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Code · BILL · 117th Congress · S. 3799 (Introduced in Senate) — To prepare for, and respond to, existing viruses, emerging new threats, and pandemics. · Sec. 504

Sec. 504. Third party test evaluation during emergencies

372 words·~2 min read·/bill/117/s/3799/is/section-504

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Section 565 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–4 ), as amended by section 503, is further amended by adding at the end the following: For purposes of conducting evaluations regarding whether an in vitro diagnostic product (as defined in section 809.3 of title 21, Code of Federal Regulations (or any successor regulations)) for which a request for emergency use authorization is submitted under section 564 meets the criteria for issuance of such authorization, the Secretary may, as appropriate, consult with persons with appropriate expertise with respect to such evaluations or enter into cooperative agreements or contracts with such persons under which such persons conduct such evaluations and make such recommendations, including, as appropriate, evaluations and recommendations regarding the scope of authorization and conditions of authorization.
In evaluating and making recommendations to the Secretary regarding the validity, accuracy, and reliability of in vitro diagnostic products, as described in paragraph (1), a person shall consider and document whether the relevant criteria under subsection (c)(2) of section 564 for issuance of authorization under such section are met with respect to the in vitro diagnostic product. Recommendations made by a person under this subsection shall be submitted to the Secretary in writing, and shall include the reasons for such recommendation and other information that may be requested by the Secretary.
Nothing in this subsection shall be construed to require the Secretary to consult with, or enter into cooperative agreements or contracts with, persons as described in paragraph
(1)for purposes of authorizing an in vitro diagnostic product or otherwise affecting the emergency use authorization authorities under this section or section 564. . Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the Secretary ) shall issue draft guidance on consultations with persons under subsection
(i)of section 565 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–4 ), as added by subsection (a), including considerations concerning conflicts of interest, compensation arrangements, and information sharing. Not later than 1 year after the public comment period on such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.
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  • 21 USC 360bbb–4
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Sec. 504
Third party test evaluation during emergencies
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