,,ii #aadth ,,congress #b;d ,session ,s4 #cbci ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ad1 #bjaf,mr4 ,bennet 7for himself and ,mr4 ,rubio7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to establish a program to provide additional incentives for the development of new drugs to treat pediatric cancers1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,research to ,accelerate ,cures and ,equity for ,children ,act or the ,,race for ,children ,act4 #b4 ,required pediatric assessments 7a7 ,molecular targets regarding cancer drugs ,section #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7 is amended-- 7#a7 in subsection 7a77#a7-- 7,a7 in subparagraph 7,a71 by striking or at the end2 7,b7 in subparagraph 7,b71 by inserting or after administration12 and 7,c7 by inserting after subparagraph 7,b7 the following3 7,c7 under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 as described in subparagraph 7,a7 or 7,b71 that is directed at a molecular target present in one or more cancers in one or more pediatric populations1 2 and 7#b7 in subsection 7b77#a7-- 7,a7 by amending subparagraph 7,a77i7 to read as follows3 7,a7 7i7 the drug or biological product is used for a substantial number of pediatric patients-- 7,i7 for the labeled indications2 or 7,,ii7 with respect to #a or more specific molecular targets present in cancers in pediatric populations2 and 2 7,b7 by amending subparagraph 7,b7 to read as follows3 7,b7 there is reason to believe that the drug or biological product would represent a meaningful therapeutic benefit over existing therapies for pediatric patients-- 7i7 for #a or more of the claimed indications2 or 7ii7 with respect to #a or more specific molecular targets present in cancers in pediatric populations2 or 2 and 7,c7 by amending paragraph 7#b7 of subsection 7c7 to read as follows3 7#b7 the drug or biological product is in a class of products1 is for an indication1 or is directed at a specific molecular target present in cancers in pediatric populations1 for which there is need for additional options4 4 7b7 ,early meeting on pediatric study plan 7#a7 ,in general ,clause 7i7 of section #eje;,b7e77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77#b77;,c77 is amended to read as follows3 7i7 shall meet with the applicant-- 7,i7 if requested by the applicant with respect to a drug that is directed at a molecular target that is present in one or more cancers in one or more pediatric populations1 as described in subsection 7a77#a77;,c71 to discuss1 not later than the end-of-,phase #a meeting 7as such term is used in section #cab4hb7;b7 of title #ba1 ,code of ,federal ,regulations1 or successor regulations71 preparation of the initial pediatric study plan2 7,,ii7 to discuss the initial pediatric study plan as soon as practicable1 but not later than #ij calendar days after the receipt of such plan under subparagraph 7,a72 and 7,,iii7 to discuss any scientific or operational challenges that may be the basis of a deferral under subsection 7a77#c7 or a full or partial waiver under subsection 7a77#d72 4 7#b7 ,conforming changes ,section #eje;,b7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77 is amended-- 7,a7 in the heading of paragraph 7#b71 by striking meeting and inserting meetings2 7,b7 in the heading of paragraph 7#b77;,c71 by striking ,meeting and inserting ,meetings2 7,c7 in clauses 7ii7 and 7iii7 of paragraph 7#b77;,c71 by striking no meeting each place it appears and inserting no meeting under clause 7i77,,ii72 and 7,d7 in paragraph 7#c7 by striking meeting under paragraph 7#b77;,c77i7 and inserting meeting under paragraph 7#b77;,c77i77,,ii74 7c7 ,orphan drugs ,section #eje;,b7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7k77 is amended by inserting except in the case of a drug or biological product that is the subject of an application described in subsection 7a77#a77;,c71 after regulation14 7d7 ,guidance ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue guidance on the implementation of this section 7including the amendments made by this section71 including study designs and molecular targets likely to be present in one or more cancers in pediatric populations that are appropriate for assessment under the amendments made by this ,act4 7e7 ,applicability ,this ,act and the amendments made by this ,act apply with respect to applications for a drug submitted under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 on or after the date that is #ah months after the date of enactment of this ,act4 7f7 ,report to ,congress ,not later than ,july #ab1 #bjba1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall submit to ,congress a report on the implementation of the amendments made by this section1 together with any recommendations of the ,secretary regarding such amendments4 7g7 ,rule of construction ,nothing in this ,act1 including the amendments made by this ,act1 shall limit the authority of the ,secretary of ,health and ,human ,services to issue written requests under section #eje;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a74