§6627 — Title 42 The Public Health and Welfare | U.S. Code

Summary

The head of the Office of Science and Technology Policy (the Director) must work with other federal agencies to review and set a single federal policy by December 29, 2023 for deciding which federally funded research needs extra oversight when it could reasonably be expected to create, move, or use lab-altered germs that might cause a pandemic. That policy must be reviewed and updated at least every 4 years. The policy must say which projects are covered, spell out a review process that looks at safety, security, and ethics, make non-sensitive information more public without harming security or private data, and require consistent steps across agencies to find projects that need review, watch awarded projects (including sub-awards) for compliance, and catch unexpected results that produce such risky germs. The Director must tell agencies to update their guidance and keep their rules in line with the federal policy. These reviews are in addition to other reviews required under the Public Health Service Act. Within 60 days after December 29, 2022, the Secretary of Health and Human Services must not fund research done by a foreign entity at a facility in a country of concern (as identified by the Director of National Intelligence or another relevant agency) if it involves pathogens that could cause a pandemic or agents listed in section 351A(a)(1) of the Public Health Service Act. That funding ban can only be lifted after the review above is finished and after HHS notifies Congress at least 15 days before lifting the ban.

Title 42, §6627

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

(a)(1)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)not later than 1 year after December 29, 2022—

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

(b)(1)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)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)(1)Beginning not later than 60 days after December 29, 2022, 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 (42 U.S.C. 262a(a)(1)).

(2)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.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (a)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, 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 section 201 of this title 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.

§6627 Federally-funded research with enhanced pathogens of pandemic potential