I 
118TH CONGRESS 
1ST SESSION H. R. 3433 
To amend the Federal Food, Drug, and Cosmetic Act with respect to 
molecularly targeted pediatric cancer investigations, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 17, 2023 
Mr. MCCAUL (for himself, Ms. ESHOO, Mr. KELLY of Pennsylvania, Mrs. KIM 
of California, Mr. SMITH of New Jersey, Ms. SCHRIER, Mr. BACON, Mr. 
MOYLAN, Mr. BUCHANAN, Mr. FITZPATRICK, Mr. HUIZENGA, Mr. 
GROTHMAN, Mr. JOHNSON of Ohio, and Mr. PHILLIPS) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to molecularly targeted pediatric cancer investiga-
tions, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Give Kids a Chance 
Act of 2023’’. 
VerDate Sep 11 2014 
02:09 Jun 02, 2023
Jkt 039200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.IH
H3433
kjohnson on DSK79L0C42PROD with BILLS
SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDI-
TIONAL AUTHORITIES OF FOOD AND DRUG 
ADMINISTRATION 
REGARDING 
MOLECU-
LARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.— 
(1) ADDITIONAL ACTIVE INGREDIENT FOR AP-
PLICATION DRUG; LIMITATION REGARDING NOVEL- 
COMBINATION
APPLICATION
DRUG.—Section 
505B(a)(3) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(3)) is amended— 
(A) by redesignating subparagraphs (B) 
and (C) as subparagraphs (C) and (D), respec-
tively; and 
(B) by striking subparagraph (A) and in-
serting the following: 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the investigation described in this 
paragraph is (as determined by the Secretary) 
a molecularly targeted pediatric cancer inves-
tigation of— 
‘‘(i) the drug or biological product for 
which the application referred to in such 
paragraph is submitted; or 
‘‘(ii) such drug or biological product 
in combination with— 
VerDate Sep 11 2014 
02:09 Jun 02, 2023
Jkt 039200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.IH
H3433
kjohnson on DSK79L0C42PROD with BILLS
‘‘(I) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(j) 
under this Act or under section 
351(k) of the Public Health 
Service Act is in effect; and 
‘‘(bb) that is determined by 
the Secretary to be the standard 
of care for treating a pediatric 
cancer; or 
‘‘(II) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(b) 
of this Act or section 351(a) of 
the Public Health Service Act to 
treat an adult cancer is in effect 
and is held by the same person 
submitting the application under 
paragraph (1)(B); and 
‘‘(bb) that is directed at a 
molecular target that the Sec-
retary determines to be substan-
VerDate Sep 11 2014 
02:09 Jun 02, 2023
Jkt 039200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.IH
H3433
kjohnson on DSK79L0C42PROD with BILLS
tially relevant to the growth or 
progression of a pediatric cancer. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) DESIGN
OF
INVESTIGATION.—A 
molecularly targeted pediatric cancer inves-
tigation referred to in subparagraph (A) 
shall be designed to yield clinically mean-
ingful pediatric study data that is gathered 
using appropriate formulations for each 
age group for which the study is required, 
regarding dosing, safety, and preliminary 
efficacy to inform potential pediatric label-
ing. 
‘‘(ii) LIMITATION.—An investigation 
described in subparagraph (A)(ii) may be 
required only if the drug or biological 
product for which the application referred 
to in paragraph (1)(B) contains either— 
‘‘(I) a single new active ingre-
dient; or 
‘‘(II) more than one active ingre-
dient, if an application for the com-
bination of active ingredients has not 
previously been approved but each ac-
VerDate Sep 11 2014 
02:09 Jun 02, 2023
Jkt 039200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.IH
H3433
kjohnson on DSK79L0C42PROD with BILLS
tive ingredient has been previously ap-
proved to treat an adult cancer. 
‘‘(iii) RESULTS
OF
ALREADY-COM-
PLETED PRECLINICAL STUDIES OF APPLI-
CATION
DRUG.—The Secretary may re-
quire that reports on an investigation re-
quired pursuant to paragraph (1)(B) in-
clude the results of all preclinical studies 
on which the decision to conduct such in-
vestigation was based. 
‘‘(iv) RULE
OF
CONSTRUCTION
RE-
GARDING
INACTIVE
INGREDIENTS.—With 
respect to a combination of active ingredi-
ents referred to in subparagraph (A)(ii), 
such subparagraph shall not be construed 
as addressing the use of inactive ingredi-
ents with such combination.’’. 
(2) DETERMINATION OF APPLICABLE REQUIRE-
MENTS.—Section 505B(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 
amended by adding at the end the following: ‘‘The 
Secretary shall determine whether subparagraph (A) 
or (B) of subsection (a)(1) shall apply with respect 
to an application before the date on which the appli-
VerDate Sep 11 2014 
02:09 Jun 02, 2023
Jkt 039200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.IH
H3433
kjohnson on DSK79L0C42PROD with BILLS
cant is required to submit the initial pediatric study 
plan under paragraph (2)(A).’’. 
(3) 
CLARIFYING
APPLICABILITY.—Section 
505B(a)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(1)) is amended by 
adding at the end the following: 
‘‘(C) RULE OF CONSTRUCTION.—No appli-
cation that is subject to the requirements of 
subparagraph (B) shall be subject to the re-
quirements of subparagraph (A), and no appli-
cation (or supplement to an application) that is 
subject to the requirements of subparagraph 
(A) shall be subject to the requirements of sub-
paragraph (B).’’. 
(4) 
CONFORMING
AMENDMENTS.—Section 
505B(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)) is amended— 
(A) in paragraph (3)(C), as redesignated 
by paragraph (1)(A) of this subsection, by 
striking ‘‘investigations described in this para-
graph’’ and inserting ‘‘investigations referred to 
in subparagraph (A)’’; and 
(B) in paragraph (3)(D), as redesignated 
by paragraph (1)(A) of this subsection, by 
striking ‘‘the assessments under paragraph 
VerDate Sep 11 2014 
02:09 Jun 02, 2023
Jkt 039200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.IH
H3433
kjohnson on DSK79L0C42PROD with BILLS
(2)(B)’’ and inserting ‘‘the assessments re-
quired under paragraph (1)(A)’’. 
(b) GUIDANCE.—The Secretary shall— 
(1) not later than 12 months after the date of 
enactment of this Act, issue draft guidance on the 
implementation of the requirements in subsection 
(a); and 
(2) not later than 12 months after closing the 
comment period on such draft guidance, finalize 
such guidance. 
(c) APPLICABILITY.—The amendments made by this 
section apply with respect to any application under section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)) and any application under section 351(a) 
of the Public Health Service Act (42 U.S.C. 262), that 
is submitted on or after the date that is 3 years after the 
date of enactment of this Act. 
(d) REPORTS TO CONGRESS.— 
(1) SECRETARY OF HEALTH AND HUMAN SERV-
ICES.—Not later than 2 years after the date of en-
actment of this Act, the Secretary of Health and 
Human Services shall submit to the Committee on 
Energy and Commerce of the House of Representa-
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the 
VerDate Sep 11 2014 
02:09 Jun 02, 2023
Jkt 039200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.IH
H3433
kjohnson on DSK79L0C42PROD with BILLS
Secretary’s efforts, in coordination with industry, to 
ensure implementation of the amendments made by 
subsection (a). 
(2) GAO STUDY AND REPORT.— 
(A) STUDY.—Not later than 3 years after 
the date of enactment of this Act, the Comp-
troller General of the United States shall con-
duct a study of the effectiveness of requiring 
assessments and investigations described in sec-
tion 505B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C.355c), as amended by sub-
section (a), in the development of drugs and bi-
ological products for pediatric cancer indica-
tions. 
(B) FINDINGS.—Not later than 7 years 
after the date of enactment of this Act, the 
Comptroller General shall submit to the Com-
mittee on Energy and Commerce of the House 
of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the 
Senate a report containing the findings of the 
study conducted under subparagraph (A). 
Æ 
VerDate Sep 11 2014 
02:09 Jun 02, 2023
Jkt 039200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6301
E:\BILLS\H3433.IH
H3433
kjohnson on DSK79L0C42PROD with BILLS