42 U.S.C. § 6627 | Federally-funded research with enhanced pathogens of pandemic potential

(a)

Review and oversight of enhanced pathogens of pandemic potential

(1)

In general

The Director of the Office of Science and Technology Policy (referred to in this section as the “Director”), in consultation with the heads of relevant Federal departments and agencies, shall—

(A)

December 29, 2022 not later than 1 year after —

(i)

continue or conduct a review of existing Federal policies related to research proposed for Federal funding that may be reasonably anticipated to involve the creation, transfer, or use of enhanced pathogens of pandemic potential; and

(ii)

establish or update a Federal policy for the consistent review and oversight of such proposed research that appropriately considers the risks associated with, and potential benefits of, such research; and

(B)

not less than every 4 years thereafter, review and update such policy, as necessary and appropriate, to ensure that such policy fully accounts for relevant research that may be reasonably anticipated to involve the creation, transfer, or use of enhanced pathogens of pandemic potential, takes into consideration the benefits of such research, and supports the mitigation of related risks.

(2)

Requirements

The policy established pursuant to paragraph (1) shall include—

(A)

a clear scope to support the consistent identification of research proposals subject to such policy by relevant Federal departments and agencies;

(B)

a framework for such reviews that accounts for safety, security, and ethical considerations related to the creation, transfer, or use of enhanced pathogens of pandemic potential;

(C)

measures to enhance the transparency and public availability of information related to such research activities in a manner that does not compromise national security, the safety and security of such research activities, or any identifiable, sensitive information of relevant individuals; and

(D)

consistent procedures across relevant Federal department and agencies to ensure that—

(i)

proposed research that has been determined to have scientific and technical merit and may be subject to such policy is identified and referred for review;

(ii)

subjected research activities conducted under an award, including activities undertaken by any subrecipients of such award, are monitored regularly throughout the project period to ensure compliance with such policy and the terms and conditions of such award; and

(iii)

in the event that federally-funded research activities not subject to such policy produce unanticipated results related to the creation, transfer, or use of enhanced pathogens of pandemic potential, such research activities are identified and appropriately reviewed under such policy.

(3)

Clarification

42 U.S.C. 201 42 U.S.C. 289aReviews required pursuant to this section shall be in addition to any applicable requirements for research project applications required under the Public Health Service Act [ et seq.], including reviews required under section 492 of such Act (), as applicable, or other applicable laws.

(b)

Implementation

(1)

In general

The Director shall direct all heads of relevant Federal departments and agencies to update, modernize, or promulgate applicable implementing guidance to implement the requirements of this section.

(2)

Updates

Consistent with the requirements under subsection (a)(1)(B), the Director shall require all heads of relevant Federal departments and agencies to update such policies consistent with any changes to the policy established pursuant to subsection (a)(1).

(c)

Limitations on countries of concern conducting certain research

(1)

In general

December 29, 202242 U.S.C. 262a(a)(1)Beginning not later than 60 days after , the Secretary of Health and Human Services shall not fund research conducted by a foreign entity at a facility located in a country of concern, in the estimation of the Director of National Intelligence or the head of another relevant Federal department or agency, as appropriate, in consultation with the Secretary of Health and Human Services, involving pathogens of pandemic potential or biological agents or toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act ().

(2)

Conditions for lifting or suspending prohibition

The Secretary of Health and Human Services may lift or suspend the prohibition of funding under paragraph (1)—

(A)

only after the review required under subsection (a)(1)(A)(i) is complete; and

(B)

only if the Secretary notifies Congress not less than 15 days before such prohibition is lifted or suspended.

Pub. L. 117–328, div. FF, title II, § 2315Dec. 29, 2022136 Stat. 5763(, , .)

Editorial Notes

References in Text

act July 1, 1944, ch. 373 58 Stat. 682 section 201 of this titleThe Public Health Service Act, referred to in subsec. (a)(3), is , , which is classified generally to chapter 6A (§ 201 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under and Tables.

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 National Science and Technology Policy, Organization, and Priorities Act of 1976 which comprises this chapter.