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SMALL ENTITY COMPLIANCE GUIDE

National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions – Small Entity Compliance Guide Guidance for Industry October 2015

Final
Docket Number:
FDA-2013-N-1282-0016
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Tobacco Products

This guidance is intended to help small businesses understand and comply with FDA’s implementation of the National Environmental Policy Act (NEPA) and the Council on Environmental Quality (CEQ) regulations for classes of actions for tobacco products as amended by this final rule. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).


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-2013-N-1282-0016.

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)