UPDATE: NIH Prior Approval Restrictions on Fixed Price Subawards

With the release of the latest version of the NIH Grants Policy Statement – Nov. 2016, the NIH has changed their requirements for prior approval to issue fixed price subawards. 

The NIH now requires prior approval to issue fixed price subawards of any dollar amount up to the simplified acquisition threshold ($150,000).  This new condition applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2016. See section of the NIHGPS, and the Significant Changes Document

It was confirmed at the most recent Federal Demonstration Partnership (FDP) meeting that if theproposed subrecipients were named in the original proposal, along with an indication that the pass-through entity intends to issue those subawards on a fixed-price basis, this will be considered prior agency approval provided that there is no contrary language in the award notice.   However, sites classified as subrecipients and yet ‘to be named’ in proposals, a common practice for PTEs of multi-site clinical trials, would need separate prior approvals at the time they were named.  Additionally, all participating agencies will be adopting this same requirement concerning fixed price subawards once the new Research Terms & Conditions (RTCs) are released.

COGR and FDP are in the process of clarifying with NIH what is needed in order to obtain prior approval to issue fixed price subawards.  Of concern are existing subawards that may need modification in FY17 for incremental funding.COGR is also requesting clarification and guidance regarding clinical trials. 

We will provide as more information becomes available.