Questions and Answers for PAR-21-276, Limited Competition Emergency Awards, Shared Personal Protective Equipment (PPE) Resources for COVID-19 Related Vaccine and Treatment Clinical Trials and Clinical Studies (S10 Clinical Trial Not Allowed)

NIH published this funding opportunity announcement (FOA) in a July 16, 2021 Guide announcement.

Table of Contents

Questions and Answers

Our institution is already funded by NIAID to conduct COVID-19 related research. Why do we have to write another grant application to purchase personal protective equipment (PPE) to conduct this research?

According to NIH policy (NOT-OD-20-164), PPE expenses totaling $500,000 direct cost or less in a budget period can be charged as a direct cost as long as charges align with the institution’s negotiated F&A rate agreement. 

However, this S10 funding opportunity announcement (FOA) PAR-21-276 is the only option currently approved by the NIH Office of Extramural Research to allow for the purchase of PPE totaling more than $500,000 direct cost in a budget period. 

This PPE is for use by researchers, physicians, nurses, and other staff supported by the award who could be in contact with study participants and any samples (e.g., blood, fluids, tissues) taken from those participants.  

You may also provide PPE to trial and study participants who are enrolled in the specific trial or study supported by the grant. 

You may not provide PPE supported by this award to anyone other than the staff and participants listed above.

How do I know if my institution is eligible to apply to this program?

Any U.S. institution that is currently funded to conduct COVID-19 related clinical research using NIAID’s emergency appropriations (“The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020,” “The Coronavirus Aid, Relief and Economic Security (CARES) Act,” “The Coronavirus Response and Relief Supplemental Appropriations Act, 2021,” and “The American Rescue Plan Act of 2021”) is eligible to apply. 

As instructed in the FOA, indicate the grant or contract number currently conducting COVID-19 clinical trials or clinical studies that is funded by NIAID emergency appropriations in the PPE Usage Plan.

What type of PPE can be supported by this award?

Masks, gloves, gowns and coveralls, safety glasses, face shields, head caps, shoe covers shield wipes are all eligible items as long as they are used in the conduct of a COVID-19 clinical trial or clinical study.

Can multiple clinical trials or studies be supported by a single S10 grant?

This FOA allows for an application to include “linked” trials/studies (e.g., a main study and a follow-up study, a phase I trial followed by the phase II trial). However, applicants are encouraged to submit separate S10 applications for unrelated trials/studies.

Do I have to be the protocol PI of the clinical study or trial that will use the PPE to be the PD/PI on the S10 application?

No. The PD/PI of the NIAID-funded project supporting the clinical trial or study should submit the S10 application through the primary awardee institution. That PD/PI will assume the administrative, scientific oversight, and reporting responsibilities for the requested PPE.  This person does not have to also be the protocol PI of the NIAID-funded clinical trial or study that will use the PPE.

For questions regarding reimbursement of PPE costs under a contract, please contact your contracting officer.

What sources can I use to purchase the PPE?

According to the NIH Revitalization Act (P.L. 103-43, June 10, 1993), section 2004, when purchasing equipment or products under this assistance award, the recipient should, whenever possible, purchase only American-made items.

If my institution is awarded the S10 grant, what reporting is required?

Funds awarded using special appropriations are issued in unique subaccounts in the HHS Payment Management System.  These funds will require separate financial reporting from any other funds awarded.  Additionally, S10 recipients are required to submit semi-annual reports on the usage of PPE purchased and certify that it is being used only to support COVID-related clinical trials and clinical studies conducted by NIAID grantees. Semi-annual reporting will continue after the S10 award ends and until the PPE resources are depleted. If the trial or study ends before the PPE is depleted, the recipient will contact NIAID for instructions.

Whom should I contact if I have more questions about this announcement?

Direct your questions to the scientific/research contacts shown in Section VII. Agency Contacts of PAR-21-276.

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