This information collection request
supports agency regulations at 21 CFR part 200.5 and the associated
agency guidance regarding "Dear Healthcare Provider" Letters.
Respondents to the collection are manufacturers and distributors of
drugs for which such a letter would be required as provided for in
our regulations. The letters communicate important information
about prescription drug and biological products (drugs).
The information collection
reflects an adjustment. We have reduced the number of respondents
by 17, which results in a corresponding decrease to the annual
burden hours by 1,200 and the annual number of disclosures by