Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN - Appendix D
September 2003; Revised May 2006
Below are recommendations for the suggested format and the types of information to submit to the agency in an environmental assessment. An alternative approach may be used if the approach satisfies the requirements of the applicable statutes and regulations.
Appendix D is still under development and will be issued at a later date. In the interim, we recommend that you contact the Office of Food Additive Safety for assistance in submitting the necessary information.
Contact Information: Layla I. Batarseh at (301) 436-1296
The above guidance document supercedes the previous version dated September 2003.
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.