Published November 13, 2017
Starting January 25, 2018, NIH-defined clinical trial applications must be submitted using a Funding Opportunity Announcement (FOA) that is worded specifically for clinical trials. In the past, clinical trial applications could be submitted for FOAs that were not identified as being clinical-trial specific. Submitting to the wrong FOA will lead to rejection of your application.
The NIH announcement is here:
NIH guidance on requirements for clinical trials:
NIH guidance on the new NIH human subjects and clinical trial information form:
Determining whether your project should be defined as a clinical trial: