,,ii ,calendar ,no4 #gf #aaeth ,,congress #ast ,session ,s4 #icd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #be1 #bjag,mr4 ,alexander 7for himself and ,mrs4 ,murray7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,may #aa1 #bjag,reported by ,mr4 ,alexander1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to revise and extend the user-fee programs for prescription drugs1 medical devices1 generic drugs1 and biosimilar biological products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,fda ,reauthorization ,act of #bjag4 #b4 ,table of contents ,the table of contents for 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 ,authority to assess and use drug fees4,sec4 #ajc4 ,reauthorization2 reporting requirements4,sec4 #ajd4 ,sunset dates4,sec4 #aje4 ,effective date4,sec4 #ajf4 ,savings clause4,,title ,,ii--,fees relating to devices,sec4 #bja4 ,short title2 findings4,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 review4,sec4 #bjg4 ,electronic format for submissions4,sec4 #bjh4 ,savings clause4,sec4 #bji4 ,effective date4,sec4 #baj4 ,sunset clause4,,title ,,iii--,fees relating to generic drugs,sec4 #cja4 ,short title2 finding4,sec4 #cjb4 ,definitions4,sec4 #cjc4 ,authority to assess and use human generic drug fees4,sec4 #cjd4 ,reauthorization2 reporting requirements4,sec4 #cje4 ,sunset dates4,sec4 #cjf4 ,effective date4,sec4 #cjg4 ,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--,reauthorization of other programs,sec4 #eja4 ,reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers4,sec4 #ejb4 ,reauthorization of pediatric humanitarian device exceptions4,sec4 #ejc4 ,reauthorization of the critical path public-private partnerships4,sec4 #ejd4 ,reauthorization of pediatric device consortia4,sec4 #eje4 ,reauthorization of orphan grants program4 ,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 #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications1 including postmarket drug safety activities1 as set forth in the goals identified for purposes of part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #ajb4 ,authority to assess and use drug fees 7a7 ,types of fees 7#a7 ,in general ,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 #bjac and inserting fiscal year #bjah2 7,b7 in the heading of paragraph 7#a71 by striking and supplement2 7,c7 in paragraph 7#a71 by striking or a supplement and or supplement each place either appears2 7,d7 in paragraph 7#a77;,a7-- 7i7 in clause 7i71 by striking 7c77#d7 and inserting 7c77#e72 and 7ii7 in clause 7ii71 by striking ,a fee established and all that follows through are required4 and inserting the following3 ,a fee established under subsection 7c77#e7 for a human drug application for which clinical data 7other than bioavailability or bioequivalence studies7 with respect to safety or effectiveness are not required for approval42 7,e7 in the heading of paragraph 7#a77;,c71 by striking or supplement2 7,f7 in paragraph 7#a77;,f7-- 7i7 in the heading1 by striking or indication2 and 7ii7 by striking the second sentence2 7,g7 by striking paragraph 7#b7 7relating to a prescription drug establishment fee72 7,h7 by redesignating paragraph 7#c7 as paragraph 7#b72 7,i7 in the heading of paragraph 7#b71 as so redesignated1 by striking ,prescription drug product fee and inserting ,prescription drug program fee2 7,j7 in subparagraph 7,a7 of such paragraph 7#b71 by amending the first sentence to read as follows3 ,except as provided in subparagraphs 7,b7 and 7,c71 each person who is named as the applicant in a human drug application1 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#e7 for each prescription drug product that is identified in such a human drug application approved as of ,october #a of such fiscal year4 2 7,k7 in subparagraph 7,b7 of such paragraph 7#b7-- 7i7 in the heading of subparagraph 7,b71 by inserting after ,exception the following3 for certain prescription drug products2 and 7ii7 by striking ,a prescription drug product shall not be assessed a fee and inserting ,a prescription drug program fee shall not be assessed for a prescription drug product2 and 7,l7 by adding at the end of such paragraph 7#b7 the following3 7,c7 ,limitation ,a person who is named as the applicant in an approved human drug application shall not be assessed more than #e prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application4 4 7#b7 ,conforming amendment ,subparagraph 7,c7 of section #gdj7;a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;a77#c77 is amended to read as follows3 7,c7 ,limitation ,an establishment shall be assessed only one fee per fiscal year under this section4 4 7b7 ,fee revenue amounts ,subsection 7b7 of section #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7 is amended to read as follows3 7b7 ,fee revenue amounts 7#a7 ,in general ,for each of the fiscal years #bjah through #bjbb1 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 capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#b772 7,d7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#c772 7,e7 the dollar amount equal to the additional direct cost adjustment for the fiscal year 7as determined under subsection 7c77#d772 and 7,f7 additional dollar amounts for each fiscal year as follows3 7i7 #bj1jgg1gic for fiscal year #bjah2 7ii7 #ba1cag1dgb for fiscal year #bjai2 7iii7 #af1iec1cbi for fiscal year #bjbj2 7iv7 #e1dbf1hif for fiscal year #bjba2 and 7v7 #b1gfi1fji for fiscal year #bjbb4 7#b7 ,types of fees ,of the total revenue amount determined for a fiscal year under paragraph 7#a7-- 7,a7 #bj percent shall be derived from human drug application fees under subsection 7a77#a72 and 7,b7 #hj percent shall be derived from prescription drug program fees under subsection 7a77#b74 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 #bjah1 #hgh1eij1jjj2 and 7,b7 for fiscal years #bjai through #bjbb1 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#c7 or 7c77#d74 4 7c7 ,adjustments2 annual fee setting ,subsection 7c7 of section #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7 is amended to read as follows3 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#a77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b77#a77;,a72 and 7ii7 the inflation adjustment percentage under subparagraph 7,b74 7,b7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of-- 7i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications 7as defined in section #gce7f77 for the first #c years of the preceding #d fiscal years2 and 7ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications 7as defined in section #gce7f77 for the first #c years of the preceding #d fiscal years4 7#b7 ,capacity planning adjustment 7,a7 ,in general ,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 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 ,interim methodology 7i7 ,in general ,until the capacity planning methodology described in subparagraph 7,c7 is effective1 the adjustment under this paragraph for a fiscal year shall be based on the product of-- 7,i7 the annual base revenue for such year1 as adjusted for inflation under paragraph 7#a72 and 7,,ii7 the adjustment percentage under clause 7ii74 7ii7 ,adjustment percentage ,the adjustment percentage under this clause for a fiscal year is the weighted change in the #c-year average ending in the most recent year for which data are available1 over the #c-year average ending in the previous year1 for-- 7,i7 the total number of human drug applications1 efficacy supplements1 and manufacturing supplements submitted to the ,secretary2 7,,ii7 the total number of active commercial investigational new drug applications2 and 7,,iii7 the total number of formal meetings scheduled by the ,secretary1 and written responses issued by the ,secretary in lieu of such formal meetings1 as identified in section ,i4,h of the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag4 7,c7 ,capacity planning methodology 7i7 ,development2 evaluation and report ,the ,secretary shall obtain1 through a contract with an independent accounting or consulting firm1 a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications4 ,the capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input4 ,the report shall be published for public comment no later than the end of fiscal year #bjbj4 7ii7 ,establishment and implementation ,after review of the report described in clause 7i7 and any public comments thereon1 the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7,i7 replace the interim methodology under subparagraph 7,b72 7,,ii7 incorporate such approaches and attributes as the ,secretary determines appropriate2 and 7,,iii7 be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established4 7,d7 ,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 year7 and 7b77#a77;,b7 7the dollar amount of the inflation adjustment for the fiscal year74 7,e7 ,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#c7 ,operating reserve adjustment 7,a7 ,increase ,for fiscal year #bjah and subsequent fiscal years1 the ,secretary may1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than #ad weeks of operating reserves of carryover user fees for the process for the review of human drug applications4 7,b7 ,decrease ,if the ,secretary has carryover balances for such process in excess of #ad weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #ad weeks of such operating reserves4 7,c7 ,notice of rationale ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e7 establishing fee revenue and fees for the fiscal year involved4 7#d7 ,additional direct cost adjustment 7,a7 ,in general ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees-- 7i7 for fiscal year #bjah1 by #h1gcj1jjj2 and 7ii7 for fiscal year #bjai and subsequent fiscal years1 by the amount determined under subparagraph 7,b74 7,b7 ,amount ,the amount determined under this subparagraph is-- 7i7 #h1gcj1jjj1 multiplied by 7ii7 the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all ,items2 ,annual ,index7 for the most recent year of available data1 divided by such ,index for #bjaf4 7#e7 ,annual fee setting ,the ,secretary shall1 not later than #fj days before the start of each fiscal year that begins after ,september #cj1 #bjag-- 7,a7 establish1 for the next fiscal year1 human drug application fees and prescription drug program fees under subsection 7a71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under this subsection2 and 7,b7 publish such fee revenue and fees in the ,federal ,register4 7#f7 ,limit ,the total amount of fees charged1 as adjusted under this subsection1 for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications4 4 7d7 ,fee waiver or reduction ,section #gcf7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7d77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by inserting or at the end of subparagraph 7,b72 7,b7 by striking subparagraph 7,c72 and 7,c7 by redesignating subparagraph 7,d7 as subparagraph 7,c72 7#b7 by striking paragraph 7#c7 7relating to use of standard costs72 7#c7 by redesignating paragraph 7#d7 as paragraph 7#c72 and 7#d7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraphs 7,a7 and 7,b71 by striking paragraph 7#a77;,d7 and inserting paragraph 7#a77;,c72 and 7,b7 in subparagraph 7,b7-- 7i7 by striking clause 7ii72 7ii7 by striking shall pay through 7i7 application fees and inserting shall pay application fees2 and 7iii7 by striking 2 and at the end and inserting a period4 7e7 ,effect of failure ,to pay fees ,section #gcf7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7e77 is amended by striking all fees and inserting all such fees4 7f7 ,limitations ,section #gcf7;f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7f77#b77 is amended by striking supplements1 prescription drug establishments1 and prescription drug products and inserting prescription drug program fees4 7g7 ,crediting and availability of fees ,section #gcf7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77 is amended-- 7#a7 in paragraph 7#c7-- 7,a7 by striking #bjac through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking and paragraph 7#d7 of this subsection2 and 7#b7 by striking paragraph 7#d74 7h7 ,orphan drugs ,section #gcf7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is amended by striking product and establishment fees each place it appears and inserting prescription drug program fees4 #ajc4 ,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#a7-- 7,a7 in the matter before subparagraph 7,a71 by striking #bjac and inserting #bjah2 and 7,b7 in subparagraph 7,a71 by striking ,prescription ,drug ,user ,fee ,amendments of #bjab and inserting ,prescription ,drug ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 and 7#c7 in subsection 7d71 by striking #bjag each place it appears and inserting #bjbb4 #ajd4 ,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 #bjbb4 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 #bjbc4 7c7 ,previous ,sunset ,provision ,effective ,october #a1 #bjag1 subsections 7a7 and 7b7 of section #aje of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 are repealed4 #aje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 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 shall be assessed for all human drug applications received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #ajf4 ,savings clause ,notwithstanding the amendments made by this title1 part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to human drug applications and supplements 7as defined in such part as of such day7 that on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 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 #bjah4 ,,ii ,fees relating to devices #bja4 ,short title2 findings 7a7 ,short ,title ,this title may be cited as the ,medical ,device ,user ,fee ,amendments of #bjag4 7b7 ,findings ,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 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 by redesignating paragraphs 7#h7 through 7#ac7 as paragraphs 7#i7 through 7#ad71 respectively2 7#b7 by inserting after paragraph 7#g7 the following new paragraph3 7#h7 ,the term de novo classification request means a request made under section #eac7;f77#b77;,a7 with respect to the classification of a device4 2 7#c7 in subparagraph 7,d7 of paragraph 7#aj7 7as redesignated by paragraph 7#a771 by striking and submissions and inserting submissions1 and de novo classification requests2 and 7#d7 in paragraph 7#aa7 7as redesignated by paragraph 7#a771 by striking #bjaa and inserting #bjaf4 #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 #bjac and inserting fiscal year #bjah2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking ,october #a1 #bjab and inserting ,october #a1 #bjag2 7ii7 in clause 7viii71 by striking #b and inserting #c4d2 and 7iii7 by adding at the end the following new clause3 7xi7 ,for a de novo classification request1 a fee equal to #cj percent of the fee that applies under clause 7i74 2 and 7,b7 in subparagraph 7,b77v77,i71 by striking or premarket notification submission and inserting premarket notification submission1 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 to read as follows3 7b7 ,fee ,amounts 7#a7 ,in ,general ,subject to subsections 7c71 7d71 7e71 and 7h71 for each of fiscal years #bjah through #bjbb1 fees under subsection 7a7 shall be derived from the base fee amounts specified in paragraph 7#b71 to generate the total revenue amounts specified in paragraph 7#c74 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 #bjah;,fiscal ,year #bjai;,fiscal ,year #bjbj;,fiscal ,year #bjba;,fiscal ,year #bjbb,premarket ,application#bid1jjjcjj1jjjcaj1jjjcbh1jj jcbi1jjj;,establishment ,registration#d1cged1edhd1gfjd1iged1igh 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 #ahc1bhj1gef for fiscal year #bjah4 7,b7 #aij1fed1hge for fiscal year #bjai4 7,c7 #bjj1acb1jad for fiscal year #bjbj4 7,d7 #baa1gdh1ghi for fiscal year #bjba4 7,e7 #bac1fhg1ffj for fiscal year #bjbb4 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 #bjab and inserting #bjag2 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by striking #bjad and inserting #bjah2 7,b7 by striking subparagraph 7,b7 and inserting the following new subparagraph3 7,b7 ,applicable inflation adjustment ,the applicable inflation adjustment for fiscal year #bjah and each subsequent fiscal year is the product of-- 7i7 the base inflation adjustment under subparagraph 7,c7 for such fiscal year2 and 7ii7 the product of the base inflation adjustment under subparagraph 7,c7 for each of the fiscal years preceding such fiscal year1 beginning with fiscal year #bjaf4 2 7,c7 in subparagraph 7,c71 in the heading1 by striking to total revenue amounts2 and 7,d7 by amending subparagraph 7,d7 to read as follows3 7,d7 ,adjustment to base fee amounts ,for each of fiscal years #bjah through #bjbb1 the ,secretary shall-- 7i7 adjust the base fee amounts specified in subsection 7b77#b7 for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph 7,b7 for such year2 and 7ii7 if the ,secretary determines necessary1 increase 7in addition to the adjustment under clause 7i77 such base fee amounts1 on a uniform proportionate basis1 to generate the total revenue amounts under subsection 7b77#c71 as adjusted for inflation under subparagraph 7,a74 2 and 7#c7 in paragraph 7#c7-- 7,a7 by striking #bjad through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking further adjusted and inserting increased4 7d7 ,small businesses2 ,fee ,waiver and ,fee ,reduction ,regarding ,premarket ,approval ,fees ,section #gch7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7d77 is amended-- 7#a7 in paragraph 7#a71 by striking specified in clauses 7i7 through 7v7 and clauses 7vii71 7ix71 and 7x7 and inserting specified in clauses 7i7 through 7vii7 and clauses 7ix71 7x71 and 7xi72 and 7#b7 in paragraph 7#b77;,c7-- 7,a7 by striking supplement1 or and inserting supplement12 and 7,b7 by inserting 1 or a de novo classification request after class ,,iii device4 7e7 ,small ,businesses2 ,fee ,reduction ,regarding ,premarket ,notification ,submissions ,section #gch7;e77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7e77#b77;,c77 is amended by striking #ej and inserting #be4 7f7 ,fee ,waiver or ,reduction 7#a7 ,repeal ,section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended by striking subsection 7f74 7#b7 ,conforming changes 7,a7 ,section #eae7;c77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7c77#d77;,a77 is amended by striking #gch7;h7 and inserting #gch7;g74 7,b7 ,section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j71 as amended by paragraph 7#a71 is further amended-- 7i7 by redesignating subsections 7g7 through 7l7 as subsections 7f7 through 7k72 7ii7 in subsection 7a77#b77;,a71 by striking 7d71 7e71 and 7f7 and inserting 7d7 and 7e72 and 7iii7 in subsection 7a77#c77;,a71 by striking and subsection 7f74 7g7 ,effect of failure ,to pay fees ,subsection 7f77#a71 as redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended-- 7#a7 by striking or periodic reporting concerning a class ,,iii device and inserting periodic reporting concerning a class ,,iii device1 or de novo classification request2 and 7#b7 by striking all fees and inserting all such fees4 7h7 ,conditions ,subsection 7g77#a77;,a71 as redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended by striking #bhj1ehg1jjj and inserting #cbj1hbe1jjj4 7i7 ,crediting and ,availability of ,fees ,subsection 7h71 as redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended-- 7#a7 in paragraph 7#c7-- 7,a7 by striking #bjac through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking subsection 7c7 and all that follows through the period at the end and inserting subsection 7c742 and 7#b7 by striking paragraph 7#d74 #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 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking #bjac and inserting #bjah2 and 7ii7 by striking the ,medical ,device ,user ,fee ,amendments of #bjab and inserting ,medical ,device ,user ,fee ,amendments of #bjag2 and 7,b7 in subparagraph 7,b71 by striking the ,medical ,device ,user ,fee ,amendments of #bjab and inserting ,medical ,device ,user ,fee ,amendments of #bjag2 and 7#b7 in paragraph 7#b71 by striking #bjac through #bjag and inserting #bjah through #bjbb4 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 #bjag and inserting #bjbb2 and 7#b7 in paragraph 7#e71 by striking #bjag and inserting #bjbb4 #bje4 ,conformity assessment pilot program 7a7 ,in general ,section #ead of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7 is amended by adding at the end the following3 7d7 ,pilot accreditation scheme for conformity assessment 7#a7 ,in general ,the ,secretary shall establish a pilot program under which-- 7,a7 testing laboratories may be accredited1 by accreditation bodies meeting criteria specified by the ,secretary1 to assess the conformance of a device with certain standards recognized under this section2 and 7,b7 subject to paragraph 7#b71 determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the ,secretary for purposes of demonstrating such conformity under this section unless the ,secretary finds that a particular such determination shall not be so accepted4 7#b7 ,secretarial review of accredited laboratory determinations ,the ,secretary may-- 7,a7 review determinations by testing laboratories accredited pursuant to this subsection1 including by conducting periodic audits of such determinations or processes of accredited bodies or testing laboratories and1 following such review1 taking additional measures under this ,act1 such as suspension or withdrawal of accreditation of such testing laboratory under paragraph 7#a77;,a7 or requesting additional information with respect to such device1 as the ,secretary determines appropriate2 and 7,b7 if the ,secretary becomes aware of information materially bearing on safety or effectiveness of a device assessed for conformity by a testing laboratory so accredited1 take such additional measures under this ,act as the ,secretary determines appropriate1 such as suspension or withdrawal of accreditation of such testing laboratory under paragraph 7#a77;,a71 or requesting additional information with regard to such device4 7#c7 ,implementation and reporting 7,a7 ,public meeting ,the ,secretary shall publish in the ,federal ,register a notice of a public meeting to be held no later than ,september #cj1 #bjah1 to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of1 and a suitable framework and procedures and requirements for1 the pilot program under this subsection4 7,b7 ,pilot program guidance ,the ,secretary shall-- 7i7 not later than ,september #cj1 #bjai1 issue draft guidance regarding the goals and implementation of the pilot program under this subsection2 and 7ii7 not later than ,september #cj1 #bjba1 issue final guidance with respect to the implementation of such program4 7,c7 ,pilot program initiation ,not later than ,september #cj1 #bjbj1 the ,secretary shall initiate the pilot program under this subsection4 7,d7 ,report ,the ,secretary shall make available on the website of the ,food and ,drug ,administration an annual report on the progress of the pilot program under this subsection4 7#d7 ,sunset ,as of ,october #a1 #bjbb-- 7,a7 the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph 7#a77;,a7 shall cease to have force or effect2 7,b7 the ,secretary-- 7i7 may not accept a determination pursuant to paragraph 7#a77;,b7 made by a testing laboratory after such date2 and 7ii7 may accept such a determination made prior to such date2 7,c7 except for purposes of accepting a determination described in subparagraph 7,b77ii71 the ,secretary shall not continue to recognize the accreditation of testing laboratories accredited under paragraph 7#a77;,a72 and 7,d7 the ,secretary may take actions in accordance with paragraph 7#b7 with respect to the determinations made prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date4 4 #bjf4 ,reauthorization of review ,section #ebc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7 is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 in subparagraph 7,a71 by striking clauses 7ii7 and 7iii7 and inserting the following3 7ii7 a device classified under section #eac7;f77#b7 or designated under section #eae;,c7d72 or 7iii7 a device that is of a type1 or subset of a type1 listed as not eligible for review under subparagraph 7,b77iii74 2 7,b7 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,designation for review ,the ,secretary shall-- 7i7 issue draft guidance on the factors the ,secretary will use in determining whether a class ,i or class ,,ii device type1 or subset of such device types1 is eligible for review by an accredited person1 including-- 7,i7 the risk of the device type1 or subset of such device type2 and 7,,ii7 whether the device type1 or subset of such device type1 is permanently implantable1 life sustaining1 or life supporting2 7ii7 not later than #bd months after the date on which the ,secretary issues such draft guidance1 finalize such guidance2 and 7iii7 beginning on the date such guidance is finalized1 designate and post on the ,internet website of the ,food and ,drug ,administration1 an updated list of class ,i and class ,,ii device types1 or subsets of such device types1 and the ,secretary's determination with respect to whether each such device type1 or subset of a device type1 is eligible or not eligible for review by an accredited person under this section based on the factors described in clause 7i74 2 and 7,c7 by adding at the end the following3 7,c7 ,interim rule ,until the date on which the updated list is designated and posted in accordance with subparagraph 7,b77iii71 the list in effect on the date of enactment the ,medical ,device ,user ,fee ,amendments of #bjag shall be in effect4 2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b7-- 7i7 by striking subparagraph 7,d72 and 7ii7 by redesignating subparagraph 7,e7 as subparagraph 7,d72 and 7,b7 in paragraph 7#c7-- 7i7 by redesignating subparagraph 7,e7 as subparagraph 7,f72 7ii7 in subparagraph 7,f7 7as so redesignated71 by striking ,the operations of and all that follows through it will-- and inserting ,such person shall agree1 at a minimum1 to include in its request for accreditation a commitment to1 at the time of accreditation1 and at any time it is performing any review pursuant to this section--2 and 7iii7 by inserting after subparagraph 7,d7 the following new subparagraph3 7,e7 ,the operations of such person shall be in accordance with generally accepted professional and ethical business practices4 2 and 7#c7 in subsection 7c71 by striking #bjag and inserting #bjbb4 #bjg4 ,electronic format for submissions ,section #gde;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgik-#a7;b77 is amended by adding at the end the following new paragraph3 7#c7 ,presubmissions and submissions solely in electronic format 7,a7 ,in general ,beginning on ,october #a1 #bjba 7or such later date as may be specified by the ,secretary under subparagraph 7,b771 presubmissions and submissions for devices described in paragraph 7#a7 7and any appeals of action taken by the ,secretary with respect to such presubmissions or submissions7 shall be submitted solely in such electronic format as specified by the ,secretary in guidance issued under subparagraph 7,c74 7,b7 ,extension ,the ,secretary may1 if the ,secretary determines an extension of the date specified in subparagraph 7,a7 is necessary for the development and adoption of the electronic format referred to in such paragraph1 extend such date until such later date as the ,secretary may specify1 but in no event later than ,april #a1 #bjbc4 7,c7 ,guidance ,the ,secretary shall1 not later than ,january #a1 #bjba1 or such later date as may be specified by the ,secretary under subparagraph 7,b71 issue guidance providing for-- 7i7 any further standards for the submission by electronic format required under subparagraph 7,a72 7ii7 a timetable for the establishment by the ,secretary of such further standards2 and 7iii7 set forth criteria for waivers of and exemptions from the requirements of this subsection4 4 #bjh4 ,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 #bjab1 but before ,october #a1 #bjag1 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 #bjah4 #bji4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 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 shall be assessed for all submissions listed in section #gch7;a77#b77;,a7 of such ,act received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #baj4 ,sunset clause 7a7 ,authorization ,sections #gcg and #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #gci;i2 #gci;j7 shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting requirements ,section #gch;,a 7#ba ,u4,s4,c4 #gci;j-#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7regarding reauthorization and reporting requirements7 shall cease to be effective ,january #ca1 #bjbc4 7c7 ,previous ,sunset ,provision 7#a7 ,in general ,effective ,october #a1 #bjag1 section #bjg7;a7 of the ,medical ,device ,user ,fee ,amendments of #bjab 7,public ,law #aab-add7 is repealed4 7#b7 ,conforming amendment ,the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is amended in the table of contents in section #b by striking the item relating to section #bjg4 ,,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 #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities1 as set forth in the goals identified for purposes of part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #cjb4 ,definitions ,section #gdd;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da7 is amended-- 7#a7 in paragraph 7#a77;,b71 by striking application for a positron emission tomography drug4 and inserting 8application-- 7i7 for a positron emission tomography drug2 or 7ii7 submitted by a ,state or ,federal governmental entity for a drug that is not distributed commercially4 2 7#b7 by redesignating paragraphs 7#e7 through 7#ab7 as paragraphs 7#f7 through 7#ac71 respectively2 and 7#c7 by inserting after paragraph 7#d7 the following3 7#e7 ,the term contract manufacturing organization facility means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application1 where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility4 4 #cjc4 ,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 #bjac and inserting fiscal year #bjah2 7#b7 in paragraph 7#a71 by adding at the end the following3 7,e7 ,sunset ,this paragraph shall cease to be effective ,october #a1 #bjbb4 2 7#c7 in paragraph 7#b7-- 7,a7 by amending subparagraph 7,c7 to read as follows3 7,c7 ,notice ,not later than #fj days before the start of each of fiscal years #bjah through #bjbb1 the ,secretary shall publish in the ,federal ,register the amount of the drug master file fee established by this paragraph for such fiscal year4 2 and 7,b7 in subparagraph 7,e7-- 7i7 in clause 7i7-- 7,i7 by striking no later than the date and inserting 8on the earlier of-- 7,i7 the date 2 7,,ii7 by striking the period and inserting 2 or2 and 7,,iii7 by adding at the end the following3 7,,ii7 the date on which the drug master file holder requests the initial completeness assessment4 2 and 7ii7 in clause 7ii71 by striking notice provided for in clause 7i7 or 7ii7 of subparagraph 7,c71 as applicable and inserting notice provided for in subparagraph 7,c72 7#d7 in paragraph 7#c7-- 7,a7 in the heading1 by striking and prior approval supplement2 7,b7 in subparagraph 7,a71 by striking or a prior approval supplement to an abbreviated new drug application2 7,c7 by amending subparagraphs 7,b7 and 7,c7 to read as follows3 7,b7 ,notice ,not later than #fj days before the start of each of fiscal years #bjah through #bjbb1 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 7,c7 ,fee due date ,the fees required by subparagraphs 7,a7 and 7,f7 shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies4 2 7,d7 in subparagraph 7,d7-- 7i7 in the heading1 by inserting 1 is withdrawn prior to being received1 or is no longer received after received2 and 7ii7 by striking ,the ,secretary shall and all that follows through the period and inserting the following3 7i7 ,applications not considered to have been received and applications withdrawn prior to being received ,the ,secretary shall refund #ge percent of the fee paid under subparagraph 7,a7 for any abbreviated new drug application that the ,secretary considers not to have been received within the meaning of section #eje7;j77#e77;,a7 for a cause other than failure to pay fees1 or that has been withdrawn prior to being received within the meaning of section #eje7;j77#e77;,a74 7ii7 ,applications no longer received ,the ,secretary shall refund #ajj percent of the fee paid under subparagraph 7,a7 for any abbreviated new drug application if the ,secretary initially receives the application under section #eje7;j77#e77;,a7 and subsequently determines that an exclusivity period for a listed drug should have prevented the ,secretary from receiving such application1 such that the abbreviated new drug application is no longer received within the meaning of section #eje7;j77#e77;,a74 2 7,e7 in subparagraph 7,e71 by striking or prior approval supplement2 and 7,f7 in the matter preceding clause 7i7 of subparagraph 7,f7-- 7i7 by striking #bjab and inserting #bjag2 and 7ii7 by striking subsection 7d77#c7 and inserting subsection 7d77#b72 7#e7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i7 and in clause 7iii71 by striking 1 or intended to be identified1 in at least one generic drug submission that is pending or and inserting in at least one generic drug submission that is2 7ii7 in clause 7i71 by striking or intended to be identified in at least one generic drug submission that is pending or and inserting in at least one generic drug submission that is2 7iii7 in clause 7ii71 by striking produces1 and all that follows through such a and inserting is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a ,type ,,ii active pharmaceutical ingredient drug master file referenced in at least one such2 and 7iv7 in clause 7iii71 by striking to fees under both such clauses and inserting only to the fee attributable to the manufacture of the finished dosage forms2 and 7,b7 by amending subparagraphs 7,c7 and 7,d7 to read as follows3 7,c7 ,notice ,within the timeframe specified in subsection 7d77#a71 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 4 7,d7 ,fee due date ,for each of fiscal years #bjah through #bjbb1 the fees under subparagraph 7,a7 for such fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such year2 or 7ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees for such year under this section for such year4 2 7#f7 by redesignating paragraph 7#e7 as paragraph 7#f72 and 7#g7 by inserting after paragraph 7#d7 the following3 7#e7 ,generic drug applicant program fee 7,a7 ,in general ,a generic drug applicant program fee shall be assessed annually as described in subsection 7b77#b77;,e74 7,b7 ,amount ,the amount of fees established under subparagraph 7,a7 shall be established under subsection 7d74 7,c7 ,notice ,within the timeframe specified in subsection 7d77#a71 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 7,d7 ,fee due date ,for each of fiscal years #bjah through #bjbb1 the fees under subparagraph 7,a7 for such fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such fiscal year2 or 7ii7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year4 4 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 #bjac and inserting #bjah2 7ii7 by striking #bjac and inserting #bjah2 7iii7 by striking #bii1jjj1jjj and inserting #dic1fjj1jjj2 and 7iv7 by striking ,of that amount and all that follows through the end of clause 7ii72 and 7,b7 in subparagraph 7,b7-- 7i7 in the heading1 by striking #bjad through #bjag and inserting #bjai through #bjbb2 7ii7 by striking #bjad through #bjag and inserting #bjai through #bjbb2 7iii7 by striking paragraphs 7#b7 through 7#d7 and inserting paragraphs 7#b7 through 7#e72 and 7iv7 by striking #bii1jjj1jjj and inserting #dic1fjj1jjj2 and 7#b7 in paragraph 7#b7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking paragraph 7#a77;,a77ii7 for fiscal year #bjac and paragraph 7#a77;,b7 for each of fiscal years #bjad through #bjag and inserting such paragraph for a fiscal year2 and 7ii7 by striking through 7#d7 and inserting through 7#e72 7,b7 in subparagraph 7,a71 by striking ,six percent and inserting ,five percent2 7,c7 by amending subparagraphs 7,b7 and 7,c7 to read as follows3 7,b7 ,thirty-three percent shall be derived from fees under subsection 7a77#c7 7relating to abbreviated new drug applications74 7,c7 ,twenty percent shall be derived from fees under subsection 7a77#d77;,a77i7 7relating to generic drug facilities74 ,the amount of the fee for a contract manufacturing organization facility shall be equal to one-third the amount of the fee for a facility that is not a contract manufacturing organization facility4 ,the amount of the fee for a facility located outside the ,united ,states and its territories and possessions shall be #ae1jjj higher than the amount of the fee for a facility located in the ,united ,states and its territories and possessions4 2 7,d7 in subparagraph 7,d7-- 7i7 by striking ,fourteen percent and inserting ,seven percent2 7ii7 by striking not less than #ae1jjj and not more than #cj1jjj and inserting #ae1jjj2 and 7iii7 by striking 1 as determined and all that follows through the period at the end and inserting a period2 and 7,e7 by adding at the end the following3 7,e7 7i7 ,thirty-five percent shall be derived from fees under subsection 7a77#e7 7relating to generic drug applicant program fees74 ,for purposes of this subparagraph1 if a person has affiliates1 a single program fee shall be assessed with respect to that person1 including its affiliates1 and may be paid by that person or any one of its affiliates4 ,the ,secretary shall determine the fees as follows3 7,i7 ,if a person 7including its affiliates7 owns at least one but not more than #e approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee4 7,,ii7 ,if a person 7including its affiliates7 owns at least #f but not more than #ai approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee4 7,,iii7 ,if a person 7including its affiliates7 owns #bj or more approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a large size operation generic drug applicant program fee4 7ii7 ,for purposes of this subparagraph1 an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by ,april #a of the previous fiscal year4 4 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 by striking #bjad and inserting #bjai2 7,b7 by inserting to equal the product of the total revenues established in such notice for the prior fiscal year multiplied after a fiscal year12 and 7,c7 by striking the flush text following subparagraph 7,c72 and 7#b7 in paragraph 7#b7-- 7,a7 by striking #bjag each place it appears and inserting #bjbb2 and 7,b7 by striking #bjah and inserting #bjbc4 7d7 ,annual fee setting ,section #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7 is amended-- 7#a7 in subsection 7c77#b71 by striking ,such fees may only be used in fiscal year #bjah42 and 7#b7 in subsection 7d7-- 7,a7 by striking paragraphs 7#a7 and 7#b7 and inserting the following3 7#a7 ,fiscal years #bjah through #bjbb ,not more than #fj days before the first day of each of fiscal years #bjah through #bjbb1 the ,secretary shall establish the fees described in paragraphs 7#b7 through 7#e7 of subsection 7a71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under subsection 7c74 2 7,b7 by redesignating paragraph 7#c7 as paragraph 7#b72 and 7,c7 in paragraph 7#b7 7as so redesignated71 in the matter preceding subparagraph 7,a71 by striking fees under paragraphs 7#a7 and 7#b7 and inserting fee under paragraph 7#a74 7e7 ,identification of facilities ,section #gdd;,b7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;f77 is amended-- 7#a7 by striking paragraph 7#a72 7#b7 by redesignating paragraphs 7#b7 through 7#d7 as paragraphs 7#a7 through 7#c71 respectively2 7#c7 in paragraph 7#a7 7as so redesignated7-- 7,a7 by striking paragraph 7#d7 and inserting paragraph 7#c72 and 7,b7 by striking ,such information shall and all that follows through the end of subparagraph 7,b7 and inserting ,such information shall1 for each fiscal year1 be submitted1 updated1 or reconfirmed on or before ,june #a of the previous fiscal year42 and 7#d7 in paragraph 7#b71 as so redesignated-- 7,a7 in the heading1 by striking ,contents of notice and inserting ,information required to be submitted2 7,b7 in the matter preceding subparagraph 7,a71 by striking paragraph 7#b7 and inserting paragraph 7#a72 7,c7 in subparagraph 7,a71 by striking or intended to be identified2 7,d7 in subparagraph 7,d71 by striking and at the end2 7,e7 in subparagraph 7,e71 by striking the period and inserting 2 and2 and 7,f7 by adding at the end the following3 7,f7 whether the facility is a contract manufacturing organization facility4 4 7f7 ,effect of failure ,to pay fees ,section #gdd;,b7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7;g77 is amended-- 7#a7 in paragraph 7#a71 by adding at the end the following3 ,this paragraph shall cease to be effective on ,october #a1 #bjbb42 7#b7 in paragraph 7#b77;,c77ii71 by striking of #eje7;j77#e77;,a7 and inserting of section #eje7;j77#e77;,a72 and 7#c7 by adding at the end the following3 7#e7 ,generic drug applicant program fee 7,a7 ,in general ,a person who fails to pay a fee as required under subsection 7a77#e7 by the date that is #bj calendar days after the due date1 as specified in subparagraph 7,d7 of such subsection1 shall be subject to the following3 7i7 ,the ,secretary shall place the person on a publicly available arrears list4 7ii7 ,any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received1 within the meaning of section #eje7;j77#e77;,a74 7iii7 ,all drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section #ejb7;aa74 7,b7 ,application of penalties ,the penalties under subparagraph 7,a7 shall apply until the fee required under subsection 7a77#e7 is paid4 4 7g7 ,limitations ,section #gdd;,b7h77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7;h77#b77 is amended by striking for ,type ,,ii active pharmaceutical ingredient drug master files1 abbreviated new drug applications and prior approval supplements1 and generic drug facilities and active pharmaceutical ingredient facilities4 7h7 ,crediting and availability of fees ,section #gdd;,b7i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7;i77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by striking subparagraph 7,c7 7relating to fee collection during first program year72 7,b7 in subparagraph 7,d7-- 7i7 in the heading1 by striking in subsequent years2 and 7ii7 by striking 7after fiscal year #bjac72 and 7,c7 by redesignating subparagraph 7,d7 as subparagraph 7,c72 and 7#b7 in paragraph 7#c71 by striking fiscal years #bjac through #bjag and inserting fiscal years #bjah through #bjbb4 7i7 ,information on abbreviated new drug applications held by applicants and their affiliates ,section #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7 is amended by adding at the end the following3 7o7 ,information on abbreviated new drug applications owned by applicants and their affiliates 7#a7 ,in general ,by ,april #a of each year1 each person that owns an abbreviated new drug application1 or any affiliate of such person1 shall submit to the ,secretary a list of-- 7,a7 all approved abbreviated new drug applications owned by such person2 and 7,b7 if any affiliate of such person also owns an abbreviated new drug application1 all approved abbreviated new drug applications owned by any such affiliate4 7#b7 ,format and method ,the ,secretary shall specify in guidance the format and method for submission of lists under this subsection4 4 #cjd4 ,reauthorization2 reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking #bjac and inserting #bjah2 and 7,b7 by striking ,generic ,drug ,user ,fee ,amendments of #bjab and inserting ,generic ,drug ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 and 7#c7 in subsection 7d71 by striking #bjag each place it appears and inserting #bjbb4 #cje4 ,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 #bjbb4 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 #bjbc4 7c7 ,previous sunset provision ,effective ,october #a1 #bjag1 subsections 7a7 and 7b7 of section #cjd of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 are repealed4 #cjf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be assessed for all abbreviated new drug applications received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #cjg4 ,savings clause ,notwithstanding the amendments made by this title1 part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to abbreviated new drug applications 7as defined in such part as of such day7 that on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 were received by the ,food and ,drug ,administration within the meaning of #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 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjah4 ,,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 #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications1 including postmarket safety activities1 as set forth in the goals identified for purposes of part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #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 all urban consumers 7all items2 ,united ,states city average7 for ,october of the preceding fiscal year divided by such ,index for ,october #bjaa4 4 7b7 ,biosimilar biological product ,section #gdd;,g7#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7c77 is amended by striking means a product and inserting means a specific strength of a biological product in final dosage form4 #djc4 ,authority to assess and use biosimilar fees 7a7 ,types of fees ,section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking fiscal year #bjac and inserting fiscal year #bjah2 7#b7 in the heading of paragraph 7#a71 by striking ,biosimilar and inserting ,biosimilar biological product2 7#c7 in paragraph 7#a77;,a77i71 by striking 7b77#a77;,a7 and inserting 7c77#e72 7#d7 in paragraph 7#a77;,b77i71 by striking 7b77#a77;,b7 for biosimilar biological product development and inserting 7c77#e7 for the biosimilar biological product development program2 7#e7 in paragraph 7#a77;,b77ii71 by striking annual biosimilar biological product development program fee and inserting annual biosimilar biological product development fee2 7#f7 in paragraph 7#a77;,b77iii71 by striking annual biosimilar development program fee and inserting annual biosimilar biological product development fee2 7#g7 in paragraph 7#a77;,b71 by adding at the end the following3 7iv7 ,refund ,if a person submits a marketing application for a biosimilar biological product before ,october #a of a fiscal year and such application is accepted for filing on or after ,october #a of such fiscal year1 the person may request a refund equal to the annual biosimilar development fee paid by the person for the product for such fiscal year4 ,to qualify for consideration for a refund under this clause1 a person shall submit to the ,secretary a written request for such refund not later than #ahj days after the marketing application is accepted for filing4 2 7#h7 in paragraph 7#a77;,c71 by striking for a product effective ,october #a of a fiscal year by1 and inserting for a product1 effective ,october #a of a fiscal year1 by12 7#i7 in paragraph 7#a77;,d7-- 7,a7 in clause 7i7 in the matter preceding subclause 7,i71 by inserting 1 if the person seeks to resume participation in such program1 before pay a fee2 7,b7 in clause 7i77,i71 by inserting after grants a request the following3 by such person2 and 7,c7 in clause 7i77,,ii71 by inserting after discontinued7 the following3 by such person2 7#aj7 in the heading of paragraph 7#a77;,e71 by striking biosimilar development program2 7#aa7 in the heading of subparagraph 7,f7 of paragraph 7#a71 by striking biosimilar development program fees and inserting biosimilar biological product development fees2 7#ab7 in paragraph 7#a77;,f7-- 7,a7 in the heading of subparagraph 7,f71 by striking biosimilar development program before fees2 and 7,b7 by amending clause 7i7 to read as follows3 7i7 ,refunds ,except as provided in subparagraph 7,b77iv71 the ,secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph 7,a7 or 7,b71 or any reactivation fee paid under subparagraph 7,d74 2 7#ac7 in paragraph 7#b7-- 7,a7 in the heading of paragraph 7#b71 by striking and supplement2 7,b7 by amending subparagraphs 7,a7 and 7,b7 to read as follows3 7,a7 ,in general ,each person that submits1 on or after ,october #a1 #bjag1 a biosimilar biological product application shall be subject to the following fees3 7i7 ,a fee established under subsection 7c77#e7 for a biosimilar biological product application for which clinical data 7other than comparative bioavailability studies7 with respect to safety or effectiveness are required for approval4 7ii7 ,a fee established under subsection 7c77#e7 for a biosimilar biological product application for which clinical data 7other than comparative bioavailability studies7 with respect to safety or effectiveness are not required for approval4 ,such fee shall be equal to half of the amount of the fee described in clause 7i74 7,b7 ,rule of applicability2 treatment of certain previously paid fees ,any person who pays a fee under subparagraph 7,a71 7,b71 or 7,d7 of paragraph 7#a7 for a product before ,october #a1 #bjag1 but submits a biosimilar biological product application for that product after such date1 shall-- 7i7 be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted2 and 7ii7 be entitled to no reduction of such application fees based on the amount of fees paid for that product before ,october #a1 #bjag1 under such subparagraph 7,a71 7,b71 or 7,d74 2 7,c7 in the heading of subparagraph 7,d71 by striking or supplement2 and 7,d7 in subparagraphs 7,c7 through 7,f7-- 7i7 by striking or supplement each place it appears2 and 7ii7 in subparagraph 7,d71 by striking or a supplement2 and 7#ad7 by amending paragraph 7#c7 to read as follows3 7#c7 ,biosimilar biological product program fee 7,a7 ,in general ,each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection 7c77#e7 for each biosimilar biological product that-- 7i7 is identified in such a biosimilar biological product application approved as of ,october #a of such fiscal year2 and 7ii7 as of ,october #a of such fiscal year1 does not appear on a list1 developed and maintained by the ,secretary1 of discontinued biosimilar biological products4 7,b7 ,due date ,the biosimilar biological product program fee for a fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such year2 or 7ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees for such year under this section4 7,c7 ,one fee per product per year ,the biosimilar biological product program fee shall be paid only once for each product for each fiscal year4 7,d7 ,limitation ,a person who is named as the applicant in a biosimilar biological product application shall not be assessed more than #e biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application4 4 7b7 ,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 to read as follows3 7b7 ,fee revenue amounts 7#a7 ,fiscal year #bjah ,for fiscal year #bjah1 fees under subsection 7a7 shall be established to generate a total revenue amount equal to the sum of-- 7,a7 #de1jjj1jjj2 and 7,b7 the dollar amount equal to the fiscal year #bjah adjustment 7as determined under subsection 7c77#d774 7#b7 ,subsequent fiscal years ,for each of the fiscal years #bjai through #bjbb1 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#d772 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 capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#b772 and 7,d7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#c774 7#c7 ,allocation of revenue amount among fees2 limitations on fee amounts 7,a7 ,allocation ,the ,secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from1 respectively-- 7i7 initial and annual biosimilar development fees and reactivation fees under subsection 7a77#a72 7ii7 biosimilar biological product application fees under subsection 7a77#b72 and 7iii7 biosimilar biological product program fees under subsection 7a77#c74 7,b7 ,limitations on fee amounts ,until the first fiscal year for which the capacity planning adjustment under subsection 7c77#b7 is effective1 the amount of any fee under subsection 7a7 for a fiscal year after fiscal year #bjah shall not exceed #abe percent of the amount of such fee for fiscal year #bjah4 7,c7 ,biosimilar biological product development fees ,the initial biosimilar biological product development fee under subsection 7a77#a77;,a7 for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection 7a77#a77;,b7 for that fiscal year4 7,d7 ,reactivation fee ,the reactivation fee under subsection 7a77#a77;,d7 for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection 7a77#a77;,b7 for that fiscal year4 7#d7 ,annual base revenue ,for purposes of paragraph 7#b71 the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year1 excluding any adjustments to such revenue amount under subsection 7c77#c74 4 7c7 ,adjustments2 annual fee setting ,section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is amended-- 7#a7 by redesignating subsections 7c7 through 7h7 as subsections 7d7 through 7i71 respectively2 7#b7 in subsections 7a77#b77;,f7 and 7g71 by striking subsection 7c7 and inserting subsection 7d72 7#c7 in subsection 7a77#d77;,a71 by striking subsection 7b77#a77;,f7 and inserting subsection 7c77#e72 and 7#d7 by inserting after subsection 7b7 the following3 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#b77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b72 and 7ii7 the inflation adjustment percentage under subparagraph 7,b74 7,b7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of-- 7i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications 7as defined in section #gdd;,g7#ac77 for the first #c years of the preceding #d fiscal years2 and 7ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications 7as defined in section #gdd;,g7#ac77 for the first #c years of the preceding #d fiscal years4 7#b7 ,capacity planning adjustment 7,a7 ,in general ,beginning with the fiscal year described in subparagraph 7,b77ii77,,ii71 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 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 ,capacity planning methodology 7i7 ,development2 evaluation and report ,the ,secretary shall obtain1 through a contract with an independent accounting or consulting firm1 a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications4 ,the capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input4 ,the report shall be published for public comment not later than ,september #cj1 #bjbj4 7ii7 ,establishment and implementation ,after review of the report described in clause 7i7 and receipt and review of public comments thereon1 the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7,i7 incorporate such approaches and attributes as the ,secretary determines appropriate2 and 7,,ii7 be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established4 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#b77;,a7 7the annual base revenue for the fiscal year7 and 7b77#b77;,b7 7the dollar amount of the inflation adjustment for the fiscal year74 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#c7 ,operating reserve adjustment 7,a7 ,interim application2 fee reduction ,until the first fiscal year for which the capacity planning adjustment under paragraph 7#b7 is effective1 the ,secretary may1 in addition to the adjustment under paragraph 7#a71 reduce the fee revenue and fees under this section for a fiscal year as the ,secretary determines appropriate for long-term financial planning purposes4 7,b7 ,general application and methodology ,beginning with the first fiscal year for which the capacity planning adjustment under paragraph 7#b7 is effective1 the ,secretary may1 in addition to the adjustments under paragraphs 7#a7 and 7#b7-- 7i7 reduce the fee revenue and fees under this section as the ,secretary determines appropriate for long-term financial planning purposes2 or 7ii7 increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than #ba weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications4 7,c7 ,federal register notice ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e7 establishing fee revenue and fees for the fiscal year involved4 7#d7 ,fiscal year #bjah adjustment 7,a7 ,in general ,for fiscal year #bjah1 the ,secretary shall adjust the fee revenue and fees under this section in such amount 7if any7 as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications4 7,b7 ,methodology ,the ,secretary shall publish under paragraph 7#e7 a description of the methodology used to calculate the fiscal year #bjah adjustment under this paragraph in the ,federal ,register notice establishing fee revenue and fees for fiscal year #bjah4 7,c7 ,limitation ,no adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of #i1jjj1jjj4 7#e7 ,annual fee setting ,for fiscal year #bjah and each subsequent fiscal year1 the ,secretary shall1 not later than #fj days before the start of each such fiscal year-- 7,a7 establish1 for the fiscal year1 initial and annual biosimilar biological product development fees and reactivation fees under subsection 7a77#a71 biosimilar biological product application fees under subsection 7a77#b71 and biosimilar biological product program fees under subsection 7a77#c71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under this subsection2 and 7,b7 publish such fee revenue and fees in the ,federal ,register4 7#f7 ,limit ,the total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications4 4 7d7 ,application fee waiver for small business ,subsection 7d77#a7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended-- 7#a7 by striking subparagraph 7,b72 7#b7 by striking shall pay-- and all that follows through application fees and inserting shall pay application fees2 and 7#c7 by striking 2 and at the end and inserting a period4 7e7 ,effect of failure ,to pay fees ,subsection 7e7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended by striking all fees and inserting all such fees4 7f7 ,crediting and availability of fees ,subsection 7f7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by striking subparagraph 7,c7 7relating to fee collection during first program year7 and inserting the following3 7,c7 ,compliance ,the ,secretary shall be considered to have met the requirements of subparagraph 7,b7 in any fiscal year if the costs described in such subparagraph are not more than #ae percent below the level specified in such subparagraph4 2 and 7,b7 in subparagraph 7,d7-- 7i7 in the heading1 by striking in subsequent years2 and 7ii7 by striking 7after fiscal year #bjac72 and 7#b7 in paragraph 7#c71 by striking #bjac through #bjag and inserting #bjah through #bjbb4 #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 7a7-- 7,a7 by striking #bjac and inserting #bjah2 and 7,b7 by striking ,biosimilar ,user ,fee ,act of #bjab and inserting ,biosimilar ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 7#c7 by striking subsection 7d72 7#d7 by redesignating subsection 7e7 as subsection 7d72 and 7#e7 in subsection 7d71 as so redesignated1 by striking #bjag each place it appears and inserting #bjbb4 #dje4 ,sunset dates 7a7 ,authorization ,sections #gdd;,g and #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #djc of this ,act1 shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting ,requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #djd of this ,act1 shall cease to be effective ,january #ca1 #bjbc4 7c7 ,previous ,sunset ,provision 7#a7 ,in general ,effective ,october #a1 #bjag1 section #djd of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is repealed4 7#b7 ,conforming amendment ,the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is amended in the table of contents in section #b by striking the item relating to section #djd4 #djf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 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 shall be assessed for all biosimilar biological product applications received on or after ,october #a1 #bjag1 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 ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to 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 #bjab1 but before ,october #a1 #bjag1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjah4 ,v ,reauthorization of other programs #eja4 ,reauthorization of provision relating 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 #bjag and inserting #bjbb4 #ejb4 ,reauthorization of pediatric humanitarian device exceptions ,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 #bjag and inserting #bjbb4 #ejc4 ,reauthorization of the critical path public-private partnerships ,section #eff7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #ejd4 ,reauthorization of pediatric device consortia ,section #cje7;e7 of ,pediatric ,medical ,device ,safety and ,improvement ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #eje4 ,reauthorization of orphan grants program ,section #e7;c7 of the ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #a4 ,short title ,this ,act may be cited as the ,,fda ,reauthorization ,act of #bjag4 #b4 ,table of contents ,the table of contents for 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 ,authority to assess and use drug fees4,sec4 #ajc4 ,reauthorization2 reporting requirements4,sec4 #ajd4 ,sunset dates4,sec4 #aje4 ,effective date4,sec4 #ajf4 ,savings clause4,,title ,,ii--,fees relating to devices,sec4 #bja4 ,short title2 findings4,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 review4,sec4 #bjg4 ,electronic format for submissions4,sec4 #bjh4 ,savings clause4,sec4 #bji4 ,effective date4,sec4 #baj4 ,sunset clause4,,title ,,iii--,fees relating to generic drugs,sec4 #cja4 ,short title2 finding4,sec4 #cjb4 ,definitions4,sec4 #cjc4 ,authority to assess and use human generic drug fees4,sec4 #cjd4 ,reauthorization2 reporting requirements4,sec4 #cje4 ,sunset dates4,sec4 #cjf4 ,effective date4,sec4 #cjg4 ,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--,pediatric drugs and devices,sec4 #eja4 ,pediatric devices4,sec4 #ejb4 ,pediatric drug development4,sec4 #ejc4 ,guidance on molecular targets in pediatric oncology4,sec4 #ejd4 ,best pharmaceuticals for children4,,title ,,vi--,reauthorizations and improvements related to drugs,sec4 #fja4 ,reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers4,sec4 #fjb4 ,reauthorization of the critical path public-private partnerships4,sec4 #fjc4 ,reauthorization of orphan grants program4,sec4 #fjd4 ,guidance regarding bioequivalence4,sec4 #fje4 ,patient experience data4,sec4 #fjf4 ,communications plans4,sec4 #fjg4 ,protecting and strengthening the drug supply chain4,sec4 #fjh4 ,technical corrections4,,title ,,vii--,device inspection and regulatory improvements,sec4 #gja4 ,risk-based inspections for devices4,sec4 #gjb4 ,improvements to inspections process4,sec4 #gjc4 ,reauthorization of inspection program4,sec4 #gjd4 ,certificates to foreign governments for devices4,sec4 #gje4 ,facilitating international harmonization4,sec4 #gjf4 ,notification of guidance related to lab-developed tests4,sec4 #gjg4 ,diagnostic imaging devices intended for use with contrast agents4,sec4 #gjh4 ,diagnostic clarity4,sec4 #gji4 ,appropriate classification of device accessories4,sec4 #gaj4 ,device pilot projects4,sec4 #gaa4 ,regulation of over-the-counter hearing aids4,,title ,,viii--,additional provisions,sec4 #hja4 ,,gao report4,sec4 #hjb4 ,streamlining and improving consistency in performance reporting4,sec4 #hjc4 ,analysis of use of funds4,sec4 #hjd4 ,information on technology contracting4,sec4 #hje4 ,facilities management4,sec4 #hjf4 ,expanded access4,sec4 #hjg4 ,technical corrections4,,title ,,ix--,generic drug access,subtitle ,a--,removing regulatory barriers to competition ,sec4 #ija4 ,improving access to generic drugs4,sec4 #ijb4 ,reporting on pending generic drug applications1 priority review applications1 and inspections4,subtitle ,b--,incentivizing competition,sec4 #iaa4 ,expediting generic competition4,sec4 #iab4 ,list of generic drugs with limited competition4,sec4 #iac4 ,suitability petitions4,sec4 #iad4 ,inspections4 ,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 #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications1 including postmarket drug safety activities1 as set forth in the goals identified for purposes of part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #ajb4 ,authority to assess and use drug fees 7a7 ,types of fees 7#a7 ,in general ,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 #bjac and inserting fiscal year #bjah2 7,b7 in the heading of paragraph 7#a71 by striking and supplement2 7,c7 in paragraph 7#a71 by striking or a supplement and or supplement each place either appears2 7,d7 in paragraph 7#a77;,a7-- 7i7 in clause 7i71 by striking 7c77#d7 and inserting 7c77#e72 and 7ii7 in clause 7ii71 by striking ,a fee established and all that follows through are required4 and inserting the following3 ,a fee established under subsection 7c77#e7 for a human drug application for which clinical data 7other than bioavailability or bioequivalence studies7 with respect to safety or effectiveness are not required for approval42 7,e7 in the heading of paragraph 7#a77;,c71 by striking or supplement2 7,f7 in paragraph 7#a77;,f7-- 7i7 in the heading1 by striking or indication2 and 7ii7 by striking the second sentence2 7,g7 by striking paragraph 7#b7 7relating to a prescription drug establishment fee72 7,h7 by redesignating paragraph 7#c7 as paragraph 7#b72 7,i7 in the heading of paragraph 7#b71 as so redesignated1 by striking ,prescription drug product fee and inserting ,prescription drug program fee2 7,j7 in subparagraph 7,a7 of such paragraph 7#b71 by amending the first sentence to read as follows3 ,except as provided in subparagraphs 7,b7 and 7,c71 each person who is named as the applicant in a human drug application1 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#e7 for each prescription drug product that is identified in such a human drug application approved as of ,october #a of such fiscal year4 2 7,k7 in subparagraph 7,b7 of such paragraph 7#b7-- 7i7 in the heading of subparagraph 7,b71 by inserting after ,exception the following3 for certain prescription drug products2 and 7ii7 by striking ,a prescription drug product shall not be assessed a fee and inserting ,a prescription drug program fee shall not be assessed for a prescription drug product2 and 7,l7 by adding at the end of such paragraph 7#b7 the following3 7,c7 ,limitation ,a person who is named as the applicant in an approved human drug application shall not be assessed more than #e prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application4 4 7#b7 ,conforming amendment ,subparagraph 7,c7 of section #gdj7;a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;a77#c77 is amended to read as follows3 7,c7 ,limitation ,an establishment shall be assessed only one fee per fiscal year under this section4 4 7b7 ,fee revenue amounts ,subsection 7b7 of section #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7 is amended to read as follows3 7b7 ,fee revenue amounts 7#a7 ,in general ,for each of the fiscal years #bjah through #bjbb1 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 capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#b772 7,d7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#c772 7,e7 the dollar amount equal to the additional direct cost adjustment for the fiscal year 7as determined under subsection 7c77#d772 and 7,f7 additional dollar amounts for each fiscal year as follows3 7i7 #bj1jgg1gic for fiscal year #bjah2 7ii7 #ba1cag1dgb for fiscal year #bjai2 7iii7 #af1iec1cbi for fiscal year #bjbj2 7iv7 #e1dbf1hif for fiscal year #bjba2 and 7v7 #b1gfi1fji for fiscal year #bjbb4 7#b7 ,types of fees ,of the total revenue amount determined for a fiscal year under paragraph 7#a7-- 7,a7 #bj percent shall be derived from human drug application fees under subsection 7a77#a72 and 7,b7 #hj percent shall be derived from prescription drug program fees under subsection 7a77#b74 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 #bjah1 #hgh1eij1jjj2 and 7,b7 for fiscal years #bjai through #bjbb1 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#c7 or 7c77#d74 4 7c7 ,adjustments2 annual fee setting ,subsection 7c7 of section #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7 is amended to read as follows3 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#a77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b77#a77;,a72 and 7ii7 the inflation adjustment percentage under subparagraph 7,b74 7,b7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of-- 7i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications 7as defined in section #gce7f77 for the first #c years of the preceding #d fiscal years2 and 7ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications 7as defined in section #gce7f77 for the first #c years of the preceding #d fiscal years4 7#b7 ,capacity planning adjustment 7,a7 ,in general ,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 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 ,interim methodology 7i7 ,in general ,until the capacity planning methodology described in subparagraph 7,c7 is effective1 the adjustment under this paragraph for a fiscal year shall be based on the product of-- 7,i7 the annual base revenue for such year1 as adjusted for inflation under paragraph 7#a72 and 7,,ii7 the adjustment percentage under clause 7ii74 7ii7 ,adjustment percentage ,the adjustment percentage under this clause for a fiscal year is the weighted change in the #c-year average ending in the most recent year for which data are available1 over the #c-year average ending in the previous year1 for-- 7,i7 the total number of human drug applications1 efficacy supplements1 and manufacturing supplements submitted to the ,secretary2 7,,ii7 the total number of active commercial investigational new drug applications2 and 7,,iii7 the total number of formal meetings scheduled by the ,secretary1 and written responses issued by the ,secretary in lieu of such formal meetings1 as identified in section ,i4,h of the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag4 7,c7 ,capacity planning methodology 7i7 ,development2 evaluation and report ,the ,secretary shall obtain1 through a contract with an independent accounting or consulting firm1 a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications4 ,the capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input4 ,the report shall be published for public comment no later than the end of fiscal year #bjbj4 7ii7 ,establishment and implementation ,after review of the report described in clause 7i7 and any public comments thereon1 the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7,i7 replace the interim methodology under subparagraph 7,b72 7,,ii7 incorporate such approaches and attributes as the ,secretary determines appropriate2 and 7,,iii7 be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established4 7,d7 ,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 year7 and 7b77#a77;,b7 7the dollar amount of the inflation adjustment for the fiscal year74 7,e7 ,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#c7 ,operating reserve adjustment 7,a7 ,increase ,for fiscal year #bjah and subsequent fiscal years1 the ,secretary may1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than #ad weeks of operating reserves of carryover user fees for the process for the review of human drug applications4 7,b7 ,decrease ,if the ,secretary has carryover balances for such process in excess of #ad weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #ad weeks of such operating reserves4 7,c7 ,notice of rationale ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e7 establishing fee revenue and fees for the fiscal year involved4 7#d7 ,additional direct cost adjustment 7,a7 ,in general ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees-- 7i7 for fiscal year #bjah1 by #h1gcj1jjj2 and 7ii7 for fiscal year #bjai and subsequent fiscal years1 by the amount determined under subparagraph 7,b74 7,b7 ,amount ,the amount determined under this subparagraph is-- 7i7 #h1gcj1jjj1 multiplied by 7ii7 the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all ,items2 ,annual ,index7 for the most recent year of available data1 divided by such ,index for #bjaf4 7#e7 ,annual fee setting ,the ,secretary shall1 not later than #fj days before the start of each fiscal year that begins after ,september #cj1 #bjag-- 7,a7 establish1 for the next fiscal year1 human drug application fees and prescription drug program fees under subsection 7a71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under this subsection2 and 7,b7 publish such fee revenue and fees in the ,federal ,register4 7#f7 ,limit ,the total amount of fees charged1 as adjusted under this subsection1 for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications4 4 7d7 ,fee waiver or reduction ,section #gcf7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7d77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by inserting or at the end of subparagraph 7,b72 7,b7 by striking subparagraph 7,c72 and 7,c7 by redesignating subparagraph 7,d7 as subparagraph 7,c72 7#b7 by striking paragraph 7#c7 7relating to use of standard costs72 7#c7 by redesignating paragraph 7#d7 as paragraph 7#c72 and 7#d7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraphs 7,a7 and 7,b71 by striking paragraph 7#a77;,d7 and inserting paragraph 7#a77;,c72 and 7,b7 in subparagraph 7,b7-- 7i7 by striking clause 7ii72 7ii7 by striking shall pay through 7i7 application fees and inserting shall pay application fees2 and 7iii7 by striking 2 and at the end and inserting a period4 7e7 ,effect of failure ,to pay fees ,section #gcf7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7e77 is amended by striking all fees and inserting all such fees4 7f7 ,limitations ,section #gcf7;f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7f77#b77 is amended by striking supplements1 prescription drug establishments1 and prescription drug products and inserting prescription drug program fees4 7g7 ,crediting and availability of fees ,section #gcf7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77 is amended-- 7#a7 in paragraph 7#c7-- 7,a7 by striking #bjac through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking and paragraph 7#d7 of this subsection2 and 7#b7 by striking paragraph 7#d74 7h7 ,orphan drugs ,section #gcf7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is amended by striking product and establishment fees each place it appears and inserting prescription drug program fees4 #ajc4 ,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#a7-- 7,a7 in the matter before subparagraph 7,a71 by striking #bjac and inserting #bjah2 and 7,b7 in subparagraph 7,a71 by striking ,prescription ,drug ,user ,fee ,amendments of #bjab and inserting ,prescription ,drug ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 and 7#c7 in subsection 7d71 by striking #bjag each place it appears and inserting #bjbb4 #ajd4 ,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 #bjbb4 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 #bjbc4 7c7 ,previous ,sunset ,provision ,effective ,october #a1 #bjag1 subsections 7a7 and 7b7 of section #aje of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 are repealed4 #aje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 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 shall be assessed for all human drug applications received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #ajf4 ,savings clause ,notwithstanding the amendments made by this title1 part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to human drug applications and supplements 7as defined in such part as of such day7 that on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 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 #bjah4 ,,ii ,fees relating to devices #bja4 ,short title2 findings 7a7 ,short ,title ,this title may be cited as the ,medical ,device ,user ,fee ,amendments of #bjag4 7b7 ,findings ,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 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 by redesignating paragraphs 7#h7 through 7#ac7 as paragraphs 7#i7 through 7#ad71 respectively2 7#b7 by inserting after paragraph 7#g7 the following new paragraph3 7#h7 ,the term de novo classification request means a request made under section #eac7;f77#b77;,a7 with respect to the classification of a device4 2 7#c7 in subparagraph 7,d7 of paragraph 7#aj7 7as redesignated by paragraph 7#a771 by striking and submissions and inserting submissions1 and de novo classification requests2 and 7#d7 in paragraph 7#aa7 7as redesignated by paragraph 7#a771 by striking #bjaa and inserting #bjaf4 #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 #bjac and inserting fiscal year #bjah2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking ,october #a1 #bjab and inserting ,october #a1 #bjag2 7ii7 in clause 7viii71 by striking #b and inserting #c4d2 and 7iii7 by adding at the end the following new clause3 7xi7 ,for a de novo classification request1 a fee equal to #cj percent of the fee that applies under clause 7i74 2 and 7,b7 in subparagraph 7,b77v77,i71 by striking or premarket notification submission and inserting premarket notification submission1 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 to read as follows3 7b7 ,fee ,amounts 7#a7 ,in ,general ,subject to subsections 7c71 7d71 7e71 and 7h71 for each of fiscal years #bjah through #bjbb1 fees under subsection 7a7 shall be derived from the base fee amounts specified in paragraph 7#b71 to generate the total revenue amounts specified in paragraph 7#c74 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 #bjah;,fiscal ,year #bjai;,fiscal ,year #bjbj;,fiscal ,year #bjba;,fiscal ,year #bjbb,premarket ,application#bid1jjjcjj1jjjcaj1jjjcbh1jj jcbi1jjj;,establishment ,registration#d1cged1edhd1gfjd1iged1igh 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 #ahc1bhj1gef for fiscal year #bjah4 7,b7 #aij1fed1hge for fiscal year #bjai4 7,c7 #bjj1acb1jad for fiscal year #bjbj4 7,d7 #baa1gdh1ghi for fiscal year #bjba4 7,e7 #bac1fhg1ffj for fiscal year #bjbb4 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 #bjab and inserting #bjag2 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by striking #bjad and inserting #bjah2 7,b7 by striking subparagraph 7,b7 and inserting the following new subparagraph3 7,b7 ,applicable inflation adjustment ,the applicable inflation adjustment for fiscal year #bjah and each subsequent fiscal year is the product of-- 7i7 the base inflation adjustment under subparagraph 7,c7 for such fiscal year2 and 7ii7 the product of the base inflation adjustment under subparagraph 7,c7 for each of the fiscal years preceding such fiscal year1 beginning with fiscal year #bjaf4 2 7,c7 in subparagraph 7,c71 in the heading1 by striking to total revenue amounts2 and 7,d7 by amending subparagraph 7,d7 to read as follows3 7,d7 ,adjustment to base fee amounts ,for each of fiscal years #bjah through #bjbb1 the ,secretary shall-- 7i7 adjust the base fee amounts specified in subsection 7b77#b7 for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph 7,b7 for such year2 and 7ii7 if the ,secretary determines necessary1 increase 7in addition to the adjustment under clause 7i77 such base fee amounts1 on a uniform proportionate basis1 to generate the total revenue amounts under subsection 7b77#c71 as adjusted for inflation under subparagraph 7,a74 2 and 7#c7 in paragraph 7#c7-- 7,a7 by striking #bjad through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking further adjusted and inserting increased4 7d7 ,small businesses2 ,fee ,waiver and ,fee ,reduction ,regarding ,premarket ,approval ,fees ,section #gch7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7d77 is amended-- 7#a7 in paragraph 7#a71 by striking specified in clauses 7i7 through 7v7 and clauses 7vii71 7ix71 and 7x7 and inserting specified in clauses 7i7 through 7vii7 and clauses 7ix71 7x71 and 7xi72 and 7#b7 in paragraph 7#b77;,c7-- 7,a7 by striking supplement1 or and inserting supplement12 and 7,b7 by inserting 1 or a de novo classification request after class ,,iii device4 7e7 ,small ,businesses2 ,fee ,reduction ,regarding ,premarket ,notification ,submissions ,section #gch7;e77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7e77#b77;,c77 is amended by striking #ej and inserting #be4 7f7 ,fee ,waiver or ,reduction 7#a7 ,repeal ,section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended by striking subsection 7f74 7#b7 ,conforming changes 7,a7 ,section #eae7;c77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7c77#d77;,a77 is amended by striking #gch7;h7 and inserting #gch7;g74 7,b7 ,section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j71 as amended by paragraph 7#a71 is further amended-- 7i7 by redesignating subsections 7g7 through 7l7 as subsections 7f7 through 7k72 7ii7 in subsection 7a77#b77;,a71 by striking 7d71 7e71 and 7f7 and inserting 7d7 and 7e72 and 7iii7 in subsection 7a77#c77;,a71 by striking and subsection 7f74 7g7 ,effect of failure ,to pay fees ,subsection 7f77#a71 as redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended-- 7#a7 by striking or periodic reporting concerning a class ,,iii device and inserting periodic reporting concerning a class ,,iii device1 or de novo classification request2 and 7#b7 by striking all fees and inserting all such fees4 7h7 ,conditions ,subsection 7g77#a77;,a71 as redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended by striking #bhj1ehg1jjj and inserting #cbj1hbe1jjj4 7i7 ,crediting and ,availability of ,fees ,subsection 7h71 as redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended-- 7#a7 in paragraph 7#c7-- 7,a7 by striking #bjac through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking subsection 7c7 and all that follows through the period at the end and inserting subsection 7c742 and 7#b7 by striking paragraph 7#d74 #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 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking #bjac and inserting #bjah2 and 7ii7 by striking the ,medical ,device ,user ,fee ,amendments of #bjab and inserting ,medical ,device ,user ,fee ,amendments of #bjag2 and 7,b7 in subparagraph 7,b71 by striking the ,medical ,device ,user ,fee ,amendments of #bjab and inserting ,medical ,device ,user ,fee ,amendments of #bjag2 and 7#b7 in paragraph 7#b71 by striking #bjac through #bjag and inserting #bjah through #bjbb4 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 #bjag and inserting #bjbb2 and 7#b7 in paragraph 7#e71 by striking #bjag and inserting #bjbb4 #bje4 ,conformity assessment pilot program 7a7 ,in general ,section #ead of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7 is amended by adding at the end the following3 7d7 ,pilot accreditation scheme for conformity assessment 7#a7 ,in general ,the ,secretary shall establish a pilot program under which-- 7,a7 testing laboratories may be accredited1 by accreditation bodies meeting criteria specified by the ,secretary1 to assess the conformance of a device with certain standards recognized under this section2 and 7,b7 subject to paragraph 7#b71 determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the ,secretary for purposes of demonstrating such conformity under this section unless the ,secretary finds that a particular such determination shall not be so accepted4 7#b7 ,secretarial review of accredited laboratory determinations ,the ,secretary may-- 7,a7 review determinations by testing laboratories accredited pursuant to this subsection1 including by conducting periodic audits of such determinations or processes of accredited bodies or testing laboratories and1 following such review1 taking additional measures under this ,act1 such as suspension or withdrawal of accreditation of such testing laboratory under paragraph 7#a77;,a7 or requesting additional information with respect to such device1 as the ,secretary determines appropriate2 and 7,b7 if the ,secretary becomes aware of information materially bearing on safety or effectiveness of a device assessed for conformity by a testing laboratory so accredited1 take such additional measures under this ,act as the ,secretary determines appropriate1 such as suspension or withdrawal of accreditation of such testing laboratory under paragraph 7#a77;,a71 or requesting additional information with regard to such device4 7#c7 ,implementation and reporting 7,a7 ,public meeting ,the ,secretary shall publish in the ,federal ,register a notice of a public meeting to be held no later than ,september #cj1 #bjah1 to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of1 and a suitable framework and procedures and requirements for1 the pilot program under this subsection4 7,b7 ,pilot program guidance ,the ,secretary shall-- 7i7 not later than ,september #cj1 #bjai1 issue draft guidance regarding the goals and implementation of the pilot program under this subsection2 and 7ii7 not later than ,september #cj1 #bjba1 issue final guidance with respect to the implementation of such program4 7,c7 ,pilot program initiation ,not later than ,september #cj1 #bjbj1 the ,secretary shall initiate the pilot program under this subsection4 7,d7 ,report ,the ,secretary shall make available on the website of the ,food and ,drug ,administration an annual report on the progress of the pilot program under this subsection4 7#d7 ,sunset ,as of ,october #a1 #bjbb-- 7,a7 the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph 7#a77;,a7 shall cease to have force or effect2 7,b7 the ,secretary-- 7i7 may not accept a determination pursuant to paragraph 7#a77;,b7 made by a testing laboratory after such date2 and 7ii7 may accept such a determination made prior to such date2 7,c7 except for purposes of accepting a determination described in subparagraph 7,b77ii71 the ,secretary shall not continue to recognize the accreditation of testing laboratories accredited under paragraph 7#a77;,a72 and 7,d7 the ,secretary may take actions in accordance with paragraph 7#b7 with respect to the determinations made prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date4 4 #bjf4 ,reauthorization of review ,section #ebc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7 is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 in subparagraph 7,a71 by striking clauses 7ii7 and 7iii7 and inserting the following3 7ii7 a device classified under section #eac7;f77#b7 or designated under section #eae;,c7d72 7iii7 a device that is intended to be life sustaining or life supporting1 unless otherwise determined by the ,secretary in accordance with subparagraph 7,b77i77,,ii7 and listed as eligible for review under subparagraph 7,b77iii72 or 7iv7 a device that is of a type1 or subset of a type1 listed as not eligible for review under subparagraph 7,b77iii74 2 7,b7 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,designation for review ,the ,secretary shall-- 7i7 issue draft guidance on the factors the ,secretary will use in determining whether a class ,i or class ,,ii device type1 or subset of such device types1 is eligible for review by an accredited person1 including-- 7,i7 the risk of the device type1 or subset of such device type2 and 7,,ii7 whether the device type1 or subset of such device type1 is permanently implantable1 life sustaining1 or life supporting1 and whether there is a detailed public health justification for permitting the review by an accredited person of a specific life sustaining or life supporting device2 7ii7 not later than #bd months after the date on which the ,secretary issues such draft guidance1 finalize such guidance2 and 7iii7 beginning on the date such guidance is finalized1 designate and post on the ,internet website of the ,food and ,drug ,administration1 an updated list of class ,i and class ,,ii device types1 or subsets of such device types1 and the ,secretary's determination with respect to whether each such device type1 or subset of a device type1 is eligible or not eligible for review by an accredited person under this section based on the factors described in clause 7i74 2 and 7,c7 by adding at the end the following3 7,c7 ,interim rule ,until the date on which the updated list is designated and posted in accordance with subparagraph 7,b77iii71 the list in effect on the date of enactment the ,medical ,device ,user ,fee ,amendments of #bjag shall be in effect4 2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b7-- 7i7 by striking subparagraph 7,d72 and 7ii7 by redesignating subparagraph 7,e7 as subparagraph 7,d72 and 7,b7 in paragraph 7#c7-- 7i7 by redesignating subparagraph 7,e7 as subparagraph 7,f72 7ii7 in subparagraph 7,f7 7as so redesignated71 by striking ,the operations of and all that follows through it will-- and inserting ,such person shall agree1 at a minimum1 to include in its request for accreditation a commitment to1 at the time of accreditation1 and at any time it is performing any review pursuant to this section--2 and 7iii7 by inserting after subparagraph 7,d7 the following new subparagraph3 7,e7 ,the operations of such person shall be in accordance with generally accepted professional and ethical business practices4 2 and 7#c7 in subsection 7c71 by striking #bjag and inserting #bjbb4 #bjg4 ,electronic format for submissions ,section #gde;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgik-#a7;b77 is amended by adding at the end the following new paragraph3 7#c7 ,presubmissions and submissions solely in electronic format 7,a7 ,in general ,beginning such date as the ,secretary specifies in final guidance issued under subparagraph 7,c71 presubmissions and submissions for devices described in paragraph 7#a7 7and any appeals of action taken by the ,secretary with respect to such presubmissions or submissions7 shall be submitted solely in such electronic format as specified by the ,secretary in such guidance4 7,b7 ,draft guidance ,the ,secretary shall1 not later than ,october #a1 #bjai1 issue draft guidance providing for-- 7i7 any further standards for the submission by electronic format required under subparagraph 7,a72 7ii7 a timetable for the establishment by the ,secretary of such further standards2 and 7iii7 set forth criteria for waivers of and exemptions from the requirements of this subsection4 7,c7 ,final guidance ,the ,secretary shall1 not later than #a year after the close of the public comment period on the draft guidance issued under subparagraph 7,b71 issue final guidance4 4 #bjh4 ,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 #bjab1 but before ,october #a1 #bjag1 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 #bjah4 #bji4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 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 shall be assessed for all submissions listed in section #gch7;a77#b77;,a7 of such ,act received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #baj4 ,sunset clause 7a7 ,authorization ,sections #gcg and #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #gci;i2 #gci;j7 shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting requirements ,section #gch;,a 7#ba ,u4,s4,c4 #gci;j-#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7regarding reauthorization and reporting requirements7 shall cease to be effective ,january #ca1 #bjbc4 7c7 ,previous ,sunset ,provision 7#a7 ,in general ,effective ,october #a1 #bjag1 section #bjg7;a7 of the ,medical ,device ,user ,fee ,amendments of #bjab 7,public ,law #aab-add7 is repealed4 7#b7 ,conforming amendment ,the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is amended in the table of contents in section #b by striking the item relating to section #bjg4 ,,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 #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities1 as set forth in the goals identified for purposes of part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #cjb4 ,definitions ,section #gdd;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da7 is amended-- 7#a7 in paragraph 7#a77;,b71 by striking application for a positron emission tomography drug4 and inserting 8application-- 7i7 for a positron emission tomography drug2 or 7ii7 submitted by a ,state or ,federal governmental entity for a drug that is not distributed commercially4 2 7#b7 by redesignating paragraphs 7#e7 through 7#ab7 as paragraphs 7#f7 through 7#ac71 respectively2 and 7#c7 by inserting after paragraph 7#d7 the following3 7#e7 ,the term contract manufacturing organization facility means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application1 where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility4 4 #cjc4 ,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 #bjac and inserting fiscal year #bjah2 7#b7 in paragraph 7#a71 by adding at the end the following3 7,e7 ,sunset ,this paragraph shall cease to be effective ,october #a1 #bjbb4 2 7#c7 in paragraph 7#b7-- 7,a7 by amending subparagraph 7,c7 to read as follows3 7,c7 ,notice ,not later than #fj days before the start of each of fiscal years #bjah through #bjbb1 the ,secretary shall publish in the ,federal ,register the amount of the drug master file fee established by this paragraph for such fiscal year4 2 and 7,b7 in subparagraph 7,e7-- 7i7 in clause 7i7-- 7,i7 by striking no later than the date and inserting 8on the earlier of-- 7,i7 the date 2 7,,ii7 by striking the period and inserting 2 or2 and 7,,iii7 by adding at the end the following3 7,,ii7 the date on which the drug master file holder requests the initial completeness assessment4 2 and 7ii7 in clause 7ii71 by striking notice provided for in clause 7i7 or 7ii7 of subparagraph 7,c71 as applicable and inserting notice provided for in subparagraph 7,c72 7#d7 in paragraph 7#c7-- 7,a7 in the heading1 by striking and prior approval supplement2 7,b7 in subparagraph 7,a71 by striking or a prior approval supplement to an abbreviated new drug application2 7,c7 by amending subparagraphs 7,b7 and 7,c7 to read as follows3 7,b7 ,notice ,not later than #fj days before the start of each of fiscal years #bjah through #bjbb1 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 7,c7 ,fee due date ,the fees required by subparagraphs 7,a7 and 7,f7 shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies4 2 7,d7 in subparagraph 7,d7-- 7i7 in the heading1 by inserting 1 is withdrawn prior to being received1 or is no longer received after received2 and 7ii7 by striking ,the ,secretary shall and all that follows through the period and inserting the following3 7i7 ,applications not considered to have been received and applications withdrawn prior to being received ,the ,secretary shall refund #ge percent of the fee paid under subparagraph 7,a7 for any abbreviated new drug application that the ,secretary considers not to have been received within the meaning of section #eje7;j77#e77;,a7 for a cause other than failure to pay fees1 or that has been withdrawn prior to being received within the meaning of section #eje7;j77#e77;,a74 7ii7 ,applications no longer received ,the ,secretary shall refund #ajj percent of the fee paid under subparagraph 7,a7 for any abbreviated new drug application if the ,secretary initially receives the application under section #eje7;j77#e77;,a7 and subsequently determines that an exclusivity period for a listed drug should have prevented the ,secretary from receiving such application1 such that the abbreviated new drug application is no longer received within the meaning of section #eje7;j77#e77;,a74 2 7,e7 in subparagraph 7,e71 by striking or prior approval supplement2 and 7,f7 in the matter preceding clause 7i7 of subparagraph 7,f7-- 7i7 by striking #bjab and inserting #bjag2 and 7ii7 by striking subsection 7d77#c7 and inserting subsection 7d77#b72 7#e7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i7 and in clause 7iii71 by striking 1 or intended to be identified1 in at least one generic drug submission that is pending or and inserting in at least one generic drug submission that is2 7ii7 in clause 7i71 by striking or intended to be identified in at least one generic drug submission that is pending or and inserting in at least one generic drug submission that is2 7iii7 in clause 7ii71 by striking produces1 and all that follows through such a and inserting is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a ,type ,,ii active pharmaceutical ingredient drug master file referenced in at least one such2 and 7iv7 in clause 7iii71 by striking to fees under both such clauses and inserting only to the fee attributable to the manufacture of the finished dosage forms2 and 7,b7 by amending subparagraphs 7,c7 and 7,d7 to read as follows3 7,c7 ,notice ,within the timeframe specified in subsection 7d77#a71 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 4 7,d7 ,fee due date ,for each of fiscal years #bjah through #bjbb1 the fees under subparagraph 7,a7 for such fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such year2 or 7ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees for such year under this section for such year4 2 7#f7 by redesignating paragraph 7#e7 as paragraph 7#f72 and 7#g7 by inserting after paragraph 7#d7 the following3 7#e7 ,generic drug applicant program fee 7,a7 ,in general ,a generic drug applicant program fee shall be assessed annually as described in subsection 7b77#b77;,e74 7,b7 ,amount ,the amount of fees established under subparagraph 7,a7 shall be established under subsection 7d74 7,c7 ,notice ,within the timeframe specified in subsection 7d77#a71 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 7,d7 ,fee due date ,for each of fiscal years #bjah through #bjbb1 the fees under subparagraph 7,a7 for such fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such fiscal year2 or 7ii7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year4 4 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 #bjac and inserting #bjah2 7ii7 by striking #bjac and inserting #bjah2 7iii7 by striking #bii1jjj1jjj and inserting #dic1fjj1jjj2 and 7iv7 by striking ,of that amount and all that follows through the end of clause 7ii72 and 7,b7 in subparagraph 7,b7-- 7i7 in the heading1 by striking #bjad through #bjag and inserting #bjai through #bjbb2 7ii7 by striking #bjad through #bjag and inserting #bjai through #bjbb2 7iii7 by striking paragraphs 7#b7 through 7#d7 and inserting paragraphs 7#b7 through 7#e72 and 7iv7 by striking #bii1jjj1jjj and inserting #dic1fjj1jjj2 and 7#b7 in paragraph 7#b7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking paragraph 7#a77;,a77ii7 for fiscal year #bjac and paragraph 7#a77;,b7 for each of fiscal years #bjad through #bjag and inserting such paragraph for a fiscal year2 and 7ii7 by striking through 7#d7 and inserting through 7#e72 7,b7 in subparagraph 7,a71 by striking ,six percent and inserting ,five percent2 7,c7 by amending subparagraphs 7,b7 and 7,c7 to read as follows3 7,b7 ,thirty-three percent shall be derived from fees under subsection 7a77#c7 7relating to abbreviated new drug applications74 7,c7 ,twenty percent shall be derived from fees under subsection 7a77#d77;,a77i7 7relating to generic drug facilities74 ,the amount of the fee for a contract manufacturing organization facility shall be equal to one-third the amount of the fee for a facility that is not a contract manufacturing organization facility4 ,the amount of the fee for a facility located outside the ,united ,states and its territories and possessions shall be #ae1jjj higher than the amount of the fee for a facility located in the ,united ,states and its territories and possessions4 2 7,d7 in subparagraph 7,d7-- 7i7 by striking ,fourteen percent and inserting ,seven percent2 7ii7 by striking not less than #ae1jjj and not more than #cj1jjj and inserting #ae1jjj2 and 7iii7 by striking 1 as determined and all that follows through the period at the end and inserting a period2 and 7,e7 by adding at the end the following3 7,e7 7i7 ,thirty-five percent shall be derived from fees under subsection 7a77#e7 7relating to generic drug applicant program fees74 ,for purposes of this subparagraph1 if a person has affiliates1 a single program fee shall be assessed with respect to that person1 including its affiliates1 and may be paid by that person or any one of its affiliates4 ,the ,secretary shall determine the fees as follows3 7,i7 ,if a person 7including its affiliates7 owns at least one but not more than #e approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee4 7,,ii7 ,if a person 7including its affiliates7 owns at least #f but not more than #ai approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee4 7,,iii7 ,if a person 7including its affiliates7 owns #bj or more approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a large size operation generic drug applicant program fee4 7ii7 ,for purposes of this subparagraph1 an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by ,april #a of the previous fiscal year4 4 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 by striking #bjad and inserting #bjai2 7,b7 by inserting to equal the product of the total revenues established in such notice for the prior fiscal year multiplied after a fiscal year12 and 7,c7 by striking the flush text following subparagraph 7,c72 and 7#b7 in paragraph 7#b7-- 7,a7 by striking #bjag each place it appears and inserting #bjbb2 and 7,b7 by striking #bjah and inserting #bjbc4 7d7 ,annual fee setting ,section #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7 is amended-- 7#a7 in subsection 7c77#b71 by striking ,such fees may only be used in fiscal year #bjah42 and 7#b7 in subsection 7d7-- 7,a7 by striking paragraphs 7#a7 and 7#b7 and inserting the following3 7#a7 ,fiscal years #bjah through #bjbb ,not more than #fj days before the first day of each of fiscal years #bjah through #bjbb1 the ,secretary shall establish the fees described in paragraphs 7#b7 through 7#e7 of subsection 7a71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under subsection 7c74 2 7,b7 by redesignating paragraph 7#c7 as paragraph 7#b72 and 7,c7 in paragraph 7#b7 7as so redesignated71 in the matter preceding subparagraph 7,a71 by striking fees under paragraphs 7#a7 and 7#b7 and inserting fee under paragraph 7#a74 7e7 ,identification of facilities ,section #gdd;,b7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;f77 is amended-- 7#a7 by striking paragraph 7#a72 7#b7 by redesignating paragraphs 7#b7 through 7#d7 as paragraphs 7#a7 through 7#c71 respectively2 7#c7 in paragraph 7#a7 7as so redesignated7-- 7,a7 by striking paragraph 7#d7 and inserting paragraph 7#c72 and 7,b7 by striking ,such information shall and all that follows through the end of subparagraph 7,b7 and inserting ,such information shall1 for each fiscal year1 be submitted1 updated1 or reconfirmed on or before ,june #a of the previous fiscal year42 and 7#d7 in paragraph 7#b71 as so redesignated-- 7,a7 in the heading1 by striking ,contents of notice and inserting ,information required to be submitted2 7,b7 in the matter preceding subparagraph 7,a71 by striking paragraph 7#b7 and inserting paragraph 7#a72 7,c7 in subparagraph 7,a71 by striking or intended to be identified2 7,d7 in subparagraph 7,d71 by striking and at the end2 7,e7 in subparagraph 7,e71 by striking the period and inserting 2 and2 and 7,f7 by adding at the end the following3 7,f7 whether the facility is a contract manufacturing organization facility4 4 7f7 ,effect of failure ,to pay fees ,section #gdd;,b7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7;g77 is amended-- 7#a7 in paragraph 7#a71 by adding at the end the following3 ,this paragraph shall cease to be effective on ,october #a1 #bjbb42 7#b7 in paragraph 7#b77;,c77ii71 by striking of #eje7;j77#e77;,a7 and inserting of section #eje7;j77#e77;,a72 and 7#c7 by adding at the end the following3 7#e7 ,generic drug applicant program fee 7,a7 ,in general ,a person who fails to pay a fee as required under subsection 7a77#e7 by the date that is #bj calendar days after the due date1 as specified in subparagraph 7,d7 of such subsection1 shall be subject to the following3 7i7 ,the ,secretary shall place the person on a publicly available arrears list4 7ii7 ,any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received1 within the meaning of section #eje7;j77#e77;,a74 7iii7 ,all drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section #ejb7;aa74 7,b7 ,application of penalties ,the penalties under subparagraph 7,a7 shall apply until the fee required under subsection 7a77#e7 is paid4 4 7g7 ,limitations ,section #gdd;,b7h77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7;h77#b77 is amended by striking for ,type ,,ii active pharmaceutical ingredient drug master files1 abbreviated new drug applications and prior approval supplements1 and generic drug facilities and active pharmaceutical ingredient facilities4 7h7 ,crediting and availability of fees ,section #gdd;,b7i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7;i77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by striking subparagraph 7,c7 7relating to fee collection during first program year72 7,b7 in subparagraph 7,d7-- 7i7 in the heading1 by striking in subsequent years2 and 7ii7 by striking 7after fiscal year #bjac72 and 7,c7 by redesignating subparagraph 7,d7 as subparagraph 7,c72 and 7#b7 in paragraph 7#c71 by striking fiscal years #bjac through #bjag and inserting fiscal years #bjah through #bjbb4 7i7 ,information on abbreviated new drug applications held by applicants and their affiliates ,section #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi-db7 is amended by adding at the end the following3 7o7 ,information on abbreviated new drug applications owned by applicants and their affiliates 7#a7 ,in general ,by ,april #a of each year1 each person that owns an abbreviated new drug application1 or any affiliate of such person1 shall submit to the ,secretary a list of-- 7,a7 all approved abbreviated new drug applications owned by such person2 and 7,b7 if any affiliate of such person also owns an abbreviated new drug application1 all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate4 7#b7 ,format and method ,the ,secretary shall specify in guidance the format and method for submission of lists under this subsection4 4 #cjd4 ,reauthorization2 reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking #bjac and inserting #bjah2 and 7,b7 by striking ,generic ,drug ,user ,fee ,amendments of #bjab and inserting ,generic ,drug ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 and 7#c7 in subsection 7d71 by striking #bjag each place it appears and inserting #bjbb4 #cje4 ,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 #bjbb4 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 #bjbc4 7c7 ,previous sunset provision ,effective ,october #a1 #bjag1 subsections 7a7 and 7b7 of section #cjd of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 are repealed4 #cjf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be assessed for all abbreviated new drug applications received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #cjg4 ,savings clause ,notwithstanding the amendments made by this title1 part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to abbreviated new drug applications 7as defined in such part as of such day7 that on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 were received by the ,food and ,drug ,administration within the meaning of #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 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjah4 ,,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 #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications1 including postmarket safety activities1 as set forth in the goals identified for purposes of part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #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 all urban consumers 7all items2 ,united ,states city average7 7,washington-,baltimore1 ,,dc-,,md1 ,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items7 for ,october of the preceding fiscal year divided by such ,index for ,october #bjaa divided by such index for ,september #bjaa4 4 7b7 ,biosimilar biological product ,section #gdd;,g7#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7c77 is amended by striking means a product and inserting means a specific strength of a biological product in final dosage form4 #djc4 ,authority to assess and use biosimilar fees 7a7 ,types of fees ,section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking fiscal year #bjac and inserting fiscal year #bjah2 7#b7 in the heading of paragraph 7#a71 by striking ,biosimilar and inserting ,biosimilar biological product2 7#c7 in paragraph 7#a77;,a77i71 by striking 7b77#a77;,a7 and inserting 7c77#e72 7#d7 in paragraph 7#a77;,b77i71 by striking 7b77#a77;,b7 for biosimilar biological product development and inserting 7c77#e7 for the biosimilar biological product development program2 7#e7 in paragraph 7#a77;,b77ii71 by striking annual biosimilar biological product development program fee and inserting annual biosimilar biological product development fee2 7#f7 in paragraph 7#a77;,b77iii71 by striking annual biosimilar development program fee and inserting annual biosimilar biological product development fee2 7#g7 in paragraph 7#a77;,b71 by adding at the end the following3 7iv7 ,refund ,if a person submits a marketing application for a biosimilar biological product before ,october #a of a fiscal year and such application is accepted for filing on or after ,october #a of such fiscal year1 the person may request a refund equal to the annual biosimilar development fee paid by the person for the product for such fiscal year4 ,to qualify for consideration for a refund under this clause1 a person shall submit to the ,secretary a written request for such refund not later than #ahj days after the marketing application is accepted for filing4 2 7#h7 in paragraph 7#a77;,c71 by striking for a product effective ,october #a of a fiscal year by1 and inserting for a product1 effective ,october #a of a fiscal year1 by12 7#i7 in paragraph 7#a77;,d7-- 7,a7 in clause 7i7 in the matter preceding subclause 7,i71 by inserting 1 if the person seeks to resume participation in such program1 before pay a fee2 7,b7 in clause 7i77,i71 by inserting after grants a request the following3 by such person2 and 7,c7 in clause 7i77,,ii71 by inserting after discontinued7 the following3 by such person2 7#aj7 in the heading of paragraph 7#a77;,e71 by striking biosimilar development program2 7#aa7 in the heading of subparagraph 7,f7 of paragraph 7#a71 by striking biosimilar development program fees and inserting biosimilar biological product development fees2 7#ab7 in paragraph 7#a77;,f7-- 7,a7 in the heading of subparagraph 7,f71 by striking biosimilar development program before fees2 and 7,b7 by amending clause 7i7 to read as follows3 7i7 ,refunds ,except as provided in subparagraph 7,b77iv71 the ,secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph 7,a7 or 7,b71 or any reactivation fee paid under subparagraph 7,d74 2 7#ac7 in paragraph 7#b7-- 7,a7 in the heading of paragraph 7#b71 by striking and supplement2 7,b7 by amending subparagraphs 7,a7 and 7,b7 to read as follows3 7,a7 ,in general ,each person that submits1 on or after ,october #a1 #bjag1 a biosimilar biological product application shall be subject to the following fees3 7i7 ,a fee established under subsection 7c77#e7 for a biosimilar biological product application for which clinical data 7other than comparative bioavailability studies7 with respect to safety or effectiveness are required for approval4 7ii7 ,a fee established under subsection 7c77#e7 for a biosimilar biological product application for which clinical data 7other than comparative bioavailability studies7 with respect to safety or effectiveness are not required for approval4 ,such fee shall be equal to half of the amount of the fee described in clause 7i74 7,b7 ,rule of applicability2 treatment of certain previously paid fees ,any person who pays a fee under subparagraph 7,a71 7,b71 or 7,d7 of paragraph 7#a7 for a product before ,october #a1 #bjag1 but submits a biosimilar biological product application for that product after such date1 shall-- 7i7 be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted2 and 7ii7 be entitled to no reduction of such application fees based on the amount of fees paid for that product before ,october #a1 #bjag1 under such subparagraph 7,a71 7,b71 or 7,d74 2 7,c7 in the heading of subparagraph 7,d71 by striking or supplement2 and 7,d7 in subparagraphs 7,c7 through 7,f7-- 7i7 by striking or supplement each place it appears2 and 7ii7 in subparagraph 7,d71 by striking or a supplement2 and 7#ad7 by amending paragraph 7#c7 to read as follows3 7#c7 ,biosimilar biological product program fee 7,a7 ,in general ,each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection 7c77#e7 for each biosimilar biological product that-- 7i7 is identified in such a biosimilar biological product application approved as of ,october #a of such fiscal year2 and 7ii7 as of ,october #a of such fiscal year1 does not appear on a list1 developed and maintained by the ,secretary1 of discontinued biosimilar biological products4 7,b7 ,due date ,the biosimilar biological product program fee for a fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such year2 or 7ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees for such year under this section4 7,c7 ,one fee per product per year ,the biosimilar biological product program fee shall be paid only once for each product for each fiscal year4 7,d7 ,limitation ,a person who is named as the applicant in a biosimilar biological product application shall not be assessed more than #e biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application4 4 7b7 ,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 to read as follows3 7b7 ,fee revenue amounts 7#a7 ,fiscal year #bjah ,for fiscal year #bjah1 fees under subsection 7a7 shall be established to generate a total revenue amount equal to the sum of-- 7,a7 #de1jjj1jjj2 and 7,b7 the dollar amount equal to the fiscal year #bjah adjustment 7as determined under subsection 7c77#d774 7#b7 ,subsequent fiscal years ,for each of the fiscal years #bjai through #bjbb1 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#d772 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 capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#b772 and 7,d7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#c774 7#c7 ,allocation of revenue amount among fees2 limitations on fee amounts 7,a7 ,allocation ,the ,secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from1 respectively-- 7i7 initial and annual biosimilar development fees and reactivation fees under subsection 7a77#a72 7ii7 biosimilar biological product application fees under subsection 7a77#b72 and 7iii7 biosimilar biological product program fees under subsection 7a77#c74 7,b7 ,limitations on fee amounts ,until the first fiscal year for which the capacity planning adjustment under subsection 7c77#b7 is effective1 the amount of any fee under subsection 7a7 for a fiscal year after fiscal year #bjah shall not exceed #abe percent of the amount of such fee for fiscal year #bjah4 7,c7 ,biosimilar biological product development fees ,the initial biosimilar biological product development fee under subsection 7a77#a77;,a7 for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection 7a77#a77;,b7 for that fiscal year4 7,d7 ,reactivation fee ,the reactivation fee under subsection 7a77#a77;,d7 for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection 7a77#a77;,b7 for that fiscal year4 7#d7 ,annual base revenue ,for purposes of paragraph 7#b71 the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year1 excluding any adjustments to such revenue amount under subsection 7c77#c74 4 7c7 ,adjustments2 annual fee setting ,section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is amended-- 7#a7 by redesignating subsections 7c7 through 7h7 as subsections 7d7 through 7i71 respectively2 7#b7 in subsections 7a77#b77;,f7 and 7g71 by striking subsection 7c7 and inserting subsection 7d72 7#c7 in subsection 7a77#d77;,a71 by striking subsection 7b77#a77;,f7 and inserting subsection 7c77#e72 and 7#d7 by inserting after subsection 7b7 the following3 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#b77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b72 and 7ii7 the inflation adjustment percentage under subparagraph 7,b74 7,b7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of-- 7i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications 7as defined in section #gdd;,g7#ac77 for the first #c years of the preceding #d fiscal years2 and 7ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications 7as defined in section #gdd;,g7#ac77 for the first #c years of the preceding #d fiscal years4 7#b7 ,capacity planning adjustment 7,a7 ,in general ,beginning with the fiscal year described in subparagraph 7,b77ii77,,ii71 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 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 ,capacity planning methodology 7i7 ,development2 evaluation and report ,the ,secretary shall obtain1 through a contract with an independent accounting or consulting firm1 a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications4 ,the capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input4 ,the report shall be published for public comment not later than ,september #cj1 #bjbj4 7ii7 ,establishment and implementation ,after review of the report described in clause 7i7 and receipt and review of public comments thereon1 the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7,i7 incorporate such approaches and attributes as the ,secretary determines appropriate2 and 7,,ii7 be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established4 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#b77;,a7 7the annual base revenue for the fiscal year7 and 7b77#b77;,b7 7the dollar amount of the inflation adjustment for the fiscal year74 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#c7 ,operating reserve adjustment 7,a7 ,interim application2 fee reduction ,until the first fiscal year for which the capacity planning adjustment under paragraph 7#b7 is effective1 the ,secretary may1 in addition to the adjustment under paragraph 7#a71 reduce the fee revenue and fees under this section for a fiscal year as the ,secretary determines appropriate for long-term financial planning purposes4 7,b7 ,general application and methodology ,beginning with the first fiscal year for which the capacity planning adjustment under paragraph 7#b7 is effective1 the ,secretary may1 in addition to the adjustments under paragraphs 7#a7 and 7#b7-- 7i7 reduce the fee revenue and fees under this section as the ,secretary determines appropriate for long-term financial planning purposes2 or 7ii7 increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than #ba weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications4 7,c7 ,federal register notice ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e7 establishing fee revenue and fees for the fiscal year involved4 7#d7 ,fiscal year #bjah adjustment 7,a7 ,in general ,for fiscal year #bjah1 the ,secretary shall adjust the fee revenue and fees under this section in such amount 7if any7 as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications4 7,b7 ,methodology ,the ,secretary shall publish under paragraph 7#e7 a description of the methodology used to calculate the fiscal year #bjah adjustment under this paragraph in the ,federal ,register notice establishing fee revenue and fees for fiscal year #bjah4 7,c7 ,limitation ,no adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of #i1jjj1jjj4 7#e7 ,annual fee setting ,for fiscal year #bjah and each subsequent fiscal year1 the ,secretary shall1 not later than #fj days before the start of each such fiscal year-- 7,a7 establish1 for the fiscal year1 initial and annual biosimilar biological product development fees and reactivation fees under subsection 7a77#a71 biosimilar biological product application fees under subsection 7a77#b71 and biosimilar biological product program fees under subsection 7a77#c71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under this subsection2 and 7,b7 publish such fee revenue and fees in the ,federal ,register4 7#f7 ,limit ,the total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications4 4 7d7 ,application fee waiver for small business ,subsection 7d77#a7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended-- 7#a7 by striking subparagraph 7,b72 7#b7 by striking shall pay-- and all that follows through application fees and inserting shall pay application fees2 and 7#c7 by striking 2 and at the end and inserting a period4 7e7 ,effect of failure ,to pay fees ,subsection 7e7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended by striking all fees and inserting all such fees4 7f7 ,crediting and availability of fees ,subsection 7f7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by striking subparagraph 7,c7 7relating to fee collection during first program year7 and inserting the following3 7,c7 ,compliance ,the ,secretary shall be considered to have met the requirements of subparagraph 7,b7 in any fiscal year if the costs described in such subparagraph are not more than #ae percent below the level specified in such subparagraph4 2 and 7,b7 in subparagraph 7,d7-- 7i7 in the heading1 by striking in subsequent years2 and 7ii7 by striking 7after fiscal year #bjac72 and 7#b7 in paragraph 7#c71 by striking #bjac through #bjag and inserting #bjah through #bjbb4 #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 7a7-- 7,a7 by striking #bjac and inserting #bjah2 and 7,b7 by striking ,biosimilar ,user ,fee ,act of #bjab and inserting ,biosimilar ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 7#c7 by striking subsection 7d72 7#d7 by redesignating subsection 7e7 as subsection 7d72 and 7#e7 in subsection 7d71 as so redesignated1 by striking #bjag each place it appears and inserting #bjbb4 #dje4 ,sunset dates 7a7 ,authorization ,sections #gdd;,g and #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #djc of this ,act1 shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting ,requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #djd of this ,act1 shall cease to be effective ,january #ca1 #bjbc4 7c7 ,previous ,sunset ,provision 7#a7 ,in general ,effective ,october #a1 #bjag1 section #djd of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is repealed4 7#b7 ,conforming amendment ,the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is amended in the table of contents in section #b by striking the item relating to section #djd4 #djf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 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 shall be assessed for all biosimilar biological product applications received on or after ,october #a1 #bjag1 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 ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to 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 #bjab1 but before ,october #a1 #bjag1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjah4 ,v ,pediatric drugs and devices #eja4 ,pediatric devices 7a7 ,pediatric use of devices ,section #eae;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7 is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 by redesignating subparagraphs 7,b7 through 7,d7 as subparagraphs 7,d7 through 7,f71 respectively2 7,b7 by inserting after subparagraph 7,a7 the following3 7,b7 an assessment of pediatric device labeling needs based on a review of real world evidence collected on the off-label use of medical devices in children1 using data available to the ,secretary2 7,c7 the number of devices that receive a humanitarian use exemption under section #ebj7m72 2 7,c7 in subparagraph 7,e71 as so redesignated1 by striking 2 and and inserting 22 7,d7 in subparagraph 7,f7 7as so redesignated71 by striking 7,b71 and 7,c74 and inserting 7,c71 7,d71 and 7,e72 and2 and 7,e7 by adding at the end the following3 7,g7 the number of devices for which extrapolation was used to support the approval of pediatric labeling of such devices4 ,for the items described in this paragraph1 such report shall disaggregate the number of devices by pediatric subpopulation4 2 7#b7 by redesignating subsection 7c7 as subsection 7d72 and 7#c7 by inserting after subsection 7b71 the following3 7c7 ,pediatric device innovation 7#a7 ,in general ,the ,secretary shall1 not later than #a year after the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 establish within the ,center for ,devices and ,radiological ,health a structure to-- 7,a7 provide assistance to device manufacturers that would result in the development1 approval1 and labeling of medical devices for children2 7,b7 oversee an internal pediatrics team that-- 7i7 is comprised of employees of the ,food and ,drug ,administration with expertise in pediatrics and appropriate expertise pertaining to the relevant devices under review2 and 7ii7 provides expertise and consultation1 to all applicable divisions within the ,center for ,devices and ,radiological ,health1 on-- 7,i7 the application of subsection 7b71 section #ebj7m71 section #eaj7k71 and section #ebb of this ,act and section #djb of the ,public ,health ,service ,act to pediatric devices2 and 7,,ii7 pediatrics1 as it pertains to reviewing devices2 7,c7 coordinate pediatric activities within the ,center for ,devices and ,radiological ,health2 and 7,d7 collaborate with other programs1 offices1 and centers of the ,food and ,drug ,administration1 including the consortia program authorized under section #cje of the ,pediatric ,medical ,device ,safety and ,improvement ,act of #bjjg4 7#b7 ,staff ,such structure shall include a chief pediatric medical officer and other appropriate individuals1 as the ,secretary determines necessary4 4 7b7 ,humanitarian device exemption ,section #ebj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77 is amended-- 7#a7 in paragraph 7#d7-- 7,a7 in subparagraph 7,b71 by inserting or an appropriate local committee after review committee each place such term appears2 and 7,b7 in the matter following subparagraph 7,b71 by inserting or an appropriate local committee after review committee each place such term appears2 and 7#b7 in paragraph 7#f77;,a77iv71 by striking #bjag and inserting #bjbb4 7c7 ,demonstration grants for improving pediatric availability ,section #cje of the ,pediatric ,medical ,device ,safety and ,improvement ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#d71 by striking and at the end2 7,b7 in paragraph 7#e71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7#f7 providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device1 where appropriate4 2 and 7#b7 in subsection 7e71 by striking #bjag and inserting #bjbb4 7d7 ,meeting on pediatric device development 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 convene a public meeting regarding opportunities and barriers to the development1 approval1 and labeling of pediatric medical devices4 ,such meeting shall include representatives from the medical device industry1 academia1 recipients of funding under section #cje of the ,pediatric ,medical ,device ,safety and ,improvement ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note71 medical provider organizations1 and organizations representing patients and consumers4 7#b7 ,topics ,the meeting described in paragraph 7#a7 shall include consideration of ways to-- 7,a7 improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices for children that would result in the approval and labeling of medical devices for children2 7,b7 appropriately use extrapolation under section #eae;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7;b772 7,c7 enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling2 7,d7 increase ,food and ,drug ,administration assistance to medical device manufactures in developing devices for children that are approved and labeled for their use2 and 7,e7 identify current barriers to pediatric device development and incentives to address such barriers4 7#c7 ,report ,not later than #f months after the meeting described in paragraph 7#a71 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 ,senate1 and publish1 including on the ,internet website of the ,food and ,drug ,administration1 a report that summarizes and responds to the recommendations raised in such meeting4 #ejb4 ,pediatric drug development 7a7 ,early meeting on pediatric study plan 7#a7 ,in general ,clause 7i7 of section #eje;,b7e77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#b77;,c77 is amended to read as follows3 7i7 shall meet with the applicant-- 7,i7 if requested by the applicant with respect to a drug that is intended to treat a serious or life-threatening disease or condition1 to discuss preparation of the initial pediatric study plan1 not later than the end-of-,phase #a meeting 7as such term is used in section #cab4hb7;b7 of title #ba1 ,code of ,federal ,regulations1 or successor regulations7 or within #cj calendar days of receipt of such request1 whichever is later2 7,,ii7 to discuss the initial pediatric study plan as soon as practicable1 but not later than #ij calendar days after the receipt of such plan under subparagraph 7,a72 and 7,,iii7 to discuss any scientific or operational challenges that may be the basis of a deferral under subsection 7a77#c7 or a full or partial waiver under subsection 7a77#d72 4 7#b7 ,conforming changes ,section #eje;,b7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77 is amended-- 7,a7 in the heading of paragraph 7#b71 by striking meeting and inserting meetings2 7,b7 in the heading of paragraph 7#b77;,c71 by striking ,meeting and inserting ,meetings2 7,c7 in clauses 7ii7 and 7iii7 of paragraph 7#b77;,c71 by striking no meeting each place it appears and inserting no meeting under clause 7i77,,ii72 and 7,d7 in paragraph 7#c7 by striking meeting under paragraph 7#b77;,c77i7 and inserting meeting under paragraph 7#b77;,c77i77,,ii74 7b7 ,informing internal review committee ,section #eje;,a7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7f77 is amended by adding at the end the following3 7#g7 ,informing internal review committee ,the ,secretary shall provide to the committee referred to in paragraph 7#a7 any response issued to an applicant or holder with respect to a proposed pediatric study request4 4 7c7 ,action on submissions 7#a7 ,in general ,section #eje;,a7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7d77 is amended-- 7,a7 by redesignating paragraphs 7#c7 through 7#e7 as paragraphs 7#d7 through 7#f71 respectively2 and 7,b7 by inserting after paragraph 7#b7 the following3 7#c7 ,action on submissions ,the ,secretary shall review and act upon a submission of a proposed pediatric study request or a sponsor's proposed amendment to a written request for pediatric studies within #abj calendar days of the submission4 4 7#b7 ,conforming amendments 7,a7 ,,ffdca ,section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a71 as amended by paragraph 7#a71 is further amended by striking subsection 7d77#c7 each place it appears and inserting 7d77#d74 7,b7 ,,phsa ,paragraphs 7#b71 7#c71 and 7#d7 of section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m77 are amended by striking section #eje;,a7d77#c7 each place it appears and inserting section #eje;,a7d77#d74 7d7 ,study ,the ,secretary of ,health and ,human ,services1 acting through the internal review committee established under section #eje;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;d7 shall1 not later than one year after the date of enactment of this ,act1 develop and implement a plan to achieve1 when appropriate1 earlier submission of pediatric studies under section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 or section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m774 ,such plan shall include recommendations to achieve-- 7#a7 earlier discussion of proposed pediatric study requests and written requests with sponsors1 and if appropriate1 at the meeting required under section #eje;,b7e77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#b77;,c771 as amended by subsection 7a72 7#b7 earlier issuance of written requests for a pediatric study under such section #eje;,a1 including for investigational new drugs prior to the submission of an application under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a772 and 7#c7 shorter timelines1 when appropriate1 for the completion of studies pursuant to a written request under such section #eje;,a or such section #cea7m74 7e7 ,neonatology expertise 7#a7 ,in general ,section #f7;d7 of the ,best ,pharmaceuticals for ,children ,act 7#ba ,u4,s4,c4 #cic;a7d77 is amended by striking ,for the #e-year period beginning on the date of enactment of this subsection1 at and inserting ,at4 7#b7 ,draft guidance ,not later than #b years after the date of enactment of this ,act1 the ,secretary shall issue draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products4 7f7 ,submission of assessments ,section #eje;,b7d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d77#a77 is amended by adding at the end the following3 ,the ,secretary shall inform the ,pediatric ,advisory ,committee of all letters and responses to such letters issued under this paragraph44 7g7 ,internal committee ,section #eje;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;d7 is amended by inserting or pediatric rare diseases after psychiatry4 #ejc4 ,guidance on molecular targets in pediatric oncology 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 shall issue guidance on the development of oncology drugs or biological products directed at molecular targets1 including for pediatric populations4 7b7 ,collaboration2 public meeting ,in developing the guidance under subsection 7a71 the ,secretary1 acting through the ,commissioner of ,food and ,drugs and in collaboration with the ,director of the ,national ,cancer ,institute1 shall convene a public meeting not later than #ahj days after the date of enactment of this ,act to solicit feedback from physicians and researchers 7including pediatric oncologists71 patients1 and other stakeholders to provide input on development of the guidance4 ,the ,secretary shall seek input at such meeting on-- 7#a7 the scientific data necessary to determine when an oncology drug or biological product directed at a molecular target is sufficient to support pediatric clinical development given the ethical1 practical1 and other barriers to clinical investigations in the pediatric population2 7#b7 how to determine relevancy of a molecular target to the growth or progression of a pediatric cancer1 including the clinical data necessary to make such a determination2 7#c7 how to overcome the challenges related to pediatric oncology drug development1 including issues related to conducting clinical trials in pediatric rare cancers with small patient populations2 7#d7 the advantages and disadvantages of innovative clinical trial designs in addressing the development of oncology drugs or biological products directed at molecular targets in pediatric cancer patients2 and 7#e7 the ways in which the ,secretary can improve the current process outlined under sections #eje;,a and #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;c7 to encourage additional research and development of pediatric cancer treatments4 #ejd4 ,best pharmaceuticals for children ,section #dji;,i of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7 is amended-- 7#a7 in subsection 7a77#b77;,a77ii71 by inserting and identification of biomarkers for such diseases1 disorders1 or conditions1 after biologics12 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#f77;,b7-- 7i7 by striking shall be assigned a docket number by the ,commissioner of ,food and ,drugs and inserting 1 not later than #ij days after submission1 shall be posted on the ,internet website of the ,food and ,drug ,administration in an accessible manner2 and 7ii7 by striking become part of the docket file with respect to each of the drugs and inserting be posted on the ,internet website of the ,food and ,drug ,administration2 and 7,b7 in paragraph 7#g7-- 7i7 in the matter preceding subparagraph 7,a71 by striking submitted and inserting posted2 and 7ii7 in subparagraph 7,c71 by striking 7i7 place and all that follows through the period at the end and inserting publish through posting on the ,internet website of the ,food and ,drug ,administration a summary of the report and a copy of any requested labeling changes42 7#c7 by striking subsection 7d72 7#d7 by redesignating subsection 7e7 as subsection 7d72 and 7#e7 in paragraph 7#a7 of subsection 7d71 as so redesignated1 by striking #bjac through #bjag and inserting #bjah through #bjbb4 ,,vi ,reauthorizations and improvements related to drugs #fja4 ,reauthorization of provision relating 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 #bjag and inserting #bjbb4 #fjb4 ,reauthorization of the critical path public-private partnerships ,section #eff7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #fjc4 ,reauthorization of orphan grants program ,section #e7;c7 of the ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #fjd4 ,guidance regarding bioequivalence 7a7 ,in general ,in accordance with subsection 7b71 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue product-specific guidance that-- 7#a7 applies to complex non-biologic drugs2 and 7#b7 outlines how to demonstrate bioequivalence to the reference drug1 in order to facilitate generic development for such drugs4 7b7 ,deadline for issuing guidance ,after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall publish a guidance1 for each complex non-biologic drug that is approved under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b771 not less than #b years prior to the earliest date on which an abbreviated new drug application may be submitted pursuant to section #eje7;j7 of the ,federal1 ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 that references such drug4 7c7 ,applicability ,this section applies to guidances for abbreviated new drug applications that reference new drug applications first approved on or after ,october #a1 #bjag4 #fje4 ,patient experience data ,section #efi;,c7c77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7c77#b77;,a77 is amended by striking impact of such disease or condition1 or a related therapy1 and inserting physical and psychosocial impacts of such disease or condition1 related therapy1 or clinical investigation4 #fjf4 ,communications plans ,section #eje-a7;e77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;e77#c77 is amended-- 7#a7 in subparagraph 7,b71 by striking 2 or2 7#b7 in subparagraph 7,c71 by striking the period and inserting 2 or2 and 7#c7 by adding at the end the following3 7,d7 disseminating information to health care providers about the meaning of terms related to drug formulations or properties that are described in the drug labeling1 including information about the limitations or patient care implications of such formulations or properties1 and how such formulations or properties may be related to serious adverse drug events associated with use of the drug4 4 #fjg4 ,protecting and strengthening the drug supply chain 7a7 ,diverted drugs ,paragraph 7#a7 of section #hja7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;d77 is amended-- 7#a7 by striking 7d77#a7 ,except as and inserting 7d77#a77;,a7 ,except as2 and 7#b7 by adding at the end the following3 7,b7 ,except as authorized by the ,secretary in the case of a drug that appears on the drug shortage list under section #ejf;,e or in the case of importation pursuant to section #hjd7;j71 no drug that is subject to section #ejc7;b77#a7 may be imported into the ,united ,states for commercial use if such drug is manufactured outside the ,united ,states1 the manufacturer has not authorized the drug to be marketed in the ,united ,states1 and the manufacturer has not caused the drug to be labeled to be marketed in the ,united ,states4 4 7b7 ,counterfeit drugs ,subsection 7b7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended by adding at the end the following3 7#h7 ,notwithstanding subsection 7a71 any person who violates section #cja7;i77#c7 by selling or dispensing1 or holding for sale or dispensing1 a drug that is a counterfeit drug shall be fined under title #ah1 ,united ,states ,code1 imprisoned for not more than #aj years1 or both1 unless the person acted in good faith and had no reason to believe the drug was a counterfeit drug4 4 #fjh4 ,technical corrections ,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 such drug for such disease or condition and inserting the same drug for the same disease or condition2 7#b7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking ,if an application and all that follows through such license if and inserting ,during the #g-year period described in subsection 7a7 for an approved application under section #eje or license under section #cea of the ,public ,health ,service ,act1 the ,secretary may approve an application or issue a license for a drug that is otherwise the same1 as determined by the ,secretary1 as the already approved drug for the same rare disease or condition if2 7,b7 in paragraph 7#a71 by striking notice and all that follows through assure and inserting of exclusive approval or licensure notice and opportunity for the submission of views1 that during such period the holder of the exclusive approval or licensure cannot ensure2 and 7,c7 in paragraph 7#b71 by striking such holder provides and inserting the holder provides2 and 7#c7 by adding at the end the following3 7c7 ,condition of clinical superiority 7#a7 ,in general ,if a sponsor of a drug that is designated under section #ebf and is otherwise the same1 as determined by the ,secretary1 as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection 7a7 for the same rare disease or condition as the already approved drug1 the ,secretary shall require such sponsor1 as a condition of such exclusive approval or licensure1 to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug4 7#b7 ,definition ,for purposes of paragraph 7#a71 the term clinically superior with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy1 greater safety1 or by providing a major contribution to patient care4 7d7 ,regulations ,the ,secretary may promulgate regulations for the implementation of subsection 7c74 ,until such time as the ,secretary promulgates regulations in accordance with this subsection1 any definitions set forth in regulations implementing this section that were promulgated prior to the date of enactment of the ,,fda ,reauthorization ,act of #bjag shall continue to apply4 4 ,,vii ,device inspection and regulatory improvements #gja4 ,risk-based inspections for devices 7a7 ,in general ,section #eaj7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77 is amended-- 7#a7 by striking paragraph 7#b7 and inserting the following3 7#b7 ,risk-based schedule for devices 7,a7 ,in general ,the ,secretary1 acting through one or more officers or employees duly designated by the ,secretary1 shall inspect establishments described in paragraph 7#a7 that are engaged in the manufacture1 propagation1 compounding1 or processing of a device or devices 7referred to in this subsection as device establishments7 in accordance with a risk-based schedule established by the ,secretary4 7,b7 ,factors and considerations ,in establishing the risk-based schedule under subparagraph 7,a71 the ,secretary shall-- 7i7 apply1 to the extent applicable for device establishments1 the factors identified in paragraph 7#d72 and 7ii7 consider the participation of the device establishment1 as applicable1 in international device audit programs in which the ,united ,states participates or the ,united ,states recognizes4 2 and 7#b7 in paragraph 7#d7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking paragraph 7#c7 and inserting paragraph 7#b7 or 7#c72 and 7,b7 in subparagraph 7,c71 by inserting or device after drug4 7b7 ,foreign inspections ,section #hji7;a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is amended by striking section #eaj7;h77#c7 and inserting paragraph 7#b7 or 7#c7 of section #eaj7;h74 #gjb4 ,improvements to inspections process 7a7 ,inspection procedure ,section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is amended by adding at the end the following3 7h7 7#a7 ,in the case of inspections that are not for-cause inspections1 the ,secretary shall review existing processes and standards for inspections of domestic and foreign device establishments1 and update such processes and standards to ensure uniform processes and standards1 with exceptions as appropriate4 ,such processes and standards shall include-- 7,a7 announcing the inspection to the establishment within a reasonable time before such inspection1 which shall include notification to the owner1 operator1 or agent in charge of the establishment regarding the type and nature of the inspection2 7,b7 providing a reasonable estimate of the timeframe for the duration of the inspection1 an opportunity for advancing communications between the officers or employees carrying out the inspection under subsection 7a77#a7 and the owner1 operator1 or agent in charge of the establishment concerning appropriate working hours during the inspection1 and1 to the extent feasible1 advance notice of records that will be requested in order to expedite the inspection2 and 7,c7 providing for requirements with respect to the frequency and conditions of communications during the inspection with the owner1 operator1 or agent in charge of the establishment regarding inspection status1 which may be recorded by either party with advance notice and mutual consent4 7#b7 ,nothing in this subsection affects the authority of the ,secretary to conduct inspections otherwise permitted under this ,act in order to ensure compliance4 4 7b7 ,report responses ,section #gjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b77 is amended-- 7#a7 by striking ,upon completion and inserting 7#a7 ,upon completion2 and 7#b7 by adding at the end the following3 7#b7 ,in the case of establishments registered under section #eaj that have received a report pursuant to paragraph 7#a71 and for which the owner1 operator1 or agent in charge of such establishment submits a timely response to such report that includes a request for feedback to the actions proposed in such response1 and which involves a public health priority1 the ,secretary shall provide nonbinding feedback regarding such proposed actions within #de days of receipt of such request4 4 7c7 ,guidance 7#a7 ,draft guidance ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue draft guidance that-- 7,a7 specifies how the ,food and ,drug ,administration will implement the process described in subsection 7h7 of section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd71 as amended by this section1 and the requirements described in subsection 7b77#b7 of such section2 7,b7 provides standard methods for communications described in such subsections2 7,c7 establishes standard timeframes over consecutive days applicable to both domestic and foreign inspections1 to which each inspector shall adhere unless an investigator can identify to the establishment a reason that more time is needed2 and 7,d7 identifies practices for investigators and device establishments to facilitate the continuity of inspections4 7#b7 ,final guidance ,not later than #ah months after the close of the comment period on the draft guidance under paragraph 7#a71 the ,secretary shall issue final guidance consistent with such paragraph4 #gjc4 ,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 ,october #a1 #bjag and inserting ,october #a1 #bjbb4 #gjd4 ,certificates to foreign governments for devices ,subsection 7e77#d7 of section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77 is amended-- 7#a7 by adding at the end the following3 7,e7 7i7 7,i7 ,if the ,secretary denies a request for certification under subparagraph 7,a77ii7 with respect to a device manufactured in an establishment 7foreign or domestic7 registered under section #eaj1 the ,secretary shall provide in writing to the person seeking such certification the basis for such denial1 and specifically identify the finding upon which such denial is based4 7,,ii7 ,if the denial of a request as described in subclause 7,i7 is based on grounds other than an injunction proceeding pursuant to section #cjb1 seizure action pursuant to section #cjd1 or a recall designated ,class ,i or ,class ,,ii pursuant to part #g1 title #ba1 ,code of ,federal ,regulations1 the ,secretary shall provide a substantive summary of the specific grounds for noncompliance identified4 7,,iii7 ,with respect to a device manufactured in an establishment that has received a report under section #gjd7;b71 the ,secretary shall not deny a request for certification with respect to a device pursuant to subparagraph 7,a77ii7 if the ,secretary and the owner1 operator1 or agent in charge of such establishment have agreed to a plan of correction in response to such report4 7ii7 7,i7 ,the ,secretary shall provide a process for a person who is denied a certification as described in clause 7i77,i7 to request a review that conforms to the standards of section #eag;,a7b74 7,,ii7 ,notwithstanding any previous review conducted pursuant to subclause 7,i71 a person who has been denied a certification as described in clause 7i77,i7 may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the ,secretary for the denial of certification1 including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the ,secretary4 7,,iii7 ,not later than #a year after date of enactment of the ,,fda ,reauthorization ,act of #bjag1 the ,secretary shall issue guidance providing for a process to carry out this subparagraph4 ,not later than #a year after the close of the comment period for such guidance1 the ,secretary shall issue final guidance4 2 and 7#b7 by moving the margins of subparagraphs 7,c7 and 7,d7 #d ems to the left4 #gje4 ,facilitating international harmonization ,section #gjd7;g7 of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is amended by adding at the end the following3 7#ae7 ,notwithstanding any other provision of this subsection1 for purposes of conducting inspections of establishments that manufacture1 prepare1 propagate1 compound1 or process devices except types of devices licensed under section #cea of the ,public ,health ,service ,act1 which inspections are required under section #eaj7;h7 or are inspections of such establishments required to register pursuant to section #eaj7;i71 the ,secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization4 ,nothing in this paragraph affects the authority of the ,secretary to inspect any device establishment pursuant to this ,act4 ,nothing in this paragraph affects the authority of the ,secretary to determine the official classification of an inspection4 4 #gjf4 ,notification of guidance related to lab-developed tests ,section #aadc of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is amended-- 7#a7 in subsection 7a71 by striking #fj and inserting #ij2 and 7#b7 in subsection 7b71 by striking #e and inserting #aj4 #gjg4 ,diagnostic imaging devices intended for use with contrast agents ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is amended by adding at the end the following3 7p7 7#a7 ,the ,secretary may approve an application or supplement to an application under section #eae for an applicable medical imaging device1 may make a substantial equivalence determination as to an applicable medical imaging device for which a report or a supplement to a report has been submitted under section #eaj7k71 or may grant a request under section #eac7;f77#b7 for an applicable medical imaging device if the requirements of this subsection and other applicable premarket requirements are met1 and the indications and conditions of use proposed in such application or notification involve the use of a contrast agent that is not-- 7,a7 in a concentration1 rate of administration1 or route of administration that is different from those described in the approved labeling of such contrast agent1 unless the ,secretary determines1 based on information contained in the application or report1 that the difference does not adversely affect the safety or effectiveness of the contrast agent when used with the device2 7,b7 in a region1 organ1 or system of the body that is different from those described in the approved labeling of the contrast agent1 unless the ,secretary determines1 based on information contained in the device application1 request1 or report1 that any difference does not affect the safety or effectiveness of the contrast agent when used with the device2 7,c7 in a patient population different from the patient population in the approved labeling for such contrast agent1 unless the ,secretary determines1 based on information contained in the application or report1 that the difference does not adversely affect the safety or effectiveness of the contrast agent when used with the device2 or 7,d7 in an imaging modality1 such as ultrasound1 magnetic resonance1 x-ray1 fluorescent imaging technology1 or diagnostic radiopharmaceutical-based technology that is different from those described in the approved labeling of the contrast agent4 7#b7 ,an applicable medical imaging device that is eligible for approval under section #eae1 clearance under section #eaj7k71 or classification under section #eac7;f77#b71 or approval1 clearance1 or classification as described in paragraph 7#a7 shall be subject only to such requirements of this ,act that are applicable to devices4 7#c7 ,an application under section #eae1 report under section #eaj7k71 or classification under section #eac7;f77#b7 for an applicable medical imaging device intended for use in conjunction with a contrast agent to which clause 7ii7 or 7iii7 of section #eje7;c77#c77;,e7 applies shall refer to such contrast agent in such application1 report1 or request by trade or brand name1 rather than to the international nonproprietary name4 7#d7 ,in conducting a review of an application or report submitted for an applicable medical imaging device1 the agency center charged with the premarket review of devices center may consult with the agency center charged with the premarket review of drugs and biological products4 7#e7 ,for purposes of this subsection-- 7,a7 the term applicable medical imaging device means a device intended to be used in conjunction with a contrast agent or class of contrast agents for a use that is not described in the indications and usage section of the approved labeling of such contrast agent or the approved labeling of any contrast agent in such class1 as applicable2 and 7,b7 the term contrast agent means a drug that is approved under section #eje or licensed under section #cea of the ,public ,health ,service ,act1 is intended for use in conjunction with an applicable medical imaging device1 and-- 7i7 is a diagnostic radiopharmaceutical1 as defined in sections #cae4b and #fja4cj 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 4 #gjh4 ,diagnostic clarity ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall update guidance with respect to the circumstances under which reagents1 new instruments1 or new combinations of instruments may be added to groups of instruments that have been cleared under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k774 ,the updated guidance shall provide standard definitions and describe procedures for sponsors seeking to add a new instrument1 reagent1 or combination of instruments to a cleared group of instruments to submit information to the ,secretary demonstrating that the new reagent1 new instrument1 or new combination of instruments does not alter the assay's performance1 as applicable4 ,the ,secretary shall consult with affected entities and other stakeholders in updating the guidance4 #gji4 ,appropriate classification of device accessories ,section #eac7;b77#i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77#i77 is amended-- 7#a7 by striking 7#i7 ,the ,secretary and inserting 7#i77;,a7 ,the ,secretary2 and 7#b7 by adding at the end the following3 7,b7 ,the classification of any accessory classified prior to ,december #ac1 #bjaf1 based on the intended use or uses of such accessory1 shall continue to apply1 unless otherwise determined by the ,secretary under section #eae7;e77#a74 7,c7 7i7 ,if an accessory has been cleared or approved based on the classification of another device with which such accessory is intended to be used and the ,secretary has established a classification for such accessory based on the intended use or uses of the accessory1 in accordance with subparagraph 7,a71 the manufacturer of such accessory may identify the classification so established for such accessory in a written notification to the ,secretary4 7ii7 ,unless the ,secretary notifies a manufacturer within #cj calendar days of receipt of a written notification described in clause 7i7 that the ,secretary does not agree that the classification identified in such written notification is appropriate for the accessory1 the accessory shall be automatically reclassified in accordance with the classification identified in such written notification4 7iii7 ,a written notification that the ,secretary disagrees with the classification identified in a written notification described in clause 7ii7 shall include a detailed description and justification for the determination to disagree4 7,d7 7i7 ,a manufacturer of an accessory that has not been classified by the ,secretary based on the intended use or uses of the accessory as described in subparagraph 7,a71 and for which the ,secretary has not established a classification for the accessory type as a stand-alone device1 may submit to the ,secretary a written recommendation for the appropriate classification of such accessory based on its intended use or uses4 ,such submission shall include such information to support the recommendation as the ,secretary may require4 7ii7 ,the ,secretary shall respond to a submission under clause 7i7 within #fj calendar days of receiving the submission by approving or denying the recommended classification of the accessory4 ,if the ,secretary does not agree with the recommendation for classification submitted by the sponsor1 the response shall include a detailed description and justification for such determination to disagree4 ,the ,secretary shall provide an opportunity for a manufacturer to meet with appropriate personnel to discuss appropriate classification of such accessory prior to submitting a written recommendation4 7,e7 7i7 ,at the time a sponsor submits an application for premarket approval pursuant to section #eae7;c7 or a report pursuant to #eaj7k71 the sponsor of such application or report may include a recommendation and supporting information for the proper classification of an accessory pursuant to subparagraph 7,a71 if applicable4 ,if such accessory type has not been classified by the ,secretary based on its intended use or uses as a stand-alone device as described in subparagraph 7,a71 the ,secretary shall-- 7,i7 approve or deny such application pursuant to section #eae7;d71 or find such report substantially equivalent or not substantially equivalent pursuant to section #eaj7k72 and 7,,ii7 approve or deny the classification of the accessory proposed in such application or report4 7,f7 ,a manufacturer may at any time use the classification process described in section #eac7;f77#b7 to obtain classification of an accessory4 4 #gaj4 ,device pilot projects 7a7 ,postmarket pilot ,section #eai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7 is amended by adding at the end the following3 7i7 ,pilot projects 7#a7 ,in general ,in order to provide timely and reliable information on the safety and effectiveness of cleared or approved devices1 including responses to adverse events and malfunctions1 and to advance the objectives of part #hjc of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 and advance the objectives of1 and evaluate innovative new methods of compliance with1 this section and section #ebb1 the ,secretary shall1 within one year of the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 initiate one or more pilot projects for voluntary participation by a manufacturer or manufacturers of device or device type1 or continue existing projects1 in accordance with paragraph 7#c71 that meet all of the following requirements3 7,a7 ,are designed to efficiently generate reliable and timely safety and active surveillance data for use by the ,secretary or manufacturers of the devices that are involved in the pilot project4 7,b7 ,inform the development of methods1 systems1 data criteria1 and programs that could be used to support safety and active surveillance activities for devices not included in such project4 7,c7 ,are designed and conducted in coordination with a comprehensive system for evaluating medical device technology that operates under a governing board with appropriate representation of stakeholders1 including consumer groups and device manufacturers4 7,d7 ,use electronic health data including claims data1 patient survey data1 and any other data1 as the ,secretary determines appropriate4 7,e7 ,prioritize devices and device types that meet one or more of the following criteria3 7i7 ,devices and device types for which the collection and analysis of real world evidence regarding a device's safety and effectiveness is likely to advance public health4 7ii7 ,devices and device types that are widely used4 7iii7 ,devices and device types1 the failure of which has significant health consequences4 7iv7 ,devices and device types for which the ,secretary has received public recommendations in accordance with paragraph 7#b77;,b7 and has determined to meet one of the criteria under clauses 7i7 through 7iii7 and is appropriate for a project under this subsection4 7#b7 ,participation ,the ,secretary shall establish the conditions and processes for-- 7,a7 authorizing voluntary participation of a manufacturer of a device in the pilot project described in paragraph 7#a72 and 7,b7 facilitating public recommendations for devices to be prioritized under the pilot project described in paragraph 7#a71 including requirements for the data necessary to support such recommendation4 7#c7 ,implementation ,the ,secretary may satisfy the requirements of paragraphs 7#a7 and 7#b7 by continuing or expanding existing projects1 or by beginning new projects1 that meet the criteria of subparagraphs 7,a7 through 7,e7 of paragraph 7#a7 or by entering into contracts1 cooperative agreements1 grants1 or other appropriate agreements with public or private entities that have a significant presence in the ,united ,states1 and meet the following additional conditions3 7,a7 ,if such public or private entities are a component of another organization1 the entities have established appropriate security measures to maintain the confidentiality and privacy of the data described in paragraph 7#a77;,d7 and the entity shall not make an unauthorized disclosure of such data to the other components of the organization in breach of such confidentiality and privacy requirements4 7,b7 ,in the case of the termination or nonrenewal of such contracts1 cooperative agreements1 grants1 or other appropriate agreements1 the entities shall comply with each of the following3 7i7 ,continue to comply with the confidentiality and privacy requirements under this subsection with respect to all data disclosed to the entity4 7ii7 ,return any data disclosed to such entity under this subsection to which it would not otherwise have access or1 if returning the data is not practicable1 destroy the data4 7,c7 ,have at least one of the following qualifications3 7i7 ,research1 statistical1 epidemiologic1 or clinical capability and expertise to conduct and complete the activities under this subsection1 including the capability and expertise to provide the ,secretary access to de-identified data consistent with the requirements of this subsection4 7ii7 ,an information technology infrastructure in place to support electronic data and operational standards to provide security for such data1 as appropriate4 7iii7 ,experience with1 and expertise on1 the development of device safety and effectiveness research and surveillance using electronic health data4 7iv7 ,other expertise which the ,secretary determines necessary to fulfill the activities under this subsection4 7#d7 ,review of contract in the event of a merger or acquisition ,the ,secretary shall review a contract with a qualified entity under this subsection in the event of a merger or acquisition of the entity in order to ensure that the requirements under this subsection will continue to be met4 7#e7 ,report to ,congress ,not later than #ah months after the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 and annually thereafter1 the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing a description of the pilot projects being conducted pursuant to this subsection1 including for each pilot project-- 7,a7 how the project is being implemented in accordance with paragraph 7#c7 and the contractor or grantee as applicable2 7,b7 the number of manufacturers that have agreed to participate2 7,c7 the data sources used2 7,d7 the devices or device categories involved2 and 7,e7 the number of patients involved4 7#f7 ,compliance with requirements for records or reports on devices ,the participation of a manufacturer in a pilot project under this subsection shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program implemented under this ,act4 ,the ,secretary may determine that1 for the specified time period to be determined by the ,secretary1 a manufacturer's participation in a pilot project under this subsection may meet certain other requirements of this section or section #ebb if-- 7,a7 the project has demonstrated success in capturing relevant adverse event information2 and 7,b7 the ,secretary has established procedures for making adverse event and safety information collected from the pilot public1 to the extent possible1 if collected pursuant to this section or section #ebb4 7#g7 ,privacy requirements ,with respect to the pilot projects conducted pursuant to this subsection-- 7,a7 individual identifiable health information shall not be disclosed when presenting any information from such project2 and 7,b7 such projects shall comply with section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 and sections #eeb and #eeb;a of title #e1 ,united ,states ,code4 7#h7 ,other compliance ,any pilot program undertaken in coordination with the comprehensive system described in paragraph 7#a77;,c71 including pilot projects under this subsection1 that relates to the use of real world evidence for devices shall comply with paragraph 7#a77;,b71 the conditions listed in subparagraphs 7,a7 and 7,b7 of paragraph 7#c71 and paragraphs 7#d71 7#e71 7#f71 and 7#g74 7#i7 ,sunset ,this subsection shall cease to have force or effect on ,october #a1 #bjbb4 4 7b7 ,report ,not later than ,january #ca1 #bjba1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall conduct a review through an independent third party to evaluate the strengths1 limitations1 and appropriate use of evidence collected pursuant to real world evidence pilot projects described in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag and subsection 7i7 of section #eai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i71 as amended by subsection 7a71 for informing premarket and postmarket decisionmaking for multiple device types1 and to determine whether the methods1 systems1 and programs in such pilot projects efficiently generate reliable and timely evidence about the effectiveness or safety surveillance of devices4 #gaa4 ,regulation of over-the-counter hearing aids 7a7 ,in general ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as amended by section #gjg1 is further amended by adding at the end the following3 7q7 ,regulation of ,over-the-,counter hearing aids 7#a7 ,definition ,in this subsection1 the term over-the-counter hearing aid means a device that-- 7,a7 uses the same fundamental scientific technology as air conduction hearing aids 7as defined in section #hgd4ccjj of title #ba1 ,code of ,federal ,regulations7 7or any successor regulation7 or wireless air conduction hearing aids 7as defined in section #hgd4ccje of title #ba1 ,code of ,federal ,regulations7 7or any successor regulation72 7,b7 is intended to be used by adults over the age of #ah to compensate for perceived mild to moderate hearing impairment2 7,c7 through tools1 tests1 or software1 allows the user to control the over-the-counter hearing aid and customize it to the user's hearing needs2 7,d7 may-- 7i7 use wireless technology2 or 7ii7 include tests for self-assessment of hearing loss2 and 7,e7 is available over-the-counter1 without the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person1 to consumers through in-person transactions1 by mail1 or online4 7#b7 ,regulation ,an over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section #gaa7;b7 of the ,,fda ,reauthorization ,act of #bjag and shall be exempt from sections #hja4dbj and #hja4dba of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 4 7b7 ,regulations ,to establish category 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 not later than #c years after the date of enactment of this ,act1 shall promulgate proposed regulations to establish a category of over-the-counter hearing aids1 as defined in subsection 7q7 of section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 as amended by subsection 7a71 and1 not later than #ahj days after the date on which the public comment period on the proposed regulations closes1 shall issue such final regulations4 7#b7 ,requirements ,in promulgating the regulations under paragraph 7#a71 the ,secretary shall-- 7,a7 include requirements that provide reasonable assurances of the safety and efficacy of over-the-counter hearing aids2 7,b7 include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids2 7,c7 include requirements for appropriate labeling of the over-the-counter hearing aid1 including how consumers may report adverse events1 any conditions or contraindications1 and any advisements to consult promptly with a licensed physician2 and 7,d7 describe the requirements under which the sale of over-the-counter hearing aids is permitted1 without the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person1 to consumers through in-person transactions1 by mail1 or online4 7#c7 ,premarket notification ,the ,secretary shall make findings under section #eaj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 to determine whether over-the-counter hearing aids 7as defined in section #ebj7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as amended by subsection 7a77 require a report under section #eaj7k7 to provide reasonable assurance of safety and effectiveness4 7#d7 ,effect on state law ,no ,state or local government shall establish or continue in effect any law1 regulation1 or order specifically applicable to hearing products that would restrict or interfere with the servicing1 marketing1 sale1 dispensing1 use1 customer support1 or distribution of over-the-counter hearing aids 7as defined in section #ebj7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as amended by subsection 7a77 through in-person transactions1 by mail1 or online1 that is different from1 in addition to1 or otherwise not identical to1 the regulations promulgated under this subsection1 including any ,state or local requirement for the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person for consumers to access over-the-counter hearing aids4 7c7 ,new guidance issued ,not later than the date on which final regulations are issued under subsection 7b71 the ,secretary shall update and finalize the draft guidance of the ,department of ,health and ,human ,services entitled1 ,regulatory ,requirements for ,hearing ,aid ,devices and ,personal ,sound ,amplification ,products1 issued on ,november #g1 #bjac4 ,such updated and finalized guidance shall clarify which products1 on the basis of claims or other marketing1 advertising1 or labeling material1 meet the definition of a device in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 and which products meet the definition of a personal sound amplification product1 as set forth in such guidance4 7d7 ,study ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report evaluating consumer experience with hearing health care1 hearing screening in the primary care setting1 and consumer adoption1 usage1 and outcomes related to hearing technology4 ,the ,comptroller ,general shall update such report not later than #b years after the final regulations described in subsection 7b7 are issued1 and shall evaluate how implementation of such regulations has impacted hearing health care1 including recommendations for improving consumer access to appropriate hearing health care4 ,,viii ,additional provisions #hja4 ,,gao report 7a7 ,in general ,not later than ,september #cj1 #bjah1 the ,comptroller ,general of the ,united ,states shall issue a report1 after consultation with patients and drug and medical device manufacturers1 regarding the implementation of sections #efi;,a and #efi;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;a1 #cfj;bbb-#h;b74 ,such report shall assess the progress the ,food and ,drug ,administration has made on-- 7#a7 working with other regulatory authorities of similar standing to foster and encourage uniform1 scientifically driven clinical trial standards with respect to medical products around the world2 7#b7 providing consistent parallel scientific advice to manufacturers seeking simultaneous global development and approval of new medical products1 in coordination with regulatory authorities of similar standing2 and 7#c7 facilitating the use of foreign clinical trial data to minimize duplicative clinical trials4 7b7 ,additional requirements ,the report under subsection 7a7 shall include specific examples1 if possible and available1 and a list of activities at the ,food and ,drug ,administration regarding the harmonization of premarket medical product requirements4 #hjb4 ,streamlining and improving consistency in performance reporting 7a7 ,,pdufa ,section #gcf;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a77 is amended-- 7#a7 in paragraph 7#a77;,b7-- 7,a7 in clause 7vi71 by inserting and the number of designations and denials issued by the agency for such applications before the semicolon2 7,b7 in clause 7vii71 by striking 2 and and inserting and the number of designations and denials issued by the agency for such applications2 and2 and 7,c7 in clause 7viii7 by striking the period and inserting and the number of designations and denials issued by the agency for such applications42 and 7#b7 by inserting after paragraph 7#b7 the following3 7#c7 ,real time reporting 7,a7 ,in general ,beginning with fiscal year #bjah1 every #cj calendar days1 the ,secretary shall post the data described in subparagraph 7,b7 on the ,internet website of the ,food and ,drug ,administration and remove duplicative data from the annual performance report4 7,b7 ,data ,the following data is required to be posted in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance issued by the ,center for ,drug ,evaluation and ,research or the ,center for ,biologics ,evaluation and ,research1 and the justification for the issuance and finalization of each such guidance4 7ii7 ,the number and titles of public meetings held by the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research each fiscal year4 7iii7 ,the list of standard new drug applications and biologics license applications1 by fiscal year of receipt4 7iv7 ,the number of filed applications by each review division4 7#d7 ,capacity planning and improved time reporting ,beginning with fiscal year #bjbj1 the ,secretary shall include in the annual report under paragraph 7#a7-- 7,a7 the number of full-time equivalents agreed upon in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag and the number of appropriated full time equivalents at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,b7 identification by name of all time reporting categories that ,food and ,drug ,administration uses for capacity planning and time reporting with respect to the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 pursuant to the resource capacity planning and modernized time reporting implementation plan in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag2 7,c7 the processes by which the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner require reporting on the amount of an employee's time that is dedicated to the review of human drug applications1 as required by the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag1 including information regarding employees dedicated to such activities on a full-time basis1 and employees dedicated to such activities on a part-time basis2 and 7,d7 for each of the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the number of employees described in subparagraph 7,c7 7both full-time equivalents and employees dedicated to such activities on a part-time basis7 for whom time reporting is required as described in subparagraph 7,c71 and the number of such employees required to estimate time dedicated to the review of human drug applications4 4 7b7 ,,mdufa ,section #gch;,a7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a77 is amended-- 7#a7 by striking ,beginning with and inserting the following3 7i7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7ii7 ,additional information ,beginning with fiscal year #bjah1 the annual report under this subparagraph shall include the progress of the ,center for ,devices and ,radiological ,health in achieving the goals1 and future plans for meeting the goals1 including1 for each review division-- 7,i7 the number of premarket applications filed under section #eae per fiscal year for each review division1 and the number of approvable letters1 major deficiency letters1 not approvable letters1 and denials for such applications2 7,,ii7 the number of reports filed under section #eaj7k7 per fiscal year for each review division and the number of devices cleared or not substantially equivalent for such reports2 and 7,,iii7 the number of expedited access pathway designations for a fiscal year for each review division and the number of cleared or approved devices or denials for such applications4 7iii7 ,real time reporting 7,i7 ,in general ,beginning with fiscal year #bjah1 the ,secretary shall1 every #cj calendar days1 post the data described in subclause 7,,ii7 on the ,internet website of the ,food and ,drug ,administration and remove duplicative data from the annual report under this subparagraph4 7,,ii7 ,data ,the following data is required to be posted in accordance with subclause 7,i73 7aa7 ,the number and titles of draft and final guidance issued by the ,center for ,devices and ,radiological ,health and the justification for the issuance and finalization of such guidance4 7bb7 ,the number and titles of public meetings held by the ,center for ,devices and ,radiological ,health each fiscal year4 4 7c7 ,,gdufa ,section #gdd;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a77 is amended-- 7#a7 by striking ,beginning with and inserting the following3 7#a7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7#b7 ,additional information ,beginning with fiscal year #bjah1 the report under this subsection shall include the progress of the ,office of ,generic ,drugs in achieving the goals1 and future plans for meeting the goals1 including-- 7,a7 the number of original abbreviated new drug applications filed per fiscal year2 7,b7 the number of amendments to abbreviated new drug applications filed per fiscal year2 and 7,c7 the number of actions taken delineated by the type of action1 including final approvals1 tentative approvals1 complete response letters1 and the number of refuse to receive letters issued by the ,food and ,drug ,administration per fiscal year4 7#c7 ,real time reporting 7,a7 ,in general ,beginning with fiscal year #bjah1 the ,secretary shall1 every #cj calendar days1 post the data described in subparagraph 7,b7 on the ,internet website of the ,food and ,drug ,administration and remove duplicative data from the annual report under this subsection4 7,b7 ,data ,the following data is required to be posted in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance issued by the ,office of ,generic ,drugs and the justification for the issuance and finalization of such guidance4 7ii7 ,the number and titles of public meetings held by the ,office of ,generic ,drugs each fiscal year4 4 7d7 ,bs,u,f,a ,section #gdd;,i7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77 is amended-- 7#a7 by striking ,beginning with and inserting the following3 7#a7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7#b7 ,additional information ,beginning with fiscal year #bjah1 the report under this subsection shall include the progress of the ,center for ,biologics ,evaluation and ,research in achieving the goals1 and future plans for meeting the goals1 including-- 7,a7 information on all previous cohorts for which the ,secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort2 7,b7 the number of original biosimilar biological product applications filed per fiscal year1 and the number of approvals or complete response letters issued by the agency for such applications2 and 7,c7 the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals or complete response letters issued by the agency for such applications4 7#c7 ,real time reporting 7,a7 ,in general ,beginning with fiscal year #bjah1 the ,secretary shall1 every #cj calendar days1 post the data described in subparagraph 7,b7 on the ,internet website of the ,food and ,drug ,administration and remove duplicative data from the annual report under this subsection4 7,b7 ,data ,the following data is required to be posted in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance issued by the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research and the justification for the issuance and finalization of such guidance4 7ii7 ,the number and titles of public meetings held by the ,center for ,drug ,evaluation and ,research and the ,center for ,biologic ,evaluation and ,research each fiscal year4 4 7#d7 ,capacity planning and time reporting ,beginning with fiscal year #bjbj1 the ,secretary shall include in the annual report under paragraph 7#a7-- 7,a7 the number of full-time equivalents agreed upon in the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag and the number of appropriated full time equivalents at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,b7 identification by name of all time reporting categories that the ,food and ,drug ,administration uses for capacity planning and time reporting under the resource capacity planning and modernized time reporting implementation plan in the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs and the ,office of the ,commissioner2 7,c7 the process by which the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner require reporting on the amount of an employee's time that is dedicated to the review of biosimilar biological product applications1 required pursuant to the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag1 including information regarding both employees dedicated to such activities on a full-time basis1 and employees dedicated to such activities on a part-time basis2 and 7,d7 for each of the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the actual number of employees described in subparagraph 7,c7 7both full-time equivalents and employees dedicated to such activities on a part-time basis7 for whom time reporting is required as described in subparagraph 7,c71 and the number of such employees required to estimate time dedicated to the review of biosimilar biological product applications4 4 #hjc4 ,analysis of use of funds 7a7 ,,pdufa reports 7#a7 ,analysis in ,,pdufa performance reports ,section #gcf;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a771 as amended by section #hjb7;a71 is further amended by adding at the end the following3 7#e7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report under paragraph 7#a7 an analysis of the following3 7,a7 ,the difference between the number of human drug applications filed and the number of approvals or complete response letters issued by the agency1 accounting for-- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7ii7 such applications pending with the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research that did not meet the goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag for the corresponding fiscal year and the future plans of the ,food and ,drug ,administration to meet these goals2 and 7iii7 the most common causes within the agency for missing such goals4 7,b7 ,relevant data to determine whether the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research have met performance enhancement goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag for the corresponding fiscal year4 7,c7 ,external or other circumstances impacting the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 or the ,food and ,drug ,administration1 that impacted the ability of the agency to meet the review time and performance enhancement goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag4 4 7#b7 ,issuance of corrective action reports ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is amended-- 7,a7 by redesignating subsections 7c7 and 7d7 as subsections 7e7 and 7f71 respectively2 and 7,b7 inserting after subsection 7b7 the following3 7c7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate upon submission of the performance report in subsection 7a7 for the corresponding fiscal year4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#e71 that each of the goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag for the corresponding fiscal year have been met1 the corrective action report shall include a summary of goals met1 and recommendations on ways in which the ,secretary can improve and streamline the human drug application review process4 7#b7 ,goals missed ,for each of the goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag for the corresponding fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include a detailed justification for such determination and-- 7,a7 a detailed description of the circumstances under which each drug application that missed the review goal time was approved during the first cycle review1 as applicable2 7,b7 aggregate data on the circumstances for all unapproved drug applications for which the review goal time was missed2 and 7,c7 the performance enhancement goals that were not achieved during the previous fiscal year and a detailed description of efforts the agency has put in place for the current fiscal year to improve the ability of the agency to meet each such goal1 while maintaining standards of approval1 for the current fiscal year4 7d7 ,enhanced communication 7#a7 ,communications with ,congress ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7#b7 ,participation in ,congressional hearing ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 7#c7 ,publicly available updates ,the ,secretary shall provide an update on progress made for the corrective action report during the following fiscal year on the publically available ,internet website of the ,food and ,drug ,administration every #cj business days4 4 7b7 ,,mdufa reports 7#a7 ,analysis in ,,mdufa performance reports ,section #gch;,a7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a771 as amended by section #hjb7;b71 is further amended by adding at the end the following3 7iv7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report under clause 7i7 an analysis of the following3 7,i7 ,the difference between the number of premarket applications filed under section #eae and applications filed under section #eaj7k7 and the number of major deficiency letters1 not approvable letters1 and denials for such applications issued by the agency1 accounting for-- 7aa7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7bb7 such applications pending with the ,center for ,devices and ,radiological ,health that did not meet the goals as identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag for the corresponding fiscal year and the future plans of the ,food and ,drug ,administration to meet these goals2 and 7cc7 the most common causes within the agency for missing such goals4 7,,ii7 ,relevant data to determine whether the ,center ,devices and ,radiological ,health have met performance enhancement goals identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag for the corresponding fiscal year4 7,,iii7 ,external or other circumstances impacting the ,center ,devices and ,radiological ,health or the ,food and ,drug ,administration that impacted the ability of the agency to meet review time and performance enhancement goals identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag4 4 7#b7 ,issuance of corrective action 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 redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#d7 and 7#e71 respectively2 and 7,b7 by inserting after paragraph 7#a7 the following3 7#b7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate upon submission of the performance report in paragraph 7#a77;,a7 for the corresponding fiscal year4 ,the report shall include the following information1 as applicable3 7,a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under paragraph 7#a77;,a77iv71 that each of the goals identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag for the corresponding fiscal year have been met1 the corrective action report shall include a summary of goals met1 and recommendations on ways in which the ,secretary can improve and streamline the medical device application review process4 7,b7 ,goals missed ,for each of the goals identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag for the corresponding fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include a detailed justification for such determination and-- 7i7 a detailed description of the circumstances under which each application or report submitted under section #eae or section #eaj7k7 missed the review goal time but was approved during the first cycle review1 as applicable2 7ii7 aggregate data on the circumstances for all unapproved medical device applications for which the review goal time was missed2 and 7iii7 the performance enhancement goals that were not achieved during the previous fiscal year and a detailed description of efforts the agency has put in place for the current fiscal year to improve the ability of the agency to meet each such goal1 while maintaining standards of approval1 for the current fiscal year4 7#c7 ,enhanced communication 7,a7 ,communications with congress ,each fiscal year1 as applicable1 representatives from the ,center for ,devices and ,radiological ,health shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7,b7 ,participation in congressional hearing ,each fiscal year1 as applicable1 representatives from the ,center for ,devices and ,radiological ,health shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 7,c7 ,publicly available updates ,the ,secretary shall provide an update on progress made for the corrective action report during the following fiscal year on the publically available ,internet website of the ,food and ,drug ,administration every #cj business days4 4 7c7 ,,gdufa reports 7#a7 ,analysis in ,,gdufa performance reports ,section #gdd;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a771 as amended by section #hjb7;c7 is further amended by adding at the end the following3 7#d7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report an analysis of the following3 7,a7 ,the difference between the number of abbreviated new drug applications filed and the number of approvals or complete response letters issued by the agency1 accounting for -- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7ii7 such applications pending with the ,office of ,generic ,drugs that did not meet the goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag for the corresponding fiscal year and the future plans of the ,food and ,drug ,administration to meet these goals2 and 7iii7 the most common causes within the agency for missing such goals4 7,b7 ,relevant data to determine whether the ,office of ,generic ,drugs has met the performance enhancement goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag for the corresponding fiscal year4 7,c7 ,external or other circumstances impacting the ,office of ,generic ,drugs or the ,food and ,drug ,administration that impacted the ability of the agency to meet review time and performance enhancement goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag4 4 7#b7 ,issuance of corrective action reports ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7,a7 by redesignating subsections 7c7 and 7d7 as subsections 7e7 and 7f71 respectively2 and 7,b7 inserting after subsection 7b7 the following3 7c7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate upon submission of the performance report in subsection 7a7 for the corresponding fiscal year4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#d71 that each of the goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag for the corresponding fiscal year have been met1 the corrective action report shall include a summary of goals met1 and recommendations on ways in which the ,secretary can improve and streamline the abbreviated new drug application review process4 7#b7 ,goals missed ,for each of the goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag for the corresponding fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include a detailed justification for such determination and-- 7,a7 a detailed description of the circumstances under which each abbreviated new drug application missed the review goal time but was approved during the first cycle review1 as applicable2 7,b7 aggregate data on the circumstances for all unapproved abbreviated new drug applications for which the review goal time was missed2 and 7,c7 the performance enhancement goals that were not achieved during the previous fiscal year and a detailed description of efforts the agency has put in place for the current fiscal year to improve the ability of the agency to meet each such goal for the current fiscal year4 7d7 ,enhanced communication 7#a7 ,communications with congress ,each fiscal year1 as applicable1 representatives from the ,office of ,generic ,drugs shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7#b7 ,participation in congressional hearing ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 7#c7 ,publicly available updates ,the ,secretary shall provide an update on progress made for the corrective action report during the following fiscal year on the publically available ,internet website of the ,food and ,drug ,administration every #cj business days4 4 7d7 ,bs,u,f,a reports 7#a7 ,analysis in ,bs,u,f,a performance reports ,section #gdd;,i7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77 as amended by section #hjb7;d7 is further amended by adding at the end the following3 7#e7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report an analysis of the following3 7,a7 ,the difference between the number of biosimilar biological product applications and supplements filed and the number of approvals or complete response letters issued by the agency1 accounting for-- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7ii7 such applications pending with the ,center for ,drug ,evaluation and ,research or the ,center for ,biologics ,evaluation and ,research that did not meet the goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the corresponding fiscal year and the future plans of the ,food and ,drug ,administration to meet these goals2 and 7iii7 the most common causes within the agency for missing such goals4 7,b7 ,relevant data to determine whether the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research have met the performance enhancement goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the corresponding fiscal year4 7,c7 ,external or other circumstances impacting the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 and the ,food and ,drug ,administration that impacted the ability of the agency to meet review time and performance enhancement goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag4 4 7#b7 ,issuance of corrective action reports ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec71 as amended by section #djd1 is further amended-- 7,a7 by redesignating subsections 7c7 and 7d7 as subsections 7e7 and 7f71 respectively2 and 7,b7 inserting after subsection 7b7 the following3 7c7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,energy and ,commerce and ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and ,committee on ,appropriations of the ,senate upon submission of the performance report in subsection 7a7 for the corresponding fiscal year4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#e71 that each of the goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the corresponding fiscal year have been met1 the corrective action report shall include a summary of goals met1 and recommendations on ways in which the ,secretary can improve and streamline the biosimilar biological product application review process4 7#b7 ,goals missed ,for each of the goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the corresponding fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include a detailed justification for such determination and-- 7,a7 a detailed description of the circumstances under which each biosimilar biological product application missed the review goal time but was approved during the first cycle review1 as applicable2 7,b7 aggregate data on the circumstances for all biosimilar biological product applications for which the review goal time was missed2 and 7,c7 the performance enhancement goals that were not achieved during the previous fiscal year and a detailed description of efforts the agency has put in place for the current fiscal year to improve the ability of the agency to meet each such goal for the current fiscal year4 7d7 ,enhanced communication 7#a7 ,communications with congress ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7#b7 ,participation in congressional hearing ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 7#c7 ,publicly available updates ,the ,secretary shall provide an update on progress made for the corrective action report during the following fiscal year on the publically available ,internet website of the ,food and ,drug ,administration every #cj business days4 4 #hjd4 ,information on technology contracting ,section #gcf;,b7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;b77 is amended-- 7#a7 by striking report on the and inserting 8report on-- 7#a7 the 2 7#b7 by striking the period at the end and inserting 2 and2 7#c7 by adding at the end the following3 7#b7 the amount of the fees collected that are invested in the information technology infrastructure of the ,food and ,drug ,administration1 the entities receiving contracts to develop such infrastructure1 the length of such contracts 7including renewals71 and the progress such entities have made toward meeting the goals described in such contracts4 4 #hje4 ,facilities management 7a7 ,evaluation 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the expenses incurred by the ,food and ,drug ,administration related to facility maintenance and renovation in fiscal years #bjab through #bjai4 ,the study shall include the following3 7,a7 ,a review of purchases and expenses differentiated by appropriated funds1 and resources authorized by the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 and this ,act1 as applicable1 that contributed to-- 7i7 the maintenance of scientific equipment and any existing facility plan or plans to maintain previously purchased scientific equipment2 7ii7 the renovation of facilities in the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 and the ,center for ,devices and ,radiological ,health1 and the purpose of such renovation including the need for the renovation2 7iii7 the assets purchased or repaired under the repair of facilities and acquisition authority under parts #b1 #c1 #g1 and #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq472 7iv7 the maintenance and repair of facilities and fixtures1 including a description of any unanticipated repairs and maintenance as well as scheduled repairs maintenance1 and the budget plan for the scheduled or anticipated maintenance2 7v7 the acquisition of furniture1 a description of the furniture purchased1 and the purpose of the furniture including purchases for the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 and the ,center for ,devices and ,radiological ,health2 and 7vi7 the acquisition of other necessary materials and supplies by product category under the authority under parts #b1 #c1 #g1 and #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq474 7,b7 ,an analysis of the ,food and ,drug ,administration's ability to further its public health mission and review medical products by incurring the expenses listed in clauses 7i7 through 7vi7 of subparagraph 7,a74 ,in conducting the analysis1 the ,comptroller ,general shall request information from and consult with appropriate employees1 including staff and those responsible for the fiscal decisions regarding facility maintenance and renovation for the agency4 7,c7 ,recommendations ,the ,comptroller ,general may provide recommendations1 as applicable1 on methods through which the ,food and ,drug ,administration may improve planning for-- 7i7 the maintenance1 renovation1 and repair of facilities2 7ii7 the purchase of furniture or other acquisitions2 and 7iii7 ways the agency may allocate the expenses described in clauses 7i7 and 7ii71 as informed by the analysis under subparagraph 7,b74 7#b7 ,report ,the ,comptroller ,general shall issue a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives not later than ,september #cj1 #bjbj1 containing the results of the study under paragraph 7#a74 7b7 ,administration 7#a7 ,,pdufa ,section #gcf7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7f77 is amended by adding at the end the following3 7#c7 ,limitation ,beginning on ,october #a1 #bjbc1 the authorities under section #gce7g77;,c7 shall only include expenditures for leasing and necessary scientific equipment4 4 7#b7 ,,mdufa ,section #gch7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77 is amended by adding at the end the following3 7#c7 ,limitation ,beginning on ,october #a1 #bjbc1 the authorities under section #gcg7i77;,c7 shall only include leasing and necessary scientific equipment4 4 7#c7 ,,gdufa ,section #gdd;,b7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;e77 is amended-- 7,a7 in the subsection heading1 by striking limit and inserting limitations2 7,b7 by striking ,the total amount and inserting the following3 7#a7 ,in general ,the total amount 2 and 7,c7 by adding at the end the following3 7#b7 ,leasing and necessary equipment ,beginning on ,october #a1 #bjbc1 the authorities under section #gdd;,a7#aa77;,c7 shall only include leasing and necessary scientific equipment4 4 7#d7 ,bs,u,f,a ,section #gdd;,h7e77#b77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;e77#b77;,b77 is amended-- 7,a7 in the subparagraph heading1 by striking limitation and inserting limitations2 7,b7 by striking ,the fees authorized and inserting the following3 7i7 ,in general ,the fees authorized 2 and 7,c7 by adding at the end the following3 7ii7 ,leasing and necessary equipment ,beginning on ,october #a1 #bjbc1 the authorities under section #gdd;,g7#i77;,c7 shall only include leasing and necessary scientific equipment4 4 #hjf4 ,expanded access 7a7 ,patient access to experimental treatments 7#a7 ,public meeting 7,a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 in coordination with the ,director of the ,national ,institutes of ,health1 and in consultation with patients1 health care providers1 drug sponsors1 bioethicists1 and other stakeholders1 shall1 not later than #ahj days after the date of enactment of this ,act1 convene a public meeting to discuss clinical trial inclusion and exclusion criteria to inform the guidance under paragraph 7#c74 ,the ,secretary shall inform the ,comptroller ,general of the ,united ,states of the date when the public meeting will take place4 7,b7 ,topics ,the ,secretary shall provide a publicly available report on the topics discussed at the meeting described in subparagraph 7,a7 within #cj days of such meeting4 ,such topics shall include discussion of-- 7i7 the rationale for1 and potential barriers for patients created by1 clinical trial inclusion and exclusion criteria2 7ii7 how patient populations most likely to be affected by a drug can benefit from the results of trials that employ alternative designs1 as well as potential risks associated with alternative clinical trial designs2 7iii7 barriers to participation in clinical trials1 including-- 7,i7 information regarding any potential risks and benefits of participation2 7,,ii7 regulatory1 geographical1 and socioeconomic barriers2 and 7,,iii7 the impact of exclusion criteria on the enrollment in clinical trials of infants and children1 pregnant and lactating women1 seniors1 individuals with advanced disease1 and individuals with co-morbid conditions2 7iv7 clinical trial designs and methods that increase enrollment of more diverse patient populations while facilitating the collection of data to support substantial evidence of safety and effectiveness2 and 7v7 how changes to clinical trial inclusion and exclusion criteria may impact the complexity of the clinical trial design and length of clinical trials1 and potential approaches to mitigating those impacts to ensure that the ability to demonstrate safety and effectiveness is not hindered through potential changes in eligibility criteria4 7#b7 ,report ,not later than #a year after the ,secretary issues a report on the topics discussed at the public meeting under paragraph 7#a77;,b71 the ,comptroller ,general of the ,united ,states shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on individual access to investigational drugs through the expanded access program under section #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,the report shall include-- 7,a7 a description of actions taken by manufacturers under section #efa;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j72 7,b7 consideration of whether ,form ,,fda #cibf and the guidance document entitled ,expanded ,access to ,investigational ,drugs for ,treatment ,use--,questions and ,answers1 issued by the ,food and ,drug ,administration in ,june #bjaf1 has reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 and improved clarity for patients1 physicians1 and drug manufacturers about such process2 7,c7 consideration of whether the guidance or regulations released or updated under section #efa of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 have improved access for individual patients who do not qualify for clinical trials of such investigational drugs1 and what barriers to such access remain2 7,d7 an assessment of how patients and health care providers navigate different avenues to engage with the ,food and ,drug ,administration or drug sponsors on expanded access2 and 7,e7 an analysis of the ,secretary's report under paragraph 7#a77;,b74 7#c7 ,guidance 7,a7 ,in general ,not later than #ahj days after the publication of the report under paragraph 7#a71 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall issue one or more draft guidances regarding eligibility criteria for clinical trials4 ,not later than #ah months after the public comment period on each such draft guidance ends1 the ,secretary shall issue a revised draft guidance or final guidance4 7,b7 ,contents ,the guidance documents described in subparagraph 7,a7 shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to-- 7i7 broaden eligibility criteria for clinical trials1 especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need2 and 7ii7 develop eligibility criteria for1 and increase trial recruitment to1 clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug1 as applicable and as appropriate1 while supporting findings of substantial evidence of safety and effectiveness4 7b7 ,improving institutional review board review of single patient expanded access protocol ,not later than #a year after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall issue guidance or regulations1 or revise existing guidance or regulations1 to streamline the institutional review board review for individual pediatric and adult patient expanded access protocol under #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,such guidance or regulation may include a description of the conditions under which an institutional review board chair 7or designee7 may review individual patient expanded access protocol submitted under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 for a drug and how centralized institutional review boards may facilitate the use of expanded access protocols4 ,the ,secretary shall update any relevant forms associated with individual patient expanded access protocol as necessary4 7c7 ,expanded access policy transparency ,section #efa;,a7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j7;f77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking later and inserting earlier2 7#b7 by striking paragraph 7#a72 7#c7 by redesignating paragraph 7#b7 as paragraph 7#a72 7#d7 in paragraph 7#a7 as so redesignated1 by striking the period at the end and inserting 2 or2 and 7#e7 by adding at the end the following3 7#b7 as applicable1 #ae days after the drug receives a designation as a breakthrough therapy1 fast track product1 or regenerative advanced therapy under subsection 7a71 7b71 or 7g71 respectively1 of section #ejf4 4 #hjg4 ,technical corrections 7a7 ,cross-reference ,section #cjge7;a7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking as amended by section #bjgd and inserting as amended by section #cajb2 and 7#b7 in paragraph 7#b71 by striking section #bjgd7a77;,c7 and inserting section #cajb7a77;,c74 7b7 #ejf;,g ,section #ejf;,g7b77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;g7b77#a77;,a77 is amended by striking identity and inserting identify4 ,,ix ,generic drug access ,a ,removing regulatory barriers to competition #ija4 ,improving access to generic drugs ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is amended by adding at the end the following3 7#aa7 7,a7 ,the ,secretary shall prioritize the review of1 and act within #bdj calendar days of the date of the submission of1 an original abbreviated new drug application submitted for review under this subsection1 or on a supplement to such an application1 that is for a drug-- 7i7 for which there are not more than #c approved drugs listed under paragraph 7#g71 except that the review of an application submitted more than #cj months in advance of the last applicable expiration date for a patent for which a certification under paragraph 7#b77;,a77vii77,,iii7 has been submitted1 or of the expiration date for an applicable period of exclusivity under this ,act1 will not be expedited2 or 7ii7 that has been included on the list under section #ejf;,e4 7,b7 ,the ,secretary shall require the applicant1 not later than #fj days prior to the submission of an application described in subparagraph 7,a71 to provide complete1 accurate information regarding facilities involved in manufacturing processes and testing1 including facilities in corresponding ,type ,,ii active pharmaceutical ingredients drug master files submitted with an application and sites or organizations involved in bioequivalence and clinical studies used to support the application1 in order to make a determination regarding whether an inspection of an establishment is necessary4 7,c7 ,the ,secretary may expedite an inspection or reinspection under section #gjd of an establishment that proposes to manufacture a drug described in subparagraph 7,a74 7,d7 ,nothing in this paragraph shall prevent the ,secretary from prioritizing the review of other applications as the ,secretary determines appropriate4 7#ab7 ,the ,secretary shall provide review status updates to applicants regarding applications under this subsection1 as appropriate1 including when the application is awaiting final regulatory action by the office charged with review4 7#ac7 ,the ,secretary shall publish on the ,internet website of the ,food and ,drug ,administration a list of all drugs approved under subsection 7b7 for which all patents and periods of exclusivity under this ,act have expired4 ,such list shall be updated at least once every #ahj days4 4 #ijb4 ,reporting on pending generic drug applications1 priority review applications1 and inspections 7a7 ,in general ,not later than #ahj calendar days after the date of enactment of this ,act1 and quarterly thereafter until ,october #a1 #bjbb1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall post on the ,internet website of the ,food and ,drug ,administration a report that provides-- 7#a7 the number of applications filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 awaiting action by the applicant1 including such applications that were filed prior to ,october #a1 #bjad2 7#b7 the number of applications filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 awaiting action by the ,secretary1 including such applications that were filed prior to ,october #a1 #bjad2 7#c7 the number of applications filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 and prior approval supplements withdrawn in each month covered by the report2 7#d7 the mean and median approval and tentative approval times for applications covered by the report2 7#e7 the number of applications described in paragraphs 7#a71 7#b71 and 7#c7 that are subject to priority review2 and 7#f7 the number of such applications on which the ,secretary has taken action pursuant to section #ejf;,h7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #iaa4 7b7 ,annual report on priority review applications 7#a7 ,in general ,the ,secretary shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,special ,committee on ,aging of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives an annual report1 not later than ,march #ca of each year1 on the following3 7,a7 ,the number of applications filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 that are subject to priority review during the most recent calendar year and are awaiting action by the applicant4 7,b7 ,the number of applications filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 that are subject to priority review during the most recent calendar year and are awaiting action by the ,secretary4 7,c7 ,the number of applications filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 that are subject to priority review during the most recent calendar year and have been approved by the ,secretary4 7,d7 ,for each of subparagraphs 7,a7 through 7,c71 the number of such applications-- 7i7 for which there are not more than #c approved drugs listed under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g772 and 7ii7 the number of such applications that are for a drug on the drug shortage list under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e74 7c7 ,annual report on inspections ,not later than ,march #a of each year1 the ,secretary shall post on the ,internet website of the ,food and ,drug ,administration-- 7#a7 the average and median amount of time1 following a request by staff of the ,food and ,drug ,administration reviewing an application or report submitted under an applicable section described in subparagraph 7,a71 7,b71 or 7,c71 to schedule and complete inspections of facilities necessary for-- 7,a7 approval of a drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 7,b7 approval of a device under section #eae of such ,act 7#ba ,u4,s4,c4 #cfj;e72 and 7,c7 clearance of a device under section #eaj7k7 of such ,act 7#ba ,u4,s4,c4 #cfj7k772 and 7#b7 the average and median amount of time to schedule and complete for-cause inspections of facilities of drugs and devices4 ,b ,incentivizing competition #iaa4 ,expediting generic competition ,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;,g the following3 #ejf;,h4 ,expediting generic drug development 7a7 ,in general ,the ,secretary shall1 at the request of an applicant1 expedite the development and review of an application under subsection 7j7 of section #eje for a drug-- 7#a7 for which there are not more than #c approved drug products listed under section #eje7;j77#g72 or 7#b7 that is included on the list under section #ejf;,e4 7b7 ,request from sponsors ,a request to expedite the development and review of an application under subsection 7a7 shall be submitted by the applicant prior to the submission of such application4 7c7 ,other applications ,nothing in this section shall prevent the ,secretary from expediting the development and review of other applications as the ,secretary determines appropriate4 7d7 ,additional communication ,the ,secretary shall take such actions as are appropriate to expedite the development and review of the application for approval of a drug described in subsection 7a71 including1 as appropriate-- 7#a7 holding meetings with the sponsor and the review team throughout the development of the drug prior to submission of the application2 7#b7 providing timely advice to1 and interactive communication with1 the sponsor regarding the development of the application to ensure that the collection of nonclinical and clinical data necessary for approval is as efficient as practicable2 7#c7 in the case of a complex product1 assigning a cross-disciplinary project lead for the review team to facilitate an efficient review of the development program and application1 including manufacturing inspections2 and 7#d7 in the case of a complex product1 including drug-device combinations1 involving senior managers and experienced review staff1 as appropriate1 in a collaborative1 cross- disciplinary review4 7e7 ,reporting requirement ,a sponsor of a drug expedited under this section shall report to the ,secretary1 one year following approval of an application under section #eje7;j71 on whether the approved drug has been marketed in interstate commerce since approval4 4 #iab4 ,list of generic drugs with limited competition ,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;,h1 as added by section #iaa1 the following3 #ejf;,i4 ,drug listing 7a7 ,removal1 withdrawal1 or transfer ,the holder of an application approved under subsection 7b7 or 7j7 of section #eje shall notify the ,secretary within #ahj days of removing the drug that is the subject of such application from interstate commerce1 withdrawing such approved application1 or transferring such approved application1 and a reason for such removal1 withdrawal1 or transfer4 ,if compliance with this subsection within such #ahj-;day period is not practicable1 then the holder shall comply as soon as practicable4 ,the ,secretary shall cross-reference information listed pursuant to section #ejf;,c where applicable to avoid duplicative reporting4 7b7 ,drugs with limited competition 7#a7 ,information ,the ,secretary shall-- 7,a7 maintain information with respect to applications approved under section #eje7;j72 and 7,b7 publish on the ,internet website of the ,food and ,drug ,administration such information under subparagraph 7,a7 with respect to drugs for which there are #c or fewer application holders2 and 7,c7 update the information published pursuant to subparagraph 7,b7 every #ahj days4 7#b7 ,contents ,the public information maintained and published under paragraph 7#a77;,b7 shall include-- 7,a7 the name of the drug1 name of the holder of the approved application1 and the marketing status for each drug2 and 7,b7 an indication of whether the ,secretary considers the drug to be for the treatment or prevention of a serious disease or medical condition1 for which there is no alternative drug that is judged by medical professionals to be an adequate substitute available in adequate supply4 7c7 ,public health exception ,the ,secretary may choose not to make information collected under this section publicly available if the ,secretary determines that disclosure of such information would adversely affect the public health4 7d7 ,notification ,when the ,secretary first publishes the information under subsection 7b71 the ,secretary shall notify relevant ,federal agencies1 including the ,centers for ,medicare ,medicaid ,services and the ,federal ,trade ,commission1 that the information has been published and will be updated regularly4 4 #iac4 ,suitability petitions 7a7 ,in general ,it is the sense of the ,senate that the ,food and ,drug ,administration shall meet the requirement under section #eje7;j77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,c77 and section #cad4ic7;e7 of title #ba1 ,code of ,federal ,regulations1 of responding to suitability petitions within #ij days of submission4 7b7 ,report ,the ,secretary of ,health and ,human ,services shall include in the annual reports under section #ijb7;b7-- 7#a7 the number of pending petitions under section #eje7;j77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,c772 and 7#b7 the number of such petitions pending a substantive response for more than #ahj days from the date of receipt4 #iad4 ,inspections ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771 as amended by section #ija1 is further amended by adding at the end the following3 7#ad7 ,if the ,secretary issues feedback pursuant to section #gjd7;b77#b7 with respect to information submitted in response to a report under section #gjd7;b77#a71 and a report that was issued under section #gjd7;b77#a7 is the only obstacle to approval of an application under this subsection or the ,secretary determines that the public health benefit of approving an application under this subsection outweighs any risk to public health1 the ,secretary shall1 within #de days of notification by the applicant that necessary changes have been made to the establishment to address any findings or deficiencies identified previously by the ,secretary-- 7,a7 re-inspect the establishment with respect to which the report was issued2 or 7,b7 make a determination regarding the response to such report and review of such application4 4 ,may #aa1 #bjag,reported with an amendment