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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Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product Draft Guidance for Industry July 2014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Not for implementation.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.

Docket Number:
FDA-2014-D-0800-0002
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Tobacco Products

This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA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

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-2014-D-0800-0002.

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)