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NOT-OD-20-173 - Notice of Limited Availability of Research Non-human Primates (RESCINDED)

Issued by

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Purpose

This notice informs biomedical and behavioral scientists who are currently conducting or planning to conduct COVID-19 research studies involving non-human primate (NHP) species housed at the ORIP-supported National Primate Research Centers (P51) or P40 facilities that the criteria used by the NIH COVID-19 Expert Panel to provide programmatic priority recommendations are being updated to reflect the current state of the COVID-19 pandemic. Access to and availability of NHPs continues to be limited and specific procedures are in place to prioritize requests and minimize impact of the shortage.

Background

On March 13, 2020, the President declared the ongoing Coronavirus Disease 2019 (COVID-19) pandemic a national emergency for all states, tribes, territories, and the District of Columbia [pursuant to section 501 (b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act”)]. Under this emergency, public health officials may take protective measures to respond to the COVID-19 pandemic.

Nonhuman primates (NHPs) serve as critical animal models for several research areas during this pandemic. The demand for NIH-supported NHPs and access to biocontainment facilities is expected to escalate as researchers around the country seek to investigate COVID-19 pathology, treatments, and preventions using these models. With limited resources, there is a need to implement strategies to ensure the safe and effective use of biomedical research resources to urgently deliver outputs that will improve public health. The NIH is addressing this increased demand by coordinating and streamlining research processes.

All requestors from the biomedical research community seeking to utilize National Primate Research Center (NPRC) or ORIP-supported resources for COVID-19 studies must submit the information requested in the COVID-19 NHP Study Information Portal so that the urgency of the proposed research and its timeline for potential impact on public health can be assessed by the NIH COVID-19 Expert Panel (the “Expert Panel”). The NIH is only collecting information on studies that have secured a source of funding, whether that be from a government, private, or other source. The Expert Panel is composed of federal NIH staff with expertise in virology, immunology, therapeutic and vaccine development, NHP models, and other highly relevant subject matter areas. The Expert Panel will provide a programmatic recommendation to the NIH Office of Research Infrastructure Programs (NIH/ORIP), which provides funding and programmatic oversight of the NPRCs and NHP facilities, on the urgency for a study to be conducted and the timeline for public health impact of each study. The NIH/ORIP will then convey those recommendations to the Research Advisory Committee at each NPRC or the NHP Facility Director. All information submitted via the portal will be treated as confidential and proprietary to the submitter and will not be shared outside of NIH.

The highest programmatic priority was initially given to studies “urgently required to save human lives or shorten the COVID-19 pandemic.” The course of the pandemic, the development and authorization of vaccines and treatments, and the demand for and supply of non-human primates (NHPs) have continued to evolve. The NIH is updating the prioritization criteria to retain research urgently required to save lives but also to serve a long-term research strategy for a better understanding of disease pathology including post-acute COVID-19 sequalae, developing additional and novel prevention measures and treatments, and validating new NHP models that address knowledge gaps in current models.

Effective immediately, the NIH COVID-19 Expert Panel will use the following criteria to make their programmatic priority recommendations:

• Extent to which the proposed study addresses an urgent, unmet need in the pandemic, as identified by the Expert Panel and guided by NIH program priorities related to COVID-19, which evolve over time (see https://covid19.nih.gov/funding/open-funding-opportunities)
• Extent to which the proposed study is required for the development of a novel treatment, preventative measure, or platform technology
• Extent to which the proposed study seeks to uncover a critical aspect of disease pathology or virus biology that is likely to inform treatment or prevention development
• Extent to which the proposed study intends to validate a new NHP model of COVID-19 to address limitations or knowledge gaps with current NHP models or to relieve demand on current models

Inquiries

Please direct all inquiries to:

[email protected]