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GUIDANCE DOCUMENT

Tobacco Product Master Files Guidance for Industry May 2016

Final
Docket Number:
FDA-2015-D-2325-0002
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Tobacco Products

This guidance provides recommendations to industry on tobacco product master files (TPMFs). TPMFs are used to permit the person that owns the TPMF (TPMF owner) to authorize other persons to rely on information in the TPMF to support a submission to FDA without the TPMF owner having to disclose that information to other persons. These files typically contain trade secret and/or confidential commercial information that the TPMF owner does not wish to make public.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-2325-0002.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)