Change Request Memo

Change Request for OMB Control No. 0910-0650

Tobacco Product Establishment Registration and Listing

March 2023

The Food and Drug Administration (FDA, us, or we) is submitting this nonmaterial/non-substantive change request (83-C) to include a revised version of the associated Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments guidance.

Per the conforming changes from the Consolidated Appropriations Act of 2022 we are revising this guidance to amend the term “tobacco product” in the FD&C Act to include products that contain nicotine from any source. In the previous ICR under this control number (Reference # 202112-0910-010), we included the new definition of tobacco products to cover the submission of these products. No other changes are being made to the information collection.

Tracked guidance: