,i #aagth ,,congress #b;d ,session ,h4 ,r4 #figb ,,in ,,the ,,house ,,of ,,representatives ,march #h1 #bjbb,mr4 ,butterfield 7for himself and ,mr4 ,mc,caul7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to establish additional authorities of the ,food and ,drug ,administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,give ,kids a ,chance ,act of #bjbb4 #b4 ,research into pediatric uses of drugs2 additional authorities of ,food and ,drug ,administration regarding molecularly targeted cancer drugs 7a7 ,in general 7#a7 ,authority regarding investigation of novel combination drugs ,section #eje;,b7a77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a77;,b77 is amended1 in the matter preceding clause 7i71 by inserting after ,public ,health ,service ,act1 the following3 or an application under such section #eje or such section #cea for a drug or biological product that contains a novel combination of two or more active ingredients 7subject to paragraph 7#c77;,b77iii774 7#b7 ,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 the active ingredient or ingredients of such drug or biological product in combination with-- 7,i7 an active ingredient of a drug for which an approved application under section #eje7;j7 is in effect or an active ingredient of a biological product for which an approved application under section #cea7k7 of the ,public ,health ,service ,act is in effect1 which drug or biological product is determined by the ,secretary to be the standard of care for treating a pediatric cancer2 7,,ii7 an active ingredient of a drug for which an approved application under section #eje7;b7 is in effect to treat an adult cancer1 or an active ingredient of a biological product for which an approved application under section #cea7;a7 of the ,public ,health ,service ,act is in effect to treat an adult cancer1 which approved application is held by the same person submitting the application referred to in paragraph 7#a77;,b72 or 7,,iii7 an active ingredient of a drug or biological product for which there is in effect an exemption for investigational use under section #eje7;i71 which drug or biological product is under such exemption being studied jointly by the person submitting the application referred to in paragraph 7#a77;,b7 and by another person pursuant to an agreement between such persons4 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 data1 gathered using appropriate formulations for each age group for which the study is required1 regarding dosing1 safety1 and preliminary efficacy4 7ii7 ,purpose of investigation ,the purpose of a molecularly targeted pediatric cancer investigation referred to in subparagraph 7,a7 shall be-- 7,i7 in the case of such an investigation conducted with respect to a drug or biological product referred to in clause 7i7 of such subparagraph1 to inform potential pediatric labeling of the drug or biological product for which the application referred to in paragraph 7#a77;,b7 is submitted2 and 7,,ii7 in the case of such an investigation conducted with respect to a combination of active ingredients described to in clause 7ii7 of such subparagraph1 to assist in determining the relevance of its molecular target to the growth or progression of a pediatric cancer4 7iii7 ,limitation regarding investigation of novel combination ,for purposes of paragraph 7#a77;,b71 a novel combination is a combination of two or more active ingredients for which an application under section #eje of this ,act or section #cea of the ,public ,health ,service ,act for such combination has not previously been approved4 ,a pediatric investigation under this paragraph of such novel combination is required only if each of the active ingredients in the combination has been approved under such section #eje or such section #cea to treat an adult cancer4 7iv7 ,preclinical data ,the ,secretary may require that reports on an investigation required pursuant to paragraph 7#a77;,b7 shall include the results of all preclinical studies on which the decision to conduct such investigation was based4 7v7 ,rule of construction regarding inactive ingredients ,with respect to a combination of active ingredients referred to in subparagraph 7,a77ii71 such subparagraph may not be construed as addressing the use of inactive ingredients with such combination4 4 7#c7 ,clarifying applicability of certain provisions ,section #eje;,b7a77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#c771 as amended by paragraph 7#b71 is further amended by adding at the end the following3 7,e7 ,internal committee review2 labeling changes2 dissemination of information2 adverse events2 scope of authority ,subsections 7f7 through 7j7 shall apply with respect to investigations described in this paragraph to the same extent and in the same manner as such subsections apply with respect to the assessments required under paragraph 7#a77;,a71 except that subsection 7g7 does not apply with respect to an investigation referred to in subparagraph 7,a77ii7 of this paragraph4 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#b77;,a7 of this subsection1 by striking investigations described in this paragraph and inserting investigations referred to in subparagraph 7,a77i72 7,b7 in paragraph 7#c77;,d71 as redesignated by paragraph 7#b77;,a7 of this subsection1 by striking the assessments under paragraph 7#b77;,b7 and inserting the assessments required under paragraph 7#a77;,a72 and 7,c7 in paragraph 7#e77;,d71 by inserting before the period at the end the following3 1 except this subparagraph is not applicable to an investigation referred to in paragraph 7#c77;,a77ii74 7b7 ,authority regarding preclinical studies ,section #eje;,b7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7a77#a771 as amended by subsection 7a77#a71 is further amended by adding at the end the following3 7,c7 ,preclinical studies generally 7i7 ,in general ,with respect to an application for an exemption for investigational use under section #eje7;i7 for a drug or biological product that is intended for the treatment of an adult cancer1 the ,secretary may require1 as a condition of permitting the exemption to go into effect1 that the sponsor involved enter into an agreement with the ,secretary to conduct not more than two preclinical studies of the drug or biological product in order to assist in determining the relevance of its molecular target to the growth or progression of a pediatric cancer4 7ii7 ,timeframe for preclinical studies ,with respect to the drug or biological product involved1 an agreement under clause 7i7 for a preclinical study shall specify the date by which an initial plan for the study will be submitted to the ,secretary except that the ,secretary may not require the submission of such plan any earlier than one year after the exemption referred to in clause 7i7 goes into effect4 ,the results of the preclinical study shall be submitted to the ,secretary in accordance with a timeframe to which the ,secretary and the sponsor involved have agreed4 ,such timeframe shall provide for deferrals equivalent to deferrals under paragraph 7#d74 4 7c7 ,applicability ,the amendments made by this section apply with respect to any application under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i771 any application under section #eje of such ,act 7#ba ,u4,s4,c4 #cee71 and any application under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 that is submitted on or after the expiration of the #c-year period beginning on the date of the enactment of this ,act4