Mailing of Important Information About Drugs

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 Mailing of Important Information About Drugs expires 2022-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0754 Dear HCP Letters SSA 2023 Ext.docx Supporting Statement A
Dear Healthcare Provider Letter; Improving Communication of Important Safety Information Other-Agency Guidance

All Historical Document Collections

202212-0910-003 Approved without change	Extension without change of a currently approved collection	2022-12-19
201911-0910-007 Approved without change	Extension without change of a currently approved collection	2019-12-06
201610-0910-007 Approved without change	Extension without change of a currently approved collection	2016-10-24
201309-0910-005 Approved with change	New collection (Request for a new OMB Control Number)	2013-09-13