We are still hopeful that Congress will, in an appropriations package that eventually passes, roll back NIH’s expansion of the definition of clinical trials. Meanwhile, NIH is moving full-steam ahead with the changes. Therefore, if you are submitting an application to NIH for the January 25th round, you will need to make sure that you are responding to the right funding opportunity announcement (see:https://nexus.od.nih.gov/all/2017/12/07/be-careful-to-pick-the-right-funding-opportunity-announcement-foa/). Also, if you are uncertain as to whether you are proposing a clinical trial or not, you should contact the relevant program officer. If your program officer is unsure, the NIH Deputy Director for Extramural Research, Mike Lauer, has informed us that he welcomes the question and will make the decision. He can be reached email@example.com.