Part B—All-Hazards Emergency Preparedness and Response

Editorial Notes

Codification

Pub. L. 109–417, title I, §102(a)(1), Dec. 19, 2006, 120 Stat. 2832, inserted "All-Hazards" before "Emergency Preparedness" in heading.

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

(a) In general

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

(b) Duties

Subject to the authority of the Secretary, the Assistant Secretary for Preparedness and Response shall utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to carry out the following functions:

(1) Leadership

Serve as the principal advisor to the Secretary on all matters related to Federal public health and medical preparedness and response for public health emergencies and, consistent with the National Response Framework and other applicable provisions of law, assist the Secretary in carrying out the functions under section 300hh of this title.

(2) Personnel

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

(3) Countermeasures

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

(4) Coordination

(A) Federal integration

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

(B) State, local, and tribal integration

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

(C) Emergency medical services

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

(D) Policy coordination and strategic direction

Provide integrated policy coordination and strategic direction, before, during, and following public health emergencies, with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan described in section 314(a)(6) of title 6, or any successor plan; and such Federal responses covered by the National Cybersecurity Incident Response Plan developed under section 660(b) of title 6, including public health emergencies or incidents related to cybersecurity threats that present a threat to national health security.

(E) Identification of inefficiencies

Identify and minimize gaps, duplication, and other inefficiencies in medical and public health preparedness and response activities and recommend actions necessary to overcome these obstacles, such as—

(i) improving coordination with relevant Federal officials;

(ii) partnering with other public or private entities to leverage capabilities maintained by such entities, as appropriate and consistent with this subsection; and

(iii) coordinating efforts to support or establish new capabilities, as appropriate.

(F) Coordination of grants and agreements

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.

(G) Drill and operational exercises

Carry out drills and operational exercises each year, including national-level and State-level full-scale exercises not less than once every 4 years, 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—

(i) based on ¹

(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;

(ii) that assess the ability of the Strategic National Stockpile, as appropriate, to provide medical countermeasures, medical products, and other supplies, including ancillary medical supplies, to support the response to a public health emergency or potential public health emergency, including a threat that requires the large-scale and simultaneous deployment of stockpiles and a long-term public health and medical response; and

(iii) conducted in coordination with State and local health officials.

(H) National security priority

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.

(I) Threat awareness

Coordinate with the Director of the Centers for Disease Control and Prevention, the Director of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Security Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of Agriculture, to maintain a current assessment of national security threats and inform preparedness and response capabilities based on the range of the threats that have the potential to result in a public health emergency.

(J) Medical product and supply capacity planning

Coordinate efforts within the Department of Health and Human Services to support—

(i) preparedness for medical product and medical supply needs directly related to responding to chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, and incidents covered by the National Response Framework, including—

(I) sharing information, including with appropriate stakeholders, related to the anticipated need for, and availability of, such products and supplies during such responses;

(II) supporting activities, which may include public-private partnerships, to maintain capacity of medical products and medical supplies, as applicable and appropriate; and

(III) planning for potential surges in medical supply needs for purposes of a response to such a threat; and

(ii) situational awareness with respect to anticipated need for, and availability of, such medical products and medical supplies within the United States during a response to such a threat.

(5) Logistics

In coordination with the Secretary of Veterans Affairs, the Secretary of Homeland Security, the General Services Administration, and other public and private entities, provide logistical support for medical and public health aspects of Federal responses to public health emergencies. Such logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 247d(a) of this title or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise.

(6) Leadership

Provide leadership in international programs, initiatives, and policies that deal with public health and medical emergency preparedness and response.

(7) Countermeasures budget plan

Develop, and update not later than March 15 of each year, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to develop qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title) for each such threat. Each such plan shall—

(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;

(iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing capabilities) of all products in the Strategic National Stockpile;

(iv) the availability of technologies that may assist in the advanced research and development of countermeasures and opportunities to use such technologies to accelerate and navigate challenges unique to countermeasure research and development; and

(v) potential deployment, distribution, and utilization of medical countermeasures; development of clinical guidance and emergency use instructions for the use of medical countermeasures; and, as applicable, potential postdeployment activities related to medical countermeasures;

(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;

(D) identify the full range of anticipated medical countermeasure needs related to research and development, procurement, and stockpiling, including the potential need for indications, dosing, and administration technologies, and other countermeasure needs as applicable and appropriate;

(E) be made available, not later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and

(F) not later than March 15 of each year, be made publicly available in a manner that does not compromise national security.

(c) Functions

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.

(d) Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan

(1) In general

Not later than March 15, 2020, and biennially thereafter, the Assistant Secretary for Preparedness and Response shall develop and submit to the appropriate committees of Congress a coordinated strategy and accompanying implementation plan for medical countermeasures to address chemical, biological, radiological, and nuclear threats. In developing such a plan, the Assistant Secretary for Preparedness and Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title. Such strategy and plan shall be known as the "Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan".

(2) Requirements

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, and ancillary medical supplies to assist with the utilization of such countermeasures or products, to address a chemical, biological, radiological, and nuclear threat or threats;

(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–7g 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 2-year period for which the report is submitted, the number of persons who were paid amounts totaling $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less than $100,000; and

(K) be made publicly available.

(3) GAO report

(A) In general

Not later than 1 year after the date of the submission to the Congress of the first Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller General of the United States shall conduct an independent evaluation, and submit to the appropriate committees of Congress a report, concerning such Strategy and Implementation Plan.

(B) Content

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.

(e) Protection of national security

In carrying out subsections (b)(7) and (d), the Secretary shall ensure that information and items that could compromise national security, contain confidential commercial information, or contain proprietary information are not disclosed.

(f) Protection of national security from threats

(1) In general

In carrying out subsection (b)(3), the Assistant Secretary for Preparedness and Response shall implement strategic initiatives or activities to address threats, including pandemic influenza and which may include a chemical, biological, radiological, or nuclear agent (including any such agent with a significant potential to become a pandemic), that pose a significant level of risk to public health and national security based on the characteristics of such threat. Such initiatives shall include activities to—

(A) accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 247d–7e(c)(4)(F) of this title;

(B) support the development and manufacturing of virus seeds, clinical trial lots, and stockpiles of novel virus strains; and

(C) maintain or improve preparedness activities, including for pandemic influenza.

(2) Authorization of appropriations

(A) In general

To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023.

(B) Supplement, not supplant

Amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections 247d–7e(d) and 247d–6b(g) of this title.

(C) Documentation required

The Assistant Secretary for Preparedness and Response, in accordance with subsection (b)(7), shall document amounts expended for purposes of carrying out this subsection, including amounts appropriated under the heading "Public Health and Social Services Emergency Fund" under the heading "Office of the Secretary" under title II of division H of the Consolidated Appropriations Act, 2018 (Public Law 115–141) and allocated to carrying out section 247d–7e(c)(4)(F) of this title.

(g) Appearances before Congress

(1) In general

Each fiscal year, the Assistant Secretary for Preparedness and Response shall appear before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives at hearings, on topics such as—

(A) coordination of Federal activities to prepare for, and respond to, public health emergencies;

(B) activities and capabilities of the Strategic National Stockpile, including whether, and the degree to which, recommendations made pursuant to section 300hh–10a(c)(1)(A) of this title have been met;

(C) support for State, local, and Tribal public health and medical preparedness;

(D) activities implementing the countermeasures budget plan described under subsection (b)(7), including—

(i) any challenges in meeting the full range of identified medical countermeasure needs; and

(ii) progress in supporting advanced research, development, and procurement of medical countermeasures, pursuant to subsection (b)(3);

(E) the strategic direction of, and activities related to, the sustainment of manufacturing surge capacity and capabilities for medical countermeasures pursuant to section 247d–7e of this title and the distribution and deployment of such countermeasures;

(F) any additional objectives, activities, or initiatives that have been carried out or are planned by the Assistant Secretary for Preparedness and Response and associated challenges, as appropriate;

(G) the specific all-hazards threats that the Assistant Secretary for Preparedness and Response is preparing to address, or that are being addressed, through the activities described in subparagraphs (A) through (F); and

(H) objectives, activities, or initiatives related to the coordination and consultation required under subsections (b)(4)(H) and (b)(4)(I), in a manner consistent with paragraph (3), as appropriate.

(2) Clarifications

(A) Waiver authority

The Chair of the Committee on Health, Education, Labor, and Pensions of the Senate or the Chair of the Committee on Energy and Commerce of the House of Representatives may waive the requirements of paragraph (1) for the applicable fiscal year with respect to the applicable Committee.

(B) Scope of requirements

The requirements of this subsection shall not be construed to impact the appearance of other Federal officials or the Assistant Secretary at hearings of either Committee described in paragraph (1) at other times and for purposes other than the times and purposes described in paragraph (1) ³

(3) Closed hearings

Information that is not appropriate for disclosure during an open hearing under paragraph (1) in order to protect national security may instead be discussed in a closed hearing that immediately follows such open hearing.

(July 1, 1944, ch. 373, title XXVIII, §2811, as added Pub. L. 109–417, title I, §102(a)(3), Dec. 19, 2006, 120 Stat. 2833; amended Pub. L. 113–5, title I, §102(a), Mar. 13, 2013, 127 Stat. 163; Pub. L. 114–255, div. A, title III, §3083, Dec. 13, 2016, 130 Stat. 1141; Pub. L. 116–22, title III, §302(a), (b), title IV, §§401, 402(b), 404(b), title V, §501, title VII, §703(b), June 24, 2019, 133 Stat. 934, 942, 943, 948, 950, 963; Pub. L. 117–263, div. G, title LXXI, §7143(d)(4), Dec. 23, 2022, 136 Stat. 3663; Pub. L. 117–328, div. FF, title II, §2103(b)(2), (c), Dec. 29, 2022, 136 Stat. 5712, 5713.)

Editorial Notes

References in Text

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.

The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (b)(5), is Pub. L. 93–288, May 22, 1974, 88 Stat. 143, which is classified principally to chapter 68 (§5121 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 5121 of this title and Tables.

The National Emergencies Act, referred to in subsec. (b)(5), is Pub. L. 94–412, Sept. 14, 1976, 90 Stat. 1255, which is classified principally to chapter 34 (§1601 et seq.) of Title 50, War and National Defense. For complete classification of this Act to the Code, see Short Title note set out under section 1601 of Title 50 and Tables.

The Consolidated Appropriations Act, 2018, referred to in subsec. (f)(2)(C), is Pub. L. 115–141, Mar. 23, 2018, 132 Stat. 348. Title II of division H of the Act is title II of div. H of Pub. L. 115–141, Mar. 23, 2018, 132 Stat. 714, which is not classified to the Code. For complete classification of this Act to the Code, see Tables.

Prior Provisions

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

Amendments

2022—Subsec. (b)(1). Pub. L. 117–328, §2103(b)(2)(A), inserted "and, consistent with the National Response Framework and other applicable provisions of law, assist the Secretary in carrying out the functions under section 300hh of this title" after "emergencies".

Subsec. (b)(4)(D). Pub. L. 117–263 substituted "section 660(b) of title 6" for "section 228(c) of the Homeland Security Act of 2002 (6 U.S.C. 149(c))".

Subsec. (b)(4)(E). Pub. L. 117–328, §2103(b)(2)(B)(i), substituted "recommend actions necessary to overcome these obstacles, such as—" and cls. (i) to (iii) for "the actions necessary to overcome these obstacles."

Subsec. (b)(4)(G). Pub. L. 117–328, §2103(b)(2)(B)(ii), inserted "each year, including national-level and State-level full-scale exercises not less than once every 4 years" after "operational exercises", substituted "exercises—" and "(i) based on" for "exercises based on—", added cls. (ii) and (iii), and redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i).

Subsec. (b)(4)(J). Pub. L. 117–328, §2103(b)(2)(B)(iii), added subpar. (J).

Subsec. (g). Pub. L. 117–328, §2103(c), added subsec. (g).

2019—Subsec. (b). Pub. L. 116–22, §401(1), inserted "utilize experience related to public health emergency preparedness and response, biodefense, medical countermeasures, and other relevant topics to" after "shall" in introductory provisions.

Subsec. (b)(4)(D). Pub. L. 116–22, §703(b), amended subpar. (D) generally. Prior to amendment, text read as follows: "Provide integrated policy coordination and strategic direction with respect to all matters related to Federal public health and medical preparedness and execution and deployment of the Federal response for public health emergencies and incidents covered by the National Response Plan developed pursuant to section 314(a)(6) of title 6, or any successor plan, before, during, and following public health emergencies."

Subsec. (b)(4)(I). Pub. L. 116–22, §401(2), added subpar. (I).

Subsec. (b)(5). Pub. L. 116–22, §302(a), inserted at end "Such logistical support shall include working with other relevant Federal, State, local, Tribal, and territorial public health officials and private sector entities to identify the critical infrastructure assets, systems, and networks needed for the proper functioning of the health care and public health sectors that need to be maintained through any emergency or disaster, including entities capable of assisting with, responding to, and mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary pursuant to section 247d(a) of this title or an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods to exchange critical information and deliver products consumed or used to preserve, protect, or sustain life, health, or safety, and sharing of specialized expertise."

Subsec. (b)(7). Pub. L. 116–22, §501(1), substituted "March 15" for "March 1" in introductory provisions.

Subsec. (b)(7)(A)(iii) to (v). Pub. L. 116–22, §501(2), added cls. (iii) to (v) and struck out former cl. (iii) which read as follows: "procurement, stockpiling, maintenance, and replenishment of all products in the Strategic National Stockpile;".

Subsec. (b)(7)(D) to (F). Pub. L. 116–22, §501(3), (4), added subpar. (D) and redesignated former subpars. (D) and (E) as (E) and (F), respectively.

Subsec. (d)(1). Pub. L. 116–22, §402(b)(1), substituted "Not later than March 15, 2020, and biennially thereafter" for "Not later than 180 days after March 13, 2013, and every year thereafter" and "Public Health Emergency Medical Countermeasures Enterprise established under section 300hh–10a of this title" for "Director of the Biomedical Advanced Research and Development Authority, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs".

Subsec. (d)(2)(C). Pub. L. 116–22, §302(b), inserted ", and ancillary medical supplies to assist with the utilization of such countermeasures or products," after "products".

Subsec. (d)(2)(J)(v). Pub. L. 116–22, §402(b)(2), substituted "2-year period" for "one-year period".

Subsec. (f). Pub. L. 116–22, §404(b), added subsec. (f).

2016—Subsec. (b)(7). Pub. L. 114–255, §3083(1), in introductory provisions, substituted "Develop, and update not later than March 1 of each year, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to develop qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title) for each such threat." for "Develop, and update on an annual basis, a coordinated 5-year budget plan based on the medical countermeasure priorities described in subsection (d)."

Subsec. (b)(7)(D). Pub. L. 114–255, §3083(3), substituted ", not later than March 15 of each year, to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives; and" for "to the appropriate committees of Congress upon request."

Subsec. (b)(7)(E). Pub. L. 114–255, §3083(2), (4), added subpar. (E).

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).

Statutory Notes and Related Subsidiaries

Transfer of Functions

Pub. L. 109–417, title I, §102(b), Dec. 19, 2006, 120 Stat. 2834, provided that:

"(1) Transfer of functions.—There shall be transferred to the Office of the Assistant Secretary for Preparedness and Response the functions, personnel, assets, and liabilities of the Assistant Secretary for Public Health Emergency Preparedness as in effect on the day before the date of enactment of this Act [Dec. 19, 2006].

"(2) References.—Any reference in any Federal law, Executive order, rule, regulation, or delegation of authority, or any document of or pertaining to the Assistant Secretary for Public Health Emergency Preparedness as in effect the day before the date of enactment of this Act, shall be deemed to be a reference to the Assistant Secretary for Preparedness and Response."

Interagency Coordination Plan

Pub. L. 113–5, title I, §102(b), Mar. 13, 2013, 127 Stat. 168, provided that: "In the first Public Health Emergency [Medical] Countermeasures Enterprise Strategy and Implementation Plan submitted under subsection (d) of section 2811 of the Public Health Service Act (42 U.S.C. 300hh–10) (as added by subsection (a)(3)), the Secretary of Health and Human Services, in consultation with the Secretary of Defense, shall include a description of the manner in which the Department of Health and Human Services is coordinating with the Department of Defense regarding countermeasure activities to address chemical, biological, radiological, and nuclear threats. Such report shall include information with respect to—

"(1) the research, advanced research, development, procurement, stockpiling, and distribution of countermeasures to meet identified needs; and

"(2) the coordination of efforts between the Department of Health and Human Services and the Department of Defense to address countermeasure needs for various segments of the population."

¹ So in original. Probably should be followed by a dash.

² So in original. The word "section" probably should appear.

³ So in original. Probably should be followed by a period.

§300hh–10a. Public Health Emergency Medical Countermeasures Enterprise

(a) In general

The Secretary shall establish the Public Health Emergency Medical Countermeasures Enterprise (referred to in this section as the "PHEMCE"). The Assistant Secretary for Preparedness and Response and the Director of the Office of Pandemic Preparedness and Response Policy shall serve as co-chairs of the PHEMCE.

(b) Members

The PHEMCE shall include each of the following members, or the designee of such members:

(1) The Assistant Secretary for Preparedness and Response.

(2) The Director of the Centers for Disease Control and Prevention.

(3) The Director of the National Institutes of Health.

(4) The Commissioner of Food and Drugs.

(5) The Secretary of Defense.

(6) The Secretary of Homeland Security.

(7) The Secretary of Agriculture.

(8) The Secretary of Veterans Affairs.

(9) The Director of National Intelligence.

(10) The Director of the Office of Pandemic Preparedness and Response Policy.

(11) Representatives of any other Federal agency, which may include the Director of the Biomedical Advanced Research and Development Authority, the Director of the Strategic National Stockpile, the Director of the National Institute of Allergy and Infectious Diseases, and the Director of the Office of Public Health Preparedness and Response, as the Secretary determines appropriate.

(c) Functions

(1) In general

The functions of the PHEMCE shall include the following:

(A) Utilize a process to make recommendations to the Secretary regarding research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization with respect to countermeasures, as defined in section 247d–6b(c) of this title, including prioritization based on the health security needs of the United States. Such recommendations shall be informed by, when available and practicable, the National Health Security Strategy pursuant to section 300hh–1 of this title, the Strategic National Stockpile needs pursuant to section 247d–6b of this title, and assessments of current national security threats, including chemical, biological, radiological, and nuclear threats, including emerging infectious diseases. In the event that members of the PHEMCE do not agree upon a recommendation, the Secretary shall provide a determination regarding such recommendation.

(B) Identify national health security needs, including gaps in public health preparedness and response related to countermeasures and challenges to addressing such needs (including any regulatory challenges), and support alignment of countermeasure procurement with recommendations to address such needs under subparagraph (A).

(C) Assist the Secretary in developing strategies related to logistics, deployment, distribution, dispensing, and use of countermeasures that may be applicable to the activities of the strategic national stockpile under section 247d–6b(a) of this title.

(D) Provide consultation for the development of the strategy and implementation plan under section 300hh–10(d) of this title.

(2) Input

In carrying out subparagraphs (B) and (C) of paragraph (1), the PHEMCE shall solicit and consider input from State, local, Tribal, and territorial public health departments or officials, as appropriate.

(July 1, 1944, ch. 373, title XXVIII, §2811–1, as added Pub. L. 116–22, title IV, §402(a), June 24, 2019, 133 Stat. 942; amended Pub. L. 117–328, div. FF, title II, §2104(k)(1), Dec. 29, 2022, 136 Stat. 5719.)

Editorial Notes

Prior Provisions

A prior section 300hh–10a, act July 1, 1944, ch. 373, title XXVIII, §2811A, as added Pub. L. 113–5, title I, §103, Mar. 13, 2013, 127 Stat. 168; amended Pub. L. 116–22, title III, §305(a), June 24, 2019, 133 Stat. 936, which related to the National Advisory Committee on Children and Disasters, was transferred to section 300hh–10b of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–328, §2104(k)(1)(A), substituted "and the Director of the Office of Pandemic Preparedness and Response Policy shall serve as co-chairs" for "shall serve as chair".

Subsec. (b)(10), (11). Pub. L. 117–328, §2104(k)(1)(B), added par. (10) and redesignated former par. (10) as (11).

§300hh–10b. National Advisory Committee on Children and Disasters

(a) Establishment

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").

(b) Duties

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, mental, behavioral, developmental, and public health needs of children as they relate to preparation for, response to, and recovery from all-hazards emergencies;

(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; and

(4) provide advice and consultation with respect to continuity of care and education for all children and supporting parents and caregivers during all-hazards emergencies.

(c) Additional duties

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.

(d) Membership

(1) In general

The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint not to exceed 25 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.

(2) Required non-Federal members

The Secretary, in consultation with such other heads of Federal agencies as may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—

(A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, response, or recovery;

(B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric disaster planning, preparedness, response, or recovery;

(C) at least 4 members representing health care professionals, which may include members with expertise in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric patients affected by chemical, biological, radiological, or nuclear agents, including emerging infectious diseases; pediatric mental or behavioral health related to children affected by a public health emergency; or pediatric primary care;

(D) at least 4 non-Federal members representing child care settings, State or local educational agencies, individuals with expertise in children with disabilities, and parents; and

(E) other members as the Secretary determines appropriate, of whom—

(i) at least one such member shall represent a children's hospital;

(ii) at least one such member shall be an individual with expertise in children and youth with special health care needs; and

(iii) at least one such member shall be an individual with expertise in the needs of parents or family caregivers, including the parents or caregivers of children with disabilities.

(3) Federal members

The Advisory Committee under paragraph (1) shall include the following Federal members or their designees (who may be nonvoting members, as determined by the Secretary):

(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 Health Resources and Services Administration.

(H) The Administrator of the Federal Emergency Management Agency.

(I) The Administrator of the Administration for Community Living.

(J) The Secretary of Education.

(K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services Administration and the Department of Homeland Security) as the Secretary determines appropriate to fulfill the duties of the Advisory Committee under subsections (b) and (c).

(4) Term of appointment

Each member of the Advisory Committee appointed under paragraph (2) shall serve for a term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees serving on June 24, 2019, or appointees who are initially appointed after such date, in order to provide for a staggered term of appointment for all members.

(5) Consecutive appointments; maximum terms

A member appointed under paragraph (2) may serve not more than 3 terms on the Advisory Committee, and not more than two of such terms may be served consecutively.

(e) Meetings

The Advisory Committee shall meet not less than biannually. At least one meeting per year shall be an in-person meeting.

(f) Coordination

The Secretary shall coordinate duties and activities authorized under this section in accordance with section 300hh–10e of this title.

(g) Sunset

The Advisory Committee shall terminate on December 31, 2024.

(July 1, 1944, ch. 373, title XXVIII, §2811A, as added Pub. L. 113–5, title I, §103, Mar. 13, 2013, 127 Stat. 168; amended Pub. L. 116–22, title III, §305(a), June 24, 2019, 133 Stat. 936; Pub. L. 117–328, div. FF, title II, §2236, Dec. 29, 2022, 136 Stat. 5756; Pub. L. 118–15, div. B, title III, §2333(a), Sept. 30, 2023, 137 Stat. 96; Pub. L. 118–22, div. B, title II, §203(d)(1), Nov. 17, 2023, 137 Stat. 121; Pub. L. 118–35, div. B, title I, §103(d)(1), Jan. 19, 2024, 138 Stat. 5; Pub. L. 118–42, div. G, title I, §103(d)(1), Mar. 9, 2024, 138 Stat. 398.)

Editorial Notes

Codification

Section was formerly classified to section 300hh–10a of this title.

Amendments

2024—Subsec. (g). Pub. L. 118–42 substituted "December 31, 2024" for "March 8, 2024".

Pub. L. 118–35 substituted "March 8, 2024" for "January 19, 2024".

2023—Subsec. (g). Pub. L. 118–22 substituted "January 19, 2024" for "November 17, 2023".

Pub. L. 118–15 substituted "November 17, 2023" for "September 30, 2023".

2022—Subsec. (b)(2). Pub. L. 117–328, §2236(1)(A)(i), substituted ", behavioral, developmental" for "and behavioral".

Subsec. (b)(4). Pub. L. 117–328, §2236(1)(A)(ii)–(C), added par. (4).

Subsec. (d)(2)(D), (E). Pub. L. 117–328, §2236(2)(A)–(C), added subpar. (D) and redesignated former subpar. (D) as (E).

Subsec. (d)(2)(E)(ii) to (iv). Pub. L. 117–328, §2236(2)(D), redesignated cls. (iii) and (iv) as (ii) and (iii), respectively, and struck out former cl. (ii) which read as follows: "at least one such member shall be an individual with expertise in schools or child care settings;".

2019—Subsec. (b)(2). Pub. L. 116–22, §305(a)(1), inserted ", mental and behavioral," after "medical".

Subsec. (d)(1). Pub. L. 116–22, §305(a)(2)(A), substituted "25 members" for "15 members".

Subsec. (d)(2) to (5). Pub. L. 116–22, §305(a)(2)(B), added pars. (2) to (5) and struck out former par. (2) which related to required members of the Advisory Committee.

Subsec. (e). Pub. L. 116–22, §305(a)(3), inserted at end "At least one meeting per year shall be an in-person meeting."

Subsec. (f). Pub. L. 116–22, §305(a)(5), added subsec. (f). Former subsec. (f) redesignated (g).

Subsec. (g). Pub. L. 116–22, §305(a)(4), (6), redesignated subsec. (f) as (g) and substituted "2023" for "2018".

§300hh–10c. National Advisory Committee on Seniors and Disasters

(a) Establishment

The Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Veterans Affairs, shall establish an advisory committee to be known as the National Advisory Committee on Seniors and Disasters (referred to in this section as the "Advisory Committee").

(b) Duties

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 seniors related 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 relating to seniors, including related drills and exercises pursuant to the preparedness goals under section 300hh–1(b) of this title.

(c) Additional duties

The Advisory Committee may provide advice and recommendations to the Secretary with respect to seniors and the medical and public health grants and cooperative agreements as applicable to preparedness and response activities under this subchapter and subchapter III.

(d) Membership

(1) In general

The Secretary, in consultation with such other heads of agencies as appropriate, shall appoint not more than 17 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.

(2) Required members

The Advisory Committee shall include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and non-Federal members, as follows:

(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 Administrator of the Centers for Medicare & Medicaid Services.

(G) The Administrator of the Administration for Community Living.

(H) The Administrator of the Federal Emergency Management Agency.

(I) The Under Secretary for Health of the Department of Veterans Affairs.

(J) At least 2 non-Federal health care professionals with expertise in geriatric medical disaster planning, preparedness, response, or recovery.

(K) At least 2 representatives of State, local, Tribal, or territorial agencies with expertise in geriatric disaster planning, preparedness, response, or recovery.

(L) Representatives of such other Federal agencies (such as the Department of Energy and the Department of Homeland Security) as the Secretary determines necessary to fulfill the duties of the Advisory Committee.

(e) Meetings

The Advisory Committee shall meet not less frequently than biannually. At least one meeting per year shall be an in-person meeting.

(f) Coordination

The Secretary shall coordinate duties and activities authorized under this section in accordance with section 300hh–10e of this title.

(g) Sunset

(1) In general

The Advisory Committee shall terminate on December 31, 2024.

(2) Extension of Committee

Not later than October 1, 2022, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.

(July 1, 1944, ch. 373, title XXVIII, §2811B, as added Pub. L. 116–22, title III, §305(b), June 24, 2019, 133 Stat. 938; amended Pub. L. 118–15, div. B, title III, §2333(b), Sept. 30, 2023, 137 Stat. 96; Pub. L. 118–22, div. B, title II, §203(d)(2), Nov. 17, 2023, 137 Stat. 121; Pub. L. 118–35, div. B, title I, §103(d)(2), Jan. 19, 2024, 138 Stat. 5; Pub. L. 118–42, div. G, title I, §103(d)(2), Mar. 9, 2024, 138 Stat. 398.)

Editorial Notes

Amendments

2024—Subsec. (g)(1). Pub. L. 118–42 substituted "December 31, 2024" for "March 8, 2024".

Pub. L. 118–35 substituted "March 8, 2024" for "January 19, 2024".

2023—Subsec. (g)(1). Pub. L. 118–22 substituted "January 19, 2024" for "November 17, 2023".

Pub. L. 118–15 substituted "November 17, 2023" for "September 30, 2023".

§300hh–10d. National Advisory Committee on Individuals With Disabilities and Disasters

(a) Establishment

The Secretary, in consultation with the Secretary of Homeland Security, shall establish a national advisory committee to be known as the National Advisory Committee on Individuals with Disabilities and Disasters (referred to in this section as the "Advisory Committee").

(b) Duties

The Advisory Committee shall—

(1) provide advice and consultation with respect to 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, public health, and accessibility needs of individuals with disabilities related 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, including related drills and exercises pursuant to the preparedness goals under section 300hh–1(b) of this title.

(c) Membership

(1) In general

The Secretary, in consultation with such other heads of agencies and departments as appropriate, shall appoint not more than 17 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.

(2) Required members

The Advisory Committee shall include Federal members or their designees (who may be nonvoting members, as determined by the Secretary) and non-Federal members, as follows:

(A) The Assistant Secretary for Preparedness and Response.

(B) The Administrator of the Administration for Community Living.

(C) The Director of the Biomedical Advanced Research and Development Authority.

(D) The Director of the Centers for Disease Control and Prevention.

(E) The Commissioner of Food and Drugs.

(F) The Director of the National Institutes of Health.

(G) The Administrator of the Federal Emergency Management Agency.

(H) The Chair of the National Council on Disability.

(I) The Chair of the United States Access Board.

(J) The Under Secretary for Health of the Department of Veterans Affairs.

(K) At least 2 non-Federal health care professionals with expertise in disability accessibility before, during, and after disasters, medical and mass care disaster planning, preparedness, response, or recovery.

(L) At least 2 representatives from State, local, Tribal, or territorial agencies with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities.

(M) At least 2 individuals with a disability with expertise in disaster planning, preparedness, response, or recovery for individuals with disabilities.

(d) Meetings

The Advisory Committee shall meet not less frequently than biannually. At least one meeting per year shall be an in-person meeting.

(e) Disability defined

For purposes of this section, the term "disability" has the meaning given such term in section 12102 of this title.

(f) Coordination

The Secretary shall coordinate duties and activities authorized under this section in accordance with section 300hh–10e of this title.

(g) Sunset

(1) In general

The Advisory Committee shall terminate on December 31, 2024.

(2) Recommendation

Not later than October 1, 2022, the Secretary shall submit to Congress a recommendation on whether the Advisory Committee should be extended.

(July 1, 1944, ch. 373, title XXVIII, §2811C, as added Pub. L. 116–22, title III, §305(c), June 24, 2019, 133 Stat. 939; amended Pub. L. 118–15, div. B, title III, §2333(c), Sept. 30, 2023, 137 Stat. 96; Pub. L. 118–22, div. B, title II, §203(d)(3), Nov. 17, 2023, 137 Stat. 121; Pub. L. 118–35, div. B, title I, §103(d)(3), Jan. 19, 2024, 138 Stat. 5; Pub. L. 118–42, div. G, title I, §103(d)(3), Mar. 9, 2024, 138 Stat. 398.)

Editorial Notes

Amendments

2024—Subsec. (g)(1). Pub. L. 118–42 substituted "December 31, 2024" for "March 8, 2024".

Pub. L. 118–35 substituted "March 8, 2024" for "January 19, 2024".

2023—Subsec. (g)(1). Pub. L. 118–22 substituted "January 19, 2024" for "November 17, 2023".

Pub. L. 118–15 substituted "November 17, 2023" for "September 30, 2023".

§300hh–10e. Advisory Committee Coordination

(a) In general

The Secretary shall coordinate duties and activities authorized under sections 300hh–10b, 300hh–10c, and 300hh–10d of this title, and make efforts to reduce unnecessary or duplicative reporting, or unnecessary duplicative meetings and recommendations under such sections, as practicable. Members of the advisory committees authorized under such sections, or their designees, shall annually meet to coordinate any recommendations, as appropriate, that may be similar, duplicative, or overlapping with respect to addressing the needs of children, seniors, and individuals with disabilities during public health emergencies. If such coordination occurs through an in-person meeting, it shall not be considered the required in-person meetings under any of sections 300hh–10b(e), 300hh–10c(e), or 300hh–10d(d) of this title.

(b) Coordination and alignment

The Secretary, acting through the employee designated pursuant to section 300hh–16 of this title, shall align preparedness and response programs or activities to address similar, dual, or overlapping needs of children, seniors, and individuals with disabilities, and any challenges in preparing for and responding to such needs.

(c) Notification

The Secretary shall annually notify the congressional committees of jurisdiction regarding the steps taken to coordinate, as appropriate, the recommendations under this section, and provide a summary description of such coordination.

(July 1, 1944, ch. 373, title XXVIII, §2811D, as added Pub. L. 116–22, title III, §305(d), June 24, 2019, 133 Stat. 941.)

§300hh–11. National Disaster Medical System

(a) National Disaster Medical System

(1) In general

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.

(2) Federal and State collaborative System

(A) In general

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).

(B) Participating Federal agencies

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.

(3) Purpose of System

(A) In general

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, or there is a significant potential for a public health emergency.

(B) Ongoing activities

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.

(C) Considerations for at-risk populations

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.

(D) Administration

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.

(E) Test for mobilization of System

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.

(b) Modifications

(1) In general

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.

(2) Joint review and medical surge capacity strategic plan

(A) Review

Not later than 180 days after June 24, 2019, 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—

(i) an evaluation of medical surge capacity, as described in section 300hh–2(a) of this title;

(ii) an assessment of the available workforce of the intermittent disaster response personnel described in subsection (c);

(iii) the capacity of the workforce described in clause (ii) to respond to all hazards, including capacity to simultaneously respond to multiple public health emergencies and the capacity to respond to a nationwide public health emergency;

(iv) the effectiveness of efforts to recruit, retain, and train such workforce; and

(v) gaps that may exist in such workforce and recommendations for addressing such gaps.

(B) Updates

As part of the National Health Security Strategy under section 300hh–1 of this title, the Secretary shall update the findings from the review under subparagraph (A) and provide recommendations to modify the policies of the National Disaster Medical System as necessary.

(3) Participation agreements for non-Federal entities

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). 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.

(c) Intermittent disaster-response personnel

(1) In general

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.

(2) Liability

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), 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).

(3) Notification

Not later than 30 days after the date on which the Secretary determines the number of intermittent disaster-response personnel of the National Disaster Medical System is insufficient to address a public health emergency or potential public health emergency, the Secretary shall submit to the congressional committees of jurisdiction a notification detailing—

(A) the impact such shortage could have on meeting public health needs and emergency medical personnel needs during a public health emergency; and

(B) any identified measures to address such shortage.

(4) Certain appointments

(A) In general

If the Secretary determines that the number of intermittent disaster response personnel within the National Disaster Medical System under this section is insufficient to address a public health emergency or potential public health emergency, the Secretary may appoint candidates directly to personnel positions for intermittent disaster response within such system. The Secretary shall provide updates on the number of vacant or unfilled positions within such system to the congressional committees of jurisdiction each quarter for which this authority is in effect.

(B) Sunset

The authority under this paragraph shall expire on December 31, 2024.

(5) Omitted

(d) Certain employment issues regarding intermittent appointments

(1) Intermittent disaster-response appointee

For purposes of this subsection, the term "intermittent disaster-response appointee" means an individual appointed by the Secretary under subsection (c).

(2) Compensation for work injuries

(A) In general

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.

(B) Application to training programs

With respect to the participation of individuals appointed under subsection (c) 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), 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).

(C) Responsibility of Labor Secretary

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.

(D) Computation of pay

In the event of an injury to such an intermittent disaster response appointee, the position of the employee shall be deemed to be "one which would have afforded employment for substantially a whole year", for purposes of section 8114(d)(2) of such title.

(E) Continuation of pay

The weekly pay of such an employee shall be deemed to be the hourly pay in effect on the date of the injury multiplied by 40, for purposes of computing benefits under section 8118 of such title.

(3) Employment and reemployment rights

(A) In general

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) 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.

(B) Notice of absence from position of employment

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.

(4) Limitation

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.

(e) Rule of construction regarding use of commissioned corps

If the Secretary assigns commissioned officers of the Regular or Reserve Corps ³ 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).

(f) Definition

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).

(g) Authorization of appropriations

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 $57,400,000 for each of fiscal years 2019 through 2023.

(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; Pub. L. 114–113, div. H, title V, §527, Dec. 18, 2015, 129 Stat. 2653; Pub. L. 116–22, title III, §301(a), (d)(1), June 24, 2019, 133 Stat. 931, 933; Pub. L. 117–43, div. D, title I, §3101, Sept. 30, 2021, 135 Stat. 379; Pub. L. 117–70, div. C, title I, §2101, Dec. 3, 2021, 135 Stat. 1504; Pub. L. 117–86, div. B, title I, §1101, Feb. 18, 2022, 136 Stat. 17; Pub. L. 117–103, div. P, title I, §101, Mar. 15, 2022, 136 Stat. 789; Pub. L. 118–15, div. B, title III, §2331, Sept. 30, 2023, 137 Stat. 95; Pub. L. 118–22, div. B, title II, §203(e), Nov. 17, 2023, 137 Stat. 121; Pub. L. 118–35, div. B, title I, §103(e), Jan. 19, 2024, 138 Stat. 5; Pub. L. 118–42, div. G, title I, §103(e), Mar. 9, 2024, 138 Stat. 399.)

Editorial Notes

References in Text

The Omnibus Crime Control and Safe Streets Act of 1968, referred to in subsec. (c)(5), is Pub. L. 90–351, June 19, 1968, 82 Stat. 197. Part L of title I of the Act is classified generally to subchapter XI (§10281 et seq.) of chapter 101 of Title 34, Crime Control and Law Enforcement. For complete classification of this Act to the Code, see Short Title of 1968 Act note set out under section 10101 of Title 34 and Tables.

Codification

Subsec. (c)(5) of this section was omitted in light of section 301(d)(3) of Pub. L. 116–22, which provided that the amendment adding subsec. (c)(5) would cease to have force or effect on Oct. 1, 2021. See 2019 Amendment and Termination Date of 2019 Amendment notes below.

Amendments

2024—Subsec. (c)(4)(B). Pub. L. 118–42 substituted "December 31, 2024" for "March 8, 2024".

Pub. L. 118–35 substituted "March 8, 2024" for "January 19, 2024".

2023—Subsec. (c)(4)(B). Pub. L. 118–22 substituted "January 19, 2024" for "November 17, 2023".

Pub. L. 118–15 substituted "November 17, 2023" for "September 30, 2023".

2022—Subsec. (c)(4)(B). Pub. L. 117–103 substituted "September 30, 2023" for "March 11, 2022".

Pub. L. 117–86 substituted "March 11, 2022" for "February 18, 2022".

2021—Subsec. (c)(4)(B). Pub. L. 117–70 substituted "February 18, 2022" for "December 3, 2021".

Pub. L. 117–43 substituted "December 3, 2021" for "September 30, 2021".

2019—Subsec. (a)(3)(A)(ii). Pub. L. 116–22, §301(a)(1), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: "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."

Subsec. (b)(2). Pub. L. 116–22, §301(a)(2), amended par. (2) generally. Prior to amendment, text read as follows: "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."

Subsec. (c)(3), (4). Pub. L. 116–22, §301(a)(3), added pars. (3) and (4).

Subsec. (c)(5). Pub. L. 116–22, §301(d)(1), added par. (5), which ceased to have force or effect on Oct. 1, 2021. Text read as follows: "Individuals appointed to serve under this subsection shall be considered eligible for benefits under part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 [42 U.S.C. 10281 et seq.]. The Secretary shall provide notification to any eligible individual of any effect such designation may have on other benefits for which such individual is eligible, including benefits from private entities." See Termination Date of 2019 Amendment note below.

Subsec. (g). Pub. L. 116–22, §301(a)(4), substituted "$57,400,000 for each of fiscal years 2019 through 2023" for "$52,700,000 for each of fiscal years 2014 through 2018".

2015—Subsec. (d)(2). Pub. L. 114–113 designated first, second, and third sentences of existing provisions as subpars. (A), (B), and (C), respectively, realigned margins, inserted subpar. headings, and added subpars. (D) and (E).

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".

Statutory Notes and Related Subsidiaries

Change of Name

Reference to Reserve Corps of the Public Health Service deemed to be a reference to the Ready Reserve Corps, see section 204(c)(3) of this title.

Termination Date of 2019 Amendment

Amendment by section 301(d)(1) of Pub. L. 116–22 to cease to have force or effect on Oct. 1, 2021, see section 301(d)(3) of Pub. L. 116–22, set out as a note under section 10284 of Title 34, Crime Control and Law Enforcement.

Transfer of Functions

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".

³ See Change of Name note below.

§300hh–12. Transferred

Editorial Notes

Codification

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.

§300hh–13. Evaluation of new and emerging technologies regarding bioterrorist attack and other public health emergencies

(a) In general

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.

(b) Certain activities

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).

(c) Consultation and evaluation

In carrying out subsection (b)(3), 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.

(d) Report

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.)

Editorial Notes

References in Text

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.

Codification

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.

§300hh–14. Protection of health and safety during disasters

(a) Definitions

In this section:

(1) Certified monitoring program

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.

(2) Disaster area

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.

(3) High exposure level

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.

(4) Individual

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.

(5) Participating responder

The term "participating responder" means an individual described in paragraph (4)(A).

(6) Program

The term "program" means a program described in subsection (b) that is carried out for a disaster area.

(7) Substance of concern

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.

(b) Program

(1) In general

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.

(2) Activities

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.

(3) Timing

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.

(4) Participation in registries and studies

(A) In general

Participation in any registry or study that is part of a program carried out under paragraph (1) shall be voluntary.

(B) Protection of privacy

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).

(C) Priority

(i) In general

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.

(ii) Modifications

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.

(5) Cooperative agreements

(A) In general

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.

(B) Selection criteria

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.

(6) Involvement

(A) In general

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.

(B) Committees

Involvement under subparagraph (A) may be provided through the establishment of an advisory or oversight committee or board.

(7) Privacy

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).

(8) Existing programs

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).

(c) Reports

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.

(d) National Academy of Sciences report on disaster area health and environmental protection and monitoring

(1) In general

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.

(2) Participation of experts

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.

(3) Contents

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.

(4) Authorization of appropriations

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.)

Editorial Notes

References in Text

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.

Codification

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;".

§300hh–15. Volunteer Medical Reserve Corps

(a) In general

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 Secretary may appoint a Director to head the Corps and oversee the activities of the Corps chapters that exist at the State, local, Tribal, and territorial levels.

(b) State, local, and tribal coordination

The Corps shall be established using existing State, local, and tribal teams and shall not alter such teams.

(c) Composition

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.

(d) Certification; drills

(1) Certification

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.

(2) Drills

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.

(e) Deployment

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.

(f) Expenses and transportation

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.

(g) Identification

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.

(h) Intermittent disaster-response personnel

(1) In general

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.

(2) Applicable protections

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.

(3) Limitation

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.

(i) Authorization of appropriations

There is authorized to be appropriated to carry out this section, $11,200,000 for each of fiscal years 2019 through 2023.

(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; Pub. L. 116–22, title III, §301(b), June 24, 2019, 133 Stat. 932.)

Editorial Notes

Amendments

2019—Subsec. (a). Pub. L. 116–22, §301(b)(1), substituted "The Secretary may appoint a Director to head the Corps and oversee the activities of the Corps chapters that exist at the State, local, Tribal, and territorial levels." for "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."

Subsec. (i). Pub. L. 116–22, §301(b)(2), substituted "2019 through 2023" for "2014 through 2018".

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".

§300hh–16. At-risk individuals

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;

(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; and

(9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance network under section 247d–4 of this title, the Secretary considers incorporating data and information from Federal, State, local, Tribal, and territorial public health officials and entities relevant to detecting emerging public health threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, including adverse health outcomes of such populations related to such emerging public health threats.

(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; Pub. L. 116–22, title III, §303(c), June 24, 2019, 133 Stat. 935.)

Editorial Notes

Amendments

2019—Par. (9). Pub. L. 116–22 added par. (9).

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."

§300hh–17. Emergency response coordination of primary care providers

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".