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:

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)).