Notice Number: NOT-OD-17-071
Key Dates
Release Date: December 19, 2017
NOT-OD-15-011
Issued by
National Institutes of Health (NIH)
Purpose
The purpose of this Guide Notice is to notify applicants that in accordance with the December 2017 issuance of the Department of Health and Human Services "HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework), the National Institutes of Health is removing the funding pause on the provision of new or continuation funding for gain-of-function research projects.
Background
On October 17, 2014, the U.S. Government announced that it would be instituting a funding pause on gain-of-function research projects that could be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the resulting virus has enhanced pathogenicity and/or transmissibility (via the respiratory route) in mammals. During the funding pause, the U.S. Government undertook a deliberative process to assess the potential benefits and risks associated with these types of studies. Completion of the deliberative process resulted in the Department of Health and Human Services issuing the HHS P3CO Framework on December 19, 2017. The HHS P3CO Framework is responsive to and in accordance with the "Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight" issued on January 9, 2017 and supersedes the previous "Framework for Guiding U.S. Department of Health and Human Services Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets.
The HHS P3CO Framework is intended to guide agency funding decisions on proposed research that is reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens (PPPs). A PPP is any pathogen that satisfies both of the following:
It is likely highly transmissible and likely capable of wide and uncontrollable spread in human populations; and
It is likely highly virulent and likely to cause significant morbidity and/or mortality in humans.
An enhanced PPP is defined as a PPP resulting from the enhancement of the transmissibility and/or virulence of a pathogen.
The HHS P3CO Framework ensures a multidisciplinary, department-level pre-funding review and evaluation of proposed research meeting the scope of the framework. The HHS P3CO Framework can be viewed HERE.
Impact
The HHS P3CO Framework impacts research with any pathogen that meets the definition of enhanced PPP. NIH will continue to accept applications for research projects including studies that are reasonably anticipated to create, transfer or use enhanced PPPs. As described in the background section of this Guide Notice, NIH will identify meritorious research applications meeting the scope of the HHS P3CO Framework for a multidisciplinary, department-level review prior to any funding decision.
If a Scientific Review Group (SRG) identifies research that may create, transfer, or use enhanced PPPs as described above, the Scientific Review Officer will record this as an administrative note and instruct the SRG members that the presence of such research in the application will not affect their impact scores. Following completion of the SRG review, Program officials will review all proposed research being considered for funding to determine if the research meets the scope of the HHS P3CO Framework, and if it does, will work with the applicant, institution, and funding agency staff, as appropriate, to comply with the HHS P3CO Framework.Inquiries
Please direct all inquiries to the Program Official that is listed in the Funding Opportunity Announcement or the Notice of Award under the Contacts Section.
and Human Services (HHS)
