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GUIDANCE DOCUMENT

Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product Draft Guidance for Industry July 2014

Draft

Not for implementation. Contains non-binding recommendations.

Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product

Issued by:
Guidance Issuing Office
Center for Tobacco Products

July 2014

This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA has identified, and manufacturer requests to change the predicate tobacco product, in substantial equivalence (SE) reports.


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)