Sec. 102. Assistant Secretary for Preparedness and Response

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Section 2811 of the Public Health Service Act ( 42 U.S.C. 300hh–10 ) is amended— in subsection (b)— in paragraph (3), by inserting , security countermeasures (as defined in section 319F–2), after qualified countermeasures (as defined in section 319F–1) ; in paragraph (4), by adding at the end the following: Provide integrated policy coordination and strategic direction with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan developed pursuant to section 504(6) of the Homeland Security Act of 2002, or any successor plan, before, during, and following public health emergencies.

Identify and minimize gaps, duplication, and other inefficiencies in medical and public health preparedness and response activities and the actions necessary to overcome these obstacles. Align and coordinate medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this Act, to the extent possible, including program requirements, timelines, and measurable goals, and in consultation with the Secretary of Homeland Security, to— optimize and streamline medical and public health preparedness and response capabilities and the ability of local communities to respond to public health emergencies; and gather and disseminate best practices among grant and cooperative agreement recipients, as appropriate.

Carry out drills and operational exercises, in consultation with the Department of Homeland Security, the Department of Defense, the Department of Veterans Affairs, and other applicable Federal departments and agencies, as necessary and appropriate, to identify, inform, and address gaps in and policies related to all-hazards medical and public health preparedness and response, including exercises based on— identified threats for which countermeasures are available and for which no countermeasures are available; and unknown threats for which no countermeasures are available.

On a periodic basis consult with, as applicable and appropriate, the Assistant to the President for National Security Affairs, to provide an update on, and discuss, medical and public health preparedness and response activities pursuant to this Act and the Federal Food, Drug, and Cosmetic Act, including progress on the development, approval, clearance, and licensure of medical countermeasures. ; and by adding at the end the following: Develop, and update on an annual basis, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d).

Each such plan shall— include consideration of the entire medical countermeasures enterprise, including— basic research and advanced research and development; approval, clearance, licensure, and authorized uses of products; and procurement, stockpiling, maintenance, and replenishment of all products in the Strategic National Stockpile; inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities; identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs within the continuum of the medical countermeasure enterprise consistent with section 319F–2; and be made available to the appropriate committees of Congress upon request. ; by striking subsection

(c)and inserting the following: The Assistant Secretary for Preparedness and Response shall— have lead responsibility within the Department of Health and Human Services for emergency preparedness and response policy coordination and strategic direction; have authority over and responsibility for— the National Disaster Medical System pursuant to section 2812; the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C–2; the Biomedical Advanced Research and Development Authority pursuant to section 319L; the Medical Reserve Corps pursuant to section 2813; the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I; and administering grants and related authorities related to trauma care under parts A through C of title XII, such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services Administration to such Assistant Secretary; exercise the responsibilities and authorities of the Secretary with respect to the coordination of— the Public Health Emergency Preparedness Cooperative Agreement Program pursuant to section 319C–1; the Strategic National Stockpile pursuant to section 319F–2; and the Cities Readiness Initiative; and assume other duties as determined appropriate by the Secretary. ; and by adding at the end the following: Not later than 180 days after the date of enactment of this subsection, and every year thereafter, the Assistant Secretary for Preparedness and Response shall develop and submit to the appropriate committees of Congress a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. In developing such a plan, the Assistant Secretary for Preparedness and Response shall consult with the Director of the Biomedical Advanced Research and Development Authority, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs. Such strategy and plan shall be known as the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan . The plan under paragraph

(1)shall— describe the chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in section 319F–1), security countermeasures (as defined in section 319F–2), or qualified pandemic or epidemic products (as defined in section 319F–3) for each threat; evaluate the progress of all activities with respect to such countermeasures or products, including research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization; identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or products to address a chemical, biological, radiological, and nuclear threat or threats; identify, with respect to each category of threat, a summary of all awards and contracts, including advanced research and development and procurement, that includes— the time elapsed from the issuance of the initial solicitation or request for a proposal to the adjudication (such as the award, denial of award, or solicitation termination); and an identification of projected timelines, anticipated funding allocations, benchmarks, and milestones for each medical countermeasure priority under subparagraph (C), including projected needs with regard to replenishment of the Strategic National Stockpile; be informed by the recommendations of the National Biodefense Science Board pursuant to section 319M; evaluate progress made in meeting timelines, allocations, benchmarks, and milestones identified under subparagraph (D)(ii); report on the amount of funds available for procurement in the special reserve fund as defined in section 319F–2(h) and the impact this funding will have on meeting the requirements under section 319F–2; incorporate input from Federal, State, local, and tribal stakeholders; identify the progress made in meeting the medical countermeasure priorities for at-risk individuals (as defined in 2802(b)(4)(B)), as applicable under subparagraph (C), including with regard to the projected needs for related stockpiling and replenishment of the Strategic National Stockpile, including by addressing the needs of pediatric populations with respect to such countermeasures and products in the Strategic National Stockpile, including— a list of such countermeasures and products necessary to address the needs of pediatric populations; a description of measures taken to coordinate with the Office of Pediatric Therapeutics of the Food and Drug Administration to maximize the labeling, dosages, and formulations of such countermeasures and products for pediatric populations; a description of existing gaps in the Strategic National Stockpile and the development of such countermeasures and products to address the needs of pediatric populations; and an evaluation of the progress made in addressing priorities identified pursuant to subparagraph (C); identify the use of authority and activities undertaken pursuant to sections 319F–1(b)(1), 319F–1(b)(2), 319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F–2(c)(7)(C)(iii), 319F–2(c)(7)(C)(iv), and 319F–2(c)(7)(C)(v) of this Act, and subsections (a)(1), (b)(1), and

(e)of section 564 of the Federal Food, Drug, and Cosmetic Act, by summarizing— the particular actions that were taken under the authorities specified, including, as applicable, the identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the authority was used; the reasons underlying the decision to use such authorities, including, as applicable, the options that were considered and rejected with respect to the use of such authorities; the number of, nature of, and other information concerning the persons and entities that received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and entities that were considered and rejected for such a grant, cooperative agreement, or contract, except that the report need not disclose the identity of any such person or entity; whether, with respect to each procurement that is approved by the President under section 319F–2(c)(6), a contract was entered into within one year after such approval by the President; and with respect to section 319F–1(d), for the one-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and be made publicly available. Not later than 1 year after the date of the submission to the Congress of the first Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of Congress a report, concerning such Strategy and Implementation Plan. The report described in subparagraph

(A)shall review and assess— the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of the Federal Government pursuant to paragraph (2)(C); the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 319L; and the progress made toward meeting the timelines, allocations, benchmarks, and milestones identified in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan under this subsection. In carrying out subsections (b)(7) and (d), the Secretary shall ensure that information and items that could compromise national security, contain confidential commercial information, or contain proprietary information are not disclosed. . In the first Public Health Emergency Countermeasures Enterprise Strategy and Implementation Plan submitted under subsection

(d)of section 2811 of the Public Health Service Act (42 U.S.C. 300hh–10) (as added by subsection (a)(3)), the Secretary of Health and Human Services, in consultation with the Secretary of Defense, shall include a description of the manner in which the Department of Health and Human Services is coordinating with the Department of Defense regarding countermeasure activities to address chemical, biological, radiological, and nuclear threats. Such report shall include information with respect to— the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet identified needs; and the coordination of efforts between the Department of Health and Human Services and the Department of Defense to address countermeasure needs for various segments of the population.

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42 USC 300hh–10

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Sec. 102

Assistant Secretary for Preparedness and Response

Cite42 USC 300hh–10

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