,,ib ,union ,calendar ,no4 #ach #aaeth ,,congress #ast ,session ,h4 ,r4 #bdcj ,report ,no4 #aae-bja ,,in ,,the ,,house ,,of ,,representatives ,may #af1 #bjag ,mr4 ,walden 7for himself1 ,mr4 ,pallone1 ,mr4 ,burgess1 and ,mr4 ,gene ,green of ,texas7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,july #aa1 #bjag ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed ,strike out all after the enacting clause and insert the part printed in italic ,for text of introduced bill1 see copy of bill as introduced on ,may #af1 #bjag ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to revise and extend the user-fee programs for prescription drugs1 medical devices1 generic drugs1 and biosimilar biological products1 and for other purposes4 #a4 ,short 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 findings4 ,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 clause4 ,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--,reauthorizations and improvements related to drugs ,sec4 #eja4 ,reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers4 ,sec4 #ejb4 ,reauthorization of orphan grants program4 ,sec4 #ejc4 ,reauthorization of pediatric study of drugs4 ,sec4 #ejd4 ,protecting and strengthening the drug supply chain4 ,sec4 #eje4 ,sense of ,congress on lowering the cost of prescription drugs4 ,title ,,vi--,device ,inspection and regulatory improvements ,subtitle ,a--,improving the process for inspections of device establishments ,sec4 #fja4 ,risk-based inspections for devices4 ,sec4 #fjb4 ,recognition of foreign government inspections4 ,sec4 #fjc4 ,improvements to inspections process for device establishments4 ,sec4 #fjd4 ,certificates to foreign governments for devices4 ,sec4 #fje4 ,facilitating international harmonization4 ,sec4 #fjf4 ,reauthorization of inspection program4 ,subtitle ,b--,other provisions ,sec4 #faa4 ,reauthorization of pediatric humanitarian device exceptions4 ,sec4 #fab4 ,reauthorization of pediatric device consortia4 ,sec4 #fac4 ,regulation of over-the-counter hearing aids4 ,sec4 #fad4 ,report on ensuring quality1 safety1 and continued effectiveness of devices that have been serviced4 ,sec4 #fae4 ,device pilot projects to generate reliable and timely safety and active surveillance data4 ,sec4 #faf4 ,risk-based classification of accessories4 ,title ,,vii--,generic ,drug ,access and ,competition ,sec4 #gja4 ,competitive ,generic ,therapies4 ,sec4 #gjb4 ,enhancing regulatory transparency ,to enhance generic competition4 ,sec4 #gjc4 ,incentivizing competitive generic therapy development4 ,sec4 #gjd4 ,tropical disease product application4 ,sec4 #gje4 ,,gao study of issues regarding first cycle approvals of generic medicines4 ,title ,,viii--,fostering ,innovation in ,medical ,imaging ,sec4 #hja4 ,approval of applications for certain diagnostic medical imaging devices4 ,sec4 #hjb4 ,applications for approval of contrast agents intended for use with certain diagnostic medical imaging devices4 ,title ,,ix--,additional ,provisions ,sec4 #ija4 ,technical corrections4 ,sec4 #ijb4 ,reauthorization of the critical path public-private partnerships4 ,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 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 the next 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 findings 7a7 ,short ,title ,this title may be cited as the ,medical ,device ,user ,fee ,amendments of #bjag4 7b7 ,findings ,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 ,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 #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 changes 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 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 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 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 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 or 7iii7 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 supporting2 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 #ab months after the close of the public comment period on the draft guidance issued under subparagraph 7,b71 issue final guidance described in clauses 7i7 through 7iii7 of such subparagraph4 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 clause 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 ,medical ,device ,user ,fee ,amendments of #bjab 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-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-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-db7;i77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by striking subparagraph 7,c7 7relating to fee collection during first program year72 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,c7 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-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 any affiliate of such person1 shall submit1 on behalf of the person and its affiliates1 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 applications 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 ,effective ,october #a1 #bjag1 subsections 7a7 and 7b7 of section #cjd of the ,food and ,drug ,administration ,safety and ,innovation ,act 7,public ,law #aab-add7 are repealed4 #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 on or after ,october #a1 #bjab1 but before ,october #a1 #bjag1 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 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 items2 ,annual ,index7 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 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 program before fees2 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 subparagraphs 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 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#e7 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#e7 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 shall pay-- and all that follows through application fees and inserting shall pay application fees2 and 7#c7 by striking 2 and at the end and inserting a period4 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 ,act1 as amended by section #djc of this ,act1 shall cease to be effective ,october #a1 #bjbb4 7b7 ,reporting ,requirements ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as amended by section #djd of this ,act1 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 ,reauthorizations and improvements related to drugs #eja4 ,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 #ejb4 ,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 #ejc4 ,reauthorization of pediatric study of drugs ,section #dji;,i7e77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7e77#a77 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #ejd4 ,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 in effect under section #ejf;,e1 no drug that would be subject to section #ejc7;b71 and which is manufactured outside the ,united ,states and intended by the manufacturer or labeled to be marketed outside the ,united ,states1 may be imported into the ,united ,states for sale or commercial use4 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 #eje4 ,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 ,,vi ,device ,inspection and regulatory improvements ,a ,improving the process for inspections of device establishments #fja4 ,risk-based inspections for devices ,paragraph 7#b7 of section #eaj7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;h77 is amended to read as follows3 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 which the ,united ,states recognizes for purposes of inspecting device establishments4 4 #fjb4 ,recognition of foreign government inspections ,subsection 7a77#a7 of section #hji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7a77#a77 is amended by inserting or #eaj7;h77#b7 7as applicable7 before the semicolon at the end4 #fjc4 ,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 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 requested in order to expedite the inspection2 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 limits 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 section1 the ,secretary of ,health and ,human ,services shall issue draft guidance that-- 7,a7 specifies how the ,food and ,drug ,administration will implement the process 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 subsection2 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 #fjd4 ,certificates to foreign governments for devices 7a7 ,in general ,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 ,if the ,secretary denies a request made under subparagraph 7,a77ii7 for certification with respect to a device1 the ,secretary shall provide1 in writing1 to the person seeking such certification the basis for such denial1 and specifically identify the finding upon which such denial is based4 7ii7 ,if the denial of a request as described in clause 7i7 is based on-- 7,i7 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 7,,ii7 an establishment being considered out of compliance with part #hbj1 title #ba1 ,code of ,federal ,regulations1 the ,secretary shall provide a substantive summary of the specific grounds for noncompliance so identified1 if such grounds have not been previously communicated to the manufacturer4 7iii7 ,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 under subparagraph 7,a77ii7 based exclusively 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 7,f7 7i7 ,the ,secretary shall provide a process for a person who is denied a certification as described in subparagraph 7,e77i7 to request a review that conforms to the standards of section #eag;,a7b74 7ii7 ,notwithstanding any previous review conducted pursuant to clause 7i71 a person who has been denied a certification for a device as described in subparagraph 7,e77i7 may1 at any time1 request a review of that denial in order to present new information relating to actions taken by such person to address the reasons identified by the ,secretary for such denial1 including evidence that corrective actions are being or have been implemented to address the grounds for noncompliance identified by the ,secretary under subparagraph 7,e77ii74 7,g7 7i7 ,this paragraph applies to requests for certification on behalf of any device establishment registered under section #eaj1 whether the establishment is located in the ,united ,states or another country4 7ii7 ,the ,secretary may charge a fee for the issuance of a certification described in clause 7i71 and such fee is subject to the same conditions and requirements as a fee charged under subparagraph 7,b7 for a certification issued under such subparagraph4 2 and 7#b7 by moving the margins of subparagraphs 7,c7 and 7,d7 #d ems to the left4 7b7 ,guidance ,not later than #a year after date of the enactment of this section1 the ,secretary of ,health and ,human ,services shall issue guidance providing for a process to carry out subparagraph 7,f7 of section #hja7;e77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d771 as added by subsection 7a74 ,not later than #ab months after the comment period closes for the draft guidance1 the ,secretary shall issue final guidance4 #fje4 ,facilitating international harmonization ,section #gjd7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;g77 is amended by adding at the end the following3 7#ae7 ,notwithstanding any other provision of this subsection1 for purposes of conducting inspections of establishments that manufacture1 prepare1 propagate1 compound1 or process devices except types of devices licensed under section #cea of the ,public ,health ,service ,act1 which inspections are required under section #eaj7;h7 or are inspections of such establishments required to register pursuant to section #eaj7;i71 the ,secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization4 ,nothing in this paragraph affects the authority of the ,secretary to inspect any device establishment pursuant to this ,act4 ,nothing in this paragraph affects the authority of the ,secretary to determine the official classification of an inspection4 4 #fjf4 ,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 ,b ,other provisions #faa4 ,reauthorization of pediatric humanitarian device exceptions ,section #ebj7m77#f77;,a77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7m77#f77;,a77iv77 is amended by striking #bjag and inserting #bjbb4 #fab4 ,reauthorization of pediatric device consortia ,section #cje7;e7 of the ,pediatric ,medical ,device ,safety and ,improvement ,act of #bjjg 7,public ,law #aaj-he2 #db ,u4,s4,c4 #bhb note77 is amended by striking #bjac through #bjag and inserting #bjah through #bjbb4 #fac4 ,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;j7 is amended by adding at the end the following3 7p7 ,regulation of ,over-the-,counter hearing aids 7#a7 ,definition 7,a7 ,in this subsection1 the term over-the-counter hearing aid means a device-- 7i7 that 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 that is intended to be used by adults over the age of #ah to compensate for perceived mild to moderate hearing impairment2 7iii7 that1 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 that may-- 7,i7 use wireless technology2 or 7,,ii7 include tests for self-assessment of hearing loss2 and 7v7 that 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 ,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 #fac7;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 7p7 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 efficacy 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 the over-the-counter hearing aid1 including requirements that such labeling include a conspicuous statement that the device is only intended for adults over the age of #ah1 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 physician2 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 #ebj7p7 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 #ebj7p7 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 7p77#a7 of section #ebj of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j774 #fad4 ,report on ensuring quality1 safety1 and continued effectiveness of devices that have been serviced 7a7 ,in general ,not later than #ahj 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 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 on how the ,food and ,drug ,administration intends to ensure the quality1 safety1 and continued effectiveness of devices 7as defined in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja7;h777 with respect to which servicing 7as defined in subsection 7c77 has been performed by any entity engaging in such servicing4 7b7 ,contents ,the report submitted under subsection 7a7 shall contain-- 7#a7 the status of1 and findings to date with respect to1 the notice entitled ,refurbishing1 ,reconditioning1 ,rebuilding1 ,remarketing1 ,remanufacturing1 and ,servicing of ,medical ,devices ,performed by ,third-,party ,entities and ,original ,equipment ,manufacturers2 ,request for ,comments published by the ,food and ,drug ,administration on ,april #be1 #bjaf 7#ha ,fed4 ,reg4 #bdjda et seq471 including how the ,food and ,drug ,administration intends to define the specific activities performed on a device by the manufacturer of the device or other entities2 7#b7 a description of the statutory or regulatory authority of the ,food and ,drug ,administration used to oversee and regulate servicing conducted with respect to devices2 7#c7 details on how the ,food and ,drug ,administration intends to protect the public health by ensuring consistent quality1 safety1 and continued effectiveness of devices with respect to which servicing has been performed by any entity engaging in such servicing2 7#d7 information on how the ,food and ,drug ,administration can better understand the device servicing industry1 including the size1 scope1 location1 and composition of entities performing such servicing and the rate of adverse events related to such servicing2 7#e7 information regarding the current regulation by ,states1 the ,joint ,commission1 or other regulatory bodies of servicing conducted with respect to devices by all entities1 including original equipment manufacturers1 third-party entities1 and hospitals2 and 7#f7 any additional information determined by the ,secretary 7acting through the ,commissioner7 to be relevant to ensuring the quality1 safety1 and continued effectiveness of devices with respect to which servicing has been performed1 including whether additional ,federal statutory authority is necessary to ensure such quality1 safety1 and continued effectiveness4 7c7 ,servicing defined ,in this section1 the term servicing includes1 with respect to a device1 refurbishing1 reconditioning1 rebuilding1 remarketing1 remanufacturing1 repairing1 or other servicing of the device by a person other than the manufacturer of the device4 #fae4 ,device pilot projects to generate reliable and timely safety and active surveillance data 7a7 ,in general ,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 ,pilot projects ,to generate reliable and timely safety and active surveillance data 7#a7 ,in general ,the ,secretary shall1 not later than one year after the date of the enactment of the ,,fda ,reauthorization ,act of #bjag1 initiate one or more pilot projects relating 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 in which a manufacturer or manufacturers of a device or device type voluntarily participate4 ,any such project shall meet each of the following criteria3 7,a7 ,the project is 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 project4 7,b7 ,the project informs1 to the extent applicable1 the development of methods1 systems1 data criteria1 and programs that could be used to support safety and active surveillance activities for any device4 7,c7 ,the project shall be designed and conducted in coordination with a comprehensive system for evaluating device technology that operates under a governing board with appropriate representation of stakeholders1 including patient groups and device manufacturers4 7,d7 ,the project uses electronic health data including1 as appropriate1 claims data1 patient survey data1 and any other data1 as the ,secretary determines appropriate4 7,e7 ,the project prioritizes 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 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 under this subparagraph 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 shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program with respect to devices carried out under section #eai or #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 section #eai or #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 7,a7 ,in general ,no pilot project under this subsection undertaken in coordination with the comprehensive system described in paragraph 7#a77;,c71 shall allow for an entity participating in such program1 other than the ,secretary or the ,secretary's designee1 to make determinations of safety or effectiveness1 or substantial equivalence1 for purposes of the ,act4 7,b7 ,no use of fees ,pilot projects initiated under this subsection may not primarily utilize funds collected pursuant to the ,medical ,device ,user ,fee ,amendments of #bjag4 7#h7 ,other projects required ,to comply ,paragraphs 7#a77;,b71 7#d77;,a77i71 7#d77;,a77ii71 7#e71 and 7#f7 shall apply with respect to any pilot program 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 may 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 added by subsection 7a7-- 7#a7 for purposes of informing premarket and postmarket decisionmaking for multiple device types2 and 7#b7 to determine whether the methods1 systems1 and programs carried out through such pilot projects efficiently generate reliable and timely evidence about the effectiveness of the surveillance of devices with respect to safety4 #faf4 ,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 section shall preclude the ,secretary's ability to initiate the classification of an accessory through regulation or written order1 as appropriate4 7,c7 7i7 ,in the case of an accessory that has been granted marketing authorization as part of a submission under section #eae7;c71 #eaj7k71 or paragraph 7#b7 of this subsection with another device with which such accessory is intended to be used1 and with respect to which the ,secretary has issued a written order classifying such accessory type distinct from another device in accordance with subparagraph 7,a71 the manufacturer or importer of such accessory may1 in lieu of submitting a request for classification of such accessory1 submit a written request to the ,secretary identifying such classification4 ,a request under this clause shall include such information to support the request as may be specified by the ,secretary4 7ii7 ,a request under clause 7i7 shall include a recommendation for the proper classification of the accessory pursuant to subparagraph 7,a71 and 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 7iii7 ,the ,secretary shall respond to a request under clause 7i7 within #ij calendar days by granting or denying the request for reclassification of the accessory4 7iv7 ,within #cj calendar days after granting a request submitted under clause 7i71 the ,secretary shall publish a notice in the ,federal ,register announcing such response4 7v7 ,a written notification that the ,secretary disagrees with the classification recommended in a request pursuant to clause 7ii7 shall include a detailed description and justification for the determination to disagree4 7,d7 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,e7 ,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 and that have not been classified by the ,secretary based on the risks and appropriate level of regulatory controls in accordance with subparagraph 7,a73 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 deems appropriate1 pursuant to this paragraph1 the ,secretary shall publish in the ,federal ,register a notice proposing a list of such accessories that the ,secretary believes may be suitable for a distinct classification in class ,i and the proposed regulations for such classifications4 ,in developing such lists1 the ,secretary shall consider recommendations from sponsors of device submissions and other stakeholders for accessories to be included on such lists4 ,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,a7 or 7,c71 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 #ij calendar days after receiving such submission by granting or denying the request for classification of the accessory1 and the ,secretary shall by written order classify such accessory or deny 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,f7 ,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 ,,vii ,generic ,drug ,access and ,competition #gja4 ,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 shall1 at the request of the sponsor of a drug that is designated as a competitive generic therapy pursuant to subsection 7b71 expedite the development and review of such drug pursuant to section #eje7;j74 7b7 ,designation process 7#a7 ,request ,the sponsor of a drug 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 shall-- 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 a drug under subsection 7a71 the ,secretary shall1 as requested by the sponsor1 take actions including the following3 7#a7 ,hold meetings with the sponsor 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 sponsor 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 review1 including with respect to drug-device combination products and other complex products4 7#d7 ,assign a cross-disciplinary project lead for the ,food and ,drug ,administration review team-- 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 sponsor4 7d7 ,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 product1 there is not more than one approved drug product on the list of products described in section #eje7;j77#g77;,a7 7not including products 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 the provisions of 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 provisions4 7,b7 ,contents ,the guidance issued under this subsection 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 will 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 7,a7 ,in general ,if the ,secretary of ,health and ,human ,services determines that it is necessary to amend the regulations under title #ba1 ,code of ,federal ,regulations1 in order to implement section #ejf;,h of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 the ,secretary shall amend such regulations not later than #b years after the date of enactment of this ,act4 7,b7 ,procedure ,in carrying out subparagraph 7,a71 and in issuing any other regulations to implement such section #ejf;,h1 the ,secretary shall-- 7i7 issue a notice of proposed rulemaking that includes the proposed regulation2 7ii7 provide a period of not less than #fj days for comments on the proposed regulation2 and 7iii7 publish the final regulation not less than #cj days before the effective date of the regulation4 #gjb4 ,enhancing regulatory transparency to enhance generic competition ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7#aa7 ,upon the request of an applicant regarding one or more specified pending applications under this subsection1 the ,secretary shall-- 7,a7 by telephone or electronic mail1 provide review status updates2 and 7,b7 indicate in such updates the categorical status of the applications by each relevant review discipline4 4 #gjc4 ,incentivizing competitive generic therapy 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 blocking exclusivities on the list of products described in section #eje7;j77#g77;,a7 at the time of approval4 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 #gjd4 ,tropical disease product application ,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 #gje4 ,,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 generic drug applications submitted 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 7,,dmf7 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 ,,viii ,fostering ,innovation in ,medical ,imaging #hja4 ,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;j71 as amended by section #fac1 is further amended by adding at the end the following3 7q7 ,diagnostic imaging devices intended for use with contrast agents 7#a7 ,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 the indications and conditions of use proposed in such application1 notification1 or request involve 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 7such as an ultrasound1 an x-ray1 diagnostic radiopharmaceutical-based technologies1 fluorescent imaging technology1 or magnetic resonance7 that is different from those described in the approved labeling of the contrast agent4 7#b7 ,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 ,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 ,for purposes of this subsection and section #eje7y7-- 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 #hjb4 ,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 ,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 the use of the contrast agent for a new indication and conditions of use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section #ebj7q77#a74 7#b7 ,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 ,for purposes of this subsection-- 7,a7 the term new indication means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section #ebj7q71 but that is not described in the approved labeling of the contrast agent2 and 7,b7 the term applicable medical imaging device and contrast agent have the meanings given such terms in section #ebj7q74 4 ,,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 ,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 7f7 ,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 7g7 ,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 ,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 ,july #aa1 #bjag ,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed