§ 300hh–10. Coordination of preparedness for and response to all-hazards public health emergencies  


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  • (a) In general

    There is established within the Department of Health and Human Services the position of the Assistant Secretary for Preparedness and Response. The President, with the advice and consent of the Senate, shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Secretary.

    (b) DutiesSubject to the authority of the Secretary, the Assistant Secretary for Preparedness and Response shall carry out the following functions:(1) Leadership

    Serve as the principal advisor to the Secretary on all matters related to Federal public health and medical preparedness and response for public health emergencies.

    (2) Personnel

    Register, credential, organize, train, equip, and have the authority to deploy Federal public health and medical personnel under the authority of the Secretary, including the National Disaster Medical System, and coordinate such personnel with the Medical Reserve Corps and the Emergency System for Advance Registration of Volunteer Health Professionals.

    (3) Countermeasures

    Oversee advanced research, development, and procurement of qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title).

    (4) Coordination(A) Federal integration

    Coordinate with relevant Federal officials to ensure integration of Federal preparedness and response activities for public health emergencies.

    (B) State, local, and tribal integration

    Coordinate with State, local, and tribal public health officials, the Emergency Management Assistance Compact, health care systems, and emergency medical service systems to ensure effective integration of Federal public health and medical assets during a public health emergency.

    (C) Emergency medical services

    Promote improved emergency medical services medical direction, system integration, research, and uniformity of data collection, treatment protocols, and policies with regard to public health emergencies.

    (D) Policy coordination and strategic direction

    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 314(a)(6) 300hh–1(b)(4)(B) of this title), 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—(i) a list of such countermeasures and products necessary to address the needs of pediatric populations;(ii) 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;(iii) 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(iv) an evaluation of the progress made in addressing priorities identified pursuant to subparagraph (C);(J) identify the use of authority and activities undertaken pursuant to sections 247d–6a(b)(1), 247d–6a(b)(2), 247d–6a(b)(3), 247d–6a(c), 247d–6a(d), 247d–6a(e), 247d–6b(c)(7)(C)(iii), 247d–6b(c)(7)(C)(iv), and 247d–6b(c)(7)(C)(v) of this title, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3], by summarizing—(i) 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;(ii) 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;(iii) 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;(iv) whether, with respect to each procurement that is approved by the President under section 247d–6b(c)(6) of this title, a contract was entered into within one year after such approval by the President; and(v) with respect to section 247d–6a(d) of this title, 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(K) be made publicly available.(3) GAO report(A) In general

    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.

    (B) ContentThe report described in subparagraph (A) shall review and assess—(i) the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of the Federal Government pursuant to paragraph (2)(C);(ii) the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 247d–7e of this title; and(iii) 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.
    (e) Protection of national security

    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.

(July 1, 1944, ch. 373, title XXVIII, § 2811, as added Pub. L. 109–417, title I, § 102(a)(3), Dec. 19, 2006, 120 Stat. 2833; amended Pub. L. 113–5, title I, § 102(a), Mar. 13, 2013, 127 Stat. 163.)

References In Text

References in Text

Section 314(a)(6) of title 6, referred to in subsec. (b)(4)(D), was in the original “section 504(6) of the Homeland Security Act of 2002” and was translated as meaning section 504(a)(6) of the Homeland Security Act of 2002 to reflect the probable intent of Congress.

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(4)(H), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

Section 301 of the Pandemic and All-Hazards Preparedness Act, referred to in subsec. (c)(1)(A), is section 301 of Pub. L. 109–417, title III, Dec. 19, 2006, 120 Stat. 2853, which amended sections 247d–6 and 300hh–11 of this title and sections 313 and 314 of Title 6, Domestic Security, and enacted provisions set out as notes under section 300hh–11 of this title and section 313 of Title 6.

Prior Provisions

Prior Provisions

A prior section 2811 of act July 1, 1944, was renumbered section 2812 and is classified to section 300hh–11 of this title.

Amendments

Amendments

2013—Subsec. (b)(3). Pub. L. 113–5, § 102(a)(1)(A), inserted “, security countermeasures (as defined in section 247d–6b of this title),” after “qualified countermeasures (as defined in section 247d–6a of this title)”.

Subsec. (b)(4)(D) to (H). Pub. L. 113–5, § 102(a)(1)(B), added subpars. (D) to (H).

Subsec. (b)(7). Pub. L. 113–5, § 102(a)(1)(C), added par. (7).

Subsec. (c). Pub. L. 113–5, § 102(a)(2), added subsec. (c) and struck out former subsec. (c). Prior to amendment, subsec. (c) directed that the Assistant Secretary would have authority over and responsibility for the National Disaster Medical System and the Hospital Preparedness Cooperative Agreement Program, would exercise the responsibilities and authorities of the Secretary with respect to the coordination of the Medical Reserve Corps, the Emergency System for Advance Registration of Volunteer Health Professionals, the Strategic National Stockpile, and the Cities Readiness Initiative, and would assume other duties as determined appropriate by the Secretary.

Subsecs. (d), (e). Pub. L. 113–5, § 102(a)(3), added subsecs. (d) and (e).

Transfer Of Functions

Transfer of Functions

Pub. L. 109–417, title I, § 102(b), Dec. 19, 2006, 120 Stat. 2834, provided that:“(1)Transfer of functions.—There shall be transferred to the Office of the Assistant Secretary for Preparedness and Response the functions, personnel, assets, and liabilities of the Assistant Secretary for Public Health Emergency Preparedness as in effect on the day before the date of enactment of this Act [Dec. 19, 2006].“(2)References.—Any reference in any Federal law, Executive order, rule, regulation, or delegation of authority, or any document of or pertaining to the Assistant Secretary for Public Health Emergency Preparedness as in effect the day before the date of enactment of this Act, shall be deemed to be a reference to the Assistant Secretary for Preparedness and Response.”

Miscellaneous

Interagency Coordination Plan

Pub. L. 113–5, title I, § 102(b), Mar. 13, 2013, 127 Stat. 168, provided that: “In the first Public Health Emergency [Medical] 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—“(1) the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet identified needs; and“(2) 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.”