,,ii ,calendar ,no4 #agd #aaeth ,,congress #ast ,session ,h4 ,r4 #bdcj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ac1 #bjag,received2 read the first time ,july #ag1 #bjag,read the second time and placed on the calendar ,,an ,,act ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to revise and extend the user-fee programs for prescription drugs1 medical devices1 generic drugs1 and biosimilar biological products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,fda ,reauthorization ,act of #bjag4 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,title ,i--,fees relating to drugs ,sec4 #aja4 ,short title2 finding4 ,sec4 #ajb4 ,authority to assess and use drug fees4 ,sec4 #ajc4 ,reauthorization2 reporting requirements4 ,sec4 #ajd4 ,sunset dates4 ,sec4 #aje4 ,effective date4 ,sec4 #ajf4 ,savings clause4 ,title ,,ii--,fees relating to devices ,sec4 #bja4 ,short title2 finding4 ,sec4 #bjb4 ,definitions4 ,sec4 #bjc4 ,authority to assess and use device fees4 ,sec4 #bjd4 ,reauthorization2 reporting requirements4 ,sec4 #bje4 ,conformity assessment pilot program4 ,sec4 #bjf4 ,reauthorization of review4 ,sec4 #bjg4 ,electronic format for submissions4 ,sec4 #bjh4 ,savings clause4 ,sec4 #bji4 ,effective date4 ,sec4 #baj4 ,sunset dates4 ,title ,,iii--,fees relating to generic drugs ,sec4 #cja4 ,short title2 finding4 ,sec4 #cjb4 ,definitions4 ,sec4 #cjc4 ,authority to assess and use human generic drug fees4 ,sec4 #cjd4 ,reauthorization2 reporting requirements4 ,sec4 #cje4 ,sunset dates4 ,sec4 #cjf4 ,effective date4 ,sec4 #cjg4 ,savings clause4 ,title ,,iv--,fees relating to biosimilar biological products ,sec4 #dja4 ,short title2 finding4 ,sec4 #djb4 ,definitions4 ,sec4 #djc4 ,authority to assess and use biosimilar fees4 ,sec4 #djd4 ,reauthorization2 reporting requirements4 ,sec4 #dje4 ,sunset dates4 ,sec4 #djf4 ,effective date4 ,sec4 #djg4 ,savings clause4 ,title ,v--,pediatric drugs and devices ,sec4 #eja4 ,best pharmaceuticals for children4 ,sec4 #ejb4 ,pediatric devices4 ,sec4 #ejc4 ,early meeting on pediatric study plan4 ,sec4 #ejd4 ,development of drugs and biological products for pediatric cancers4 ,sec4 #eje4 ,additional provisions on development of drugs and biological products for pediatric use4 ,title ,,vi--,reauthorizations and improvements related to drugs ,sec4 #fja4 ,reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers4 ,sec4 #fjb4 ,reauthorization of the critical path public-private partnerships4 ,sec4 #fjc4 ,reauthorization of orphan grants program4 ,sec4 #fjd4 ,protecting and strengthening the drug supply chain4 ,sec4 #fje4 ,patient experience data4 ,sec4 #fjf4 ,communication plans4 ,sec4 #fjg4 ,orphan drugs4 ,sec4 #fjh4 ,pediatric information added to labeling4 ,sec4 #fji4 ,sense of ,congress on lowering the cost of prescription drugs4 ,sec4 #faj4 ,expanded access4 ,sec4 #faa4 ,tropical disease product application4 ,title ,,vii--,device inspection and regulatory improvements ,sec4 #gja4 ,risk-based inspections for devices4 ,sec4 #gjb4 ,improvements to inspections process for device establishments4 ,sec4 #gjc4 ,reauthorization of inspection program4 ,sec4 #gjd4 ,certificates to foreign governments for devices4 ,sec4 #gje4 ,facilitating international harmonization4 ,sec4 #gjf4 ,fostering innovation in medical imaging4 ,sec4 #gjg4 ,risk-based classification of accessories4 ,sec4 #gjh4 ,device pilot projects4 ,sec4 #gji4 ,regulation of over-the-counter hearing aids4 ,sec4 #gaj4 ,report on servicing of devices4 ,title ,,viii--,improving generic drug access ,sec4 #hja4 ,priority review of generic drugs4 ,sec4 #hjb4 ,enhancing regulatory transparency to enhance generic competition4 ,sec4 #hjc4 ,competitive generic therapies4 ,sec4 #hjd4 ,accurate information about drugs with limited competition4 ,sec4 #hje4 ,suitability petitions4 ,sec4 #hjf4 ,inspections4 ,sec4 #hjg4 ,reporting on pending generic drug applications and priority review applications4 ,sec4 #hjh4 ,incentivizing competitive generic drug development4 ,sec4 #hji4 ,,gao study of issues regarding first cycle approvals of generic medicines4 ,title ,,ix--,additional provisions ,sec4 #ija4 ,technical corrections4 ,sec4 #ijb4 ,annual report on inspections4 ,sec4 #ijc4 ,streamlining and improving consistency in performance reporting4 ,sec4 #ijd4 ,analysis of use of funds4 ,sec4 #ije4 ,facilities management4 ,i ,fees relating to drugs #aja4 ,short title2 finding 7a7 ,short ,title ,this title may be cited as the ,prescription ,drug ,user ,fee ,amendments of #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications1 including postmarket drug safety activities1 as set forth in the goals identified for purposes of part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #ajb4 ,authority to assess and use drug fees 7a7 ,types of fees 7#a7 ,in general ,section #gcf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7a77 is amended-- 7,a7 in the matter preceding paragraph 7#a71 by striking fiscal year #bjac and inserting fiscal year #bjah2 7,b7 in the heading of paragraph 7#a71 by striking and supplement2 7,c7 in paragraph 7#a71 by striking or a supplement and or supplement each place either appears2 7,d7 in paragraph 7#a77;,a7-- 7i7 in clause 7i71 by striking 7c77#d7 and inserting 7c77#e72 and 7ii7 in clause 7ii71 by striking ,a fee established and all that follows through are required4 and inserting the following3 ,a fee established under subsection 7c77#e7 for a human drug application for which clinical data 7other than bioavailability or bioequivalence studies7 with respect to safety or effectiveness are not required for approval42 7,e7 in the heading of paragraph 7#a77;,c71 by striking or supplement2 7,f7 in paragraph 7#a77;,f7-- 7i7 in the heading1 by striking or indication2 and 7ii7 by striking the second sentence2 7,g7 by striking paragraph 7#b7 7relating to a prescription drug establishment fee72 7,h7 by redesignating paragraph 7#c7 as paragraph 7#b72 7,i7 in the heading of paragraph 7#b71 as so redesignated1 by striking ,prescription drug product fee and inserting ,prescription drug program fee2 7,j7 in subparagraph 7,a7 of such paragraph 7#b71 by amending the first sentence to read as follows3 ,except as provided in subparagraphs 7,b7 and 7,c71 each person who is named as the applicant in a human drug application1 and who1 after ,september #a1 #aiib1 had pending before the ,secretary a human drug application or supplement1 shall pay the annual prescription drug program fee established for a fiscal year under subsection 7c77#e7 for each prescription drug product that is identified in such a human drug application approved as of ,october #a of such fiscal year4 2 7,k7 in subparagraph 7,b7 of such paragraph 7#b7-- 7i7 in the heading of subparagraph 7,b71 by inserting after ,exception the following3 for certain prescription drug products2 and 7ii7 by striking ,a prescription drug product shall not be assessed a fee and inserting ,a prescription drug program fee shall not be assessed for a prescription drug product2 and 7,l7 by adding at the end of such paragraph 7#b7 the following3 7,c7 ,limitation ,a person who is named as the applicant in an approved human drug application shall not be assessed more than #e prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application4 4 7#b7 ,conforming amendment ,subparagraph 7,c7 of section #gdj7;a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ab7;a77#c77 is amended to read as follows3 7,c7 ,limitation ,an establishment shall be assessed only one fee per fiscal year under this section4 4 7b7 ,fee revenue amounts ,subsection 7b7 of section #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7 is amended to read as follows3 7b7 ,fee revenue amounts 7#a7 ,in general ,for each of the fiscal years #bjah through #bjbb1 fees under subsection 7a7 shall1 except as provided in subsections 7c71 7d71 7f71 and 7g71 be established to generate a total revenue amount under such subsection that is equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#b772 7,d7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#c772 7,e7 the dollar amount equal to the additional direct cost adjustment for the fiscal year 7as determined under subsection 7c77#d772 and 7,f7 additional dollar amounts for each fiscal year as follows3 7i7 #bj1jgg1gic for fiscal year #bjah4 7ii7 #ba1cag1dgb for fiscal year #bjai4 7iii7 #af1iec1cbi for fiscal year #bjbj4 7iv7 #e1dbf1hif for fiscal year #bjba4 7v7 #b1gfi1fji for fiscal year #bjbb4 7#b7 ,types of fees ,of the total revenue amount determined for a fiscal year under paragraph 7#a7-- 7,a7 #bj percent shall be derived from human drug application fees under subsection 7a77#a72 and 7,b7 #hj percent shall be derived from prescription drug program fees under subsection 7a77#b74 7#c7 ,annual base revenue ,for purposes of paragraph 7#a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjah1 #hgh1eij1jjj2 and 7,b7 for fiscal years #bjai through #bjbb1 the dollar amount of the total revenue amount established under paragraph 7#a7 for the previous fiscal year1 not including any adjustments made under subsection 7c77#c7 or 7c77#d74 4 7c7 ,adjustments2 annual fee setting ,subsection 7c7 of section #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7 is amended to read as follows3 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#a77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b77#a77;,a72 and 7ii7 the inflation adjustment percentage under subparagraph 7,b74 7,b7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of-- 7i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications 7as defined in section #gce7f77 for the first #c years of the preceding #d fiscal years2 and 7ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications 7as defined in section #gce7f77 for the first #c years of the preceding #d fiscal years4 7#b7 ,capacity planning adjustment 7,a7 ,in general ,for each fiscal year1 after the annual base revenue established in subsection 7b77#a77;,a7 is adjusted for inflation in accordance with paragraph 7#a71 such revenue shall be adjusted further for such fiscal year1 in accordance with this paragraph1 to reflect changes in the resource capacity needs of the ,secretary for the process for the review of human drug applications4 7,b7 ,interim methodology 7i7 ,in general ,until the capacity planning methodology described in subparagraph 7,c7 is effective1 the adjustment under this paragraph for a fiscal year shall be based on the product of-- 7,i7 the annual base revenue for such year1 as adjusted for inflation under paragraph 7#a72 and 7,,ii7 the adjustment percentage under clause 7ii74 7ii7 ,adjustment percentage ,the adjustment percentage under this clause for a fiscal year is the weighted change in the #c-year average ending in the most recent year for which data are available1 over the #c-year average ending in the previous year1 for-- 7,i7 the total number of human drug applications1 efficacy supplements1 and manufacturing supplements submitted to the ,secretary2 7,,ii7 the total number of active commercial investigational new drug applications2 and 7,,iii7 the total number of formal meetings scheduled by the ,secretary1 and written responses issued by the ,secretary in lieu of such formal meetings1 as identified in section ,i4,h of the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag4 7,c7 ,capacity planning methodology 7i7 ,development2 evaluation and report ,the ,secretary shall obtain1 through a contract with an independent accounting or consulting firm1 a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications4 ,the capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input4 ,the report shall be published for public comment no later than the end of fiscal year #bjbj4 7ii7 ,establishment and implementation ,after review of the report described in clause 7i7 and any public comments thereon1 the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7,i7 replace the interim methodology under subparagraph 7,b72 7,,ii7 incorporate such approaches and attributes as the ,secretary determines appropriate2 and 7,,iii7 be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established4 7,d7 ,limitation ,under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections 7b77#a77;,a7 7the annual base revenue for the fiscal year7 and 7b77#a77;,b7 7the dollar amount of the inflation adjustment for the fiscal year74 7,e7 ,publication in federal register ,the ,secretary shall publish in the ,federal ,register notice under paragraph 7#e7 of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph4 7#c7 ,operating reserve adjustment 7,a7 ,increase ,for fiscal year #bjah and subsequent fiscal years1 the ,secretary may1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than #ad weeks of operating reserves of carryover user fees for the process for the review of human drug applications4 7,b7 ,decrease ,if the ,secretary has carryover balances for such process in excess of #ad weeks of such operating reserves1 the ,secretary shall decrease such fee revenue and fees to provide for not more than #ad weeks of such operating reserves4 7,c7 ,notice of rationale ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e7 establishing fee revenue and fees for the fiscal year involved4 7#d7 ,additional direct cost adjustment 7,a7 ,in general ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a71 7#b71 and 7#c71 further increase the fee revenue and fees-- 7i7 for fiscal year #bjah1 by #h1gcj1jjj2 and 7ii7 for fiscal year #bjai and subsequent fiscal years1 by the amount determined under subparagraph 7,b74 7,b7 ,amount ,the amount determined under this subparagraph is-- 7i7 #h1gcj1jjj1 multiplied by 7ii7 the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all ,items2 ,annual ,index7 for the most recent year of available data1 divided by such ,index for #bjaf4 7#e7 ,annual fee setting ,the ,secretary shall1 not later than #fj days before the start of each fiscal year that begins after ,september #cj1 #bjag-- 7,a7 establish1 for each such fiscal year1 human drug application fees and prescription drug program fees under subsection 7a71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under this subsection2 and 7,b7 publish such fee revenue and fees in the ,federal ,register4 7#f7 ,limit ,the total amount of fees charged1 as adjusted under this subsection1 for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications4 4 7d7 ,fee waiver or reduction ,section #gcf7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7d77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by inserting or at the end of subparagraph 7,b72 7,b7 by striking subparagraph 7,c72 and 7,c7 by redesignating subparagraph 7,d7 as subparagraph 7,c72 7#b7 by striking paragraph 7#c7 7relating to use of standard costs72 7#c7 by redesignating paragraph 7#d7 as paragraph 7#c72 and 7#d7 in paragraph 7#c71 as so redesignated-- 7,a7 in subparagraphs 7,a7 and 7,b71 by striking paragraph 7#a77;,d7 and inserting paragraph 7#a77;,c72 and 7,b7 in subparagraph 7,b7-- 7i7 by striking clause 7ii72 7ii7 by striking shall pay through 7i7 application fees and inserting shall pay application fees2 and 7iii7 by striking 2 and at the end and inserting a period4 7e7 ,effect of failure ,to pay fees ,section #gcf7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7e77 is amended by striking all fees and inserting all such fees4 7f7 ,limitations ,section #gcf7;f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7f77#b77 is amended by striking supplements1 prescription drug establishments1 and prescription drug products and inserting prescription drug program fees4 7g7 ,crediting and availability of fees ,section #gcf7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7g77 is amended-- 7#a7 in paragraph 7#c7-- 7,a7 by striking #bjac through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking and paragraph 7#d7 of this subsection2 and 7#b7 by striking paragraph 7#d74 7h7 ,orphan drugs ,section #gcf7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7k77 is amended by striking product and establishment fees each place it appears and inserting prescription drug program fees4 #ajc4 ,reauthorization2 reporting requirements ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is amended-- 7#a7 in subsection 7a77#a7-- 7,a7 in the matter before subparagraph 7,a71 by striking #bjac and inserting #bjah2 and 7,b7 in subparagraph 7,a71 by striking ,prescription ,drug ,user ,fee ,amendments of #bjab and inserting ,prescription ,drug ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 and 7#c7 in subsection 7d71 by striking #bjag each place it appears and inserting #bjbb4 #ajd4 ,sunset dates 7a7 ,authorization ,sections #gce and #gcf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g2 #cgi;h7 shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting ,requirements ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 shall cease to be effective ,january #ca1 #bjbc4 7c7 ,previous ,sunset ,provision ,effective ,october #a1 #bjag1 subsections 7a7 and 7b7 of section #aje of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 are repealed4 #aje4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be assessed for all human drug applications received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #ajf4 ,savings clause ,notwithstanding the amendments made by this title1 part #b of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to human drug applications and supplements 7as defined in such part as of such day7 that on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 were accepted by the ,food and ,drug ,administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjah4 ,,ii ,fees relating to devices #bja4 ,short title2 finding 7a7 ,short ,title ,this title may be cited as the ,medical ,device ,user ,fee ,amendments of #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices1 as set forth in the goals identified for purposes of part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #bjb4 ,definitions 7a7 ,in general ,section #gcg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7 is amended-- 7#a7 by redesignating paragraphs 7#h7 through 7#ac7 as paragraphs 7#i7 through 7#ad71 respectively2 7#b7 by inserting after paragraph 7#g7 the following new paragraph3 7#h7 ,the term de novo classification request means a request made under section #eac7;f77#b77;,a7 with respect to the classification of a device4 2 7#c7 in subparagraph 7,d7 of paragraph 7#aj7 7as redesignated by paragraph 7#a771 by striking and submissions and inserting submissions1 and de novo classification requests2 and 7#d7 in paragraph 7#aa7 7as redesignated by paragraph 7#a771 by striking #bjaa and inserting #bjaf4 7b7 ,conforming amendment ,section #gad7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;d-#c7;b77#a77 is amended by striking #gcg7h7 and inserting #gcg7i74 #bjc4 ,authority to assess and use device fees 7a7 ,types of ,fees ,section #gch7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7a77 is amended-- 7#a7 in paragraph 7#a71 by striking fiscal year #bjac and inserting fiscal year #bjah2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by striking ,october #a1 #bjab and inserting ,october #a1 #bjag2 7ii7 in clause 7viii71 by striking #b and inserting #c4d2 and 7iii7 by adding at the end the following new clause3 7xi7 ,for a de novo classification request1 a fee equal to #cj percent of the fee that applies under clause 7i74 2 and 7,b7 in subparagraph 7,b77v77,i71 by striking or premarket notification submission and inserting premarket notification submission1 or de novo classification request4 7b7 ,fee ,amounts ,section #gch7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7b77 is amended to read as follows3 7b7 ,fee ,amounts 7#a7 ,in ,general ,subject to subsections 7c71 7d71 7e71 and 7h71 for each of fiscal years #bjah through #bjbb1 fees under subsection 7a7 shall be derived from the base fee amounts specified in paragraph 7#b71 to generate the total revenue amounts specified in paragraph 7#c74 7#b7 ,base fee amounts specified ,for purposes of paragraph 7#a71 the base fee amounts specified in this paragraph are as follows3 ,fee ,type,fiscal ,year #bjah;,fiscal ,year #bjai;,fiscal ,year #bjbj;,fiscal ,year #bjba;,fiscal ,year #bjbb ,premarket ,application#bid1jjjcjj1jjjcaj1jjjcbh1jj jcbi1jjj ,establishment ,registration#d1cged1edhd1gfjd1iged1igh 7#c7 ,total revenue amounts specified ,for purposes of paragraph 7#a71 the total revenue amounts specified in this paragraph are as follows3 7,a7 #ahc1bhj1gef for fiscal year #bjah4 7,b7 #aij1fed1hge for fiscal year #bjai4 7,c7 #bjj1acb1jad for fiscal year #bjbj4 7,d7 #baa1gdh1ghi for fiscal year #bjba4 7,e7 #bac1fhg1ffj for fiscal year #bjbb4 4 7c7 ,annual ,fee ,setting2 ,adjustments ,section #gch7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7c77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjab and inserting #bjag2 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by striking #bjad and inserting #bjah2 7,b7 by striking subparagraph 7,b7 and inserting the following new subparagraph3 7,b7 ,applicable inflation adjustment ,the applicable inflation adjustment for fiscal year #bjah and each subsequent fiscal year is the product of-- 7i7 the base inflation adjustment under subparagraph 7,c7 for such fiscal year2 and 7ii7 the product of the base inflation adjustment under subparagraph 7,c7 for each of the fiscal years preceding such fiscal year1 beginning with fiscal year #bjaf4 2 7,c7 in subparagraph 7,c71 in the heading1 by striking to total revenue amounts2 and 7,d7 by amending subparagraph 7,d7 to read as follows3 7,d7 ,adjustment to base fee amounts ,for each of fiscal years #bjah through #bjbb1 the ,secretary shall-- 7i7 adjust the base fee amounts specified in subsection 7b77#b7 for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph 7,b7 for such year2 and 7ii7 if the ,secretary determines necessary1 increase 7in addition to the adjustment under clause 7i77 such base fee amounts1 on a uniform proportionate basis1 to generate the total revenue amounts under subsection 7b77#c71 as adjusted for inflation under subparagraph 7,a74 2 and 7#c7 in paragraph 7#c7-- 7,a7 by striking #bjad through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking further adjusted and inserting increased4 7d7 ,small businesses2 ,fee ,waiver and ,fee ,reduction ,regarding ,premarket ,approval ,fees ,section #gch7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7d77 is amended-- 7#a7 in paragraph 7#a71 by striking specified in clauses 7i7 through 7v7 and clauses 7vii71 7ix71 and 7x7 and inserting specified in clauses 7i7 through 7vii7 and clauses 7ix71 7x71 and 7xi72 and 7#b7 in paragraph 7#b77;,c7-- 7,a7 by striking supplement1 or and inserting supplement12 and 7,b7 by inserting 1 or a de novo classification request after class ,,iii device4 7e7 ,small ,businesses2 ,fee ,reduction ,regarding ,premarket ,notification ,submissions ,section #gch7;e77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7e77#b77;,c77 is amended by striking #ej and inserting #be4 7f7 ,fee ,waiver or ,reduction 7#a7 ,repeal ,section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended by striking subsection 7f74 7#b7 ,conforming amendments 7,a7 ,section #eae7;c77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7c77#d77;,a77 is amended by striking #gch7;h7 and inserting #gch7;g74 7,b7 ,section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j71 as amended by paragraph 7#a71 is further amended-- 7i7 by redesignating subsections 7g7 through 7l7 as subsections 7f7 through 7k72 7ii7 in subsection 7a77#b77;,a71 by striking 7d71 7e71 and 7f7 and inserting 7d7 and 7e72 and 7iii7 in subsection 7a77#c77;,a71 by striking and subsection 7f74 7g7 ,effect of failure ,to pay fees ,subsection 7f77#a71 as so redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended-- 7#a7 by striking or periodic reporting concerning a class ,,iii device and inserting periodic reporting concerning a class ,,iii device1 or de novo classification request2 and 7#b7 by striking all fees and inserting all such fees4 7h7 ,conditions ,subsection 7g77#a77;,a71 as so redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended by striking #bhj1ehg1jjj and inserting #cbj1hbe1jjj4 7i7 ,crediting and ,availability of ,fees ,subsection 7h71 as so redesignated1 of section #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is amended-- 7#a7 in paragraph 7#c7-- 7,a7 by striking #bjac through #bjag and inserting #bjah through #bjbb2 and 7,b7 by striking subsection 7c7 and all that follows through the period at the end and inserting subsection 7c742 and 7#b7 by striking paragraph 7#d74 #bjd4 ,reauthorization2 reporting requirements 7a7 ,performance ,reports ,section #gch;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 by striking #bjac and inserting #bjah2 and 7ii7 by striking the ,medical ,device ,user ,fee ,amendments of #bjab and inserting the ,medical ,device ,user ,fee ,amendments of #bjag2 and 7,b7 in subparagraph 7,b71 by striking the ,medical ,device ,user ,fee ,amendments ,act of #bjab and inserting the ,medical ,device ,user ,fee ,amendments of #bjag2 and 7#b7 in paragraph 7#b71 by striking #bjac through #bjag and inserting #bjah through #bjbb4 7b7 ,reauthorization ,section #gch;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;b77 is amended-- 7#a7 in paragraph 7#a71 by striking #bjag and inserting #bjbb2 and 7#b7 in paragraph 7#e71 by striking #bjag and inserting #bjbb4 #bje4 ,conformity assessment pilot program 7a7 ,in general ,section #ead of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;d7 is amended by adding at the end the following3 7d7 ,pilot accreditation scheme for conformity assessment 7#a7 ,in general ,the ,secretary shall establish a pilot program under which-- 7,a7 testing laboratories may be accredited1 by accreditation bodies meeting criteria specified by the ,secretary1 to assess the conformance of a device with certain standards recognized under this section2 and 7,b7 subject to paragraph 7#b71 determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the ,secretary for purposes of demonstrating such conformity under this section unless the ,secretary finds that a particular such determination shall not be so accepted4 7#b7 ,secretarial review of accredited laboratory determinations ,the ,secretary may-- 7,a7 review determinations by testing laboratories accredited pursuant to this subsection1 including by conducting periodic audits of such determinations or processes of accredited bodies or testing laboratories and1 following such review1 taking additional measures under this ,act1 such as suspension or withdrawal of accreditation of such testing laboratory under paragraph 7#a77;,a7 or requesting additional information with respect to such device1 as the ,secretary determines appropriate2 and 7,b7 if the ,secretary becomes aware of information materially bearing on safety or effectiveness of a device assessed for conformity by a testing laboratory so accredited1 take such additional measures under this ,act as the ,secretary determines appropriate1 such as suspension or withdrawal of accreditation of such testing laboratory under paragraph 7#a77;,a71 or requesting additional information with regard to such device4 7#c7 ,implementation and reporting 7,a7 ,public meeting ,the ,secretary shall publish in the ,federal ,register a notice of a public meeting to be held no later than ,september #cj1 #bjah1 to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of1 and a suitable framework and procedures and requirements for1 the pilot program under this subsection4 7,b7 ,pilot program guidance ,the ,secretary shall-- 7i7 not later than ,september #cj1 #bjai1 issue draft guidance regarding the goals and implementation of the pilot program under this subsection2 and 7ii7 not later than ,september #cj1 #bjba1 issue final guidance with respect to the implementation of such program4 7,c7 ,pilot program initiation ,not later than ,september #cj1 #bjbj1 the ,secretary shall initiate the pilot program under this subsection4 7,d7 ,report ,the ,secretary shall make available on the internet website of the ,food and ,drug ,administration an annual report on the progress of the pilot program under this subsection4 7#d7 ,sunset ,as of ,october #a1 #bjbb-- 7,a7 the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph 7#a77;,a7 shall cease to have force or effect2 7,b7 the ,secretary-- 7i7 may not accept a determination pursuant to paragraph 7#a77;,b7 made by a testing laboratory after such date2 and 7ii7 may accept such a determination made prior to such date2 7,c7 except for purposes of accepting a determination described in subparagraph 7,b77ii71 the ,secretary shall not continue to recognize the accreditation of testing laboratories accredited under paragraph 7#a77;,a72 and 7,d7 the ,secretary may take actions in accordance with paragraph 7#b7 with respect to the determinations made prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date4 4 #bjf4 ,reauthorization of review ,section #ebc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjm7 is amended-- 7#a7 in subsection 7a77#c7-- 7,a7 in subparagraph 7,a71 by striking clauses 7ii7 and 7iii7 and inserting the following3 7ii7 a device classified under section #eac7;f77#b7 or designated under section #eae;,c7d72 7iii7 a device that is intended to be permanently implantable1 life sustaining1 or life supporting1 unless otherwise determined by the ,secretary in accordance with subparagraph 7,b77i77,,ii7 and listed as eligible for review under subparagraph 7,b77iii72 or 7iv7 a device that is of a type1 or subset of a type1 listed as not eligible for review under subparagraph 7,b77iii74 2 7,b7 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,designation for review ,the ,secretary shall-- 7i7 issue draft guidance on the factors the ,secretary will use in determining whether a class ,i or class ,,ii device type1 or subset of such device types1 is eligible for review by an accredited person1 including-- 7,i7 the risk of the device type1 or subset of such device type2 and 7,,ii7 whether the device type1 or subset of such device type1 is permanently implantable1 life sustaining1 or life supporting1 and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset2 7ii7 not later than #bd months after the date on which the ,secretary issues such draft guidance1 finalize such guidance2 and 7iii7 beginning on the date such guidance is finalized1 designate and post on the internet website of the ,food and ,drug ,administration1 an updated list of class ,i and class ,,ii device types1 or subsets of such device types1 and the ,secretary's determination with respect to whether each such device type1 or subset of a device type1 is eligible or not eligible for review by an accredited person under this section based on the factors described in clause 7i74 2 and 7,c7 by adding at the end the following3 7,c7 ,interim rule ,until the date on which the updated list is designated and posted in accordance with subparagraph 7,b77iii71 the list in effect on the date of enactment the ,medical ,device ,user ,fee ,amendments of #bjag shall be in effect4 2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b7-- 7i7 by striking subparagraph 7,d72 and 7ii7 by redesignating subparagraph 7,e7 as subparagraph 7,d72 and 7,b7 in paragraph 7#c7-- 7i7 by redesignating subparagraph 7,e7 as subparagraph 7,f72 7ii7 in subparagraph 7,f7 7as so redesignated71 by striking ,the operations of and all that follows through it will-- and inserting ,such person shall agree1 at a minimum1 to include in its request for accreditation a commitment to1 at the time of accreditation1 and at any time it is performing any review pursuant to this section--2 and 7iii7 by inserting after subparagraph 7,d7 the following new subparagraph3 7,e7 ,the operations of such person shall be in accordance with generally accepted professional and ethical business practices4 2 and 7#c7 in subsection 7c71 by striking #bjag and inserting #bjbb4 #bjg4 ,electronic format for submissions ,section #gde;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgik-#a7;b77 is amended by adding at the end the following new paragraph3 7#c7 ,presubmissions and submissions solely in electronic format 7,a7 ,in general ,beginning on such date as the ,secretary specifies in final guidance issued under subparagraph 7,c71 presubmissions and submissions for devices described in paragraph 7#a7 7and any appeals of action taken by the ,secretary with respect to such presubmissions or submissions7 shall be submitted solely in such electronic format as specified by the ,secretary in such guidance4 7,b7 ,draft guidance ,the ,secretary shall1 not later than ,october #a1 #bjai1 issue draft guidance providing for-- 7i7 any further standards for the submission by electronic format required under subparagraph 7,a72 7ii7 a timetable for the establishment by the ,secretary of such further standards2 and 7iii7 criteria for waivers of and exemptions from the requirements of this subsection4 7,c7 ,final guidance ,the ,secretary shall1 not later than #a year after the close of the public comment period on the draft guidance issued under subparagraph 7,b71 issue final guidance4 4 #bjh4 ,savings clause ,notwithstanding the amendments made by this title1 part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i et seq471 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to the submissions listed in section #gch7;a77#b77;,a7 of such ,act 7as defined in such part as of such day7 that on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 were accepted by the ,food and ,drug ,administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjah4 #bji4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #c of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be assessed for all submissions listed in section #gch7;a77#b77;,a7 of such ,act received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #baj4 ,sunset dates 7a7 ,authorization ,sections #gcg and #gch of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #gci;i2 #gci;j7 shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting requirements ,section #gch;,a 7#ba ,u4,s4,c4 #gci;j-#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7regarding reauthorization and reporting requirements7 shall cease to be effective ,january #ca1 #bjbc4 7c7 ,previous ,sunset ,provision ,effective ,october #a1 #bjag1 section #bjg7;a7 of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is repealed4 ,,iii ,fees relating to generic drugs #cja4 ,short title2 finding 7a7 ,short title ,this title may be cited as the ,generic ,drug ,user ,fee ,amendments of #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities1 as set forth in the goals identified for purposes of part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #cjb4 ,definitions ,section #gdd;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da7 is amended-- 7#a7 in paragraph 7#a77;,b71 by striking application for a positron emission tomography drug4 and inserting 8application-- 7i7 for a positron emission tomography drug2 or 7ii7 submitted by a ,state or ,federal governmental entity for a drug that is not distributed commercially4 2 7#b7 by redesignating paragraphs 7#e7 through 7#ab7 as paragraphs 7#f7 through 7#ac71 respectively2 and 7#c7 by inserting after paragraph 7#d7 the following3 7#e7 ,the term contract manufacturing organization facility means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application1 where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility4 4 #cjc4 ,authority to assess and use human generic drug fees 7a7 ,types of fees ,section #gdd;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking fiscal year #bjac and inserting fiscal year #bjah2 7#b7 in paragraph 7#a71 by adding at the end the following3 7,e7 ,sunset ,this paragraph shall cease to be effective ,october #a1 #bjbb4 2 7#c7 in paragraph 7#b7-- 7,a7 by amending subparagraph 7,c7 to read as follows3 7,c7 ,notice ,not later than #fj days before the start of each of fiscal years #bjah through #bjbb1 the ,secretary shall publish in the ,federal ,register the amount of the drug master file fee established by this paragraph for such fiscal year4 2 and 7,b7 in subparagraph 7,e7-- 7i7 in clause 7i7-- 7,i7 by striking no later than the date and inserting 8on the earlier of-- 7,i7 the date 2 7,,ii7 by striking the period and inserting 2 or2 and 7,,iii7 by adding at the end the following3 7,,ii7 the date on which the drug master file holder requests the initial completeness assessment4 2 and 7ii7 in clause 7ii71 by striking notice provided for in clause 7i7 or 7ii7 of subparagraph 7,c71 as applicable and inserting notice provided for in subparagraph 7,c72 7#d7 in paragraph 7#c7-- 7,a7 in the heading1 by striking and prior approval supplement2 7,b7 in subparagraph 7,a71 by striking or a prior approval supplement to an abbreviated new drug application2 7,c7 by amending subparagraphs 7,b7 and 7,c7 to read as follows3 7,b7 ,notice ,not later than #fj days before the start of each of fiscal years #bjah through #bjbb1 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 7,c7 ,fee due date ,the fees required by subparagraphs 7,a7 and 7,f7 shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies4 2 7,d7 in subparagraph 7,d7-- 7i7 in the heading1 by inserting 1 is withdrawn prior to being received1 or is no longer received after received2 and 7ii7 by striking ,the ,secretary shall and all that follows through the period and inserting the following3 7i7 ,applications not considered to have been received and applications withdrawn prior to being received ,the ,secretary shall refund #ge percent of the fee paid under subparagraph 7,a7 for any abbreviated new drug application that the ,secretary considers not to have been received within the meaning of section #eje7;j77#e77;,a7 for a cause other than failure to pay fees1 or that has been withdrawn prior to being received within the meaning of section #eje7;j77#e77;,a74 7ii7 ,applications no longer received ,the ,secretary shall refund #ajj percent of the fee paid under subparagraph 7,a7 for any abbreviated new drug application if the ,secretary initially receives the application under section #eje7;j77#e77;,a7 and subsequently determines that an exclusivity period for a listed drug should have prevented the ,secretary from receiving such application1 such that the abbreviated new drug application is no longer received within the meaning of section #eje7;j77#e77;,a74 2 7,e7 in subparagraph 7,e71 by striking or prior approval supplement2 and 7,f7 in the matter preceding clause 7i7 of subparagraph 7,f7-- 7i7 by striking #bjab and inserting #bjag2 and 7ii7 by striking subsection 7d77#c7 and inserting subsection 7d77#b72 7#e7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i7 and in clause 7iii71 by striking 1 or intended to be identified1 in at least one generic drug submission that is pending or and inserting in at least one generic drug submission that is2 7ii7 in clause 7i71 by striking or intended to be identified in at least one generic drug submission that is pending or and inserting in at least one generic drug submission that is2 7iii7 in clause 7ii71 by striking produces1 and all that follows through such a and inserting is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a ,type ,,ii active pharmaceutical ingredient drug master file referenced in at least one such2 and 7iv7 in clause 7iii71 by striking to fees under both such clauses and inserting only to the fee attributable to the manufacture of the finished dosage forms2 and 7,b7 by amending subparagraphs 7,c7 and 7,d7 to read as follows3 7,c7 ,notice ,within the timeframe specified in subsection 7d77#a71 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 7,d7 ,fee due date ,for each of fiscal years #bjah through #bjbb1 the fees under subparagraph 7,a7 for such fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such year2 or 7ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees for such year under this section for such year4 2 7#f7 by redesignating paragraph 7#e7 as paragraph 7#f72 and 7#g7 by inserting after paragraph 7#d7 the following3 7#e7 ,generic drug applicant program fee 7,a7 ,in general ,a generic drug applicant program fee shall be assessed annually as described in subsection 7b77#b77;,e74 7,b7 ,amount ,the amount of fees established under subparagraph 7,a7 shall be established under subsection 7d74 7,c7 ,notice ,within the timeframe specified in subsection 7d77#a71 the ,secretary shall publish in the ,federal ,register the amount of the fees under subparagraph 7,a7 for such fiscal year4 7,d7 ,fee due date ,for each of fiscal years #bjah through #bjbb1 the fees under subparagraph 7,a7 for such fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such fiscal year2 or 7ii7 the first business day after the date of enactment of an appropriations ,act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year4 4 7b7 ,fee revenue amounts ,section #gdd;,b7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a7-- 7i7 in the heading1 by striking #bjac and inserting #bjah2 7ii7 by striking #bjac and inserting #bjah2 7iii7 by striking #bii1jjj1jjj and inserting #dic1fjj1jjj2 and 7iv7 by striking ,of that amount and all that follows through the end of clause 7ii72 and 7,b7 in subparagraph 7,b7-- 7i7 in the heading1 by striking #bjad through #bjag and inserting #bjai through #bjbb2 7ii7 by striking #bjad through #bjag and inserting #bjai through #bjbb2 7iii7 by striking paragraphs 7#b7 through 7#d7 and inserting paragraphs 7#b7 through 7#e72 and 7iv7 by striking #bii1jjj1jjj and inserting #dic1fjj1jjj2 and 7#b7 in paragraph 7#b7-- 7,a7 in the matter preceding subparagraph 7,a7-- 7i7 by striking paragraph 7#a77;,a77ii7 for fiscal year #bjac and paragraph 7#a77;,b7 for each of fiscal years #bjad through #bjag and inserting such paragraph for a fiscal year2 and 7ii7 by striking through 7#d7 and inserting through 7#e72 7,b7 in subparagraph 7,a71 by striking ,six percent and inserting ,five percent2 7,c7 by amending subparagraphs 7,b7 and 7,c7 to read as follows3 7,b7 ,thirty-three percent shall be derived from fees under subsection 7a77#c7 7relating to abbreviated new drug applications74 7,c7 ,twenty percent shall be derived from fees under subsection 7a77#d77;,a77i7 7relating to generic drug facilities74 ,the amount of the fee for a contract manufacturing organization facility shall be equal to one-third the amount of the fee for a facility that is not a contract manufacturing organization facility4 ,the amount of the fee for a facility located outside the ,united ,states and its territories and possessions shall be #ae1jjj higher than the amount of the fee for a facility located in the ,united ,states and its territories and possessions4 2 7,d7 in subparagraph 7,d7-- 7i7 by striking ,fourteen percent and inserting ,seven percent2 7ii7 by striking not less than #ae1jjj and not more than #cj1jjj and inserting #ae1jjj2 and 7iii7 by striking 1 as determined and all that follows through the period at the end and inserting a period2 and 7,e7 by adding at the end the following3 7,e7 7i7 ,thirty-five percent shall be derived from fees under subsection 7a77#e7 7relating to generic drug applicant program fees74 ,for purposes of this subparagraph1 if a person has affiliates1 a single program fee shall be assessed with respect to that person1 including its affiliates1 and may be paid by that person or any one of its affiliates4 ,the ,secretary shall determine the fees as follows3 7,i7 ,if a person 7including its affiliates7 owns at least one but not more than #e approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee4 7,,ii7 ,if a person 7including its affiliates7 owns at least #f but not more than #ai approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee4 7,,iii7 ,if a person 7including its affiliates7 owns #bj or more approved abbreviated new drug applications on the due date for the fee under this subsection1 the person 7including its affiliates7 shall be assessed a large size operation generic drug applicant program fee4 7ii7 ,for purposes of this subparagraph1 an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by ,april #a of the previous fiscal year4 4 7c7 ,adjustments ,section #gdd;,b7c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;c77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking #bjad and inserting #bjai2 7,b7 by inserting to equal the product of the total revenues established in such notice for the prior fiscal year multiplied after a fiscal year12 and 7,c7 by striking the flush text following subparagraph 7,c72 and 7#b7 in paragraph 7#b7-- 7,a7 by striking #bjag each place it appears and inserting #bjbb2 7,b7 by striking the first #c months of fiscal year #bjah and inserting the first #c months of fiscal year #bjbc2 and 7,c7 by striking ,such fees may only be used in fiscal year #bjah44 7d7 ,annual fee setting ,section #gdd;,b7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;d77 is amended-- 7#a7 by striking paragraphs 7#a7 and 7#b7 and inserting the following3 7#a7 ,fiscal years #bjah through #bjbb ,not more than #fj days before the first day of each of fiscal years #bjah through #bjbb1 the ,secretary shall establish the fees described in paragraphs 7#b7 through 7#e7 of subsection 7a71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under subsection 7c74 2 7#b7 by redesignating paragraph 7#c7 as paragraph 7#b72 and 7#c7 in paragraph 7#b7 7as so redesignated71 in the matter preceding subparagraph 7,a71 by striking fees under paragraphs 7#a7 and 7#b7 and inserting fee under paragraph 7#a74 7e7 ,identification of facilities ,section #gdd;,b7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;f77 is amended-- 7#a7 by striking paragraph 7#a72 7#b7 by redesignating paragraphs 7#b7 through 7#d7 as paragraphs 7#a7 through 7#c71 respectively2 7#c7 in paragraph 7#a7 7as so redesignated7-- 7,a7 by striking paragraph 7#d7 and inserting paragraph 7#c72 and 7,b7 by striking ,such information shall and all that follows through the end of subparagraph 7,b7 and inserting ,such information shall1 for each fiscal year1 be submitted1 updated1 or reconfirmed on or before ,june #a of the previous fiscal year42 and 7#d7 in paragraph 7#b71 as so redesignated-- 7,a7 in the heading1 by striking ,contents of notice and inserting ,information required to be submitted2 7,b7 in the matter preceding subparagraph 7,a71 by striking paragraph 7#b7 and inserting paragraph 7#a72 7,c7 in subparagraph 7,a71 by striking or intended to be identified2 7,d7 in subparagraph 7,d71 by striking and at the end2 7,e7 in subparagraph 7,e71 by striking the period and inserting 2 and2 and 7,f7 by adding at the end the following3 7,f7 whether the facility is a contract manufacturing organization facility4 4 7f7 ,effect of failure ,to pay fees ,section #gdd;,b7g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;g77 is amended-- 7#a7 in paragraph 7#a71 by adding at the end the following3 ,this paragraph shall cease to be effective on ,october #a1 #bjbb42 7#b7 in paragraph 7#b77;,c77ii71 by striking of #eje7;j77#e77;,a7 and inserting of section #eje7;j77#e77;,a72 and 7#c7 by adding at the end the following3 7#e7 ,generic drug applicant program fee 7,a7 ,in general ,a person who fails to pay a fee as required under subsection 7a77#e7 by the date that is #bj calendar days after the due date1 as specified in subparagraph 7,d7 of such subsection1 shall be subject to the following3 7i7 ,the ,secretary shall place the person on a publicly available arrears list4 7ii7 ,any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received1 within the meaning of section #eje7;j77#e77;,a74 7iii7 ,all drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section #ejb7;aa74 7,b7 ,application of penalties ,the penalties under subparagraph 7,a7 shall apply until the fee required under subsection 7a77#e7 is paid4 4 7g7 ,limitations ,section #gdd;,b7h77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;h77#b77 is amended by striking for ,type ,,ii active pharmaceutical ingredient drug master files1 abbreviated new drug applications and prior approval supplements1 and generic drug facilities and active pharmaceutical ingredient facilities4 7h7 ,crediting and availability of fees ,section #gdd;,b7i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;i77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by striking subparagraphs 7,c7 and 7,d7 and inserting subparagraph 7,c72 7,b7 by striking subparagraph 7,c7 7relating to fee collection during first program year72 7,c7 in subparagraph 7,d7-- 7i7 in the heading1 by striking in subsequent years2 and 7ii7 by striking 7after fiscal year #bjac72 and 7,d7 by redesignating subparagraph 7,d7 as subparagraph 7,c72 and 7#b7 in paragraph 7#c71 by striking fiscal years #bjac through #bjag and inserting fiscal years #bjah through #bjbb4 7i7 ,information on abbreviated new drug applications owned by applicants and their affiliates ,section #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7 is amended by adding at the end the following3 7o7 ,information on abbreviated new drug applications owned by applicants and their affiliates 7#a7 ,in general ,by ,april #a of each year1 each person that owns an abbreviated new drug application1 or a designated affiliate of such person1 shall submit1 on behalf of the person and the affiliates of such person1 to the ,secretary a list of-- 7,a7 all approved abbreviated new drug applications owned by such person2 and 7,b7 if any affiliate of such person also owns an abbreviated new drug application1 all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate4 7#b7 ,format and method ,the ,secretary shall specify in guidance the format and method for submission of lists under this subsection4 4 #cjd4 ,reauthorization2 reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking #bjac and inserting #bjah2 and 7,b7 by striking ,generic ,drug ,user ,fee ,amendments of #bjab and inserting ,generic ,drug ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 and 7#c7 in subsection 7d71 by striking #bjag each place it appears and inserting #bjbb4 #cje4 ,sunset dates 7a7 ,authorization ,sections #gdd;,a and #gdd;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da2 #cgi;j-#db7 shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting requirements ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 shall cease to be effective ,january #ca1 #bjbc4 7c7 ,previous sunset provision 7#a7 ,in general ,effective ,october #a1 #bjag1 section #cjd of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is repealed4 7#b7 ,conforming amendment ,the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is amended in the table of contents in section #b by striking the item relating to section #cjd4 #cjf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be assessed for all abbreviated new drug applications received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #cjg4 ,savings clause ,notwithstanding the amendments made by this title1 part #g of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to abbreviated new drug applications 7as defined in such part as of such day7 that were received by the ,food and ,drug ,administration within the meaning of section #eje7;j77#e77;,a7 of such ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,a771 prior approval supplements that were submitted1 and drug master files for ,type ,,ii active pharmaceutical ingredients that were first referenced on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjah4 ,,iv ,fees relating to biosimilar biological products #dja4 ,short title2 finding 7a7 ,short ,title ,this title may be cited as the ,biosimilar ,user ,fee ,amendments of #bjag4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications1 including postmarket safety activities1 as set forth in the goals identified for purposes of part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #djb4 ,definitions 7a7 ,adjustment factor ,section #gdd;,g7#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7a77 is amended to read as follows3 7#a7 ,the term adjustment factor applicable to a fiscal year is the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items7 for ,october of the preceding fiscal year divided by such ,index for ,october #bjaa4 4 7b7 ,biosimilar biological product ,section #gdd;,g7#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7c77 is amended by striking means a product and inserting means a specific strength of a biological product in final dosage form4 #djc4 ,authority to assess and use biosimilar fees 7a7 ,types of fees ,section #gdd;,h7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;a77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking fiscal year #bjac and inserting fiscal year #bjah2 7#b7 in the heading of paragraph 7#a71 by striking ,biosimilar and inserting ,biosimilar biological product2 7#c7 in paragraph 7#a77;,a77i71 by striking 7b77#a77;,a7 and inserting 7c77#e72 7#d7 in paragraph 7#a77;,b77i71 by striking 7b77#a77;,b7 for biosimilar biological product development and inserting 7c77#e7 for the biosimilar biological product development program2 7#e7 in paragraph 7#a77;,b77ii71 by striking annual biosimilar biological product development program fee and inserting annual biosimilar biological product development fee2 7#f7 in paragraph 7#a77;,b77iii71 by striking annual biosimilar development program fee and inserting annual biosimilar biological product development fee2 7#g7 in paragraph 7#a77;,b71 by adding at the end the following3 7iv7 ,refund ,if a person submits a marketing application for a biosimilar biological product before ,october #a of a fiscal year and such application is accepted for filing on or after ,october #a of such fiscal year1 the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year4 ,to qualify for consideration for a refund under this clause1 a person shall submit to the ,secretary a written request for such refund not later than #ahj days after the marketing application is accepted for filing4 2 7#h7 in paragraph 7#a77;,c71 by striking for a product effective ,october #a of a fiscal year by1 and inserting for a product1 effective ,october #a of a fiscal year1 by12 7#i7 in paragraph 7#a77;,d7-- 7,a7 in clause 7i7 in the matter preceding subclause 7,i71 by inserting 1 if the person seeks to resume participation in such program1 before pay a fee2 7,b7 in clause 7i77,i71 by inserting after grants a request the following3 by such person2 and 7,c7 in clause 7i77,,ii71 by inserting after discontinued7 the following3 by such person2 7#aj7 in the heading of paragraph 7#a77;,e71 by striking biosimilar development program2 7#aa7 in paragraph 7#a77;,f7-- 7,a7 in the subparagraph heading1 by striking biosimilar development program2 and 7,b7 by amending clause 7i7 to read as follows3 7i7 ,refunds ,except as provided in subparagraph 7,b77iv71 the ,secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph 7,a7 or 7,b71 or any reactivation fee paid under subparagraph 7,d74 2 7#ab7 in paragraph 7#b7-- 7,a7 in the paragraph heading1 by striking and supplement2 7,b7 by amending subparagraphs 7,a7 and 7,b7 to read as follows3 7,a7 ,in general ,each person that submits1 on or after ,october #a1 #bjag1 a biosimilar biological product application shall be subject to the following fees3 7i7 ,a fee established under subsection 7c77#e7 for a biosimilar biological product application for which clinical data 7other than comparative bioavailability studies7 with respect to safety or effectiveness are required for approval4 7ii7 ,a fee established under subsection 7c77#e7 for a biosimilar biological product application for which clinical data 7other than comparative bioavailability studies7 with respect to safety or effectiveness are not required for approval4 ,such fee shall be equal to half of the amount of the fee described in clause 7i74 7,b7 ,rule of applicability2 treatment of certain previously paid fees ,any person who pays a fee under subparagraph 7,a71 7,b71 or 7,d7 of paragraph 7#a7 for a product before ,october #a1 #bjag1 but submits a biosimilar biological product application for that product after such date1 shall-- 7i7 be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted2 and 7ii7 be entitled to no reduction of such application fees based on the amount of fees paid for that product before ,october #a1 #bjag1 under such subparagraph 7,a71 7,b71 or 7,d74 2 7,c7 in the heading of subparagraph 7,d71 by striking or supplement2 7,d7 in subparagraphs 7,c7 through 7,f71 by striking or supplement each place it appears2 and 7,e7 in subparagraph 7,d71 by striking or a supplement2 7#ac7 by amending paragraph 7#c7 to read as follows3 7#c7 ,biosimilar biological product program fee 7,a7 ,in general ,each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection 7c77#e7 for each biosimilar biological product that-- 7i7 is identified in such a biosimilar biological product application approved as of ,october #a of such fiscal year2 and 7ii7 as of ,october #a of such fiscal year1 does not appear on a list1 developed and maintained by the ,secretary1 of discontinued biosimilar biological products4 7,b7 ,due date ,the biosimilar biological product program fee for a fiscal year shall be due on the later of-- 7i7 the first business day on or after ,october #a of each such year2 or 7ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees for such year under this section4 7,c7 ,one fee per product per year ,the biosimilar biological product program fee shall be paid only once for each product for each fiscal year4 7,d7 ,limitation ,a person who is named as the applicant in a biosimilar biological product application shall not be assessed more than #e biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application4 4 7b7 ,fee revenue amounts ,subsection 7b7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is amended to read as follows3 7b7 ,fee revenue amounts 7#a7 ,fiscal year #bjah ,for fiscal year #bjah1 fees under subsection 7a7 shall be established to generate a total revenue amount equal to the sum of-- 7,a7 #de1jjj1jjj2 and 7,b7 the dollar amount equal to the fiscal year #bjah adjustment 7as determined under subsection 7c77#d774 7#b7 ,subsequent fiscal years ,for each of the fiscal years #bjai through #bjbb1 fees under subsection 7a7 shall1 except as provided in subsection 7c71 be established to generate a total revenue amount equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#d772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the capacity planning adjustment for the fiscal year 7as determined under subsection 7c77#b772 and 7,d7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#c774 7#c7 ,allocation of revenue amount among fees2 limitations on fee amounts 7,a7 ,allocation ,the ,secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from1 respectively-- 7i7 initial and annual biosimilar biological product development fees and reactivation fees under subsection 7a77#a72 7ii7 biosimilar biological product application fees under subsection 7a77#b72 and 7iii7 biosimilar biological product program fees under subsection 7a77#c74 7,b7 ,limitations on fee amounts ,until the first fiscal year for which the capacity planning adjustment under subsection 7c77#b7 is effective1 the amount of any fee under subsection 7a7 for a fiscal year after fiscal year #bjah shall not exceed #abe percent of the amount of such fee for fiscal year #bjah4 7,c7 ,biosimilar biological product development fees ,the initial biosimilar biological product development fee under subsection 7a77#a77;,a7 for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection 7a77#a77;,b7 for that fiscal year4 7,d7 ,reactivation fee ,the reactivation fee under subsection 7a77#a77;,d7 for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection 7a77#a77;,b7 for that fiscal year4 7#d7 ,annual base revenue ,for purposes of paragraph 7#b71 the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year1 excluding any adjustments to such revenue amount under subsection 7c77#c74 4 7c7 ,adjustments2 annual fee setting ,section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7 is amended-- 7#a7 by redesignating subsections 7c7 through 7h7 as subsections 7d7 through 7i71 respectively2 7#b7 in subsections 7a77#b77;,f7 and 7h7 7as redesignated by paragraph 7#a771 by striking subsection 7c7 and inserting subsection 7d72 7#c7 in subsection 7a77#d77;,a71 by striking subsection 7b77#a77;,f7 and inserting subsection 7c77#e72 and 7#d7 by inserting after subsection 7b7 the following3 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#b77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b72 and 7ii7 the inflation adjustment percentage under subparagraph 7,b74 7,b7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of-- 7i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications 7as defined in section #gdd;,g7#ac77 for the first #c years of the preceding #d fiscal years2 and 7ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications 7as defined in section #gdd;,g7#ac77 for the first #c years of the preceding #d fiscal years4 7#b7 ,capacity planning adjustment 7,a7 ,in general ,beginning with the fiscal year described in subparagraph 7,b77ii77,,ii71 the ,secretary shall1 in addition to the adjustment under paragraph 7#a71 further increase the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the ,secretary for the process for the review of biosimilar biological product applications4 7,b7 ,capacity planning methodology 7i7 ,development2 evaluation and report ,the ,secretary shall obtain1 through a contract with an independent accounting or consulting firm1 a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications4 ,the capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input4 ,the report shall be published for public comment not later than ,september #cj1 #bjbj4 7ii7 ,establishment and implementation ,after review of the report described in clause 7i7 and receipt and review of public comments thereon1 the ,secretary shall establish a capacity planning methodology for purposes of this paragraph1 which shall-- 7,i7 incorporate such approaches and attributes as the ,secretary determines appropriate2 and 7,,ii7 be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established4 7,c7 ,limitation ,under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections 7b77#b77;,a7 7the annual base revenue for the fiscal year7 and 7b77#b77;,b7 7the dollar amount of the inflation adjustment for the fiscal year74 7,d7 ,publication in federal register ,the ,secretary shall publish in the ,federal ,register notice under paragraph 7#e7 the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph4 7#c7 ,operating reserve adjustment 7,a7 ,interim application2 fee reduction ,until the first fiscal year for which the capacity planning adjustment under paragraph 7#b7 is effective1 the ,secretary may1 in addition to the adjustment under paragraph 7#a71 reduce the fee revenue and fees under this section for a fiscal year as the ,secretary determines appropriate for long-term financial planning purposes4 7,b7 ,general application and methodology ,beginning with the first fiscal year for which the capacity planning adjustment under paragraph 7#b7 is effective1 the ,secretary may1 in addition to the adjustments under paragraphs 7#a7 and 7#b7-- 7i7 reduce the fee revenue and fees under this section as the ,secretary determines appropriate for long-term financial planning purposes2 or 7ii7 increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than #ba weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications4 7,c7 ,federal register notice ,if an adjustment under subparagraph 7,a7 or 7,b7 is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#e77;,b7 establishing fee revenue and fees for the fiscal year involved4 7#d7 ,fiscal year #bjah adjustment 7,a7 ,in general ,for fiscal year #bjah1 the ,secretary shall adjust the fee revenue and fees under this section in such amount 7if any7 as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications4 7,b7 ,methodology ,the ,secretary shall publish under paragraph 7#e77;,b7 a description of the methodology used to calculate the fiscal year #bjah adjustment under this paragraph in the ,federal ,register notice establishing fee revenue and fees for fiscal year #bjah4 7,c7 ,limitation ,no adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of #i1jjj1jjj4 7#e7 ,annual fee setting ,for fiscal year #bjah and each subsequent fiscal year1 the ,secretary shall1 not later than #fj days before the start of each such fiscal year-- 7,a7 establish1 for the fiscal year1 initial and annual biosimilar biological product development fees and reactivation fees under subsection 7a77#a71 biosimilar biological product application fees under subsection 7a77#b71 and biosimilar biological product program fees under subsection 7a77#c71 based on the revenue amounts established under subsection 7b7 and the adjustments provided under this subsection2 and 7,b7 publish such fee revenue and fees in the ,federal ,register4 7#f7 ,limit ,the total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications4 4 7d7 ,application fee waiver for small business ,subsection 7d77#a7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended-- 7#a7 by striking subparagraph 7,b72 7#b7 by striking 2 and at the end of subparagraph 7,a7 and inserting a period2 and 7#c7 by striking shall pay-- and all that follows through application fees and inserting shall pay application fees4 7e7 ,effect of failure ,to pay fees ,subsection 7e7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended by striking all fees and inserting all such fees4 7f7 ,crediting and availability of fees ,subsection 7f7 of section #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb71 as redesignated by subsection 7c77#a71 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by striking subparagraph 7,c7 7relating to fee collection during first program year7 and inserting the following3 7,c7 ,compliance ,the ,secretary shall be considered to have met the requirements of subparagraph 7,b7 in any fiscal year if the costs described in such subparagraph are not more than #ae percent below the level specified in such subparagraph4 2 and 7,b7 in subparagraph 7,d7-- 7i7 in the heading1 by striking in subsequent years2 and 7ii7 by striking 7after fiscal year #bjac72 and 7#b7 in paragraph 7#c71 by striking #bjac through #bjag and inserting #bjah through #bjbb4 #djd4 ,reauthorization2 reporting requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is amended-- 7#a7 in subsection 7a7-- 7,a7 by striking #bjac and inserting #bjah2 and 7,b7 by striking ,biosimilar ,user ,fee ,act of #bjab and inserting ,biosimilar ,user ,fee ,amendments of #bjag2 7#b7 in subsection 7b71 by striking #bjac and inserting #bjah2 7#c7 by striking subsection 7d72 7#d7 by redesignating subsection 7e7 as subsection 7d72 and 7#e7 in subsection 7d71 as so redesignated1 by striking #bjag each place it appears and inserting #bjbb4 #dje4 ,sunset dates 7a7 ,authorization ,sections #gdd;,g and #gdd;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting ,requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall cease to be effective ,january #ca1 #bjbc4 7c7 ,previous ,sunset ,provision 7#a7 ,in general ,effective ,october #a1 #bjag1 section #djd of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is repealed4 7#b7 ,conforming amendment ,the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 is amended in the table of contents in section #b by striking the item relating to section #djd4 #djf4 ,effective date ,the amendments made by this title shall take effect on ,october #a1 #bjag1 or the date of the enactment of this ,act1 whichever is later1 except that fees under part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall be assessed for all biosimilar biological product applications received on or after ,october #a1 #bjag1 regardless of the date of the enactment of this ,act4 #djg4 ,savings clause ,notwithstanding the amendments made by this title1 part #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as in effect on the day before the date of the enactment of this title1 shall continue to be in effect with respect to biosimilar biological product applications and supplements 7as defined in such part as of such day7 that were accepted by the ,food and ,drug ,administration for filing on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year #bjah4 ,v ,pediatric drugs and devices #eja4 ,best pharmaceuticals for children ,section #dji;,i of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7 is amended-- 7#a7 in subsection 7a77#b77;,a77ii71 by inserting and identification of biomarkers for such diseases1 disorders1 or conditions1 after biologics12 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#f7-- 7i7 by amending subparagraph 7,b7 to read as follows3 7,b7 ,availability of reports 7i7 ,in general ,each report submitted under subparagraph 7,a7 shall be considered to be in the public domain 7subject to section #eje;,a7d77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 and not later than #ij days after submission of such report1 shall be-- 7,i7 posted on the internet website of the ,national ,institutes of ,health in a manner that is accessible and consistent with all applicable ,federal laws and regulations1 including such laws and regulations for the protection of-- 7aa7 human research participants1 including with respect to privacy1 security1 informed consent1 and protected health information2 and 7bb7 proprietary interests1 confidential commercial information1 and intellectual property rights2 and 7,,ii7 assigned a docket number by the ,commissioner of ,food and ,drugs and made available for the submission of public comments4 7ii7 ,submission of comments ,an interested person may submit written comments concerning such pediatric studies to the ,commissioner of ,food and ,drugs1 and the submitted comments shall become part of the docket file with respect to each of the drugs4 2 and 7ii7 in subparagraph 7,c71 by striking appropriate action and all that follows through the period and inserting action in a timely and appropriate manner in response to the reports submitted under subparagraph 7,a71 and shall begin such action upon receipt of the report under subparagraph 7,a71 in accordance with paragraph 7#g742 and 7,b7 in paragraph 7#g7-- 7i7 in the matter preceding subparagraph 7,a71 by striking ,during and inserting ,within2 7ii7 in subparagraph 7,c77i71 by striking place and all that follows through and of and inserting include in the public docket file a reference to the location of the report on the internet website of the ,national ,institutes of ,health and a copy of2 and 7iii7 in clause 7ii71 by striking in the ,federal ,register and2 7#c7 by striking subsection 7d72 7#d7 by redesignating subsection 7e7 as subsection 7d72 and 7#e7 in paragraph 7#a7 of subsection 7d71 as so redesignated1 by striking #bjac through #bjag and inserting #bjah through #bjbb4 #ejb4 ,pediatric devices 7a7 ,pediatric use of devices ,section #eae;,a7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7;a77#c77 is amended-- 7#a7 by redesignating subparagraphs 7,b7 through 7,d7 as subparagraphs 7,d7 through 7,f71 respectively2 7#b7 by inserting after subparagraph 7,a7 the following3 7,b7 any information1 based on a review of data available to the ,secretary1 regarding devices used in pediatric patients but not labeled for such use for which the ,secretary determines that approved pediatric labeling could confer a benefit to pediatric patients2 7,c7 the number of pediatric devices that receive a humanitarian use exemption under section #ebj7m72 2 7#c7 in subparagraph 7,e71 as so redesignated1 by striking 2 and and inserting 22 7#d7 in subparagraph 7,f7 7as so redesignated71 by striking 7,b71 and 7,c74 and inserting 7,c71 7,d71 and 7,e722 and 7#e7 by adding at the end the following3 7,g7 the number of devices for which the ,secretary relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients2 and 7,h7 the number of devices for which the ,secretary relied on data from one pediatric subpopulation to support a determination of a reasonable assurance of safety and effectiveness in another pediatric subpopulation4 ,for the items described in this paragraph1 such report shall disaggregate the number of devices by pediatric subpopulation4 4 7b7 ,humanitarian device exemption ,section #ebj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77 is amended-- 7#a7 in paragraph 7#d7-- 7,a7 in subparagraph 7,b71 by inserting or an appropriate local committee after review committee each place such term appears2 and 7,b7 in the matter following subparagraph 7,b71 by inserting or an appropriate local committee after review committee each place such term appears2 and 7#b7 in paragraph 7#f77;,a77iv71 by striking #bjag and inserting #bjbb4 7c7 ,demonstration grants for improving pediatric availability ,section #cje of the ,pediatric ,medical ,device ,safety and ,improvement ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note77 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#d71 by striking and at the end2 7,b7 in paragraph 7#e71 by striking the period and inserting 2 and2 and 7,c7 by adding at the end the following3 7#f7 providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device1 where appropriate4 2 and 7#b7 in subsection 7e71 by striking #bjac through #bjag and inserting #bjah through #bjbb4 7d7 ,meeting on pediatric device development 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall convene a public meeting on the development1 approval or clearance1 and labeling of pediatric medical devices4 ,the ,secretary shall invite to such meeting representatives from the medical device industry1 academia1 recipients of funding under section #cje of the ,pediatric ,medical ,device ,safety and ,improvement ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note71 medical provider organizations1 and organizations representing patients and consumers4 7#b7 ,topics ,the meeting described in paragraph 7#a7 shall include consideration of ways to-- 7,a7 improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices for pediatric populations that would result in the approval or clearance1 and labeling1 of medical devices for such populations2 7,b7 appropriately use extrapolation under section #eae;,a7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7;b772 7,c7 enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling2 7,d7 increase ,food and ,drug ,administration assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared1 and labeled1 for their use2 and 7,e7 identify current barriers to pediatric device development and incentives to address such barriers4 7#c7 ,report ,the report submitted under section #eae;,a7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#a7;a77#c77 with respect to the calendar year in which the meeting described in paragraph 7#a7 is held shall include a summary of1 and responses to1 recommendations raised in such meeting4 #ejc4 ,early meeting on pediatric study plan 7a7 ,in general ,clause 7i7 of section #eje;,b7e77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#b77;,c77 is amended to read as follows3 7i7 shall meet with the applicant-- 7,i7 if requested by the applicant with respect to a drug or biological product that is intended to treat a serious or life-threatening disease or condition1 to discuss preparation of the initial pediatric study plan1 not later than the end-of-,phase #a meeting 7as such term is used in section #cab4hb7;b7 of title #ba1 ,code of ,federal ,regulations1 or successor regulations7 or within #cj calendar days of receipt of such request1 whichever is later2 7,,ii7 to discuss the initial pediatric study plan as soon as practicable1 but not later than #ij calendar days after the receipt of such plan under subparagraph 7,a72 and 7,,iii7 to discuss the bases for the deferral under subsection 7a77#d7 or a full or partial waiver under subsection 7a77#e72 4 7b7 ,conforming changes ,section #eje;,b7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77 is amended-- 7#a7 in the heading of paragraph 7#b71 by striking meeting and inserting meetings2 7#b7 in the heading of paragraph 7#b77;,c71 by striking ,meeting and inserting ,meetings2 7#c7 in clauses 7ii7 and 7iii7 of paragraph 7#b77;,c71 by striking no meeting each place it appears and inserting no meeting under clause 7i77,,ii72 and 7#d7 in paragraph 7#c7 by striking meeting under paragraph 7#b77;,c77i7 and inserting meeting under paragraph 7#b77;,c77i77,,ii74 #ejd4 ,development of drugs and biological products for pediatric cancers 7a7 ,molecular targets regarding cancer drugs and biological products ,section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#a7-- 7i7 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii71 respectively1 and adjusting the margins accordingly2 7ii7 by striking ,a person and inserting the following3 7,a7 ,general requirements ,except with respect to an application for which subparagraph 7,b7 applies1 a person 2 7iii7 in clause 7i71 as so redesignated1 by striking 1 or at the end and inserting 2 or2 and 7iv7 by adding after subparagraph 7,a71 as so designated by clause 7ii71 the following3 7,b7 ,certain molecularly targeted cancer indications ,a person that submits1 on or after the date that is #c years after the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 an original application for a new active ingredient under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 shall submit with the application reports on the investigation described in paragraph 7#c7 if the drug or biological product that is the subject of the application is-- 7i7 intended for the treatment of an adult cancer2 and 7ii7 directed at a molecular target that the ,secretary determines to be substantially relevant to the growth or progression of a pediatric cancer4 2 7,b7 in paragraph 7#b77;,a71 by striking paragraph 7#a7 and inserting paragraph 7#a77;,a72 7,c7 by redesignating paragraphs 7#c7 and 7#d7 as paragraphs 7#d7 and 7#e71 respectively2 7,d7 by inserting after paragraph 7#b7 the following3 7#c7 ,molecularly targeted pediatric cancer investigation 7,a7 ,in general ,with respect to a drug or biological product described in paragraph 7#a77;,b71 the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation1 which shall be designed to yield clinically meaningful pediatric study data1 gathered using appropriate formulations for each age group for which the study is required1 regarding dosing1 safety1 and preliminary efficacy to inform potential pediatric labeling4 7,b7 ,extrapolation of data ,paragraph 7#b77;,b7 shall apply to investigations described in this paragraph to the same extent and in the same manner as paragraph 7#b77;,b7 applies with respect to the assessments required under paragraph 7#a77;,a74 7,c7 ,deferrals and waivers ,deferrals and waivers under paragraphs 7#d7 and 7#e7 shall apply to investigations described in this paragraph to the same extent and in the same manner as such deferrals and waivers apply with respect to the assessments under paragraph 7#b77;,b74 2 7,e7 in paragraph 7#d71 as so redesignated-- 7i7 by striking assessments required under paragraph 7#a7 each place it appears and inserting assessments required under paragraph 7#a77;,a7 or reports on the investigation required under paragraph 7#a77;,b72 7ii7 in subparagraph 7,a77ii77,i71 by inserting or reports on the investigation after assessments2 7iii7 in subparagraph 7,b77ii71 by striking assessment under paragraph 7#a7 and inserting assessment under paragraph 7#a77;,a7 or reports on the investigation under paragraph 7#a77;,b72 and 7iv7 in subparagraph 7,c77ii77,,ii71 by inserting or investigation after assessment2 and 7,f7 in paragraph 7#e71 as so redesignated1 by inserting or reports on the investigation after assessments each place it appears2 7#b7 in subsection 7d7-- 7,a7 by striking subsection 7a77#c7 each place it appears and inserting subsection 7a77#d72 7,b7 by inserting and reports on the investigation after submission of assessments in the heading2 and 7,c7 by inserting or the investigation described in subsection 7a77#c7 after assessment described in subsection 7a77#b7 each place it appears2 7#c7 in subsection 7e7-- 7,a7 in paragraph 7#a71 by inserting or the investigation described in subsection 7a77#c7 after under subsection 7a77#b72 and 7,b7 in paragraph 7#b77;,a77i71 by inserting or the investigation described in subsection 7a77#c7 after under subsection 7a77#b72 and 7#d7 by adding at the end the following3 7m7 ,list of primary molecular targets 7#a7 ,in general ,within one year of the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 the ,secretary shall establish and update regularly1 and shall publish on the internet website of the ,food and ,drug ,administration-- 7,a7 a list of molecular targets considered1 on the basis of data the ,secretary determines to be adequate1 to be substantially relevant to the growth and progression of a pediatric cancer1 and that may trigger the requirements under this section2 and 7,b7 a list of molecular targets of new cancer drugs and biological products in development for which pediatric cancer study requirements under this section will be automatically waived4 7#b7 ,consultation ,in establishing the lists described in paragraph 7#a71 the ,secretary shall consult the ,national ,cancer ,institute1 members of the internal committee under section #eje;,c1 and the ,pediatric ,oncology ,subcommittee of the ,oncologic ,drugs ,advisory ,committee1 and shall take into account comments from the meeting under subsection 7c74 7#c7 ,rule of construction ,nothing in paragraph 7#a7 shall be construed-- 7,a7 to require the inclusion of a molecular target on the list published under such paragraph as a condition for triggering the requirements under subsection 7a77#a77;,b7 with respect to a drug or biological product directed at such molecular target2 or 7,b7 to authorize the disclosure of confidential commercial information1 as prohibited under section #cja7;j7 of this ,act or section #aije of title #ah1 ,united ,states ,code4 4 7b7 ,orphan drugs ,section #eje;,b7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7k77 is amended to read as follows3 7k7 ,relation to orphan drugs 7#a7 ,in general2 exemption for orphan indications ,unless the ,secretary requires otherwise by regulation and except as provided in paragraph 7#b71 this section does not apply to any drug or biological product for an indication for which orphan designation has been granted under section #ebf4 7#b7 ,applicability despite orphan designation of certain indications ,this section shall apply with respect to a drug or biological product for which an indication has been granted orphan designation under #ebf if the investigation described in subsection 7a77#c7 applies to the drug or biological product as described in subsection 7a77#a77;,b74 4 7c7 ,meeting1 consultation1 and guidance 7#a7 ,meeting ,the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary71 acting through the ,commissioner of ,food and ,drugs and in collaboration with the ,director of the ,national ,cancer ,institute1 shall convene a public meeting not later than #a year after the date of enactment of this ,act to solicit feedback from physicians and researchers 7including pediatric oncologists and rare disease specialists71 patients1 and other stakeholders to provide input on development of the guidance under paragraph 7#b7 and the list under subsection 7m7 of section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c71 as added by subsection 7a74 ,the ,secretary shall seek input at such meeting on-- 7,a7 the data necessary to determine that there is scientific evidence that a drug or biological product is directed at a molecular target that is considered to be substantially relevant to the growth or progression of a pediatric cancer2 7,b7 the data necessary to determine that there is scientific evidence that a molecular target is considered to be substantially relevant to the growth or progression of a pediatric cancer2 7,c7 the data needed to meet the requirement of conducting an investigation described in section #eje;,b7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by subsection 7a72 7,d7 considerations when developing the list under section #eje;,b7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act that contains molecular targets shared between different tumor types2 7,e7 the process the ,secretary shall utilize to update regularly a list of molecular targets that may trigger a pediatric study under section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as so amended1 and how often such updates shall occur2 7,f7 how to overcome the challenges related to pediatric cancer drug and biological product development1 including issues related to the ethical1 practical1 and other barriers to conducting clinical trials in pediatric cancer with small patient populations2 7,g7 scientific or operational challenges associated with performing an investigation described in section #eje;,b7a77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 including the effect on pediatric studies currently underway in a pediatric patient population1 treatment of a pediatric patient population1 and the ability to complete adult clinical trials2 7,h7 the advantages and disadvantages of innovative clinical trial designs in addressing the development of cancer drugs or biological products directed at molecular targets in pediatric cancer patients2 7,i7 the ways in which the ,secretary can improve the current process outlined under sections #eje;,a and #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;c7 to encourage additional research and development of pediatric cancer treatments2 7,j7 the ways in which the ,secretary might streamline and improve the written request process1 including when studies contained in a request under such section #eje;,a are not feasible due to the ethical1 practical1 or other barriers to conducting clinical trials in pediatric cancer populations2 7,k7 how the ,secretary will facilitate collaboration among pediatric networks1 academic centers and experts in pediatric cancer to conduct an investigation described in such section #eje;,b7a77#c72 7,l7 how the ,secretary may facilitate collaboration among sponsors of same-in-class drugs and biological products that would be subject to the requirements for an investigation under such section #eje;,b based on shared molecular targets2 and 7,m7 the ways in which the ,secretary will help to mitigate the risks1 if any1 of discouraging the research and development of orphan drugs when implementing such section #eje;,b as amended4 7#b7 ,guidance ,not later than #b years after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall issue final guidance on implementation of the amendments to section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7 regarding molecularly targeted cancer drugs made by this section1 including-- 7,a7 the scientific criteria1 types of data1 and regulatory considerations for determining whether a molecular target is substantially relevant to the growth or progression of a pediatric cancer and would trigger an investigation under section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended2 7,b7 the process by which the ,secretary will engage with sponsors to discuss determinations1 investigation requirements1 deferrals1 waivers1 and any other issues that need to be resolved to ensure that any required investigation based on a molecular target can be reasonably conducted2 7,c7 the scientific or operational challenges for which the ,secretary may issue deferrals or waivers for an investigation described in subsection 7a77#c7 of such section #eje;,b1 including adverse impacts on current pediatric studies underway in a pediatric patient population1 studies involving drugs designated as orphan drugs1 treatment of a pediatric patient population1 or the ability to complete adult clinical trials2 7,d7 how the ,secretary and sponsors will facilitate collaboration among pediatric networks1 academic centers1 and experts in pediatric cancer to conduct an investigation described in subsection 7a77#c7 of such section #eje;,b2 7,e7 scientific and regulatory considerations for study designs1 including the applicability of innovative clinical trial designs for pediatric cancer drug and biological product developments under sections #eje;,a and #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;c72 7,f7 approaches to streamline and improve the amendment process1 including when studies contained in a request under such section #eje;,a are not feasible due to the ethical1 practical1 or other barriers to conducting clinical trials in pediatric cancer populations2 7,g7 the process for submission of an initial pediatric study plan for the investigation described in section #eje;,b7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c771 including the process for a sponsor to meet and reach agreement with the ,secretary on the initial pediatric study plan2 and 7,h7 considerations for implementation of such section #eje;,b1 as so amended1 and waivers of the requirements of such section #eje;,b with regard to molecular targets for which several drugs or biological products may be under investigation4 7d7 ,report to ,congress ,section #ejh7;b7 of the ,food and ,drug ,administration ,safety and ,innovation ,act 7#ba ,u4,s4,c4 #cee;c-#a7;b77 is amended-- 7#a7 in paragraph 7#aj71 by striking 2 and and inserting 22 and 7#b7 by striking paragraph 7#aa7 and inserting the following3 7#aa7 an assessment of the impact of the amendments to such section #eje;,b made by the ,,fda ,reauthorization ,act of #bjag on pediatric research and labeling of drugs and biological products and pediatric labeling of molecularly targeted drugs and biological products for the treatment of cancer2 7#ab7 an assessment of the efforts of the ,secretary to implement the plan developed under section #eje;,c-#a of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 regarding earlier submission of pediatric studies under sections #eje;,a and #eje;,b of such ,act and section #cea7m7 of the ,public ,health ,service ,act1 including-- 7,a7 the average length of time after the approval of an application under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 before studies conducted pursuant to such section #eje;,a1 #eje;,b1 or section #cea7m7 are completed1 submitted1 and incorporated into labeling2 7,b7 the average length of time after the receipt of a proposed pediatric study request before the ,secretary responds to such request2 7,c7 the average length of time after the submission of a proposed pediatric study request before the ,secretary issues a written request for such studies2 7,d7 the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 of the ,public ,health ,service ,act2 and 7,e7 the average number1 and range of numbers1 of amendments to written requests issued1 and the time the ,secretary requires to review and act on proposed amendments to written requests2 7#ac7 a list of sponsors of applications or holders of approved applications who received exclusivity under such section #eje;,a or such section #cea7m7 after receiving a letter issued under such section #eje;,b7d77#a7 for any drug or biological product before the studies referred to in such letter were completed and submitted2 7#ad7 a list of assessments and investigations required under such section #eje;,b2 7#ae7 how many requests under such section #eje;,a for molecular targeted cancer drugs1 as defined by subsection 7a77#a77;,b7 of such section #eje;,b1 approved prior to #c years after the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 have been issued by the ,food and ,drug ,administration1 and how many such requests have been completed2 and 7#af7 the ,secretary's assessment of the overall impact of the amendments made by section #ejd of the ,,fda ,reauthorization ,act of #bjag on the conduct and effectiveness of pediatric cancer research and the orphan drug program1 as well any subsequent recommendations4 4 7e7 ,rule of construction ,nothing in this section1 including the amendments made by this section1 shall limit the authority of the ,secretary of ,health and ,human ,services to issue written requests under section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 or section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m771 or to negotiate or implement amendments to such requests proposed by the an applicant4 7f7 ,,gao report 7#a7 ,in general ,beginning on the date that is #e years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of requiring assessments and investigations described in section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c71 as amended by this section1 in the development of drugs and biological products for pediatric cancer indications4 ,the ,comptroller ,general shall examine-- 7,a7 the indications and associated molecular targets studied in assessments and investigations required for drugs or biological products intended for the treatment of an adult cancer2 7,b7 the indication for which the study was requested as compared to the indication requested under the new drug application filed by the sponsor2 7,c7 the number of pediatric cancer indications for which assessments and investigations have been required under such section #eje;,b2 7,d7 the number of requests for deferral and waiver of pediatric assessments and investigations required under such section and the number of such deferral and waiver requests granted and denied2 7,e7 the number of orphan-designated indications for drugs and biological products for which assessments and investigations were required under such section2 7,f7 the number of drugs and biological products approved for the treatment of cancer in the pediatric population for which the supportive studies were required to be conducted under such section2 7,g7 the number of written requests made under section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 relating to investigations required under subsection 7a77#a77;,b7 of such section #eje;,b2 and 7,h7 any additional considerations by the ,secretary regarding the effectiveness of requiring pediatric assessments described in such section #eje;,b in the development of drugs and biological products for pediatric cancer indications4 7#b7 ,review ,the study under paragraph 7#a7 shall include a review of the ,food and ,drug ,administration's use of the authority under section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c71 as amended by this section1 including the amendments to the deferral and waiver criteria under such section and how such criteria have been applied4 7#c7 ,consultation ,in conducting the study under paragraph 7#a71 the ,comptroller ,general of the ,united ,states shall consult with appropriate stakeholders that may be required to conduct the trials under section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and the ability of such stakeholders to adhere to the requests issued by the ,food and ,drug ,administration4 7#d7 ,report ,not later than the date that is #f years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a report containing the results of the study under paragraph 7#a7 to the ,secretary of ,health and ,human ,services1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 #eje4 ,additional provisions on development of drugs and biological products for pediatric use 7a7 ,informing internal review committee ,section #eje;,a7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7f77 is amended by adding at the end the following3 7#g7 ,informing internal review committee ,the ,secretary shall provide to the committee referred to in paragraph 7#a7 any response issued to an applicant or holder with respect to a proposed pediatric study request4 4 7b7 ,action on ,submissions 7#a7 ,in general ,section #eje;,a7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7d77 is amended-- 7,a7 by redesignating paragraphs 7#c7 through 7#e7 as paragraphs 7#d7 through 7#f71 respectively2 and 7,b7 by inserting after paragraph 7#b7 the following3 7#c7 ,action on submissions ,the ,secretary shall review and act upon a submission by a sponsor or holder of a proposed pediatric study request or a proposed amendment to a written request for pediatric studies within #abj calendar days of the submission4 4 7#b7 ,conforming amendments 7,a7 ,federal ,food1 ,drug1 and ,cosmetic ,act ,section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a71 as amended by paragraph 7#a71 is further amended by striking subsection 7d77#c7 each place it appears and inserting 7d77#d74 7,b7 ,public ,health ,service ,act ,paragraphs 7#b71 7#c71 and 7#d7 of section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m77 are amended by striking section #eje;,a7d77#c7 each place it appears and inserting section #eje;,a7d77#d74 7c7 ,plan ,the ,secretary of ,health and ,human ,services1 acting through the internal review committee established under section #eje;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;d7 shall1 not later than one year after the date of enactment of this ,act1 develop and implement a plan to achieve1 when appropriate1 earlier submission of pediatric studies under section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7 or section #cea7m7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7m774 ,such plan shall include recommendations to achieve-- 7#a7 earlier discussion of proposed pediatric study requests and written requests with sponsors1 and if appropriate1 discussion of such requests at the meeting required under section #eje;,b7e77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#b77;,c771 as amended by section #ejc7;a72 7#b7 earlier issuance of written requests for a pediatric study under such section #eje;,a1 including for investigational new drugs prior to the submission of an application under section #eje7;b77#a7 of such ,act 7#ba ,u4,s4,c4 #cee7;b77#a772 and 7#c7 shorter timelines1 when appropriate1 for the completion of studies pursuant to a written request under such section #eje;,a or such section #cea7m74 7d7 ,neonatology ,expertise 7#a7 ,in general ,section #f7;d7 of the ,best ,pharmaceuticals for ,children ,act 7#ba ,u4,s4,c4 #cic;a7d77 is amended by striking ,for the #e-year period beginning on the date of enactment of this subsection1 at and inserting ,at4 7#b7 ,draft guidance ,not later than #b years after the date of enactment of this ,act1 the ,secretary shall issue draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products4 7e7 ,submission of ,assessments ,section #eje;,b7d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d77#a77 is amended by adding at the end the following3 ,the ,secretary shall inform the ,pediatric ,advisory ,committee of letters issued under this paragraph and responses to such letters44 7f7 ,internal ,committee ,section #eje;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;d7 is amended by inserting or pediatric rare diseases after psychiatry4 7g7 ,report on labeling of orphan drugs 7#a7 ,in general ,not later than #b years after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 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 ,representatives1 and make publicly available1 including through posting on the internet website of the ,food and ,drug ,administration1 a report on the lack of information in the labeling of drugs for indications that have received an orphan designation under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 with respect to the use of such drugs pediatric populations4 7#b7 ,contents ,the report described in paragraph 7#a7 shall include-- 7,a7 a list of drugs for which-- 7i7 an indication was granted an orphan designation under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb72 7ii7 an application described under section #eje;,b7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77 for such indication was submitted to the ,secretary of ,health and ,human ,services on or after ,april #a1 #aiii2 and 7iii7 the labeling for such indication lacks important pediatric information1 including information related to safety1 dosing1 and effectiveness2 7,b7 a description of the lack of information referred to in subparagraph 7,a77iii7 for each drug for an indication on such list2 and 7,c7 ,federal policy recommendations to improve the labeling of drugs for indications that have received an orphan designation under such section #ebf with respect to the use of such drugs pediatric populations40 ,,vi ,reauthorizations and improvements related to drugs #fja4 ,reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers ,section #eje7u77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7u77#d77 is amended by striking #bjag and inserting #bjbb4 #fjb4 ,reauthorization of the critical path public-private partnerships ,section #eff7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#e7;f77 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #fjc4 ,reauthorization of orphan grants program ,section #e7;c7 of the ,orphan ,drug ,act 7#ba ,u4,s4,c4 #cfj;ee7c77 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #fjd4 ,protecting and strengthening the drug supply chain 7a7 ,diverted drugs ,paragraph 7#a7 of section #hja7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;d77 is amended-- 7#a7 by striking 7d77#a7 ,except as and inserting 7d77#a77;,a7 ,except as2 and 7#b7 by adding at the end the following3 7,b7 ,except as authorized by the ,secretary in the case of a drug that appears on the drug shortage list under section #ejf;,e or in the case of importation pursuant to section #hjd1 no drug that is subject to section #ejc7;b77#a7 may be imported into the ,united ,states for commercial use if such drug is manufactured outside the ,united ,states1 unless the manufacturer has authorized the drug to be marketed in the ,united ,states and has caused the drug to be labeled to be marketed in the ,united ,states4 4 7b7 ,counterfeit drugs ,subsection 7b7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended by adding at the end the following3 7#h7 ,notwithstanding subsection 7a71 any person who violates section #cja7;i77#c7 by knowingly making1 selling or dispensing1 or holding for sale or dispensing1 a counterfeit drug shall be imprisoned for not more than #aj years or fined in accordance with title #ah1 ,united ,states ,code1 or both4 4 #fje4 ,patient experience data ,section #efi;,c7c77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7c77#b77;,a77 is amended by striking impact of such disease or condition1 or a related therapy1 and inserting impact 7including physical and psychosocial impacts7 of such disease or condition1 or a related therapy or clinical investigation4 #fjf4 ,communication plans ,section #eje-a7;e77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;e77#c77 is amended-- 7#a7 in subparagraph 7,b71 by striking 2 or2 7#b7 in subparagraph 7,c71 by striking the period and inserting 2 or2 and 7#c7 by adding at the end the following3 7,d7 disseminating information to health care providers about drug formulations or properties1 including information about the limitations or patient care implications of such formulations or properties1 and how such formulations or properties may be related to serious adverse drug events associated with use of the drug4 4 #fjg4 ,orphan drugs 7a7 ,in general ,section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended-- 7#a7 in subsection 7a71 in the matter following paragraph 7#b71 by striking such drug for such disease or condition and inserting the same drug for the same disease or condition2 7#b7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking ,if an application and all that follows through such license if and inserting ,during the #g-year period described in subsection 7a7 for an approved application under section #eje or license under section #cea of the ,public ,health ,service ,act1 the ,secretary may approve an application or issue a license for a drug that is otherwise the same1 as determined by the ,secretary1 as the already approved drug for the same rare disease or condition if2 7,b7 in paragraph 7#a71 by striking notice and all that follows through assure and inserting of exclusive approval or licensure notice and opportunity for the submission of views1 that during such period the holder of the exclusive approval or licensure cannot ensure2 and 7,c7 in paragraph 7#b71 by striking such holder provides and inserting the holder provides2 and 7#c7 by adding at the end the following3 7c7 ,condition of clinical superiority 7#a7 ,in general ,if a sponsor of a drug that is designated under section #ebf and is otherwise the same1 as determined by the ,secretary1 as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection 7a7 for the same rare disease or condition as the already approved drug1 the ,secretary shall require such sponsor1 as a condition of such exclusive approval or licensure1 to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug4 7#b7 ,definition ,for purposes of paragraph 7#a71 the term clinically superior with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy1 greater safety1 or by providing a major contribution to patient care4 7d7 ,regulations ,the ,secretary may promulgate regulations for the implementation of subsection 7c74 ,beginning on the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 until such time as the ,secretary promulgates regulations in accordance with this subsection1 the ,secretary may apply any definitions set forth in regulations that were promulgated prior to such date of enactment1 to the extent such definitions are not inconsistent with the terms of this section1 as amended by such ,act4 7e7 ,demonstration of clinical superiority standard ,to assist sponsors in demonstrating clinical superiority as described in subsection 7c71 the ,secretary-- 7#a7 upon the designation of any drug under section #ebf1 shall notify the sponsor of such drug in writing of the basis for the designation1 including1 as applicable1 any plausible hypothesis offered by the sponsor and relied upon by the ,secretary that the drug is clinically superior to a previously approved drug2 and 7#b7 upon granting exclusive approval or licensure under subsection 7a7 on the basis of a demonstration of clinical superiority as described in subsection 7c71 shall publish a summary of the clinical superiority findings4 4 7b7 ,rule of ,construction ,nothing in the amendments made by subsection 7a7 shall affect any determination under sections #ebf and #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb1 #cfj;cc7 made prior to the date of enactment of the ,,fda ,reauthorization ,act of #bjag4 #fjh4 ,pediatric information added to labeling ,section #eje;,a7o7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a7o77 is amended-- 7#a7 in the subsection heading1 by striking ,under ,section #eje7;j72 7#b7 in paragraph 7#a7-- 7,a7 by striking under section #eje7;j7 and inserting under subsection 7b77#b7 or 7j7 of section #eje2 and 7,b7 by striking or by exclusivity under clause 7iii7 or 7iv7 of section #eje7;j77#e77;,f7 and inserting 1 or by exclusivity under clause 7iii7 or 7iv7 of section #eje7;j77#e77;,f71 clause 7iii7 or 7iv7 of section #eje7;c77#c77;,e71 or section #ebg7;a71 or by an extension of such exclusivity under this section or section #eje;,e2 7#c7 in paragraph 7#b71 in the matter preceding subparagraph 7,a7-- 7,a7 by inserting clauses 7iii7 and 7iv7 of section #eje7;c77#c77;,e71 or section #ebg1 after section #eje7;j77#e77;,f712 and 7,b7 by striking drug approved under section #eje7;j7 and inserting drug approved pursuant to an application submitted under subsection 7b77#b7 or 7j7 of section #eje2 and 7#d7 by amending paragraph 7#c7 to read as follows3 7#c7 ,preservation of pediatric exclusivity and extensions ,this subsection does not affect-- 7,a7 the availability or scope of exclusivity under-- 7i7 this section2 7ii7 section #eje for pediatric formulations2 or 7iii7 section #ebg2 7,b7 the availability or scope of an extension to any such exclusivity1 including an extension under this section or section #eje;,e2 7,c7 the question of the eligibility for approval under section #eje of any application described in subsection 7b77#b7 or 7j7 of such section that omits any other aspect of labeling protected by exclusivity under-- 7i7 clause 7iii7 or 7iv7 of section #eje7;j77#e77;,f72 7ii7 clause 7iii7 or 7iv7 of section #eje7;c77#c77;,e72 or 7iii7 section #ebg7;a72 or 7,d7 except as expressly provided in paragraphs 7#a7 and 7#b71 the operation of section #eje or section #ebg4 4 #fji4 ,sense of ,congress on lowering the cost of prescription drugs ,it is the sense of the ,congress that the ,secretary of ,health and ,human ,services should commit to engaging with the ,house of ,representatives and the ,senate to take administrative actions and enact legislative changes that-- 7#a7 will lower the cost of prescription drugs for consumers and reduce the burden of such cost on taxpayers2 and 7#b7 in lowering such cost1 will-- 7,a7 balance the need to encourage innovation with the need to improve affordability2 and 7,b7 strive to increase competition in the pharmaceutical market1 prevent anticompetitive behavior1 and promote the timely availability of affordable1 high-quality generic drugs and biosimilars4 #faj4 ,expanded access 7a7 ,patient access to investigational drugs 7#a7 ,public meeting 7,a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 in coordination with the ,director of the ,national ,institutes of ,health1 and in consultation with patients1 health care providers1 drug sponsors1 bioethicists1 and other stakeholders1 shall1 not later than #bgj days after the date of enactment of this ,act1 convene a public meeting to discuss clinical trial inclusion and exclusion criteria to inform the guidance under paragraph 7#c74 ,the ,secretary shall inform the ,comptroller ,general of the ,united ,states of the date when the public meeting will take place4 7,b7 ,topics ,the ,secretary shall make available on the internet website of the ,food and ,drug ,administration a report on the topics discussed at the meeting described in subparagraph 7,a7 within #ij days of such meeting4 ,such topics shall include discussion of-- 7i7 the rationale for1 and potential barriers for patients created by1 research clinical trial inclusion and exclusion criteria2 7ii7 how appropriate patient populations can benefit from the results of trials that employ alternative designs2 7iii7 barriers to participation in clinical trials1 including-- 7,i7 information regarding any potential risks and benefits of participation2 7,,ii7 regulatory1 geographical1 and socioeconomic barriers2 and 7,,iii7 the impact of exclusion criteria on the enrollment in clinical trials of particular populations1 including infants and children1 pregnant and lactating women1 seniors1 individuals with advanced disease1 and individuals with co-morbid conditions2 7iv7 clinical trial designs and methods1 including expanded access trials1 that increase enrollment of more diverse patient populations1 when appropriate1 while facilitating the collection of data to establish safe use and support substantial evidence of effectiveness1 including data obtained from expanded access trials2 and 7v7 how changes to clinical trial inclusion and exclusion criteria may impact the complexity and length of clinical trials1 the data necessary to demonstrate safety and effectiveness1 and potential approaches to mitigating those impacts4 7#b7 ,report ,not later than #a year after the ,secretary issues the report under paragraph 7#a77;,b71 the ,comptroller ,general of the ,united ,states shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives on individual access to investigational drugs through the expanded access program under section #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,the report shall include-- 7,a7 a description of actions taken by manufacturers and distributors under section #efa;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j72 7,b7 consideration of whether ,form ,,fda #cibf and the guidance documents titled ,expanded ,access to ,investigational ,drugs for ,treatment ,use--,questions and ,answers and ,individual ,patient ,expanded ,access ,applications3 ,form ,,fda #cibf1 issued by the ,food and ,drug ,administration in ,june #bjaf1 have reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 and improved clarity for patients1 physicians1 and drug manufacturers about such process2 7,c7 consideration of whether the guidance or regulations issued to implement section #efa of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7 have improved access for individual patients to investigational drugs who do not qualify for clinical trials of such investigational drugs1 and what barriers to such access remain2 7,d7 an assessment of methods patients and health care providers use to engage with the ,food and ,drug ,administration or drug sponsors on expanded access2 and 7,e7 an analysis of the ,secretary's report under paragraph 7#a77;,b74 7#c7 ,guidance 7,a7 ,in general ,not later than #a year after the publication of the report under paragraph 7#a77;,b71 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall issue one or more draft guidances regarding eligibility criteria for clinical trials4 ,not later than #a year after the public comment period on each such draft guidance ends1 the ,secretary shall issue a revised draft guidance or final guidance4 7,b7 ,contents ,the guidance documents described in subparagraph 7,a7 shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to-- 7i7 broaden eligibility criteria for clinical trials and expanded access trials1 especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need2 7ii7 develop eligibility criteria for1 and increase trial recruitment to1 clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug1 as applicable and as appropriate1 while establishing safe use and supporting findings of substantial evidence of effectiveness2 and 7iii7 use the criteria described in clauses 7i7 and 7ii7 in a manner that is appropriate for drugs intended for the treatment of rare diseases or conditions4 7b7 ,improving institutional review board review of single patient expanded access protocol ,not later than #a year after the date of enactment of this ,act1 the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall issue guidance or regulations1 or revise existing guidance or regulations1 to streamline the institutional review board review of individual patient expanded access protocols submitted under #efa7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb7b774 ,to facilitate the use of expanded access protocols1 any guidance or regulations so issued or revised may include a description of the process for any person acting through a physician licensed in accordance with ,state law to request that an institutional review board chair 7or designated member of the institutional review board7 review a single patient expanded access protocol submitted under such section #efa7;b7 for a drug4 ,the ,secretary shall update any relevant forms associated with individual patient expanded access requests under such section #efa7;b7 as necessary4 7c7 ,expanded access policy transparency ,section #efa;,a7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j7;f77 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking later and inserting earlier2 7#b7 by striking paragraph 7#a72 7#c7 by redesignating paragraph 7#b7 as paragraph 7#a72 7#d7 in paragraph 7#a7 as so redesignated1 by striking the period at the end and inserting 2 or2 and 7#e7 by adding at the end the following3 7#b7 as applicable1 #ae days after the drug receives a designation as a breakthrough therapy1 fast track product1 or regenerative advanced therapy under subsection 7a71 7b71 or 7g71 respectively1 of section #ejf4 4 #faa4 ,tropical disease product application 7a7 ,in general ,subparagraph 7,a7 of section #ebd7;a77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7a77#d77 is amended-- 7#a7 in clause 7i71 by striking and at the end2 and 7#b7 by adding at the end the following3 7iii7 that contains reports of one or more new clinical investigations 7other than bioavailability studies7 that are essential to the approval of the application and conducted or sponsored by the sponsor of such application2 and 7iv7 that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in ,india1 ,brazil1 ,thailand1 or any country that is a member of the ,pharmaceutical ,inspection ,convention or the ,pharmaceutical ,inspection ,cooperation ,scheme prior to ,september #bg1 #bjjg4 4 7b7 ,effective date ,the amendments made by subsection 7a7 shall apply to human drug applications submitted after ,september #cj1 #bjag4 ,,vii ,device inspection and regulatory improvements #gja4 ,risk-based inspections for devices 7a7 ,in general ,section #eaj7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77 is amended-- 7#a7 by striking paragraph 7#b7 and inserting the following3 7#b7 ,risk-based schedule for devices 7,a7 ,in general ,the ,secretary1 acting through one or more officers or employees duly designated by the ,secretary1 shall inspect establishments described in paragraph 7#a7 that are engaged in the manufacture1 propagation1 compounding1 or processing of a device or devices 7referred to in this subsection as device establishments7 in accordance with a risk-based schedule established by the ,secretary4 7,b7 ,factors and considerations ,in establishing the risk-based schedule under subparagraph 7,a71 the ,secretary shall-- 7i7 apply1 to the extent applicable for device establishments1 the factors identified in paragraph 7#d72 and 7ii7 consider the participation of the device establishment1 as applicable1 in international device audit programs in which the ,united ,states participates or the ,united ,states recognizes for purposes of inspecting device establishments4 2 and 7#b7 in paragraph 7#d7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking paragraph 7#c7 and inserting paragraph 7#b7 or 7#c72 and 7,b7 in subparagraph 7,c71 by inserting or device after drug4 7b7 ,foreign inspections ,section #hji7;a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is amended by striking section #eaj7;h77#c7 and inserting paragraph 7#b7 or 7#c7 of section #eaj7;h74 #gjb4 ,improvements to inspections process for device establishments 7a7 ,in general ,section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is amended by adding at the end the following3 7h7 7#a7 ,in the case of inspections other than for-cause inspections1 the ,secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of the date of the enactment of this subsection1 and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections4 ,such uniform processes and standards shall provide for-- 7,a7 exceptions to such processes and standards1 as appropriate2 7,b7 announcing the inspection of the establishment within a reasonable time before such inspection occurs1 including by providing to the owner1 operator1 or agent in charge of the establishment a notification regarding the type and nature of the inspection2 7,c7 a reasonable estimate of the timeframe for the inspection1 an opportunity for advance communications between the officers or employees carrying out the inspection under subsection 7a77#a7 and the owner1 operator1 or agent in charge of the establishment concerning appropriate working hours during the inspection1 and1 to the extent feasible1 advance notice of some records that will be requested2 and 7,d7 regular communications during the inspection with the owner1 operator1 or agent in charge of the establishment regarding inspection status1 which may be recorded by either party with advance notice and mutual consent4 7#b7 7,a7 ,the ,secretary shall1 with respect to a request described in subparagraph 7,b71 provide nonbinding feedback with respect to such request not later than #de days after the ,secretary receives such request4 7,b7 ,a request described in this subparagraph is a request for feedback-- 7i7 that is made by the owner1 operator1 or agent in charge of such establishment in a timely manner2 and 7ii7 with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection 7b7 that involve a public health priority1 that implicate systemic or major actions1 or relate to emerging safety issues 7as determined by the ,secretary74 7#c7 ,nothing in this subsection affects the authority of the ,secretary to conduct inspections otherwise permitted under this ,act in order to ensure compliance with this ,act4 4 7b7 ,guidance 7#a7 ,draft guidance ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue draft guidance that-- 7,a7 specifies how the ,food and ,drug ,administration will implement the processes and standards described in paragraph 7#a7 of subsection 7h7 of section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd71 as added by subsection 7a71 and the requirements described in paragraph 7#b7 of such subsection 7h72 7,b7 provides for standardized methods for communications described in such paragraphs2 7,c7 establishes1 with respect to inspections of both domestic and foreign device establishments 7as referred to in section #eaj7;h77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by subsection 7a771 a standard timeframe for such inspections-- 7i7 that occurs over consecutive days2 and 7ii7 to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation2 and 7,d7 identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments4 7#b7 ,final guidance ,not later than #a year after providing notice and opportunity for public comment on the draft guidance issued under paragraph 7#a71 the ,secretary of ,health and ,human ,services shall issue final guidance to implement subsection 7h7 of section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd71 as added by subsection 7a74 7c7 ,adulterated devices ,subsection 7j7 of section #eja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is amended by inserting or device after drug4 #gjc4 ,reauthorization of inspection program ,section #gjd7;g77#aa7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77#aa77 is amended by striking ,october #a1 #bjag and inserting ,october #a1 #bjbb4 #gjd4 ,certificates to foreign governments for devices ,subsection 7e77#d7 of section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77 is amended-- 7#a7 by adding at the end the following3 7,e7 7i7 7,i7 ,if the ,secretary denies a request for certification under subparagraph 7,a77ii7 with respect to a device manufactured in an establishment 7foreign or domestic7 registered under section #eaj1 the ,secretary shall provide in writing to the person seeking such certification the basis for such denial1 and specifically identify the finding upon which such denial is based4 7,,ii7 ,if the denial of a request as described in subclause 7,i7 is based on grounds other than an injunction proceeding pursuant to section #cjb1 seizure action pursuant to section #cjd1 or a recall designated ,class ,i or ,class ,,ii pursuant to part #g1 title #ba1 ,code of ,federal ,regulations1 and is based on the facility being out of compliance with part #hbj of title #ba1 ,code of ,federal ,regulations1 the ,secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the ,secretary4 7,,iii7 ,with respect to a device manufactured in an establishment that has received a report under section #gjd7;b71 the ,secretary shall not deny a request for certification as described in subclause 7,i7 with respect to a device based solely on the issuance of that report if the owner1 operator1 or agent in charge of such establishment has agreed to a plan of correction in response to such report4 7ii7 7,i7 ,the ,secretary shall provide a process for a person who is denied a certification as described in clause 7i77,i7 to request a review that conforms to the standards of section #eag;,a7b74 7,,ii7 ,notwithstanding any previous review conducted pursuant to subclause 7,i71 a person who has been denied a certification as described in clause 7i77,i7 may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the ,secretary for the denial of certification1 including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the ,secretary4 7,,iii7 ,not later than #a year after the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 the ,secretary shall issue guidance providing for a process to carry out this subparagraph4 ,not later than #a year after the close of the comment period for such guidance1 the ,secretary shall issue final guidance4 7iii7 7,i7 ,subject to subclause 7,,ii71 this subparagraph applies to requests for certification on behalf of any device establishment registered under section #eaj1 whether the establishment is located inside or outside of the ,united ,states1 and regardless of whether such devices are to be exported from the ,united ,states4 7,,ii7 ,if an establishment described in subclause 7,i7 is not located within the ,united ,states and does not demonstrate that the devices manufactured1 prepared1 propagated1 compounded1 or processed at such establishment are to be exported from the ,united ,states1 this subparagraph shall apply only if-- 7aa7 the establishment has been inspected by the ,secretary within #c years of the date of the request2 or 7bb7 the establishment participates in an audit program in which the ,united ,states participates or the ,united ,states recognizes1 an audit under such program has been conducted1 and the findings of such audit are provided to the ,secretary within #c years of the date of the request4 2 and 7#b7 by moving the margins of subparagraphs 7,c7 and 7,d7 #d ems to the left4 #gje4 ,facilitating international harmonization ,section #gjd7;g7 of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is amended by adding at the end the following3 7#ae7 7,a7 ,notwithstanding any other provision of this subsection1 the ,secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of-- 7i7 establishments that manufacture1 prepare1 propagate1 compound1 or process devices 7other than types of devices licensed under section #cea of the ,public ,health ,service ,act71 as required under section #eaj7;h72 or 7ii7 establishments required to register pursuant to section #eaj7;i74 7,b7 ,nothing in this paragraph affects-- 7i7 the authority of the ,secretary to inspect any device establishment pursuant to this ,act2 or 7ii7 the authority of the ,secretary to determine the official classification of an inspection4 4 #gjf4 ,fostering innovation in medical imaging 7a7 ,approval of applications for certain diagnostic medical imaging devices ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#db ,u4,s4,c4 #cfj;j7 is amended by adding at the end the following3 7p7 ,diagnostic imaging devices intended for use with contrast agents 7#a7 ,in general ,the ,secretary may1 subject to the succeeding provisions of this subsection1 approve an application 7or a supplement to such an application7 submitted under section #eae with respect to an applicable medical imaging device1 or1 in the case of an applicable medical imaging device for which a notification is submitted under section #eaj7k71 may make a substantial equivalence determination with respect to an applicable medical imaging device1 or may grant a request submitted under section #eac7;f77#b7 for an applicable medical imaging device1 if such application1 notification1 or request involves the use of a contrast agent that is not-- 7,a7 in a concentration1 rate of administration1 or route of administration that is different from those described in the approved labeling of the contrast agent1 except that the ,secretary may approve such application1 make such substantial equivalence determination1 or grant such request if the ,secretary determines that such differences in concentration1 rate of administration1 or route of administration exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device2 7,b7 in a region1 organ1 or system of the body that is different from those described in the approved labeling of the contrast agent1 except that the ,secretary may approve such application1 make such substantial equivalence determination1 or grant such request if the ,secretary determines that such differences in region1 organ1 or system of the body exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device2 7,c7 in a patient population that is different from those described in the approved labeling of the contrast agent1 except that the ,secretary may approve such application1 make such substantial equivalence determination1 or grant such request if the ,secretary determines such differences in patient population exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device2 or 7,d7 in an imaging modality that is different from those described in the approved labeling of the contrast agent4 7#b7 ,premarket review ,the agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application1 notification1 or request described in paragraph 7#a74 ,in conducting such review1 such agency center may-- 7,a7 consult with the agency center charged with the premarket review of drugs or biological products2 and 7,b7 review information and data provided to the ,secretary by the sponsor of a contrast agent in an application submitted under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference and the application is submitted in accordance with this subsection4 7#c7 ,applicable requirements ,an application submitted under section #eae1 a notification submitted under section #eaj7k71 or a request submitted under section #eac7;f77#b71 as described in paragraph 7#a71 with respect to an applicable medical imaging device shall be subject to the requirements of such respective section4 ,such application1 notification1 or request shall only be subject to the requirements of this ,act applicable to devices4 7#d7 ,definitions ,for purposes of this subsection-- 7,a7 the term applicable medical imaging device means a device intended to be used in conjunction with a contrast agent 7or class of contrast agents7 for an imaging use that is not described in the approved labeling of such contrast agent 7or the approved labeling of any contrast agent in the same class as such contrast agent72 and 7,b7 the term contrast agent means a drug that is approved under section #eje or licensed under section #cea of the ,public ,health ,service ,act1 is intended for use in conjunction with an applicable medical imaging device1 and-- 7i7 is a diagnostic radiopharmaceutical1 as defined in section #cae4b and #fja4ca of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 or 7ii7 is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue1 structure1 or fluid4 4 7b7 ,applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7y7 ,contrast agents intended for use with applicable medical imaging devices 7#a7 ,in general ,the sponsor of a contrast agent for which an application has been approved under this section may submit a supplement to the application seeking approval for a new use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section #ebj7p77#a74 7#b7 ,review of supplement ,in reviewing a supplement submitted under this subsection1 the agency center charged with the premarket review of drugs may-- 7,a7 consult with the center charged with the premarket review of devices2 and 7,b7 review information and data submitted to the ,secretary by the sponsor of an applicable medical imaging device pursuant to section #eae1 #eaj7k71 or #eac7;f77#b7 so long as the sponsor of such applicable medical imaging device has provided to the sponsor of the contrast agent a right of reference4 7#c7 ,definitions ,for purposes of this subsection-- 7,a7 the term new use means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section #ebj7p71 but that is not described in the approved labeling of the contrast agent2 and 7,b7 the terms applicable medical imaging device and contrast agent have the meanings given such terms in section #ebj7p74 4 #gjg4 ,risk-based classification of accessories 7a7 ,in general ,subsection 7f7 of section #eac of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7 is amended by adding at the end the following new paragraph3 7#f7 7,a7 ,subject to the succeeding subparagraphs of this paragraph1 the ,secretary shall1 by written order1 classify an accessory under this section based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory1 notwithstanding the classification of any other device with which such accessory is intended to be used4 7,b7 ,the classification of any accessory distinct from another device by regulation or written order issued prior to ,december #ac1 #bjaf1 shall continue to apply unless and until the accessory is reclassified by the ,secretary1 notwithstanding the classification of any other device with which such accessory is intended to be used4 ,nothing in this paragraph shall preclude the ,secretary's authority to initiate the classification of an accessory through regulation or written order1 as appropriate4 7,c7 7i7 ,in the case of a device intended to be used with an accessory1 where the accessory has been included in an application for premarket approval of such device under section #eae or a report under section #eaj7k7 for clearance of such device and the ,secretary has not classified such accessory distinctly from another device in accordance with subparagraph 7,a71 the person filing the application or report 7as applicable7 at the time such application or report is filed-- 7,i7 may include a written request for the proper classification of the accessory pursuant to subparagraph 7,a72 7,,ii7 shall include in any such request such information as may be necessary for the ,secretary to evaluate1 based on the least burdensome approach1 the appropriate class for the accessory under subsection 7a72 and 7,,iii7 shall1 if the request under subclause 7,i7 is requesting classification of the accessory in class ,,ii1 include in the application an initial draft proposal for special controls1 if special controls would be required pursuant to subsection 7a77#a77;,b74 7ii7 ,the ,secretary's response under section #eae7;d7 or section #eaj7n7 7as applicable7 to an application or report described in clause 7i7 shall also contain the ,secretary's granting or denial of the request for classification of the accessory involved4 7iii7 ,the ,secretary's evaluation of an accessory under clause 7i7 shall constitute an order establishing a new classification for such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses as such accessory4 7,d7 ,for accessories that have been granted marketing authorization as part of a submission for another device with which the accessory involved is intended to be used1 through an application for such other device under section #eae7;c71 a report under section #eaj7k71 or a request for classification under paragraph 7#b7 of this subsection1 the following shall apply3 7i7 ,not later than the date that is one year after the date of enactment of the ,,fda ,reauthorization ,act of #bjag and at least once every #e years thereafter1 and as the ,secretary otherwise determines appropriate1 pursuant to this paragraph1 the ,secretary shall publish in the ,federal ,register a notice proposing a list of such accessories that the ,secretary determines may be suitable for a distinct classification in class ,i and the proposed regulations for such classifications4 ,in developing such list1 the ,secretary shall consider recommendations from sponsors of device submissions and other stakeholders for accessories to be included on such list4 ,the notices shall provide for a period of not less than #fj calendar days for public comment4 ,within #ahj days after the end of the comment period1 the ,secretary shall publish in the ,federal ,register a final action classifying such suitable accessories into class ,i4 7ii7 ,a manufacturer or importer of an accessory that has been granted such marketing authorization may submit to the ,secretary a written request for the appropriate classification of the accessory based on the risks and appropriate level of regulatory controls as described in subparagraph 7,a71 and shall1 if the request is requesting classification of the accessory in class ,,ii1 include in the submission an initial draft proposal for special controls1 if special controls would be required pursuant to subsection 7a77#a77;,b74 ,such request shall include such information as may be necessary for the ,secretary to evaluate1 based on the least burdensome approach1 the appropriate class for the accessory under subsection 7a74 ,the ,secretary shall provide an opportunity for a manufacturer or importer to meet with appropriate personnel of the ,food and ,drug ,administration to discuss the appropriate classification of such accessory prior to submitting a written request under this clause for classification of the accessory4 7iii7 ,the ,secretary shall respond to a request made under clause 7ii7 not later than #he calendar days after receiving such request by issuing a written order classifying the accessory or denying the request4 ,if the ,secretary does not agree with the recommendation for classification submitted by the manufacturer or importer1 the response shall include a detailed description and justification for such determination4 ,within #cj calendar days after granting such a request1 the ,secretary shall publish a notice in the ,federal ,register announcing such response4 7,e7 ,nothing in this paragraph may be construed as precluding a manufacturer of an accessory of a new type from using the classification process described in subsection 7f77#b7 to obtain classification of such accessory in accordance with the criteria and requirements set forth in that subsection4 4 7b7 ,conforming change ,section #eac7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77 is amended by striking paragraph 7#i7 7relating to classification of an accessory74 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall take effect on the date that is #fj days after the date of enactment of this ,act4 #gjh4 ,device pilot projects 7a7 ,postmarket pilot ,section #eai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i7 is amended by adding at the end the following3 7i7 ,postmarket pilot 7#a7 ,in general ,in order to provide timely and reliable information on the safety and effectiveness of devices approved under section #eae1 cleared under section #eaj7k71 or classified under section #eac7;f77#b71 including responses to adverse events and malfunctions1 and to advance the objectives of part #hjc of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 and advance the objectives of1 and evaluate innovative new methods of compliance with1 this section and section #ebb1 the ,secretary shall1 within one year of the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 initiate one or more pilot projects for voluntary participation by a manufacturer or manufacturers of a device or device type1 or continue existing projects1 in accordance with paragraph 7#c71 that-- 7,a7 are designed to efficiently generate reliable and timely safety and active surveillance data for use by the ,secretary or manufacturers of the devices that are involved in the pilot project2 7,b7 inform the development of methods1 systems1 data criteria1 and programs that could be used to support safety and active surveillance activities for devices included or not included in such project2 7,c7 may be designed and conducted in coordination with a comprehensive system for evaluating medical device technology that operates under a governing board with appropriate representation of stakeholders1 including patient groups and device manufacturers2 7,d7 use electronic health data including claims data1 patient survey data1 or any other data1 as the ,secretary determines appropriate2 and 7,e7 prioritize devices and device types that meet one or more of the following criteria3 7i7 ,devices and device types for which the collection and analysis of real world evidence regarding a device's safety and effectiveness is likely to advance public health4 7ii7 ,devices and device types that are widely used4 7iii7 ,devices and device types1 the failure of which has significant health consequences4 7iv7 ,devices and device types for which the ,secretary-- 7,i7 has received public recommendations in accordance with paragraph 7#b77;,b72 and 7,,ii7 has determined to meet one or more of the criteria under clause 7i71 7ii71 or 7iii7 and is appropriate for such a pilot project4 7#b7 ,participation ,the ,secretary shall establish the conditions and processes-- 7,a7 under which a manufacturer of a device may voluntarily participate in a pilot project described in paragraph 7#a72 and 7,b7 for facilitating public recommendations for devices to be prioritized under such a pilot project1 including requirements for the data necessary to support such a recommendation4 7#c7 ,continuation of ongoing projects ,the ,secretary may continue or expand projects1 with respect to providing timely and reliable information on the safety and effectiveness of devices approved under section #eae1 cleared under section #eaj7k71 or classified under section #eac7;f77#b71 that are being carried out as of the date of the enactment of the ,,fda ,reauthorization ,act of #bjag4 ,the ,secretary shall1 beginning on such date of enactment1 take such steps as may be necessary-- 7,a7 to ensure such projects meet the requirements of subparagraphs 7,a7 through 7,e7 of paragraph 7#a72 and 7,b7 to increase the voluntary participation in such projects of manufacturers of devices and facilitate public recommendations for any devices prioritized under such a project4 7#d7 ,implementation 7,a7 ,contracting authority ,the ,secretary may carry out a pilot project meeting the criteria specified in subparagraphs 7,a7 through 7,e7 of paragraph 7#a7 or a project continued or expanded under paragraph 7#c7 by entering into contracts1 cooperative agreements1 grants1 or other appropriate agreements with public or private entities that have a significant presence in the ,united ,states and meet the following conditions3 7i7 ,if such an entity is a component of another organization1 the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph 7#a77;,d7 and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures4 7ii7 ,in the case of the termination or nonrenewal of such a contract1 cooperative agreement1 grant1 or other appropriate agreement1 the entity or entities involved shall comply with each of the following3 7,i7 ,the entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause 7i7 with respect to all data disclosed to the entity under such an agreement4 7,,ii7 ,the entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or1 if returning such data is not practicable1 destroy the data4 7iii7 ,the entity or entities shall have one or more qualifications with respect to-- 7,i7 research1 statistical1 epidemiologic1 or clinical capability and expertise to conduct and complete the activities under this subsection1 including the capability and expertise to provide the ,secretary access to de-identified data consistent with the requirements of this subsection2 7,,ii7 an information technology infrastructure to support electronic data and operational standards to provide security for such data1 as appropriate2 7,,iii7 experience with1 and expertise on1 the development of research on1 and surveillance of1 device safety and effectiveness using electronic health data2 or 7,,iv7 such other expertise which the ,secretary determines necessary to carry out such a project4 7,b7 ,review of contract in the event of a merger or acquisition ,the ,secretary shall review any contract1 cooperative agreement1 grant1 or other appropriate agreement entered into under this paragraph with an entity meeting the conditions specified in subparagraph 7,a7 in the event of a merger or acquisition of the entity in order to ensure that the requirements specified in this subsection will continue to be met4 7#e7 ,compliance with requirements for records or reports on devices ,the participation of a manufacturer in pilot projects under this subsection or a project continued or expanded under paragraph 7#c7 shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program with respect to devices carried out under this section #eai or section #ebb4 ,the ,secretary may determine that1 for a specified time period to be determined by the ,secretary1 a manufacturer's participation in a pilot project under this subsection or a project continued or expanded under paragraph 7#c7 may meet the applicable requirements of this section or section #ebb1 if-- 7,a7 the project has demonstrated success in capturing relevant adverse event information2 and 7,b7 the ,secretary has established procedures for making adverse event and safety information collected from such project public1 to the extent possible4 7#f7 ,privacy requirements ,with respect to the disclosure of any health information collected through a project conducted under this subsection-- 7,a7 individually identifiable health information so collected shall not be disclosed when presenting any information from such project2 and 7,b7 any such disclosure shall be made in compliance with regulations issued pursuant to section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note7 and sections #eeb and #eeb;a of title #e1 ,united ,states ,code4 7#g7 ,limitations ,no pilot project under this subsection1 or in coordination with the comprehensive system described in paragraph 7#a77;,c71 may allow for an entity participating in such project1 other than the ,secretary1 to make determinations of safety or effectiveness1 or substantial equivalence1 for purposes of this ,act4 7#h7 ,other projects required ,to comply ,paragraphs 7#a77;,b71 7#d77;,a77i71 7#d77;,a77ii71 7#e71 7#f71 and 7#g7 shall apply with respect to any pilot project undertaken in coordination with the comprehensive system described in paragraph 7#a77;,c7 that relates to the use of real world evidence for devices in the same manner and to the same extent as such paragraphs apply with respect to pilot projects conducted under this subsection4 7#i7 ,report to congress ,not later than #ah months after the date of enactment of this ,act1 and annually thereafter1 the ,secretary shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate a report containing a description of the pilot projects being conducted under this subsection and projects continued or expanded pursuant to paragraph 7#c71 including for each such project-- 7,a7 how the project is being implemented in accordance with paragraph 7#d71 including how such project is being implemented through a contract1 cooperative agreement1 grant1 or other appropriate agreement1 if applicable2 7,b7 the number of manufacturers that have agreed to participate in such project2 7,c7 the data sources used to conduct such project2 7,d7 the devices or device categories involved in such project2 7,e7 the number of patients involved in such project2 and 7,f7 the findings of the project in relation to device safety1 including adverse events1 malfunctions1 and other safety information4 7#aj7 ,sunset ,the ,secretary may not carry out a pilot project initiated by the ,secretary under this subsection after ,october #a1 #bjbb4 4 7b7 ,report ,not later than ,january #ca1 #bjba1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall conduct a review through an independent third party to evaluate the strengths1 limitations1 and appropriate use of evidence collected pursuant to real world evidence pilot projects described in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag and subsection 7i7 of section #eai of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;i71 as amended by subsection 7a71 for informing premarket and postmarket decisionmaking for multiple device types1 and to determine whether the methods1 systems1 and programs in such pilot projects efficiently generate reliable and timely evidence about the effectiveness or safety surveillance of devices4 #gji4 ,regulation of over-the-counter hearing aids 7a7 ,in general ,section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as amended by section #gjh1 is further amended by adding at the end the following3 7q7 ,regulation of ,over-the-,counter hearing aids 7#a7 ,definition 7,a7 ,in general ,in this subsection1 the term over-the-counter hearing aid means a device that-- 7i7 uses the same fundamental scientific technology as air conduction hearing aids 7as defined in section #hgd4ccjj of title #ba1 ,code of ,federal ,regulations7 7or any successor regulation7 or wireless air conduction hearing aids 7as defined in section #hgd4ccje of title #ba1 ,code of ,federal ,regulations7 7or any successor regulation72 7ii7 is intended to be used by adults age #ah and older to compensate for perceived mild to moderate hearing impairment2 7iii7 through tools1 tests1 or software1 allows the user to control the over-the-counter hearing aid and customize it to the user's hearing needs2 7iv7 may-- 7,i7 use wireless technology2 or 7,,ii7 include tests for self-assessment of hearing loss2 and 7v7 is available over-the-counter1 without the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person1 to consumers through in-person transactions1 by mail1 or online4 7,b7 ,exception ,such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching4 7#b7 ,regulation ,an over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section #gji7;b7 of the ,,fda ,reauthorization ,act of #bjag and shall be exempt from sections #hja4dbj and #hja4dba of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 4 7b7 ,regulations ,to establish category 7#a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 not later than #c years after the date of enactment of this ,act1 shall promulgate proposed regulations to establish a category of over-the-counter hearing aids1 as defined in subsection 7q7 of section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 as amended by subsection 7a71 and1 not later than #ahj days after the date on which the public comment period on the proposed regulations closes1 shall issue such final regulations4 7#b7 ,requirements ,in promulgating the regulations under paragraph 7#a71 the ,secretary shall-- 7,a7 include requirements that provide reasonable assurances of the safety and effectiveness of over-the-counter hearing aids2 7,b7 include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids2 7,c7 include requirements for appropriate labeling of over-the-counter hearing aids1 including requirements that such labeling include a conspicuous statement that the device is only intended for adults age #ah and older1 information on how consumers may report adverse events1 information on any contraindications1 conditions1 or symptoms of medically treatable causes of hearing loss1 and advisements to consult promptly with a licensed health care practitioner2 and 7,d7 describe the requirements under which the sale of over-the-counter hearing aids is permitted1 without the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person1 to consumers through in-person transactions1 by mail1 or online4 7#c7 ,premarket notification ,the ,secretary shall make findings under section #eaj7m7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7m77 to determine whether over-the-counter hearing aids 7as defined in section #ebj7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as amended by subsection 7a77 require a report under section #eaj7k7 to provide reasonable assurance of safety and effectiveness4 7#d7 ,effect on state law ,no ,state or local government shall establish or continue in effect any law1 regulation1 order1 or other requirement specifically related to hearing products that would restrict or interfere with the servicing1 marketing1 sale1 dispensing1 use1 customer support1 or distribution of over-the-counter hearing aids 7as defined in section #ebj7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j71 as amended by subsection 7a77 through in-person transactions1 by mail1 or online1 that is different from1 in addition to1 or otherwise not identical to1 the regulations promulgated under this subsection1 including any ,state or local requirement for the supervision1 prescription1 or other order1 involvement1 or intervention of a licensed person for consumers to access over-the-counter hearing aids4 7#e7 ,no effect on private remedies ,nothing in this section shall be construed to modify or otherwise affect the ability of any person to exercise a private right of action under any ,state or ,federal product liability1 tort1 warranty1 contract1 or consumer protection law4 7c7 ,new guidance issued ,not later than the date on which final regulations are issued under subsection 7b71 the ,secretary shall update and finalize the draft guidance of the ,department of ,health and ,human ,services entitled ,regulatory ,requirements for ,hearing ,aid ,devices and ,personal ,sound ,amplification ,products1 issued on ,november #g1 #bjac4 ,such updated and finalized guidance shall clarify which products1 on the basis of claims or other marketing1 advertising1 or labeling material1 meet the definition of a device in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 and which products meet the definition of a personal sound amplification product1 as set forth in such guidance4 7d7 ,report ,not later than #b years after the date on which the final regulations described in subsection 7b77#a7 are issued1 the ,secretary of ,health and ,human ,services shall submit to ,congress a report analyzing any adverse events relating to over-the-counter hearing aids 7as defined in subsection 7q77#a7 of section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j774 #gaj4 ,report on servicing of devices 7a7 ,in general ,not later than #bgj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall post on the internet website of the ,food and ,drug ,administration a report on the continued quality1 safety1 and effectiveness of devices 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h777 with respect to servicing 7as defined in subsection 7c774 7b7 ,contents ,the report submitted under subsection 7a7 shall contain-- 7#a7 the status of1 and findings to date1 with respect to1 the proposed rule entitled ,refurbishing1 ,reconditioning1 ,rebuilding1 ,remarketing1 ,remanufacturing1 and ,servicing of ,medical ,devices ,performed by ,third-,party ,entities and ,original ,equipment ,manufacturers2 ,request for ,comments published in the ,federal ,register by the ,food and ,drug ,administration on ,march #d1 #bjaf 7#ha ,fed4 ,reg4 #aadgg72 7#b7 information presented during the ,october #bjaf public workshop entitled ,refurbishing1 ,reconditioning1 ,rebuilding1 ,remarketing1 ,remanufacturing1 and ,servicing of ,medical ,devices ,performed by ,third-,party ,entities and ,original ,equipment ,manufacturers2 7#c7 a description of the statutory and regulatory authority of the ,food and ,drug ,administration with respect to the servicing of devices conducted by any entity1 including original equipment manufacturers and third party entities2 7#d7 details regarding how the ,food and ,drug ,administration currently regulates devices with respect to servicing to ensure safety and effectiveness1 how the agency could improve such regulation using the authority described in paragraph 7#c71 and whether additional authority is recommended2 7#e7 information on actions the ,food and ,drug ,administration could take under the authority described in paragraphs 7#c7 and 7#d7 to assess the servicing of devices1 including the size1 scope1 location1 and composition of third party entities2 7#f7 information on actions the ,food and ,drug ,administration could take to track adverse events caused by servicing errors performed by any entity1 including original equipment manufacturers and third party entities2 7#g7 information regarding the regulation by ,states1 the ,joint ,commission1 or other regulatory bodies of device servicing performed by any entity1 including original equipment manufacturers and third party entities2 and 7#h7 any additional information determined by the ,secretary 7acting through the ,commissioner7 to be relevant to ensuring the quality1 safety1 and effectiveness of devices with respect to servicing4 7c7 ,servicing defined ,in this section1 the term servicing includes1 with respect to a device1 refurbishing1 reconditioning1 rebuilding1 remarketing1 repairing1 remanufacturing1 or other servicing of the device4 ,,viii ,improving generic drug access #hja4 ,priority review of generic drugs ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is amended by adding at the end the following3 7#aa7 7,a7 ,subject to subparagraph 7,b71 the ,secretary shall prioritize the review of1 and act within #h months of the date of the submission of1 an original abbreviated new drug application submitted for review under this subsection that is for a drug-- 7i7 for which there are not more than #c approved drug products listed under paragraph 7#g7 and for which there are no blocking patents and exclusivities2 or 7ii7 that has been included on the list under section #ejf;,e4 7,b7 ,to qualify for priority review under this paragraph1 not later than #fj days prior to the submission of an application described in subparagraph 7,a7 or that the ,secretary may prioritize pursuant to subparagraph 7,d71 the applicant shall provide complete1 accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application1 including facilities in corresponding ,type ,,ii active pharmaceutical ingredients drug master files referenced in an application and sites or organizations involved in bioequivalence and clinical studies used to support the application1 to enable the ,secretary to make a determination regarding whether an inspection of a facility is necessary4 ,such information shall include the relevant 7as determined by the ,secretary7 sections of such application1 which shall be unchanged relative to the date of the submission of such application1 except to the extent that a change is made to such information to exclude a facility that was not used to generate data to meet any application requirements for such submission and that is not the only facility intended to conduct one or more unit operations in commercial production4 ,information provided by an applicant under this subparagraph shall not be considered the submission of an application under this subsection4 7,c7 ,the ,secretary may expedite an inspection or reinspection under section #gjd of an establishment that proposes to manufacture a drug described in subparagraph 7,a74 7,d7 ,nothing in this paragraph shall prevent the ,secretary from prioritizing the review of other applications as the ,secretary determines appropriate4 7#ab7 ,the ,secretary shall publish on the internet website of the ,food and ,drug ,administration1 and update at least once every #f months1 a list of all drugs approved under subsection 7c7 for which all patents and periods of exclusivity under this ,act have expired and for which no application has been approved under this subsection4 4 #hjb4 ,enhancing regulatory transparency to enhance generic competition ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 as amended by section #hja1 is further amended by adding at the end the following3 7#ac7 ,upon the request of an applicant regarding one or more specified pending applications under this subsection1 the ,secretary shall1 as appropriate1 provide review status updates indicating the categorical status of the applications by each relevant review discipline4 4 #hjc4 ,competitive generic therapies 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejf;,g the following3 #ejf;,h4 ,competitive generic therapies 7a7 ,in general ,the ,secretary may1 at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection 7b71 expedite the development and review of an abbreviated new drug application under section #eje7;j7 for such drug4 7b7 ,designation process 7#a7 ,request ,the applicant may request the ,secretary to designate the drug as a competitive generic therapy4 7#b7 ,timing ,a request under paragraph 7#a7 may be made concurrently with1 or at any time prior to1 the submission of an abbreviated new drug application for the drug under section #eje7;j74 7#c7 ,criteria ,a drug is eligible for designation as a competitive generic therapy under this section if the ,secretary determines that there is inadequate generic competition4 7#d7 ,designation ,not later than #fj calendar days after the receipt of a request under paragraph 7#a71 the ,secretary may-- 7,a7 determine whether the drug that is the subject of the request meets the criteria described in paragraph 7#c72 and 7,b7 if the ,secretary finds that the drug meets such criteria1 designate the drug as a competitive generic therapy4 7c7 ,actions ,in expediting the development and review of an application under subsection 7a71 the ,secretary may1 as requested by the applicant1 take actions including the following3 7#a7 ,hold meetings with the applicant and the review team throughout the development of the drug prior to submission of the application for such drug under section #eje7;j74 7#b7 ,provide timely advice to1 and interactive communication with1 the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable4 7#c7 ,involve senior managers and experienced review staff1 as appropriate1 in a collaborative1 coordinated review of such application1 including with respect to drug-device combination products and other complex products4 7#d7 ,assign a cross-disciplinary project lead-- 7,a7 to facilitate an efficient review of the development program and application1 including manufacturing inspections2 and 7,b7 to serve as a scientific liaison between the review team and the applicant4 7d7 ,reporting requirement ,not later than one year after the date of the approval of an application under section #eje7;j7 with respect to a drug for which the development and review is expedited under this section1 the sponsor of such drug shall report to the ,secretary on whether the drug has been marketed in interstate commerce since the date of such approval4 7e7 ,definitions ,in this section3 7#a7 ,the term generic drug means a drug that is approved pursuant to section #eje7;j74 7#b7 ,the term inadequate generic competition means1 with respect to a drug1 there is not more than one approved drugs on the list of drugs described in section #eje7;j77#g77;,a7 7not including drugs on the discontinued section of such list7 that is-- 7,a7 the reference listed drug2 or 7,b7 a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought4 7#c7 ,the term reference listed drug means the listed drug 7as such term is used in section #eje7;j77 for the drug involved4 4 7b7 ,guidance2 amended regulations 7#a7 ,in general 7,a7 ,issuance ,the ,secretary of ,health and ,human ,services shall-- 7i7 not later than #ah months after the date of enactment of this ,act1 issue draft guidance on section #ejf;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a72 and 7ii7 not later than #a year after the close of the comment period for the draft guidance1 issue final guidance on such section #ejf;,h4 7,b7 ,contents ,the guidance issued under this paragraph shall-- 7i7 specify the process and criteria by which the ,secretary makes a designation under section #ejf;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a72 7ii7 specify the actions the ,secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation2 and 7iii7 include good review management practices for competitive generic therapies4 7#b7 ,amended regulations ,the ,secretary of ,health and ,human ,services shall issue or revise any regulations as may be necessary to carry out this section not later than #b years after the date of enactment of this ,act4 #hjd4 ,accurate information about drugs with limited competition ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejf;,h1 as added by section #hjc1 the following3 #ejf;,i4 ,prompt reports of marketing status 7a7 ,notification of withdrawal ,the holder of an application approved under subsection 7c7 or 7j7 of section #eje shall notify the ,secretary in writing #ahj days prior to withdrawing the approved drug from sale1 or if #ahj days is not practicable as soon as practicable but not later than the date of withdrawal4 ,the holder shall include with such notice the-- 7#a7 ,national ,drug ,code2 7#b7 identity of the drug by established name and by proprietary name1 if any2 7#c7 new drug application number or abbreviated application number2 7#d7 strength of the drug2 7#e7 date on which the drug is expected to no longer be available for sale2 and 7#f7 reason for withdrawal of the drug4 7b7 ,notification of drug not available for sale ,the holder of an application approved under subsection 7c7 or 7j7 shall notify the ,secretary in writing within #ahj calendar days of the date of approval of the drug if the drug will not be available for sale within #ahj calendar days of such date of approval4 ,the holder shall include with such notice the-- 7#a7 identity of the drug by established name and by proprietary name1 if any2 7#b7 new drug application number or abbreviated application number2 7#c7 strength of the drug2 7#d7 date on which the drug will be available for sale1 if known2 and 7#e7 reason for not marketing the drug after approval4 7c7 ,additional one-time report ,within #ahj days of the date of enactment of this section1 all holders of applications approved under subsection 7c7 or 7j7 of section #eje shall review the information in the list published under subsection #eje7;j77#g77;,a7 and shall notify the ,secretary in writing that-- 7#a7 all of the application holder's drugs in the active section of the list published under subsection #eje7;j77#g77;,a7 are available for sale2 or 7#b7 one or more of the application holder's drugs in the active section of the list published under subsection #eje7;j77#g77;,a7 have been withdrawn from sale or have never been available for sale1 and include with such notice the information required pursuant to subsection 7a7 or 7b71 as applicable4 7d7 ,failure to meet requirements ,if a holder of an approved application fails to submit the information required under subsection 7a71 7b71 or 7c71 the ,secretary may move the application holder's drugs from the active section of the list published under subsection #eje7;j77#g77;,a7 to the discontinued section of the list1 except that the ,secretary shall remove from the list in accordance with subsection #eje7;j77#g77;,c7 drugs the ,secretary determines have been withdrawn from sale for reasons of safety of effectiveness4 7e7 ,updates ,the ,secretary shall update the list published under subsection #eje7;j77#g77;,a7 based on the information provided under subsections 7a71 7b71 and 7c7 by moving drugs that are not available for sale from the active section to the discontinued section of the list1 except that drugs the ,secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with subsection #eje7;j77#g77;,c74 ,the ,secretary shall make monthly updates to the list based on the information provided pursuant to subsections 7a7 and 7b71 and shall update the list based on the information provided under subsection 7c7 as soon as practicable4 7f7 ,limitation on use of notices ,any notice submitted under this section shall not be made public by the ,secretary and shall be used solely for the purpose of the updates described in subsection 7e74 4 #hje4 ,suitability petitions 7a7 ,in general ,it is the sense of ,congress that the ,food and ,drug ,administration shall meet the requirement under section #eje7;j77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,c77 and section #cad4ic7;e7 of title #ba1 ,code of ,federal ,regulations1 of responding to suitability petitions within #ij days of submission4 7b7 ,report ,the ,secretary of ,health and ,human ,services shall include in the annual reports under section #hjg-- 7#a7 the number of pending petitions under section #eje7;j77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,c772 and 7#b7 the number of such petitions pending a substantive response for more than #ahj days from the date of receipt4 #hjf4 ,inspections ,within #f months of the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section #gjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd74 ,such protocol shall-- 7#a7 apply to responses to such reports pertaining to applications submitted under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7-- 7,a7 for which the approval is dependent upon remediation of conditions identified in the report2 7,b7 for which concerns related to observations from an inspection under such section #gjd are the only barrier to approval2 and 7,c7 where the drug that is the subject of the application is a drug-- 7i7 for which there are not more than #c other approved applications under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 that reference the same listed drug and for which there are less than #f abbreviated new drug applications tentatively approved2 or 7ii7 that is included on the list under section #ejf;,e of such ,act 7#ba ,u4,s4,c4 #cef;e72 7#b7 address expedited re-inspection of facilities1 as appropriate2 and 7#c7 establish a #f-month timeline for completion of review of such responses to such reports4 #hjg4 ,reporting on pending generic drug applications and priority review applications ,not later than #ahj calendar days after the date of enactment of this ,act1 and quarterly thereafter until ,october #a1 #bjbb1 the ,secretary of ,health and ,human ,services shall post on the internet website of the ,food and ,drug ,administration a report that provides1 with respect to the months covered by the report-- 7#a7 with respect to applications filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 that1 during the most recent calendar year1 were subject to priority review under paragraph 7#aa7 of such section #eje7;j7 7as added by section #hja7 or expedited development and review under section #ejf;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by section #hjc71 the numbers of such applications 7with denotation of such applications that were filed prior to ,october #a1 #bjad7 that are-- 7,a7 awaiting action by the applicant2 7,b7 awaiting action by the ,secretary2 and 7,c7 approved by the ,secretary2 7#b7 the number of applications filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 and prior approval supplements withdrawn in each month2 7#c7 the mean and median approval and tentative approval times and the number of review cycles for such applications2 7#d7 the number and type of meetings requested and held under such section #ejf;,h 7as added by section #hjc72 and 7#e7 the number of such applications on which the ,secretary has taken action pursuant to subsection 7c7 of such section #ejf;,h 7as added by section #hjc7 and any effect such section #ejf;,h may have on the length of time for approval of applications under such section #eje7;j7 and the number of review cycles for such approvals4 #hjh4 ,incentivizing competitive generic drug development ,section #eje7;j77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77 is amended-- 7#a7 in subparagraph 7,b71 by adding at the end the following3 7v7 #ahj-;day exclusivity period for competitive generic therapies 7,i7 ,effectiveness of application ,subject to subparagraph 7,d77iv71 if the application is for a drug that is the same as a competitive generic therapy for which any first approved applicant has commenced commercial marketing1 the application shall be made effective on the date that is #ahj days after the date of the first commercial marketing of the competitive generic therapy 7including the commercial marketing of the listed drug7 by any first approved applicant4 7,,ii7 ,limitation ,the exclusivity period under subclause 7,i7 shall not apply with respect to a competitive generic therapy that has previously received an exclusivity period under subclause 7,i74 7,,iii7 ,definitions ,in this clause and subparagraph 7,d77iv73 7aa7 ,the term competitive generic therapy means a drug-- 7,,aa7 that is designated as a competitive generic therapy under section #ejf;,h2 and 7,,bb7 for which there are no unexpired patents or exclusivities on the list of products described in section #eje7;j77#g77;,a7 at the time of submission4 7bb7 ,the term first approved applicant means any applicant that has submitted an application that-- 7,,aa7 is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved2 7,,bb7 is not eligible for a #ahj-;day exclusivity period under clause 7iv7 for the drug that is the subject of the application for the competitive generic therapy2 and 7,,cc7 is not for a drug for which all drug versions have forfeited eligibility for a #ahj-;day exclusivity period under clause 7iv7 pursuant to subparagraph 7,d74 2 and 7#b7 in subparagraph 7,d71 by adding at the end the following3 7iv7 ,special forfeiture rule for competitive generic therapy ,the #ahj-;day exclusivity period described in subparagraph 7,b77v7 shall be forfeited by a first approved applicant if the applicant fails to market the competitive generic therapy within #ge days after the date on which the approval of the first approved applicant's application for the competitive generic therapy is made effective4 4 #hji4 ,,gao study of issues regarding first cycle approvals of generic medicines 7a7 ,study by ,,gao ,the ,comptroller ,general of the ,united ,states shall conduct a study to determine the following3 7#a7 ,the rate of first cycle approvals and tentative approvals for applications submitted under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 during the period beginning on ,october #a1 #bjab1 and ending on ,september #cj1 #bjag4 ,the rate of first cycle approvals and tentative approvals shall be determined and reported per each ,,gdufa cohort year during this period4 7#b7 ,if the rate determined pursuant to paragraph 7#a7 for any ,,gdufa cohort year is lower than #bj percent1 the reasons contributing to the relatively low rate of first cycle approvals and tentative approvals for generic drug applications shall be itemized1 assessed1 and reported4 ,in making the assessment required by this paragraph1 the ,comptroller ,general shall consider1 among other things1 the role played by-- 7,a7 the ,food and ,drug ,administration's implementation of approval standards for generic drug applications2 7,b7 the extent to which those approval standards are communicated clearly to industry and applied consistently during the review process2 7,c7 the procedures for reviewing generic drug applications1 including timelines for review activities by the ,food and ,drug ,administration2 7,d7 the extent to which those procedures are followed consistently 7and those timelines are met7 by the ,food and ,drug ,administration2 7,e7 the processes and practices for communication between the ,food and ,drug ,administration and sponsors of generic drug applications2 and 7,f7 the completeness and quality of original generic drug applications submitted to the ,food and ,drug ,administration4 7#c7 ,taking into account the determinations made pursuant to paragraphs 7#a7 and 7#b7 and any review process improvements implemented pursuant to this ,act1 whether there are ways the review process for generic drugs could be improved to increase the rate of first cycle approvals and tentative approvals for generic drug applications4 ,in making this determination1 the ,comptroller ,general shall consider1 among other things1 options for increasing review efficiency and communication effectiveness4 7b7 ,completion date ,not later than the expiration of the #b-year period beginning on the date of enactment of this ,act1 the ,comptroller ,general shall complete the study under subsection 7a7 and submit a report describing the findings and conclusions of the study to the ,secretary1 the ,committee on ,energy and ,commerce of the ,house of ,representatives1 and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate4 7c7 ,definitions ,for purposes of this section3 7#a7 ,the term ,,gdufa cohort year means a fiscal year4 7#b7 ,the term generic drug means a drug that is approved or is seeking approval under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j774 7#c7 ,the term generic drug application means an abbreviated new drug application for the approval of a generic drug under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j774 7#d7 ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#e7 7,a7 ,the term first cycle approvals and tentative approvals means the approval or tentative approval of a generic drug application after the ,food and ,drug ,administration's complete review of the application and without issuance of one or more complete response letters4 7,b7 ,for purposes of this paragraph1 the term complete response letter means a written communication to the sponsor of a generic drug application or holder of a drug master file from the ,food and ,drug ,administration describing all of the deficiencies that the ,administration has identified in the generic drug application 7including pending amendments7 or drug master file that must be satisfactorily addressed before the generic drug application can be approved4 ,,ix ,additional provisions #ija4 ,technical corrections 7a7 ,section #cjge7;a7 of the #bast ,century ,cures ,act 7,public ,law #aad-bee7 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by striking as amended by section #bjgd and inserting as amended by section #cajb2 and 7#b7 in paragraph 7#b71 by striking section #bjgd7a77;,c7 and inserting section #cajb7a77;,c74 7b7 ,section #ejf;,g7b77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;g7b77#a77;,a77 is amended by striking identity and inserting identify4 7c7 ,section #eje;,f7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g7b77 is amended by striking randomized and inserting traditional4 7d7 ,section #eje;,f7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;g7d77 is amended by striking #b and inserting #c4 7e7 ,section #eaj7;h77#f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77#f77 is amended by striking ,february #a and replacing with ,may #a4 7f7 ,effective as of the enactment of the #bast ,century ,cures ,act 7,public ,law #aad-bee7-- 7#a7 section #cjea7;a7 of such ,act is amended by striking by inserting after section #eae;,b and inserting by inserting after section #eae;,a2 and 7#b7 section #eae;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c71 as inserted by such section #cjea7;a71 is redesignated as section #eae;,b4 7g7 ,section #eae;,b7f77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c7;f77#b771 as redesignated by subsection 7e77#b7 of this section1 is amended by striking a proposed guidance and inserting a draft version of that guidance4 7h7 ,section #eac7;b77#e77;,d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7b77#e77;,d77 is amended by striking medical device submissions and inserting medical devices that may be specifically the subject of a review by a classification panel4 #ijb4 ,annual report on inspections ,not later than ,march #a of each year1 the ,secretary of ,health and ,human ,services shall post on the internet website of the ,food and ,drug ,administration information related to inspections of facilities necessary for approval of a drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 approval of a device under section #eae of such ,act 7#ba ,u4,s4,c4 #cfj;e71 or clearance of a device under section #eaj7k7 of such ,act 7#ba ,u4,s4,c4 #cfj7k77 that were conducted during the previous calendar year4 ,such information shall include the following3 7#a7 ,the median time following a request from staff of the ,food and ,drug ,administration reviewing an application or report to the beginning of the inspection1 and the median time from the beginning of an inspection to the issuance of a report pursuant to section #gjd7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b774 7#b7 ,the median time from the issuance of a report pursuant to such section #gjd7;b7 to the sending of a warning letter1 issuance of an import alert1 or holding of a regulatory meeting for inspections for which the ,secretary concluded that regulatory or enforcement action was indicated4 7#c7 ,the median time from the sending of a warning letter1 issuance of an import alert1 or holding of a regulatory meeting to resolution of the regulatory or enforcement action indicated for inspections for which the ,secretary concluded that such action was indicated4 7#d7 ,the number of times that a facility was issued a report pursuant to such section #gjd7;b7 and approval of an application was delayed due to the issuance of a withhold recommendation4 #ijc4 ,streamlining and improving consistency in performance reporting 7a7 ,,pdufa ,section #gcf;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a771 as amended by section #ajc1 is further amended by inserting after paragraph 7#b7 the following3 7#c7 ,real time reporting 7,a7 ,in general ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter1 the ,secretary shall post the data described in subparagraph 7,b7 on the internet website of the ,food and ,drug ,administration for such quarter and on a cumulative basis for such fiscal year1 and may remove duplicative data from the annual performance report under this subsection4 7,b7 ,data ,the ,secretary shall post the following data in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance on topics related to the process for the review of human drug applications1 and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag4 7ii7 ,the number and titles of public meetings held on topics related to the process for the review of human drug applications1 and whether such meetings were required by statute or pursuant to a commitment under the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag4 7iii7 ,the number of new drug applications and biological licensing applications approved4 7iv7 ,the number of new drug applications and biological licensing applications filed4 7#d7 ,rationale for ,,pdufa program changes ,beginning with fiscal year #bjbj1 the ,secretary shall include in the annual report under paragraph 7#a7-- 7,a7 data1 analysis1 and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag and the number of full time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,b7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drugs1 including identifying drivers of such changes2 and 7,c7 for each of the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required4 4 7b7 ,,mdufa ,section #gch;,a7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a771 as amended by section #bjd1 is further amended-- 7#a7 by striking ,beginning with and inserting the following3 7i7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7ii7 ,additional information ,beginning with fiscal year #bjah1 the annual report under this subparagraph shall include the progress of the ,center for ,devices and ,radiological ,health in achieving the goals1 and future plans for meeting the goals1 including-- 7,i7 the number of premarket applications filed under section #eae per fiscal year for each review division2 7,,ii7 the number of reports submitted under section #eaj7k7 per fiscal year for each review division2 and 7,,iii7 the number of expedited development and priority review designations under section #eae;,c per fiscal year4 7iii7 ,real time reporting 7,i7 ,in general ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter1 the ,secretary shall post the data described in subclause 7,,ii7 on the internet website of the ,food and ,drug ,administration for such quarter and on a cumulative basis for such fiscal year1 and may remove duplicative data from the annual report under this subparagraph4 7,,ii7 ,data ,the ,secretary shall post the following data in accordance with subclause 7,i73 7aa7 ,the number and titles of draft and final guidance on topics related to the process for the review of devices1 and whether such guidances were issued as required by statute or pursuant to the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag2 and 7bb7 ,the number and titles of public meetings held on topics related to the process for the review of devices1 and if such meetings were required by statute or pursuant to a commitment under the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag4 7iv7 ,rationale for mdufa program changes ,beginning with fiscal year #bjbj1 the ,secretary shall include in the annual report under paragraph 7#a7-- 7,i7 data1 analysis1 and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag and the number of full time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,devices and ,radiological ,health1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,,ii7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices1 including identifying drivers of such changes2 and 7,,iii7 for each of the ,center for ,devices and ,radiological ,health1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required4 4 7c7 ,,gdufa ,section #gdd;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a771 as amended by section #cjd1 is further amended-- 7#a7 by striking ,beginning with and inserting the following3 7#a7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7#b7 ,real time reporting 7,a7 ,in general ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter1 the ,secretary shall post the data described in subparagraph 7,b7 on the internet website of the ,food and ,drug ,administration1 and may remove duplicative data from the annual report under this subsection4 7,b7 ,data ,the ,secretary shall post the following data in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag4 7ii7 ,the number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag4 7#c7 ,rationale for gdufa program changes ,beginning with fiscal year #bjbj1 the ,secretary shall include in the annual report under paragraph 7#a7-- 7,a7 data1 analysis1 and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag and the number of full time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,b7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for human generic drug activities1 including identifying drivers of such changes2 and 7,c7 for each of the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required4 4 7d7 ,bs,u,f,a ,section #gdd;,i7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a771 as amended by section #djd1 is further amended-- 7#a7 by striking ,beginning with and inserting the following3 7#a7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7#b7 ,additional information ,beginning with fiscal year #bjah1 the report under this subsection shall include the progress of the ,food and ,drug ,administration in achieving the goals1 and future plans for meeting the goals1 including-- 7,a7 information on all previous cohorts for which the ,secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort2 7,b7 the number of original biosimilar biological product applications filed per fiscal year1 and the number of approvals issued by the agency for such applications2 and 7,c7 the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals letters issued by the agency for such applications4 7#c7 ,real time reporting 7,a7 ,in general ,not later than #cj calendar days after the end of the second quarter of fiscal year #bjah1 and not later than #cj calendar days after the end of each quarter of each fiscal year thereafter1 the ,secretary shall post the data described in subparagraph 7,b7 for such quarter and on a cumulative basis for the fiscal year on the internet website of the ,food and ,drug ,administration1 and may remove duplicative data from the annual report under this subsection4 7,b7 ,data ,the ,secretary shall post the following data in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance on topics related to the process for the review of biosimilars1 and whether such guidances were required by statute or pursuant to a commitment under the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag4 7ii7 ,the number and titles of public meetings held on topics related to the process for the review of biosimilars1 and whether such meetings were required by statute or pursuant to a commitment under the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag4 7#d7 ,rationale for ,bs,u,f,a program changes ,beginning with fiscal year #bjbj1 the ,secretary shall include in the annual report under paragraph 7#a7-- 7,a7 data1 analysis1 and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag and the number of full time equivalents funded by budget authority at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,b7 data1 analysis1 and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications1 including identifying drivers of such changes2 and 7,c7 for each of the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required4 4 #ijd4 ,analysis of use of funds 7a7 ,,pdufa reports 7#a7 ,analysis in pdufa performance reports ,section #gcf;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a771 as amended by section #ijc7;a71 is further amended by adding at the end the following3 7#e7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report under paragraph 7#a7 an analysis of the following3 7,a7 ,the difference between the aggregate number of human drug applications filed and the aggregate number of approvals1 accounting for-- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7ii7 the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag for the applicable fiscal year4 7,b7 ,relevant data to determine whether the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research have met performance enhancement goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag for the applicable fiscal year4 7,c7 ,the most common causes and trends of external or other circumstances affecting the ability of the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 ,office of ,regulatory ,affairs1 and the ,food and ,drug ,administration to meet the review time and performance enhancement goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag4 4 7#b7 ,issuance of corrective action reports ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is amended-- 7,a7 by redesignating subsections 7c7 and 7d7 as subsections 7e7 and 7f71 respectively2 and 7,b7 by inserting after subsection 7b7 the following3 7c7 ,corrective action report ,beginning with fiscal year #bjah1 for each fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#e71 that each of the goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag for the applicable fiscal year have been met1 the corrective action report shall include recommendations on ways in which the ,secretary can improve and streamline the human drug application review process4 7#b7 ,goals missed ,for any of the goals identified in the letters described in section #aja7;b7 of the ,prescription ,drug ,user ,fee ,amendments of #bjag for the applicable fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include-- 7,a7 a detailed justification for such determination and a description1 as applicable1 of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review1 or application review goals were missed2 and 7,b7 with respect to performance enhancement goals that were not achieved1 a description of efforts the ,food and ,drug ,administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year4 7d7 ,enhanced communication 7#a7 ,communications with congress ,each fiscal year1 as applicable and requested1 representatives from the ,centers with expertise in the review of human drugs shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7#b7 ,participation in congressional hearing ,each fiscal year1 as applicable and requested1 representatives from the ,food and ,drug ,administration shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 4 7b7 ,,mdufa reports 7#a7 ,analysis in mdufa performance reports ,section #gch;,a7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a771 as amended by section #ijc7;b71 is further amended by adding at the end the following3 7iv7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report under clause 7i7 an analysis of the following3 7,i7 ,the difference between the aggregate number of premarket applications filed under section #eae and aggregate reports submitted under section #eaj7k7 and the aggregate number of major deficiency letters1 not approvable letters1 and denials for such applications issued by the agency1 accounting for-- 7aa7 the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 and 7bb7 the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag for the applicable fiscal year4 7,,ii7 ,relevant data to determine whether the ,center for ,devices and ,radiological ,health has met performance enhancement goals identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag for the applicable fiscal year4 7,,iii7 ,the most common causes and trends for external or other circumstances affecting the ability of the ,center for ,devices and ,radiological ,health1 the ,office of ,regulatory ,affairs1 or the ,food and ,drug ,administration to meet review time and performance enhancement goals identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag4 4 7#b7 ,issuance of corrective action reports ,section #gch;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77 is amended-- 7,a7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#d7 and 7#e71 respectively2 and 7,b7 by inserting after paragraph 7#a7 the following3 7#b7 ,corrective action report ,beginning with fiscal year #bjah1 for each fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate4 ,the report shall include the following information1 as applicable3 7,a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under paragraph 7#a77;,a77iv71 that each of the goals identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag for the applicable fiscal year have been met1 the corrective action report shall include recommendations on ways in which the ,secretary can improve and streamline the medical device application review process4 7,b7 ,goals missed ,for each of the goals identified by the letters described in section #bja7;b7 of the ,medical ,device ,user ,fee ,amendments of #bjag for the applicable fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include-- 7i7 a justification for such determination2 7ii7 a description of the types of circumstances1 in the aggregate1 under which applications or reports submitted under section #eae or notifications submitted under section #eaj7k7 missed the review goal times but were approved during the first cycle review1 as applicable2 7iii7 a summary and any trends with regard to the circumstances for which a review goal was missed2 and 7iv7 the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the ,food and ,drug ,administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year4 7#c7 ,enhanced communication 7,a7 ,communications with congress ,each fiscal year1 as applicable and requested1 representatives from the ,centers with expertise in the review of devices shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7,b7 ,participation in congressional hearing ,each fiscal year1 as applicable and requested1 representatives from the ,food and ,drug ,administration shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 4 7c7 ,,gdufa reports 7#a7 ,analysis in gdufa performance reports ,section #gdd;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a771 as amended by section #ijc7;c7 is further amended by adding at the end the following3 7#d7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report an analysis of the following3 7,a7 ,the difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency1 accounting for-- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 and 7ii7 the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag for the applicable fiscal year4 7,b7 ,relevant data to determine whether the ,food and ,drug ,administration has met the performance enhancement goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag for the applicable fiscal year4 7,c7 ,the most common causes and trends for external or other circumstances that affected the ability of the ,secretary to meet review time and performance enhancement goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag4 4 7#b7 ,issuance of corrective action reports ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7,a7 by redesignating subsections 7c7 and 7d7 as subsections 7e7 and 7f71 respectively2 and 7,b7 by inserting after subsection 7b7 the following3 7c7 ,corrective action report ,beginning with fiscal year #bjah1 for each fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,energy and ,commerce and the ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#d71 that each of the goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag for the applicable fiscal year have been met1 the corrective action report shall include recommendations on ways in which the ,secretary can improve and streamline the abbreviated new drug application review process4 7#b7 ,goals missed ,for each of the goals identified by the letters described in section #cja7;b7 of the ,generic ,drug ,user ,fee ,amendments of #bjag for the applicable fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include-- 7,a7 a detailed justification for such determination and a description1 as applicable1 of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review1 or review goals were missed2 and 7,b7 with respect to performance enhancement goals that were not achieved1 a detailed description of efforts the ,food and ,drug ,administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year4 7d7 ,enhanced communication 7#a7 ,communications with congress ,each fiscal year1 as applicable and requested1 representatives from the ,centers with expertise in the review of human drugs shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7#b7 ,participation in congressional hearing ,each fiscal year1 as applicable and requested1 representatives from the ,food and ,drug ,administration shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 4 7d7 ,bs,u,f,a reports 7#a7 ,analysis in bsufa performance reports ,section #gdd;,i7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77 as amended by section #ijc7;d7 is further amended by adding at the end the following3 7#e7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report an analysis of the following3 7,a7 ,the difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency1 accounting for-- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 and 7ii7 the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the applicable fiscal year4 7,b7 ,relevant data to determine whether the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research have met the performance enhancement goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the applicable fiscal year4 7,c7 ,the most common causes and trends for external or other circumstances affecting the ability of the ,secretary to meet review time and performance enhancement goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag4 4 7#b7 ,issuance of corrective action reports ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec71 as amended by section #djd1 is further amended-- 7,a7 by redesignating subsections 7c7 and 7d7 as subsections 7e7 and 7f71 respectively2 and 7,b7 by inserting after subsection 7b7 the following3 7c7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit a corrective action report to the ,committee on ,energy and ,commerce and ,committee on ,appropriations of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions and ,committee on ,appropriations of the ,senate4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#e71 that each of the goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the applicable fiscal year have been met1 the corrective action report shall include recommendations on ways in which the ,secretary can improve and streamline the biosimilar biological product application review process4 7#b7 ,goals missed ,for each of the goals identified by the letters described in section #dja7;b7 of the ,biosimilar ,user ,fee ,amendments of #bjag for the applicable fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include-- 7,a7 a justification for such determination and a description of the types of circumstances and trends1 as applicable1 under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review1 or review goals were missed2 and 7,b7 with respect to performance enhancement goals that were not achieved1 a description of efforts the ,food and ,drug ,administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year4 7d7 ,enhanced communication 7#a7 ,communications with ,congress ,each fiscal year1 as applicable and requested1 representatives from the ,centers with expertise in the review of human drugs shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives to report on the contents described in the reports under this section4 7#b7 ,participation in congressional hearing ,each fiscal year1 as applicable and requested1 representatives from the ,food and ,drug ,administration shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 4 #ije4 ,facilities management 7a7 ,evaluation 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the expenses incurred by the ,food and ,drug ,administration related to facility maintenance and renovation in fiscal years #bjab through #bjai4 ,the study under this paragraph shall include the following3 7,a7 ,a review of purchases and expenses differentiated by appropriated funds1 and resources authorized by the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 and this ,act1 as applicable1 that contributed to-- 7i7 the maintenance of scientific equipment and any existing facility plan or plans to maintain previously purchased scientific equipment2 7ii7 the renovation of facilities in the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 and the ,center for ,devices and ,radiological ,health1 and the purpose of such renovation including the need for the renovation2 7iii7 the assets purchased or repaired under the repair of facilities and acquisition authority under parts #b1 #c1 #g1 and #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq472 7iv7 the maintenance and repair of facilities and fixtures1 including a description of any unanticipated repairs and maintenance as well as scheduled repairs maintenance1 and the budget plan for the scheduled or anticipated maintenance2 7v7 the acquisition of furniture1 a description of the furniture purchased1 and the purpose of the furniture including purchases for the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 and the ,center for ,devices and ,radiological ,health2 and 7vi7 the acquisition of other necessary materials and supplies by product category under the authority under parts #b1 #c1 #g1 and #h of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq474 7,b7 ,an analysis of the ,food and ,drug ,administration's ability to further its public health mission and review medical products by incurring the expenses listed in clauses 7i7 through 7vi7 of subparagraph 7,a74 ,in conducting the analysis1 the ,comptroller ,general shall request information from and consult with appropriate employees1 including staff and those responsible for the fiscal decisions regarding facility maintenance and renovation for the agency4 7#b7 ,report 7,a7 ,in general ,the ,comptroller ,general shall issue a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives not later than ,july #cj1 #bjbj1 containing the results of the study under paragraph 7#a74 7,b7 ,recommendations ,as part of the report under this paragraph1 the ,comptroller ,general may provide recommendations1 as applicable1 on methods through which the ,food and ,drug ,administration may improve planning for-- 7i7 the maintenance1 renovation1 and repair of facilities2 7ii7 the purchase of furniture or other acquisitions2 and 7iii7 ways the ,food and ,drug ,administration may allocate the expenses described in clauses 7i7 and 7ii7 of paragraph 7#a77;,a71 as informed by the analysis under paragraph 7#a77;,b74 7b7 ,administration 7#a7 ,,pdufa ,section #gcf7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h7f77 is amended by adding at the end the following3 7#c7 ,limitation ,beginning on ,october #a1 #bjbc1 the authorities under section #gce7g77;,c7 shall include only expenditures for leasing and necessary scientific equipment4 4 7#b7 ,,mdufa ,section #gch7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7h77 is amended by adding at the end the following3 7#c7 ,limitation ,beginning on ,october #a1 #bjbc1 the authorities under section #gcg7i77;,c7 shall include only leasing and necessary scientific equipment4 4 7#c7 ,,gdufa ,section #gdd;,b7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#db7;e77 is amended-- 7,a7 in the subsection heading1 by striking ,limit and inserting ,limitations2 7,b7 by striking ,the total amount and inserting the following3 7#a7 ,in general ,the total amount 2 and 7,c7 by adding at the end the following3 7#b7 ,leasing and necessary equipment ,beginning on ,october #a1 #bjbc1 the authorities under section #gdd;,a7#aa77;,c7 shall include only leasing and necessary scientific equipment4 4 7#d7 ,bs,u,f,a ,section #gdd;,h7e77#b77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#eb7;e77#b77;,b77 is amended-- 7,a7 in the subparagraph heading1 by striking limitation and inserting limitations2 7,b7 by striking ,the fees authorized and inserting the following3 7i7 ,in general ,the fees authorized 2 and 7,c7 by adding at the end the following3 7ii7 ,leasing and necessary equipment ,beginning on ,october #a1 #bjbc1 the authorities under section #gdd;,g7#i77;,c7 shall include only leasing and necessary scientific equipment4 4 ,passed the ,house of ,representatives ,july #ab1 #bjag4,karen ,l4 ,haas1,clerk ,july #ag1 #bjag,read the second time and placed on the calendar