[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7155 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 7155
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
January 31, 2024
Mrs. Harshbarger (for herself, Mr. Vargas, Mr. Weber of Texas, Mr.
Peters, Mr. Harris, Mr. Levin, and Mr. Allen) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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.
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 BUREAU 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 BUREAU.
``(a) In General.--The Secretary, acting through the Commissioner
of Food and Drugs, shall establish within the Food and Drug
Administration a bureau, to be known as the Abraham Accords Bureau, to
be headed by a director.
``(b) Offices.--Not later than one year after the date of enactment
of this section, the Secretary shall--
``(1) in consultation with the governments of Abraham
Accords countries--
``(A) select the locations of one or more offices
of the Abraham Accords Bureau in one or more Abraham
Accords countries; and
``(B) establish each such office; and
``(2) assign to each 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 Bureau, shall--
``(1) not later than 90 days after all offices of the
Abraham Accords Bureau are established--
``(A) develop a list of essential medical,
biomedical, and life sciences products, the key raw
pharmaceutical ingredients of such products, and the
active pharmaceutical ingredients of such products,
that are primarily manufactured in a covered country;
``(B) develop a list of medical, biomedical, and
life sciences facilities and entities in Abraham Accord
countries that can engage with offices of the Abraham
Accords Bureau to bolster the United States' health
care and medical supply needs; and
``(C) submit such lists to the Congress;
``(2) not less than every 3 years thereafter, update the
lists under paragraph (1) and submit the updated lists to the
Congress;
``(3) consult with parties in Abraham Accords countries on
good manufacturing practices and other issues relevant to
manufacturing medical products that are regulated by the Food
and Drug Administration;
``(4) 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;
``(5) offer technical assistance on manufacturing drugs and
devices to interested parties in Abraham Accords countries; and
``(6) carry out other functions and activities as the
Secretary determines to be necessary to carry out this section.
``(d) Limitation.--Notwithstanding any other provision of this
section, this section does not authorize any assistance to any entity
in an Abrahams Accords country that, for purposes of manufacturing,
uses any ingredient or product that is produced or manufactured in a
covered country.
``(e) Definitions.--In this section:
``(1) The term `Abraham Accords country' means a country
identified by the Department of State as having signed the
Abraham Accords Declaration.
``(2) The term `covered country' means a country--
``(A) designated as a country of particular concern
for religious freedom under section 402(b)(1)(A)(ii) of
the International Religious Freedom Act of 1998; or
``(B) the government of which engages in a
consistent pattern of gross violations of
internationally recognized human rights, as defined in
section 502B(d)(1) of the Foreign Assistance Act of
1961.
``(3) The term `essential medical products' shall have such
definition as the Secretary may determine for purposes of this
section.
``(4) The term `primarily manufactured in a covered
country' means--
``(A) manufactured in a covered country in final
form; or
``(B) containing any active pharmaceutical
ingredient or excipient that was manufactured in a
covered country.''.
(b) Report to Congress.--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 Bureau,
including--
(1) an evaluation of--
(A) how each office of the Bureau has advanced
progress toward shifting United States supply chains of
essential medical products from covered countries to
Abraham Accords countries (as such terms are defined in
section 1015 of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a)); and
(B) the effectiveness of the activities carried out
pursuant to section 1015(c) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a); and
(2) recommendations for increasing and improving
coordination between the Food and Drug Administration and
entities in Abraham Accords countries (as such term is defined
in section 1015 of the Federal Food, Drug, and Cosmetic Act, as
added by subsection (a)).
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