Sec. 811. Establishment of Abraham Accords Office within Food and Drug Administration
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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: 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. Not later than 2 years after the date of enactment of this section, the Secretary shall— in consultation with the governments of Abraham Accords countries, as well as appropriate United States Government diplomatic and security personnel— select the location of the Abraham Accords Office in an Abraham Accords country; and establish such office; and assign to such office such personnel of the Food and Drug Administration as the Secretary determines necessary to carry out the functions of such office.
The Secretary, acting through the Director of the Abraham Accords Office, shall— after the Abraham Accords Office is established— as part of the Food and Drug Administration’s work to strengthen the international oversight of regulated commodities, provide technical assistance to regulatory partners in Abraham Accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products, including good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the Food and Drug Administration; and 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, and facilitate feedback on the research, development, and manufacturing of products regulated in accordance with this Act; and carry out other functions and activities as the Secretary determines to be necessary to carry out this section.
In this section, the term Abraham Accords country means a country identified by the Department of State as having signed the Abraham Accords Declaration. Nothing in this section shall be construed to require any action inconsistent with a national security recommendation provided by the Federal Government. . 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, including— an evaluation of how the Office has advanced progress toward conformance with Food and Drug Administration regulatory requirements by manufacturers in the Abraham Accords countries; a numerical count of parties that the Office has helped facilitate interactions or feedback pursuant to section 1015(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)); a summary of technical assistance provided to regulatory partners in Abraham Accords countries pursuant to subparagraph
(A)of such section 1015(c)(1); and recommendations for increasing and improving coordination between the Food and Drug Administration and entities in Abraham Accords countries. In this subsection, the term Abraham Accords country has the meaning given such term in section 1015(d) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).
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Sec. 811
Establishment of Abraham Accords Office within Food and Drug Administration
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