II 

118TH CONGRESS 

2D SESSION S. 5517 

To provide for the establishment, within the Food and Drug Administration, 

of an Abraham Accords Office 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 SENATE OF THE UNITED STATES 

DECEMBER 12, 2024 

Mr. BUDD (for himself and Ms. HASSAN) introduced the following bill; which 

was read twice and referred to the Committee on Foreign Relations 

A BILL 

To provide for the establishment, within the Food and Drug 

Administration, of an Abraham Accords Office 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. 

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 ‘‘United States-Abra5 ham Accords Cooperation and Security Act of 2024’’. 


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1 SEC. 2. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE 

2 WITHIN FOOD AND DRUG ADMINISTRATION. 

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

4 Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend5 ed by adding at the end the following: 

6 ‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 

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

8 the Commissioner of Food and Drugs, shall establish with9 in the Food and Drug Administration an office, to be 

10 known as the Abraham Accords Office, to be headed by 

11 a director. 

12 ‘‘(b) OFFICE.—Not later than 2 years after the date 

13 of enactment of this section, the Secretary shall— 

14 ‘‘(1) in consultation with the governments of 

15 Abraham Accords countries, establish the Abraham 

16 Accords Office in an Abraham Accords country; and 

17 ‘‘(2) assign to such Office such personnel of the 

18 Food and Drug Administration as the Secretary de19 termines necessary to carry out the functions of the 

20 Office. 

21 ‘‘(c) DUTIES.—The Secretary, acting through the Di22 rector of the Abraham Accords Office, shall, not later than 

23 30 days after the Abraham Accords Office is established— 

24 ‘‘(1) provide technical assistance to parties in 

25 Abraham Accords countries on oversight of good 

26 manufacturing practices and other issues relevant to 


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1 manufacturing medical products that are regulated 

2 by the Food and Drug Administration; 

3 ‘‘(2) facilitate interactions between the Food 

4 and Drug Administration and interested parties in 

5 Abraham Accords countries, including by sharing 

6 relevant information regarding United States regu7 latory pathways with such parties; 

8 ‘‘(3) offer technical assistance regarding re9 search, development, and manufacturing of drugs 

10 and devices to parties located in an Abraham Ac11 cords country that intend to file an application for 

12 approval, licensure, clearance, or authorization of 

13 such a drug or device under section 505, 510(k), 

14 513(f)(2), or 515 of this Act or section 351 of the 

15 Public Health Service Act; and 

16 ‘‘(4) carry out other functions and activities as 

17 the Secretary determines to be necessary to carry 

18 out this section. 

19 ‘‘(d) WAIVER AUTHORITY.— 

20 ‘‘(1) IN GENERAL.—The Secretary, in consulta21 tion with the Secretary of State, may suspend, for 

22 a period of not more than 6 months, the application 

23 of any of the actions described in subsection (b) or 

24 (c) with respect to an Abraham Accords country if 


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1 the Secretary determines, and reports to the appro2 priate congressional committees, that— 

3 ‘‘(A) the exercise of such waiver authority 

4 would further the purposes of this section; or 

5 ‘‘(B) such a suspension is necessary to 

6 protect the national security interests of the 

7 United States. 

8 ‘‘(2) RENEWAL OF WAIVER.—The Secretary, in 

9 consultation with the Secretary of State, may renew 

10 a waiver under paragraph (1) for an additional pe11 riod of not more than 6 months, not later than 15 

12 days before the initial waiver expires, if the Sec13 retary makes an additional determination and report 

14 described in paragraph (1). 

15 ‘‘(e) DEFINITION.—In this section, the term ‘Abra16 ham Accords country’ means a country identified by the 

17 Department of State as having signed the Abraham Ac18 cords. 

19 ‘‘(f) SUNSET.—This section shall cease to have force 

20 or effect on the date that is 12 years after the date on 

21 which the Abraham Accords Office is established under 

22 subsection (a).’’. 

23 (b) REPORT TO CONGRESS.— 

24 (1) IN GENERAL.—Not later than 3 years after 

25 the date of enactment of this Act, the Secretary of 


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1 Health and Human Services shall submit to the 

2 Congress a report on the Abraham Accords Office 

3 established under section 1015 of the Federal Food, 

4 Drug, and Cosmetic Act, as added by subsection (a), 

5 including— 

6 (A) an evaluation of— 

7 (i) how such Office has made progress 

8 in ensuring that manufacturers in Abra9 ham Accords countries comply with appli10 cable requirements with respect to applica11 tions submitted for approval, licensure, 

12 clearance, or authorization of a drug or de13 vice under section 505, 510(k), 513(f)(2), 

14 or 515 of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 355, 360(k), 

16 360c(f)(2), 360e) or section 351 of the 

17 Public Health Service Act (42 U.S.C. 

18 262); and 

19 (ii) a list of parties that such Office 

20 has assisted pursuant to section 1015(c) of 

21 the Federal Food, Drug, and Cosmetic 

22 Act, as added by subsection (a), and the 

23 drugs and devices that such parties intend 

24 to be the subjects of an application de25 scribed in clause (i); and 


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1 (B) recommendations for increasing and 

2 improving coordination between the Food and 

3 Drug Administration and entities in Abraham 

4 Accords countries. 

5 (2) DEFINITION.—In this section, the term 

6 ‘‘Abraham Accords country’’ has the meaning given 

7 such term in section 1015 of the Federal Food, 

8 Drug, and Cosmetic Act, as added by subsection (a). 

Æ 


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