NIH Forms E clinical trials requirements - how's it going?

Have you had your first experience with submission of the new NIH human subjects attachments? Have you written the sections for a clinical trial application?  How did it go?

Since February, I have had the nightmare-inducing task of working on several applications that count as clinical trials under the new guidelines but would not have under the previous ones.  The amount of extra work involved in completion of the text fields and attachments is staggering. Considering that roughly 90% of submitted proposals will not be funded, that is a lot of extra time and financial burden to researchers and administrators.  I hope there are enough complaints from faculty and reviewers to catalyze changes that will minimize this burden.  Perhaps much of this information could be requested at the Just-in-Time stage instead of at the time of proposal submission.  It would save wasted effort and require only those investigators who truly have a chance at being funded to submit their clinical trial details.