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