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Regulatory Submissions - Part IX: FDA References

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Information for all regulatory submissions

Regulatory submissions for program areas

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Guidance for Industry
Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety
Part IX: FDA References

Contains Nonbinding Recommendations

March 2010

Draft Guidance

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Draft — Not for Implementation

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.

  1. Administrative Information Web Site References
  2. Chemistry Information Web Site References
  3. Safety Study Information Web Site References
  4. Environmental Information Web Site References
  5. Biotechnology Information Web Site References

A. Administrative Information Web Site References

  1. FDA Electronic Submissions Gateway (ESG). Information on setting up an FDA ESG Account (Webtrader and AS2).
  2. Guidance for Industry - Questions and Answers About the Petition Process.
  3. Inventory of Effective Food Contact Substance (FCS) Notifications.
  4. Definitions of Food Types and Conditions of Use for Food Contact Substances.
  5. Guidance for Industry - Preparation of Food Contact Notifications: Administrative.
  6. Guidance for Industry - Frequently Asked Questions About GRAS.

B. Chemistry Information Web Site References

  1. Guidance for Industry - Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions.
  2. 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.
  3. Guidance for Industry - Estimating Dietary Intake of Substances in Food.
  4. Guidance for Industry - Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations.
  5. Enzyme Preparations: Chemistry Recommendations For Food Additive And GRAS Affirmation Petitions.

C. Safety Study Information Web Site References

  1. Guidance to Industry - Computerized Systems Used in Clinical Investigations.
  2. Guidance for Industry: Templates for Reporting Toxicology Data.
  3. Standard for Exchange of Non-Clinical Data.
  4. Guidance for Industry - Summary Table of Recommended Toxicological Testing for Additives Used in Food.
  5. Guidance for Industry and Other Stakeholders - Toxicological Principles for the Safety Assessment of Food Ingredients. Redbook 2000.
  6. Appendix E - Color Additives For Medical Devices.
  7. Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations.

D. Environmental Information Web Site References

  1. 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

  1. Guidance on Consultation Procedures. Foods Derived From New Plant Varieties.
  2. Statement of Policy: Foods Derived From New Plant Varieties.
  3. Guidance for Industry - Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.