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(Original Signature of Member)

H. R. ll
118TH CONGRESS
2D SESSION

To provide for the establishment, within the Food and Drug Administration,
of an Abraham Accords Bureau to promote and facilitate cooperation
between the Food and Drug Administration and entities in Abraham
Accords countries wishing to work with the agency in order to develop
and sell products in the United States, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

Mrs. HARSHBARGER introduced the following bill; which was referred to the
Committee on llllllllllllll

A BILL
To provide for the establishment, within the Food and Drug
Administration, of an Abraham Accords Bureau to pro-
mote and facilitate cooperation between the Food and
Drug Administration and entities in Abraham Accords
countries wishing to work with the agency in order to
develop and sell products in the United States, and for
other purposes.

1 Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled,

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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘United States-Abra-

3 ham Accords Cooperation and Security Act of 2024’’.
4 SEC. 2. ESTABLISHMENT OF ABRAHAM ACCORDS BUREAU

5 WITHIN FOOD AND DRUG ADMINISTRATION.

6 (a) IN GENERAL.—Chapter X of the Federal Food,

7 Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-
8 ed by adding at the end the following:
9 ‘‘SEC. 1015. ABRAHAM ACCORDS BUREAU.

10 ‘‘(a) IN GENERAL.—The Secretary, acting through

11 the Commissioner of Food and Drugs, shall establish with-
12 in the Food and Drug Administration a bureau, to be
13 known as the Abraham Accords Bureau, to be headed by
14 a director.
15 ‘‘(b) OFFICES.—Not later than one year after the
16 date of enactment of this section, the Secretary shall—
17 ‘‘(1) in consultation with the governments of
18 Abraham Accords countries—
19 ‘‘(A) select the locations of one or more of-
20 fices of the Abraham Accords Bureau in one or
21 more Abraham Accords countries; and
22 ‘‘(B) establish each such office; and
23 ‘‘(2) assign to each such office such personnel
24 of the Food and Drug Administration as the Sec-
25 retary determines necessary to carry out the func-
26 tions of the office.
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1 ‘‘(c) DUTIES.—The Secretary, acting through the Di-
2 rector of the Abraham Accords Bureau, shall—
3 ‘‘(1) not later than 90 days after all offices of
4 the Abraham Accords Bureau are established—
5 ‘‘(A) develop a list of essential medical,
6 biomedical, and life sciences products, the key
7 raw pharmaceutical ingredients of such prod-
8 ucts, and the active pharmaceutical ingredients
9 of such products, that are primarily manufac-
10 tured in a covered country;
11 ‘‘(B) develop a list of medical, biomedical,
12 and life sciences facilities and entities in Abra-
13 ham Accord countries that can engage with of-
14 fices of the Abraham Accords Bureau to bolster
15 the United States’ health care and medical sup-
16 ply needs; and
17 ‘‘(C) submit such lists to the Congress;
18 ‘‘(2) not less than every 3 years thereafter, up-
19 date the lists under paragraph (1) and submit the
20 updated lists to the Congress;
21 ‘‘(3) consult with parties in Abraham Accords
22 countries on good manufacturing practices and other
23 issues relevant to manufacturing medical products
24 that are regulated by the Food and Drug Adminis-
25 tration;

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1 ‘‘(4) facilitate interactions between the Food
2 and Drug Administration and interested parties in
3 Abraham Accords countries, including by sharing
4 relevant information regarding United States regu-
5 latory pathways with such parties;
6 ‘‘(5) offer technical assistance on manufac-
7 turing drugs and devices to interested parties in
8 Abraham Accords countries; and
9 ‘‘(6) carry out other functions and activities as
10 the Secretary determines to be necessary to carry
11 out this section.
12 ‘‘(d) LIMITATION.—Notwithstanding any other provi-
13 sion of this section, this section does not authorize any
14 assistance to any entity in an Abrahams Accords country
15 that, for purposes of manufacturing, uses any ingredient
16 or product that is produced or manufactured in a covered
17 country.
18 ‘‘(e) DEFINITIONS.—In this section:
19 ‘‘(1) The term ‘Abraham Accords country’
20 means a country identified by the Department of
21 State as having signed the Abraham Accords Dec-
22 laration.
23 ‘‘(2) The term ‘covered country’ means a coun-
24 try—

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1 ‘‘(A) designated as a country of particular
2 concern for religious freedom under section
3 402(b)(1)(A)(ii) of the International Religious
4 Freedom Act of 1998; or
5 ‘‘(B) the government of which engages in
6 a consistent pattern of gross violations of inter-
7 nationally recognized human rights, as defined
8 in section 502B(d)(1) of the Foreign Assistance
9 Act of 1961.
10 ‘‘(3) The term ‘essential medical products’ shall
11 have such definition as the Secretary may determine
12 for purposes of this section.
13 ‘‘(4) The term ‘primarily manufactured in a
14 covered country’ means—
15 ‘‘(A) manufactured in a covered country in
16 final form; or
17 ‘‘(B) containing any active pharmaceutical
18 ingredient or excipient that was manufactured
19 in a covered country.’’.
20 (b) REPORT TO CONGRESS.—Not later than 3 years
21 after the date of enactment of this Act, the Secretary of
22 Health and Human Services shall submit to the Congress
23 a report on the Abraham Accords Bureau, including—
24 (1) an evaluation of—

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1 (A) how each office of the Bureau has ad-
2 vanced progress toward shifting United States
3 supply chains of essential medical products
4 from covered countries to Abraham Accords
5 countries (as such terms are defined in section
6 1015 of the Federal Food, Drug, and Cosmetic
7 Act, as added by subsection (a)); and
8 (B) the effectiveness of the activities car-
9 ried out pursuant to section 1015(c) of the
10 Federal Food, Drug, and Cosmetic Act, as
11 added by subsection (a); and
12 (2) recommendations for increasing and improv-
13 ing coordination between the Food and Drug Admin-
14 istration and entities in Abraham Accords countries
15 (as such term is defined in section 1015 of the Fed-
16 eral Food, Drug, and Cosmetic Act, as added by
17 subsection (a)).

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