Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300hh-10&num=0&edition=prelim
Timestamp: 2020-01-22 18:29:41
Document Index: 121894213

Matched Legal Cases: ['§2811', '§102', '§102', '§3083', '§302', '§401', '§501', '§703', '§2', '§5121', '§1601', '§401', '§703', '§401', '§302', '§501', '§501', '§501', '§402', '§302', '§402', '§404']

42 USC 300hh-10: Coordination of preparedness for and response to all-hazards public health emergencies Text contains those laws in effect on January 21, 2020
Subject to the authority of the Secretary, the Assistant Secretary for Preparedness and Response shall utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to carry out the following functions:
Provide integrated policy coordination and strategic direction, before, during, and following public health emergencies, 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 described in section 314(a)(6) of title 6, or any successor plan; and such Federal responses covered by the National Cybersecurity Incident Response Plan developed under section 660(c) 1 of title 6, including public health emergencies or incidents related to cybersecurity threats that present a threat to national health security.
(I) Threat awareness
Coordinate with the Director of the Centers for Disease Control and Prevention, the Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Security Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of Agriculture, to maintain a current assessment of national security threats and inform preparedness and response capabilities based on the range of the threats that have the potential to result in a public health emergency.
In coordination with the Secretary of Veterans Affairs, the Secretary of Homeland Security, the General Services Administration, and other public and private entities, provide logistical support for medical and public health aspects of Federal responses to public health emergencies. Such logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 247d(a) of this title or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise.
Develop, and update not later than March 15 of each year, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to develop 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) for each such threat. Each such plan shall-
(ii) approval, clearance, licensure, and authorized uses of products;
(iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing capabilities) of all products in the Strategic National Stockpile;
(iv) the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development; and
(v) potential deployment, distribution, and utilization of medical countermeasures; development of clinical guidance and emergency use instructions for the use of medical countermeasures; and, as applicable, potential postdeployment activities related to medical countermeasures;
(D) identify the full range of anticipated medical countermeasure needs related to research and development, procurement, and stockpiling, including the potential need for indications, dosing, and administration technologies, and other countermeasure needs as applicable and appropriate;
(E) be made available, not later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and
(F) not later than March 15 of each year, be made publicly available in a manner that does not compromise national security.
Not later than March 15, 2020, and biennially 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 Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title. Such strategy and plan shall be known as the "Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan".
(C) identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or products, and ancillary medical supplies to assist with the utilization of such countermeasures or products, to address a chemical, biological, radiological, and nuclear threat or threats;
(E) be informed by the recommendations of the National Biodefense Science Board pursuant to section 247d–7g of this title;
(v) with respect to section 247d–6a(d) of this title, for the 2-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
(f) Protection of national security from threats
In carrying out subsection (b)(3), the Assistant Secretary for Preparedness and Response shall implement strategic initiatives or activities to address threats, including pandemic influenza and which may include a chemical, biological, radiological, or nuclear agent (including any such agent with a significant potential to become a pandemic), that pose a significant level of risk to public health and national security based on the characteristics of such threat. Such initiatives shall include activities to-
(A) accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 247d–7e(c)(4)(F) of this title;
(B) support the development and manufacturing of virus seeds, clinical trial lots, and stockpiles of novel virus strains; and
(C) maintain or improve preparedness activities, including for pandemic influenza.
To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023.
Amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections 247d–7e(d) and 247d–6b(g) of this title.
(C) Documentation required
The Assistant Secretary for Preparedness and Response, in accordance with subsection (b)(7), shall document amounts expended for purposes of carrying out this subsection, including amounts appropriated under the heading "Public Health and Social Services Emergency Fund" under the heading "Office of the Secretary" under title II of division H of the Consolidated Appropriations Act, 2018 (Public Law 115–141) and allocated to carrying out section 247d–7e(c)(4)(F) of this title.
(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 ; Pub. L. 114–255, div. A, title III, §3083, Dec. 13, 2016, 130 Stat. 1141 ; Pub. L. 116–22, title III, §302(a), (b), title IV, §§401, 402(b), 404(b), title V, §501, title VII, §703(b), June 24, 2019, 133 Stat. 934 , 942, 943, 948, 950, 963.)
Section 660(c) of title 6, referred to in subsec. (b)(4)(D), was in the original "section 228(c) of the Homeland Security Act of 2002", and was translated as meaning section 2210(c) of the Homeland Security Act of 2002 to reflect the probable intent of Congress. Section 228 of the Homeland Security Act of 2002, meaning section 228 of Pub. L. 107–296, was renumbered section 2210 of Pub. L. 107–296 by Pub. L. 115–278, §2(g)(2)(I), Nov. 16, 2018, 132 Stat. 4178 , and transferred to section 660 of Title 6, Domestic Security. Pub. L. 107–296 no longer contains a section 228.
The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (b)(5), is Pub. L. 93–288, May 22, 1974, 88 Stat. 143 , which is classified principally to chapter 68 (§5121 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 5121 of this title and Tables.
The National Emergencies Act, referred to in subsec. (b)(5), is Pub. L. 94–412, Sept. 14, 1976, 90 Stat. 1255 , which is classified principally to chapter 34 (§1601 et seq.) of Title 50, War and National Defense. For complete classification of this Act to the Code, see Short Title note set out under section 1601 of Title 50 and Tables.
The Consolidated Appropriations Act, 2018, referred to in subsec. (f)(2)(C), is Pub. L. 115–141, Mar. 23, 2018, 132 Stat. 348 . Title II of division H of the Act is title II of div. H of Pub. L. 115–141, Mar. 23, 2018, 132 Stat. 714 , which is not classified to the Code. For complete classification of this Act to the Code, see Tables.
2019-Subsec. (b). Pub. L. 116–22, §401(1), inserted "utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to" after "shall" in introductory provisions.
Subsec. (b)(4)(D). Pub. L. 116–22, §703(b), amended subpar. (D) generally. Prior to amendment, text read as follows: "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) of title 6, or any successor plan, before, during, and following public health emergencies."
Subsec. (b)(4)(I). Pub. L. 116–22, §401(2), added subpar. (I).
Subsec. (b)(5). Pub. L. 116–22, §302(a), inserted at end "Such logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 247d(a) of this title or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise."
Subsec. (b)(7). Pub. L. 116–22, §501(1), substituted "March 15" for "March 1" in introductory provisions.
Subsec. (b)(7)(A)(iii) to (v). Pub. L. 116–22, §501(2), added cls. (iii) to (v) and struck out former cl. (iii) which read as follows: "procurement, stockpiling, maintenance, and replenishment of all products in the Strategic National Stockpile;".
Subsec. (b)(7)(D) to (F). Pub. L. 116–22, §501(3), (4), added subpar. (D) and redesignated formers subpars. (D) and (E) as (E) and (F), respectively.
Subsec. (d)(1). Pub. L. 116–22, §402(b)(1), substituted "Not later than March 15, 2020, and biennially thereafter" for "Not later than 180 days after March 13, 2013, and every year thereafter" and "Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title" for "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".
Subsec. (d)(2)(C). Pub. L. 116–22, §302(b), inserted ", and ancillary medical supplies to assist with the utilization of such countermeasures or products," after "products".
Subsec. (d)(2)(J)(v). Pub. L. 116–22, §402(b)(2), substituted "2-year period" for "one-year period".
Subsec. (f). Pub. L. 116–22, §404(b), added subsec. (f).