,,ii #aadth ,,congress #ast ,session ,s4 #bjda ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #af1 #bjae ,mr4 ,casey 7for himself1 ,mr4 ,cassidy1 and ,mr4 ,menendez7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to promote the development of safe drugs for neonates4 #a4 ,short title ,this ,act may be cited as the ,promoting ,life-,saving ,new ,therapies for ,neonates ,act of #bjae4 #b4 ,promoting the development of safe and effective therapies for neonates ,subchapter ,b of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;aa et seq47 is amended by inserting after section #ebi the following3 #ecj4 ,exclusivity to encourage development of safe and effective therapies for neonates 7a7 ,definitions ,in this section3 7#a7 ,neonatal drug ,the term neonatal drug means a drug for the prevention or treatment of a disease or condition of a preterm or full-term neonate4 7#b7 ,neonatal drug application ,the term neonatal drug application means a human drug application1 as defined in section #gce7a71 that-- 7,a7 is for a drug or biological product-- 7i7 that is for the prevention or treatment of a disease or condition listed on the ,priority ,list of ,critical ,needs for ,neonates described in subsection 7c72 and 7ii7 that contains no active ingredient 7including any ester or salt of the active ingredient7 that has been previously approved in any other application under section #eje7;b77#a71 #eje7;b77#b71 or #eje7;j7 of this ,act or section #cea7;a7 or #cea7k7 of the ,public ,health ,service ,act2 7,b7 is submitted under section #eje7;b77#a7 of this ,act or section #cea7;a7 of the ,public ,health ,service ,act2 7,c7 the ,secretary determines to be eligible for a neonatal drug exclusivity voucher1 in accordance with subsection 7b72 7,d7 relies on clinical data derived from studies examining a neonatal population and dosages of the drug intended for that population2 and 7,e7 is approved after the date of the enactment of the ,promoting ,life-,saving ,new ,therapies for ,neonates ,act of #bjae4 7#c7 ,neonatal drug exclusivity voucher ,the term neonatal drug exclusivity voucher means a voucher issued by the ,secretary to the sponsor of a neonatal drug application that entitles the holder of such voucher to one year of transferable extension of all existing patents and marketing exclusivities1 including any extensions1 for a single human drug with respect to an application submitted under section #eje7;b77#a7 or for a single human biologic product with respect to an application submitted under section #cea7;a7 of the ,public ,health ,service ,act1 including the #f-month period described in section #eje;,a1 the #d- and #e-year periods described in subsections 7c77#c77;,e77ii7 and 7j77#e77;,f77ii7 of section #eje1 the #c-year periods described in clauses 7iii7 and 7iv7 of subsection 7c77#c77;,e7 and clauses 7iii7 and 7iv7 of subsection 7j77#e77;,f7 of section #eje1 the #g-year period described in section #ebg1 the #e-year period described in section #eje;,e1 and the #ab-year period described in section #cea7k77#g74 7b7 ,neonatal drug exclusivity voucher 7#a7 ,in general ,the ,secretary shall award a neonatal drug exclusivity voucher to the sponsor of a neonatal drug application upon approval by the ,secretary of such neonatal drug application4 7#b7 ,transferability 7,a7 ,in general ,the sponsor of a neonatal drug application that receives a neonatal drug exclusivity voucher under this section may transfer 7including by sale7 the voucher to a sponsor of a human drug for which an application under section #eje7;b77#a7 or section #cea of the ,public ,health ,service ,act has been approved1 will be submitted1 or has been submitted4 7,b7 ,nontransferability ,a neonatal exclusivity voucher may not be transferred to1 or used for1 a drug with respect to which all patents and exclusivities have expired as of the date of the transfer4 7,c7 ,notification of transfer ,each person to whom a voucher is transferred shall notify the ,secretary of such change in ownership of the voucher not later than #cj calendar days after such transfer4 7,d7 ,prohibition on additional fees ,the ,secretary shall not apply a fee for the exercise of a voucher under this section4 ,the preceding sentence shall not affect the authority of the ,secretary to apply fees with respect to a neonatal drug application that are otherwise applicable under law4 7,e7 ,revocation of voucher ,the ,secretary may revoke any neonatal exclusivity voucher if the neonatal drug product for which such voucher was awarded is not marketed in the ,united ,states within the #cfe-;day period beginning on the date of the approval of such drug under section #eje of this ,act or section #cea of the ,public ,health ,service ,act4 7#c7 ,limitations 7,a7 ,no award for prior approved application ,a sponsor of a neonatal drug may not receive a voucher under this section if the neonatal drug application was submitted to the ,secretary prior to the date of enactment of this section4 7,b7 ,required ,pediatric ,research ,the ,secretary shall limit grants of exclusivity under this section to drugs that are not required to complete neonatal studies under section #eje;,b4 7,c7 ,no combining vouchers ,a sponsor may not use a neonatal exclusivity voucher on a product for which the sponsor also intends to use a voucher obtained or purchased pursuant to section #ebd or section #ebi4 7#d7 ,notification of intent to use voucher 7,a7 ,notification by sponsor ,the sponsor of a human drug application intending to use a voucher awarded or transferred under this section shall notify the ,secretary not later than #ae months prior to loss of patent and exclusivities on the drug for which the voucher will be redeemed1 in such form as the ,secretary may require4 7,b7 ,notification by ,secretary ,within #cj calendar days of such notification to the ,secretary1 the ,secretary shall notify the sponsor of its eligibility to redeem a voucher for the intended drug4 7c7 ,priority list of critical needs for neonates 7#a7 ,in general ,the ,secretary1 in consultation with the ,pediatric ,advisory ,committee1 the ,national ,institutes of ,health1 the ,international ,neonatal ,consortium sponsored by ,critical ,path ,institute1 and other stakeholders1 shall1 within one year of the date of enactment of the ,promoting ,life-,saving ,new ,therapies for ,neonates ,act of #bjae-- 7,a7 develop and publish a list of critical research priorities related to specific diseases or conditions common to the neonatal population 7referred to as the ,priority ,list of ,critical ,needs for ,neonates72 7,b7 issue guidance specific to the neonatal drug exclusivity voucher program2 and 7,c7 perform other activities necessary to support neonatal drug applications4 7#b7 ,public comment ,the ,secretary shall provide a period of public notice and comment on the proposed list and shall hold public meetings to elicit input from patient advocacy and other organizations prior to publishing the final list4 7#c7 ,subsequent update ,the ,secretary may revise1 and publish in accordance with paragraph 7#a77;,a71 the ,priority ,list of ,critical ,needs for ,neonates every #c years1 or as frequently as the ,secretary determines necessary4 7#d7 ,restriction on removal from list ,no disease or condition on the ,priority ,list of ,critical ,needs for ,neonates may be removed until after completion of the study and report under subsection 7d74 7d7 ,,gao study and report 7#a7 ,study 7,a7 ,in general ,beginning #h years after the date of enactment of the ,promoting ,life-,saving ,new ,therapies for ,neonates ,act of #bjae or on the date that the ,secretary awards the third neonatal exclusivity voucher under this section1 whichever is earlier1 the ,comptroller ,general of the ,united ,states shall conduct a study of the effectiveness of the program under this section for the development of human drugs to treat and prevent diseases or conditions in the neonatal population4 7,b7 ,contents of the study ,in conducting the study under subparagraph 7,a71 the ,comptroller ,general shall examine the following3 7i7 ,the number of neonatal drug vouchers awarded under this section4 7ii7 ,the indications for each drug for which a neonatal exclusivity voucher was approved under section #eje or section #cea of the ,public ,health ,service ,act1 and whether any other drugs with indications for populations other than neonates were approved with an indication for neonates under those sections4 7iii7 ,whether1 and to what extent1 an unmet need related to the treatment or prevention of a disease or condition that affects the neonatal population was met through the approval of a neonatal drug4 7iv7 ,the value of the neonatal exclusivity voucher if transferred4 7v7 ,identification of each drug for which a neonatal exclusivity voucher was used4 7vi7 ,the length of the period of time between the date on which a neonatal exclusivity voucher was awarded and the date on which it was used4 7#b7 ,report ,not later than #a year after the date under paragraph 7#a77;,a71 the ,comptroller ,general 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 under paragraph 7#a74 4