0695 83-I Justification Memo

“Testing Communications on Drugs”

(OMB Control Number 0910-0695)

Change Request (83-I)

September 23, 2015

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-I) to add 9,500 burden hours and 20,500 annual responses.

This generic clearance was originally thought to include projects originating in only the Center for Drug Evaluation and Research but because various programs within FDA deal with drug products we experienced more use of this generic approval then anticipated and, therefore, require an increase in hours until the expiration date in 2017.