,,ib ,union ,calendar ,no4 #eid #aahth ,,congress #b;d ,session ,h4 ,r4 #cdcc ,report ,no4 #aah-gjj ,,in ,,the ,,house ,,of ,,representatives ,may #ag1 #bjbc,mr4 ,mc,caul 7for himself1 ,ms4 ,eshoo1 ,mr4 ,kelly of ,pennsylvania1 ,mrs4 ,kim of ,california1 ,mr4 ,smith of ,new ,jersey1 ,ms4 ,schrier1 ,mr4 ,bacon1 ,mr4 ,moylan1 ,mr4 ,buchanan1 ,mr4 ,fitzpatrick1 ,mr4 ,huizenga1 ,mr4 ,grothman1 ,mr4 ,johnson of ,ohio1 and ,mr4 ,phillips7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,september #bj1 #bjbd;,additional sponsors3 ,ms4 ,kuster1 ,mr4 ,wilson of ,south ,carolina1 ,ms4 ,salazar1 ,mr4 ,neguse1 ,mr4 ,la,lota1 ,mr4 ,valadao1 ,mr4 ,mullin1 ,mr4 ,waltz1 ,mr4 ,allred1 ,mr4 ,lawler1 ,ms4 ,castor of ,florida1 ,ms4 ,ross1 ,ms4 ,lofgren1 ,mr4 ,crdenas1 ,mr4 ,calvert1 ,mr4 ,kilmer1 ,mr4 ,rouzer1 ,mr4 ,davis of ,north ,carolina1 ,ms4 ,mace1 ,ms4 ,pettersen1 ,ms4 ,leger ,fernandez1 ,ms4 ,perez1 ,ms4 ,caraveo1 ,mr4 ,pappas1 ,mr4 ,jackson of ,north ,carolina1 ,mr4 ,rutherford1 ,mr4 ,owens1 ,mr4 ,baird1 ,mr4 ,nehls1 ,mr4 ,schneider1 ,mr4 ,van ,drew1 ,mr4 ,smith of ,nebraska1 ,mr4 ,bean of ,florida1 ,mr4 ,westerman1 ,mr4 ,ferguson1 ,mr4 ,yakym1 ,ms4 ,sewell1 ,mr4 ,kean of ,new ,jersey1 ,mr4 ,casten1 ,ms4 ,de ,la ,cruz1 ,mr4 ,steube1 ,mr4 ,lamborn1 ,mr4 ,cohen1 ,ms4 ,titus1 ,ms4 ,brown1 ,mr4 ,veasey1 ,ms4 ,slotkin1 ,mr4 ,garbarino1 ,mr4 ,luetkemeyer1 ,mr4 ,peters1 ,mr4 ,mc,garvey1 ,mr4 ,lieu1 ,mr4 ,zinke1 ,mr4 ,harder of ,california1 ,mr4 ,gooden of ,texas1 ,mr4 ,grijalva1 ,mr4 ,norman1 ,ms4 ,blunt ,rochester1 ,mr4 ,mc,govern1 ,mr4 ,moulton1 ,mr4 ,quigley1 ,mr4 ,crow1 ,mr4 ,la,hood1 ,mr4 ,thanedar1 ,mr4 ,gottheimer1 ,mr4 ,moskowitz1 ,mr4 ,swalwell1 ,mr4 ,austin ,scott of ,georgia1 ,mr4 ,bera1 ,mr4 ,diaz-,balart1 ,ms4 ,budzinski1 ,mr4 ,aderholt1 ,ms4 ,tokuda1 ,ms4 ,granger1 ,mr4 ,cline1 ,mr4 ,finstad1 ,ms4 ,velzquez1 ,mr4 ,nunn of ,iowa1 ,ms4 ,wasserman ,schultz1 ,mr4 ,trone1 ,mr4 ,tonko1 ,mrs4 ,trahan1 ,mr4 ,carl1 ,ms4 ,matsui1 ,mr4 ,keating1 ,ms4 ,houlahan1 ,mrs4 ,miller of ,west ,virginia1 ,mrs4 ,foushee1 ,mrs4 ,watson ,coleman1 ,mr4 ,thompson of ,pennsylvania1 ,mr4 ,carey1 ,mr4 ,nickel1 ,mr4 ,fleischmann1 ,mr4 ,donalds1 ,ms4 ,waters1 ,mr4 ,ivey1 ,mr4 ,sablan1 ,mrs4 ,cherfilus-,mc,cormick1 ,mrs4 ,napolitano1 ,mr4 ,lynch1 ,mr4 ,correa1 ,mr4 ,goldman of ,new ,york1 ,mr4 ,deluzio1 ,mr4 ,raskin1 ,mr4 ,mike ,garcia of ,california1 ,mr4 ,larson of ,connecticut1 ,mr4 ,panetta1 ,ms4 ,del,bene1 ,mrs4 ,fletcher1 ,mr4 ,arrington1 ,ms4 ,brownley1 ,mr4 ,sessions1 ,mr4 ,la,malfa1 ,mr4 ,amodei1 ,mr4 ,d',esposito1 ,mr4 ,scott ,franklin of ,florida1 ,ms4 ,jacobs1 ,mr4 ,costa1 ,mr4 ,graves of ,missouri1 ,ms4 ,meng1 ,ms4 ,wild1 ,ms4 ,norton1 ,mr4 ,kim of ,new ,jersey1 ,mr4 ,de,saulnier1 ,ms4 ,pingree1 ,mr4 ,takano1 ,ms4 ,clarke of ,new ,york1 ,mr4 ,khanna1 ,ms4 ,lee of ,pennsylvania1 ,mr4 ,kildee1 ,mrs4 ,dingell1 ,ms4 ,malliotakis1 ,mr4 ,mills1 ,ms4 ,spanberger1 ,ms4 ,stansbury1 ,mr4 ,burchett1 ,mr4 ,kelly of ,mississippi1 ,mr4 ,jackson of ,illinois1 ,mr4 ,soto1 ,mr4 ,castro of ,texas1 ,mrs4 ,bice1 ,mr4 ,mooney1 ,mr4 ,mann1 ,ms4 ,scanlon1 ,ms4 ,porter1 ,mr4 ,bucshon1 ,ms4 ,craig1 ,mr4 ,ruiz1 ,mr4 ,cuellar1 ,mr4 ,carter of ,louisiana1 ,mr4 ,flood1 ,mrs4 ,hayes1 ,mr4 ,clyde1 ,ms4 ,jayapal1 ,mr4 ,la,turner1 ,ms4 ,letlow1 ,ms4 ,kamlager-,dove1 ,mr4 ,pocan1 ,ms4 ,wexton1 ,ms4 ,sherrill1 ,ms4 ,strickland1 ,mrs4 ,kiggans of ,virginia1 ,ms4 ,barragn1 ,mr4 ,higgins of ,louisiana1 ,mr4 ,sorensen1 ,ms4 ,crockett1 ,mr4 ,ciscomani1 ,mr4 ,alford1 ,mr4 ,kiley1 ,mr4 ,smucker1 ,mr4 ,mc,henry1 ,mr4 ,james1 ,ms4 ,stefanik1 ,mr4 ,mc,cormick1 ,mrs4 ,miller of ,illinois1 ,mr4 ,meuser1 ,mrs4 ,harshbarger1 ,ms4 ,davids of ,kansas1 ,mr4 ,williams of ,new ,york1 ,mr4 ,krishnamoorthi1 ,mr4 ,morelle1 ,ms4 ,tenney1 ,mr4 ,posey1 ,mr4 ,weber of ,texas1 ,mr4 ,schweikert1 ,mr4 ,gimenez1 ,mr4 ,vicente ,gonzalez of ,texas1 ,ms4 ,bush1 ,mrs4 ,hinson1 ,mr4 ,des,jarlais1 ,mr4 ,miller of ,ohio1 ,mr4 ,jackson of ,texas1 ,mr4 ,boyle of ,pennsylvania1 ,ms4 ,williams of ,georgia1 ,mr4 ,robert ,garcia of ,california1 ,ms4 ,de,gette1 ,mrs4 ,luna1 ,mr4 ,carbajal1 ,mr4 ,thompson of ,mississippi1 ,mr4 ,suozzi1 ,mr4 ,garamendi1 ,ms4 ,bonamici1 ,ms4 ,kaptur1 ,ms4 ,mc,collum1 ,ms4 ,jackson ,lee1 ,mr4 ,cleaver1 ,mr4 ,espaillat1 ,ms4 ,moore of ,wisconsin1 ,mr4 ,nadler1 ,mr4 ,sarbanes1 ,ms4 ,salinas1 ,mrs4 ,beatty1 ,mr4 ,garca of ,illinois1 ,mr4 ,norcross1 ,ms4 ,mc,clellan1 ,ms4 ,lee of ,california1 ,mr4 ,bilirakis1 ,ms4 ,schakowsky1 ,mr4 ,evans1 ,ms4 ,scholten1 ,mr4 ,levin1 and ,mr4 ,wittman ,september #bj1 #bjbd,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 #ag1 #bjbc ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to molecularly targeted pediatric cancer investigations1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,give ,kids a ,chance ,act of #bjbd4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,title ,i--,give ,kids a ,chance,sec4 #aja4 ,research into pediatric uses of drugs2 additional authorities of ,food and ,drug ,administration regarding molecularly targeted cancer drugs4,sec4 #ajb4 ,ensuring completion of pediatric study requirements4,sec4 #ajc4 ,,fda report on ,,prea enforcement4,sec4 #ajd4 ,extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases4,sec4 #aje4 ,limitations on exclusive approval or licensure of orphan drugs4,sec4 #ajf4 ,program for pediatric studies of drugs4,title ,,ii--,united ,states-,abraham ,accords ,cooperation and ,security,sec4 #bja4 ,establishment of ,abraham ,accords ,office within ,food and ,drug ,administration4,title ,,iii--,organ ,procurement and ,transplantation ,network,sec4 #cja4 ,registration fees4 ,i ,give ,kids a ,chance #aja4 ,research into pediatric uses of drugs2 additional authorities of ,food and ,drug ,administration regarding molecularly targeted cancer drugs 7a7 ,in general 7#a7 ,additional active ingredient for application drug2 limitation regarding novel-combination application drug ,section #eje;,b7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c77 is amended-- 7,a7 by redesignating subparagraphs 7,b7 and 7,c7 as subparagraphs 7,c7 and 7,d71 respectively2 and 7,b7 by striking subparagraph 7,a7 and inserting the following3 7,a7 ,in general ,for purposes of paragraph 7#a77;,b71 the investigation described in this paragraph is 7as determined by the ,secretary7 a molecularly targeted pediatric cancer investigation of-- 7i7 the drug or biological product for which the application referred to in such paragraph is submitted2 or 7ii7 such drug or biological product in combination with-- 7,i7 an active ingredient of a drug or biological product-- 7aa7 for which an approved application under section #eje7;j7 under this ,act or under section #cea7k7 of the ,public ,health ,service ,act is in effect2 and 7bb7 that is determined by the ,secretary to be the standard of care for treating a pediatric cancer2 or 7,,ii7 an active ingredient of a drug or biological product-- 7aa7 for which an approved application under section #eje7;b7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph 7#a77;,b72 and 7bb7 that is directed at a molecular target that the ,secretary determines to be substantially relevant to the growth or progression of a pediatric cancer4 7,b7 ,additional requirements 7i7 ,design of investigation ,a molecularly targeted pediatric cancer investigation referred to in subparagraph 7,a7 shall be designed to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required1 regarding dosing1 safety1 and preliminary efficacy to inform potential pediatric labeling4 7ii7 ,limitation ,an investigation described in subparagraph 7,a77ii7 may be required only if the drug or biological product for which the application referred to in paragraph 7#a77;,b7 contains either-- 7,i7 a single new active ingredient2 or 7,,ii7 more than one active ingredient1 if an application for the combination of active ingredients has not previously been approved but each active ingredient has been previously approved to treat an adult cancer4 7iii7 ,results of already-completed preclinical studies of application drug ,the ,secretary may require that reports on an investigation required pursuant to paragraph 7#a77;,b7 include the results of all preclinical studies on which the decision to conduct such investigation was based4 7iv7 ,rule of construction regarding inactive ingredients ,with respect to a combination of active ingredients referred to in subparagraph 7,a77ii71 such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination4 4 7#b7 ,determination of applicable requirements ,section #eje;,b7e77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#a77 is amended by adding at the end the following3 ,the ,secretary shall determine whether subparagraph 7,a7 or 7,b7 of subsection 7a77#a7 shall apply with respect to an application before the date on which the applicant is required to submit the initial pediatric study plan under paragraph 7#b77;,a744 7#c7 ,clarifying applicability ,section #eje;,b7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77 is amended by adding at the end the following3 7,c7 ,rule of construction ,no application that is subject to the requirements of subparagraph 7,b7 shall be subject to the requirements of subparagraph 7,a71 and no application 7or supplement to an application7 that is subject to the requirements of subparagraph 7,a7 shall be subject to the requirements of subparagraph 7,b74 4 7#d7 ,conforming amendments ,section #eje;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77 is amended-- 7,a7 in paragraph 7#c77;,c71 as redesignated by paragraph 7#a77;,a7 of this subsection1 by striking investigations described in this paragraph and inserting investigations referred to in subparagraph 7,a72 and 7,b7 in paragraph 7#c77;,d71 as redesignated by paragraph 7#a77;,a7 of this subsection1 by striking the assessments under paragraph 7#b77;,b7 and inserting the assessments required under paragraph 7#a77;,a74 7b7 ,guidance ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall-- 7#a7 not later than #ab months after the date of enactment of this ,act1 issue draft guidance on the implementation of the amendments made by subsection 7a72 and 7#b7 not later than #ab months after closing the comment period on such draft guidance1 finalize such guidance4 7c7 ,applicability ,the amendments made by this section apply with respect to any application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 and any application under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 that is submitted on or after the date that is #c years after the date of enactment of this ,act4 7d7 ,reports to ,congress 7#a7 ,secretary of ,health and ,human ,services ,not later than #b years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the ,secretary's efforts1 in coordination with industry1 to ensure implementation of the amendments made by subsection 7a74 7#b7 ,,gao study and report 7,a7 ,study ,not later than #c years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of requiring assessments and investigations described in section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4#cee;c71 as amended by subsection 7a71 in the development of drugs and biological products for pediatric cancer indications4 7,b7 ,findings ,not later than #g years after the date of enactment of this ,act1 the ,comptroller ,general shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report containing the findings of the study conducted under subparagraph 7,a74 #ajb4 ,ensuring completion of pediatric study requirements 7a7 ,equal accountability for pediatric study requirements ,section #eje;,b7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d77 is amended-- 7#a7 in paragraph 7#a71 by striking ,beginning #bgj and inserting ,noncompliance letter4--,beginning #bgj2 7#b7 in paragraph 7#b7-- 7,a7 by striking ,the drug or and inserting ,effect of noncompliance4--,the drug or2 and 7,b7 by striking 7except that the drug or biological product shall not be subject to action under section #cjc7 and inserting 7except that the drug or biological product shall be subject to action under section #cjc only if such person demonstrated a lack of due diligence in satisfying the applicable requirement72 and 7#c7 by adding at the end the following3 7#c7 ,limitation ,the ,secretary shall not issue enforcement actions under section #cjc for failures under this subsection in the case of a drug or biological product that is no longer marketed4 4 7b7 ,due diligence ,section #eje;,b7d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7d771 as amended by subsection 7a71 is further amended by adding at the end the following3 7#d7 ,due diligence ,before the ,secretary may conclude that a person failed to submit or otherwise meet a requirement as described in the matter preceding paragraph 7#a71 the ,secretary shall-- 7,a7 issue a noncompliance letter pursuant to paragraph 7#a72 7,b7 provide such person with a #de-;day period beginning on the date of receipt of such noncompliance letter to respond in writing as set forth in such paragraph2 and 7,c7 after reviewing such written response1 determine whether the person demonstrated a lack of due diligence in satisfying such requirement4 4 7c7 ,conforming amendments ,section #cjc7;f77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f77#d77;,a77 is amended by striking or #eje-a and inserting #eje-a1 or #eje;,b4 7d7 ,transition rule ,the ,secretary of ,health and ,human ,services may take enforcement action under section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 only for failures described in section #eje;,b7d7 of such ,act 7#ba ,u4,s4,c4 #cee;c7d77 that occur on or after the date that is #ahj days after the date of enactment of this ,act4 #ajc4 ,,fda report on ,,prea enforcement ,section #ejh7;b7 of the ,food and ,drug ,administration ,safety and ,innovation ,act 7#ba ,u4,s4,c4 #cee;c-#a7;b77 is amended-- 7#a7 in paragraph 7#aa71 by striking the semicolon at the end and inserting 1 including an evaluation of compliance with deadlines provided for in deferrals and deferral extensions22 7#b7 in paragraph 7#ae71 by striking and at the end2 7#c7 in paragraph 7#af71 by striking the period at the end and inserting 2 and2 and 7#d7 by adding at the end the following3 7#ag7 a listing of penalties1 settlements1 or payments under section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 for failure to comply with requirements under such section #eje;,b1 including1 for each penalty1 settlement1 or payment1 the name of the drug1 the sponsor thereof1 and the amount of the penalty1 settlement1 or payment imposed2 and 4 #ajd4 ,extension of authority to issue priority review vouchers to encourage treatments for rare pediatric diseases 7a7 ,extension ,paragraph 7#e7 of section #ebi7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7b77 is amended by striking ,september #cj1 #bjbd1 unless and all that follows through the period at the end and inserting ,september #cj1 #bjbi44 7b7 ,,gao report on effectiveness of rare pediatric disease priority voucher awards in incentivizing rare pediatric disease drug development 7#a7 ,,gao study 7,a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of awarding rare pediatric disease priority vouchers under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff71 as amended by subsection 7a71 in the development of human drug products that treat or prevent rare pediatric diseases 7as defined in such section #ebi74 7,b7 ,contents of study ,in conducting the study under subparagraph 7,a71 the ,comptroller ,general shall examine the following3 7i7 ,the indications for each drug or biological product that-- 7,i7 is the subject of a rare pediatric disease product application 7as defined in section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff77 for which a priority review voucher was awarded2 and 7,,ii7 was approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7ii7 ,whether1 and to what extent1 an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval or licensure of such a drug or biological product4 7iii7 ,the size of the company to which a priority review voucher was awarded under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 for such a drug or biological product4 7iv7 ,the value of such priority review voucher if transferred4 7v7 ,identification of each drug for which a priority review voucher awarded under such section #ebi was used4 7vi7 ,the size of the company using each priority review voucher awarded under such section #ebi4 7vii7 ,the length of the period of time between the date on which a priority review voucher was awarded under such section #ebi and the date on which it was used4 7viii7 ,whether1 and to what extent1 an unmet need related to the treatment or prevention of a rare pediatric disease was met through the approval under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#db ,u4,s4,c4 #cee7 or licensure under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 of a drug for which a priority review voucher was used4 7ix7 ,whether1 and to what extent1 companies were motivated by the availability of priority review vouchers under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 to attempt to develop a drug for a rare pediatric disease4 7x7 ,whether1 and to what extent1 pediatric review vouchers awarded under such section were successful in stimulating development and expedited patient access to drug products for treatment or prevention of a rare pediatric disease that wouldn't otherwise take place without the incentive provided by such vouchers4 7xi7 ,the impact of such priority review vouchers on the workload1 review process1 and public health prioritization efforts of the ,food and ,drug ,administration4 7xii7 ,any other incentives in ,federal law that exist for companies developing drugs or biological products described in clause 7i74 7#b7 ,report on findings ,not later than #e years after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report containing the findings of the study conducted under paragraph 7#a74 #aje4 ,limitations on exclusive approval or licensure of orphan drugs 7a7 ,in general ,section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 is amended-- 7#a7 in subsection 7a71 in the matter following paragraph 7#b71 by striking same disease or condition and inserting same approved use or indication within such rare disease or condition2 7#b7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking same rare disease or condition and inserting same approved use or indication for which such #g-year period applies to such already approved or licensed drug2 and 7,b7 in paragraph 7#a71 by inserting 1 relating to the approved use or indication1 after the needs2 7#c7 in subsection 7c77#a71 by striking same rare disease or condition as the already approved drug and inserting same use or indication for which the already approved or licensed drug was approved or licensed2 and 7#d7 by adding at the end the following3 7f7 ,approved use or indication defined ,in this section1 the term approved use or indication means the use or indication approved under section #eje of this ,act or licensed under section #cea of the ,public ,health ,service ,act for a drug designated under section #ebf for a rare disease or condition4 4 7b7 ,application of amendments ,the amendments made by subsection 7a7 shall apply with respect to any drug designated under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb71 regardless of the date on which the drug was so designated1 and regardless of the date on which the drug was approved under section #eje of such ,act 7#ba ,u4,s4,c4 #cee7 or licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 #ajf4 ,program for pediatric studies of drugs ,section #dji;,i7d7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhdm7d77 is amended to read as follows3 7d7 ,funding ,of the amount made available for pediatric research to each national research institute and national center under this title for each of fiscal years #bjbe1 #bjbf1 and #bjbg1 the ,director of ,,nih is authorized to make available up to one percent of such amount for pediatric research under this section4 4 ,,ii ,united ,states-,abraham ,accords ,cooperation and ,security #bja4 ,establishment of ,abraham ,accords ,office within ,food and ,drug ,administration 7a7 ,in general ,chapter ,x of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cia et seq47 is amended by adding at the end the following3 #ajae4 ,abraham ,accords ,office 7a7 ,in general ,the ,secretary1 acting through the ,commissioner of ,food and ,drugs1 shall establish within the ,food and ,drug ,administration an office1 to be known as the ,abraham ,accords ,office1 to be headed by a director4 7b7 ,office ,not later than two years after the date of enactment of this section1 the ,secretary shall-- 7#a7 in consultation with the governments of ,abraham ,accords countries1 as well as appropriate ,united ,states ,government diplomatic and security personnel-- 7,a7 select the location of the ,abraham ,accords ,office in an ,abraham ,accords country2 and 7,b7 establish such office2 and 7#b7 assign to such office such personnel of the ,food and ,drug ,administration as the ,secretary determines necessary to carry out the functions of such office4 7c7 ,duties ,the ,secretary1 acting through the ,director of the ,abraham ,accords ,office1 shall-- 7#a7 after the ,abraham ,accords ,office is established-- 7,a7 as part of the ,food and ,drug ,administration's work to strengthen the international oversight of regulated commodities1 provide technical assistance to regulatory partners in ,abraham ,accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products1 including good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the ,food and ,drug ,administration2 7,b7 facilitate interactions between the ,food and ,drug ,administration and interested parties in ,abraham ,accords countries1 including by sharing relevant information regarding ,united ,states regulatory pathways with such parties2 and 7,c7 facilitate feedback between the ,food and ,drug ,administration and such parties located within ,abraham ,accords countries prior to submission of an application under section #eje7;b71 #eje7;j71 or #eae of this ,act or section #cea7;a7 or #cea7k7 of the ,public ,health ,service ,act1 or a notification under section #eaj7k7 of this ,act1 such as feedback on research1 development1 and manufacturing of drugs1 biologics1 and medical devices2 and 7#b7 carry out other functions and activities as the ,secretary determines to be necessary to carry out this section4 7d7 ,abraham ,accords country defined ,in this section1 the term ,abraham ,accords country means a country identified by the ,department of ,state as having signed the ,abraham ,accords ,declaration4 4 7b7 ,report to ,congress 7#a7 ,in general ,not later than #c years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall submit to the ,congress a report on the ,abraham ,accords ,office1 including-- 7,a7 an evaluation of how the ,office has advanced progress toward conformance with ,food and ,drug ,administration regulatory requirements by manufacturers in the ,abraham ,accords countries2 7,b7 a numerical count of parties that the ,office has helped facilitate interactions or feedback pursuant to subparagraphs 7,b7 and 7,c7 of section #ajae7;c77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a772 7,c7 a summary of technical assistance provided to regulatory partners in ,abraham ,accords countries pursuant to subparagraph 7,a7 of such section #ajae7;c77#a72 and 7,d7 recommendations for increasing and improving coordination between the ,food and ,drug ,administration and entities in ,abraham ,accords countries4 7#b7 ,abraham ,accords country defined ,in this subsection1 the term ,abraham ,accords country has the meaning given such term in section #ajae7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a774 ,,iii ,organ ,procurement and ,transplantation ,network #cja4 ,registration fees ,section #cgb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bgd7 is amended by adding at the end the following3 7d7 ,registration fees 7#a7 ,in general ,the ,secretary may collect registration fees from any member of the ,organ ,procurement and ,transplantation ,network for each transplant candidate such member places on the list described in subsection 7b77#b77;,a77i74 ,such registration fees shall only be collected and distributed to support the operation of the ,organ ,procurement and ,transplantation ,network4 ,such registration fees are authorized to remain available until expended4 7#b7 ,collection ,the ,secretary may collect the registration fees under paragraph 7#a7 directly or through awards made under subsection 7b77#a77;,a74 7#c7 ,distribution ,the ,secretary may distribute such fees among the awardees described in subsection 7b77#a77;,a74 7#d7 ,transparency ,the ,secretary shall-- 7,a7 promptly post on the ,internet website of the ,organ ,procurement and ,transplant ,network-- 7i7 the amount of registration fees collected under this subsection from each member of the ,organ ,procurement and ,transplantation ,network2 and 7ii7 a list of activities such fees are used to support2 and 7,b7 update the information posted pursuant to subparagraph 7,a71 as applicable for each calendar quarter for which fees are collected under paragraph 7#a74 7#e7 ,,gao review ,not later than #b years after the date of enactment of this subsection1 the ,comptroller ,general of the ,united ,states shall1 to the extent data are available-- 7,a7 conduct a review concerning the activities under this subsection2 and 7,b7 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,finance of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report on such review1 including related recommendations1 as applicable4 4 ,september #bj1 #bjbd,reported with an amendment1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed