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GUIDANCE DOCUMENT

Tobacco Product Master Files Guidance for Industry May 2016

Final

Tobacco Product Master Files

Issued by:
Guidance Issuing Office
Center for Tobacco Products

May 2016

pdf icon small Guidance for Industry:Tobacco Product Master Files

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

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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)