Change request memo 12.9.16

“Tobacco Product Establishment Registration and Submission of Certain Health Information”

(OMB Control Number 0910-0650)

Change Request (83-C)

December 9, 2016

The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to include a revised version of the associated Listing of Ingredients in Tobacco Products guidance. OMB was previously notified of this change request submission.

FDA is revising this guidance to reflect our authority over newly deemed products and provide information for manufacturers and importers who now must submit ingredient listings for newly regulated products.

The revised guidance will extend the general compliance date for ingredient listing submission from February 8, 2017 to August 8, 2017.