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GUIDANCE DOCUMENT

Draft Guidance for Industry: Regulatory Submissions to OFAS, Quick Links March 2010

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of Food Additive Safety

Contains Nonbinding Recommendations

Draft — Not for Implementation

March 2010

Table of Contents and Introduction (Part I)

For instructions to unzip the downloadable folders see Appendix 15 (available in PDF).

FDA Forms Form Instructions Downloadable Folders (Zip)
3503 Part IV FAP-CAP
3480 Part V FCN
3480A Part V FCN
3667 Part VI GRN
3665 Part VII BNF
3666 Part VIII NPC

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.