I 

117TH CONGRESS 

2D SESSION H. R. 6972 

To amend the Federal Food, Drug, 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 cancer, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 8, 2022 

Mr. BUTTERFIELD (for himself and Mr. MCCAUL) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, 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 cancer, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Give Kids a Chance 

5 Act of 2022’’. 


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1 SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDI2 TIONAL AUTHORITIES OF FOOD AND DRUG 

3 ADMINISTRATION REGARDING MOLECU4 LARLY TARGETED CANCER DRUGS. 

5 (a) IN GENERAL.— 

6 (1) AUTHORITY REGARDING INVESTIGATION OF

7 NOVEL COMBINATION DRUGS.—Section 

8 505B(a)(1)(B) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 355c(a)(1)(B)) is amended, in 

10 the matter preceding clause (i), by inserting after 

11 ‘‘Public Health Service Act,’’ the following: ‘‘or an 

12 application under such section 505 or such section 

13 351 for a drug or biological product that contains a 

14 novel combination of two or more active ingredients 

15 (subject to paragraph (3)(B)(iii))’’. 

16 (2) ADDITIONAL ACTIVE INGREDIENT FOR AP17 PLICATION DRUG; LIMITATION REGARDING NOVEL18 COMBINATION APPLICATION DRUG.—Section 

19 505B(a)(3) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 355c(a)(3)) is amended— 

21 (A) by redesignating subparagraphs (B) 

22 and (C) as subparagraphs (C) and (D), respec23 tively; and 

24 (B) by striking subparagraph (A) and in25 serting the following: 


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1 ‘‘(A) IN GENERAL.—For purposes of para2 graph (1)(B), the investigation described in this 

3 paragraph is (as determined by the Secretary) 

4 a molecularly targeted pediatric cancer inves5 tigation of— 

6 ‘‘(i) the drug or biological product for 

7 which the application referred to in such 

8 paragraph is submitted; or 

9 ‘‘(ii) the active ingredient or ingredi10 ents of such drug or biological product in 

11 combination with— 

12 ‘‘(I) an active ingredient of a 

13 drug for which an approved applica14 tion under section 505(j) is in effect 

15 or an active ingredient of a biological 

16 product for which an approved appli17 cation under section 351(k) of the 

18 Public Health Service Act is in effect, 

19 which drug or biological product is de20 termined by the Secretary to be the 

21 standard of care for treating a pedi22 atric cancer; 

23 ‘‘(II) an active ingredient of a 

24 drug for which an approved applica25 tion under section 505(b) is in effect 


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1 to treat an adult cancer, or an active 

2 ingredient of a biological product for 

3 which an approved application under 

4 section 351(a) of the Public Health 

5 Service Act is in effect to treat an 

6 adult cancer, which approved applica7 tion is held by the same person sub8 mitting the application referred to in 

9 paragraph (1)(B); or 

10 ‘‘(III) an active ingredient of a 

11 drug or biological product for which 

12 there is in effect an exemption for in13 vestigational use under section 505(i), 

14 which drug or biological product is 

15 under such exemption being studied 

16 jointly by the person submitting the 

17 application referred to in paragraph 

18 (1)(B) and by another person pursu19 ant to an agreement between such 

20 persons. 

21 ‘‘(B) ADDITIONAL REQUIREMENTS.— 

22 ‘‘(i) DESIGN OF INVESTIGATION.—A 

23 molecularly targeted pediatric cancer inves24 tigation referred to in subparagraph (A) 

25 shall be designed to yield clinically meanVerDate Sep 11 2014 00:38 Mar 10, 2022 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6972.IH H6972

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1 ingful pediatric study data, gathered using 

2 appropriate formulations for each age 

3 group for which the study is required, re4 garding dosing, safety, and preliminary ef5 ficacy. 

6 ‘‘(ii) PURPOSE OF INVESTIGATION.— 

7 The purpose of a molecularly targeted pe8 diatric cancer investigation referred to in 

9 subparagraph (A) shall be— 

10 ‘‘(I) in the case of such an inves11 tigation conducted with respect to a 

12 drug or biological product referred to 

13 in clause (i) of such subparagraph, to 

14 inform potential pediatric labeling of 

15 the drug or biological product for 

16 which the application referred to in 

17 paragraph (1)(B) is submitted; and 

18 ‘‘(II) in the case of such an in19 vestigation conducted with respect to 

20 a combination of active ingredients 

21 described to in clause (ii) of such sub22 paragraph, to assist in determining 

23 the relevance of its molecular target 

24 to the growth or progression of a pe25 diatric cancer. 


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1 ‘‘(iii) LIMITATION REGARDING INVES2 TIGATION OF NOVEL COMBINATION.—For 

3 purposes of paragraph (1)(B), a novel 

4 combination is a combination of two or 

5 more active ingredients for which an appli6 cation under section 505 of this Act or sec7 tion 351 of the Public Health Service Act 

8 for such combination has not previously 

9 been approved. A pediatric investigation 

10 under this paragraph of such novel com11 bination is required only if each of the ac12 tive ingredients in the combination has 

13 been approved under such section 505 or 

14 such section 351 to treat an adult cancer. 

15 ‘‘(iv) PRECLINICAL DATA.—The Sec16 retary may require that reports on an in17 vestigation required pursuant to paragraph 

18 (1)(B) shall include the results of all pre19 clinical studies on which the decision to 

20 conduct such investigation was based. 

21 ‘‘(v) RULE OF CONSTRUCTION RE22 GARDING INACTIVE INGREDIENTS.—With 

23 respect to a combination of active ingredi24 ents referred to in subparagraph (A)(ii), 

25 such subparagraph may not be construed 


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1 as addressing the use of inactive ingredi2 ents with such combination.’’. 

3 (3) CLARIFYING APPLICABILITY OF CERTAIN

4 PROVISIONS.—Section 505B(a)(3) of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 

6 355c(a)(3)), as amended by paragraph (2), is fur7 ther amended by adding at the end the following: 

8 ‘‘(E) INTERNAL COMMITTEE REVIEW; LA9 BELING CHANGES; DISSEMINATION OF INFOR10 MATION; ADVERSE EVENTS; SCOPE OF AUTHOR11 ITY.—Subsections (f) through (j) shall apply 

12 with respect to investigations described in this 

13 paragraph to the same extent and in the same 

14 manner as such subsections apply with respect 

15 to the assessments required under paragraph 

16 (1)(A), except that subsection (g) does not 

17 apply with respect to an investigation referred 

18 to in subparagraph (A)(ii) of this paragraph.’’. 

19 (4) CONFORMING AMENDMENTS.—Section 

20 505B(a) of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 355c(a)) is amended— 

22 (A) in paragraph (3)(C), as redesignated 

23 by paragraph (2)(A) of this subsection, by 

24 striking ‘‘investigations described in this paraVerDate Sep 11 2014 00:38 Mar 10, 2022 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6972.IH H6972

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1 graph’’ and inserting ‘‘investigations referred to 

2 in subparagraph (A)(i)’’; 

3 (B) in paragraph (3)(D), as redesignated 

4 by paragraph (2)(A) of this subsection, by 

5 striking ‘‘the assessments under paragraph 

6 (2)(B)’’ and inserting ‘‘the assessments re7 quired under paragraph (1)(A)’’; and 

8 (C) in paragraph (5)(D), by inserting be9 fore the period at the end the following: ‘‘, ex10 cept this subparagraph is not applicable to an 

11 investigation referred to in paragraph 

12 (3)(A)(ii)’’. 

13 (b) AUTHORITY REGARDING PRECLINICAL STUD14 IES.—Section 505B(a)(1) of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 355c(a)(1)), as amended by sub16 section (a)(1), is further amended by adding at the end 

17 the following: 

18 ‘‘(C) PRECLINICAL STUDIES GEN19 ERALLY.— 

20 ‘‘(i) IN GENERAL.—With respect to an 

21 application for an exemption for investiga22 tional use under section 505(i) for a drug 

23 or biological product that is intended for 

24 the treatment of an adult cancer, the Sec25 retary may require, as a condition of perVerDate Sep 11 2014 00:38 Mar 10, 2022 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H6972.IH H6972

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1 mitting the exemption to go into effect, 

2 that the sponsor involved enter into an 

3 agreement with the Secretary to conduct 

4 not more than two preclinical studies of 

5 the drug or biological product in order to 

6 assist in determining the relevance of its 

7 molecular target to the growth or progres8 sion of a pediatric cancer. 

9 ‘‘(ii) TIMEFRAME FOR PRECLINICAL

10 STUDIES.—With respect to the drug or bi11 ological product involved, an agreement 

12 under clause (i) for a preclinical study 

13 shall specify the date by which an initial 

14 plan for the study will be submitted to the 

15 Secretary except that the Secretary may 

16 not require the submission of such plan 

17 any earlier than one year after the exemp18 tion referred to in clause (i) goes into ef19 fect. The results of the preclinical study 

20 shall be submitted to the Secretary in ac21 cordance with a timeframe to which the 

22 Secretary and the sponsor involved have 

23 agreed. Such timeframe shall provide for 

24 deferrals equivalent to deferrals under 

25 paragraph (4).’’. 


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1 (c) APPLICABILITY.—The amendments made by this 

2 section apply with respect to any application under section 

3 505(i) of the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 355(i)), any application under section 505 of such 

5 Act (21 U.S.C. 355), and any application under section 

6 351(a) of the Public Health Service Act (42 U.S.C. 262), 

7 that is submitted on or after the expiration of the 3-year 

8 period beginning on the date of the enactment of this Act. 

Æ 


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