SUBCHAPTER XXVI—NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH EMERGENCIES
Editorial Notes
Codification
Part A—National All-Hazards Preparedness and Response Planning, Coordinating, and Reporting
Editorial Notes
Codification
§300hh. Public health and medical preparedness and response functions
(a) In general
The Secretary of Health and Human Services shall lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Plan developed pursuant to section 314(6) 1 of title 6, or any successor plan.
(b) Interagency agreement
The Secretary, in collaboration with the Secretary of Veterans Affairs, the Secretary of Transportation, the Secretary of Defense, the Secretary of Homeland Security, and the head of any other relevant Federal agency, shall establish an interagency agreement, consistent with the National Response Plan or any successor plan, under which agreement the Secretary of Health and Human Services shall assume operational control of emergency public health and medical response assets, as necessary, in the event of a public health emergency, except that members of the armed forces under the authority of the Secretary of Defense shall remain under the command and control of the Secretary of Defense, as shall any associated assets of the Department of Defense.
(c) Coordination with Federal agencies
In leading the Federal public health and medical response to a declared or potential public health emergency, consistent with this section, the Secretary shall coordinate with, and may request support from, other Federal departments and agencies, as appropriate in order to carry out necessary activities and leverage the expertise of such departments and agencies, which may include the provision of assistance at the direction of the Secretary related to supporting the public health and medical response for States, localities, and Tribes.
(d) Annual report on emergency response and preparedness
The Secretary shall submit a written report each fiscal year to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, containing—
(1) updated information related to an assessment of the response to any public health emergency declared, or otherwise in effect, during the previous fiscal year;
(2) findings related to drills and operational exercises completed in the previous fiscal year pursuant to
(3) the state of public health preparedness and response capabilities for chemical, biological, radiological, and nuclear threats, including emerging infectious diseases; and
(4) any challenges in preparing for or responding to such threats, as appropriate.
(July 1, 1944, ch. 373, title XXVIII, §2801, as added
Editorial Notes
References in Text
Amendments
2022—Subsec. (c).
Subsec. (d).
2006—
Statutory Notes and Related Subsidiaries
Data Use Agreements
"(1)
"(A)
"(B)
"(i) ensure that the agreements and memoranda of understanding described in such subparagraph—
"(I) address the methods of granting access to data held by one agency or office with another to support the respective missions of such agencies or offices;
"(II) consider minimum necessary principles of data sharing for appropriate use;
"(III) include appropriate privacy and cybersecurity protections; and
"(IV) are subject to regular updates, as appropriate;
"(ii) collaborate with the Centers for Disease Control and Prevention, the Office of the Assistant Secretary for Preparedness and Response, the Office of the Chief Information Officer, and, as appropriate, the Office of the National Coordinator for Health Information Technology, and other entities within the Department of Health and Human Services; and
"(iii) consider the terms and conditions of any existing data use agreements with other public or private entities and any need for updates to such existing agreements, consistent with paragraph (2).
"(2)
"(3)
Guidance for Participation in Exercises and Drills
Government Accountability Office Report
"(a)
"(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population;
"(2) the coordination of the activities described in paragraph (1);
"(3) the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population;
"(4) the activities and costs of the Civil Support Teams of the National Guard in responding to biological threats or attacks against the civilian population;
"(5) the activities of the working group under subsection (a) and the efforts made by such group to carry out the activities described in such subsection; and
"(6) the ability of private sector contractors to enhance governmental responses to biological threats or attacks."
1 See References in Text note below.
§300hh–1. National Health Security Strategy
(a) In general
(1) Preparedness and response regarding public health emergencies
Beginning in 2018 and every four years thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a coordinated strategy (to be known as the National Health Security Strategy) and any revisions thereof, and an accompanying implementation plan for public health emergency preparedness and response. Such National Health Security Strategy shall describe potential emergency health security threats and identify the process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond to such threats and shall be consistent with the national preparedness goal (as described in
(2) Evaluation of progress
The National Health Security Strategy shall include an evaluation of the progress made by Federal, State, local, and tribal entities, based on the evidence-based benchmarks and objective standards that measure levels of preparedness established pursuant to
(3) Public health workforce
In 2022, the National Health Security Strategy shall include a national strategy for establishing an effective and prepared public health workforce, including defining the functions, capabilities, and gaps in such workforce (including gaps in the environmental health and animal health workforces, as applicable), describing the status of such workforce, identifying strategies to recruit, retain, and protect such workforce from workplace exposures during public health emergencies, and identifying current capabilities to meet the requirements of
(b) Preparedness goals
The National Health Security Strategy shall include provisions in furtherance of the following:
(1) Integration
Integrating public health and public and private medical capabilities with other first responder systems, including through—
(A) the periodic evaluation of Federal, State, local, and tribal preparedness and response capabilities through drills and exercises, including drills and exercises to ensure medical surge capacity for events without notice; and
(B) integrating public and private sector public health and medical donations and volunteers.
(2) Public health
Developing and sustaining Federal, State, local, and tribal essential public health security capabilities, including the following:
(A) Disease situational awareness domestically and abroad, including detection, identification, investigation, and related information technology activities.
(B) Disease containment including capabilities for isolation, quarantine, social distancing, decontamination, relevant health care services and supplies, and transportation and disposal of medical waste.
(C) Risk communication and public preparedness.
(D) Rapid distribution and administration of medical countermeasures.
(E) Response to environmental hazards.
(3) Medical
Increasing the preparedness, response capabilities, and surge capacity of hospitals, other health care facilities (including pharmacies, mental health facilities, and ambulatory care facilities and which may include dental health facilities), and trauma care, critical care, and emergency medical service systems, with respect to public health emergencies (including related availability, accessibility, and coordination), which shall include developing plans for the following:
(A) Strengthening public health emergency medical and trauma management and treatment capabilities.
(B) Fatality management.
(C) Coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care.
(D) Rapid distribution and administration of medical countermeasures.
(E) Effective utilization of any available public and private mobile medical assets (which may include such dental health assets) and integration of other Federal assets.
(F) Protecting health care workers and health care first responders from workplace exposures during a public health emergency or exposures to agents that could cause a public health emergency.
(G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hospitals, other health care facilities, critical care, trauma care (which may include trauma centers), and emergency medical systems.
(4) At-risk individuals
(A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs and considerations of individuals with disabilities, in the event of a public health emergency.
(B) For the purpose of this chapter, the term "at-risk individuals" means children, pregnant women, senior citizens and other individuals who have access or functional needs in the event of a public health emergency, as determined by the Secretary.
(5) Coordination
Minimizing duplication of, and ensuring coordination between, Federal, State, local, and tribal planning, preparedness, and response activities (including the State Emergency Management Assistance Compact and other applicable compacts). Such planning shall be consistent with the National Response Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
(6) Continuity of operations
Maintaining vital public health and medical services to allow for optimal Federal, State, local, and tribal operations in the event of a public health emergency.
(7) Countermeasures
(A) Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.
(B) For purposes of this paragraph, the term "countermeasures" has the same meaning as the terms "qualified countermeasures" under
(8) Medical and public health community resiliency
Strengthening the ability of States, local communities, and tribal communities to prepare for, respond to, and be resilient in the event of public health emergencies, whether naturally occurring, unintentional, or deliberate by—
(A) optimizing alignment and integration of medical and public health preparedness and response planning and capabilities with and into routine daily activities; and
(B) promoting familiarity with local medical and public health systems.
(9) Zoonotic disease, food, and agriculture
Improving coordination among Federal, State, local, Tribal, and territorial entities (including through consultation with the Secretary of Agriculture) to prevent, detect, and respond to outbreaks of plant or animal disease (including zoonotic disease) that could compromise national security resulting from a deliberate attack, a naturally occurring threat, the intentional adulteration of food, or other public health threats, taking into account interactions between animal health, human health, and animals' and humans' shared environment as directly related to public health emergency preparedness and response capabilities, as applicable.
(10) Global health security
Assessing current or potential health security threats from abroad to inform domestic public health preparedness and response capabilities.
(July 1, 1944, ch. 373, title XXVIII, §2802, as added
Editorial Notes
Amendments
2019—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B).
Subsec. (b)(2)(E).
Subsec. (b)(3).
Subsec. (b)(3)(F).
Subsec. (b)(3)(G).
Subsec. (b)(4)(B).
Subsec. (b)(5).
Subsec. (b)(9), (10).
2013—Subsec. (a)(1).
Subsec. (b)(1)(A).
Subsec. (b)(3).
Subsec. (b)(3)(A).
Subsec. (b)(3)(B).
Subsec. (b)(3)(C), (D).
Subsec. (b)(3)(E).
Subsec. (b)(3)(F).
Subsec. (b)(3)(G).
Subsec. (b)(4)(A).
Subsec. (b)(4)(B).
Subsec. (b)(7), (8).
Executive Documents
Ex. Ord. No. 13527. Establishing Federal Capability for the Timely Provision of Medical Countermeasures Following a Biological Attack
Ex. Ord. No. 13527, Dec. 30, 2009, 75 F.R. 737, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
This policy would seek to: (1) mitigate illness and prevent death; (2) sustain critical infrastructure; and (3) complement and supplement State, local, territorial, and tribal government medical countermeasure distribution capacity.
(b) The Secretaries of Health and Human Services and Homeland Security, in coordination with the U.S. Postal Service, within 180 days of the date of this order, shall establish a national U.S. Postal Service medical countermeasures dispensing model for U.S. cities to respond to a large-scale biological attack, with anthrax as the primary threat consideration.
(c) In support of the national U.S. Postal Service model, the Secretaries of Homeland Security, Health and Human Services, and Defense, and the Attorney General, in coordination with the U.S. Postal Service, and in consultation with State and local public health, emergency management, and law enforcement officials, within 180 days of the date of this order, shall develop an accompanying plan for supplementing local law enforcement personnel, as necessary and appropriate, with local Federal law enforcement, as well as other appropriate personnel, to escort U.S. Postal workers delivering medical countermeasures.
(b) The Secretaries of Homeland Security and Health and Human Services, in coordination with the Secretary of Defense, within 90 days of the date of this order, shall develop a concept of operations and establish requirements for a Federal rapid response to dispense medical countermeasures to an affected population following a large-scale biological attack.
(b) The Secretaries of Health and Human Services and Homeland Security, within 180 days of the date of this order, shall develop a plan for the provision of medical countermeasures to ensure that mission-essential functions of executive branch departments and agencies continue to be performed following a large-scale biological attack.
(a) Nothing in this order shall be construed to impair or otherwise affect:
(i) authority granted by law to a department or agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Barack Obama.
§300hh–2. Enhancing medical surge capacity
(a) Study of enhancing medical surge capacity
As part of the joint review described in
(1) acquisition and operation of mobile medical assets by the Secretary to be deployed, on a contingency basis, to a community in the event of a public health emergency;
(2) integrating the practice of telemedicine within the National Disaster Medical System; and
(3) other strategies to improve such capacity as determined appropriate by the Secretary.
(b) Authority to acquire and operate mobile medical assets
In addition to any other authority to acquire, deploy, and operate mobile medical assets, the Secretary may acquire, deploy, and operate mobile medical assets if, taking into consideration the evaluation conducted under subsection (a), such acquisition, deployment, and operation is determined to be beneficial and feasible in improving the capacity of the Department of Health and Human Services to provide additional medical surge capacity to local communities in the event of a public health emergency.
(c) Using Federal facilities to enhance medical surge capacity
(1) Analysis
The Secretary shall conduct an analysis of whether there are Federal facilities which, in the event of a public health emergency, could practicably be used as facilities in which to provide health care.
(2) Memoranda of understanding
If, based on the analysis conducted under paragraph (1), the Secretary determines that there are Federal facilities which, in the event of a public health emergency, could be used as facilities in which to provide health care, the Secretary shall, with respect to each such facility, seek to conclude a memorandum of understanding with the head of the Department or agency that operates such facility that permits the use of such facility to provide health care in the event of a public health emergency.
(July 1, 1944, ch. 373, title XXVIII, §2803, as added
§300hh–3. Office of Pandemic Preparedness and Response Policy
(a) In general
There is established in the Executive Office of the President an Office of Pandemic Preparedness and Response Policy (referred to in this section as the "Office"), which shall be headed by a Director (referred to in this section as the "Director") appointed by the President and who shall be compensated at the rate provided for level II of the Executive Schedule in
(b) Functions of the Director
The primary function of the Director is to provide advice, within the Executive Office of the President, on policy related to preparedness for, and response to, pandemic and other biological threats that may impact national security, and support strategic coordination and communication with respect to relevant activities across the Federal Government. In addition to such other functions and activities as the President may assign, the Director, consistent with applicable laws and the National Response Framework, shall—
(1) serve as the principal advisor to the President on all matters related to pandemic preparedness and response policy and make recommendations to the President regarding pandemic and other biological threats that may impact national security;
(2) coordinate Federal activities to prepare for, and respond to, pandemic and other biological threats, by—
(A) providing strategic direction to the heads of applicable Federal departments, agencies, and offices, including—
(i) the establishment, implementation, prioritization, and assessment of policy goals and objectives across the Executive Office of the President and such departments, agencies, and offices;
(ii) supporting the assessment and clarification of roles and responsibilities related to such Federal activities; and
(iii) supporting the development and implementation of metrics and performance measures to evaluate the extent to which applicable activities meet such goals and objectives;
(B) providing, in consultation with the Secretary of Health and Human Services and the heads of other relevant Federal departments, agencies, and offices, leadership with respect to the National Biodefense Strategy and related activities pursuant to
(C) facilitating coordination and communication between such Federal departments, agencies, and offices to improve preparedness for, and response to, such threats;
(D) ensuring that the authorities, capabilities, and expertise of each such department, agency, and office are appropriately leveraged to facilitate the whole-of-Government response to such threats;
(E) overseeing coordination of Federal efforts to prepare for and support the production, supply, and distribution of relevant medical products and supplies during a response to a pandemic or other biological threat, as applicable and appropriate, including supporting Federal efforts to assess any relevant vulnerabilities in the supply chain of such products and supplies, and identify opportunities for private entities to engage with the Federal Government to address medical product and medical supply needs during such a response;
(F) overseeing coordination of Federal efforts for the basic and advanced research, development, manufacture, and procurement of medical countermeasures for such threats, including by—
(i) serving, with the Secretary of Health and Human Services, as co-Chair of the Public Health Emergency Medical Countermeasures Enterprise established pursuant to
(ii) promoting coordination between the medical countermeasure research, development, and procurement activities of respective Federal departments and agencies, including to advance the discovery and development of new medical products and technologies;
(G) convening heads of Federal departments and agencies, as appropriate, on topics related to capabilities to prepare for, and respond to, such threats;
(H) assessing and advising on international cooperation in preparing for, and responding to, such threats to advance the national security objectives of the United States; and
(I) overseeing other Federal activities to assess preparedness for, and responses to, such threats, including—
(i) drills and operational exercises conducted pursuant to applicable provisions of law; and
(ii) Federal after-action reports developed following such drills and exercises or a response to a pandemic or other biological threat;
(3) promote and support the development of relevant expertise and capabilities within the Federal Government to ensure that the United States can quickly detect, identify, and respond to such threats, and provide recommendations, as appropriate, to the President;
(4) consult with the Director of the Office of Management and Budget and other relevant officials within the Executive Office of the President, including the Assistant to the President for National Security Affairs and the Director of the Office of Science and Technology Policy, regarding activities related to preparing for, and responding to, such threats and relevant research and emerging technologies that may advance the biosecurity and preparedness and response goals of the Federal Government;
(5) identify opportunities to leverage current and emerging technologies, including through public-private partnerships, as appropriate, to address such threats and advance the preparedness and response goals of the Federal Government; and
(6) ensure that findings of Federal after-action reports conducted pursuant to paragraph (2)(I)(ii) are implemented to the maximum extent feasible within the Federal Government.
(c) Support from other agencies
Each department, agency, and instrumentality of the executive branch of the Federal Government, including any independent agency, is authorized to support the Director by providing the Director such information as the Director determines necessary to carry out the functions of the Director under this section.
(d) Preparedness outlook report
(1) In general
Within its first year of operation, the Director, in consultation with the heads of relevant Federal departments and agencies and other officials within the Executive Office of the President, shall through a report submitted to the President and made available to the public, to the extent practicable, identify and describe situations and conditions which warrant special attention within the next 5 years, involving current and emerging problems of national significance related to pandemic or other biological threats, and opportunities for, and the barriers to, the research, development, and procurement of medical countermeasures to adequately respond to such threats.
(2) Revisions
The Office shall revise the report under paragraph (1) not less than once every 5 years and work with relevant Federal officials to address the problems, barriers, opportunities, and actions identified under this report through the development of the President's Budgets and programs.
(e) Interdepartmental working group
The Director shall lead an interdepartmental working group that will meet on a regular basis to evaluate national biosecurity and pandemic preparedness issues and make recommendations to the heads of applicable Federal departments, agencies and offices. The working group shall consist of representatives from—
(1) the Office of Pandemic Preparedness and Response Policy, to serve as the chair;
(2) the Department of Health and Human Services;
(3) the Department of Homeland Security;
(4) the Department of Defense;
(5) the Office of Management and Budget; and
(6) other Federal Departments and agencies.
(f) Industry Liaison
(1) In general
Not later than 10 days after the initiation of a Federal response to a pandemic or other biological threat that may pose a risk to national security, the Director shall appoint an Industry Liaison within the Office of Pandemic Preparedness and Response Policy to serve until the termination of such response.
(2) Activities
The Industry Liaison shall—
(A) not later than 20 days after the initiation of such response, identify affected industries and develop a plan to regularly communicate with, and receive input from, affected industries;
(B) work with relevant Federal departments and agencies to support information sharing and coordination with industry stakeholders; and
(C) communicate, and support the provision of technical assistance, as applicable, with private entities interested in supporting such response, which may include entities not historically involved in the public health or medical sectors, as applicable and appropriate.
(g) Additional functions of the Director
The Director, in addition to the other duties and functions set forth in this section—
(1) shall—
(A) serve as a member of the Domestic Policy Council and the National Security Council;
(B) serve as a member of the Intergovernmental Science, Engineering, and Technology Advisory Panel under
(C) consult with State, Tribal, local, and territorial governments, industry, academia, professional societies, and other stakeholders, as appropriate;
(D) use for administrative purposes, on a reimbursable basis, the available services, equipment, personnel, and facilities of Federal, State, and local agencies; and
(E) at the President's request, perform such other duties and functions and enter into contracts and other arrangements for studies, analyses, and related services with public or private entities, as applicable and appropriate; and
(2) may hold such hearings in various parts of the United States as necessary to determine the views of the entities and individuals referred to in paragraph (1) and of the general public, concerning national needs and trends in pandemic preparedness and response.
(h) Staffing and detailees
In carrying out functions under this section, the Director may—
(1) appoint not more than 25 individuals to serve as employees of the Office as necessary to carry out this section;
(2) fix the compensation of such personnel at a rate to be determined by the Director, up to the amount of annual compensation (excluding expenses) specified in
(3) utilize the services of consultants, which may include by obtaining services described under
(4) direct, with the concurrence of the Secretary of a department or head of an agency, the temporary reassignment within the Federal Government of personnel employed by such department or agency, in order to carry out the functions of the Office.
(i) Preparedness review and report
The Director, in consultation with the heads of applicable Federal departments, agencies, and offices, shall—
(1) not later than 1 year after December 29, 2022, conduct a review of applicable Federal strategies, policies, procedures, and after-action reports to identify gaps and inefficiencies related to pandemic preparedness and response;
(2) not later than 18 months after December 29, 2022, and every 2 years thereafter, submit to the President and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report describing—
(A) current and emerging pandemic and other biological threats that pose a significant level of risk to national security;
(B) the roles and responsibilities of the Federal Government in preparing for, and responding to, such threats;
(C) the findings of the review conducted under paragraph (1);
(D) any barriers or limitations related to addressing such findings;
(E) current and planned activities to update Federal strategies, policies, and procedures to address such findings, consistent with applicable laws and the National Response Framework;
(F) current and planned activities to support the development of expertise within the Federal Government pursuant to subsection (b)(3); and
(G) opportunities to improve Federal preparedness and response capacities and capabilities through the use of current and emerging technologies.
(j) Nonduplication of effort
The Director shall ensure that activities carried out under this section do not unnecessarily duplicate the efforts of other Federal departments, agencies, and offices.
(
Editorial Notes
References in Text
Level IV of the Executive Schedule, referred to in subsec. (h)(3), is set out in
Codification
Section was enacted as part of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act, also known as the PREVENT Pandemics Act, and also as part of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022, and not as part of the Public Health Service Act which comprises this chapter.
Section is comprised of section 2104 of div. FF of
Part B—All-Hazards Emergency Preparedness and Response
Editorial Notes
Codification
§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
(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
(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
(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 [
(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
(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
(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
(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
(B) the Hospital Preparedness Cooperative Agreement Program pursuant to
(C) the Biomedical Advanced Research and Development Authority pursuant to
(D) the Medical Reserve Corps pursuant to
(E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to
(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
(B) the Strategic National Stockpile pursuant to
(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
(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
(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
(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
(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
(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
(v) with respect to
(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
(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
(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
(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 (
(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
(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
(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
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,
The Robert T. Stafford Disaster Relief and Emergency Assistance Act, referred to in subsec. (b)(5), is
The National Emergencies Act, referred to in subsec. (b)(5), is
The Consolidated Appropriations Act, 2018, referred to in subsec. (f)(2)(C), is
Prior Provisions
A prior section 2811 of act July 1, 1944, was renumbered section 2812 and is classified to
Amendments
2022—Subsec. (b)(1).
Subsec. (b)(4)(D).
Subsec. (b)(4)(E).
Subsec. (b)(4)(G).
Subsec. (b)(4)(J).
Subsec. (g).
2019—Subsec. (b).
Subsec. (b)(4)(D).
Subsec. (b)(4)(I).
Subsec. (b)(5).
Subsec. (b)(7).
Subsec. (b)(7)(A)(iii) to (v).
Subsec. (b)(7)(D) to (F).
Subsec. (d)(1).
Subsec. (d)(2)(C).
Subsec. (d)(2)(J)(v).
Subsec. (f).
2016—Subsec. (b)(7).
Subsec. (b)(7)(D).
Subsec. (b)(7)(E).
2013—Subsec. (b)(3).
Subsec. (b)(4)(D) to (H).
Subsec. (b)(7).
Subsec. (c).
Subsecs. (d), (e).
Statutory Notes and Related Subsidiaries
Transfer of Functions
"(1)
"(2)
Interagency Coordination Plan
"(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
(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
(D) Provide consultation for the development of the strategy and implementation plan under
(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
Editorial Notes
Prior Provisions
A prior section 300hh–10a, act July 1, 1944, ch. 373, title XXVIII, §2811A, as added
Amendments
2022—Subsec. (a).
Subsec. (b)(10), (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
(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
(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
(g) Sunset
The Advisory Committee shall terminate on December 31, 2024.
(July 1, 1944, ch. 373, title XXVIII, §2811A, as added
Editorial Notes
Codification
Section was formerly classified to
Amendments
2024—Subsec. (g).
2023—Subsec. (g).
2022—Subsec. (b)(2).
Subsec. (b)(4).
Subsec. (d)(2)(D), (E).
Subsec. (d)(2)(E)(ii) to (iv).
2019—Subsec. (b)(2).
Subsec. (d)(1).
Subsec. (d)(2) to (5).
Subsec. (e).
Subsec. (f).
Subsec. (g).
§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
(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
(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
(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
Editorial Notes
Amendments
2024—Subsec. (g)(1).
2023—Subsec. (g)(1).
§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
(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
(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
(f) Coordination
The Secretary shall coordinate duties and activities authorized under this section in accordance with
(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
Editorial Notes
Amendments
2024—Subsec. (g)(1).
2023—Subsec. (g)(1).
§300hh–10e. Advisory Committee Coordination
(a) In general
The Secretary shall coordinate duties and activities authorized under
(b) Coordination and alignment
The Secretary, acting through the employee designated pursuant to
(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
§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
(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
(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
(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
(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
(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
(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
(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
(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
(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
(July 1, 1944, ch. 373, title XXVIII, §2812, formerly §2811, as added
Editorial Notes
References in Text
The Omnibus Crime Control and Safe Streets Act of 1968, referred to in subsec. (c)(5), is
Codification
Subsec. (c)(5) of this section was omitted in light of section 301(d)(3) of
Amendments
2024—Subsec. (c)(4)(B).
2023—Subsec. (c)(4)(B).
2022—Subsec. (c)(4)(B).
2021—Subsec. (c)(4)(B).
2019—Subsec. (a)(3)(A)(ii).
Subsec. (b)(2).
Subsec. (c)(3), (4).
Subsec. (c)(5).
Subsec. (g).
2015—Subsec. (d)(2).
2013—Subsec. (a)(3)(A)(i).
Subsec. (a)(3)(C) to (E).
Subsec. (g).
2006—
Subsec. (a).
Subsec. (a)(2)(B).
Subsec. (a)(3)(C).
Subsec. (b).
Subsec. (b)(1).
Subsec. (b)(3)(A).
Subsec. (c).
Subsec. (c)(2).
Subsec. (d).
Subsec. (d)(2).
Subsec. (e).
Subsec. (e)(2), (3)(A).
Subsec. (f).
Subsec. (g).
Subsec. (h).
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
Termination Date of 2019 Amendment
Amendment by section 301(d)(1) of
Transfer of Functions
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
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,
§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.
(
Editorial Notes
References in Text
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
(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 (
(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.
(
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
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
(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
(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
Editorial Notes
Amendments
2019—Subsec. (a).
Subsec. (i).
2013—Subsec. (d)(2).
Subsec. (i).
§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
(2) oversee the implementation of the preparedness goals described in
(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
(5) ensure that the contents of the strategic national stockpile take into account at-risk populations as described in
(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
(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
(July 1, 1944, ch. 373, title XXVIII, §2814, as added
Editorial Notes
Amendments
2019—Par. (9).
2013—Par. (1).
Par. (2).
Par. (3).
Par. (4).
Par. (5).
Pars. (7), (8).
"(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
(2) encourage employees at health centers funded under
(July 1, 1944, ch. 373, title XXVIII, §2815, as added
1 So in original. Probably should be preceded by "the".
Part C—Strengthening Public Health Surveillance Systems
§300hh–31. Epidemiology-laboratory capacity grants
(a) In general
Subject to the availability of appropriations, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish an Epidemiology and Laboratory Capacity Grant Program to award grants to State health departments as well as local health departments and tribal jurisdictions that meet such criteria as the Director determines appropriate. Academic centers that assist State and eligible local and tribal health departments may also be eligible for funding under this section as the Director determines appropriate. Grants shall be awarded under this section to assist public health agencies in improving surveillance for, and response to, infectious diseases and other conditions of public health importance by—
(1) strengthening epidemiologic capacity to identify and monitor the occurrence of infectious diseases, including mosquito and other vector-borne diseases, and other conditions of public health importance;
(2) enhancing laboratory practice as well as systems to report test orders and results electronically;
(3) improving information systems including developing and maintaining an information exchange using national guidelines and complying with capacities and functions determined by an advisory council established and appointed by the Director; and
(4) developing and implementing prevention and control strategies.
(b) Authorization of appropriations
There are authorized to be appropriated to carry out this section $190,000,000 for each of fiscal years 2019 through 2023, of which—
(1) not less than $95,000,000 shall be made available each such fiscal year for activities under paragraphs (1) and (4) of subsection (a);
(2) not less than $60,000,000 shall be made available each such fiscal year for activities under subsection (a)(3); and
(3) not less than $32,000,000 shall be made available each such fiscal year for activities under subsection (a)(2).
(July 1, 1944, ch. 373, title XXVIII, §2821, as added
Editorial Notes
Amendments
2019—Subsec. (a)(1).
Subsec. (b).
§300hh–32. Enhanced support to assist health departments in addressing vector-borne diseases
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may enter into cooperative agreements with health departments of States, political subdivisions of States, and Indian Tribes and Tribal organizations in areas at high risk of vector-borne diseases in order to increase capacity to identify, report, prevent, and respond to such diseases and related outbreaks.
(b) Eligibility
To be eligible to enter into a cooperative agreement under this section, an entity described in subsection (a) shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a plan that describes—
(1) how the applicant proposes to develop or expand programs to address vector-borne disease risks, including through—
(A) related training and workforce development;
(B) programmatic efforts to improve capacity to identify, report, prevent, and respond to such disease and related outbreaks; and
(C) other relevant activities identified by the Director of the Centers for Disease Control and Prevention, as appropriate;
(2) the manner in which the applicant will coordinate with other Federal, Tribal, and State agencies and programs, as applicable, related to vector-borne diseases, as well as other relevant public and private organizations or agencies; and
(3) the manner in which the applicant will evaluate the effectiveness of any program carried out under the cooperative agreement.
(c) Authorization of appropriations
For the purposes of carrying out this section, there are authorized to be appropriated $20,000,000 for each of fiscal years 2021 through 2025.
(July 1, 1944, ch. 373, title XXVIII, §2822, as added
§300hh–33. Public health data system modernization
(a) Expanding CDC and public health department capabilities
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
(A) conduct activities to expand, modernize, improve, and sustain applicable public health data systems used by the Centers for Disease Control and Prevention, including with respect to the interoperability and improvement of such systems (including as it relates to preparedness for, prevention and detection of, and response to public health emergencies); and
(B) award grants or cooperative agreements to State, local, Tribal, or territorial public health departments for the expansion and modernization of public health data systems, to assist public health departments and public health laboratories in—
(i) assessing current data infrastructure capabilities and gaps to—
(I) improve and increase consistency in data collection, storage, and analysis; and
(II) as appropriate, improve dissemination of public health-related information;
(ii) improving secure public health data collection, transmission, exchange, maintenance, and analysis, including with respect to demographic data, as appropriate;
(iii) improving the secure exchange of data between the Centers for Disease Control and Prevention, State, local, Tribal, and territorial public health departments, public health laboratories, public health organizations, and health care providers, including by public health officials in multiple jurisdictions within such State, as appropriate, and by simplifying and supporting reporting by health care providers, as applicable, pursuant to State law, including through the use of health information technology;
(iv) enhancing the interoperability of public health data systems (including systems created or accessed by public health departments) with health information technology, including with health information technology certified under
(v) supporting and training data systems, data science, and informatics personnel;
(vi) supporting earlier disease and health condition detection, such as through near real-time data monitoring, to support rapid public health responses;
(vii) supporting activities within the applicable jurisdiction related to the expansion and modernization of electronic case reporting; and
(viii) developing and disseminating information related to the use and importance of public health data.
(2) Data standards
(A) In general
In carrying out paragraph (1), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, not later than 2 years after December 29, 2022, in consultation with the Office of the National Coordinator for Health Information Technology, designate data and technology standards (including standards for interoperability) for public health data systems, with deference given to standards published by consensus-based standards development organizations with public input and voluntary consensus-based standards bodies.
(B) No duplicative efforts
(i) In general
In carrying out the requirements of this paragraph, the Secretary, in consultation with the Office of the National Coordinator for Health Information Technology, may use input gathered (including input and recommendations gathered from the Health Information Technology Advisory Committee), and materials developed, prior to December 29, 2022.
(ii) Designation of standards
Consistent with
(C) Privacy and security
Nothing in this paragraph shall be construed as modifying applicable Federal or State information privacy or security law.
(3) Public-private partnerships
The Secretary may develop and utilize public-private partnerships for technical assistance, training, and related implementation support for State, local, Tribal, and territorial public health departments, and the Centers for Disease Control and Prevention, on the expansion and modernization of electronic case reporting and public health data systems, as applicable.
(b) Requirements
(1) Health information technology standards
The Secretary may not award a grant or cooperative agreement under subsection (a)(1)(B) unless the applicant uses or agrees to use standards endorsed by the National Coordinator for Health Information Technology pursuant to
(2) Waiver
The Secretary may waive the requirement under paragraph (1) with respect to an applicant if the Secretary determines that the activities under subsection (a)(1)(B) cannot otherwise be carried out within the applicable jurisdiction.
(3) Application
A State, local, Tribal, or territorial health department applying for a grant or cooperative agreement under this section shall submit an application to the Secretary at such time and in such manner as the Secretary may require. Such application shall include information describing—
(A) the activities that will be supported by the grant or cooperative agreement; and
(B) how the modernization of the public health data systems involved will support or impact the public health infrastructure of the health department, including a description of remaining gaps, if any, and the actions needed to address such gaps.
(c) Strategy and implementation plan
Not later than 180 days after December 27, 2020, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a coordinated strategy and an accompanying implementation plan that identifies and demonstrates the measures the Secretary will utilize to—
(1) update and improve applicable public health data systems used by the Centers for Disease Control and Prevention; and
(2) carry out the activities described in this section to support the improvement of State, local, Tribal, and territorial public health data systems.
(d) Consultation
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall consult with State, local, Tribal, and territorial health departments, professional medical and public health associations, associations representing hospitals or other health care entities, health information technology experts, and other appropriate public or private entities regarding the plan and grant program to modernize public health data systems pursuant to this section. Activities under this subsection may include the provision of technical assistance and training related to the exchange of information by such public health data systems used by relevant health care and public health entities at the local, State, Federal, Tribal, and territorial levels, and the development and utilization of public-private partnerships for implementation support applicable to this section.
(e) Report to Congress
Not later than 1 year after December 27, 2020, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—
(1) a description of any barriers to—
(A) public health authorities implementing interoperable public health data systems and electronic case reporting;
(B) the exchange of information pursuant to electronic case reporting;
(C) reporting by health care providers using such public health data systems, as appropriate, and pursuant to State law; or
(D) improving demographic data collection or analysis;
(2) an assessment of the potential public health impact of implementing electronic case reporting and interoperable public health data systems; and
(3) a description of the activities carried out pursuant to this section.
(f) Electronic case reporting
In this section, the term "electronic case reporting" means the automated identification, generation, and bilateral exchange of reports of health events among electronic health record or health information technology systems and public health authorities.
(g) Authorization of appropriations
To carry out this section, there are authorized to be appropriated $100,000,000 for each of fiscal years 2021 through 2025.
(July 1, 1944, ch. 373, title XXVIII, §2823, as added
Editorial Notes
Amendments
2022—Subsec. (a)(2).
Statutory Notes and Related Subsidiaries
Improving State, Local, and Tribal Public Health Data
"(1)
"(2)
"(A) be a health care provider, academic medical center, community-based organization, State, local governmental entity, Indian Tribe or Tribal organization (as such terms are defined in section 4 of the Indian Self Determination and Education Assistance Act (
"(B) submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
"(3)
"(A) improving, understanding, and using data standards and implementation specifications;
"(B) developing or identifying methods to improve communication with patients in a culturally- and linguistically-appropriate manner, including to better capture information related to demographics of such individuals;
"(C) developing methods for accurately categorizing and recording patient responses using available data standards;
"(D) educating providers regarding the utility of such information for public health purposes and the importance of accurate collection and recording of such data; and
"(E) providing information regarding how data will be deidentified if used for such public health purposes, as applicable and appropriate.
"(4)
"(A)
"(B)
"(5)
§300hh–34. Genomic sequencing, analytics, and public health surveillance of pathogens program
(a) Genomic sequencing, analytics, and public health surveillance of pathogens program
The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Director of the National Institutes of Health and heads of other departments and agencies, as appropriate, shall strengthen and expand activities related to genomic sequencing of pathogens, including through new and innovative approaches and technology for the detection, characterization, and sequencing of pathogens, analytics, and public health surveillance, including—
(1) continuing and expanding activities, which may include existing genomic sequencing activities related to advanced molecular detection, to—
(A) identify and respond to emerging infectious disease threats; and
(B) identify the potential use of genomic sequencing technologies, advanced computing, and other advanced technology to inform surveillance activities and incorporate the use of such technologies, as appropriate, into related activities;
(2) providing technical assistance and guidance to State, Tribal, local, and territorial public health departments to increase the capacity of such departments to perform genomic sequencing of pathogens, including recipients of funding under
(3) carrying out activities to enhance the capabilities of the public health workforce with respect to pathogen genomics, epidemiology, and bioinformatics, including through training; and
(4) continuing and expanding activities, as applicable, with public and private entities, including relevant departments and agencies, laboratories, academic institutions, and industry.
(b) Partnerships
For the purposes of carrying out the activities described in subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants, contracts, or cooperative agreements to entities, including academic and other laboratories, with expertise in genomic sequencing for public health purposes, including new and innovative approaches to, and related technology for, the detection, characterization, and sequencing of pathogens.
(c) Centers of excellence
(1) In general
The Secretary shall, as appropriate, award grants, contracts, or cooperative agreements to public health agencies for the establishment or operation of centers of excellence to promote innovation in pathogen genomics and molecular epidemiology to improve the control of and response to pathogens that may cause a public health emergency. Such centers shall, as appropriate—
(A) identify and evaluate the use of genomics, or other related technologies that may advance public health preparedness and response;
(B) improve the identification, development, and use of tools for integrating and analyzing genomic and epidemiologic data;
(C) assist with genomic surveillance of, and response to, infectious diseases, including analysis of pathogen genomic data;
(D) conduct applied research to improve public health surveillance of, and response to, infectious diseases through innovation in pathogen genomics and molecular epidemiology; and
(E) develop and provide training materials for experts in the fields of genomics, microbiology, bioinformatics, epidemiology, and other fields, as appropriate.
(2) Requirements
To be eligible for an award under paragraph (1), an entity shall submit to the Secretary an application containing such information as the Secretary may require, including a description of how the entity will partner, as applicable, with academic institutions or a consortium of academic partners that have relevant expertise, such as microbial genomics, molecular epidemiology, or the application of bioinformatics or statistics.
(July 1, 1944, ch. 373, title XXVIII, §2824, as added
Statutory Notes and Related Subsidiaries
Guidance Supporting Genomic Sequencing of Pathogens Collaboration
§300hh–35. Epidemic forecasting and outbreak analytics
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall continue activities related to the development of infectious disease outbreak analysis capabilities to enhance the prediction, modeling, and forecasting of potential public health emergencies and other infectious disease outbreaks, which may include activities to support preparedness for, and response to, such emergencies and outbreaks. In carrying out this subsection, the Secretary shall identify strategies to include and leverage, as appropriate, the capabilities to public and private entities, which may include conducting such activities through collaborative partnerships with public and private entities, including academic institutions, and other Federal agencies, consistent with
(b) Considerations
In carrying out subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may consider public health data and, as appropriate, other data sources related to preparedness for, or response to, public health emergencies and infectious disease outbreaks.
(c) Annual reports
Not later than 1 year after December 29, 2022, and annually thereafter for each of the subsequent 4 years, the Secretary shall prepare and submit a report, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, regarding an update on progress on activities conducted under this section to develop infectious disease outbreak analysis capabilities and any additional information relevant to such efforts.
(July 1, 1944, ch. 373, title XXVIII, §2825, as added
§300hh–36. Leadership exchange pilot for public health and medical preparedness and response positions at the Department of Health and Human Services
(a) In general
The Secretary may, not later than 1 year after December 29, 2022, establish a voluntary program to provide additional training to individuals in eligible positions, as described in subsection (c), to support the continuous professional development of such individuals.
(b) Criteria
(1) Duration
The program under subsection (a) shall provide for fellowships, details, or other relevant placements with Federal agencies or departments, or State or local health departments, pursuant to the guidance issued under paragraph (2), for a maximum period of 2 years.
(2) Guidance
The Secretary shall issue guidance establishing criteria for identifying placements that demonstrate ongoing sufficient mastery of knowledge, skills, and abilities to satisfy the field experience criteria under the program established under subsection (a), including assignments and experiences that develop public health and medical preparedness and response expertise.
(c) Eligible position
For purposes of subsection (a), the term "eligible position" means any position at the Department of Health and Human Services at or above grade GS–13 of the General Schedule, or the equivalent, for which not less than 50 percent of the time of such position is spent on activities related to public health preparedness or response.
(d) Pilot period and final report
The pilot program authorized under this section shall not exceed 5 years. Not later than 90 days after the end of the program, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—
(1) the number of individuals who participated in such pilot, as applicable;
(2) a description of the professional growth experience in which individuals participated; and
(3) an assessment of the outcomes of such program, including a recommendation on whether such program should be continued.
(July 1, 1944, ch. 373, title XXVIII, §2826, as added
Editorial Notes
References in Text
The General Schedule, referred to in subsec. (c), is set out under
§300hh–37. One Health framework
(a) One Health framework
The Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Director of the Centers for Disease Control and Prevention, shall develop, or update as appropriate, in coordination with other Federal departments and agencies, as appropriate, a One Health framework to address zoonotic diseases and advance public health preparedness.
(b) One Health coordination
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall coordinate with the Secretary of Agriculture and the Secretary of the Interior to develop a One Health coordination mechanism at the Federal level to strengthen One Health collaboration related to prevention, detection, control, and response for zoonotic diseases and related One Health work across the Federal Government.
(c) Reporting
Not later than 1 year after December 29, 2022, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report providing an update on the activities under subsections (a) and (b).
(
Editorial Notes
Codification
Section was enacted as part of the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act, also known as the PREVENT Pandemics Act, and also as part of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022, and not as part of the Public Health Service Act which comprises this chapter.