Draft Guidance for Industry: Regulatory Submissions to OFAS, Part IX FDA References March 2010
Not for implementation. Contains non-binding recommendations.
Contains Nonbinding Recommendations
Draft — Not for Implementation
Table of Contents and Introduction (Part I)
Information for all regulatory submissions
- Part I: Introduction
- Part II: Common Elements
- Part III: General Considerations - Electronic Format
- Part IX: FDA References
- Part X: Appendices
- Quick Links to Forms, Instructions and Downloadable Folders
Regulatory submissions for program areas
- Part IV: Food or Color Additive Submissions
- Part V: Food Contact Substance Submissions
- Part VI: GRAS Notices
- Part VII: Biotechnology Final Consultations
- Part VIII: New Protein Consultations
All parts [Printable PDF Version]
IX. FDA Web Site References
As of January 22, 2010, FDA had verified the Web site addresses for the references it makes available as hyperlinks from the Internet copy of this guidance.
- Administrative Information Web Site References
- Chemistry Information Web Site References
- Safety Study Information Web Site References
- Environmental Information Web Site References
- Biotechnology Information Web Site References
A. Administrative Information Web Site References
- FDA Electronic Submissions Gateway (ESG). Information on setting up an FDA ESG Account (Webtrader and AS2).
- Guidance for Industry - Questions and Answers About the Petition Process.
- Inventory of Effective Food Contact Substance (FCS) Notifications.
- Definitions of Food Types and Conditions of Use for Food Contact Substances.
- Guidance for Industry - Preparation of Food Contact Notifications: Administrative.
- Guidance for Industry - Frequently Asked Questions About GRAS.
B. Chemistry Information Web Site References
- Guidance for Industry - Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions.
- Guidance for Industry - Color Additive Petitions. FDA Recommendations For Submission Of Chemical And Technological Data On Color Additives For Food, Drugs, Cosmetics or Medical Devices.
- Guidance for Industry - Estimating Dietary Intake of Substances in Food.
- Guidance for Industry - Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations.
- Enzyme Preparations: Chemistry Recommendations For Food Additive And GRAS Affirmation Petitions.
C. Safety Study Information Web Site References
- Guidance to Industry - Computerized Systems Used in Clinical Investigations.
- Guidance for Industry: Templates for Reporting Toxicology Data.
- Standard for Exchange of Non-Clinical Data.
- Guidance for Industry - Summary Table of Recommended Toxicological Testing for Additives Used in Food.
- Guidance for Industry and Other Stakeholders - Toxicological Principles for the Safety Assessment of Food Ingredients. Redbook 2000.
- Appendix E - Color Additives For Medical Devices.
- Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations.
D. Environmental Information Web Site References
- Guidance for Industry - Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.
E. Biotechnology Information Web Site References
- Guidance on Consultation Procedures. Foods Derived From New Plant Varieties.
- Statement of Policy: Foods Derived From New Plant Varieties.
- Guidance for Industry - Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.