,,ii #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 ,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