We recently submitted two applications to USDE using the new
 424 forms which cover human subjects review as item #11
 on the form.  I checked the "yes" box indicating that human
 subjects were part of the research and I entered the
 exemption number in the exemption box.

 I received an e-mail message back from USDE stating that
 because I entered a date in the date box, my response was
 confusing (I see now that the date only should be used
 if the project undergoes expedited or full review).  I had to
 resubmit the entire form, eliminating the review date (even
 though we do review exempt research) AND send a cover letter
 "providing sufficient information to allow a determination
 that the designated exemptions are appropriate."

 I was really taken aback by this last request.  The original
 application material stated to "provide sufficient
 information in the APPLICATION (which, to me, meant the
 proposal) to allow a determination that the designated
 exemptions are appropriate."

 Does anyone know why USDE wants to get in the business of
 second guessing the local IRB?  Has anyone else had a similar
 experience?

         Beth Seaton
         Director, Sponsored Projects
         Western Illinois University
         xxxxxx@ccmail.wiu.edu