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.

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.

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.

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.

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.

Nancy Lewis
Executive Director, Sponsored Projects Administration
Office of Research
University of California, Irvine

COVID-19: In response to the SARS-CoV-2/COVID-19 (Coronavirus ) pandemic, the Office of Research will be telecommuting. During this time, email is the best method of contact as voicemails will be checked periodically. For information about Research Continuity planning and updates please visit:https://news.research.uci.edu/research-continuity