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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5517 Introduced in Senate (IS)]

<DOC>

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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 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:

``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 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).
                                 <all>
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