Draft Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format

Table of Contents

  1. Introduction
    1. Why FDA Is Issuing This Draft Guidance
    2. What Commercial Processors Should Do Until FDA Issues the Final Version of this Guidance
    3. What this Guidance Will Do
    4. What this Guidance Does Not Do
  2. Background
    1. Requirement for Registration
    2. Requirement for Process Filing
    3. Voluntary Registration and Process Filing
    4. Voluntary Process for FDA Evaluation of New Processing Methods or New Equipment
  3. Portals for Electronic Submissions
    1. FDA’s Industry Systems (FIS)
    2. FDA’s Unified Registration Listing Systems (FURLS)
    3. Relationship Between the Electronic Acidified Food/Low-Acid Canned Food Registration System and Food Facility Registration (FFR)
  4. Overview of Processes for Submission of Registration and Process Filing Forms
    1. Create an FDA Account, Register as a Food Facility, and Identify Your Facility as an Acidified/Low-Acid Food Processor
    2. Register as a Food Canning Establishment By Submitting Form FDA 2541
    3. FDA Receives Form FDA 2541
    4. Facility Contact Person Authorizes Individuals to Access the Electronic Acidified Food/Low-Acid Canned Food System for Your Food Canning Establishment (Optional)
    5. Submit Process Filing Forms
  5. Changes to AF/LACF Registration Information
    1. Changing the Facility Contact Person
    2. Changing the Mailing Address for the Food Canning Establishment
    3. Changing the Telephone Number and Email Address for the Facility Contact Person
    4. Adding or Deleting Product Information
    5. Cancelling Registration
    6. Relocating Your Commercial Processing Operations
  6. How to Contact FDA or Obtain Help
  7. References
  8. Appendices
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