II 

118TH CONGRESS 

1ST SESSION S. 2897 

To amend the Federal Food, Drug, and Cosmetic Act with respect to 

molecularly targeted pediatric cancer investigations, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 21, 2023 

Mr. BENNET (for himself and Mr. RUBIO) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to molecularly targeted pediatric cancer investigations, 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 2023’’. 


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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) ADDITIONAL ACTIVE INGREDIENT FOR AP7 PLICATION DRUG; LIMITATION REGARDING NOVEL8 COMBINATION APPLICATION DRUG.—Section 

9 505B(a)(3) of the Federal Food, Drug, and Cos10 metic Act (21 U.S.C. 355c(a)(3)) is amended— 

11 (A) by redesignating subparagraphs (B) 

12 and (C) as subparagraphs (C) and (D), respec13 tively; and 

14 (B) by striking subparagraph (A) and in15 serting the following: 

16 ‘‘(A) IN GENERAL.—For purposes of para17 graph (1)(B), the investigation described in this 

18 paragraph is (as determined by the Secretary) 

19 a molecularly targeted pediatric cancer inves20 tigation of— 

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

22 which the application referred to in such 

23 paragraph is submitted; or 

24 ‘‘(ii) such drug or biological product 

25 in combination with— 


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1 ‘‘(I) an active ingredient of a 

2 drug or biological product— 

3 ‘‘(aa) for which an approved 

4 application under section 505(j) 

5 under this Act or under section 

6 351(k) of the Public Health 

7 Service Act is in effect; and 

8 ‘‘(bb) that is determined by 

9 the Secretary to be the standard 

10 of care for treating a pediatric 

11 cancer; or 

12 ‘‘(II) an active ingredient of a 

13 drug or biological product— 

14 ‘‘(aa) for which an approved 

15 application under section 505(b) 

16 of this Act or section 351(a) of 

17 the Public Health Service Act to 

18 treat an adult cancer is in effect 

19 and is held by the same person 

20 submitting the application under 

21 paragraph (1)(B); and 

22 ‘‘(bb) that is directed at a 

23 molecular target that the Sec24 retary determines to be substanVerDate Sep 11 2014 03:02 Sep 23, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2897.IS S2897

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1 tially relevant to the growth or 

2 progression of a pediatric cancer. 

3 ‘‘(B) ADDITIONAL REQUIREMENTS.— 

4 ‘‘(i) DESIGN OF INVESTIGATION.—A 

5 molecularly targeted pediatric cancer inves6 tigation referred to in subparagraph (A) 

7 shall be designed to yield clinically mean8 ingful pediatric study data that is gathered 

9 using appropriate formulations for each 

10 age group for which the study is required, 

11 regarding dosing, safety, and preliminary 

12 efficacy to inform potential pediatric label13 ing. 

14 ‘‘(ii) LIMITATION.—An investigation 

15 described in subparagraph (A)(ii) may be 

16 required only if the drug or biological 

17 product for which the application referred 

18 to in paragraph (1)(B) contains either— 

19 ‘‘(I) a single new active ingre20 dient; or 

21 ‘‘(II) more than one active ingre22 dient, if an application for the com23 bination of active ingredients has not 

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1 tive ingredient has been previously ap2 proved to treat an adult cancer. 

3 ‘‘(iii) RESULTS OF ALREADY-COM4 PLETED PRECLINICAL STUDIES OF APPLI5 CATION DRUG.—The Secretary may re6 quire that reports on an investigation re7 quired pursuant to paragraph (1)(B) in8 clude the results of all preclinical studies 

9 on which the decision to conduct such in10 vestigation was based. 

11 ‘‘(iv) RULE OF CONSTRUCTION RE12 GARDING INACTIVE INGREDIENTS.—With 

13 respect to a combination of active ingredi14 ents referred to in subparagraph (A)(ii), 

15 such subparagraph shall not be construed 

16 as addressing the use of inactive ingredi17 ents with such combination.’’. 

18 (2) DETERMINATION OF APPLICABLE REQUIRE19 MENTS.—Section 505B(e)(1) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 

21 amended by adding at the end the following: ‘‘The 

22 Secretary shall determine whether subparagraph (A) 

23 or (B) of subsection (a)(1) shall apply with respect 

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1 cant is required to submit the initial pediatric study 

2 plan under paragraph (2)(A).’’. 

3 (3) CLARIFYING APPLICABILITY.—Section 

4 505B(a)(1) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355c(a)(1)) is amended by 

6 adding at the end the following: 

7 ‘‘(C) RULE OF CONSTRUCTION.—No appli8 cation that is subject to the requirements of 

9 subparagraph (B) shall be subject to the re10 quirements of subparagraph (A), and no appli11 cation (or supplement to an application) that is 

12 subject to the requirements of subparagraph 

13 (A) shall be subject to the requirements of sub14 paragraph (B).’’. 

15 (4) CONFORMING AMENDMENTS.—Section 

16 505B(a) of the Federal Food, Drug, and Cosmetic 

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

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

19 by paragraph (1)(A) of this subsection, by 

20 striking ‘‘investigations described in this para21 graph’’ and inserting ‘‘investigations referred to 

22 in subparagraph (A)’’; and 

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

24 by paragraph (1)(A) of this subsection, by 

25 striking ‘‘the assessments under paragraph 


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1 (2)(B)’’ and inserting ‘‘the assessments re2 quired under paragraph (1)(A)’’. 

3 (b) GUIDANCE.—The Secretary shall— 

4 (1) not later than 1 year after the date of en5 actment of this Act, issue draft guidance on the im6 plementation of the requirements in subsection (a); 

7 and 

8 (2) not later than 1 year after closing the com9 ment period on such draft guidance, finalize such 

10 guidance. 

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

12 section apply with respect to any application under section 

13 505(b) of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 355(b)) and any application under section 351(a) 

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

16 is submitted on or after the date that is 3 years after the 

17 date of enactment of this Act. 

18 (d) REPORTS TO CONGRESS.— 

19 (1) SECRETARY OF HEALTH AND HUMAN SERV20 ICES.—Not later than 2 years after the date of en21 actment of this Act, the Secretary of Health and 

22 Human Services shall submit to the Committee on 

23 Energy and Commerce of the House of Representa24 tives and the Committee on Health, Education, 

25 Labor, and Pensions of the Senate a report on the 


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1 Secretary’s efforts, in coordination with industry, to 

2 ensure implementation of the amendments made by 

3 subsection (a). 

4 (2) GAO STUDY AND REPORT.— 

5 (A) STUDY.—Not later than 3 years after 

6 the date of enactment of this Act, the Comp7 troller General of the United States shall con8 duct a study of the effectiveness of requiring 

9 assessments and investigations described in sec10 tion 505B of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355c), as amended by 

12 subsection (a), in the development of drugs and 

13 biological products for pediatric cancer indica14 tions. 

15 (B) FINDINGS.—Not later than 7 years 

16 after the date of enactment of this Act, the 

17 Comptroller General shall submit to the Com18 mittee on Energy and Commerce of the House 

19 of Representatives and the Committee on 

20 Health, Education, Labor, and Pensions of the 

21 Senate a report containing the findings of the 

22 study conducted under subparagraph (A). 

Æ 


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