,,ii #aagth ,,congress #b;d ,session ,s4 #dece ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ad1 #bjbb,mr4 ,burr introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to revise and extend the user-fee programs for prescription drugs1 medical devices1 generic drugs1 and biosimilar biological products1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,food and ,drug ,administration ,simple ,reauthorization ,act of #bjbb or the ,,fdasra ,act of #bjbb4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,fees relating to drugs,sec4 #aja4 ,short title2 finding4,sec4 #ajb4 ,definitions4,sec4 #ajc4 ,authority to assess and use drug fees4,sec4 #ajd4 ,reauthorization2 reporting requirement4,sec4 #aje4 ,sunset dates4,sec4 #ajf4 ,effective date4,sec4 #ajg4 ,savings clause4,,title ,,ii--,fees relating to devices,sec4 #bja4 ,short title2 finding4,sec4 #bjb4 ,definitions4,sec4 #bjc4 ,authority to assess and use device fees4,sec4 #bjd4 ,reauthorization2 reporting requirement4,sec4 #bje4 ,accreditation programs4,sec4 #bjf4 ,sunset dates4,sec4 #bjg4 ,effective date4,sec4 #bjh4 ,savings clause4,,title ,,iii--,fees relating to generic drugs,sec4 #cja4 ,short title2 finding4,sec4 #cjb4 ,authority to assess and use human generic drug fees4,sec4 #cjc4 ,reauthorization2 reporting requirements4,sec4 #cjd4 ,sunset dates4,sec4 #cje4 ,effective date4,sec4 #cjf4 ,savings clause4,,title ,,iv--,fees relating to biosimilar biological products,sec4 #dja4 ,short title2 finding4,sec4 #djb4 ,definitions4,sec4 #djc4 ,authority to assess and use biosimilar biological product fees4,sec4 #djd4 ,reauthorization2 reporting requirements4,sec4 #dje4 ,sunset dates4,sec4 #djf4 ,effective date4,sec4 #djg4 ,savings clause4,,title ,v--,other reauthorizations,sec4 #eja4 ,reauthorization of the critical path public-private partnership4,sec4 #ejb4 ,reauthorization of the best pharmaceuticals for children program4,sec4 #ejc4 ,reauthorization of the humanitarian device exemption incentive4,sec4 #ejd4 ,reauthorization of the pediatric device consortia program4,sec4 #eje4 ,reauthorization of provision pertaining to drugs containing single enantiomers4,sec4 #ejf4 ,reauthorization of orphan drug grants4,sec4 #ejg4 ,reauthorization of certain device 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 #bjbb4 7b7 ,finding ,congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications1 including postmarket drug safety activities1 as set forth in the goals identified for purposes of part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #ajb4 ,definitions ,section #gce of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7 is amended-- 7#a7 in paragraph 7#a71 in the matter following subparagraph 7,b71 by striking an allergenic extract product1 or and inserting does not include an application with respect to an allergenic extract product licensed before ,october #a1 #bjbb1 does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the ,secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before ,october #a1 #bjbb1 does not include an application with respect to2 7#b7 in paragraph 7#c71 in the matter following subparagraph 7,c7-- 7,a7 by inserting licensed before ,october #a1 #bjbb1 a standardized allergenic extract product submitted pursuant to a notification to the applicant from the ,secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before ,october #a1 #bjbb1 after an allergenic extract product2 and 7,b7 by adding at the end the following3 ,if a written request to place a product in the discontinued section of either of the lists described in subparagraph 7,c7 is submitted to the ,secretary on behalf of an applicant1 and the request identifies the date the product is1 or will be1 withdrawn from sale1 then1 for purposes of assessing the prescription drug program fee under section #gcf7;a77#b71 the ,secretary shall consider such product to have been included in the discontinued section on the later of 7i7 the date such request was received1 or 7ii7 if the product will be withdrawn from sale on a future date1 such future date when the product is withdrawn from sale4 ,for purposes of subparagraph 7,c71 a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product1 whether or not the applicant has ordered recall of all previously distributed lots of the product1 except that a routine1 temporary interruption in supply shall not render a product withdrawn from sale42 and 7#c7 by adding at the end the following3 7#ab7 ,the term skin-test diagnostic product-- 7,a7 means a product-- 7i7 for prick1 scratch1 intradermal1 or subcutaneous administration2 7ii7 expected to produce a limited1 local reaction at the site of administration 7if positive71 rather than a systemic effect2 7iii7 not intended to be a preventive or therapeutic intervention2 and 7iv7 intended to detect an immediate or delayed-type skin hypersensitivity reaction to aid in the diagnosis of-- 7,i7 an allergy to an antimicrobial agent2 7,,ii7 an allergy that is not to an antimicrobial agent1 if the diagnostic product was authorized for marketing prior to ,october #a1 #bjbb2 or 7,,iii7 infection with fungal or mycobacterial pathogens2 and 7,b7 includes positive and negative controls required to interpret the results of a product described in subparagraph 7,a74 4 #ajc4 ,authority to assess and use drug fees 7a7 ,types of fees ,section #gcf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking #bjah and inserting #bjbc2 7#b7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 by striking subsection 7c77#e7 each place it appears and inserting subsection 7c77#f72 7,b7 in subparagraph 7,c71 by inserting prior to approval after or was withdrawn2 and 7,c7 by adding at the end the following3 7,h7 ,exception for skin-test diagnostic products ,a human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph 7,a74 2 and 7#c7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking subsection 7c77#e7 and inserting subsection 7c77#f72 7ii7 by striking ,except as provided and inserting the following3 7i7 ,payment of fees ,except as provided 2 and 7iii7 by adding at the end the following3 7ii7 ,previously discontinued drug products ,if a drug product that is identified in a human drug application approved as of ,october #a of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list identified in section #gce7c71 and on any subsequent day during such fiscal year the drug product is a prescription drug product1 then except as provided in subparagraphs 7,b7 and 7,c71 each person who is named as the applicant in a human drug application with respect to such product1 and who1 after ,september #a1 #aiib1 had pending before the ,secretary a human drug application or supplement1 shall pay the annual prescription drug program fee established for a fiscal year under subsection 7c77#f7 for such prescription drug product4 ,such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for a fiscal year in which the fee is payable4 2 and 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,exception for certain prescription drug products ,a prescription drug program fee shall not be assessed for a prescription drug product under subparagraph 7,a7 if such product is-- 7i7 a large volume parenteral product 7a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to #ajj m,l1 not including powders for reconstitution or pharmacy bulk packages7 identified on the list compiled under section #eje7;j77#g72 7ii7 pharmaceutically equivalent 7as defined in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations771 to another product on the list of products compiled under section #eje7;j77#g7 7not including the discontinued section of such list72 or 7iii7 a skin-test diagnostic product4 4 7b7 ,fee revenue amounts ,section #gcf7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7,b7 by redesignating subparagraphs 7,c7 through 7,f7 as subparagraphs 7,d7 through 7,g71 respectively2 7,c7 by inserting after subparagraph 7,b7 the following3 7,c7 ,the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year 7as determined under subsection 7c77#b772 2 7,d7 in subparagraph 7,d71 as so redesignated1 by striking 7c77#b7 and inserting 7c77#c72 7,e7 in subparagraph 7,e71 as so redesignated1 by striking 7c77#c7 and inserting 7c77#d72 7,f7 in subparagraph 7,f71 as so redesignated1 by striking 7c77#d7 and inserting 7c77#e72 and 7,g7 in subparagraph 7,g71 as so redesignated1 by striking clauses 7i7 through 7v7 and inserting the following3 7i7 #fe1ggc1fic for fiscal year #bjbc4 7ii7 #be1jig1fga for fiscal year #bjbd4 7iii7 #ad1aed1afi for fiscal year #bjbe4 7iv7 #d1hfd1hfj for fiscal year #bjbf4 7v7 #a1cad1fbj for fiscal year #bjbg4 2 and 7#b7 in paragraph 7#c7-- 7,a7 in subparagraph 7,a71 by striking #bjah1 #hgh1eij1jjj and inserting #bjbc1 #a1aea1ebb1ieh2 and 7,b7 in subparagraph 7,b7-- 7i7 by striking #bjai through #bjbb and inserting #bjbd through #bjbg2 and 7ii7 by striking subsection 7c77#c7 or 7c77#d7 and inserting subsection 7c77#d7 or 7c77#e74 7c7 ,adjustments2 annual fee setting ,section #gcf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7c77 is amended-- 7#a7 in paragraph 7#a77;,b77ii71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 7#b7 by redesignating paragraphs 7#b7 through 7#f7 as paragraphs 7#c7 through 7#g71 respectively2 7#c7 by inserting after paragraph 7#a7 the following3 7#b7 ,strategic hiring and retention adjustment ,for each fiscal year1 after the annual base revenue established in subsection 7b77#a77;,a7 is adjusted for inflation in accordance with paragraph 7#a71 the ,secretary shall further increase the fee revenue and fees-- 7,a7 for fiscal year #bjbc1 by #i1jjj1jjj2 and 7,b7 for fiscal year #bjbd and each subsequent fiscal year1 by #d1jjj1jjj4 2 7#d7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraph 7,a7-- 7i7 by striking for inflation2 and 7ii7 by striking paragraph 7#a7 and inserting paragraphs 7#a7 and 7#b72 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,methodology ,for purposes of this paragraph1 the ,secretary shall employ the capacity planning methodology utilized by the ,secretary in setting fees for fiscal year #bjba1 as described in the notice titled ,prescription ,drug ,user ,fee ,rates for ,fiscal ,year #bjba 7#he ,fed4 ,reg4 #dffea2 ,august #c1 #bjbj74 ,the workload categories used in forecasting shall include only the activities described in such notice and1 as feasible1 additional activities that are directly related to the direct review of applications and supplements1 including additional formal meeting types1 the direct review of postmarketing commitments and requirements1 the direct review of risk evaluation and mitigation strategies1 and the direct review of annual reports for approved prescription drug products4 ,subject to the exceptions in the preceding sentence1 the ,secretary shall not include as workload categories in forecasting any non-core review activities1 including any activities that the ,secretary referenced for potential future use in such notice but did not utilize in the setting fees for fiscal year #bjba4 2 7,c7 by striking subparagraph 7,c72 7,d7 by redesignating subparagraphs 7,d7 and 7,e7 as subparagraphs 7,c7 and 7,d71 respectively2 7,e7 in subparagraph 7,c71 as so redesignated-- 7i7 by striking year7 and and inserting year712 and 7ii7 by striking the period and inserting 1 and subsection 7b77#a77;,c7 7the dollar amount of the strategic hiring and retention adjustment742 and 7,f7 in subparagraph 7,d71 as so redesignated1 by striking paragraph 7#e7 and inserting paragraph 7#f72 7#e7 in paragraph 7#d71 as so redesignated-- 7,a7 by amending subparagraph 7,a7 to read as follows3 7,a7 ,increase ,for fiscal year #bjbc and subsequent fiscal years1 the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees if such an adjustment is necessary to provide for at least the following amounts of operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year1 as follows3 7i7 ,for fiscal year #bjbc1 at least #h weeks of operating reserves4 7ii7 ,for fiscal year #bjbd1 at least #i weeks of operating reserves4 7iii7 ,for fiscal year #bjbe and subsequent fiscal years1 at least #aj weeks of operating reserves4 2 and 7,b7 in subparagraph 7,c71 by striking paragraph 7#e7 and inserting paragraph 7#f72 7#f7 by amending paragraph 7#e71 as so redesignated1 to read as follows3 7#e7 ,additional direct cost adjustment ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 7#c71 and 7#d71 further increase the fee revenue and fees-- 7,a7 for fiscal year #bjbc1 by #dd1chf1aej2 and 7,b7 for fiscal years #bjbd through #bjbg1 by the amount set forth in clauses 7i7 through 7iv71 as applicable1 multiplied by the ,consumer ,price ,index for urban consumers 7,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 ,not ,seasonally ,adjusted2 ,all ,items2 ,annual ,index7 for the most recent year of available data1 divided by such ,index for #bjba-- 7i7 for fiscal year #bjbd1 #fj1ifg1iic2 7ii7 for fiscal year #bjbe1 #ce1gii1cad2 7iii7 for fiscal year #bjbf1 #ce1gii1cad2 and 7iv7 for fiscal year #bjbg1 #ce1gii1cad4 2 and 7#g7 in paragraph 7#f71 as so redesignated1 by striking #bjag and inserting #bjbb4 7d7 ,crediting and availability of fees ,section #gcf7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77#c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7e7 ,written requests for waivers1 reductions1 and refunds ,section #gcf7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7i77 is amended to read as follows3 7i7 ,written requests for waivers1 reductions1 exemptions1 and returns2 disputes concerning fees ,to qualify for consideration for a waiver or reduction under subsection 7d71 an exemption under subsection 7k71 or the return of any fee paid under this section1 including if the fee is claimed to have been paid in error1 a person shall submit to the ,secretary a written request justifying such waiver1 reduction1 exemption1 or return not later than #ahj days after such fee is due4 ,a request submitted under this paragraph shall include any legal authorities under which the request is made4 4 7f7 ,orphan drugs ,section #gcf7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is amended-- 7#a7 in paragraph 7#a77;,b71 by striking during the previous year and inserting 1 as determined under paragraph 7#b72 and 7#b7 in paragraph 7#b71 by striking that its gross annual revenues and all that follows through the period at the end and inserting supported by tax returns submitted to the ,internal ,revenue ,service1 or1 as necessary1 by other appropriate financial information1 that its gross annual revenues did not exceed #ej1jjj1jjj for the last calendar year ending prior to the fiscal year for which the exemption is requested44 #ajd4 ,reauthorization2 reporting requirement ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is amended-- 7#a7 by striking #bjah each place it appears and inserting #bjbc2 7#b7 by striking ,prescription ,drug ,user ,fee ,amendments of #bjag each place it appears and inserting ,prescription ,drug ,user ,fee ,amendments of #bjbb2 7#c7 in subsection 7a77#d71 by striking #bjbj and inserting #bjbc2 and 7#d7 in subsection 7f71 by striking #bjbb each place it appears and inserting #bjbg4 #aje4 ,sunset dates 7a7 ,authorization ,sections #gce and #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #ajd of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #ajf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq47 shall be assessed for all human drug applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #ajg4 ,savings clause ,notwithstanding the amendments made by this title1 part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to human drug applications and supplements 7as defined in such part as of such day7 that were accepted by the ,food and ,drug ,administration for filing on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,ii ,fees relating to devices #bja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,medical ,device ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices1 as set forth in the goals identified for purposes of part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #bjb4 ,definitions ,section #gcg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is amended-- 7#a7 in paragraph 7#i7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking and premarket notification submissions and inserting premarket notification submissions1 and de novo classification requests2 7,b7 in subparagraph 7,d71 by striking and submissions and inserting submissions1 and de novo classification requests2 7,c7 in subparagraph 7,f71 by striking and premarket notification submissions and inserting premarket notification submissions1 and de novo classification requests2 7,d7 in subparagraphs 7,g7 and 7,h71 by striking or submissions each place it appears and inserting submissions1 or requests2 and 7,e7 in subparagraph 7,k71 by striking or premarket notification submissions and inserting premarket notification submissions1 or de novo classification requests2 and 7#b7 in paragraph 7#aa71 by striking #bjaf and inserting #bjba4 #bjc4 ,authority to assess and use device fees 7a7 ,types of fees ,section #gch7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjah and inserting #bjbc2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking #bjag and inserting #bjbb2 7ii7 in clause 7iii71 by striking #ge percent and inserting #hj percent2 and 7iii7 in clause 7viii71 by striking #c4d percent and inserting #d4e percent2 7,b7 in subparagraph 7,b77iii71 by striking or premarket notification submission and inserting premarket notification submission1 or de novo classification request2 and 7,c7 in subparagraph 7,c71 by striking or periodic reporting concerning a class ,,iii device and inserting periodic reporting concerning a class ,,iii device1 or de novo classification request4 7b7 ,fee amounts ,section #gch7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#b7 by amending the table in paragraph 7#b7 to read as follows3 ,fee ,type,fiscal ,year #bjbc;,fiscal ,year #bjbd;,fiscal ,year #bjbe;,fiscal ,year #bjbf;,fiscal ,year #bjbg,premarket ,application#dbe1jjjdce1jjjdde1jjjdee1jj jdgj1jjj;,establishment ,registration#f1bejf1hgeg1ajjg1egeh1dfe 2 and 7#c7 in paragraph 7#c71 by amending subparagraphs 7,a7 through 7,e7 to read as follows3 7,a7 #cab1fjf1jjj for fiscal year #bjbc4 7,b7 #cce1gej1jjj for fiscal year #bjbd4 7,c7 #cej1gdf1djj for fiscal year #bjbe4 7,d7 #cff1dhf1cjj for fiscal year #bjbf4 7,e7 #dah1cdc1jjj for fiscal year #bjbg4 4 7c7 ,annual fee setting2 adjustments ,section #gch7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7c77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjag and inserting #bjbb2 7#b7 in paragraph 7#b7-- 7,a7 by striking #bjah each place it appears and inserting #bjbc2 7,b7 in subparagraph 7,b77ii71 by striking #bjaf and inserting #bjbb2 7,c7 in subparagraph 7,c77i77,,ii71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 and 7,d7 in subparagraph 7,d71 by striking #bjbb and inserting #bjbg2 7#c7 in paragraph 7#c71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#d7 by redesignating paragraphs 7#d7 and 7#e7 as paragraphs 7#g7 and 7#h71 respectively2 and 7#e7 by inserting after paragraph 7#c7 the following3 7#d7 ,performance improvement adjustment 7,a7 ,in general ,for each of fiscal years #bjbe through #bjbg1 after the adjustment under paragraph 7#c71 the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the ,secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb1 as the ,secretary determines necessary to achieve an increase in total fee collections for such fiscal year1 equal to the following amounts1 as applicable3 7i7 ,for fiscal year #bjbe1 the product of-- 7,i7 the amount determined under subparagraph 7,b77i77,i72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7ii7 ,for fiscal year #bjbf1 the product of-- 7,i7 the sum of the amounts determined under subparagraphs 7,b77i77,,ii71 7,b77ii77,i71 and 7,b77iii77,i72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7iii7 ,for fiscal year #bjbg1 the product of-- 7,i7 the sum of the amounts determined under subparagraphs 7,b77i77,,iii71 7,b77ii77,,ii71 and 7,b77iii77,,ii72 and 7,,ii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for such fiscal year4 7,b7 ,amounts 7i7 ,presubmission amount ,for purposes of subparagraph 7,a71 with respect to the presubmission written feedback goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbe1 #ae1cif1fjj if the goal for fiscal year #bjbc is met4 7,,ii7 ,for fiscal year #bjbf-- 7aa7 #ae1cif1fjj if the goal for fiscal year #bjbc is met and the goal for fiscal year #bjbd is missed2 or 7bb7 #cf1gib1bjj if the goal for fiscal year #bjbd is met4 7,,iii7 ,for fiscal year #bjbg-- 7aa7 #ae1cif1fjj if the goal for fiscal year #bjbc is met and the goal for each of fiscal years #bjbd and #bjbe is missed2 7bb7 #cf1gib1bjj if the goal for fiscal year #bjbd is met and the goal for fiscal year #bjbe is missed2 or 7cc7 #dj1egb1fjj if the goal for fiscal year #bjbe is met4 7ii7 ,de novo classification request amount ,for purposes of subparagraph 7,a71 with respect to the de novo decision goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbf1 #f1cbc1ejj if the goal for fiscal year #bjbc is met4 7,,ii7 ,for fiscal year #bjbg-- 7aa7 #f1cbc1ejj if the goal for fiscal year #bjbc is met and the goal for fiscal year #bjbd is missed2 or 7bb7 #aa1gfe1djj if the goal for fiscal year #bjbd is met4 7iii7 ,premarket notification and premarket approval amount ,for purposes of subparagraph 7,a71 with respect to the #eaj7k7 decision goal1 #eaj7k7 shared outcome total time to decision goal1 ,,pma decision goal1 and ,,pma shared outcome total time to decision goal1 the amounts determined under this subparagraph are as follows3 7,i7 ,for fiscal year #bjbf1 #a1jbj1jjj if the #d goals for fiscal year #bjbc are met4 7,,ii7 ,for fiscal year #bjbg-- 7aa7 #a1jbj1jjj if the #d goals for fiscal year #bjbc are met and one or more of the #d goals for fiscal year #bjbd is missed2 or 7bb7 #c1ijf1jjj if the #d goals for fiscal year #bjbd are met4 7,c7 ,performance calculation ,for purposes of this paragraph1 performance of the following goals shall be determined as specified in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb and based on data available as of the applicable dates as follows3 7i7 ,the performance of the presubmission written feedback goal-- 7,i7 for fiscal year #bjbc1 shall be based on data available as of ,march #ca1 #bjbd2 7,,ii7 for fiscal year #bjbd1 shall be based on data available as of ,march #ca1 #bjbe2 and 7,,iii7 for fiscal year #bjbe1 shall be based on data available as of ,march #ca1 #bjbf4 7ii7 ,the performance of the de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 shared outcome total time to decision goal1 ,,pma decision goal1 and ,,pma shared outcome total time to decision goal-- 7,i7 for fiscal year #bjbc1 shall be based on data available as of ,march #ca1 #bjbe2 and 7,,ii7 for fiscal year #bjbd1 shall be based on data available as of ,march #ca1 #bjbf4 7,d7 ,definitions ,for purposes of this paragraph1 the terms presubmission written feedback goal1 de novo decision goal1 #eaj7k7 decision goal1 #eaj7k7 shared outcome total time to decision goal1 ,,pma decision goal1 and ,,pma shared outcome total time to decision goal have the meanings given such terms in the goals identified in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb4 7#e7 ,hiring adjustment 7,a7 ,in general ,for each of fiscal years #bjbe through #bjbg1 after the adjustments under paragraphs 7#c7 and 7#d71 if applicable1 the base establishment registration fee amounts shall be decreased as the ,secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph 7,b71 if the number of hires to support the process for the review of device applications falls below the following thresholds for the applicable fiscal years3 7i7 ,for fiscal year #bjbe1 #he percent of the hiring goal specified in subparagraph 7,c7 for fiscal year #bjbc4 7ii7 ,for fiscal year #bjbf1 #ij percent of the hiring goal specified in subparagraph 7,c7 for fiscal year #bjbd4 7iii7 ,for fiscal year #bjbg1 #ij percent of the hiring goal specified in subparagraph 7,c7 for fiscal year #bjbe4 7,b7 ,hiring adjustment amount ,the hiring adjustment amount for fiscal year #bjbe and each subsequent fiscal year is the product of-- 7i7 the number of hires by which the hiring goal specified in subparagraph 7,c7 for the fiscal year before the prior fiscal year was missed2 7ii7 #gb1hgg2 and 7iii7 the applicable inflation adjustment under paragraph 7#b77;,b7 for the fiscal year for which the hiring goal was missed4 7,c7 ,hiring goals 7i7 ,in general ,for purposes of subparagraph 7,b71 the hiring goals for each of fiscal years #bjbc through #bjbe are as follows3 7,i7 ,for fiscal year #bjbc1 #add hires4 7,,ii7 ,for fiscal year #bjbd1 #db hires4 7,,iii7 ,for fiscal year #bjbe-- 7aa7 #bd hires if the base establishment registration fees are not increased by the amount determined under paragraph 7#d77;,a77i72 or 7bb7 #hc hires if the base establishment registration fees are increased by the amount determined under paragraph 7#d77;,a77i74 7ii7 ,number of hires ,for purposes of this paragraph1 the number of hires for a fiscal year shall be determined by the ,secretary1 as set forth in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjbb4 7#f7 ,operating reserve adjustment 7,a7 ,in general ,for each of fiscal years #bjbc through #bjbg1 after the adjustments under paragraphs 7#c71 7#d71 and 7#e71 if applicable1 if the ,secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph 7,b71 the ,secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves4 7,b7 ,designated amount ,subject to subparagraph 7,c71 for each fiscal year1 the designated amount in this subparagraph is equal to the sum of-- 7i7 #ac weeks of operating reserves of carryover user fees2 and 7ii7 the #a month of operating reserves described in paragraph 7#h74 7,c7 ,excluded amount ,for the period of fiscal years #bjbc through #bjbf1 a total amount equal to #aah1jjj1jjj shall not be considered part of the designated amount under subparagraph 7,b7 and shall not be subject to the decrease under subparagraph 7,a74 4 7d7 ,conditions ,section #gch7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7g77 is amended-- 7#a7 in paragraph 7#a77;,a71 by striking #cbj1hbe1jjj and inserting #cih1eff1jjj2 and 7#b7 in paragraph 7#b71 by inserting de novo classification requests1 after class ,,iii device14 7e7 ,authorization of appropriations ,section #gch7;h77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77#c77 is amended to read as follows3 7#c7 ,authorization of appropriations 7,a7 ,in general ,for each of the fiscal years #bjbc through #bjbg1 there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined in subparagraph 7,b71 less the amount of reductions determined in subparagraph 7,c74 7,b7 ,revenue amount ,for purposes of this paragraph1 the revenue amount for each fiscal year is the sum of-- 7i7 the total revenue amount under subsection 7b77#c7 for the fiscal year1 as adjusted under subsection 7c77#b72 and 7ii7 the performance improvement adjustment amount for the fiscal year under subsection 7c77#d77;,a71 if applicable4 7,c7 ,amount of reductions ,for purposes of this paragraph1 the amount of reductions for each fiscal year is the sum of-- 7i7 the hiring adjustment amount for the fiscal year under subsection 7c77#e71 if applicable2 and 7ii7 the operating reserve adjustment amount for the fiscal year under subsection 7c77#f71 if applicable4 4 #bjd4 ,reauthorization2 reporting requirement 7a7 ,performance reports ,section #gch;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is amended-- 7#a7 by striking fiscal year #bjah each place it appears and inserting fiscal year #bjbc2 7#b7 by striking ,medical ,device ,user ,fee ,amendments of #bjag each place it appears and inserting ,medical ,device ,user ,fee ,amendments of #bjbb2 7#c7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 by redesignating the second clause 7iv7 7relating to analysis7 as clause 7v72 and 7,b7 in subparagraph 7,a77iv7 7relating to rationale for ,,mdufa program changes71 by striking fiscal year #bjbj and inserting fiscal year #bjbc2 and 7#d7 in paragraph 7#d71 by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7b7 ,reauthorization ,section #gch;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjbb and inserting #bjbg2 and 7#b7 in paragraph 7#e71 by striking #bjbb and inserting #bjbg4 #bje4 ,accreditation programs 7a7 ,accreditation scheme for conformity assessment ,section #ead7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7d77 is amended-- 7#a7 in the subsection heading1 by striking ,pilot2 7#b7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking pilot2 7,b7 in subparagraph 7,a7-- 7i7 by inserting meeting criteria specified by the ,secretary in guidance after testing laboratories2 7ii7 by inserting in guidance after by the ,secretary2 and 7iii7 by striking assess the conformance of a device with and inserting conduct testing to support the assessment of the conformance of a device to2 and 7,c7 in subparagraph 7,b7-- 7i7 by striking determinations and inserting results2 7ii7 by inserting to support after so accredited2 and 7iii7 by striking a particular such determination and inserting particular such results2 7#c7 in paragraph 7#b7-- 7,a7 in the paragraph heading1 by striking determinations and inserting results2 7,b7 in subparagraph 7,a7-- 7i7 by striking determinations by testing laboratories and all that follows through such determinations or and inserting results by testing laboratories accredited pursuant to this subsection1 including by conducting periodic audits of such results or of the2 7ii7 by inserting a comma after or testing laboratories2 7iii7 by inserting or recognition of an accreditation body after accreditation of such testing laboratory2 and 7iv7 by striking such device and inserting a device2 and 7,c7 in subparagraph 7,b7-- 7i7 by striking by a testing laboratory so accredited and inserting under this subsection2 and 7ii7 by inserting or recognition of an accreditation body before under paragraph 7#a77;,a72 7#d7 in paragraph 7#c77;,c7-- 7,a7 in the subparagraph heading1 by inserting and transition after initiation2 and 7,b7 by adding at the end the following3 ,after ,september #cj1 #bjbc1 such pilot program will be considered to be completed1 and the ,secretary shall have the authority to continue operating a program consistent with this subsection42 and 7#e7 by striking paragraph 7#d74 7b7 ,accredited persons ,section #ebc7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7c77 is amended by striking #bjbb and inserting #bjbg4 #bjf4 ,sunset dates 7a7 ,authorization ,sections #gcg and #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i2 #cgi;fj7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gch;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #baj of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #bjg4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq47 shall be assessed for all submissions listed in section #gch7;a77#b77;,a7 of such ,act received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #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 #bjag1 but before ,october #a1 #bjbb1 were received by the ,food and ,drug ,administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,iii ,fees relating to generic drugs #cja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,generic ,drug ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities1 as set forth in the goals identified for purposes of part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #cjb4 ,authority to assess and use human generic drug fees 7a7 ,types of fees ,section #gdd;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking #bjah and inserting #bjbc2 7#b7 in paragraph 7#b77;,c71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg2 7#c7 in paragraph 7#c77;,b71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg2 7#d7 in paragraph 7#d77;,d71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg2 and 7#e7 in paragraph 7#e77;,d71 by striking fiscal years #bjah through #bjbb and inserting fiscal years #bjbc through #bjbg4 7b7 ,fee revenue amounts ,section #gdd;,b7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in the heading1 by striking #bjah and inserting #bjbc2 7ii7 by striking #bjah and inserting #bjbc2 and 7iii7 by striking #dic1fjj1jjj and inserting #ehb1ejj1jjj2 and 7,b7 in subparagraph 7,b7-- 7i7 in the heading1 by striking #bjai through #bjbb and inserting #bjbd through #bjbg2 7ii7 by striking ,for each and inserting the following3 7i7 ,in general ,for each 2 7iii7 by striking #bjai through #bjbb and inserting #bjbd through #bjbg2 7iv7 by striking #dic1fjj1jjj and inserting the base revenue amount under clause 7ii72 and 7v7 by adding at the end the following3 7ii7 ,base revenue amount ,the base revenue amount for a fiscal year is the total revenue amount established under this paragraph for the previous fiscal year1 not including any adjustments made for such previous fiscal year under subsection 7c77#c74 2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,c71 by striking one-third the amount and inserting #bd percent2 7,b7 in subparagraph 7,d71 by striking ,seven and inserting ,six2 and 7,c7 in subparagraph 7,e77i71 by striking ,thirty-five and inserting ,thirty-six4 7c7 ,adjustments ,section #gdd;,b7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking #bjai and inserting #bjbd2 and 7ii7 by striking the product of the total revenues established in such notice for the prior fiscal year and inserting the base revenue amount for the fiscal year determined under subsection 7b77#a77;,b77ii72 and 7,b7 in subparagraph 7,c71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 and 7#b7 by striking paragraph 7#b7 and inserting the following3 7#b7 ,capacity planning adjustment 7,a7 ,in general ,beginning with fiscal year #bjbd1 the ,secretary shall1 in addition to the adjustment under paragraph 7#a71 further increase the fee revenue and fees under this section for a fiscal year1 in accordance with this paragraph1 to reflect changes in the resource capacity needs of the ,secretary for human generic drug activities4 7,b7 ,capacity planning methodology ,the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7i7 be derived from the methodology and recommendations made in the report titled ,independent ,evaluation of the ,,gdufa ,resource ,capacity ,planning ,adjustment ,methodology3 ,evaluation and ,recommendations as announced in the ,federal ,register on ,august #c1 #bjbj 7#he ,fed4 ,reg4 #dffeh72 and 7ii7 incorporate approaches and attributes determined appropriate by the ,secretary1 including those made in such report recommendations1 except the workload categories used in forecasting resources shall only be those specified in section ,,viii4,b4#b4;e4 of the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjbb4 7,c7 ,limitations 7i7 ,in general ,under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection 7b77#a77;,b77ii7 7the base revenue amount for the fiscal year7 and paragraph 7#a7 7the dollar amount of the inflation adjustment for the fiscal year74 7ii7 ,additional limitation ,an adjustment under this paragraph shall not exceed #c percent of the sum described in clause 7i7 for the fiscal year1 except that such limitation shall be #d percent if-- 7,i7 for purposes of an adjustment for fiscal year #bjbd1 the ,secretary determines that1 during the period from ,april #a1 #bjba1 through ,march #ca1 #bjbc-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1jjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as that term is defined in section ,,xi of the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjbb72 7,,ii7 for purposes of an adjustment for fiscal year #bjbe1 the ,secretary determines that1 during the period from ,april #a1 #bjbb1 through ,march #ca1 #bjbd-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined72 7,,iii7 for purposes of an adjustment for fiscal year #bjbf1 the ,secretary determines that1 during the period from ,april #a1 #bjbc1 through ,march #ca1 #bjbe-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined72 and 7,,iv7 for purposes of an adjustment for fiscal year #bjbg1 the ,secretary determines that1 during the period from ,april #a1 #bjbd1 through ,march #ca1 #bjbf-- 7aa7 the total number of abbreviated new drug applications submitted was greater than or equal to #b1cjj2 or 7bb7 thirty-five percent or more of abbreviated new drug applications submitted related to complex products 7as so defined74 7,d7 ,publication in federal register ,the ,secretary shall publish in the ,federal ,register notice under subsection 7a71 the fee revenue and fees resulting from the adjustment and the methodology under this paragraph4 7#c7 ,operating reserve adjustment 7,a7 ,in general ,for fiscal year #bjbd and subsequent fiscal years1 the ,secretary may1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees under this section if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph 7,b74 7,b7 ,number of weeks ,the number of weeks specified in this subparagraph is-- 7i7 #h weeks for fiscal year #bjbd2 7ii7 #i weeks for fiscal year #bjbe2 and 7iii7 #aj weeks for each of fiscal year #bjbf and #bjbg4 7,c7 ,decrease ,if the ,secretary has carryover balances for human generic drug activities in excess of #ab weeks of the operating reserves referred to in subparagraph 7,a71 the ,secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than #ab weeks of such operating reserves4 7,d7 ,rationale for adjustment ,if an adjustment under this paragraph is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under subsection 7a7 publishing the fee revenue and fees for the fiscal year involved4 4 7d7 ,annual fee setting ,section #gdd;,b7d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77#a77 is amended-- 7#a7 in the heading1 by striking #bjah through #bjbb and inserting #bjbc through #bjbg2 7#b7 by striking more and inserting later2 and 7#c7 by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7e7 ,effect of failure ,to pay fees ,the heading of paragraph 7#c7 of section #gdd;,b7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is amended by striking and prior approval supplement fee4 7f7 ,crediting and availability of fees ,section #gdd;,b7i77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77#c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #cjc4 ,reauthorization2 reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking #bjah each place it appears and inserting #bjbc2 and 7,b7 by striking ,generic ,drug ,user ,fee ,amendments of #bjag each place it appears and inserting ,generic ,drug ,user ,fee ,amendments of #bjbb2 7#b7 in subsection 7b71 by striking #bjah and inserting #bjbc2 7#c7 in subsection 7c7-- 7,a7 by striking #bjah and inserting #bjbc2 and 7,b7 by striking ,generic ,drug ,user ,fee ,amendments of #bjag each place it appears and inserting ,generic ,drug ,user ,fee ,amendments of #bjbb2 and 7#d7 in subsection 7f7-- 7,a7 in paragraph 7#a71 by striking #bjbb and inserting #bjbg2 and 7,b7 in paragraph 7#e71 by striking ,january #ae1 #bjbb and inserting ,january #ae1 #bjbg4 #cjd4 ,sunset dates 7a7 ,authorization ,sections #gdd;,a and #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #cje of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #cje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da et seq47 shall be assessed for all abbreviated new drug applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #cjf4 ,savings clause ,notwithstanding the amendments made by this title1 part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to abbreviated new drug applications 7as defined in such part as of such day7 that were received by the ,food and ,drug ,administration within the meaning of section #eje7;j77#e77;,a7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,a771 prior approval supplements that were submitted1 and drug master files for ,type ,,ii active pharmaceutical ingredients that were first referenced on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,,iv ,fees relating to biosimilar biological products #dja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,biosimilar ,user ,fee ,amendments of #bjbb4 7b7 ,finding ,congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications1 including postmarket safety activities1 as set forth in the goals identified for purposes of part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #djb4 ,definitions ,section #gdd;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 7,b7 by striking ,october of and inserting ,september of2 and 7,c7 by striking ,october #bjaa and inserting ,september #bjaa2 and 7#b7 in paragraph 7#d77;,b77iii7-- 7,a7 by striking subclause 7,,ii72 and 7,b7 by redesignating subclauses 7,,iii7 and 7,,iv7 as subclauses 7,,ii7 and 7,,iii71 respectively4 #djc4 ,authority to assess and use biosimilar biological product fees 7a7 ,types of fees ,section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking #bjah and inserting #bjbc2 7#b7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7iv77,i71 by striking #e days and inserting #g days2 and 7ii7 in clause 7v77,,ii71 by striking #e days and inserting #g days2 7,b7 in subparagraph 7,b7-- 7i7 in clause 7i71 by inserting 1 except that1 in the case that such product 7including1 where applicable1 ownership of the relevant investigational new drug application7 is transferred to a licensee1 assignee1 or successor of such person1 and written notice of such transfer is provided to the ,secretary1 such licensee1 assignee or successor shall pay the annual biosimilar biological product development fee before the period2 7ii7 in clause 7iii7-- 7,i7 in subclause 7,i71 by striking 2 or and inserting a semicolon2 7,,ii7 in subclause 7,,ii71 by striking the period and inserting 2 or2 and 7,,iii7 by adding at the end the following3 7,,iii7 been administratively removed from the biosimilar biological product development program for the product under subparagraph 7,e77v74 2 and 7iii7 in clause 7iv71 by striking accepted for filing on or after ,october #a of such fiscal year and inserting subsequently accepted for filing2 7,c7 in subparagraph 7,d7-- 7i7 in clause 7i7-- 7,i7 in the matter preceding subclause 7,i71 by striking shall1 if the person seeks to resume participation in such program1 pay and inserting or who has been administratively removed from such program for a product under subparagraph 7,e77v7 shall1 if the person seeks to resume participation in such program1 pay all annual biosimilar biological product development fees previously assessed for such product and still owed and2 7,,ii7 in subclause 7,i7-- 7aa7 by striking #e days and inserting #g days2 and 7bb7 by inserting or the date of administrative removal1 as applicable after discontinued2 and 7,,iii7 in subclause 7,,ii71 by inserting or the date of administrative removal1 as applicable after discontinued2 and 7ii7 in clause 7ii71 by inserting 1 except that1 in the case that such product 7including1 where applicable1 ownership of the relevant investigational new drug application7 is transferred to a licensee1 assignee1 or successor of such person1 and written notice of such transfer is provided to the ,secretary1 such licensee1 assignee or successor shall pay the annual biosimilar biological product development fee before the period at the end2 and 7,d7 in subparagraph 7,e71 by adding at the end the following3 7v7 ,administrative removal from the biosimilar biological product development program ,if a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph 7,b7 for a period of #b consecutive fiscal years1 the ,secretary may administratively remove such person from the biosimilar biological product development program for the product4 ,at least #cj days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause1 the ,secretary shall provide written notice to such person of the intended administrative removal4 2 7#c7 in paragraph 7#b77;,d71 by inserting prior to approval after withdrawn2 7#d7 in paragraph 7#c7-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7i71 by striking 2 and and inserting a semicolon2 7ii7 by redesignating clause 7ii7 as clause 7iii72 and 7iii7 by inserting the following after clause 7i73 7ii7 may be dispensed only under prescription pursuant to section #ejc7;b72 and 2 and 7,b7 by adding at the end the following3 7,e7 ,movement to discontinued list 7i7 ,written request to place on discontinued list 7,i7 ,in general ,if a written request to place a product on the list of discontinued biosimilar biological products referred to in subparagraph 7,a77iii7 is submitted to the ,secretary on behalf of an applicant1 and the request identifies the date the product is1 or will be1 withdrawn from sale1 then for purposes of assessing the biosimilar biological product program fee1 the ,secretary shall consider such product to have been included on such list on the later of-- 7aa7 the date such request was received2 or 7bb7 if the product will be withdrawn from sale on a future date1 such future date when the product is withdrawn from sale4 7,,ii7 ,withdrawn from sale defined ,for purposes of this clause1 a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product1 whether or not the applicant has ordered recall of all previously distributed lots of the product1 except that a routine1 temporary interruption in supply shall not render a product withdrawn from sale4 7ii7 ,products removed from discontinued list ,if a biosimilar biological product that is identified in a biosimilar biological product application approved as of ,october #a of a fiscal year appears1 as of ,october #a of such fiscal year1 on the list of discontinued biosimilar biological products referred to in subparagraph 7,a77iii71 and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list1 except as provided in subparagraph 7,d71 each person who is named as the applicant in the biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection 7c77#e7 for such biosimilar biological product4 ,notwithstanding subparagraph 7,b71 such fee shall be due on the last business day of such fiscal year and shall be paid only once for each product for each fiscal year4 2 and 7#e7 by striking paragraph 7#d74 7b7 ,fee revenue amounts ,section #gdd;,h7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;b77 is amended-- 7#a7 by striking paragraph 7#a72 7#b7 by redesignating paragraphs 7#b7 through 7#d7 as paragraphs 7#a7 through 7#c71 respectively2 7#c7 in paragraph 7#a71 as so redesignated-- 7,a7 in the paragraph heading1 by striking ,subsequent fiscal years and inserting ,in general2 7,b7 in the matter preceding subparagraph 7,a71 by striking #bjai through #bjbb and inserting #bjbc through #bjbg2 7,c7 in subparagraph 7,a71 by striking paragraph 7#d7 and inserting paragraph 7#c72 7,d7 by redesignating subparagraphs 7,c7 and 7,d7 as subparagraphs 7,d7 and 7,e71 respectively2 7,e7 by inserting after subparagraph 7,b7 the following3 7,c7 the dollar amount equal to the strategic hiring and retention adjustment 7as determined under subsection 7c77#b772 2 7,f7 in subparagraph 7,d71 as so redesignated1 by striking subsection 7c77#b772 and and inserting subsection 7c77#c7722 7,g7 in subparagraph 7,e71 as so redesignated1 by striking subsection 7c77#c774 and inserting subsection 7c77#d772 and2 and 7,h7 by adding at the end the following3 7,f7 for fiscal years #bjbc and #bjbd1 additional dollar amounts equal to-- 7i7 #d1dbh1hhf for fiscal year #bjbc2 and 7ii7 #cbj1efi for fiscal year #bjbd4 2 7#d7 in paragraph 7#b71 as so redesignated-- 7,a7 in the paragraph heading1 by striking 2 limitations on fee amounts2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating subaparagraphs 7,c7 and 7,d7 as subparagraphs 7,b7 and 7,c71 respectively2 and 7#e7 by amending paragraph 7#c71 as so redesignated1 to read as follows3 7#c7 ,annual base revenue ,for purposes of paragraph 7#a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjbc1 #dc1cgf1ibb2 and 7,b7 for fiscal years #bjbd through #bjbg1 the dollar amount of the total revenue amount established under paragraph 7#a7 for the previous fiscal year1 excluding any adjustments to such revenue amount under subsection 7c77#d74 4 7c7 ,adjustments2 annual fee setting ,section #gdd;,h7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;c77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking subsection 7b77#b77;,b7 and inserting subsection 7b77#a77;,b72 and 7ii7 in clause 7i71 by striking subsection 7b7 and inserting subsection 7b77#a77;,a72 and 7,b7 in subparagraph 7,b77ii71 by striking ,washington-,baltimore1 ,,dc-,,md-,,va-,,wv and inserting ,washington-,arlington-,alexandria1 ,,dc-,,va-,,md-,,wv2 7#b7 by striking paragraph 7#d72 7#c7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#c7 and 7#d71 respectively2 7#d7 by inserting after paragraph 7#a7 the following3 7#b7 ,strategic hiring and retention adjustment ,for each fiscal year beginning in fiscal year #bjbc1 after the annual base revenue under subsection 7b77#a77;,a7 is adjusted for inflation in accordance with paragraph 7#a71 the ,secretary shall further increase the fee revenue and fees by #aej1jjj4 2 7#e7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraph 7,a7-- 7i7 by striking ,beginning with the fiscal year described in subparagraph 7,b77ii77,,ii7 and inserting ,for each fiscal year2 and 7ii7 by striking adjustment under paragraph 7#a71 further increase and inserting adjustments under paragraphs 7#a7 and 7#b71 further adjust2 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,methodology ,for purposes of this paragraph1 the ,secretary shall employ the capacity planning methodology utilized by the ,secretary in setting fees for fiscal year #bjba1 as described in the notice titled ,biosimilar ,user ,fee ,rates for ,fiscal ,year #bjba 7#he ,fed4 ,reg4 #dgbbj2 ,august #d1 #bjbj74 ,the workload categories used in forecasting shall include only the activities described in such notice and1 as feasible1 additional activities that are also directly related to the direct review of biosimilar biological product applications and supplements1 including additional formal meeting types and the direct review of postmarketing commitments and requirements1 the direct review of risk evaluation and mitigation strategies1 and the direct review of annual reports for approved biosimilar biological products4 ,subject to the exceptions in the preceding sentence1 the ,secretary shall not include as workload categories in forecasting any non-core review activities1 including any activities that the ,secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year #bjba4 2 and 7,c7 in subparagraph 7,c7-- 7i7 by striking subsections 7b77#b77;,a7 and inserting subsections 7b77#a77;,a72 7ii7 by striking and 7b77#b77;,b7 and inserting 1 7b77#a77;,b72 and 7iii7 by inserting 1 and 7b77#a77;,c7 7the dollar amount of the strategic hiring and retention adjustment7 before the period at the end2 7#f7 by amending paragraph 7#d71 as so redesignated1 to read as follows3 7#d7 ,operating reserve adjustment 7,a7 ,increase ,for fiscal year #bjbc and subsequent fiscal years1 the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees if such an adjustment is necessary to provide for at least #aj weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications4 7,b7 ,decrease 7i7 ,fiscal year #bjbc ,for fiscal year #bjbc1 if the ,secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of #cc weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #cc weeks of such operating reserves4 7ii7 ,fiscal year #bjbd ,for fiscal year #bjbd1 if the ,secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of #bg weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #bg weeks of such operating reserves4 7iii7 ,fiscal year #bjbe and subsequent fiscal years ,for fiscal year #bjbe and subsequent fiscal years1 if the ,secretary has carryover balances for the process for the review of biosimilar biological product applications in excess of #ba weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #ba weeks of such operating reserves4 7,c7 ,federal register notice ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e77;,b7 establishing fee revenue and fees for the fiscal year involved4 2 and 7#g7 in paragraph 7#e71 in the matter preceding subparagraph 7,a71 by striking #bjah and inserting #bjbc4 7d7 ,crediting and availability of fees ,section #gdd;,h7f77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 77#ba ,u4,s4,c4 #cgi;j-#eb7;f77#c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 7e7 ,written requests for waivers and refunds ,subsection 7h7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is amended to read as follows3 7h7 ,written requests for waivers and returns2 disputes concerning fees ,to qualify for consideration for a waiver under subsection 7d71 or the return of any fee paid under this section1 including if the fee is claimed to have been paid in error1 a person shall submit to the ,secretary a written request justifying such waiver or return and1 except as otherwise specified in this section1 such written request shall be submitted to the ,secretary not later than #ahj days after such fee is due4 ,a request submitted under this paragraph shall include any legal authorities under which the request is made4 4 #djd4 ,reauthorization2 reporting requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is amended-- 7#a7 by striking #bjah each place it appears and inserting #bjbc2 7#b7 by striking ,biosimilar ,user ,fee ,amendments of #bjag each place it appears and inserting ,biosimilar ,user ,fee ,amendments of #bjbb2 7#c7 in subsection 7a77#d71 by striking #bjbj and inserting #bjbc2 and 7#d7 in subsection 7f71 by striking #bjbb each place it appears and inserting #bjbg4 #dje4 ,sunset dates 7a7 ,authorization ,sections #gdd;,g and #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea1 #cgi;j-#eb7 shall cease to be effective ,october #a1 #bjbg4 7b7 ,reporting requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 shall cease to be effective ,january #ca1 #bjbh4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbb1 subsections 7a7 and 7b7 of section #dje of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 are repealed4 #djf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbb1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq47 shall be assessed for all biosimilar biological product applications received on or after ,october #a1 #bjbb1 regardless of the date of the enactment of this ,act4 #djg4 ,savings clause ,notwithstanding the amendments made by this title1 part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to biosimilar biological product applications and supplements 7as defined in such part as of such day7 that were accepted by the ,food and ,drug ,administration for filing on or after ,october #a1 #bjag1 but before ,october #a1 #bjbb1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjbc4 ,v ,other reauthorizations #eja4 ,reauthorization of the critical path public-private partnership ,section #eff7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #ejb4 ,reauthorization of the best pharmaceuticals for children program ,section #dji;,i7d77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7d77#a77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #ejc4 ,reauthorization of the humanitarian device exemption incentive ,section #ebj7m77#f77;,a77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is amended by striking #bjbb and inserting #bjbg4 #ejd4 ,reauthorization of the pediatric device consortia program ,section #cje7;e7 of the ,food and ,drug ,administration ,amendments ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note7 is amended by striking #e1bej1jjj for each of fiscal years #bjah through #bjbb and inserting #g1jjj1jjj for each of fiscal years #bjbc through #bjbg4 #eje4 ,reauthorization of provision pertaining to 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 ,october #a1 #bjbb and inserting ,october #a1 #bjbg4 #ejf4 ,reauthorization of orphan drug grants ,section #e7;c7 of the ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is amended by striking #bjah through #bjbb and inserting #bjbc through #bjbg4 #ejg4 ,reauthorization of certain device inspections ,section #gjd7;g77#aa7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77#aa77 is amended by striking #bjbb and inserting #bjbg4