42 U.S.C. § 300hh–3: Office of Pandemic…

Summary

Creates an Office of Pandemic Preparedness and Response Policy inside the Executive Office of the President. The President must appoint a Director paid at Executive Schedule level II and may appoint up to 2 Associate Directors paid at no more than level III. The Director must advise the President on pandemic and other biological threats to national security and coordinate federal preparedness and response. That includes giving strategic direction to federal agencies, clarifying roles, tracking performance, leading or co-leading medical countermeasure research and procurement efforts (including co-chairing the Public Health Emergency Medical Countermeasures Enterprise with HHS), overseeing supply production and distribution, running drills and after-action reviews, promoting federal expertise, encouraging public-private partnerships and new technologies, working with OMB, NSC, and OSTP, and assessing international cooperation. Federal agencies must give the Director needed information. The Director also sits on the Domestic Policy Council and the National Security Council, may consult state, local, Tribal, and private stakeholders, and may hold hearings. Within one year of starting operations the Director must produce a public report for the President identifying issues to watch over the next 5 years and barriers and opportunities for medical countermeasures, and update it at least every 5 years. The Director must lead a regular interagency working group with HHS, DHS, DOD, OMB, and others. If a federal response begins, an Industry Liaison must be named within 10 days and, within 20 days, identify affected industries and set up regular communication. The Director can hire up to 25 staff, use consultants (pay up to Executive Schedule level IV), and reassign federal employees with agency agreement. By 1 year after December 29, 2022, the Director must review federal strategies and reports for gaps, and by 18 months after December 29, 2022, and every 2 years after, send Congress and the President a report covering current risks, roles, review findings, barriers, planned fixes, workforce actions, and tech opportunities. The Director must avoid needless duplication of other federal efforts.

Title 42, §300hh–3

The Public Health and Welfare, Source: USLM XML via OLRC

(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 section 5313 of title 5. The President is authorized to appoint not more than 2 Associate Directors, who shall be compensated at a rate not to exceed that provided for level III of the Executive Schedule in section 5314 of such title. Associate Directors shall perform such functions as the Director may prescribe.

(b)Functions of the Director (c) Support from other agencies

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 section 104 of title 6 and section 105 of title 6;

(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 section 300hh–10a of this title;

(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.

(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 (h) Staffing and detailees

The Director, in addition to the other duties and functions set forth in this section— (1)

(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.

(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.

Notes & Related Subsidiaries

Editorial Notes

References in Text

Level IV of the Executive Schedule, referred to in subsec. (h)(3), is set out in section 5315 of Title 5, Government Organization and Employees. 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 Pub. L. 117–328. Subsec. (k) of section 2104 of div. FF of Pub. L. 117–328 amended section 300hh–10a, 6614, and 6651 of this title and section 3021 of Title 50, War and National Defense.

Executive Documents

Ex. Ord. No. 14122. COVID–19 and Public Health Preparedness and Response Ex. Ord. No. 14122, Apr. 12, 2024, 89 F.R. 27355, provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: section 1. Policy. The Office of Pandemic Preparedness and Response Policy (OPPR), established by the Congress in December 2022 under section 2104 of Public Law 117—328 [42 U.S.C. 300hh–3], is playing a critical role in the Federal Government’s pandemic preparedness efforts. The OPPR is providing 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. The OPPR is also supporting my Administration’s continued work to address COVID–19 and other public health threats, facilitating coordination and communication among executive departments and agencies to ensure that the United States can quickly detect, identify, and respond to such threats as necessary. At this stage of my Administration’s response to COVID–19, I have determined that certain Executive Orders are no longer necessary and that certain roles and responsibilities established by other Executive Orders related to COVID–19 should be transferred to the OPPR. Sec. 2. Revocations. Executive Order 13910 of

March 23, 2020 (Preventing Hoarding of Health and Medical Resources to Respond to the Spread of COVID–19) [50 U.S.C. 4512 note], Executive Order 13991 of

January 20, 2021 (Protecting the Federal Workforce and Requiring Mask-Wearing) [42 U.S.C. 247d note], and Executive Order 13998 of

January 21, 2021 (Promoting COVID–19 Safety in Domestic and International Travel) [42 U.S.C. 247d note], are hereby revoked. Sec. 3. Transfer of Responsibilities. Responsibilities and duties of the Coordinator of the COVID–19 Response and Counselor to the President (COVID–19 Response Coordinator), including responsibilities and duties specified in Executive Order 13987 of

January 20, 2021 (Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID–19 and to Provide United States Leadership on Global Health and Security), Executive Order 13994 of

January 21, 2021 (Ensuring a Data-Driven Response to COVID–19 and Future High-Consequence Public Health Threats), and Executive Order 13996 of

January 21, 2021 (Establishing the COVID–19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID–19 and Other Biological Threats) [42 U.S.C. 247d notes], are transferred to the Director of the OPPR. The positions of COVID–19 Response Coordinator and Deputy Coordinator of the COVID–19 Response, as established by section 2 of Executive Order 13987, are hereby terminated. Sec. 4. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive department or agency, or the head thereof; or (ii) the 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. J.R. Biden, Jr.

§300hh–3 Office of Pandemic Preparedness and Response Policy