118 S5517 IS: United States-Abraham Accords Cooperation and Security Act of 2024 U.S. Senate 2024-12-12 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II118th CONGRESS2d SessionS. 5517IN THE SENATE OF THE UNITED STATESDecember 12, 2024Mr. Budd (for himself and Ms. Hassan) introduced the following bill; which was read twice and referred to the Committee on Foreign RelationsA BILLTo 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.

Short title

This Act may be cited as the United States-Abraham Accords Cooperation and Security Act of 2024.

2.

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:

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 2 years after the date of enactment of this section, the Secretary shall—(1)in consultation with the governments of Abraham Accords countries, establish the Abraham Accords Office in an Abraham Accords country; and(2)assign to such Office such personnel of the Food and Drug Administration as the Secretary determines necessary to carry out the functions of the Office.(c)

Duties

The Secretary, acting through the Director of the Abraham Accords Office, shall, not later than 30 days after the Abraham Accords Office is established—(1)provide technical assistance to parties in Abraham Accords countries on oversight of good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the Food and Drug Administration;(2)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;(3)offer technical assistance regarding research, development, and manufacturing of drugs and devices to parties located in an Abraham Accords country that intend to file an application for approval, licensure, clearance, or authorization of such a drug or device under section 505, 510(k), 513(f)(2), or 515 of this Act or section 351 of the Public Health Service Act; and(4)carry out other functions and activities as the Secretary determines to be necessary to carry out this section.(d)

Waiver authority

(1)

In general

The Secretary, in consultation with the Secretary of State, may suspend, for a period of not more than 6 months, the application of any of the actions described in subsection (b) or (c) with respect to an Abraham Accords country if the Secretary determines, and reports to the appropriate congressional committees, that—(A)the exercise of such waiver authority would further the purposes of this section; or(B)such a suspension is necessary to protect the national security interests of the United States.(2)

Renewal of waiver

The Secretary, in consultation with the Secretary of State, may renew a waiver under paragraph (1) for an additional period of not more than 6 months, not later than 15 days before the initial waiver expires, if the Secretary makes an additional determination and report described in paragraph (1).(e)

Definition

In this section, the term Abraham Accords country means a country identified by the Department of State as having signed the Abraham Accords.(f)

Sunset

This section shall cease to have force or effect on the date that is 12 years after the date on which the Abraham Accords Office is established under subsection (a).

.(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 established under section 1015 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), including—(A)an evaluation of—(i)how such Office has made progress in ensuring that manufacturers in Abraham Accords countries comply with applicable requirements with respect to applications submitted for approval, licensure, clearance, or authorization of a drug or device under section 505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or section 351 of the Public Health Service Act (42 U.S.C. 262); and(ii)a list of parties that such Office has assisted pursuant to section 1015(c) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and the drugs and devices that such parties intend to be the subjects of an application described in clause (i); and(B)recommendations for increasing and improving coordination between the Food and Drug Administration and entities in Abraham Accords countries.(2)

Definition

In this section, the term Abraham Accords country has the meaning given such term in section 1015 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).