HR 3433 RFS
any drug designated under section 526 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard-
less 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). 
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 
pediatric research to each national research institute and 
national 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 amend-
ed by adding at the end the following: 
VerDate Sep 11 2014 
03:03 Sep 25, 2024
Jkt 049200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.RFS
H3433
ssavage on LAPJG3WLY3PROD with BILLS
HR 3433 RFS
‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Commissioner of Food and Drugs, shall establish with-
in 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 
United States Government diplomatic and security 
personnel— 
‘‘(A) select the location of the Abraham 
Accords 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 
VerDate Sep 11 2014 
03:03 Sep 25, 2024
Jkt 049200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.RFS
H3433
ssavage on LAPJG3WLY3PROD with BILLS
HR 3433 RFS
oversight of regulated commodities, provide 
technical assistance to regulatory partners in 
Abraham Accords countries on strengthening 
regulatory oversight and converging regulatory 
requirements for the oversight of regulated 
products, including good manufacturing prac-
tices and other issues relevant to manufacturing 
medical products that are regulated by the 
Food and Drug Administration; 
‘‘(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, develop-
ment, and manufacturing of drugs, biologics, 
and medical devices; and 
VerDate Sep 11 2014 
03:03 Sep 25, 2024
Jkt 049200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.RFS
H3433
ssavage on LAPJG3WLY3PROD with BILLS
HR 3433 RFS
‘‘(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 country identified by the Department of State as having 
signed the Abraham Accords Declaration.’’. 
(b) REPORT TO CONGRESS.— 
(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 
Congress a report on the Abraham Accords Office, 
including— 
(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 Ac-
cords 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 Ac-
VerDate Sep 11 2014 
03:03 Sep 25, 2024
Jkt 049200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.RFS
H3433
ssavage on LAPJG3WLY3PROD with BILLS
HR 3433 RFS
cords 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’’ 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 fol-
lowing: 
‘‘(d) REGISTRATION FEES.— 
‘‘(1) IN GENERAL.—The Secretary may collect 
registration fees from any member of the Organ 
Procurement and Transplantation Network for each 
transplant candidate such member places on the list 
described in subsection (b)(2)(A)(i). Such registra-
tion fees shall only be collected and distributed to 
VerDate Sep 11 2014 
03:03 Sep 25, 2024
Jkt 049200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.RFS
H3433
ssavage on LAPJG3WLY3PROD with BILLS
HR 3433 RFS
support the operation of the Organ Procurement 
and Transplantation Network. Such registration fees 
are authorized 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.—Any amounts collected 
under this subsection shall— 
‘‘(A) be credited to the currently applicable 
appropriation, account, or fund of the Depart-
ment of Health and Human Services as discre-
tionary offsetting collections; and 
‘‘(B) be available, only to the extent and in 
the amounts provided in advance in appropria-
tions Acts, to distribute such fees among the 
awardees described in subsection (b)(1)(A). 
‘‘(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 
collected under this subsection from each 
member of the Organ Procurement and 
Transplantation Network; and 
VerDate Sep 11 2014 
03:03 Sep 25, 2024
Jkt 049200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.RFS
H3433
ssavage on LAPJG3WLY3PROD with BILLS
HR 3433 RFS
‘‘(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 
Comptroller 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 Representatives, a report on such review, in-
cluding related recommendations, as applica-
ble.’’. 
Passed the House of Representatives September 23, 
2024. 
Attest: 
KEVIN F. MCCUMBER, 
Clerk. 
VerDate Sep 11 2014 
03:03 Sep 25, 2024
Jkt 049200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H3433.RFS
H3433
ssavage on LAPJG3WLY3PROD with BILLS