,,ii #aahth ,,congress #ast ,session ,s4 #ahdd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #g1 #bjbc,ms4 ,baldwin 7for herself and ,mr4 ,mullin7 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 reauthorize user fee programs relating to new animal drugs and generic new animal drugs4 #a4 ,short title ,this ,act may be cited as the ,animal ,drug and ,animal ,generic ,drug ,user ,fee ,amendments of #bjbc4 #b4 ,table of contents ,the table of contents for this ,act is the following3 ,sec4 #a4 ,short title4,sec4 #b4 ,table of contents4,,title ,i--,fees ,relating to ,animal ,drugs,sec4 #aja4 ,short title2 finding4,sec4 #ajb4 ,definitions4,sec4 #ajc4 ,authority to assess and use animal drug fees4,sec4 #ajd4 ,reauthorization2 reporting requirements4,sec4 #aje4 ,savings clause4,sec4 #ajf4 ,effective date4,sec4 #ajg4 ,sunset dates4,,title ,,ii--,fees ,relating to ,generic ,animal ,drugs,sec4 #bja4 ,short title2 finding4,sec4 #bjb4 ,authority to assess and use generic new animal drug fees4,sec4 #bjc4 ,reauthorization2 reporting requirements4,sec4 #bjd4 ,savings clause4,sec4 #bje4 ,effective date4,sec4 #bjf4 ,sunset dates4,,title ,,iii--,supporting ,animal and ,human ,health,sec4 #cja4 ,reporting requirements4,sec4 #cjb4 ,definition of major species4,sec4 #cjc4 ,antimicrobial resistance4 ,i ,fees ,relating to ,animal ,drugs #aja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,animal ,drug ,user ,fee ,amendments of #bjbc4 7b7 ,finding ,congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified for purposes of part #d of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate as set forth in the ,congressional ,record4 #ajb4 ,definitions ,section #gci of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa7 is amended-- 7#a7 in paragraph 7#c71 by striking national drug code and inserting ,national ,drug ,code2 and 7#b7 by amending paragraph 7#h77;,i7 to read as follows3 7,i7 ,the activities necessary for implementation of the ,united ,states and ,european ,union ,mutual ,recognition ,agreement for ,pharmaceutical ,good ,manufacturing ,practice ,inspections1 and the ,united ,states and ,united ,kingdom ,mutual ,recognition ,agreement ,sectoral ,annex for ,pharmaceutical ,good ,manufacturing ,practices1 and other mutual recognition agreements1 with respect to animal drug products subject to review1 including implementation activities prior to and following product approval4 4 #ajc4 ,authority to assess and use animal drug fees 7a7 ,in general ,section #gdj7;a77#a77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;a77#a77;,a77ii77 is amended-- 7#a7 in subclause 7,i71 by striking and at the end2 7#b7 in subclause 7,,ii71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7,,iii7 an application for conditional approval under section #ega of a new animal drug for which an animal drug application submitted under section #eab7;b77#a7 has been previously approved under section #eab7;d77#a7 for another intended use4 4 7b7 ,fee revenue amounts ,section #gdj7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;b77#a77 is amended to read as follows3 7#a7 ,in general ,subject to subsections 7c71 7d71 7f71 and 7g71 for each of fiscal years #bjbd through #bjbh1 the fees required under subsection 7a7 shall be established to generate a total revenue amount of #cc1ejj1jjj4 4 7c7 ,annual fee setting2 adjustments 7#a7 ,annual fee setting ,section #gdj7;c77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#a77 is amended to read as follows3 7#a7 ,annual fee setting ,not later than #fj days before the start of each fiscal year beginning after ,september #cj1 #bjbc1 the ,secretary shall-- 7,a7 establish for that fiscal year animal drug application fees1 supplemental animal drug application fees1 animal drug sponsor fees1 animal drug establishment fees1 and animal drug product fees based on the revenue amounts established under subsection 7b7 and the adjustments provided under this subsection2 and 7,b7 publish such fee revenue amounts and fees in the ,federal ,register4 4 7#b7 ,inflation adjustment ,section #gdj7;c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#b77 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking #bjbj and inserting #bjbe2 and 7ii7 in clause 7iii71 by striking ,baltimore and inserting ,arlington-,alexandria2 and 7,b7 in subparagraph 7,b71 by striking #bjbj and inserting #bjbe4 7#c7 ,workload adjustments ,section #gdj7;c77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#c77 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i7-- 7,i7 by striking #bjbj and inserting #bjbe2 and 7,,ii7 by striking subparagraphs 7,b7 and 7,c7 and inserting subparagraph 7,b72 7ii7 in clause 7i7 by striking and at the end2 and 7iii7 by striking clause 7ii7 and inserting the following3 7ii7 such adjustment shall be made for each fiscal year that the adjustment determined by the ,secretary is greater than #c percent1 except for the first fiscal year that the adjustment is greater than #c percent2 and 7iii7 the ,secretary shall publish in the ,federal ,register notice under paragraph 7#a7 the amount of such adjustment and the supporting methodologies4 2 7,b7 by striking subparagraph 7,b72 and 7,c7 by redesignating subparagraph 7,c7 as subparagraph 7,b74 7#d7 ,final year adjustment ,section #gdj7;c77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#d77 is amended to read as follows3 7#d7 ,operating reserve adjustment 7,a7 ,in general ,for fiscal year #bjbe and each subsequent fiscal year1 after the fee revenue amount established under subsection 7b7 is adjusted in accordance with paragraphs 7#b7 and 7#c71 the ,secretary shall-- 7i7 increase the fee revenue amount for such fiscal year1 if necessary to provide an operating reserve of not less than #ab weeks2 or 7ii7 if the ,secretary has an operating reserve in excess of the number of weeks specified in subparagraph 7,c7 for that fiscal year1 the ,secretary shall decrease the fee revenue amount to provide not more than the number of weeks specified in subparagraph 7,c7 for that fiscal year4 7,b7 ,carryover user fees ,for purposes of this paragraph1 the operating reserve of carryover user fees for the process for the review of animal drug applications does not include carryover user fees that have not been appropriated4 7,c7 ,number of weeks of operating reserves ,the number of weeks of operating reserves specified in this subparagraph is-- 7i7 #bb weeks for fiscal year #bjbe2 7ii7 #bj weeks for fiscal year #bjbf2 7iii7 #ah weeks for fiscal year #bjbg2 and 7iv7 #af weeks for fiscal year #bjbh4 7,d7 ,publication ,if an adjustment to the operating reserve is made under this paragraph1 the ,secretary shall publish in the ,federal ,register notice under paragraph 7#a7 the rationale for the amount of the adjustment and the supporting methodologies4 4 7d7 ,exemption from fees ,section #gdj7;d77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;d77#d77 is amended to read as follows3 7#d7 ,exemption from fees ,fees under paragraphs 7#b71 7#c71 and 7#d7 of subsection 7a7 shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application1 supplemental animal drug application1 or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug1 device1 or biological product subject to fees under section #gcf1 #gch1 #gdd;,b1 or #gdd;,h4 4 7e7 ,crediting and availability of fees 7#a7 ,authorization of appropriations ,section #gdj7;g77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;g77#c77 is amended by striking #bjai through #bjbc and inserting #bjbd through #bjbh4 7#b7 ,collection shortfalls ,section #gdj7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;g77 is amended-- 7,a7 in paragraph 7#c71 by striking and paragraph 7#e72 and 7,b7 by striking paragraph 7#e74 #ajd4 ,reauthorization2 reporting requirements ,section #gdj;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ac7 is amended-- 7#a7 in subsection 7a71 by striking #bjah and inserting #bjbc2 7#b7 by striking #bjai each place it appears in subsections 7a7 and 7b7 and inserting #bjbd2 and 7#c7 in subsection 7d7-- 7,a7 in paragraph 7#a71 by striking #bjbc and inserting #bjbh2 and 7,b7 in paragraph 7#e71 by striking #bjbc and inserting #bjbh4 #aje4 ,savings clause ,notwithstanding the amendments made by this title1 part #d of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa et seq471 as in effect on the day before the date of enactment of this title1 shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications 7as defined in such part as of such day7 that on or after ,october #a1 #bjah1 but before ,october #a1 #bjbc1 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 #bjbd4 #ajf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbc1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #d of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa et seq471 as amended by this title1 shall be assessed for animal drug applications and supplemental animal drug applications received on or after ,october #a1 #bjbc1 regardless of the date of the enactment of this ,act4 #ajg4 ,sunset dates 7a7 ,authorization ,sections #gci and #gdj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ba ,u4,s4,c4 #cgi;j-#aa2 #cgi;j-#ab7 shall cease to be effective ,october #a1 #bjbh4 7b7 ,reporting requirements ,section #gdj;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ac7 shall cease to be effective ,january #ca1 #bjbi4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbc1 subsections 7a7 and 7b7 of section #ajg of the ,animal ,drug ,user ,fee ,amendments of #bjah 7,public ,law #aae-bcd7 are repealed4 ,,ii ,fees ,relating to ,generic ,animal ,drugs #bja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,animal ,generic ,drug ,user ,fee ,amendments of #bjbc4 7b7 ,finding ,congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs1 supplemental abbreviated applications for generic new animal drugs1 and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part #e of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba et seq471 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,chairman of the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate as set forth in the ,congressional ,record4 #bjb4 ,authority to assess and use generic new animal drug fees 7a7 ,generic ,investigational ,new ,animal ,drug ,file ,fee ,section #gda7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;a77 is amended by adding at the end the following3 7#d7 ,generic investigational new animal drug file fee 7,a7 ,in general 7i7 ,new file request ,each person that submits a request to establish a generic investigational new animal drug file on or after ,october #a1 #bjbc1 shall be assessed a fee as established under subsection 7c74 7ii7 ,new submission to established file ,each person that makes a submission to a generic investigational new animal drug file on or after ,october #a1 #bjbc1 where such file was established prior to ,october #a1 #bjbc1 shall be assessed a fee for the first submission on or after ,october #a1 #bjbc1 as established under subsection 7c74 7,b7 ,payment 7i7 ,new file request ,the fee required by subparagraph 7,a77i7 shall be due upon submission of the request to establish the generic investigational new animal drug file4 7ii7 ,new submission to established file ,the fee required by subparagraph 7,a77ii7 shall be due upon the first submission to the generic investigational new animal drug file4 7,c7 ,exceptions 7i7 ,terminating an existing generic investigational new animal drug file ,if a person makes a submission to the generic investigational new animal drug file to terminate that file1 the person shall not be subject to a fee under subparagraph 7,a77ii7 for that submission4 7ii7 ,transferring an existing generic investigational new animal drug file ,if a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor1 the person shall not be subject to a fee under subparagraph 7,a77ii7 for that submission4 4 7b7 ,fee revenue amounts ,section #gda7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking #bjai through #bjbc and inserting #bjbd through #bjbh2 and 7,b7 by striking #ah1ccf1cdj and inserting #be1jjj1jjj2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking #be percent and inserting #bj percent2 and 7ii7 by inserting before the semicolon at the end the following3 and fees under subsection 7a77#d7 7relating to generic investigational new animal drug files72 7,b7 in subparagraph 7,b71 by striking #cg4e percent and inserting #dj percent2 and 7,c7 in subparagraph 7,c71 by striking #cg4e percent and inserting #dj percent4 7c7 ,annual fee setting2 adjustments 7#a7 ,annual fee setting ,section #gda7;c77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77#a77 is amended to read as follows3 7#a7 ,annual fee setting ,the ,secretary shall establish1 not later than #fj days before the start of each fiscal year beginning after ,september #cj1 #bjbc1 for that fiscal year-- 7,a7 abbreviated application fees that are based on the revenue amounts established under subsection 7b71 the adjustments provided under this subsection1 and the amount of fees anticipated to be collected under subsection 7a77#d7 during that fiscal year2 7,b7 generic new animal drug sponsor fees1 and generic new animal drug product fees1 based on the revenue amounts established under subsection 7b7 and the adjustments provided under this subsection2 and 7,c7 a generic investigational new animal drug file fee of #ej1jjj for each request or submission described in subsection 7a77#d77;,a74 4 7#b7 ,inflation adjustment ,section #gda7;c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77#b77 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking #bjbj and inserting #bjbe2 and 7ii7 in clause 7iii71 by striking ,baltimore and inserting ,arlington-,alexandria2 and 7,b7 in subparagraph 7,b71 by striking #bjbj and inserting #bjbe4 7#c7 ,workload adjustment ,section #gda7;c77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77#c77 is amended-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking #bjbj and inserting #bjbe2 7ii7 in clause 7i7-- 7,i7 by striking and investigational generic new animal drug protocol submissions and inserting investigational generic new animal drug protocol submissions1 requests to establish a generic investigational new animal drug file1 and generic investigational new animal drug meeting requests2 and 7,,ii7 by striking 2 and and inserting a semicolon2 7iii7 by redesignating clause 7ii7 as clause 7iii72 and 7iv7 by inserting after clause 7i7 the following3 7ii7 if the workload adjustment calculated by the ,secretary under clause 7i7 exceeds #be percent1 the ,secretary shall use #be percent for the adjustment2 and 2 and 7,b7 in subparagraph 7,b71 by striking #bjba through #bjbc and inserting #bjbf through #bjbh4 7#d7 ,final year adjustment ,section #gda7;c77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77#d77 is amended-- 7,a7 by striking #bjbc each place it appears and inserting #bjbh2 and 7,b7 by striking #bjbd and inserting #bjbi4 7d7 ,fee waiver or reduction2 exemption from fees ,subsection 7d7 of section #gda of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7 is amended to read as follows3 7d7 ,fee waiver or reduction ,the ,secretary shall grant a waiver from1 or a reduction of1 one or more fees assessed under subsection 7a7 where the ,secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication4 4 7e7 ,effect of failure ,to pay fees ,section #gda7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;e77 is amended by striking ,the ,secretary may discontinue and inserting ,a request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection 7a7 shall be considered incomplete and shall not be accepted for action by the ,secretary until all fees owed by such person have been paid4 ,the ,secretary may discontinue4 7f7 ,assessment of fees ,section #gda7;f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;f77#b77 is amended by striking sponsors1 and generic new animal drug products at any time and inserting products1 generic new animal drug sponsors1 and generic investigational new animal drug files at any time4 7g7 ,crediting and availability of fees ,section #gda7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7;g77 is amended-- 7#a7 in paragraph 7#c71 by striking #bjai through #bjbc and inserting #bjbd through #bjbh2 7#b7 by striking the second paragraph 7#d7 7relating to ,offset71 as added by section #bjb of the ,animal ,generic ,drug ,user ,fee ,amendments of #bjac 7,public ,law #aac-ad72 and 7#c7 by adding at the end the following3 7#e7 ,recovery of collection shortfalls ,the amount of fees otherwise authorized to be collected under this section shall be increased-- 7,a7 for fiscal year #bjbf1 by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjbd falls below the amount of fees authorized for fiscal year #bjbd under paragraph 7#c72 7,b7 for fiscal year #bjbg1 by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjbe falls below the amount of fees authorized for fiscal year #bjbe under paragraph 7#c72 and 7,c7 for fiscal year #bjbh1 by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal years #bjbf and #bjbg 7including estimated collections for fiscal year #bjbg7 falls below the amount of fees authorized for such fiscal years under paragraph 7#c74 4 7h7 ,definitions ,section #gda7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7k77 is amended-- 7#a7 by redesignating paragraphs 7#h71 7#i71 7#aj71 and 7#aa7 as paragraphs 7#i71 7#aj71 7#aa71 and 7#ac71 respectively2 7#b7 by inserting after paragraph 7#g7 the following3 7#h7 ,generic investigational new animal drug meeting request ,the term generic investigational new animal drug meeting request means a request submitted by a generic new animal drug sponsor to meet with the ,secretary to discuss an investigational submission for a generic new animal drug4 2 7#c7 in paragraph 7#aa7 7as so redesignated71 by adding at the end the following3 7,i7 ,the activities necessary for exploration and implementation of the ,united ,states and ,european ,union ,mutual ,recognition ,agreement for ,pharmaceutical ,good ,manufacturing ,practice ,inspections1 and the ,united ,states and ,united ,kingdom ,mutual ,recognition ,agreement ,sectoral ,annex for ,pharmaceutical ,good ,manufacturing ,practices1 and other mutual recognition agreements1 with respect to generic new animal drug products subject to review1 including implementation activities prior to and following product approval4 2 and 7#d7 by inserting after paragraph 7#aa7 7as so redesignated7 the following3 7#ab7 ,request to establish a generic investigational new animal drug file ,the term request to establish a generic investigational new animal drug file means the submission to the ,secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug4 4 #bjc4 ,reauthorization2 reporting requirements ,section #gdb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#bb7 is amended-- 7#a7 in subsection 7a71 by striking #bjah and inserting #bjbc2 7#b7 by striking #bjai each place it appears in subsections 7a7 and 7b7 and inserting #bjbd2 and 7#c7 in subsection 7d71 by striking #bjbc each place it appears and inserting #bjbh4 #bjd4 ,savings clause ,notwithstanding the amendments made by this title1 part #e of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba et seq471 as in effect on the day before the date of enactment of this title1 shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug 7as defined in such part as of such day7 that on or after ,october #a1 #bjah1 but before ,october #a1 #bjbc1 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 #bjbd4 #bje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjbc1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #e of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba et seq471 as amended by this title1 shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after ,october #a1 #bjbc1 regardless of the date of enactment of this ,act4 #bjf4 ,sunset dates 7a7 ,authorization ,section #gda of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7 shall cease to be effective ,october #a1 #bjbh4 7b7 ,reporting requirements ,section #gdb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#bb7 shall cease to be effective ,january #ca1 #bjbi4 7c7 ,previous sunset provision ,effective ,october #a1 #bjbc1 subsections 7a7 and 7b7 of section #bjf of the ,animal ,generic ,drug ,user ,fee ,amendments of #bjah 7,public ,law #aae-bcd7 are repealed4 ,,iii ,supporting ,animal and ,human ,health #cja4 ,reporting requirements ,section #gdj;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ac71 as amended by section #ajd1 is further amended-- 7#a7 in subsection 7a7-- 7,a7 by striking ,beginning with and inserting the following3 7#a7 ,in general ,beginning with 2 and 7,b7 by adding at the end the following3 7#b7 ,contents ,the report under paragraph 7#a7 shall include the following3 7,a7 ,data1 analysis and discussion of the changes in the number of individuals hired and funded by fees collected pursuant to section #gdj1 and data1 analysis1 and discussion of the number of full-time equivalents in the animal drug review program1 including a breakdown by funding from fees collected pursuant to section #gdj versus budget authority1 and by each office within the ,center for ,veterinary ,medicine1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner4 7,b7 ,data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of animal drug applications1 including identifying-- 7i7 the drivers of such changes2 and 7ii7 changes in the total cost per full-time equivalent in the animal drug review program4 7,c7 ,data1 analysis1 and discussion of changes in the average full-time equivalent hours required to complete review of each type of animal drug application4 7,d7 ,for fiscal years #bjbd and #bjbe1 of the meeting requests from animal drug sponsors for which the ,secretary has determined that a face-to-face meeting is appropriate1 the number of face-to-face meetings requested by sponsors to be conducted in person 7in such manner as the ,secretary shall prescribe on the website of the ,food and ,drug ,administration71 and the number of such in-person meetings granted by the ,secretary4 2 and 7#b7 in subsection 7d7-- 7,a7 in paragraph 7#e71 by inserting a comma after paragraph 7#d72 7,b7 by redesignating paragraph 7#f7 as paragraph 7#g72 7,c7 by inserting after paragraph 7#e7 the following3 7#f7 ,updates to ,congress ,the ,secretary1 in consultation with regulated industry1 shall provide regular updates on negotiations on the reauthorization of this part to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 2 and 7,d7 in paragraph 7#g7 7as so redesignated7-- 7i7 in subparagraph 7,a7-- 7,i7 by striking ,before presenting the recommendations developed under paragraphs 7#a7 through 7#e7 to ,congress1 the ,secretary and inserting ,the ,secretary2 and 7,,ii7 by inserting before the period at the end the following3 1 not later than #cj days after each such negotiation meeting2 and 7ii7 in subparagraph 7,b71 by inserting 1 in sufficient detail1 after shall summarize4 #cjb4 ,definition of major species ,section #bja7nn7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7nn77 is amended by inserting 1 or remove species from1 after add species to4 #cjc4 ,antimicrobial resistance 7a7 ,report on ,antimicrobial ,stewardship ,not later than ,december #ca1 #bjbc1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report describing-- 7#a7 activities conducted by the ,center for ,veterinary ,medicine of the ,food and ,drug ,administration 7referred to in this section as the ,center7 during the period of fiscal years #bjai through #bjbc to support antimicrobial stewardship in veterinary settings1 including ongoing activities and the targeted completion date of such activities2 and 7#b7 with respect to antimicrobial stewardship in veterinary settings-- 7,a7 the goals of the ,center regarding supporting antimicrobial stewardship in veterinary settings2 7,b7 activities the ,center plans to execute during the period of fiscal years #bjbd through #bjbh to support such goals1 including targeted completion dates for such activities2 and 7,c7 metrics the ,center plans to use to evaluate progress toward its goals regarding supporting antimicrobial stewardship in veterinary settings4 7b7 ,annual progress reports ,not later than #abj days after the end of each fiscal year during which fees are collected under section #gdj1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report that includes-- 7#a7 a description of activities conducted by the ,center in the prior fiscal year to support antimicrobial stewardship in veterinary settings1 including progress made toward goals and activities specified in subsection 7a77#b72 7#b7 in the case of an incomplete activity described in subsection 7a77#b77;,b7 for which the target completion date has passed-- 7,a7 an explanation for why such target completion date was not met2 and 7,b7 if applicable1 the updated expected completion date for such activity2 7#c7 a description of emerging challenges related to antimicrobial stewardship in veterinary settings that impact ,center activities2 and 7#d7 a description of activities undertaken to incentivize the development of new drugs for the treatment1 prevention1 or control of bacterial diseases in animals4