#aadth ,,congress #b;d ,session ,s4 #ahgh ,,an ,,act ,to extend the pediatric priority review voucher program4 #a4 ,short title ,this ,act may be cited as the ,advancing ,hope ,act of #bjaf4 #b4 ,reauthorization of program for priority review to encourage treatments for rare pediatric diseases 7a7 ,in ,general ,section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#c71 by amending subparagraph 7,a7 to read as follows3 7,a7 ,the disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to #ah years1 including age groups often called neonates1 infants1 children1 and adolescents4 2 and 7,b7 in paragraph 7#d77;,f71 by striking ,prescription ,drug ,user ,fee ,amendments of #bjab and inserting ,advancing ,hope ,act of #bjaf2 7#b7 in subsection 7b7-- 7,a7 by striking paragraph 7#d7 and inserting the following3 7#d7 ,notification 7,a7 ,sponsor of a rare pediatric disease product 7i7 ,in ,general ,beginning on the date that is #ij days after the date of enactment of the ,advancing ,hope ,act of #bjaf1 the sponsor of a rare pediatric disease product application that intends to request a priority review voucher under this section shall notify the ,secretary of such intent upon submission of the rare pediatric disease product application that is the basis of the request for a priority review voucher4 7ii7 ,applications submitted but not yet approved ,the sponsor of a rare pediatric disease product application that was submitted and that has not been approved as of the date of enactment of the ,advancing ,hope ,act of #bjaf shall be considered eligible for a priority review voucher1 if-- 7,i7 such sponsor has submitted such rare pediatric disease product application-- 7aa7 on or after the date that is #ij days after the date of enactment of the ,prescription ,drug ,user ,fee ,amendments of #bjab2 and 7bb7 on or before the date of enactment of the ,advancing ,hope ,act of #bjaf2 and 7,,ii7 such application otherwise meets the criteria for a priority review voucher under this section4 7,b7 ,sponsor of a drug application using a priority review voucher 7i7 ,in ,general ,the sponsor of a human drug application shall notify the ,secretary not later than #ij days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application1 including the date on which the sponsor intends to submit the application4 ,such notification shall be a legally binding commitment to pay the user fee to be assessed in accordance with this section4 7ii7 ,transfer after notice ,the sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under clause 7i7 may transfer the voucher after such notification is provided1 if such sponsor has not yet submitted the human drug application described in the notification4 2 and 7,b7 by striking paragraph 7#e7 and inserting the following3 7#e7 ,termination of authority ,the ,secretary may not award any priority review vouchers under paragraph 7#a7 after ,december #ca1 #bjaf4 2 and 7#c7 in subsection 7g71 by inserting before the period 1 except that no sponsor of a rare pediatric disease product application may receive more than one priority review voucher issued under any section of this ,act with respect to the drug for which the application is made4 7b7 ,rule of construction ,nothing in this ,act1 or the amendments made by this ,act1 shall be construed to affect the validity of a priority review voucher that was issued under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 before the date of enactment of this ,act4 #c4 ,,gao report 7a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the effectiveness of awarding priority review vouchers under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 in providing incentives for the development of drugs that treat or prevent rare pediatric diseases 7as defined in subsection 7a77#c7 of such section7 that would not otherwise have been developed4 ,in conducting such study1 the ,comptroller ,general shall examine the following3 7#a7 ,the indications for which each drug for which a priority review voucher was awarded under such section #ebi was approved under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a774 7#b7 ,whether the priority review voucher impacted sponsors' decisions to invest in developing a drug to treat or prevent a rare pediatric disease4 7#c7 ,an analysis of the drugs for which such priority review vouchers were used1 which shall include-- 7,a7 the indications for which such drugs were approved under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a772 7,b7 whether unmet medical needs were addressed through the approval of such drugs1 including1 for each such drug-- 7i7 if an alternative therapy was previously available to treat the indication2 and 7ii7 if the drug provided a benefit or advantage over another available therapy2 7,c7 the number of patients potentially treated by such drugs2 7,d7 the value of the priority review voucher if transferred2 and 7,e7 the length of time between the date on which a priority review voucher was awarded and the date on which it was used4 7#d7 ,with respect to the priority review voucher program under section #ebi of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7-- 7,a7 the resources used by the ,food and ,drug ,administration in implementing such program1 including the effect of such program on the ,food and ,drug ,administration's review of drugs for which a priority review voucher was not awarded or used2 7,b7 the impact of the program on the public health as a result of the review and approval of drugs that received a priority review voucher and products that were the subject of a redeemed priority review voucher2 and 7,c7 alternative approaches to improving such program so that the program is appropriately targeted toward providing incentives for the development of clinically important drugs that-- 7i7 prevent or treat rare pediatric diseases2 and 7ii7 would likely not otherwise have been developed to prevent or treat such diseases4 7b7 ,report ,not later than ,january #ca1 #bjbb1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report containing the results of the study of conducted under subsection 7a74 ,passed the ,senate ,september #bb1 #bjaf4,secretary