access to the drug that is subject to the strategy or considerations with respect to the administration or prescribing of such drug by health care providers that arose as a result of such modifications2 and 7#c7 how such issues were resolved1 as applicable4 #haj4 ,facilitating exchange of product information prior to approval 7a7 ,in general ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended-- 7#a7 in paragraph 7a7-- 7,a7 by striking drugs for coverage and inserting drugs or devices for coverage2 and 7,b7 by striking drug each place it appears and inserting drug or device1 respectively2 7#b7 in paragraphs 7a77#a7 and 7a77#b77;,b71 by striking under section #eje or under section #cea of the ,public ,health ,service ,act and inserting under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act2 7#c7 in paragraph 7a77#a7-- 7,a7 by striking under section #eje or under section #cea7;a7 of the ,public ,health ,service ,act and inserting under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act2 and 7,b7 by striking in section #eje7;a7 or in subsections 7a7 and 7k7 of section #cea of the ,public ,health ,service ,act and inserting in section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act2 and 7#d7 by adding at the end the following3 7gg7 7#a7 ,unless its labeling bears adequate directions for use in accordance with paragraph 7f71 except that 7in addition to drugs or devices that conform with exemptions pursuant to such paragraph7 no drug or device shall be deemed to be misbranded under such paragraph through the provision of product information to a payor1 formulary committee1 or other similar entity with knowledge and expertise in the area of health care economic analysis carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement if the product information relates to an investigational drug or device or investigational use of a drug or device that is approved1 cleared1 granted marketing authorization1 or licensed under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act 7as applicable71 provided-- 7,a7 the product information includes-- 7i7 a clear statement that the investigational drug or device or investigational use of a drug or device has not been approved1 cleared1 granted marketing authorization1 or licensed under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act 7as applicable7 and that the safety and effectiveness of the drug or device or use has not been established2 7ii7 information related to the stage of development of the drug or device involved1 such as-- 7,i7 the status of any study or studies in which the investigational drug or device or investigational use is being investigated2 7,,ii7 how the study or studies relate to the overall plan for the development of the drug or device2 and 7,,iii7 whether an application1 premarket notification1 or request for classification for the investigational drug or device or investigational use has been submitted to the ,secretary and when such a submission is planned2 7iii7 in the case of information that includes factual presentations of results from studies1 which shall not be selectively presented1 a description of-- 7,i7 all material aspects of study design1 methodology1 and results2 and 7,,ii7 all material limitations related to the study design1 methodology1 and results2 7iv7 where applicable1 a prominent statement disclosing the indication or indications for which the ,secretary has approved1 granted marketing authorization1 cleared1 or licensed the product pursuant to section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act1 and a copy of the most current required labeling2 and 7v7 updated information1 if previously communicated information becomes materially outdated as a result of significant changes or as a result of new information regarding the product or its review status2 and 7,b7 the product information does not include-- 7i7 information that represents that an unapproved product-- 7,i7 has been approved1 cleared1 granted marketing authorization1 or licensed under section #eje1 #eaj7k71 #eac7;f77#b71 or #eae of this ,act or section #cea of the ,public ,health ,service ,act 7as applicable72 or 7,,ii7 has otherwise been determined to be safe or effective for the purpose or purposes for which the drug or device is being studied2 or 7ii7 information that represents that an unapproved use of a drug or device that has been so approved1 granted marketing authorization1 cleared1 or licensed-- 7,i7 is so approved1 granted marketing authorization1 cleared1 or licensed2 or 7,,ii7 that the product is safe or effective for the use or uses for which the drug or device is being studied4 7#b7 ,for purposes of this paragraph1 the term product information includes-- 7,a7 information describing the drug or device 7such as drug class1 device description1 and features72 7,b7 information about the indication or indications being investigated2 7,c7 the anticipated timeline for a possible approval1 clearance1 marketing authorization1 or licensure pursuant to section #eje1 #eaj7k71 #eac1 or #eae of this ,act or section #cea of the ,public ,health ,service ,act2 7,d7 drug or device pricing information2 7,e7 patient utilization projections2 7,f7 product-related programs or services2 and 7,g7 factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy4 4 7b7 ,,gao study and report ,beginning on the date that is #e years and #f months after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study on the provision and use of information pursuant to section #ejb7;gg7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this subsection 7a71 between manufacturers of drugs and devices 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 and entities described in such section #ejb7;gg74 ,such study shall include an analysis of the following3 7#a7 ,the types of information communicated between such manufacturers and payors4 7#b7 ,the manner of communication between such manufacturers and payors4 7#c7 7,a7 ,whether such manufacturers file an application for approval1 marketing authorization1 clearance1 or licensing of a new drug or device or the new use of a drug or device that is the subject of communication between such manufacturers and payors under section #ejb7;gg7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 7,b7 ,how frequently the ,food and ,drug ,administration approves1 grants marketing authorization1 clears1 or licenses the new drug or device or new use4 7,c7 ,the timeframe between the initial communications permitted under section #ejb7;gg7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 regarding an investigational drug or device or investigational use1 and the initial marketing of such drug or device4 #haa4 ,bans of devices for one or more intended uses 7a7 ,in general ,section #eaf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;f7a77 is amended-- 7#a7 in paragraph 7#a71 by inserting for one or more intended use before the semicolon at the end2 and 7#b7 in the matter following paragraph 7#b71 by inserting for any such intended use or uses4 ,a device that is banned for one or more intended uses is not a legally marketed device under section #ajjf when intended for such use or uses after banned device4 7b7 ,specific devices deemed banned ,section #eaf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;f7 is further amended by adding at the end the following3 7c7 ,specific device banned ,electrical stimulation devices that apply a noxious electrical stimulus to a person's skin intended to reduce or cease self-injurious behavior or aggressive behavior are deemed to be banned devices1 as described in subsection 7a74 7d7 ,reversal by regulation ,devices banned under this section are banned devices unless or until the ,secretary promulgates a regulation to make such devices or use of such devices no longer banned based on a finding that such devices or use of such devices does not present substantial deception or an unreasonable and substantial risk of illness or injury1 or that such risk can be corrected or eliminated by labeling4 4 #hab4 ,clarifying application of exclusive approval1 certification1 or licensure for drugs designated for rare diseases or conditions 7a7 ,application of exclusive approval1 certification1 or licensure for drugs designated for rare diseases or conditions ,section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended-- 7#a7 in subsection 7a71 in the matter following paragraph 7#b71 by striking same disease or condition and inserting same approved indication or use within such rare disease or condition2 7#b7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking same rare disease or condition and inserting same indication or use for which the ,secretary has approved or licensed such drug2 and 7,b7 in paragraph 7#a71 by striking with the disease or condition for which the drug was designated and inserting for whom the drug is indicated2 and 7#c7 in subsection 7c71 by striking same rare disease or condition and inserting same indication or use4 7b7 ,application of amendments ,the amendments made by subsection 7a7 shall apply with respect to any drug designated under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb71 regardless of the date on which the drug was so designated1 and regardless of the date on which the drug was approved under section #eje of such ,act 7#ba ,u4,s4,c4 #cee7 or licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 #hac4 ,,gao report on third-party review ,not later than ,september #cj1 #bjbf1 the ,comptroller ,general of the ,united ,states 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 on the third-party review program described in section #ebc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm74 ,such report shall include-- 7#a7 a description of the financial and staffing resources used to carry out such program2 7#b7 a description of actions taken by the ,secretary pursuant section #ebc7;b77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7b77#b77;,c772 and 7#c7 the results of an audit of the performance of select persons accredited under such program4 #had4 ,reporting on pending generic drug applications and priority review applications ,section #hjg of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 is amended1 in the matter preceding paragraph 7#a71 by striking #bjbb and inserting #bjbg4 #hae4 ,,fda ,workforce ,improvements ,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 7a71 by striking medical products and inserting products regulated by the ,food and ,drug ,administration2 and 7#b7 by striking subsection 7d7 and inserting the following3 7d7 ,agency-wide strategic workforce plan 7#a7 ,in general ,not later than #a year after the date of enactment of the ,food and ,drug ,amendments of #bjbb1 the ,commissioner of ,food and ,drugs shall develop and begin implementation of an agency-wide strategic workforce plan at the ,food and ,drug ,administration1 which shall include-- 7,a7 agency-wide human capital goals and strategies2 7,b7 performance measures1 benchmarks1 or other elements to facilitate the monitoring and evaluation of the progress made toward such goals and the effectiveness of such strategies2 and 7,c7 a process for updating such plan based on timely and relevant information on an ongoing basis4 7#b7 ,report to ,congress ,not later than #ah months after the date of enactment of the ,food and ,drug ,amendments of #bjbb1 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 plan under paragraph 7#a7 and the status of its implementation4 4 ,,ix ,miscellaneous #ija4 ,determination of budgetary effects ,the budgetary effects of this ,act1 for the purpose of complying with the ,statutory ,pay-,as-,you-,go ,act of #bjaj1 shall be determined by reference to the latest statement titled ,budgetary ,effects of ,,paygo ,legislation for this ,act1 submitted for printing in the ,congressional ,record by the ,chairman of the ,house ,budget ,committee1 provided that such statement has been submitted prior to the vote on passage4 #ijb4 ,medicaid ,improvement ,fund ,section #aida7;b77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifw-#a7;b77#c77;,a77 is amended by striking #j and inserting #dej1jjj1jjj4 ,passed the ,house of ,representatives ,june #h1 #bjbb4;,cheryl ,l4 ,johnson1,clerk4