Dear Health Care Provider Letters; Improving Communication of Important Safety Information

OMB 0910-0754

OMB 0910-0754

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 latest form for Dear Health Care Provider Letters; Improving Communication of Important Safety Information expires 2022-12-31 and can be found here.

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