Collapse to view only § 300hh-10e. Advisory Committee Coordination
- § 300hh-10. Coordination of preparedness for and response to all-hazards public health emergencies
- § 300hh-10a. Public Health Emergency Medical Countermeasures Enterprise
- § 300hh-10b. National Advisory Committee on Children and Disasters
- § 300hh-10c. National Advisory Committee on Seniors and Disasters
- § 300hh-10d. National Advisory Committee on Individuals With Disabilities and Disasters
- § 300hh-10e. Advisory Committee Coordination
- § 300hh-11. National Disaster Medical System
- § 300hh-12. Transferred
- § 300hh-13. Evaluation of new and emerging technologies regarding bioterrorist attack and other public health emergencies
- § 300hh-14. Protection of health and safety during disasters
- § 300hh-15. Volunteer Medical Reserve Corps
- § 300hh-16. At-risk individuals
- § 300hh-17. Emergency response coordination of primary care providers
§ 300hh–10. Coordination of preparedness for and response to all-hazards public health emergencies
(a) In general
(b) DutiesSubject 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
(2) Personnel
(3) Countermeasures
(4) Coordination
(A) Federal integration
(B) State, local, and tribal integration
(C) Emergency medical services
(D) Policy coordination and strategic direction
(E) Identification of inefficienciesIdentify 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 agreementsAlign 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 exercisesCarry 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
1 So in original. Probably should be followed by a dash.
(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
(I) Threat awareness
(J) Medical product and supply capacity planningCoordinate 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
(6) Leadership
(7) Countermeasures budget planDevelop, 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) FunctionsThe 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
(2) RequirementsThe 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
2 So in original. The word “section” probably should appear.
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
(B) ContentThe report described in subparagraph (A) shall review and assess—
(i) the near-term, mid-term, and long-term medical countermeasure needs and identified priorities of the Federal Government pursuant to paragraph (2)(C);
(ii) the activities of the Department of Health and Human Services with respect to advanced research and development pursuant to section 247d–7e of this title; and
(iii) the progress made toward meeting the timelines, allocations, benchmarks, and milestones identified in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan under this subsection.
(e) Protection of national security
(f) Protection of national security from threats
(1) In generalIn 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
(B) Supplement, not supplant
(C) Documentation required
(g) Appearances before Congress
(1) In generalEach 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
(B) Scope of requirements
(3) Closed hearings
(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.)
§ 300hh–10a. Public Health Emergency Medical Countermeasures Enterprise
(a) In general
(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
(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.)
§ 300hh–10b. National Advisory Committee on Children and Disasters
(a) Establishment
(b) DutiesThe 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
(d) Membership
(1) In general
(2) Required non-Federal membersThe 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 membersThe 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
(5) Consecutive appointments; maximum terms
(e) Meetings
(f) Coordination
(g) Sunset
(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.)
§ 300hh–10c. National Advisory Committee on Seniors and Disasters
(a) Establishment
(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
(d) Membership
(1) In general
(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
(f) Coordination
(g) Sunset
(1) In general
(2) Extension of Committee
(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.)
§ 300hh–10d. National Advisory Committee on Individuals With Disabilities and Disasters
(a) Establishment
(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
(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
(e) Disability defined
(f) Coordination
(g) Sunset
(1) In general
(2) Recommendation
(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.)
§ 300hh–10e. Advisory Committee Coordination
(a) In general
(b) Coordination and alignment
(c) Notification
(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
(2) Federal and State collaborative System
(A) In general
(B) Participating Federal agencies
(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
(C) Considerations for at-risk populations
(D) Administration
(E) Test for mobilization of System
(b) Modifications
(1) In general
(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
(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
(2) Liability
(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
(B) Sunset
(5) Omitted
(d) Certain employment issues regarding intermittent appointments
(1) Intermittent disaster-response appointee
(2) Compensation for work injuries
(A) In general
(B) Application to training programs
(C) Responsibility of Labor Secretary
(D) Computation of pay
(E) Continuation of pay
(3) Employment and reemployment rights
(A) In general
(B) Notice of absence from position of employment
(4) Limitation
(e) Rule of construction regarding use of commissioned corps
(f) Definition
(g) Authorization of appropriations
(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.)
§ 300hh–12. Transferred
§ 300hh–13. Evaluation of new and emerging technologies regarding bioterrorist attack and other public health emergencies
(a) In general
(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
(d) Report
(Pub. L. 107–188, title I, § 126, June 12, 2002, 116 Stat. 615.)
§ 300hh–14. Protection of health and safety during disasters
(a) DefinitionsIn this section:
(1) Certified monitoring programThe 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
(3) High exposure level
(4) IndividualThe 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
(6) Program
(7) Substance of concern
(b) Program
(1) In generalIf 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) ActivitiesA 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
(4) Participation in registries and studies
(A) In general
(B) Protection of privacy
(C) Priority
(i) In general
(ii) Modifications
(5) Cooperative agreements
(A) In general
(B) Selection criteriaTo 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 generalIn 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
(7) Privacy
(8) Existing programsIn 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
1 So in original. Probably should be “program;”.
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
(d) National Academy of Sciences report on disaster area health and environmental protection and monitoring
(1) In general
(2) Participation of expertsThe 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) ContentsThe 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
(Pub. L. 109–347, title VII, § 709, Oct. 13, 2006, 120 Stat. 1947.)
§ 300hh–15. Volunteer Medical Reserve Corps
(a) In general
(b) State, local, and tribal coordination
(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
(2) Drills
(e) Deployment
(f) Expenses and transportation
(g) Identification
(h) Intermittent disaster-response personnel
(1) In general
(2) Applicable protections
(3) Limitation
(i) Authorization of appropriations
(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.)
§ 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.)
§ 300hh–17. Emergency response coordination of primary care providers
The Secretary, acting through Administrator 1
1 So in original. Probably should be preceded by “the”.
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.)