2006—Pub. L. 109–417, title I, §101(1), Dec. 19, 2006, 120 Stat. 2832, substituted "NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH EMERGENCIES" for "NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES" in heading.
2006—Pub. L. 109–417, title I, §101(2), Dec. 19, 2006, 120 Stat. 2832, substituted "National All-Hazards Preparedness" for "National Preparedness" in heading.
The Secretary of Health and Human Services shall lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Plan developed pursuant to section 314(6) 1 of title 6, or any successor plan.
The Secretary, in collaboration with the Secretary of Veterans Affairs, the Secretary of Transportation, the Secretary of Defense, the Secretary of Homeland Security, and the head of any other relevant Federal agency, shall establish an interagency agreement, consistent with the National Response Plan or any successor plan, under which agreement the Secretary of Health and Human Services shall assume operational control of emergency public health and medical response assets, as necessary, in the event of a public health emergency, except that members of the armed forces under the authority of the Secretary of Defense shall remain under the command and control of the Secretary of Defense, as shall any associated assets of the Department of Defense.
(July 1, 1944, ch. 373, title XXVIII, §2801, as added Pub. L. 107–188, title I, §101(a), June 12, 2002, 116 Stat. 596; amended Pub. L. 109–417, title I, §101(2), Dec. 19, 2006, 120 Stat. 2832.)
Section 314(6) of title 6, referred to in subsec. (a), was in the original "section 502(6) of the Homeland Security Act of 2002", and was translated as meaning section 504(6) of Pub. L. 107–296, to reflect the probable intent of Congress and the renumbering of section 502 as 504 by Pub. L. 109–295, title VI, §611(8), Oct. 4, 2006, 120 Stat. 1395.
2006—Pub. L. 109–417 amended section generally. Prior to amendment, section consisted of subsecs. (a) to (d) relating to a national preparedness plan for carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies.
Pub. L. 107–188, title I, §157, June 12, 2002, 116 Stat. 633, provided that:
"(a)
"(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population;
"(2) the coordination of the activities described in paragraph (1);
"(3) the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population;
"(4) the activities and costs of the Civil Support Teams of the National Guard in responding to biological threats or attacks against the civilian population;
"(5) the activities of the working group under subsection (a) and the efforts made by such group to carry out the activities described in such subsection; and
"(6) the ability of private sector contractors to enhance governmental responses to biological threats or attacks."
1 See References in Text note below.
Beginning in 2014 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 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) 1 of title 6, or any successor plan.
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.
In 2009, 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, and identifying strategies to recruit, retain, and protect such workforce from workplace exposures during public health emergencies.
The National Health Security Strategy shall include provisions in furtherance of the following:
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.
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, and investigation.
(B) Disease containment including capabilities for isolation, quarantine, social distancing, and decontamination.
(C) Risk communication and public preparedness.
(D) Rapid distribution and administration of medical countermeasures.
Increasing the preparedness, response capabilities, and surge capacity of hospitals, other health care facilities (including mental health 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.
(G) 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.
(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 section and sections 247d–3a, 247d–6, and 247d–7e of this title, the term "at-risk individuals" means children, pregnant women, senior citizens and other individuals who have special needs in the event of a public health emergency, as determined by the Secretary.
Minimizing duplication of, and ensuring coordination between, Federal, State, local, and tribal planning, preparedness, and response activities (including the State Emergency Management Assistance Compact). Such planning shall be consistent with the National Response Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
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.
(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.
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.
(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.)
Section 314(6) of title 6, referred to in subsec. (a)(1), was in the original "section 502(6) of the Homeland Security Act of 2002", and was translated as meaning section 504(6) of Pub. L. 107–296, to reflect the probable intent of Congress and the renumbering of section 502 as 504 by Pub. L. 109–295, title VI, §611(8), Oct. 4, 2006, 120 Stat. 1395.
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).
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:
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.
(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.
(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.
(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.
(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.
1 See References in Text note below.
As part of the joint review described in section 300hh–11(b) of this title, the Secretary shall evaluate the benefits and feasibility of improving the capacity of the Department of Health and Human Services to provide additional medical surge capacity to local communities in the event of a public health emergency. Such study shall include an assessment of the need for and feasibility of improving surge capacity through—
(1) acquisition and operation of mobile medical assets by the Secretary to be deployed, on a contingency basis, to a community in the event of a public health emergency;
(2) integrating the practice of telemedicine within the National Disaster Medical System; and
(3) other strategies to improve such capacity as determined appropriate by the Secretary.
In addition to any other authority to acquire, deploy, and operate mobile medical assets, the Secretary may acquire, deploy, and operate mobile medical assets if, taking into consideration the evaluation conducted under subsection (a), such acquisition, deployment, and operation is determined to be beneficial and feasible in improving the capacity of the Department of Health and Human Services to provide additional medical surge capacity to local communities in the event of a public health emergency.
The Secretary shall conduct an analysis of whether there are Federal facilities which, in the event of a public health emergency, could practicably be used as facilities in which to provide health care.
If, based on the analysis conducted under paragraph (1), the Secretary determines that there are Federal facilities which, in the event of a public health emergency, could be used as facilities in which to provide health care, the Secretary shall, with respect to each such facility, seek to conclude a memorandum of understanding with the head of the Department or agency that operates such facility that permits the use of such facility to provide health care in the event of a public health emergency.
(July 1, 1944, ch. 373, title XXVIII, §2803, as added Pub. L. 109–417, title III, §302(a), Dec. 19, 2006, 120 Stat. 2855.)
2006—Pub. L. 109–417, title I, §102(a)(1), Dec. 19, 2006, 120 Stat. 2832, inserted "All-Hazards" before "Emergency Preparedness" in heading.
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.
Subject to the authority of the Secretary, the Assistant Secretary for Preparedness and Response shall carry out the following functions:
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.
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.
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).
Coordinate with relevant Federal officials to ensure integration of Federal preparedness and response activities for public health emergencies.
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.
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.
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) 1 of title 6, 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 chapter, to the extent possible, including program requirements, timelines, and measurable goals, and in consultation with the Secretary of Homeland Security, to—
(i) optimize and streamline medical and public health preparedness and response capabilities and the ability of local communities to respond to public health emergencies; and
(ii) 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—
(i) identified threats for which countermeasures are available and for which no countermeasures are available; and
(ii) 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 chapter and the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], including progress on the development, approval, clearance, and licensure of medical countermeasures.
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.
Provide leadership in international programs, initiatives, and policies that deal with public health and medical emergency preparedness and response.
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—
(A) include consideration of the entire medical countermeasures enterprise, including—
(i) basic research and advanced research and development;
(ii) approval, clearance, licensure, and authorized uses of products; and
(iii) procurement, stockpiling, maintenance, and replenishment of all products in the Strategic National Stockpile;
(B) inform prioritization of resources and include measurable outputs and outcomes to allow for the tracking of the progress made toward identified priorities;
(C) identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs within the continuum of the medical countermeasure enterprise consistent with section 247d–6b of this title; and
(D) be made available to the appropriate committees of Congress upon request.
The Assistant Secretary for Preparedness and Response shall—
(1) have lead responsibility within the Department of Health and Human Services for emergency preparedness and response policy coordination and strategic direction;
(2) have authority over and responsibility for—
(A) the National Disaster Medical System pursuant to section 300hh–11 of this title;
(B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 247d–3b of this title;
(C) the Biomedical Advanced Research and Development Authority pursuant to section 247d–7e of this title;
(D) the Medical Reserve Corps pursuant to section 300hh–15 of this title;
(E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 247d–7b of this title; and
(F) administering grants and related authorities related to trauma care under parts A through C of subchapter X, such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services Administration to such Assistant Secretary;
(3) exercise the responsibilities and authorities of the Secretary with respect to the coordination of—
(A) the Public Health Emergency Preparedness Cooperative Agreement Program pursuant to section 247d–3a of this title;
(B) the Strategic National Stockpile pursuant to section 247d–6b of this title; and
(C) the Cities Readiness Initiative; and
(4) assume other duties as determined appropriate by the Secretary.
Not later than 180 days after March 13, 2013, 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—
(A) 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 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), or qualified pandemic or epidemic products (as defined in section 247d–6d of this title) for each threat;
(B) evaluate the progress of all activities with respect to such countermeasures or products, including research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization;
(C) 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;
(D) identify, with respect to each category of threat, a summary of all awards and contracts, including advanced research and development and procurement, that includes—
(i) 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
(ii) 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;
(E) be informed by the recommendations of the National Biodefense Science Board pursuant to section 247d–7f of this title;
(F) evaluate progress made in meeting timelines, allocations, benchmarks, and milestones identified under subparagraph (D)(ii);
(G) report on the amount of funds available for procurement in the special reserve fund as defined in section 247d–6b(h) of this title and the impact this funding will have on meeting the requirements under section 247d–6b of this title;
(H) incorporate input from Federal, State, local, and tribal stakeholders;
(I) identify the progress made in meeting the medical countermeasure priorities for at-risk individuals (as defined in 2 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.
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—
(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.
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.)
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.
A prior section 2811 of act July 1, 1944, was renumbered section 2812 and is classified to section 300hh–11 of this title.
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) which 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).
Pub. L. 109–417, title I, §102(b), Dec. 19, 2006, 120 Stat. 2834, provided that:
"(1)
"(2)
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."
1 See References in Text note below.
2 So in original. The word "section" probably should appear.
The Secretary, in consultation with the Secretary of Homeland Security, shall establish an advisory committee to be known as the "National Advisory Committee on Children and Disasters" (referred to in this section as the "Advisory Committee").
The Advisory Committee shall—
(1) provide advice and consultation with respect to the activities carried out pursuant to section 300hh–16 of this title, as applicable and appropriate;
(2) evaluate and provide input with respect to the medical and public health needs of children as they relate to preparation for, response to, and recovery from all-hazards emergencies; and
(3) provide advice and consultation with respect to State emergency preparedness and response activities and children, including related drills and exercises pursuant to the preparedness goals under section 300hh–1(b) of this title.
The Advisory Committee may provide advice and recommendations to the Secretary with respect to children and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities authorized under this subchapter and subchapter II.
The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint not to exceed 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the total membership of the Advisory Committee is an odd number.
The Secretary, in consultation with such other Secretaries as may be appropriate, may appoint to the Advisory Committee under paragraph (1) such individuals as may be appropriate to perform the duties described in subsections (b) and (c), which may include—
(A) the Assistant Secretary for Preparedness and Response;
(B) the Director of the Biomedical Advanced Research and Development Authority;
(C) the Director of the Centers for Disease Control and Prevention;
(D) the Commissioner of Food and Drugs;
(E) the Director of the National Institutes of Health;
(F) the Assistant Secretary of the Administration for Children and Families;
(G) the Administrator of the Federal Emergency Management Agency;
(H) at least two non-Federal health care professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;
(I) at least two representatives from State, local, territorial, or tribal agencies with expertise in pediatric disaster planning, preparedness, response, or recovery; and
(J) representatives from such Federal agencies (such as the Department of Education and the Department of Homeland Security) as determined necessary to fulfill the duties of the Advisory Committee, as established under subsections (b) and (c).
The Advisory Committee shall meet not less than biannually.
The Advisory Committee shall terminate on September 30, 2018.
(July 1, 1944, ch. 373, title XXVIII, §2811A, as added Pub. L. 113–5, title I, §103, Mar. 13, 2013, 127 Stat. 168.)
The Secretary shall provide for the operation in accordance with this section of a system to be known as the National Disaster Medical System. The Secretary shall designate the Assistant Secretary for Preparedness and Response as the head of the National Disaster Medical System, subject to the authority of the Secretary.
The National Disaster Medical System shall be a coordinated effort by the Federal agencies specified in subparagraph (B), working in collaboration with the States and other appropriate public or private entities, to carry out the purposes described in paragraph (3).
The Federal agencies referred to in subparagraph (A) are the Department of Health and Human Services, the Department of Homeland Security, the Department of Defense, and the Department of Veterans Affairs.
The Secretary may activate the National Disaster Medical System to—
(i) provide health services, health-related social services, other appropriate human services, and appropriate auxiliary services to respond to the needs of victims of a public health emergency, including at-risk individuals as applicable (whether or not determined to be a public health emergency under section 247d of this title); or
(ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that the Secretary has determined that a location is at risk of a public health emergency during the time specified.
The National Disaster Medical System shall carry out such ongoing activities as may be necessary to prepare for the provision of services described in subparagraph (A) in the event that the Secretary activates the National Disaster Medical System for such purposes.
The Secretary shall take steps to ensure that an appropriate specialized and focused range of public health and medical capabilities are 1 represented in the National Disaster Medical System, which take 2 into account the needs of at-risk individuals, in the event of a public health emergency.
The Secretary may determine and pay claims for reimbursement for services under subparagraph (A) directly or through contracts that provide for payment in advance or by way of reimbursement.
During the one-year period beginning on December 19, 2006, the Secretary shall conduct an exercise to test the capability and timeliness of the National Disaster Medical System to mobilize and otherwise respond effectively to a bioterrorist attack or other public health emergency that affects two or more geographic locations concurrently. Thereafter, the Secretary may periodically conduct such exercises regarding the National Disaster Medical System as the Secretary determines to be appropriate.
Taking into account the findings from the joint review described under paragraph (2), the Secretary shall modify the policies of the National Disaster Medical System as necessary.
Not later than 180 days after December 19, 2006, the Secretary, in coordination with the Secretary of Homeland Security, the Secretary of Defense, and the Secretary of Veterans Affairs, shall conduct a joint review of the National Disaster Medical System. Such review shall include an evaluation of medical surge capacity, as described by section 300hh–2(a) of this title. As part of the National Health Security Strategy under section 300hh–1 of this title, the Secretary shall update the findings from such review and further modify the policies of the National Disaster Medical System as necessary.
In carrying out paragraph (1), the Secretary shall establish criteria regarding the participation of States and private entities in the National Disaster Medical System, including criteria regarding agreements for such participation. The criteria shall include the following:
(A) Provisions relating to the custody and use of Federal personal property by such entities, which may in the discretion of the Secretary include authorizing the custody and use of such property to respond to emergency situations for which the National Disaster Medical System has not been activated by the Secretary pursuant to subsection (a)(3)(A) of this section. Any such custody and use of Federal personal property shall be on a reimbursable basis.
(B) Provisions relating to circumstances in which an individual or entity has agreements with both the National Disaster Medical System and another entity regarding the provision of emergency services by the individual. Such provisions shall address the issue of priorities among the agreements involved.
For the purpose of assisting the National Disaster Medical System in carrying out duties under this section, the Secretary may appoint individuals to serve as intermittent personnel of such System in accordance with applicable civil service laws and regulations.
For purposes of section 233(a) of this title and the remedies described in such section, an individual appointed under paragraph (1) shall, while acting within the scope of such appointment, be considered to be an employee of the Public Health Service performing medical, surgical, dental, or related functions. With respect to the participation of individuals appointed under paragraph (1) in training programs authorized by the Assistant Secretary for Preparedness and Response or a comparable official of any Federal agency specified in subsection (a)(2)(B) of this section, acts of individuals so appointed that are within the scope of such participation shall be considered within the scope of the appointment under paragraph (1) (regardless of whether the individuals receive compensation for such participation).
For purposes of this subsection, the term "intermittent disaster-response appointee" means an individual appointed by the Secretary under subsection (c) of this section.
An intermittent disaster-response appointee shall, while acting in the scope of such appointment, be considered to be an employee of the Public Health Service performing medical, surgical, dental, or related functions, and an injury sustained by such an individual shall be deemed "in the performance of duty", for purposes of chapter 81 of title 5 pertaining to compensation for work injuries. With respect to the participation of individuals appointed under subsection (c) of this section in training programs authorized by the Assistant Secretary for Preparedness and Response or a comparable official of any Federal agency specified in subsection (a)(2)(B) of this section, injuries sustained by such an individual, while acting within the scope of such participation, also shall be deemed "in the performance of duty" for purposes of chapter 81 of title 5 (regardless of whether the individuals receive compensation for such participation). In the event of an injury to such an intermittent disaster-response appointee, the Secretary of Labor shall be responsible for making determinations as to whether the claimant is entitled to compensation or other benefits in accordance with chapter 81 of title 5.
Service as an intermittent disaster-response appointee when the Secretary activates the National Disaster Medical System or when the individual participates in a training program authorized by the Assistant Secretary for Preparedness and Response or a comparable official of any Federal agency specified in subsection (a)(2)(B) of this section shall be deemed "service in the uniformed services" for purposes of chapter 43 of title 38 pertaining to employment and reemployment rights of individuals who have performed service in the uniformed services (regardless of whether the individual receives compensation for such participation). All rights and obligations of such persons and procedures for assistance, enforcement, and investigation shall be as provided for in chapter 43 of title 38.
Preclusion of giving notice of service by necessity of Service as an intermittent disaster-response appointee when the Secretary activates the National Disaster Medical System shall be deemed preclusion by "military necessity" for purposes of section 4312(b) of title 38 pertaining to giving notice of absence from a position of employment. A determination of such necessity shall be made by the Secretary, in consultation with the Secretary of Defense, and shall not be subject to judicial review.
An intermittent disaster-response appointee shall not be deemed an employee of the Department of Health and Human Services for purposes other than those specifically set forth in this section.
If the Secretary assigns commissioned officers of the Regular or Reserve Corps to serve with the National Disaster Medical System, such assignments do not affect the terms and conditions of their appointments as commissioned officers of the Regular or Reserve Corps, respectively (including with respect to pay and allowances, retirement, benefits, rights, privileges, and immunities).
For purposes of this section, the term "auxiliary services" includes mortuary services, veterinary services, and other services that are determined by the Secretary to be appropriate with respect to the needs referred to in subsection (a)(3)(A) of this section.
For the purpose of providing for the Assistant Secretary for Preparedness and Response and the operations of the National Disaster Medical System, other than purposes for which amounts in the Public Health Emergency Fund under section 247d of this title are available, there are authorized to be appropriated $52,700,000 for each of fiscal years 2014 through 2018.
(July 1, 1944, ch. 373, title XXVIII, §2812, formerly §2811, as added Pub. L. 107–188, title I, §102(a), June 12, 2002, 116 Stat. 599; renumbered §2812 and amended Pub. L. 109–417, title I, §102(a)(2), (4), title III, §301(a), Dec. 19, 2006, 120 Stat. 2832, 2834, 2853; Pub. L. 113–5, title I, §104, Mar. 13, 2013, 127 Stat. 170.)
2013—Subsec. (a)(3)(A)(i). Pub. L. 113–5, §104(1)(A), inserted ", including at-risk individuals as applicable" after "victims of a public health emergency".
Subsec. (a)(3)(C) to (E). Pub. L. 113–5, §104(1)(B), (C), added subpars. (C) and (D) and redesignated former subpar. (C) as (E).
Subsec. (g). Pub. L. 113–5, §104(2), substituted "$52,700,000 for each of fiscal years 2014 through 2018" for "such sums as may be necessary for each of the fiscal years 2007 through 2011".
2006—Pub. L. 109–417, §301(a)(1), substituted "National Disaster Medical System" for "Coordination of preparedness for and response to bioterrorism and other public health emergencies" in section catchline.
Subsec. (a). Pub. L. 109–417, §301(a)(2), (3), redesignated subsec. (b) as (a) and struck out former subsec. (a) which related to establishment of position and duties of Assistant Secretary for Public Health Emergency Preparedness.
Subsec. (a)(2)(B). Pub. L. 109–417, §301(a)(4)(A), substituted "Department of Homeland Security" for "Federal Emergency Management Agency".
Subsec. (a)(3)(C). Pub. L. 109–417, §301(a)(4)(B), substituted "December 19, 2006" for "June 12, 2002".
Subsec. (b). Pub. L. 109–417, §301(a)(5), substituted "Modifications" for "Criteria" in heading, added pars. (1) and (2), redesignated former par. (2) as (3), and struck out heading and text of former par. (1). Text read as follows: "The Secretary shall establish criteria for the operation of the National Disaster Medical System."
Pub. L. 109–417, §301(a)(3), redesignated subsec. (c) as (b). Former subsec. (b) redesignated (a).
Subsec. (b)(1). Pub. L. 109–417, §102(a)(4), substituted "Assistant Secretary for Preparedness and Response" for "Assistant Secretary for Public Health Emergency Preparedness".
Subsec. (b)(3)(A). Pub. L. 109–417, §301(a)(6), substituted "subsection (a)(3)(A)" for "subsection (b)(3)(A)".
Subsec. (c). Pub. L. 109–417, §301(a)(3), redesignated subsec. (d) as (c). Former subsec. (c) redesignated (b).
Subsec. (c)(2). Pub. L. 109–417, §301(a)(6), substituted "subsection (a)(2)(B)" for "subsection (b)(2)(B)".
Subsec. (d). Pub. L. 109–417, §301(a)(7), substituted "subsection (c)" for "subsection (d)" in pars. (1) and (2).
Pub. L. 109–417, §301(a)(6), substituted "subsection (a)(2)(B)" for "subsection (b)(2)(B)" in pars. (2) and (3)(A).
Pub. L. 109–417, §301(a)(3), redesignated subsec. (e) as (d). Former subsec. (d) redesignated (c).
Subsec. (d)(2). Pub. L. 109–417, §102(a)(4), substituted "Assistant Secretary for Preparedness and Response" for "Assistant Secretary for Public Health Emergency Preparedness".
Subsec. (e). Pub. L. 109–417, §301(a)(3), redesignated subsec. (f) as (e). Former subsec. (e) redesignated (d).
Subsec. (e)(2), (3)(A). Pub. L. 109–417, §102(a)(4), substituted "Assistant Secretary for Preparedness and Response" for "Assistant Secretary for Public Health Emergency Preparedness".
Subsec. (f). Pub. L. 109–417, §301(a)(6), substituted "subsection (a)(3)(A)" for "subsection (b)(3)(A)".
Pub. L. 109–417, §301(a)(3), redesignated subsec. (g) as (f). Former subsec. (f) redesignated (e).
Subsec. (g). Pub. L. 109–417, §301(a)(8), substituted "2007 through 2011" for "2002 through 2006".
Pub. L. 109–417, §301(a)(3), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f).
Subsec. (h). Pub. L. 109–417, §301(a)(3), redesignated subsec. (h) as (g).
Pub. L. 109–417, §102(a)(4), substituted "Assistant Secretary for Preparedness and Response" for "Assistant Secretary for Public Health Emergency Preparedness".
Pub. L. 109–417, title III, §301(b), Dec. 19, 2006, 120 Stat. 2854, provided that: "There shall be transferred to the Secretary of Health and Human Services the functions, personnel, assets, and liabilities of the National Disaster Medical System of the Department of Homeland Security, including the functions of the Secretary of Homeland Security and the Under Secretary for Emergency Preparedness and Response relating thereto."
Pub. L. 109–295, title III, Oct. 4, 2006, 120 Stat. 1372, provided in part: "That the total amount appropriated and, notwithstanding any other provision of law, the functions, personnel, assets, and liabilities of the National Disaster Medical System established under section 2811(b) [now 2812(a)] of the Public Health Service Act (42 U.S.C. 300hh–11(b) [now 300hh–11(a)]), including any functions of the Secretary of Homeland Security relating to such System, shall be permanently transferred to the Secretary of the Department of Health and Human Services effective January 1, 2007."
For transfer of functions, personnel, assets, and liabilities of the National Disaster Medical System of the Department of Health and Human Services, including the functions of the Secretary of Health and Human Services and the Assistant Secretary for Public Health Emergency Preparedness (now Assistant Secretary for Preparedness and Response) relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see former section 313(5) and sections 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.
1 So in original. Probably should be "is".
2 So in original. Probably should be "takes".
Section, Pub. L. 107–188, title I, §121, June 12, 2002, 116 Stat. 611, as amended, which related to Strategic National Stockpile, was renumbered section 319F–2 of the Public Health Service Act by Pub. L. 108–276, §3(a)(1), July 21, 2004, 118 Stat. 842 and is classified to section 247d–6b of this title.
The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall promptly carry out a program to periodically evaluate new and emerging technologies that, in the determination of the Secretary, are designed to improve or enhance the ability of public health or safety officials to conduct public health surveillance activities relating to a bioterrorist attack or other public health emergency.
In carrying out this subsection, the Secretary shall, to the extent practicable—
(1) survey existing technology programs funded by the Federal Government for potentially useful technologies;
(2) promptly issue a request, as necessary, for information from non-Federal public and private entities for ongoing activities in this area; and
(3) evaluate technologies identified under paragraphs (1) and (2) pursuant to subsection (c) of this section.
In carrying out subsection (b)(3) of this section, the Secretary shall consult with the working group under section 247d–6(a) 1 of this title, as well as other appropriate public, nonprofit, and private entities, to develop criteria for the evaluation of such technologies and to conduct such evaluations.
Not later than 180 days after June 12, 2002, and periodically thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the activities under this section.
(Pub. L. 107–188, title I, §126, June 12, 2002, 116 Stat. 615.)
Section 247d–6 of this title, referred to in subsec. (c), was amended by Pub. L. 109–417, title III, §304, Dec. 19, 2006, 120 Stat. 2859, and as so amended, subsec. (a) of section 247d–6 no longer relates to a working group.
Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Public Health Service Act which comprises this chapter.
1 See References in Text note below.
In this section:
The term "certified monitoring program" means a medical monitoring program—
(A) in which a participating responder is a participant as a condition of the employment of such participating responder; and
(B) that the Secretary of Health and Human Services certifies includes an adequate baseline medical screening.
The term "disaster area" means an area in which the President has declared a major disaster (as that term is defined in section 5122 of this title), during the period of such declaration.
The term "high exposure level" means a level of exposure to a substance of concern that is for such a duration, or of such a magnitude, that adverse effects on human health can be reasonably expected to occur, as determined by the President, acting through the Secretary of Health and Human Services, in accordance with human monitoring or environmental or other appropriate indicators.
The term "individual" includes—
(A) a worker or volunteer who responds to a disaster, either natural or manmade, involving any mode of transportation in the United States or disrupting the transportation system of the United States, including—
(i) a police officer;
(ii) a firefighter;
(iii) an emergency medical technician;
(iv) any participating member of an urban search and rescue team; and
(v) any other relief or rescue worker or volunteer that the President, acting through the Secretary of Health and Human Services, determines to be appropriate;
(B) a worker who responds to a disaster, either natural or manmade, involving any mode of transportation in the United States or disrupting the transportation system of the United States, by assisting in the cleanup or restoration of critical infrastructure in and around a disaster area;
(C) a person whose place of residence is in a disaster area, caused by either a natural or manmade disaster involving any mode of transportation in the United States or disrupting the transportation system of the United States;
(D) a person who is employed in or attends school, child care, or adult day care in a building located in a disaster area, caused by either a natural or manmade disaster involving any mode of transportation in the United States or disrupting the transportation system of the United States, of the United States; and
(E) any other person that the President, acting through the Secretary of Health and Human Services, determines to be appropriate.
The term "participating responder" means an individual described in paragraph (4)(A).
The term "program" means a program described in subsection (b) that is carried out for a disaster area.
The term "substance of concern" means a chemical or other substance that is associated with potential acute or chronic human health effects, the risk of exposure to which could potentially be increased as the result of a disaster, as determined by the President, acting through the Secretary of Health and Human Services, and in coordination with the Agency for Toxic Substances and Disease Registry, the Environmental Protection Agency, the Centers for Disease Control and Prevention, the National Institutes of Health, the Federal Emergency Management Agency, the Occupational Health and Safety Administration, and other agencies.
If the President, acting through the Secretary of Health and Human Services, determines that 1 or more substances of concern are being, or have been, released in an area declared to be a disaster area and disrupts the transportation system of the United States, the President, acting through the Secretary of Health and Human Services, may carry out a program for the coordination, protection, assessment, monitoring, and study of the health and safety of individuals with high exposure levels to ensure that—
(A) the individuals are adequately informed about and protected against potential health impacts of any substance of concern in a timely manner;
(B) the individuals are monitored and studied over time, including through baseline and followup clinical health examinations, for—
(i) any short- and long-term health impacts of any substance of concern; and
(ii) any mental health impacts;
(C) the individuals receive health care referrals as needed and appropriate; and
(D) information from any such monitoring and studies is used to prevent or protect against similar health impacts from future disasters.
A program under paragraph (1) may include such activities as—
(A) collecting and analyzing environmental exposure data;
(B) developing and disseminating information and educational materials;
(C) performing baseline and followup clinical health and mental health examinations and taking biological samples;
(D) establishing and maintaining an exposure registry;
(E) studying the short- and long-term human health impacts of any exposures through epidemiological and other health studies; and
(F) providing assistance to individuals in determining eligibility for health coverage and identifying appropriate health services.
To the maximum extent practicable, activities under any program carried out under paragraph (1) (including baseline health examinations) shall be commenced in a timely manner that will ensure the highest level of public health protection and effective monitoring.
Participation in any registry or study that is part of a program carried out under paragraph (1) shall be voluntary.
The President, acting through the Secretary of Health and Human Services, shall take appropriate measures to protect the privacy of any participant in a registry or study described in subparagraph (A).
Except as provided in clause (ii), the President, acting through the Secretary of Health and Human Services, shall give priority in any registry or study described in subparagraph (A) to the protection, monitoring and study of the health and safety of individuals with the highest level of exposure to a substance of concern.
Notwithstanding clause (i), the President, acting through the Secretary of Health and Human Services, may modify the priority of a registry or study described in subparagraph (A), if the President, acting through the Secretary of Health and Human Services, determines such modification to be appropriate.
The President, acting through the Secretary of Health and Human Services, may carry out a program under paragraph (1) through a cooperative agreement with a medical institution, including a local health department, or a consortium of medical institutions.
To the maximum extent practicable, the President, acting through the Secretary of Health and Human Services, shall select, to carry out a program under paragraph (1), a medical institution or a consortium of medical institutions that—
(i) is located near—
(I) the disaster area with respect to which the program is carried out; and
(II) any other area in which there reside groups of individuals that worked or volunteered in response to the disaster; and
(ii) has appropriate experience in the areas of environmental or occupational health, toxicology, and safety, including experience in—
(I) developing clinical protocols and conducting clinical health examinations, including mental health assessments;
(II) conducting long-term health monitoring and epidemiological studies;
(III) conducting long-term mental health studies; and
(IV) establishing and maintaining medical surveillance programs and environmental exposure or disease registries.
In carrying out a program under paragraph (1), the President, acting through the Secretary of Health and Human Services, shall involve interested and affected parties, as appropriate, including representatives of—
(i) Federal, State, and local government agencies;
(ii) groups of individuals that worked or volunteered in response to the disaster in the disaster area;
(iii) local residents, businesses, and schools (including parents and teachers);
(iv) health care providers;
(v) faith based organizations; and
(vi) other organizations and persons.
Involvement under subparagraph (A) may be provided through the establishment of an advisory or oversight committee or board.
The President, acting through the Secretary of Health and Human Services, shall carry out each program under paragraph (1) in accordance with regulations relating to privacy promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note; Public Law 104–191).
In carrying out a program under paragraph (1), the President, acting through the Secretary of Health and Human Services, may—
(A) include the baseline clinical health examination of a participating responder under a certified monitoring programs; 1 and
(B) substitute the baseline clinical health examination of a participating responder under a certified monitoring program for a baseline clinical health examination under paragraph (1).
Not later than 1 year after the establishment of a program under subsection (b)(1), and every 5 years thereafter, the President, acting through the Secretary of Health and Human Services, or the medical institution or consortium of such institutions having entered into a cooperative agreement under subsection (b)(5), may submit a report to the Secretary of Homeland Security, the Secretary of Labor, the Administrator of the Environmental Protection Agency, and appropriate committees of Congress describing the programs and studies carried out under the program.
The Secretary of Health and Human Services, the Secretary of Homeland Security, and the Administrator of the Environmental Protection Agency shall jointly enter into a contract with the National Academy of Sciences to conduct a study and prepare a report on disaster area health and environmental protection and monitoring.
The report under paragraph (1) shall be prepared with the participation of individuals who have expertise in—
(A) environmental health, safety, and medicine;
(B) occupational health, safety, and medicine;
(C) clinical medicine, including pediatrics;
(D) environmental toxicology;
(E) epidemiology;
(F) mental health;
(G) medical monitoring and surveillance;
(H) environmental monitoring and surveillance;
(I) environmental and industrial hygiene;
(J) emergency planning and preparedness;
(K) public outreach and education;
(L) State and local health departments;
(M) State and local environmental protection departments;
(N) functions of workers that respond to disasters, including first responders;
(O) public health; and
(P) family services, such as counseling and other disaster-related services provided to families.
The report under paragraph (1) shall provide advice and recommendations regarding protecting and monitoring the health and safety of individuals potentially exposed to any chemical or other substance associated with potential acute or chronic human health effects as the result of a disaster, including advice and recommendations regarding—
(A) the establishment of protocols for monitoring and responding to chemical or substance releases in a disaster area to protect public health and safety, including—
(i) chemicals or other substances for which samples should be collected in the event of a disaster, including a terrorist attack;
(ii) chemical- or substance-specific methods of sample collection, including sampling methodologies and locations;
(iii) chemical- or substance-specific methods of sample analysis;
(iv) health-based threshold levels to be used and response actions to be taken in the event that thresholds are exceeded for individual chemicals or other substances;
(v) procedures for providing monitoring results to—
(I) appropriate Federal, State, and local government agencies;
(II) appropriate response personnel; and
(III) the public;
(vi) responsibilities of Federal, State, and local agencies for—
(I) collecting and analyzing samples;
(II) reporting results; and
(III) taking appropriate response actions; and
(vii) capabilities and capacity within the Federal Government to conduct appropriate environmental monitoring and response in the event of a disaster, including a terrorist attack; and
(B) other issues specified by the Secretary of Health and Human Services, the Secretary of Homeland Security, and the Administrator of the Environmental Protection Agency.
There are authorized to be appropriated such sums as are necessary to carry out this subsection.
(Pub. L. 109–347, title VII, §709, Oct. 13, 2006, 120 Stat. 1947.)
Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (b)(7), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of this title.
Section was enacted as part of the Security and Accountability For Every Port Act of 2006, also known as the SAFE Port Act, and not as part of the Public Health Service Act which comprises this chapter.
1 So in original. Probably should be "program;".
Not later than 180 days after December 19, 2006, the Secretary, in collaboration with State, local, and tribal officials, shall build on State, local, and tribal programs in existence on December 19, 2006, to establish and maintain a Medical Reserve Corps (referred to in this section as the "Corps") to provide for an adequate supply of volunteers in the case of a Federal, State, local, or tribal public health emergency. The Corps shall be headed by a Director who shall be appointed by the Secretary and shall oversee the activities of the Corps chapters that exist at the State, local, and tribal levels.
The Corps shall be established using existing State, local, and tribal teams and shall not alter such teams.
The Corps shall be composed of individuals who—
(1)(A) are health professionals who have appropriate professional training and expertise as determined appropriate by the Director of the Corps; or
(B) are non-health professionals who have an interest in serving in an auxiliary or support capacity to facilitate access to health care services in a public health emergency;
(2) are certified in accordance with the certification program developed under subsection (d);
(3) are geographically diverse in residence;
(4) have registered and carry out training exercises with a local chapter of the Medical Reserve Corps; and
(5) indicate whether they are willing to be deployed outside the area in which they reside in the event of a public health emergency.
The Director, in collaboration with State, local, and tribal officials, shall establish a process for the periodic certification of individuals who volunteer for the Corps, as determined by the Secretary, which shall include the completion by each individual of the core training programs developed under section 247d–6 of this title, as required by the Director. Such certification shall not supercede State licensing or credentialing requirements.
In conjunction with the core training programs referred to in paragraph (1), and in order to facilitate the integration of trained volunteers into the health care system at the local level, Corps members shall engage in periodic training exercises to be carried out at the local level. Such training exercises shall, as appropriate and applicable, incorporate the needs of at-risk individuals in the event of a public health emergency.
During a public health emergency, the Secretary shall have the authority to activate and deploy willing members of the Corps to areas of need, taking into consideration the public health and medical expertise required, with the concurrence of the State, local, or tribal officials from the area where the members reside.
While engaged in performing duties as a member of the Corps pursuant to an assignment by the Secretary (including periods of travel to facilitate such assignment), members of the Corps who are not otherwise employed by the Federal Government shall be allowed travel or transportation expenses, including per diem in lieu of subsistence.
The Secretary, in cooperation and consultation with the States, shall develop a Medical Reserve Corps Identification Card that describes the licensure and certification information of Corps members, as well as other identifying information determined necessary by the Secretary.
For the purpose of assisting the Corps in carrying out duties under this section, during a public health emergency, the Secretary may appoint selected individuals to serve as intermittent personnel of such Corps in accordance with applicable civil service laws and regulations. In all other cases, members of the Corps are subject to the laws of the State in which the activities of the Corps are undertaken.
Subsections (c)(2), (d), and (e) of section 300hh–11 of this title shall apply to an individual appointed under paragraph (1) in the same manner as such subsections apply to an individual appointed under section 300hh–11(c) of this title.
State, local, and tribal officials shall have no authority to designate a member of the Corps as Federal intermittent disaster-response personnel, but may request the services of such members.
There is authorized to be appropriated to carry out this section, $11,200,000 for each of fiscal years 2014 through 2018.
(July 1, 1944, ch. 373, title XXVIII, §2813, as added Pub. L. 109–417, title III, §303(a), Dec. 19, 2006, 120 Stat. 2856; amended Pub. L. 113–5, title II, §203(b)(2), Mar. 13, 2013, 127 Stat. 175.)
2013—Subsec. (d)(2). Pub. L. 113–5, §203(b)(2)(A), inserted at end "Such training exercises shall, as appropriate and applicable, incorporate the needs of at-risk individuals in the event of a public health emergency."
Subsec. (i). Pub. L. 113–5, §203(b)(2)(B), substituted "$11,200,000 for each of fiscal years 2014 through 2018" for "$22,000,000 for fiscal year 2007, and such sums as may be necessary for each of fiscal years 2008 through 2011".
The Secretary, acting through such employee of the Department of Health and Human Services as determined by the Secretary and designated publicly (which may, at the discretion of the Secretary, involve the appointment or designation of an individual as the Director of At-Risk Individuals), shall—
(1) monitor emerging issues and concerns as they relate to medical and public health preparedness and response for at-risk individuals in the event of a public health emergency declared by the Secretary under section 247d of this title;
(2) oversee the implementation of the preparedness goals described in section 300hh–1(b) of this title with respect to the public health and medical needs of at-risk individuals in the event of a public health emergency, as described in section 300hh–1(b)(4) of this title;
(3) assist other Federal agencies responsible for planning for, responding to, and recovering from public health emergencies in addressing the needs of at-risk individuals;
(4) provide guidance to and ensure that recipients of State and local public health grants include preparedness and response strategies and capabilities that take into account the medical and public health needs of at-risk individuals in the event of a public health emergency, as described in section 247d–3a(b)(2)(A)(iii) of this title;
(5) ensure that the contents of the strategic national stockpile take into account at-risk populations as described in section 300hh–1(b)(4)(B) of this title;
(6) oversee curriculum development for the public health and medical response training program on medical management of casualties, as it concerns at-risk individuals as described in subparagraphs (A) through (C) of section 247d–6(a)(2) of this title;
(7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies in as timely a manner as is practicable, including from the time a public health threat is identified; and
(8) ensure that public health and medical information distributed by the Department of Health and Human Services during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals.
(July 1, 1944, ch. 373, title XXVIII, §2814, as added Pub. L. 109–417, title I, §102(d), Dec. 19, 2006, 120 Stat. 2834; amended Pub. L. 113–5, title I, §101(b), Mar. 13, 2013, 127 Stat. 163.)
2013—Par. (1). Pub. L. 113–5, §101(b)(4), added par. (1). Former par. (1) redesignated (2).
Par. (2). Pub. L. 113–5, §101(b)(3), (5), redesignated par. (1) as (2) and amended it generally. Prior to amendment, par. (2) read as follows: "oversee the implementation of the National Preparedness goal of taking into account the public health and medical needs of at-risk individuals in the event of a public health emergency, as described in section 300hh–1(b)(4) of this title;". Former par. (2) redesignated (3).
Par. (3). Pub. L. 113–5, §101(b)(3), redesignated par. (2) as (3). Former par. (3) redesignated (4).
Par. (4). Pub. L. 113–5, §101(b)(3), redesignated par. (3) as (4). Former par. (4) redesignated (5).
Pub. L. 113–5, §101(b)(2), substituted "300hh–1(b)(4)(B)" for "300hh–10(b)(3)(B)".
Par. (5). Pub. L. 113–5, §101(b)(1), (3), redesignated par. (4) as (5) and struck out former par. (5) which read as follows: "oversee the progress of the Advisory Committee on At-Risk Individuals and Public Health Emergencies established under section 247d–6(b)(2) of this title and make recommendations with a focus on opportunities for action based on the work of the Committee;".
Pars. (7), (8). Pub. L. 113–5, §101(b)(1), (6), added pars. (7) and (8) and struck out former pars. (7) and (8) which read as follows:
"(7) disseminate novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies; and
"(8) not later than one year after December 19, 2006, prepare and submit to Congress a report describing the progress made on implementing the duties described in this section."
The Secretary, acting through Administrator 1 of the Health Resources and Services Administration, and in coordination with the Assistant Secretary for Preparedness and Response, shall
(1) provide guidance and technical assistance to health centers funded under section 254b of this title and to State and local health departments and emergency managers to integrate health centers into State and local emergency response plans and to better meet the primary care needs of populations served by health centers during public health emergencies; and
(2) encourage employees at health centers funded under section 254b of this title to participate in emergency medical response programs including the National Disaster Medical System authorized in section 300hh–11 of this title, the Volunteer Medical Reserve Corps authorized in section 300hh–15 of this title, and the Emergency System for Advance Registration of Health Professions Volunteers authorized in section 247d–7b of this title.
(July 1, 1944, ch. 373, title XXVIII, §2815, as added Pub. L. 110–355, §6(a), Oct. 8, 2008, 122 Stat. 3994.)
1 So in original. Probably should be preceded by "the".
Subject to the availability of appropriations, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish an Epidemiology and Laboratory Capacity Grant Program to award grants to State health departments as well as local health departments and tribal jurisdictions that meet such criteria as the Director determines appropriate. Academic centers that assist State and eligible local and tribal health departments may also be eligible for funding under this section as the Director determines appropriate. Grants shall be awarded under this section to assist public health agencies in improving surveillance for, and response to, infectious diseases and other conditions of public health importance by—
(1) strengthening epidemiologic capacity to identify and monitor the occurrence of infectious diseases and other conditions of public health importance;
(2) enhancing laboratory practice as well as systems to report test orders and results electronically;
(3) improving information systems including developing and maintaining an information exchange using national guidelines and complying with capacities and functions determined by an advisory council established and appointed by the Director; and
(4) developing and implementing prevention and control strategies.
There are authorized to be appropriated to carry out this section $190,000,000 for each of fiscal years 2010 through 2013, of which—
(1) not less than $95,000,000 shall be made available each such fiscal year for activities under paragraphs (1) and (4) of subsection (a);
(2) not less than $60,000,000 shall be made available each such fiscal year for activities under subsection (a)(3); and
(3) not less than $32,000,000 shall be made available each such fiscal year for activities under subsection (a)(2).
(July 1, 1944, ch. 373, title XXVIII, §2821, as added Pub. L. 111–148, title IV, §4304, Mar. 23, 2010, 124 Stat. 584.)