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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. 304

Sec. 304. Accessing specimen samples and diagnostic tests

273 words·~1 min read·/bill/117/s/3799/is/section-304·

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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 make publicly available policies and procedures related to public and private entities accessing specimens of, or specimens containing, pathogens or suitable surrogates for, or alternatives to, such pathogens as the Secretary determines appropriate to support public health preparedness and response activities or biomedical research for purposes of the development and validation, as applicable, of medical products to address emerging infectious diseases and for use to otherwise respond to emerging infectious diseases.
Such policies and procedures shall take into account, as appropriate, any applicable existing Federal resources. The Secretary shall issue guidance regarding the procedures for carrying out paragraph (1), including— the method for requesting such samples; considerations for sample availability and use of suitable surrogates or alternatives to such pathogens, as appropriate, including applicable safeguard and security measures; and information required to be provided in order to receive such samples or suitable surrogates or alternatives.
Title III of the Public Health Service Act is amended by inserting after section 319A ( 42 U.S.C. 247d–1 ) the following: The Secretary may contract with public and private entities, as appropriate, to increase capacity in the rapid development, validation, manufacture, and dissemination of diagnostic tests, as appropriate, to State, local, and Tribal health departments and other appropriate entities for immediate public health response activities to address an emerging infectious disease with respect to which a public health emergency is declared under section 319, or that has significant potential to cause such a public health emergency. .
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  • 42 USC 247d–1
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Sec. 304
Accessing specimen samples and diagnostic tests
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