42 U.S.C. § 300hh–10a: Public Health Emergency…

Summary

Create the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to advise the Secretary on medical countermeasures. The Assistant Secretary for Preparedness and Response and the Director of the Office of Pandemic Preparedness and Response Policy must co‑chair it. Members include those agency leaders or their designees from HHS (CDC, NIH, FDA), Defense, Homeland Security, Agriculture, Veterans Affairs, the Director of National Intelligence, and other federal agencies such as BARDA, the Strategic National Stockpile, NIAID, and public health preparedness offices as the Secretary chooses. PHEMCE must recommend research, development, buying, stockpiling, moving, sharing, and use of countermeasures and set priorities based on national health security. Those recommendations should use the National Health Security Strategy, stockpile needs, and threat assessments (including chemical, biological, radiological, nuclear, and new infectious diseases) when available. If members disagree, the Secretary decides. PHEMCE must also spot gaps and regulatory problems, help plan logistics and use of countermeasures, advise on the strategy and implementation plan, and get input from state, local, Tribal, and territorial public health officials.

Title 42, §300hh–10a

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

(a)In general

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

(b)Members

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

(1)The Assistant Secretary for Preparedness and Response.

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

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

(4)The Commissioner of Food and Drugs.

(5)The Secretary of Defense.

(6)The Secretary of Homeland Security.

(7)The Secretary of Agriculture.

(8)The Secretary of Veterans Affairs.

(9)The Director of National Intelligence.

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

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

(c)Functions

(1)In general

The functions of the PHEMCE shall include the following:

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

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

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

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

(2)Input

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

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

A prior section 300hh–10a, act

July 1, 1944, ch. 373, title XXVIII, § 2811A, as added Pub. L. 113–5, title I, § 103, Mar. 13, 2013, 127 Stat. 168; amended Pub. L. 116–22, title III, § 305(a),

June 24, 2019, 133 Stat. 936, which related to the National Advisory Committee on Children and Disasters, was transferred to section 300hh–10b of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–328, § 2104(k)(1)(A), substituted “and the Director of the Office of Pandemic Preparedness and Response Policy shall serve as co-chairs” for “shall serve as chair”. Subsec. (b)(10), (11). Pub. L. 117–328, § 2104(k)(1)(B), added par. (10) and redesignated former par. (10) as (11).

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