,,ii #aaeth ,,congress #b;d ,session ,h4 ,r4 #eeed ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ag1 #bjah,received ,,an ,,act ,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 #bjah4 #b4 ,table of contents2 references in ,act 7a7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,table of contents2 references in ,act4,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--,miscellaneous ,provisions,sec4 #cja4 ,electronic submissions4,sec4 #cjb4 ,index of legally marketed unapproved new animal drugs for minor species4,sec4 #cjc4 ,misbranded drugs and devices4,sec4 #cjd4 ,conditional approval of new animal drugs4,sec4 #cje4 ,guidance addressing investigation designs4,sec4 #cjf4 ,food additives intended for use in animal food4 7b7 ,references in ,act ,except as otherwise specified1 amendments made by this ,act to a section or other provision of law are amendments to such section or other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 ,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 #bjah4 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 ,act1 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 7#ba ,u4,s4,c4 #cgi;j-#aa7 is amended-- 7#a7 by amending paragraph 7#a7 to read as follows3 7#a7 7,a7 ,the term animal drug application means-- 7i7 an application for approval of any new animal drug submitted under section #eab7;b77#a72 or 7ii7 an application for conditional approval of a new animal drug submitted under section #ega4 7,b7 ,such term does not include either a new animal drug application submitted under section #eab7;b77#b7 or a supplemental animal drug application4 2 and 7#b7 in paragraph 7#h71 by adding at the end the following3 7,i7 ,the activities necessary for implementation of the ,united ,states and ,european ,union ,good ,manufacturing ,practice ,mutual ,inspection ,agreement 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 ,fee revenue amounts ,section #gdj7;b7 7#ba ,u4,s4,c4 #cgi;j-#ab7;b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking #bjad and inserting #bjai2 and 7ii7 by striking #bc1fjj1jjj and inserting #cj1cca1bdj2 and 7,b7 in subparagraph 7,b7-- 7i7 by striking #bjae through #bjah and inserting #bjbj through #bjbc2 and 7ii7 by striking #ba1fjj1jjj and inserting #bi1ica1bdj2 and 7#b7 in paragraph 7#b71 in the matter preceding subparagraph 7,a71 by striking determined and inserting established4 7b7 ,annual fee setting2 adjustments 7#a7 ,inflation adjustment ,section #gdj7;c77#b7 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#b77 is amended-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking ,for fiscal year #bjae and inserting 7,a7 ,for fiscal year #bjbj2 and 7ii7 by inserting multiplying such revenue amounts by before an amount2 7,b7 by redesignating subparagraphs 7,a71 7,b71 and 7,c7 as clauses 7i71 7ii71 and 7iii71 respectively2 7,c7 by striking the flush text at the end2 and 7,d7 by adding at the end the following new subparagraph3 7,b7 ,compounded basis ,the adjustment made each fiscal year after fiscal year #bjbj under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year4 4 7#b7 ,workload adjustments ,paragraph 7#c7 of section #gdj7;c7 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77 is amended to read as follows3 7#c7 ,workload adjustments 7,a7 ,in general ,for fiscal year #bjbj and subsequent fiscal years1 after the fee revenue amounts established under subsection 7b7 are adjusted for inflation in accordance with paragraph 7#b71 the fee revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the ,secretary for the process for the review of animal drug applications1 subject to subparagraphs 7,b7 and 7,c74 ,with respect to such adjustment-- 7i7 such adjustment shall be determined by the ,secretary based on a weighted average of the change in the total number of animal drug applications1 supplemental animal drug applications for which data with respect to safety or effectiveness are required1 manufacturing supplemental animal drug applications1 investigational animal drug study submissions1 and investigational animal drug protocol submissions submitted to the ,secretary2 and 7ii7 the ,secretary shall publish in the ,federal ,register the fees resulting from such adjustment and the supporting methodologies4 7,b7 ,reduction of workload-based increase by amount of certain excess collections ,for each of fiscal years #bjba through #bjbc1 if application of the workload adjustment under subparagraph 7,a7 increases the fee revenue amounts otherwise established for the fiscal year under subsection 7b71 as adjusted for inflation under paragraph 7#b71 such fee revenue increase shall be reduced by the amount of any excess collections1 as described in subsection 7g77#d71 for the second preceding fiscal year1 up to the amount of such fee revenue increase4 7,c7 ,rule of application ,under no circumstances shall the workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection 7b71 as adjusted for inflation under paragraph 7#b74 4 7#c7 ,final year adjustment ,section #gdj7;c77#d7 7#ba ,u4,s4,c4 #cgi;j-#ab7;c77#d77 is amended-- 7,a7 by striking #bjah each place it appears and inserting #bjbc2 and 7,b7 by striking #bjai and inserting #bjbd4 7c7 ,exemptions from fees ,section #gdj7;d7 7#ba ,u4,s4,c4 #cgi;j-#ab7;d77 is amended-- 7#a7 in the subsection heading1 by inserting 2 exemptions from fees after reduction2 7#b7 by striking the heading of paragraph 7#a7 and inserting ,waiver or reduction2 and 7#c7 by adding at the end the following3 7#d7 ,exemptions from fees 7,a7 ,certain labeling supplements ,to add number of approved application ,fees under this section shall not apply with respect to any person who-- 7i7 not later than ,september #cj1 #bjbc1 submits a supplemental animal drug application relating to a new animal drug application approved under section #eab1 solely to add the new animal drug application number to the labeling of the drug in the manner specified in section #ejb7w77#c72 and 7ii7 otherwise would be subject to fees under this section solely on the basis of such supplemental application4 7,b7 ,certain animal drug applications ,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 7d7 ,crediting and availability of fees 7#a7 ,authorization of appropriations ,section #gdj7;g77#c7 7#ba ,u4,s4,c4 #cgi;j-#ab7;g77#c77 is amended-- 7,a7 by striking #bjad through #bjah and inserting #bjai through #bjbc2 7,b7 by striking determined and inserting established2 and 7,c7 by striking paragraph 7#d7 and inserting paragraph 7#e74 7#b7 ,excess collections ,section #gdj7;g7 7#ba ,u4,s4,c4 #cgi;j-#ab7;g77 is amended by striking paragraph 7#d7 and inserting the following3 7#d7 ,excess collections ,if the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph 7#c71 the excess collections shall be credited to the appropriations account of the ,food and ,drug ,administration as provided in paragraph 7#a74 7#e7 ,recovery of collection shortfalls 7,a7 ,in general ,subject to subparagraph 7,b7-- 7i7 for fiscal year #bjba1 the amount of fees otherwise authorized to be collected under this section shall be increased by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjai falls below the amount of fees authorized for fiscal year #bjai under paragraph 7#c72 7ii7 for fiscal year #bjbb1 the amount of fees otherwise authorized to be collected under this section shall be increased by the amount1 if any1 by which the amount collected under this section and appropriated for fiscal year #bjbj falls below the amount of fees authorized for fiscal year #bjbj under paragraph 7#c72 and 7iii7 for fiscal year #bjbc1 the amount of fees otherwise authorized to be collected under this section shall be increased by the cumulative amount1 if any1 by which the amount collected under this section and appropriated for fiscal years #bjba and #bjbb 7including estimated collections for fiscal year #bjbb7 falls below the cumulative amount of fees authorized for such fiscal years under paragraph 7#c74 7,b7 ,reduction of shortfall-based fee increase by prior year excess collections 7i7 ,in general ,subject to clause 7ii71 the ,secretary shall1 in such manner as the ,secretary determines appropriate1 reduce any fee increase otherwise applicable for a fiscal year under subparagraph 7,a7 by the amount of any excess collections under this section for preceding fiscal years 7after fiscal year #bjah74 7ii7 ,workload-based fee accounting ,in applying clause 7i71 the ,secretary shall account for the reduction of workload-based fee revenue increases by excess collections under subsection 7c77#c77;,b71 in such manner as needed to provide that no portion of any excess collections described in clause 7i7 is applied for purposes of reducing fee increases under both such subsection 7c77#c77;,b7 and this paragraph4 7,c7 ,rule of application ,under no circumstances shall adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection 7b71 as adjusted or otherwise affected under subsection 7c74 4 #ajd4 ,reauthorization2 reporting requirements ,section #gdj;,a 7#ba ,u4,s4,c4 #cgi;j-#ac7 is amended-- 7#a7 in subsection 7a71 by striking #bjac and inserting #bjah2 7#b7 by striking #bjad each place it appears in subsections 7a7 and 7b7 and inserting #bjai2 and 7#c7 in subsection 7d71 by striking #bjah each place it appears and inserting #bjbc4 #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 #bjac1 but before ,october #a1 #bjah1 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 #bjai4 #ajf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjah1 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 ,act1 as amended by this title1 shall be assessed for animal drug applications and supplemental animal drug applications received on or after ,october #a1 #bjah1 regardless of the date of the enactment of this ,act4 #ajg4 ,sunset dates 7a7 ,authorization ,section #gdj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7 shall cease to be effective ,october #a1 #bjbc4 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 #bjbd4 7c7 ,previous sunset provision ,effective ,october #a1 #bjah1 subsections 7a7 and 7b7 of section #ajg of the ,animal ,drug ,user ,fee ,amendments of #bjac 7,public ,law #aac-ad7 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 #bjah4 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 ,act1 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 ,fee revenue amounts ,subsection 7b7 of section #gda 7#ba ,u4,s4,c4 #cgi;j-#ba7 is amended to read as follows3 7b7 ,fee revenue amounts 7#a7 ,in general ,subject to subsections 7c71 7d71 7f71 and 7g71 for each of fiscal years #bjai through #bjbc1 the fees required under subsection 7a7 shall be established to generate a total revenue amount of #ah1ccf1cdj4 7#b7 ,types of fees ,of the total revenue amount established for a fiscal year under paragraph 7#a7-- 7,a7 #be percent shall be derived from fees under subsection 7a77#a7 7relating to abbreviated applications for a generic new animal drug72 7,b7 #cg4e percent shall be derived from fees under subsection 7a77#b7 7relating to generic new animal drug products72 and 7,c7 #cg4e percent shall be derived from fees under subsection 7a77#c7 7relating to generic new animal drug sponsors74 4 7b7 ,annual fee setting2 adjustments 7#a7 ,inflation adjustment ,section #gda7;c7 7#ba ,u4,s4,c4 #cgi;j-#ba7;c77 is amended-- 7,a7 by redesignating paragraphs 7#b7 through 7#d7 as paragraphs 7#c7 through 7#e71 respectively2 and 7,b7 by inserting after paragraph 7#a7 the following3 7#b7 ,inflation adjustment 7,a7 ,in general ,for fiscal year #bjbj and subsequent fiscal years1 the revenue amounts established under subsection 7b7 shall be adjusted by the ,secretary by notice1 published in the ,federal ,register1 for a fiscal year1 by multiplying such revenue amounts by an amount equal to the sum of-- 7i7 one2 7ii7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c of the preceding #d fiscal years for which data are available1 multiplied by the average proportion of personnel compensation and benefits costs to total ,food and ,drug ,administration costs for the first #c of the preceding #d fiscal years for which data are available2 and 7iii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 not seasonally adjusted2 all items less food and energy2 annual index7 for the first #c of the preceding #d years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total ,food and ,drug ,administration costs for the first #c of the preceding #d fiscal years for which data are available4 7,b7 ,compounded basis ,the adjustment made each fiscal year after fiscal year #bjbj under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year4 4 7#b7 ,workload adjustments ,paragraph 7#c7 of section #gda7;c7 7#ba ,u4,s4,c4 #cgi;j-#ba7;c771 as redesignated1 is amended to read as follows3 7#c7 ,workload adjustments 7,a7 ,in general ,for fiscal year #bjbj and subsequent fiscal years1 after the fee revenue amounts established under subsection 7b7 are adjusted for inflation in accordance with paragraph 7#b71 the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the ,secretary for the process for the review of abbreviated applications for generic new animal drugs1 subject to subparagraphs 7,b7 and 7,c74 ,with respect to such adjustment-- 7i7 this adjustment shall be determined by the ,secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs1 manufacturing supplemental abbreviated applications for generic new animal drugs1 investigational generic new animal drug study submissions1 and investigational generic new animal drug protocol submissions submitted to the ,secretary2 and 7ii7 the ,secretary shall publish in the ,federal ,register the fees resulting from this adjustment and the supporting methodologies4 7,b7 ,reduction of workload-based increase by amount of certain excess collections ,for each of fiscal years #bjba through #bjbc1 if application of the workload adjustment under subparagraph 7,a7 increases the fee revenue amounts otherwise established for the fiscal year under subsection 7b71 as adjusted for inflation under paragraph 7#b71 such fee revenue increase shall be reduced by the amount of any excess collections1 as described in subsection 7g77#d71 for the second preceding fiscal year1 up to the amount of such fee revenue increase4 7,c7 ,rule of application ,under no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection 7b71 as adjusted for inflation under paragraph 7#b74 4 7#c7 ,final year adjustment ,paragraph 7#d7 of section #gda7;c7 7#ba ,u4,s4,c4 #cgi;j-#ba7;c771 as redesignated1 is amended by-- 7,a7 striking #bjah each place it appears and inserting #bjbc2 and 7,b7 striking #bjai and inserting #bjbd4 7c7 ,fee waiver or reduction2 exemption from fees ,subsection 7d7 of section #gda 7#ba ,u4,s4,c4 #cgi;j-#ba7 is amended to read as follows3 7d7 ,fee waiver or reduction2 exemption from fees 7#a7 ,fee waiver or reduction ,the ,secretary shall grant a waiver from or a reduction of 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 7#b7 ,exemption from fees ,fees under this section shall not apply with respect to any person who-- 7,a7 not later than ,september #cj1 #bjbc1 submits a supplemental abbreviated application for a generic new animal drug approved under section #eab1 solely to add the application number to the labeling of the drug in the manner specified in section #ejb7w77#c72 and 7,b7 otherwise would be subject to fees under this section solely on the basis of such supplemental abbreviated application4 4 7d7 ,crediting and availability of fees ,section #gda7;g7 7#ba ,u4,s4,c4 #cgi;j-#ba7 is amended by striking paragraph 7#c7 and inserting the following paragraphs3 7#c7 ,authorization of appropriations ,for each of the fiscal years #bjai through #bjbc1 there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection 7b7 for the fiscal year1 as adjusted or otherwise affected under subsection 7c74 7#d7 ,excess collections ,if the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph 7#c71 the excess collections shall be credited to the appropriations account of the ,food and ,drug ,administration as provided in paragraph 7#a74 4 #bjc4 ,reauthorization2 reporting requirements ,section #gdb 7#ba ,u4,s4,c4 #cgi;j-#bb7 is amended-- 7#a7 in subsection 7a71 by striking #bjac and inserting #bjah2 7#b7 in subsection 7b71 by striking ,committee on ,health1 ,education1 ,labor1 and ,pensions and inserting the ,committee on ,health1 ,education1 ,labor and ,pensions2 7#c7 by striking #bjad each place it appears in subsections 7a7 and 7b7 and inserting #bjai2 and 7#d7 in subsection 7d71 by striking #bjah each place it appears and inserting #bjbc4 #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 #bjac1 but before ,october #a1 #bjah1 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 #bjai4 #bje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjah1 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 ,act1 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 #bjah1 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 #bjbc4 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 #bjbd4 7c7 ,previous sunset provision ,effective ,october #a1 #bjah1 subsections 7a7 and 7b7 of section #bjf of the ,animal ,generic ,drug ,user ,fee ,amendments of #bjac 7,public ,law #aac-ad7 are repealed4 ,,iii ,miscellaneous ,provisions #cja4 ,electronic submissions 7a7 ,new animal drug applications and abbreviated applications for a generic new animal drug ,section #eab7;b7 7#ba ,u4,s4,c4 #cfj;b7b77 is amended by adding at the end the following3 7#d7 ,beginning on ,october #a1 #bjah1 all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the ,secretary may require4 4 7b7 ,conditional approval of new animal drugs for minor use and minor species ,section #ega7;a7 7#ba ,u4,s4,c4 #cfj;ccc7a77 is amended by adding at the end the following3 7#d7 ,beginning on ,october #a1 #bjah1 all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the ,secretary may require4 4 #cjb4 ,index of legally marketed unapproved new animal drugs for minor species ,effective on ,october #a1 #bjah1 section #egb7;h7 7#ba ,u4,s4,c4 #cfj;ccc-#a7;h77 is amended-- 7#a7 by amending paragraph 7#a7 to read as follows3 7#a7 ,,legal ,,status--,in order to be legally marketed1 a new animal drug intended for a minor species must be ,approved1 ,conditionally ,approved1 or ,indexed by the ,food and ,drug ,administration4 ,,this ,,product ,,is ,,indexed--,,mif 7followed by the applicable minor species index file number and a period7 ,extra-label use is prohibited42 2 and 7#b7 in paragraph 7#b71 by striking other animals and inserting food-producing animals4 #cjc4 ,misbranded drugs and devices 7a7 ,in general ,section #ejb7w7 7#ba ,u4,s4,c4 #ceb7w77 is amended-- 7#a7 in subparagraph 7#a71 by striking 2 or and inserting 22 7#b7 in subparagraph 7#b71 by striking the period and inserting 2 or2 and 7#c7 by adding at the end the following3 7#c7 for which an application has been approved under section #eab and the labeling of such drug does not include the application number in the format3 ,approved by ,,fda under 7,a7,,nada xxx-xxx1 except that this subparagraph shall not apply to representative labeling required under section #ead4a7;b77#c77v77b7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation7 for animal feed bearing or containing a new animal drug4 4 7b7 ,applicability ,section #ejb7w77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 shall apply beginning on ,september #cj1 #bjbc4 #cjd4 ,conditional approval of new animal drugs 7a7 ,in general ,section #ega of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc7 is amended-- 7#a7 in the section heading1 by striking species and inserting species and certain new animal drugs2 7#b7 in subsection 7a7-- 7,a7 by amending paragraph 7#a7 to read as follows3 7#a7 7,a7 ,except as provided in paragraph 7#c71 any person may file with the ,secretary an application for conditional approval of-- 7i7 a new animal drug intended for a minor use or a minor species2 or 7ii7 a new animal drug not intended for a minor use or minor species-- 7,i7 that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need2 and 7,,ii7 for which the ,secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies4 7,b7 ,the ,secretary shall1 not later than ,september #cj1 #bjai1 issue guidance or regulations further clarifying the criteria specified in subparagraph 7,a77ii74 7,c7 ,an application under this paragraph shall comply in all respects with the provisions of section #eab except for subsections 7a77#d71 7b77#b71 7c77#a71 7c77#b71 7c77#c71 7d77#a71 7e71 7h71 and 7n7 of such section unless otherwise stated in this section1 and any additional provisions of this section4 7,d7 ,new animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under section #eab7;d7 7including1 for antimicrobial new animal drugs1 with respect to antimicrobial resistance74 2 and 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,b71 by striking 1 or and inserting 2 or2 7ii7 by redesignating subparagraphs 7,a71 7,b71 and 7,c7 as clauses 7i71 7ii71 and 7iii71 respectively2 7iii7 by striking ,a person may not file and inserting 7,a7 ,a person may not file2 and 7iv7 by adding at the end the following new subparagraph3 7,b7 ,a person may not file an application under paragraph 7#a77;,a77ii7 if the application seeks conditional approval of a new animal drug that contains an antimicrobial active ingredient4 2 7#c7 in subsection 7f7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by inserting for the conditionally approved use after shall2 and 7,b7 in paragraph 7#b7-- 7i7 by striking ,an intended use and inserting ,the ,secretary shall1 through regulation or guidance1 determine under what conditions an intended use2 and 7ii7 by striking shall not and inserting may2 and 7#d7 by adding at the end the following new subsection3 7k7 ,sunset 7#a7 ,the ,secretary's authority to grant conditional approval of new animal drugs not intended for a minor use or minor species pursuant to subsection 7a77#a77;,a77ii7 terminates on ,october #a1 #bjbh4 7#b7 ,the ,secretary-- 7,a7 may not accept any new applications for such conditional approval pursuant to subsection 7a77#a77;,a77ii7 on or after such date2 and 7,b7 may continue all activities under this section with respect to drugs that were conditionally approved pursuant to 7a77#a77;,a77ii7 prior to such date4 7#c7 ,the ,secretary may1 until ,october #a1 #bjcb1 accept applications for approval under #eab of drugs conditionally approved pursuant to 7a77#a77;,a77ii74 4 7b7 ,exception from fees in case of certain previously submitted applications for conditional approval ,section #gdj7;a77#a77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;a77#a77;,c77 is amended-- 7#a7 in the caption by striking ,exception and inserting ,exceptions2 7#b7 by striking ,if an animal drug and inserting the following3 7i7 ,if an animal drug 2 and 7#c7 by inserting after clause 7i71 as so designated1 the following new clause3 7ii7 ,beginning with fiscal year #bjai1 in the case of an animal drug application submitted by a person under section #eab7;b77#a71 where such person 7or their licensor1 assignor1 or predecessor-in-interest7 previously submitted an application for conditional approval under section #ega for the same product and paid the applicable fee under subparagraph 7,a71 the application under section #eab7;b77#a7 shall not be subject to a fee under subparagraph 7,a7 if submitted within the timeframe specified in section #ega7;h74 4 7c7 ,report on incorporating veterinary oversight ,not later than ,september #cj1 #bjai1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate identifying how the ,food and ,drug ,administration will incorporate veterinary oversight for all approved medically important antimicrobial drugs administered to animals that are not yet subject to veterinary oversight4 ,such report shall address requirements related to revisions of labeling to reflect that medically important antimicrobial drugs administered to animals shall be subject to veterinary oversight4 7d7 ,,gao study of conditional approval programs 7#a7 ,study ,the ,comptroller ,general of the ,united ,states 7referred to in this section as the ,comptroller ,general7 shall conduct a study on the effectiveness and overall impact of the conditional approval pathway under section #ega of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc74 7#b7 ,issuance of report ,not later than ,january #a1 #bjbf1 the ,comptroller ,general shall submit to the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing the results of the study under paragraph 7#a74 7#c7 ,contents of reports ,the report submitted under paragraph 7#b7 shall address-- 7,a7 for each drug for which a conditional approval has been awarded since ,october #a1 #bjah-- 7i7 whether the drug was granted conditional approval pursuant to clause 7i7 or 7ii7 of section #ega7;a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by subsection 7a72 7ii7 whether the drug was dual labeled during its conditional approval2 7iii7 the indications for which the drug was granted conditional approval under section #ega of such ,act 7#ba ,u4,s4,c4 #cfj;ccc7 and whether the drug was approved or not approved under section #eab of such ,act 7#ba ,u4,s4,c4 #cfj;b72 7iv7 the number of years the drug was so conditionally approved and a description of the complexity of the investigation to demonstrate the drug's effectiveness2 7v7 whether1 and to what extent1 the conditional approval pathway under such section #ega 7#ba ,u4,s4,c4 #cfj;ccc7 impacted the sponsor's decision to develop the drug or seek approval of the drug under section #eab of such ,act 7#ba ,u4,s4,c4 #cfj;b72 7vi7 whether1 and to what extent1 conditional approval pursuant to clause 7ii7 of section #ega7;a77#a77;,a7 of such ,act 7#ba ,u4,s4,c4 #cfj;b7a77#a77;,a77 addressed a serious or life-threatening condition2 and 7vii7 whether1 and to what extent1 conditional approval pursuant to clause 7ii7 of section #ega7;a77#a77;,a7 of such ,act 7#ba ,u4,s4,c4 #cfj;b7a77#a77;,a77 addressed an unmet animal or human health need1 and whether before such conditional approval there were available therapies for the disease or condition involved2 7,b7 an analysis of the conditional approval program under section #ega of such ,act 7#ba ,u4,s4,c4 #cfj;ccc71 including-- 7i7 the resources used by the ,food and ,drug ,administration in reviewing applications for conditional approval of drugs pursuant to such program and renewal of such conditional approval1 including the effects of the program on the ,food and ,drug ,administration's review of animal drugs for which conditional approval is not used2 7ii7 whether any improvements to the program under section #eab of such ,act 7#ba ,u4,s4,c4 #cfj;b7 are necessary to incentivize the development of animal drugs that would likely not otherwise be developed1 or developed in as timely a manner1 to address-- 7,i7 serious or life-threatening conditions2 and 7,,ii7 an unmet animal or human health need2 and 7iii7 whether the conditional approval pathway has resulted in a greater number of animal drugs approved under section #eab of such ,act 7#ba ,u4,s4,c4 #cfj;b7 for serious or life-threatening conditions or unmet animal or human health needs than would have otherwise come to market under the practices and commitments of the ,center for ,veterinary ,medicine of the ,food and ,drug ,administration as such practices and commitments existed as of the day before the date of enactment of this ,act2 and 7,c7 how the ,center for ,veterinary ,medicine of the ,food and ,drug ,administration has utilized complex adaptive or other novel investigation designs1 data from foreign countries1 real-world evidence 7including ongoing surveillance activities1 observational studies1 and registry data71 biomarkers1 or surrogate endpoints-- 7i7 to support the approval of products under section #eab of such ,act 7#ba ,u4,s4,c4 #cfj;b71 including how many such products have been approved since ,october #a1 #bjah2 and 7ii7 to support the approval of products under section #eab of such ,act 7#ba ,u4,s4,c4 #cfj;b7 that received conditional approval under section #ega of such ,act 7#ba ,u4,s4,c4 #cfj;ccc71 including how many such products have been approved since ,october #a1 #bjah4 #cje4 ,guidance addressing investigation designs 7a7 ,in general ,for purposes of assisting sponsors in incorporating complex adaptive and other novel investigation designs1 data from foreign countries1 real world evidence 7including ongoing surveillance activities1 observational studies1 and registry data71 biomarkers1 and surrogate endpoints 7referred to in this section as elements of investigations7 into proposed clinical investigation protocols and applications for new animal drugs under sections #eab and #ega of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b2 #cfj;ccc71 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall issue guidance addressing the use of such elements of investigations in the development and regulatory review of such new animal drugs4 7b7 ,contents ,the guidance under subsection 7a7 shall address how the ,secretary will evaluate the elements of investigations proposed or submitted pursuant to section #eab7;b77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or to meet the commitment under section #ega7;a77#b77;,f7 of such ,act1 and how sponsors of such applications may obtain feedback from the ,secretary on technical issues related to such investigations prior to the submission of an application to the ,secretary4 7c7 ,meeting ,prior to issuing the guidance under subsection 7a71 the ,secretary shall consult with stakeholders1 including representatives of regulated industry1 consumer groups1 academia1 veterinarians1 and food producers1 through a public meeting to be held not later than #a year after the date of enactment of this ,act4 7d7 ,timing ,the ,secretary shall issue a draft guidance under subsection 7a7 not later than #a year after the date of the public meeting under subsection 7c71 and shall finalize such guidance not later than #a year after the date on which the public comment period on such draft guidance ends4 #cjf4 ,food additives intended for use in animal food 7a7 ,food additive petitions for animal food ,section #dji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdh7 is amended by adding at the end the following3 7k7 ,food additives intended for use in animal food 7#a7 ,in taking action on a petition under subsection 7c7 for1 or for recognition of1 a food additive intended for use in animal food1 the ,secretary shall review reports of investigations conducted in foreign countries1 provided by the petitioner4 7#b7 ,not later than #ab months after the date of enactment of the ,animal ,drug and ,animal ,generic ,drug ,use ,fee ,amendments of #bjah1 the ,secretary shall post on the internet website of the ,food and ,drug ,administration-- 7,a7 the number of petitions for food additives intended for use in animal food filed under subsection 7b7 that are pending2 7,b7 how long each such petition submitted under subsection 7b7 has been pending1 including such petitions the ,secretary has extended under subsection 7c77#b72 and 7,c7 the number of study protocols that have been pending review for over #ej days1 and the number that have received an extension4 7#c7 ,in the case of a food additive petition intended for use in animal food1 the ,secretary shall provide information to the petitioner on the required contents of such petition4 ,if the ,secretary requires additional studies beyond what the petitioner proposed1 the ,secretary shall provide the scientific rationale for such requirement4 4 7b7 ,ensuring the safety of pet food ,section #ajjb7;a7 of the ,food and ,drug ,administration ,amendments ,act of #bjjg 7#ba ,u4,s4,c4 #bajb7;a77 is amended-- 7#a7 by striking paragraph 7#a72 and 7#b7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#a7 and 7#b71 respectively4 7c7 ,guidance on pre-,petition consultation process for animal food additives 7#a7 ,in general ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall publish draft guidance relating to the voluntary pre-petition consultation process for food additives intended for use in animal food4 7#b7 ,contents ,the guidance under paragraph 7#a7 shall include-- 7,a7 the recommended format to submit to the ,food and ,drug ,administration existing data1 including any applicable foreign data1 for assessment prior to submission of a food additive petition for animal food under section #dji7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,b7 the manner and the number of days by which the ,food and ,drug ,administration intends to review and respond to such existing data1 including with respect to providing a scientific rationale for any additional data request2 7,c7 circumstances under which the submission of study protocols is recommended prior to submission of a food additive petition under such section #dji7;b72 7,d7 the manner in which the ,secretary intends to inform the person submitting a study protocol for a food additive if the review of such study protocol will take longer than #ej days2 and 7,e7 best practices for communication between the ,food and ,drug ,administration and industry on the development of pre-petition submissions of study protocols and existing data for food additives4 7#c7 ,final guidance ,the guidance under paragraph 7#a7 shall be finalized1 withdrawn1 or reissued not later than #a year after the close of the comment period on the draft guidance4 ,passed the ,house of ,representatives ,july #af1 #bjah4,karen ,l4 ,haas1,clerk4