NIH and AHRQ Policy Notices

Dear Colleagues:

Below is a summary of recent NIH and AHRQ policy notices. Please review the notices and forward them to faculty, researchers and staff, as appropriate. Questions regarding these notices should be directed to your Contract and Grant Officer.

• Policy Update – Results Information Reporting for Applicable Clinical Trials (ACTs)
  (NOT-OD-20-147)
  National Institutes of Health

The purpose of this notice is to inform the extramural community that a Federal court has held that Section 801 of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) requires submission of results information for any “applicable clinical trial” (“ACT”), as defined in section 402(j)(1)(A) of the Public Health Service (“PHS”) Act, that was initiated after September 27, 2007, or that was ongoing as of December 26, 2007, if the ACT studied a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date. When results information is not submitted in a timely manner, NIH may take enforcement action against recipients as outlined in the NIH Grants Policy Statement Section 8.5 and section 402(j)(5)(A) of the Public Health Service Act. Please read the notice for additional information regarding the reporting requirements and the timing for the same.

• Upcoming Changes to the Notice of Award (NoA) Beginning October 1, 2020
  (NOT-OD-20-155)
  National Institutes of Health

This notice is to alert the extramural community of upcoming changes to the format of the National Institutes of Health’s (NIH) Notice of Award (NoA). Please read the notice for additional information regarding the changes.

• Guidance for Applicants Preparing Applications for the Fall 2020 Due Dates During the COVID-19 Pandemic
  (NOT-OD-20-122)
  National Institutes of Health

   

This Notice provides guidance for investigators and institutions preparing NIH grant applications for the May 2021 Council round, beginning with applications submitted for the September 25, 2020 due date. NIH grant applications should NOT include contingency plans that would outline steps needed to recover from temporary, emergency situations, or institutional return-to-the-workplace plans, resulting from the COVID-19 pandemic. Contingency plans will not be considered in peer review but, if needed, COVID-19 contingency plans will be requested and carefully considered by NIH staff before funding. Please review the notice for additional information.

• AHRQ Grant Recipient use of the eRA Commons to Submit First-Time No-Cost Extension (NCE) Notifications for Grant Awards that are under Expanded Authorities
  (NOT-HS-20-012)
  Agency for Healthcare Research and Quality

Effective on August 1, 2020, AHRQ grant recipients may, and effective October 1, 2020, AHRQ grant recipients MUST, use the No-Cost Extension feature in the eRA Commons to notify AHRQ when they exercise their one-time authority to extend, without additional funds, the final budget period end date of a grant award that is included under expanded authorities. Please review the notice and refer to the No-Cost Extensions page on the AHRQ website (https://www.ahrq.gov/funding/grant-mgmt/nces.html) for the most up-to-date information regarding no-cost extensions, including details regarding what must be provided in a prior approval request.