42 U.S.C. § 300hh–1 (THE PUBLIC HEALTH AND WELFARE)
§ 300hh–1. National Health Security Strategy
(a) In general
(1) Preparedness and response regarding public health emergencies
Beginning in 2018 and every four years thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a coordinated strategy (to be known as the National Health Security Strategy) and any revisions thereof, and an accompanying implementation plan for public health emergency preparedness and response. Such National Health Security Strategy shall describe potential emergency health security threats and identify the process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond to such threats and shall be consistent with the national preparedness goal (as described in section 314(a)(19) of title 6), the National Incident Management System (as defined in section 311(7) of such title), and the National Response Plan developed pursuant to section 314 of such title, or any successor plan.
(2) Evaluation of progress
The National Health Security Strategy shall include an evaluation of the progress made by Federal, State, local, and tribal entities, based on the evidence-based benchmarks and objective standards that measure levels of preparedness established pursuant to section 247d–3a(g) of this title. Such evaluation shall include aggregate and State-specific breakdowns of obligated funding spent by major category (as defined by the Secretary) for activities funded through awards pursuant to sections 247d–3a and 247d–3b of this title, and an analysis of any changes to the evidence-based benchmarks and objective standards under sections 247d–3a and 247d–3b of this title.
(3) Public health workforce
In 2022, the National Health Security Strategy shall include a national strategy for establishing an effective and prepared public health workforce, including defining the functions, capabilities, and gaps in such workforce (including gaps in the environmental health and animal health workforces, as applicable), describing the status of such workforce, identifying strategies to recruit, retain, and protect such workforce from workplace exposures during public health emergencies, and identifying current capabilities to meet the requirements of section 300hh–2 of this title.
(b) Preparedness goals
The National Health Security Strategy shall include provisions in furtherance of the following:
(1) Integration
Integrating public health and public and private medical capabilities with other first responder systems, including through—
(A) the periodic evaluation of Federal, State, local, and tribal preparedness and response capabilities through drills and exercises, including drills and exercises to ensure medical surge capacity for events without notice; and
(B) integrating public and private sector public health and medical donations and volunteers.
(2) Public health
Developing and sustaining Federal, State, local, and tribal essential public health security capabilities, including the following:
(A) Disease situational awareness domestically and abroad, including detection, identification, investigation, and related information technology activities.
(B) Disease containment including capabilities for isolation, quarantine, social distancing, decontamination, relevant health care services and supplies, and transportation and disposal of medical waste.
(C) Risk communication and public preparedness.
(D) Rapid distribution and administration of medical countermeasures.
(E) Response to environmental hazards.
(3) Medical
Increasing the preparedness, response capabilities, and surge capacity of hospitals, other health care facilities (including pharmacies, mental health facilities, and ambulatory care facilities and which may include dental health facilities), and trauma care, critical care, and emergency medical service systems, with respect to public health emergencies (including related availability, accessibility, and coordination), which shall include developing plans for the following:
(A) Strengthening public health emergency medical and trauma management and treatment capabilities.
(B) Fatality management.
(C) Coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care.
(D) Rapid distribution and administration of medical countermeasures.
(E) Effective utilization of any available public and private mobile medical assets (which may include such dental health assets) and integration of other Federal assets.
(F) Protecting health care workers and health care first responders from workplace exposures during a public health emergency or exposures to agents that could cause a public health emergency.
(G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals, other health care facilities, critical care, trauma care (which may include trauma centers), and emergency medical systems.
(4) At-risk individuals
(A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs and considerations of individuals with disabilities, in the event of a public health emergency.
(B) For the purpose of this chapter, the term “at-risk individuals” means children, pregnant women, senior citizens and other individuals who have access or functional needs in the event of a public health emergency, as determined by the Secretary.
(5) Coordination
Minimizing duplication of, and ensuring coordination between, Federal, State, local, and tribal planning, preparedness, and response activities (including the State Emergency Management Assistance Compact and other applicable compacts). Such planning shall be consistent with the National Response Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
(6) Continuity of operations
Maintaining vital public health and medical services to allow for optimal Federal, State, local, and tribal operations in the event of a public health emergency.
(7) Countermeasures
(A) Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.
(B) For purposes of this paragraph, the term “countermeasures” has the same meaning as the terms “qualified countermeasures” under section 247d–6a of this title, “qualified pandemic and epidemic products” under section 247d–6d of this title, and “security countermeasures” under section 247d–6b of this title.
(8) Medical and public health community resiliency
Strengthening the ability of States, local communities, and tribal communities to prepare for, respond to, and be resilient in the event of public health emergencies, whether naturally occurring, unintentional, or deliberate by—
(A) optimizing alignment and integration of medical and public health preparedness and response planning and capabilities with and into routine daily activities; and
(B) promoting familiarity with local medical and public health systems.
(9) Zoonotic disease, food, and agriculture
Improving coordination among Federal, State, local, Tribal, and territorial entities (including through consultation with the Secretary of Agriculture) to prevent, detect, and respond to outbreaks of plant or animal disease (including zoonotic disease) that could compromise national security resulting from a deliberate attack, a naturally occurring threat, the intentional adulteration of food, or other public health threats, taking into account interactions between animal health, human health, and animals’ and humans’ shared environment as directly related to public health emergency preparedness and response capabilities, as applicable.
(10) Global health security
Assessing current or potential health security threats from abroad to inform domestic public health preparedness and response capabilities.
(July 1, 1944, ch. 373, title XXVIII, § 2802, as added Pub. L. 109–417, title I, § 103, Dec. 19, 2006, 120 Stat. 2835; amended Pub. L. 113–5, title I, § 101(a), Mar. 13, 2013, 127 Stat. 162; Pub. L. 116–22, title I, § 101, title II, § 203(d), title III, § 303(a), June 24, 2019, 133 Stat. 906, 914, 935.)
heading: Amendments
text: 2019—Subsec. (a)(1). Pub. L. 116–22, § 101(1)(A), substituted “2018” for “2014” and “Such National Health Security Strategy shall describe potential emergency health security threats and identify the process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond to such threats and shall be consistent with the national preparedness goal (as described in section 314(a)(19) of title 6), the National Incident Management System (as defined in section 311(7) of such title), and the National Response Plan developed pursuant to section 314 of such title, or any successor plan.” for “Such National Health Security Strategy shall identify the process for achieving the preparedness goals described in subsection (b) and shall be consistent with the National Preparedness Goal, the National Incident Management System, and the National Response Plan developed pursuant to section 314(6) of title 6, or any successor plan.”
Subsec. (a)(2). Pub. L. 116–22, § 101(1)(B), inserted before period at end “, and an analysis of any changes to the evidence-based benchmarks and objective standards under sections 247d–3a and 247d–3b of this title”.
Subsec. (a)(3). Pub. L. 116–22, § 101(1)(C), substituted “2022” for “2009” and “gaps in such workforce (including gaps in the environmental health and animal health workforces, as applicable), describing the status of such workforce, identifying strategies” for “gaps in such workforce, and identifying strategies” and inserted “, and identifying current capabilities to meet the requirements of section 300hh–2 of this title” before period at end.
Subsec. (b)(2)(A). Pub. L. 116–22, § 101(2)(A)(i), substituted “investigation, and related information technology activities” for “and investigation”.
Subsec. (b)(2)(B). Pub. L. 116–22, § 101(2)(A)(ii), substituted “decontamination, relevant health care services and supplies, and transportation and disposal of medical waste” for “and decontamination”.
Subsec. (b)(2)(E). Pub. L. 116–22, § 101(2)(A)(iii), added subpar. (E).
Subsec. (b)(3). Pub. L. 116–22, § 101(2)(B)(i), substituted “including pharmacies, mental health facilities,” for “including mental health” in introductory provisions.
Subsec. (b)(3)(F). Pub. L. 116–22, § 101(2)(B)(ii), inserted “or exposures to agents that could cause a public health emergency” before period at end.
Subsec. (b)(3)(G). Pub. L. 116–22, § 203(d), amended subpar. (G) generally. Prior to amendment, subpar. (G) read as follows: “Optimizing a coordinated and flexible approach to the medical surge capacity of hospitals, other health care facilities, critical care, trauma care (which may include trauma centers), and emergency medical systems.”
Subsec. (b)(4)(B). Pub. L. 116–22, § 303(a), substituted “this chapter,” for “this section and sections 247d–3a, 247d–6, and 247d–7e of this title,” and “access or functional” for “special”.
Subsec. (b)(5). Pub. L. 116–22, § 101(2)(C), inserted “and other applicable compacts” after “Compact”.
Subsec. (b)(9), (10). Pub. L. 116–22, § 101(2)(D), added pars. (9) and (10).
2013—Subsec. (a)(1). Pub. L. 113–5, § 101(a)(1), substituted “2014” for “2009”.
Subsec. (b)(1)(A). Pub. L. 113–5, § 101(a)(2)(A), inserted “, including drills and exercises to ensure medical surge capacity for events without notice” after “through drills and exercises”.
Subsec. (b)(3). Pub. L. 113–5, § 101(a)(2)(B)(i), in introductory provisions, substituted “and ambulatory care facilities and which may include dental health facilities), and trauma care, critical care,” for “facilities), and trauma care” and inserted “(including related availability, accessibility, and coordination)” after “public health emergencies”.
Subsec. (b)(3)(A). Pub. L. 113–5, § 101(a)(2)(B)(ii), inserted “and trauma” after “medical”.
Subsec. (b)(3)(B). Pub. L. 113–5, § 101(a)(2)(B)(iii), substituted “Fatality management” for “Medical evacuation and fatality management”.
Subsec. (b)(3)(C), (D). Pub. L. 113–5, § 101(a)(2)(B)(iv), (v), added subpar. (C) and redesignated former subpar. (C) as (D). Former subpar. (D) redesignated (E).
Subsec. (b)(3)(E). Pub. L. 113–5, § 101(a)(2)(B)(iv), (vi), redesignated subpar. (D) as (E) and inserted “(which may include such dental health assets)” after “medical assets”. Former subpar. (E) redesignated (F).
Subsec. (b)(3)(F). Pub. L. 113–5, § 101(a)(2)(B)(iv), redesignated subpar. (E) as (F).
Subsec. (b)(3)(G). Pub. L. 113–5, § 101(a)(2)(B)(vii), added subpar. (G).
Subsec. (b)(4)(A). Pub. L. 113–5, § 101(a)(2)(C)(i), inserted “, including the unique needs and considerations of individuals with disabilities,” after “needs of at-risk individuals”.
Subsec. (b)(4)(B). Pub. L. 113–5, § 101(a)(2)(C)(ii), inserted “the” before “purpose of this section”.
Subsec. (b)(7), (8). Pub. L. 113–5, § 101(a)(2)(D), added pars. (7) and (8).
heading: Ex. Ord. No. 13527. Establishing Federal Capability for the Timely Provision of Medical Countermeasures Following a Biological Attack
text: Ex. Ord. No. 13527, Dec. 30, 2009, 75 F.R. 737, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Policy. It is the policy of the United States to plan and prepare for the timely provision of medical countermeasures to the American people in the event of a biological attack in the United States through a rapid Federal response in coordination with State, local, territorial, and tribal governments.
This policy would seek to: (1) mitigate illness and prevent death; (2) sustain critical infrastructure; and (3) complement and supplement State, local, territorial, and tribal government medical countermeasure distribution capacity.
Sec. 2. United States Postal Service Delivery of Medical Countermeasures. (a) The U.S. Postal Service has the capacity for rapid residential delivery of medical countermeasures for self administration across all communities in the United States. The Federal Government shall pursue a national U.S. Postal Service medical countermeasures dispensing model to respond to a large-scale biological attack.
(b) The Secretaries of Health and Human Services and Homeland Security, in coordination with the U.S. Postal Service, within 180 days of the date of this order, shall establish a national U.S. Postal Service medical countermeasures dispensing model for U.S. cities to respond to a large-scale biological attack, with anthrax as the primary threat consideration.
(c) In support of the national U.S. Postal Service model, the Secretaries of Homeland Security, Health and Human Services, and Defense, and the Attorney General, in coordination with the U.S. Postal Service, and in consultation with State and local public health, emergency management, and law enforcement officials, within 180 days of the date of this order, shall develop an accompanying plan for supplementing local law enforcement personnel, as necessary and appropriate, with local Federal law enforcement, as well as other appropriate personnel, to escort U.S. Postal workers delivering medical countermeasures.
Sec. 3. Federal Rapid Response. (a) The Federal Government must develop the capacity to anticipate and immediately supplement the capabilities of affected jurisdictions to rapidly distribute medical countermeasures following a biological attack. Implementation of a Federal strategy to rapidly dispense medical countermeasures requires establishment of a Federal rapid response capability.
(b) The Secretaries of Homeland Security and Health and Human Services, in coordination with the Secretary of Defense, within 90 days of the date of this order, shall develop a concept of operations and establish requirements for a Federal rapid response to dispense medical countermeasures to an affected population following a large-scale biological attack.
Sec. 4. Continuity of Operations. (a) The Federal Government must establish mechanisms for the provision of medical countermeasures to personnel performing mission-essential functions to ensure that mission-essential functions of Federal agencies continue to be performed following a biological attack.
(b) The Secretaries of Health and Human Services and Homeland Security, within 180 days of the date of this order, shall develop a plan for the provision of medical countermeasures to ensure that mission-essential functions of executive branch departments and agencies continue to be performed following a large-scale biological attack.
Sec. 5. General Provisions.
(a) Nothing in this order shall be construed to impair or otherwise affect:
(i) authority granted by law to a department or agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Barack Obama.