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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

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

Issued by:
Guidance Issuing Office
Center for Tobacco Products

October 2015

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

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)