A new mandatory award condition has been added for Rapid Acceleration of Diagnostics-UP awards (RADx-UP) for grantees for specific Notice of Special Interest (NOSI)/Funding Opportunity Announcements (FoAs). The award condition notes that compliance with FDA Emergency Use Authorized (EUA) and FDA Clinical Laboratory Improvement Amendments (CLIA) is required of all RADx-UP projects funded under these NOSIs/FoAs.
This term will appear under Section IV (Specific Award Conditions) in the Notice of Award for the following NOSIs and FoAs, following an eRA release today:
Here is the specific award condition:
SECTION IV – SPECIFIC AWARD CONDITIONS
Compliance with FDA Emergency Use Authorized (EUA) and FDA Clinical Laboratory Improvement Amendments (CLIA) is required of all RADx-UP projects:
- NIH requires that FDA-cleared or FDA emergency use authorized (EUA) tests and supplies be used on-label (in the way authorized by FDA) for all testing. Lab Developed Test (LDT) that have not received FDA clearance or EUA are not allowed for RADx-UP projects. All parts of test, collection and processing, including any requirements on CLIA certification, must be covered by FDA authorization on label.
- NIH RADx-UP funds cannot be used to pay for any testing (including Lab Developed Test (LDT)) that has not received FDA clearance or FDA EUA. Any funds used to support tests that have not received such clearance will be considered an unallowable costs to the project and will be subject to administrative action by the administering IC.
- Only the results of FDA cleared or EUA testing may be reported to NIH and to the participants by projects running FDA cleared or EUA testing.
- State emergency use authorization is NOT an acceptable substitute for FDA clearance or EUA.
- Projects not conducting direct testing but partnering with the local Health Department or State Public Health Department who is providing the tests and conducting the testing, may receive the results of those tests but may not use NIH funds to support the purchase of those tests. Other available non-NIH funding sources must be used in these cases.
- Off-label use of FDA cleared or EUA testing is not allowed within the scope of RADx-UP award.
- For all RADx-UP projects, recipient must comply with the Terms and Conditions of Award within 30 days of the award issue date as outlined on the cover page of the Notice of Award.
- In accordance with the NIH Grants Policy Statement, Section 8.5.2, Remedies for Noncompliance or Enforcement Actions, if the recipient of RADx-Up funds fails to comply with the requirements of the renegotiated terms and conditions of the award, NIH may take one or more of the enforcement actions which include disallowing costs, withholding of further awards, or wholly or partly suspending the grant, pending corrective action by the recipient.