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Code · BILL · 115th Congress · H.R. 6378 (Introduced in House) — To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with... · Sec. 404

Sec. 404. Biological threat detection

524 words·~2 min read·/bill/115/hr/6378/ih/section-404

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Part B of title III of the Public Health Service Act ( 42 U.S.C. 243 et seq.), as amended by section 104, is further amended by inserting after section 319D–1 of such Act, the following new section: The Secretary of Health and Human Services, in coordination with the Secretary of Defense and the Secretary of Homeland Security, shall— facilitate the identification by Federal departments and agencies of technological, operational, and programmatic successes and failures of domestic detection programs for intentionally introduced, accidentally released, and naturally occurring infectious diseases; facilitate the exchange of information described in subparagraph
(A)among Federal departments and agencies that utilize biological threat detection technology; and make recommendations on research, development, and procurement to Federal departments and agencies to replace and enhance biological threat detection systems in use, including recommendation for the transfer of biological threat detection technology among Federal departments and agencies. In carrying out paragraph (1), the Secretary of Health and Human Services shall take into consideration the capabilities of the system with respect to each of the following: Rapidly detecting, identifying, characterizing, and confirming the presence of biological threat agents. Recovering live biological agents from collection devices. Determining the geographical distribution of biological agents. Determining the extent of environmental contamination and persistence of biological agents. Providing advanced molecular diagnostics to State, local, tribal, and territorial public health and other laboratories that support biological threat detection activities. The Secretary of Health and Human Services, in consultation with Secretary of Defense, the Secretary of Homeland Security, the Director of the Centers for Disease Control and Prevention, and the heads of other Federal departments and agencies that utilize biological threat detection technology, shall collaborate with State, local, tribal, and territorial public health laboratories and other users of current and future biological threat detection systems to develop— biological threat detection requirements, including— technical, quality, and biosafety standards, including the review of validation data prior to and throughout deployment of a biological threat detection system; and requirements for— the assessment of quality standards and the development and deployment of biological threat detection systems; and metrics for, collaborative assessment of, and deployment of biosafety standards; a standardized integration strategy for— the level to which biological threat detection processes and systems are defined and executed; the locations at which such processes and systems are performed; and the extent to which data is shared among State, local, tribal, and territorial public health laboratories and Federal departments and agencies; State, local, tribal, and territorial laboratory training requirements for— supporting and participating in biological threat detection systems; and addressing flexibility at the jurisdictional level allowing for adoption of technology based on need and assessment of the efficacy and local utility of technology by the jurisdiction; guidelines for a coordinated public health response addressing all aspect of a response, including clinical and epidemiological guidelines for utilizing information produced by biological threat detection systems and responding to intentionally introduced, accidentally released, and naturally occurring infectious diseases; and a coordinated remediation plan with Federal departments and agencies and State and local public health agencies to facilitate rapid, safe, and coordinated restoration of facilities and localities after a contaminating biological event. .
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Sec. 404
Biological threat detection
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