IB 
Union Calendar No. 594 
118TH CONGRESS 
2D SESSION 
H. R. 3433 
[Report No. 118–700] 
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 
SEPTEMBER 20, 2024 
Additional sponsors: Ms. KUSTER, Mr. WILSON of South Carolina, Ms. SALA-
ZAR, Mr. NEGUSE, Mr. LALOTA, Mr. VALADAO, Mr. MULLIN, Mr. 
WALTZ, Mr. ALLRED, Mr. LAWLER, Ms. CASTOR of Florida, Ms. ROSS, 
Ms. LOFGREN, Mr. CA´RDENAS, Mr. CALVERT, Mr. KILMER, Mr. 
ROUZER, Mr. DAVIS of North Carolina, Ms. MACE, Ms. PETTERSEN, Ms. 
LEGER FERNANDEZ, Ms. PEREZ, Ms. CARAVEO, Mr. PAPPAS, Mr. JACK-
SON of North Carolina, Mr. RUTHERFORD, Mr. OWENS, Mr. BAIRD, Mr. 
NEHLS, Mr. SCHNEIDER, Mr. VAN DREW, Mr. SMITH of Nebraska, Mr. 
BEAN of Florida, Mr. WESTERMAN, Mr. FERGUSON, Mr. YAKYM, Ms. SE-
WELL, Mr. KEAN of New Jersey, Mr. CASTEN, Ms. DE LA CRUZ, Mr. 
STEUBE, Mr. LAMBORN, Mr. COHEN, Ms. TITUS, Ms. BROWN, Mr. 
VEASEY, Ms. SLOTKIN, Mr. GARBARINO, Mr. LUETKEMEYER, Mr. 
PETERS, Mr. MCGARVEY, Mr. LIEU, Mr. ZINKE, Mr. HARDER of Cali-
fornia, Mr. GOODEN of Texas, Mr. GRIJALVA, Mr. NORMAN, Ms. BLUNT 
ROCHESTER, Mr. MCGOVERN, Mr. MOULTON, Mr. QUIGLEY, Mr. CROW, 
Mr. LAHOOD, Mr. THANEDAR, Mr. GOTTHEIMER, Mr. MOSKOWITZ, Mr. 
SWALWELL, Mr. AUSTIN SCOTT of Georgia, Mr. BERA, Mr. DIAZ- 
BALART, Ms. BUDZINSKI, Mr. ADERHOLT, Ms. TOKUDA, Ms. GRANGER, 
Mr. CLINE, Mr. FINSTAD, Ms. VELA´ZQUEZ, Mr. NUNN of Iowa, Ms. 
WASSERMAN SCHULTZ, Mr. TRONE, Mr. TONKO, Mrs. TRAHAN, Mr. 
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CARL, Ms. MATSUI, Mr. KEATING, Ms. HOULAHAN, Mrs. MILLER of 
West Virginia, Mrs. FOUSHEE, Mrs. WATSON COLEMAN, Mr. THOMPSON 
of Pennsylvania, Mr. CAREY, Mr. NICKEL, Mr. FLEISCHMANN, Mr. 
DONALDS, Ms. WATERS, Mr. IVEY, Mr. SABLAN, Mrs. CHERFILUS- 
MCCORMICK, Mrs. NAPOLITANO, Mr. LYNCH, Mr. CORREA, Mr. GOLD-
MAN of New York, Mr. DELUZIO, Mr. RASKIN, Mr. MIKE GARCIA of Cali-
fornia, Mr. LARSON of Connecticut, Mr. PANETTA, Ms. DELBENE, Mrs. 
FLETCHER, Mr. ARRINGTON, Ms. BROWNLEY, Mr. SESSIONS, Mr. 
LAMALFA, Mr. AMODEI, Mr. D’ESPOSITO, Mr. SCOTT FRANKLIN of Flor-
ida, Ms. JACOBS, Mr. COSTA, Mr. GRAVES of Missouri, Ms. MENG, Ms. 
WILD, Ms. NORTON, Mr. KIM of New Jersey, Mr. DESAULNIER, Ms. 
PINGREE, Mr. TAKANO, Ms. CLARKE of New York, Mr. KHANNA, Ms. 
LEE of Pennsylvania, Mr. KILDEE, Mrs. DINGELL, Ms. MALLIOTAKIS, 
Mr. MILLS, Ms. SPANBERGER, Ms. STANSBURY, Mr. BURCHETT, Mr. 
KELLY of Mississippi, Mr. JACKSON of Illinois, Mr. SOTO, Mr. CASTRO 
of Texas, Mrs. BICE, Mr. MOONEY, Mr. MANN, Ms. SCANLON, Ms. POR-
TER, Mr. BUCSHON, Ms. CRAIG, Mr. RUIZ, Mr. CUELLAR, Mr. CARTER 
of Louisiana, Mr. FLOOD, Mrs. HAYES, Mr. CLYDE, Ms. JAYAPAL, Mr. 
LATURNER, Ms. LETLOW, Ms. KAMLAGER-DOVE, Mr. POCAN, Ms. 
WEXTON, Ms. SHERRILL, Ms. STRICKLAND, Mrs. KIGGANS of Virginia, 
Ms. BARRAGA´N, Mr. HIGGINS of Louisiana, Mr. SORENSEN, Ms. CROCK-
ETT, Mr. CISCOMANI, Mr. ALFORD, Mr. KILEY, Mr. SMUCKER, Mr. 
MCHENRY, Mr. JAMES, Ms. STEFANIK, Mr. MCCORMICK, Mrs. MILLER 
of Illinois, Mr. MEUSER, Mrs. HARSHBARGER, Ms. DAVIDS of Kansas, 
Mr. WILLIAMS of New York, Mr. KRISHNAMOORTHI, Mr. MORELLE, Ms. 
TENNEY, Mr. POSEY, Mr. WEBER of Texas, Mr. SCHWEIKERT, Mr. 
GIMENEZ, Mr. VICENTE GONZALEZ of Texas, Ms. BUSH, Mrs. HINSON, 
Mr. DESJARLAIS, Mr. MILLER of Ohio, Mr. JACKSON of Texas, Mr. 
BOYLE of Pennsylvania, Ms. WILLIAMS of Georgia, Mr. ROBERT GARCIA 
of California, Ms. DEGETTE, Mrs. LUNA, Mr. CARBAJAL, Mr. THOMPSON 
of Mississippi, Mr. SUOZZI, Mr. GARAMENDI, Ms. BONAMICI, Ms. KAP-
TUR, Ms. MCCOLLUM, Ms. JACKSON
LEE, Mr. CLEAVER, Mr. 
ESPAILLAT, Ms. MOORE of Wisconsin, Mr. NADLER, Mr. SARBANES, Ms. 
SALINAS, Mrs. BEATTY, Mr. GARCI´A of Illinois, Mr. NORCROSS, Ms. 
MCCLELLAN, Ms. LEE of California, Mr. BILIRAKIS, Ms. SCHAKOWSKY, 
Mr. EVANS, Ms. SCHOLTEN, Mr. LEVIN, and Mr. WITTMAN 
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SEPTEMBER 20, 2024 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on May 17, 2023] 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to molecularly targeted pediatric cancer investiga-
tions, and for other purposes. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Give Kids a Chance Act of 2024’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
TITLE I—GIVE KIDS A CHANCE 
Sec. 101. Research into pediatric uses of drugs; additional authorities of Food 
and Drug Administration regarding molecularly targeted cancer 
drugs. 
Sec. 102. Ensuring completion of pediatric study requirements. 
Sec. 103. FDA report on PREA enforcement. 
Sec. 104. Extension of authority to issue priority review vouchers to encourage 
treatments for rare pediatric diseases. 
Sec. 105. Limitations on exclusive approval or licensure of orphan drugs. 
Sec. 106. Program for pediatric studies of drugs. 
TITLE II—UNITED STATES-ABRAHAM ACCORDS COOPERATION AND 
SECURITY 
Sec. 201. Establishment of Abraham Accords Office within Food and Drug Ad-
ministration. 
TITLE III—ORGAN PROCUREMENT AND TRANSPLANTATION 
NETWORK 
Sec. 301. Registration fees. 
TITLE I—GIVE KIDS A CHANCE 
SEC. 101. RESEARCH INTO PEDIATRIC USES OF DRUGS; AD-
DITIONAL AUTHORITIES OF FOOD AND DRUG 
ADMINISTRATION 
REGARDING 
MOLECU-
LARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.— 
(1) ADDITIONAL ACTIVE INGREDIENT FOR APPLI-
CATION
DRUG; LIMITATION
REGARDING
NOVEL-COM-
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BINATION APPLICATION DRUG.—Section 505B(a)(3) of 
the Federal Food, Drug, and Cosmetic 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 investiga-
tion 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— 
‘‘(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 Serv-
ice Act is in effect; and 
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‘‘(bb) that is determined by 
the Secretary to be the standard of 
care for treating a pediatric can-
cer; 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 submit-
ting the application under para-
graph (1)(B); and 
‘‘(bb) that is directed at a 
molecular target that the Sec-
retary determines to be substan-
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 
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using appropriate formulations for each age 
group for which the study is required, re-
garding dosing, safety, and preliminary ef-
ficacy to inform potential pediatric label-
ing. 
‘‘(ii) LIMITATION.—An investigation 
described in subparagraph (A)(ii) may be 
required only if the drug or biological prod-
uct 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-
tive ingredient has been previously ap-
proved to treat an adult cancer. 
‘‘(iii) 
RESULTS
OF
ALREADY-COM-
PLETED PRECLINICAL STUDIES OF APPLICA-
TION
DRUG.—The Secretary may require 
that reports on an investigation required 
pursuant to paragraph (1)(B) include the 
results of all preclinical studies on which 
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the decision to conduct such investigation 
was based. 
‘‘(iv) RULE
OF
CONSTRUCTION
RE-
GARDING INACTIVE INGREDIENTS.—With re-
spect to a combination of active ingredients 
referred to in subparagraph (A)(ii), such 
subparagraph shall not be construed as ad-
dressing the use of inactive ingredients 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 applicant 
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 Cosmetic 
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 sub-
paragraph (B) shall be subject to the require-
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ments of subparagraph (A), and no application 
(or supplement to an application) that is subject 
to the requirements of subparagraph (A) shall be 
subject to the requirements of subparagraph 
(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 paragraph’’ and 
inserting ‘‘investigations referred to in subpara-
graph (A)’’; and 
(B) in paragraph (3)(D), as redesignated 
by paragraph (1)(A) of this subsection, by strik-
ing ‘‘the assessments under paragraph (2)(B)’’ 
and inserting ‘‘the assessments required under 
paragraph (1)(A)’’. 
(b) GUIDANCE.—The Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall— 
(1) not later than 12 months after the date of en-
actment of this Act, issue draft guidance on the im-
plementation of the amendments made by subsection 
(a); and 
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(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(a)), 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 enact-
ment of this Act, the Secretary of Health and Human 
Services shall submit to the Committee on Energy 
and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and 
Pensions of the Senate a report on the Secretary’s ef-
forts, in coordination with industry, to ensure imple-
mentation 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 Comptroller 
General of the United States shall conduct a 
study of the effectiveness of requiring assessments 
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and investigations described in section 505B of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C.355c), as amended by subsection (a), in 
the development of drugs and biological products 
for pediatric cancer indications. 
(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 con-
ducted under subparagraph (A). 
SEC. 102. ENSURING COMPLETION OF PEDIATRIC STUDY 
REQUIREMENTS. 
(a) EQUAL ACCOUNTABILITY FOR PEDIATRIC STUDY 
REQUIREMENTS.—Section 505B(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amended— 
(1) in paragraph (1), by striking ‘‘Beginning 
270’’ and inserting ‘‘NONCOMPLIANCE LETTER.—Be-
ginning 270’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘The drug or’’ and inserting 
‘‘EFFECT
OF
NONCOMPLIANCE.—The drug or’’; 
and 
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(B) by striking ‘‘(except that the drug or bi-
ological product shall not be subject to action 
under section 303)’’ and inserting ‘‘(except that 
the drug or biological product shall be subject to 
action under section 303 only if such person 
demonstrated a lack of due diligence in satis-
fying the applicable requirement)’’; and 
(3) by adding at the end the following: 
‘‘(3) LIMITATION.—The Secretary shall not issue 
enforcement actions under section 303 for failures 
under this subsection in the case of a drug or biologi-
cal product that is no longer marketed.’’. 
(b) DUE DILIGENCE.—Section 505B(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), as 
amended by subsection (a), is further amended by adding 
at the end the following: 
‘‘(4) DUE DILIGENCE.—Before the Secretary may 
conclude that a person failed to submit or otherwise 
meet a requirement as described in the matter pre-
ceding paragraph (1), the Secretary shall— 
‘‘(A) issue a noncompliance letter pursuant 
to paragraph (1); 
‘‘(B) provide such person with a 45-day pe-
riod beginning on the date of receipt of such non-
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compliance letter to respond in writing as set 
forth in such paragraph; and 
‘‘(C) after reviewing such written response, 
determine whether the person demonstrated a 
lack of due diligence in satisfying such require-
ment.’’. 
(c) CONFORMING AMENDMENTS.—Section 303(f)(4)(A) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333(f)(4)(A)) is amended by striking ‘‘or 505–1’’ and in-
serting ‘‘505–1, or 505B’’. 
(d) TRANSITION RULE.—The Secretary of Health and 
Human Services may take enforcement action under section 
303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333) only for failures described in section 505B(d) of such 
Act (21 U.S.C. 355c(d)) that occur on or after the date that 
is 180 days after the date of enactment of this Act. 
SEC. 103. FDA REPORT ON PREA ENFORCEMENT. 
Section 508(b) of the Food and Drug Administration 
Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amend-
ed— 
(1) in paragraph (11), by striking the semicolon 
at the end and inserting ‘‘, including an evaluation 
of compliance with deadlines provided for in deferrals 
and deferral extensions;’’; 
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(2) in paragraph (15), by striking ‘‘and’’ at the 
end; 
(3) in paragraph (16), by striking the period at 
the end and inserting ‘‘; and’’; and 
(4) by adding at the end the following: 
‘‘(17) a listing of penalties, settlements, or pay-
ments under section 303 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353) for failure to com-
ply with requirements under such section 505B, in-
cluding, for each penalty, settlement, or payment, the 
name of the drug, the sponsor thereof, and the amount 
of the penalty, settlement, or payment imposed; and’’. 
SEC. 104. EXTENSION OF AUTHORITY TO ISSUE PRIORITY 
REVIEW VOUCHERS TO ENCOURAGE TREAT-
MENTS FOR RARE PEDIATRIC DISEASES. 
(a) EXTENSION.—Paragraph (5) of section 529(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff(b)) is amended by striking ‘‘September 30, 2024, un-
less’’ and all that follows through the period at the end and 
inserting ‘‘September 30, 2029.’’. 
(b) GAO REPORT ON EFFECTIVENESS OF RARE PEDI-
ATRIC
DISEASE
PRIORITY
VOUCHER
AWARDS
IN 
INCENTIVIZING RARE PEDIATRIC DISEASE DRUG DEVEL-
OPMENT.— 
(1) GAO STUDY.— 
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(A) STUDY.—The Comptroller General of 
the United States shall conduct a study of the ef-
fectiveness of awarding rare pediatric disease 
priority vouchers under section 529 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff), as amended by subsection (a), in the de-
velopment of human drug products that treat or 
prevent rare pediatric diseases (as defined in 
such section 529). 
(B) CONTENTS OF STUDY.—In conducting 
the study under subparagraph (A), the Comp-
troller General shall examine the following: 
(i) The indications for each drug or bi-
ological product that— 
(I) is the subject of a rare pedi-
atric disease product application (as 
defined in section 529 of the Federal 
Food, Drug, and Cosmetic Act (21 
U.S.C. 360ff)) for which a priority re-
view voucher was awarded; and 
(II) was approved under section 
505 of the Federal Food, Drug, and 
Cosmetic Act (42 U.S.C. 355) or li-
censed under section 351 of the Public 
Health Service Act (42 U.S.C. 262). 
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through the approval under section 505 of 
the Federal Food, Drug, and Cosmetic Act 
(42 U.S.C. 355) or licensure under section 
351 of the Public Health Service Act (42 
U.S.C. 262) of a drug for which a priority 
review voucher was used. 
(ix) Whether, and to what extent, com-
panies were motivated by the availability of 
priority review vouchers under section 529 
of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360ff) to attempt to develop 
a drug for a rare pediatric disease. 
(x) Whether, and to what extent, pedi-
atric review vouchers awarded under such 
section were successful in stimulating devel-
opment and expedited patient access to drug 
products for treatment or prevention of a 
rare pediatric disease that wouldn’t other-
wise take place without the incentive pro-
vided by such vouchers. 
(xi) The impact of such priority review 
vouchers on the workload, review process, 
and public health prioritization efforts of 
the Food and Drug Administration. 
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(xii) Any other incentives in Federal 
law that exist for companies developing 
drugs or biological products described in 
clause (i). 
(2) REPORT
ON
FINDINGS.—Not later than 5 
years after the date of the enactment of this Act, the 
Comptroller General of the United States shall submit 
to the Committee 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 con-
ducted under paragraph (1). 
SEC. 105. LIMITATIONS ON EXCLUSIVE APPROVAL OR LI-
CENSURE OF ORPHAN DRUGS. 
(a) IN GENERAL.—Section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘same disease or condi-
tion’’ and inserting ‘‘same approved use or indication 
within such rare disease or condition’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘same rare disease or condition’’ and 
inserting ‘‘same approved use or indication for 
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which such 7-year period applies to such already 
approved or licensed drug’’; and 
(B) in paragraph (1), by inserting ‘‘, relat-
ing to the approved use or indication,’’ after ‘‘the 
needs’’; 
(3) in subsection (c)(1), by striking ‘‘same rare 
disease or condition as the already approved drug’’ 
and inserting ‘‘same use or indication for which the 
already approved or licensed drug was approved or 
licensed’’; and 
(4) by adding at the end the following: 
‘‘(f) APPROVED USE OR INDICATION DEFINED.—In 
this section, the term ‘approved use or indication’ means 
the use or indication approved under section 505 of this 
Act or licensed under section 351 of the Public Health Serv-
ice Act for a drug designated under section 526 for a rare 
disease or condition.’’. 
(b) APPLICATION OF AMENDMENTS.—The amendments 
made by subsection (a) shall apply with respect to any drug 
designated under section 526 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bb), regardless of the date 
on which the drug was so designated, and regardless of the 
date on which the drug was approved under section 505 
of such Act (21 U.S.C. 355) or licensed under section 351 
of the Public Health Service Act (42 U.S.C. 262). 
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SEC. 106. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
Section 409I(d) of the Public Health Service Act (42 
U.S.C. 284m(d)) is amended to read as follows: 
‘‘(d) FUNDING.—Of the amount made available for pe-
diatric research to each national research institute and na-
tional center under this title for each of fiscal years 2025, 
2026, and 2027, the Director of NIH is authorized to make 
available up to one percent of such amount for pediatric 
research under this section.’’. 
TITLE II—UNITED STATES-ABRA-
HAM ACCORDS COOPERATION 
AND SECURITY 
SEC. 201. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE 
WITHIN FOOD AND DRUG ADMINISTRATION. 
(a) IN GENERAL.—Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 
‘‘(a) IN GENERAL.—The Secretary, acting through the 
Commissioner of Food and Drugs, shall establish within the 
Food and Drug Administration an office, to be known as 
the Abraham Accords Office, to be headed by a director. 
‘‘(b) OFFICE.—Not later than two years after the date 
of enactment of this section, the Secretary shall— 
‘‘(1) in consultation with the governments of 
Abraham Accords countries, as well as appropriate 
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United States Government diplomatic and security 
personnel— 
‘‘(A) select the location of the Abraham Ac-
cords Office in an Abraham Accords country; 
and 
‘‘(B) establish such office; and 
‘‘(2) assign to such office such personnel of the 
Food and Drug Administration as the Secretary de-
termines necessary to carry out the functions of such 
office. 
‘‘(c) DUTIES.—The Secretary, acting through the Di-
rector of the Abraham Accords Office, shall— 
‘‘(1) after the Abraham Accords Office is estab-
lished— 
‘‘(A) as part of the Food and Drug Admin-
istration’s work to strengthen the international 
oversight of regulated commodities, provide tech-
nical assistance to regulatory partners in Abra-
ham Accords countries on strengthening regu-
latory oversight and converging regulatory re-
quirements for the oversight of regulated prod-
ucts, including good manufacturing practices 
and other issues relevant to manufacturing med-
ical products that are regulated by the Food and 
Drug Administration; 
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‘‘(B) facilitate interactions between the 
Food and Drug Administration and interested 
parties in Abraham Accords countries, including 
by sharing relevant information regarding 
United States regulatory pathways with such 
parties; and 
‘‘(C) facilitate feedback between the Food 
and Drug Administration and such parties lo-
cated within Abraham Accords countries prior to 
submission of an application under section 
505(b), 505(j), or 515 of this Act or section 
351(a) or 351(k) of the Public Health Service 
Act, or a notification under section 510(k) of this 
Act, such as feedback on research, development, 
and manufacturing of drugs, biologics, and med-
ical devices; and 
‘‘(2) carry out other functions and activities as 
the Secretary determines to be necessary to carry out 
this section. 
‘‘(d) ABRAHAM ACCORDS COUNTRY DEFINED.—In this 
section, the term ‘Abraham Accords country’ means a coun-
try identified by the Department of State as having signed 
the Abraham Accords Declaration.’’. 
(b) REPORT TO CONGRESS.— 
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(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to the Con-
gress a report on the Abraham Accords Office, includ-
ing— 
(A) an evaluation of how the Office has ad-
vanced progress toward conformance with Food 
and Drug Administration regulatory require-
ments by manufacturers in the Abraham Accords 
countries; 
(B) a numerical count of parties that the 
Office has helped facilitate interactions or feed-
back pursuant to subparagraphs (B) and (C) of 
section 1015(c)(1) of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a)); 
(C) a summary of technical assistance pro-
vided to regulatory partners in Abraham Accords 
countries pursuant to subparagraph (A) of such 
section 1015(c)(1); and 
(D) recommendations for increasing and 
improving coordination between the Food and 
Drug Administration and entities in Abraham 
Accords countries. 
(2) ABRAHAM ACCORDS COUNTRY DEFINED.—In 
this subsection, the term ‘‘Abraham Accords country’’ 
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has the meaning given such term in section 1015(d) 
of the Federal Food, Drug, and Cosmetic Act (as 
added by subsection (a)). 
TITLE 
III—ORGAN 
PROCURE-
MENT 
AND 
TRANSPLAN-
TATION NETWORK 
SEC. 301. REGISTRATION FEES. 
Section 372 of the Public Health Service Act (42 
U.S.C. 274) is amended by adding at the end the following: 
‘‘(d) REGISTRATION FEES.— 
‘‘(1) IN GENERAL.—The Secretary may collect 
registration fees from any member of the Organ Pro-
curement and Transplantation Network for each 
transplant candidate such member places on the list 
described in subsection (b)(2)(A)(i). Such registration 
fees shall only be collected and distributed to support 
the operation of the Organ Procurement and Trans-
plantation Network. Such registration fees are author-
ized to remain available until expended. 
‘‘(2) COLLECTION.—The Secretary may collect 
the registration fees under paragraph (1) directly or 
through awards made under subsection (b)(1)(A). 
‘‘(3) DISTRIBUTION.—The Secretary may dis-
tribute such fees among the awardees described in sub-
section (b)(1)(A). 
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‘‘(4) TRANSPARENCY.—The Secretary shall— 
‘‘(A) promptly post on the Internet website 
of the Organ Procurement and Transplant Net-
work— 
‘‘(i) the amount of registration fees col-
lected under this subsection from each mem-
ber of the Organ Procurement and Trans-
plantation Network; and 
‘‘(ii) a list of activities such fees are 
used to support; and 
‘‘(B) update the information posted pursu-
ant to subparagraph (A), as applicable for each 
calendar quarter for which fees are collected 
under paragraph (1). 
‘‘(5) GAO REVIEW.—Not later than 2 years after 
the date of enactment of this subsection, the Comp-
troller General of the United States shall, to the extent 
data are available— 
‘‘(A) conduct a review concerning the ac-
tivities under this subsection; and 
‘‘(B) submit to the Committee on Health, 
Education, Labor, and Pensions and the Com-
mittee on Finance of the Senate and the Com-
mittee on Energy and Commerce of the House of 
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Representatives, a report on such review, includ-
ing related recommendations, as applicable.’’. 
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Union Calendar No. 594 
118TH CONGRESS 
2D SESSION 
H. R. 3433 
[Report No. 118–700] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic 
Act with respect to molecularly targeted pediatric 
cancer investigations, and for other purposes. 
SEPTEMBER 20, 2024 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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