,,ii ,calendar ,no4 #ca #aacth ,,congress #ast ,session ,s4 #fbb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #bj1 #bjac ,mr4 ,harkin1 from the ,committee on ,health1 ,education1 ,labor1 and ,pensions1 reported the following original bill2 which was read twice and placed on the calendar ,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 ,reauthorization ,act of #bjac4 #b4 ,table of contents2 references in ,act 7a7 ,table of contents ,the table of contents of 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 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 #bjac4 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 identified1 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 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#aa7 is amended to read as follows3 #gci4 ,definitions ,for purposes of this part3 7#a7 ,the term animal drug application means an application for approval of any new animal drug submitted under section #eab7;b77#a74 ,such term does not include either a new animal drug application submitted under section #eab7;b77#b7 or a supplemental animal drug application4 7#b7 ,the term supplemental animal drug application means-- 7,a7 a request to the ,secretary to approve a change in an animal drug application which has been approved2 or 7,b7 a request to the ,secretary to approve a change to an application approved under section #eab7;c77#b7 for which data with respect to safety or effectiveness are required4 7#c7 ,the term animal drug product means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor1 which is uniquely identified by the labeler code and product code portions of the national drug code1 and for which an animal drug application or a supplemental animal drug application has been approved4 7#d7 ,the term animal drug establishment means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within #e miles of each other1 at which one or more animal drug products are manufactured in final dosage form4 7#e7 ,the term investigational animal drug submission means-- 7,a7 the filing of a claim for an investigational exemption under section #eab7;j7 for a new animal drug intended to be the subject of an animal drug application or a supplemental animal drug application2 or 7,b7 the submission of information for the purpose of enabling the ,secretary to evaluate the safety or effectiveness of an animal drug application or supplemental animal drug application in the event of their filing4 7#f7 ,the term animal drug sponsor means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the ,secretary 1 or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the ,secretary4 7#g7 ,the term final dosage form means1 with respect to an animal drug product1 a finished dosage form which is approved for administration to an animal without substantial further manufacturing4 ,such term includes animal drug products intended for mixing in animal feeds4 7#h7 ,the term process for the review of animal drug applications means the following activities of the ,secretary with respect to the review of animal drug applications1 supplemental animal drug applications1 and investigational animal drug submissions3 7,a7 ,the activities necessary for the review of animal drug applications1 supplemental animal drug applications1 and investigational animal drug submissions4 7,b7 ,the issuance of action letters which approve animal drug applications or supplemental animal drug applications or which set forth in detail the specific deficiencies in animal drug applications1 supplemental animal drug applications1 or investigational animal drug submissions and1 where appropriate1 the actions necessary to place such applications1 supplements or submissions in condition for approval4 7,c7 ,the inspection of animal drug establishments and other facilities undertaken as part of the ,secretary's review of pending animal drug applications1 supplemental animal drug applications1 and investigational animal drug submissions4 7,d7 ,monitoring of research conducted in connection with the review of animal drug applications1 supplemental animal drug applications1 and investigational animal drug submissions4 7,e7 ,the development of regulations and policy related to the review of animal drug applications1 supplemental animal drug applications1 and investigational animal drug submissions4 7,f7 ,development of standards for products subject to review4 7,g7 ,meetings between the agency and the animal drug sponsor4 7,h7 ,review of advertising and labeling prior to approval of an animal drug application or supplemental animal drug application1 but not after such application has been approved4 7#i7 ,the term costs of resources allocated for the process for the review of animal drug applications means the expenses in connection with the process for the review of animal drug applications for-- 7,a7 officers and employees of the ,food and ,drug ,administration1 contractors of the ,food and ,drug ,administration1 advisory committees consulted with respect to the review of specific animal drug applications1 supplemental animal drug applications1 or investigational animal drug submissions1 and costs related to such officers1 employees1 committees1 and contractors1 including costs for travel1 education1 and recruitment and other personnel activities2 7,b7 management of information and the acquisition1 maintenance1 and repair of computer resources2 7,c7 leasing1 maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies2 and 7,d7 collecting fees under section #gdj and accounting for resources allocated for the review of animal drug applications1 supplemental animal drug applications1 and investigational animal drug submissions4 7#aj7 ,the term adjustment factor applicable to a fiscal year refers to the formula set forth in section #gce7h7 with the base or comparator month being ,october #bjjb4 7#aa7 ,the term person includes an affiliate thereof4 7#ab7 ,the term affiliate refers to the definition set forth in section #gce7aa74 4 #ajc4 ,authority to assess and use animal drug fees ,section #gdj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7 is amended to read as follows3 #gdj4 ,authority to assess and use animal drug fees 7a7 ,types of fees ,beginning in fiscal year #bjjd1 the ,secretary shall assess and collect fees in accordance with this section as follows3 7#a7 ,animal drug application and supplement fee 7,a7 ,in general ,each person that submits1 on or after ,september #a1 #bjjc1 an animal drug application or a supplemental animal drug application shall be subject to a fee as follows3 7i7 ,a fee established in subsection 7c7 for an animal drug application1 except an animal drug application subject to the criteria set forth in section #eab7;d77#d74 7ii7 ,a fee established in subsection 7c71 in an amount that is equal to #ej percent of the amount of the fee under clause 7i71 for-- 7,i7 a supplemental animal drug application for which safety or effectiveness data are required2 and 7,,ii7 an animal drug application subject to the criteria set forth in section #eab7;d77#d74 7,b7 ,payment ,the fee required by subparagraph 7,a7 shall be due upon submission of the animal drug application or supplemental animal drug application4 7,c7 ,exception for previously filed application or supplement ,if an animal drug application or a supplemental animal drug application was submitted by a person that paid the fee for such application or supplement1 was accepted for filing1 and was not approved or was withdrawn 7without a waiver or refund71 the submission of an animal drug application or a supplemental animal drug application for the same product by the same person 7or the person's licensee1 assignee1 or successor7 shall not be subject to a fee under subparagraph 7,a74 7,d7 ,refund of fee if application refused for filing ,the ,secretary shall refund #ge percent of the fee paid under subparagraph 7,b7 for any animal drug application or supplemental animal drug application which is refused for filing4 7,e7 ,refund of fee if application withdrawn ,if an animal drug application or a supplemental animal drug application is withdrawn after the application or supplement was filed1 the ,secretary may refund the fee or portion of the fee paid under subparagraph 7,b7 if no substantial work was performed on the application or supplement after the application or supplement was filed4 ,the ,secretary shall have the sole discretion to refund the fee under this paragraph4 ,a determination by the ,secretary concerning a refund under this paragraph shall not be reviewable4 7#b7 ,animal drug product fee 7,a7 ,in general ,each person-- 7i7 who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section #eaj2 and 7ii7 who1 after ,september #a1 #bjjc1 had pending before the ,secretary an animal drug application or supplemental animal drug application1 shall pay for each such animal drug product the annual fee established in subsection 7c74 7,b7 ,payment2 fee due date ,such fee shall be payable for the fiscal year in which the animal drug product is first submitted for listing under section #eaj1 or is submitted for relisting under section #eaj if the animal drug product has been withdrawn from listing and relisted4 ,after such fee is paid for that fiscal year1 such fee shall be due each subsequent fiscal year that the product remains listed1 upon the later of-- 7i7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees for such fiscal year under this section2 or 7ii7 ,january #ca of each year4 7,c7 ,limitation ,such fee shall be paid only once for each animal drug product for a fiscal year in which the fee is payable4 7#c7 ,animal drug establishment fee 7,a7 ,in general ,each person-- 7i7 who owns or operates1 directly or through an affiliate1 an animal drug establishment2 7ii7 who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section #eaj2 and 7iii7 who1 after ,september #a1 #bjjc1 had pending before the ,secretary an animal drug application or supplemental animal drug application1 shall be assessed an annual establishment fee as established in subsection 7c7 for each animal drug establishment listed in its approved animal drug application as an establishment that manufactures the animal drug product named in the application4 7,b7 ,payment2 fee due date ,the annual establishment fee shall be assessed in each fiscal year in which the animal drug product named in the application is assessed a fee under paragraph 7#b7 unless the animal drug establishment listed in the application does not engage in the manufacture of the animal drug product during the fiscal year4 ,the fee under this paragraph for a fiscal year shall be due upon the later of-- 7i7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees for such fiscal year under this section2 or 7ii7 ,january #ca of each year4 7,c7 ,limitation 7i7 ,in general ,an establishment shall be assessed only one fee per fiscal year under this section1 subject to clause 7ii74 7ii7 ,certain manufacturers ,if a single establishment manufactures both animal drug products and prescription drug products1 as defined in section #gce7c71 such establishment shall be assessed both the animal drug establishment fee and the prescription drug establishment fee1 as set forth in section #gcf7;a77#b71 within a single fiscal year4 7#d7 ,animal drug sponsor fee 7,a7 ,in general ,each person-- 7i7 who meets the definition of an animal drug sponsor within a fiscal year2 and 7ii7 who1 after ,september #a1 #bjjc1 had pending before the ,secretary an animal drug application1 a supplemental animal drug application1 or an investigational animal drug submission1 shall be assessed an annual sponsor fee as established under subsection 7c74 7,b7 ,payment2 fee due date ,the fee under this paragraph for a fiscal year shall be due upon the later of-- 7i7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees for such fiscal year under this section2 or 7ii7 ,january #ca of each year4 7,c7 ,limitation ,each animal drug sponsor shall pay only one such fee each fiscal year4 7b7 ,fee revenue amounts 7#a7 ,in general ,subject to subsections 7c71 7d71 7f71 and 7g7-- 7,a7 for fiscal year #bjad1 the fees required under subsection 7a7 shall be established to generate a total revenue amount of #bc1fjj1jjj2 and 7,b7 for each of fiscal years #bjae through #bjah1 the fees required under subsection 7a7 shall be established to generate a total revenue amount of #ba1fjj1jjj4 7#b7 ,types of fees ,of the total revenue amount determined for a fiscal year under paragraph 7#a7-- 7,a7 #bj percent shall be derived from fees under subsection 7a77#a7 7relating to animal drug applications and supplements72 7,b7 #bg percent shall be derived from fees under subsection 7a77#b7 7relating to animal drug products72 7,c7 #bf percent shall be derived from fees under subsection 7a77#c7 7relating to animal drug establishments72 and 7,d7 #bg percent shall be derived from fees under subsection 7a77#d7 7relating to animal drug sponsors74 7c7 ,annual fee setting2 adjustments 7#a7 ,annual fee setting ,the ,secretary shall establish1 #fj days before the start of each fiscal year beginning after ,september #cj1 #bjjc1 for that fiscal year1 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 subsection4 7#b7 ,inflation adjustment ,for fiscal year #bjae and subsequent fiscal years1 the revenue amounts established in subsection 7b7 shall be adjusted by the ,secretary by notice1 published in the ,federal ,register1 for a fiscal year1 by an amount equal to the sum of-- 7,a7 one2 7,b7 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 years of the preceding #d fiscal years for which data are available2 and 7,c7 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 years 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 years of the preceding #d fiscal years for which data are available4 ,the adjustment made each fiscal year under this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year #bjad under this paragraph4 7#c7 ,workload adjustment ,for fiscal year #bjae and subsequent fiscal years1 after the revenue amounts established in subsection 7b7 are adjusted for inflation in accordance with paragraph 7#b71 the 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 applications4 ,with respect to such adjustment-- 7,a7 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 7,b7 the ,secretary shall publish in the ,federal ,register the fees resulting from such adjustment and the supporting methodologies2 and 7,c7 under no circumstances shall such adjustment 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 for inflation under paragraph 7#b74 7#d7 ,final year adjustment ,for fiscal year #bjah1 the ,secretary may1 in addition to other adjustments under this subsection1 further increase the fees under this section1 if such an adjustment is necessary1 to provide for up to #c months of operating reserves of carryover user fees for the process for the review of animal drug applications for the first #c months of fiscal year #bjai4 ,if the ,food and ,drug ,administration has carryover balances for the process for the review of animal drug applications in excess of #c months of such operating reserves1 then this adjustment will not be made4 ,if this adjustment is necessary1 then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year #bjah4 7#e7 ,limit ,the total amount of fees charged1 as adjusted under this subsection1 for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of animal drug applications4 7d7 ,fee waiver or reduction 7#a7 ,in general ,the ,secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection 7a7 where the ,secretary finds that-- 7,a7 the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances2 7,b7 the fees to be paid by such person will exceed the anticipated present and future costs incurred by the ,secretary in conducting the process for the review of animal drug applications for such person2 7,c7 the animal drug application or supplemental animal drug application is intended solely to provide for use of the animal drug in-- 7i7 a ,type ,b medicated feed 7as defined in section #eeh4c7;b77#c7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation77 intended for use in the manufacture of ,type ,c free-choice medicated feeds2 or 7ii7 a ,type ,c free-choice medicated feed 7as defined in section #eeh4c7;b77#d7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation772 7,d7 the animal drug application or supplemental animal drug application is intended solely to provide for a minor use or minor species indication2 or 7,e7 the sponsor involved is a small business submitting its first animal drug application to the ,secretary for review4 7#b7 ,use of standard costs ,in making the finding in paragraph 7#a77;,b71 the ,secretary may use standard costs4 7#c7 ,rules for small businesses 7,a7 ,definition ,in paragraph 7#a77;,e71 the term small business means an entity that has fewer than #ejj employees1 including employees of affiliates4 7,b7 ,waiver of application fee ,the ,secretary shall waive under paragraph 7#a77;,e7 the application fee for the first animal drug application that a small business or its affiliate submits to the ,secretary for review4 ,after a small business or its affiliate is granted such a waiver1 the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business4 7,c7 ,certification ,the ,secretary shall require any person who applies for a waiver under paragraph 7#a77;,e7 to certify their qualification for the waiver4 ,the ,secretary shall periodically publish in the ,federal ,register a list of persons making such certifications4 7e7 ,effect of failure ,to pay fees ,an animal drug application or supplemental animal drug application submitted by a person subject to fees under subsection 7a7 shall be considered incomplete and shall not be accepted for filing by the ,secretary until all fees owed by such person have been paid4 ,an investigational animal drug submission under section #gci7e77;,b7 that is submitted by a person subject to fees under subsection 7a7 shall be considered incomplete and shall not be accepted for review by the ,secretary until all fees owed by such person have been paid4 ,the ,secretary may discontinue review of any animal drug application1 supplemental animal drug application or investigational animal drug submission from a person if such person has not submitted for payment all fees owed under this section by #cj days after the date upon which they are due4 7f7 ,assessment of fees 7#a7 ,limitation ,fees may not be assessed under subsection 7a7 for a fiscal year beginning after fiscal year #bjjc unless appropriations for salaries and expenses of the ,food and ,drug ,administration for such fiscal year 7excluding the amount of fees appropriated for such fiscal year7 are equal to or greater than the amount of appropriations for the salaries and expenses of the ,food and ,drug ,administration for the fiscal year #bjjc 7excluding the amount of fees appropriated for such fiscal year7 multiplied by the adjustment factor applicable to the fiscal year involved4 7#b7 ,authority ,if the ,secretary does not assess fees under subsection 7a7 during any portion of a fiscal year because of paragraph 7#a7 and if at a later date in such fiscal year the ,secretary may assess such fees1 the ,secretary may assess and collect such fees1 without any modification in the rate1 for animal drug applications1 supplemental animal drug applications1 investigational animal drug submissions1 animal drug sponsors1 animal drug establishments and animal drug products at any time in such fiscal year notwithstanding the provisions of subsection 7a7 relating to the date fees are to be paid4 7g7 ,crediting and availability of fees 7#a7 ,in general ,subject to paragraph 7#b77;,c71 fees authorized under subsection 7a7 shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to be appropriated to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for the process for the review of animal drug applications4 7#b7 ,collections and appropriation acts 7,a7 ,in general ,the fees authorized by this section-- 7i7 subject to subparagraph 7,c71 shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation ,acts1 or otherwise made available for obligation for such fiscal year1 and 7ii7 shall be available to defray increases in the costs of the resources allocated for the process for the review of animal drug applications 7including increases in such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such process7 over such costs1 excluding costs paid from fees collected under this section1 for fiscal year #bjjc multiplied by the adjustment factor4 7,b7 ,compliance ,the ,secretary shall be considered to have met the requirements of subparagraph 7,a77ii7 in any fiscal year if the costs funded by appropriations and allocated for the process for the review of animal drug applications-- 7i7 are not more than #c percent below the level specified in subparagraph 7,a77ii72 or 7ii7 7,i7 are more than #c percent below the level specified in subparagraph 7,a77ii71 and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of #c percent by which such costs fell below the level specified in subparagraph 7,a77ii72 and 7,,ii7 such costs are not more than #e percent below the level specified in subparagraph 7,a77ii74 7,c7 ,provision for early payments ,payment of fees authorized under this section for a fiscal year1 prior to the due date for such fees1 may be accepted by the ,secretary in accordance with authority provided in advance in a prior year appropriations ,act4 7#c7 ,authorization of appropriations ,for each of the fiscal years #bjad through #bjah1 there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection 7b7 for the fiscal year1 as adjusted or otherwise affected under subsection 7c7 and paragraph 7#d74 7#d7 ,offset of overcollections2 recovery of collection shortfalls 7,a7 ,offset of overcollections ,if the sum of the cumulative amount of fees collected under this section for fiscal years #bjad through #bjaf and the amount of fees estimated to be collected under this section for fiscal year #bjag 7including any increased fee collections attributable to subparagraph 7,b771 exceeds the cumulative amount appropriated pursuant to paragraph 7#c7 for the fiscal years #bjad through #bjag1 the excess amount shall be credited to the appropriation account of the ,food and ,drug ,administration as provided in paragraph 7#a71 and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation ,acts for fiscal year #bjah4 7,b7 ,recovery of collection shortfalls 7i7 ,fiscal year #bjaf ,for fiscal year #bjaf1 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 #bjad falls below the amount of fees authorized for fiscal year #bjad under paragraph 7#c74 7ii7 ,fiscal year #bjag ,for fiscal year #bjag1 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 #bjae falls below the amount of fees authorized for fiscal year #bjae under paragraph 7#c74 7iii7 ,fiscal year #bjah ,for fiscal year #bjah1 the amount of fees otherwise authorized to be collected under this section 7including any reduction in the authorized amount under subparagraph 7,a771 shall be increased by the cumulative amount1 if any1 by which the amount collected under this section and appropriated for fiscal years #bjaf and #bjag 7including estimated collections for fiscal year #bjag7 falls below the cumulative amount of fees authorized under paragraph 7#c7 for fiscal years #bjaf and #bjag4 7h7 ,collection of unpaid fees ,in any case where the ,secretary does not receive payment of a fee assessed under subsection 7a7 within #cj days after it is due1 such fee shall be treated as a claim of the ,united ,states ,government subject to subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7i7 ,written requests for waivers1 reductions1 and refunds ,to qualify for consideration for a waiver or reduction under subsection 7d71 or for a refund of any fee collected in accordance with subsection 7a71 a person shall submit to the ,secretary a written request for such waiver1 reduction1 or refund not later than #ahj days after such fee is due4 7j7 ,construction ,this section may not be construed to require that the number of full-time equivalent positions in the ,department of ,health and ,human ,services1 for officers1 employees1 and advisory committees not engaged in the process of the review of animal drug applications1 be reduced to offset the number of officers1 employees1 and advisory committees so engaged4 7k7 ,abbreviated new animal drug applications ,the ,secretary shall-- 7#a7 to the extent practicable1 segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications2 and 7#b7 adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program4 4 #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 to read as follows3 #gdj;,a4 ,reauthorization2 reporting requirements 7a7 ,performance report ,beginning with fiscal year #bjad1 not later than #abj days after the end of each fiscal year during which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report concerning the progress of the ,food and ,drug ,administration in achieving the goals identified in the letters described in section #aja7;b7 of the ,animal ,drug ,user ,fee ,amendments of #bjac toward expediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submissions during such fiscal year1 the future plans of the ,food and ,drug ,administration for meeting the goals1 the review times for abbreviated new animal drug applications1 and the administrative procedures adopted by the ,food and ,drug ,administration to ensure that review times for abbreviated new animal drug applications are not increased from their current level due to activities under the user fee program4 7b7 ,fiscal report ,beginning with fiscal year #bjad1 not later than #abj days after the end of each fiscal year during which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the implementation of the authority for such fees during such fiscal year and the use1 by the ,food and ,drug ,administration1 of the fees collected during such fiscal year for which the report is made4 7c7 ,public availability ,the ,secretary shall make the reports required under subsections 7a7 and 7b7 available to the public on the ,internet ,web site of the ,food and ,drug ,administration4 7d7 ,reauthorization 7#a7 ,consultation ,in developing recommendations to present to the ,congress with respect to the goals1 and plans for meeting the goals1 for the process for the review of animal drug applications for the first #e fiscal years after fiscal year #bjah1 and for the reauthorization of this part for such fiscal years1 the ,secretary shall consult with-- 7,a7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7,b7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7,c7 scientific and academic experts2 7,d7 veterinary professionals2 7,e7 representatives of patient and consumer advocacy groups2 and 7,f7 the regulated industry4 7#b7 ,prior public input ,prior to beginning negotiations with the regulated industry on the reauthorization of this part1 the ,secretary shall-- 7,a7 publish a notice in the ,federal ,register requesting public input on the reauthorization2 7,b7 hold a public meeting at which the public may present its views on the reauthorization1 including specific suggestions for changes to the goals referred to in subsection 7a72 7,c7 provide a period of #cj days after the public meeting to obtain written comments from the public suggesting changes to this part2 and 7,d7 publish the comments on the ,food and ,drug ,administration's ,internet ,web site4 7#c7 ,periodic consultation ,not less frequently than once every #d months during negotiations with the regulated industry1 the ,secretary shall hold discussions with representatives of veterinary1 patient1 and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph 7#b74 7#d7 ,public review of recommendations ,after negotiations with the regulated industry1 the ,secretary shall-- 7,a7 present the recommendations developed under paragraph 7#a7 to the ,congressional committees specified in such paragraph2 7,b7 publish such recommendations in the ,federal ,register2 7,c7 provide for a period of #cj days for the public to provide written comments on such recommendations2 7,d7 hold a meeting at which the public may present its views on such recommendations2 and 7,e7 after consideration of such public views and comments1 revise such recommendations as necessary4 7#e7 ,transmittal of recommendations ,not later than ,january #ae1 #bjah1 the ,secretary shall transmit to ,congress the revised recommendations under paragraph 7#d7 a summary of the views and comments received under such paragraph1 and any changes made to the recommendations in response to such views and comments4 7#f7 ,minutes of negotiation meetings 7,a7 ,public availability ,before presenting the recommendations developed under paragraphs 7#a7 through 7#e7 to ,congress1 the ,secretary shall make publicly available1 on the ,internet ,web site of the ,food and ,drug ,administration1 minutes of all negotiation meetings conducted under this subsection between the ,food and ,drug ,administration and the regulated industry4 7,b7 ,content ,the minutes described under subparagraph 7,a7 shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution4 4 #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 the 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 #bjjh1 but before ,october #a1 #bjac1 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 #bjad4 #ajf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjac1 or the date of 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 all animal drug applications and supplemental animal drug applications received on or after ,october #a1 #bjac1 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 #bjah4 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 #bjai4 7c7 ,previous sunset provision 7#a7 ,in general ,section #ajh of the ,animal ,drug ,user ,fee ,amendments of #bjjh 7,public ,law #aaj-caf7 is repealed4 7#b7 ,conforming amendment ,the ,animal ,drug ,user ,fee ,amendments of #bjjh 7,public ,law #aaj-caf7 is amended in the table of contents in section #a1 by striking the item relating to section #ajh4 7d7 ,technical clarification ,effective ,november #ah1 #bjjc1 section #e of the ,animal ,drug ,user ,fee ,act of #bjjc 7,public ,law #ajh-acj7 is 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 #bjac4 7b7 ,finding ,the fees authorized by 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 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 #bjb4 ,authority to assess and use generic new animal drug fees ,section #gda of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ba7 is amended to read as follows3 #gda4 ,authority to assess and use generic new animal drug fees 7a7 ,types of fees ,beginning with respect to fiscal year #bjji1 the ,secretary shall assess and collect fees in accordance with this section as follows3 7#a7 ,abbreviated application fee 7,a7 ,in general ,each person that submits1 on or after ,july #a1 #bjjh1 an abbreviated application for a generic new animal drug shall be subject to a fee as established in subsection 7c7 for such an application4 7,b7 ,payment ,the fee required by subparagraph 7,a7 shall be due upon submission of the abbreviated application4 7,c7 ,exceptions 7i7 ,previously filed application ,if an abbreviated application was submitted by a person that paid the fee for such application1 was accepted for filing1 and was not approved or was withdrawn 7without a waiver or refund71 the submission of an abbreviated application for the same product by the same person 7or the person's licensee1 assignee1 or successor7 shall not be subject to a fee under subparagraph 7,a74 7ii7 ,certain abbreviated applications involving combination animal drugs ,an abbreviated application which is subject to the criteria in section #eab7;d77#d7 and submitted on or after ,october #a1 #bjac shall be subject to a fee equal to #ej percent of the amount of the abbreviated application fee established in subsection 7c74 7,d7 ,refund of fee if application refused for filing ,the ,secretary shall refund #ge percent of the fee paid under subparagraph 7,b7 for any abbreviated application which is refused for filing4 7,e7 ,refund of fee if application withdrawn ,if an abbreviated application is withdrawn after the application was filed1 the ,secretary may refund the fee or portion of the fee paid under subparagraph 7,b7 if no substantial work was performed on the application after the application was filed4 ,the ,secretary shall have the sole discretion to refund the fee under this subparagraph4 ,a determination by the ,secretary concerning a refund under this subparagraph shall not be reviewable4 7#b7 ,generic new animal drug product fee 7,a7 ,in general ,each person-- 7i7 who is named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product which has been submitted for listing under section #eaj2 and 7ii7 who1 after ,september #a1 #bjjh1 had pending before the ,secretary an abbreviated application or supplemental abbreviated application1 shall pay for each such generic new animal drug product the annual fee established in subsection 7c74 7,b7 ,payment2 fee due date ,such fee shall be payable for the fiscal year in which the generic new animal drug product is first submitted for listing under section #eaj1 or is submitted for relisting under section #eaj if the generic new animal drug product has been withdrawn from listing and relisted4 ,after such fee is paid for that fiscal year1 such fee shall be due each subsequent fiscal year that the product remains listed1 upon the later of-- 7i7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees for such fiscal year under this section2 or 7ii7 ,january #ca of each year4 7,c7 ,limitation ,such fee shall be paid only once for each generic new animal drug product for a fiscal year in which the fee is payable4 7#c7 ,generic new animal drug sponsor fee 7,a7 ,in general ,each person-- 7i7 who meets the definition of a generic new animal drug sponsor within a fiscal year2 and 7ii7 who1 after ,september #a1 #bjjh1 had pending before the ,secretary an abbreviated application1 a supplemental abbreviated application1 or an investigational submission1 shall be assessed an annual generic new animal drug sponsor fee as established under subsection 7c74 7,b7 ,payment2 fee due date ,such fee shall be due each fiscal year upon the later of-- 7i7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees for such fiscal year under this section2 or 7ii7 ,january #ca of each year4 7,c7 ,amount of fee ,each generic new animal drug sponsor shall pay only #a such fee each fiscal year1 as follows3 7i7 #ajj percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection 7c7 for an applicant with more than #f approved abbreviated applications4 7ii7 #ge percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection 7c7 for an applicant with more than #a and fewer than #g approved abbreviated applications4 7iii7 #ej percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection 7c7 for an applicant with #a or fewer approved abbreviated applications4 7b7 ,fee amounts ,subject to subsections 7c71 7d71 7f71 and 7g71 the fees required under subsection 7a7 shall be established to generate fee revenue amounts as follows3 7#a7 ,total fee revenues for application fees ,the total fee revenues to be collected in abbreviated application fees under subsection 7a77#a7 shall be #a1hcb1jjj for fiscal year #bjad1 #a1gcf1jjj for fiscal year #bjae1 #a1heg1jjj for fiscal year #bjaf1 #a1ihd1jjj for fiscal year #bjag1 and #b1aag1jjj for fiscal year #bjah4 7#b7 ,total fee revenues for product fees ,the total fee revenues to be collected in generic new animal drug product fees under subsection 7a77#b7 shall be #b1gdh1jjj for fiscal year #bjad1 #b1fjd1jjj for fiscal year #bjae1 #b1ghf1jjj for fiscal year #bjaf1 #b1igf1jjj for fiscal year #bjag1 and #c1age1jjj for fiscal year #bjah4 7#c7 ,total fee revenues for sponsor fees ,the total fee revenues to be collected in generic new animal drug sponsor fees under subsection 7a77#c7 shall be #b1gdh1jjj for fiscal year #bjad1 #b1fjd1jjj for fiscal year #bjae1 #b1ghf1jjj for fiscal year #bjaf1 #b1igf1jjj for fiscal year #bjag1 and #c1age1jjj for fiscal year #bjah4 7c7 ,annual fee setting2 adjustments 7#a7 ,annual fee setting ,the ,secretary shall establish1 #fj days before the start of each fiscal year beginning after ,september #cj1 #bjjh1 for that fiscal year1 abbreviated application fees1 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 subsection4 7#b7 ,workload adjustment ,the fee revenues shall be adjusted each fiscal year after fiscal year #bjad to reflect changes in review workload4 ,with respect to such adjustment3 7,a7 ,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 ,secretary4 ,the ,secretary shall publish in the ,federal ,register the fees resulting from this adjustment and the supporting methodologies4 7,b7 ,under no circumstances shall this workload adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection 7b74 7#c7 ,final year adjustment ,for fiscal year #bjah1 the ,secretary may1 in addition to other adjustments under this subsection1 further increase the fees under this section1 if such an adjustment is necessary1 to provide for up to #c months of operating reserves of carryover user fees for the process for the review of abbreviated applications for generic new animal drugs for the first #c months of fiscal year #bjai4 ,if the ,food and ,drug ,administration has carryover balances for the process for the review of abbreviated applications for generic new animal drugs in excess of #c months of such operating reserves1 then this adjustment shall not be made4 ,if this adjustment is necessary1 then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year #bjah4 7#d7 ,limit ,the total amount of fees charged1 as adjusted under this subsection1 for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of abbreviated applications for generic new animal drugs4 7d7 ,fee waiver or reduction ,the ,secretary shall grant a waiver from or a reduction of #a 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 7e7 ,effect of failure to pay fees ,an abbreviated application for a generic new animal drug submitted by a person subject to fees under subsection 7a7 shall be considered incomplete and shall not be accepted for filing by the ,secretary until all fees owed by such person have been paid4 ,an investigational submission for a generic new animal drug that is submitted by a person subject to fees under subsection 7a7 shall be considered incomplete and shall not be accepted for review by the ,secretary until all fees owed by such person have been paid4 ,the ,secretary may discontinue review of any abbreviated application for a generic new animal drug1 supplemental abbreviated application for a generic new animal drug1 or investigational submission for a generic new animal drug from a person if such person has not submitted for payment all fees owed under this section by #cj days after the date upon which they are due4 7f7 ,assessment of fees 7#a7 ,limitation ,fees may not be assessed under subsection 7a7 for a fiscal year beginning after fiscal year #bjjh unless appropriations for salaries and expenses of the ,food and ,drug ,administration for such fiscal year 7excluding the amount of fees appropriated for such fiscal year7 are equal to or greater than the amount of appropriations for the salaries and expenses of the ,food and ,drug ,administration for the fiscal year #bjjc 7excluding the amount of fees appropriated for such fiscal year7 multiplied by the adjustment factor applicable to the fiscal year involved4 7#b7 ,authority ,if the ,secretary does not assess fees under subsection 7a7 during any portion of a fiscal year because of paragraph 7#a7 and if at a later date in such fiscal year the ,secretary may assess such fees1 the ,secretary may assess and collect such fees1 without any modification in the rate1 for abbreviated applications1 generic new animal drug sponsors1 and generic new animal drug products at any time in such fiscal year notwithstanding the provisions of subsection 7a7 relating to the date fees are to be paid4 7g7 ,crediting and availability of fees 7#a7 ,in general ,subject to paragraph 7#b77;,c71 fees authorized under subsection 7a7 shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to be appropriated to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for the process for the review of abbreviated applications for generic new animal drugs4 7#b7 ,collections and appropriation acts 7,a7 ,in general ,the fees authorized by this section-- 7i7 subject to subparagraph 7,c71 shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation ,acts1 or otherwise made available for obligation for such fiscal year2 and 7ii7 shall be available to defray increases in the costs of the resources allocated for the process for the review of abbreviated applications for generic new animal drugs 7including increases in such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such process7 over such costs1 excluding costs paid from fees collected under this section1 for fiscal year #bjjh multiplied by the adjustment factor4 7,b7 ,compliance ,the ,secretary shall be considered to have met the requirements of subparagraph 7,a77ii7 in any fiscal year if the costs funded by appropriations and allocated for the process for the review of abbreviated applications for generic new animal drugs-- 7i7 are not more than #c percent below the level specified in subparagraph 7,a77ii72 or 7ii7 7,i7 are more than #c percent below the level specified in subparagraph 7,a77ii71 and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of #c percent by which such costs fell below the level specified in subparagraph 7,a77ii72 and 7,,ii7 such costs are not more than #e percent below the level specified in subparagraph 7,a77ii74 7,c7 ,provision for early payments ,payment of fees authorized under this section for a fiscal year1 prior to the due date for such fees1 may be accepted by the ,secretary in accordance with authority provided in advance in a prior year appropriations ,act4 7#c7 ,authorization of appropriations ,there are authorized to be appropriated for fees under this section-- 7,a7 #g1cbh1jjj for fiscal year #bjad2 7,b7 #f1idd1jjj for fiscal year #bjae2 7,c7 #g1dbi1jjj for fiscal year #bjaf2 7,d7 #g1icf1jjj for fiscal year #bjag2 and 7,e7 #h1dfg1jjj for fiscal year #bjah2 as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by abbreviated application fees1 generic new animal drug sponsor fees1 and generic new animal drug product fees4 7#d7 ,offset ,if the sum of the cumulative amount of fees collected under this section for the fiscal years #bjad through #bjaf and the amount of fees estimated to be collected under this section for fiscal year #bjag exceeds the cumulative amount appropriated under paragraph 7#c7 for the fiscal years #bjad through #bjag1 the excess amount shall be credited to the appropriation account of the ,food and ,drug ,administration as provided in paragraph 7#a71 and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation ,acts for fiscal year #bjah4 7h7 ,collection of unpaid fees ,in any case where the ,secretary does not receive payment of a fee assessed under subsection 7a7 within #cj days after it is due1 such fee shall be treated as a claim of the ,united ,states ,government subject to subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7i7 ,written requests for waivers1 reductions1 and refunds ,to qualify for consideration for a waiver or reduction under subsection 7d71 or for a refund of any fee collected in accordance with subsection 7a71 a person shall submit to the ,secretary a written request for such waiver1 reduction1 or refund not later than #ahj days after such fee is due4 7j7 ,construction ,this section may not be construed to require that the number of full-time equivalent positions in the ,department of ,health and ,human ,services1 for officers1 employees1 and advisory committees not engaged in the process of the review of abbreviated applications for generic new animal drugs1 be reduced to offset the number of officers1 employees1 and advisory committees so engaged4 7k7 ,definitions ,in this section and section #gdb3 7#a7 ,abbreviated application for a generic new animal drug ,the terms abbreviated application for a generic new animal drug and abbreviated application mean an abbreviated application for the approval of any generic new animal drug submitted under section #eab7;b77#b74 ,such term does not include a supplemental abbreviated application for a generic new animal drug4 7#b7 ,adjustment factor ,the term adjustment factor applicable to a fiscal year is the ,consumer ,price ,index for all urban consumers 7all items2 ,united ,states city average7 for ,october of the preceding fiscal year divided by-- 7,a7 for purposes of subsection 7f77#a71 such ,index for ,october #bjjb2 and 7,b7 for purposes of subsection 7g77#b77;,a77ii71 such ,index for ,october #bjjg4 7#c7 ,costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs ,the term costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs for-- 7,a7 officers and employees of the ,food and ,drug ,administration1 contractors of the ,food and ,drug ,administration1 advisory committees consulted with respect to the review of specific abbreviated applications1 supplemental abbreviated applications1 or investigational submissions1 and costs related to such officers1 employees1 committees1 and contractors1 including costs for travel1 education1 and recruitment and other personnel activities2 7,b7 management of information1 and the acquisition1 maintenance1 and repair of computer resources2 7,c7 leasing1 maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies2 and 7,d7 collecting fees under this section and accounting for resources allocated for the review of abbreviated applications1 supplemental abbreviated applications1 and investigational submissions4 7#d7 ,final dosage form ,the term final dosage form means1 with respect to a generic new animal drug product1 a finished dosage form which is approved for administration to an animal without substantial further manufacturing4 ,such term includes generic new animal drug products intended for mixing in animal feeds4 7#e7 ,generic new animal drug ,the term generic new animal drug means a new animal drug that is the subject of an abbreviated application4 7#f7 ,generic new animal drug product ,the term generic new animal drug product means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor1 which is uniquely identified by the labeler code and product code portions of the national drug code1 and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved4 7#g7 ,generic new animal drug sponsor ,the term generic new animal drug sponsor means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the ,secretary1 or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the ,secretary4 7#h7 ,investigational submission for a generic new animal drug ,the terms investigational submission for a generic new animal drug and investigational submission mean-- 7,a7 the filing of a claim for an investigational exemption under section #eab7;j7 for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application2 or 7,b7 the submission of information for the purpose of enabling the ,secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug4 7#i7 ,person ,the term person includes an affiliate thereof 7as such term is defined in section #gce7aa774 7#aj7 ,process for the review of abbreviated applications for generic new animal drugs ,the term process for the review of abbreviated applications for generic new animal drugs means the following activities of the ,secretary with respect to the review of abbreviated applications1 supplemental abbreviated applications1 and investigational submissions3 7,a7 ,the activities necessary for the review of abbreviated applications1 supplemental abbreviated applications1 and investigational submissions4 7,b7 ,the issuance of action letters which approve abbreviated applications or supplemental abbreviated applications or which set forth in detail the specific deficiencies in abbreviated applications1 supplemental abbreviated applications1 or investigational submissions and1 where appropriate1 the actions necessary to place such applications1 supplemental applications1 or submissions in condition for approval4 7,c7 ,the inspection of generic new animal drug establishments and other facilities undertaken as part of the ,secretary's review of pending abbreviated applications1 supplemental abbreviated applications1 and investigational submissions4 7,d7 ,monitoring of research conducted in connection with the review of abbreviated applications1 supplemental abbreviated applications1 and investigational submissions4 7,e7 ,the development of regulations and policy related to the review of abbreviated applications1 supplemental abbreviated applications1 and investigational submissions4 7,f7 ,development of standards for products subject to review4 7,g7 ,meetings between the agency and the generic new animal drug sponsor4 7,h7 ,review of advertising and labeling prior to approval of an abbreviated application or supplemental abbreviated application1 but not after such application has been approved4 7#aa7 ,supplemental abbreviated application for generic new animal drug ,the terms supplemental abbreviated application for a generic new animal drug and supplemental abbreviated application mean a request to the ,secretary to approve a change in an approved abbreviated application4 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 to read as follows3 #gdb4 ,reauthorization2 reporting requirements 7a7 ,performance reports ,beginning with fiscal year #bjad1 not later than #abj days after the end of each fiscal year during which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report concerning the progress of the ,food and ,drug ,administration in achieving the goals identified in the letters described in section #bja7;b7 of the ,animal ,generic ,drug ,user ,fee ,amendments of #bjac 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 during such fiscal year4 7b7 ,fiscal report ,beginning with fiscal year #bjad1 not later than #abj days after the end of each fiscal year during which fees are collected under this part1 the ,secretary shall prepare and submit to ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the implementation of the authority for such fees during such fiscal year and the use1 by the ,food and ,drug ,administration1 of the fees collected during such fiscal year for which the report is made4 7c7 ,public availability ,the ,secretary shall make the reports required under subsections 7a7 and 7b7 available to the public on the ,internet ,web site of the ,food and ,drug ,administration4 7d7 ,reauthorization 7#a7 ,consultation ,in developing recommendations to present to ,congress with respect to the goals1 and plans for meeting the goals1 for the process for the review of abbreviated applications for generic new animal drugs for the first #e fiscal years after fiscal year #bjah1 and for the reauthorization of this part for such fiscal years1 the ,secretary shall consult with-- 7,a7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7,b7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7,c7 scientific and academic experts2 7,d7 veterinary professionals2 7,e7 representatives of patient and consumer advocacy groups2 and 7,f7 the regulated industry4 7#b7 ,prior public input ,prior to beginning negotiations with the regulated industry on the reauthorization of this part1 the ,secretary shall-- 7,a7 publish a notice in the ,federal ,register requesting public input on the reauthorization2 7,b7 hold a public meeting at which the public may present its views on the reauthorization1 including specific suggestions for changes to the goals referred to in subsection 7a72 7,c7 provide a period of #cj days after the public meeting to obtain written comments from the public suggesting changes to this part2 and 7,d7 publish the comments on the ,food and ,drug ,administration's ,internet ,web site4 7#c7 ,periodic consultation ,not less frequently than once every #d months during negotiations with the regulated industry1 the ,secretary shall hold discussions with representatives of veterinary1 patient1 and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this part as expressed under paragraph 7#b74 7#d7 ,public review of recommendations ,after negotiations with the regulated industry1 the ,secretary shall-- 7,a7 present the recommendations developed under paragraph 7#a7 to the congressional committees specified in such paragraph2 7,b7 publish such recommendations in the ,federal ,register2 7,c7 provide for a period of #cj days for the public to provide written comments on such recommendations2 7,d7 hold a meeting at which the public may present its views on such recommendations2 and 7,e7 after consideration of such public views and comments1 revise such recommendations as necessary4 7#e7 ,transmittal of recommendations ,not later than ,january #ae1 #bjah1 the ,secretary shall transmit to ,congress the revised recommendations under paragraph 7#d71 a summary of the views and comments received under such paragraph1 and any changes made to the recommendations in response to such views and comments4 7#f7 ,minutes of negotiation meetings 7,a7 ,public availability ,before presenting the recommendations developed under paragraphs 7#a7 through 7#e7 to ,congress1 the ,secretary shall make publicly available1 on the ,internet ,web site of the ,food and ,drug ,administration1 minutes of all negotiation meetings conducted under this subsection between the ,food and ,drug ,administration and the regulated industry4 7,b7 ,content ,the minutes described under subparagraph 7,a7 shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution4 4 #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 ,act1 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 #bjjh1 but before ,october #a1 #bjac1 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 #bjad4 #bje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjac1 or the date of 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 all abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after ,october #a1 #bjac1 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 #bjah4 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 #bjai4 7c7 ,previous sunset provision 7#a7 ,in general ,section #bjd of the ,animal ,generic ,drug ,user ,fee ,act of #bjjh 7,public ,law #aaj-caf7 is repealed4 7#b7 ,conforming amendment ,the ,animal ,generic ,drug ,user ,fee ,act of #bjjh 7,public ,law #aaj-caf7 is amended in the table of contents in section #a1 by striking the item relating to section #bjd4 ,march #bj1 #bjac ,read twice and placed on the calendar