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Protecting the Food Supply

October 2003

FDA Actions on New Bioterrorism Legislation

Overview of Registration Interim Final Rule Implementing the Bioterrorism Act

(Interim Final Rule, 68 FR 58893, October 10, 2003)

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Table of Contents
  1. Overview of Registration Interim Final Rule Implementing the Bioterrorism Act
  2. FDA Lead Personnel
  3. Background: FDA's Regulatory Development Timeline
  4. Background: FDA's Regulatory Development Timeline
  5. Regulatory Development Timeline (cont.)
  6. What Is An Interim Final Rule (IFR)?
  7. Who Must Register?
  8. Who Must Register? (cont.)
  9. U.S. Agent
  10. U.S. Agent (cont.)
  11. What Food is Subject to FDA's Jurisdiction?
  12. What Food is Subject to FDA's Jurisdiction (cont)?
  13. Examples of FDA-regulated Food Within Scope of the Rule
  14. Examples of FDA-regulated Food Within Scope of the Rule (cont.)
  15. Registration Definitions
  16. "Facility" Definition(cont.)
  17. Definitions (cont.)
  18. Definitions (cont.)
  19. What Facilities Are Exempt?
  20. Definitions (cont.)
  21. Definitions (cont.)
  22. Definitions (cont.)
  23. Definitions (cont.)
  24. Definitions (cont.)
  25. Farm Definition (cont.)
  26. Additional Exemption for Some Foreign Facilities
  27. Foreign Facilities - Register or Exempt?
  1. "Mixed-Type" Facilities
  2. "Mixed-Type" Facilities (cont)
  3. Two Types of Information: Mandatory and Optional
  4. What Information is Required?
  5. What Information Is Required? (cont)
  6. What Information Is Required? (cont)
  7. What Information is Optional?
  8. What Information is Optional?
  9. What Information is Optional?
  10. How to Register
  11. How to Register
  12. How to Register (cont.)
  13. Costs and Frequency of Registration
  14. What if Changes Occur?
  15. Cancellation of Registration
  16. Cancellation of Registration (cont)
  17. Where to Register, Update or Cancel a Registration
  18. FDA Industry Systems Accounts Management Web Page
  19. Food Facility Registration Module Main Menu Web Page
  20. What Are the Consequences of Failing to Register, if Required?
  21. Consequences of Failure to Register If Required (cont)
  22. Consequences of Failure to Register If Required (cont)
  23. Consequences of Failure to Register If Required (cont.)
  24. How Do I Get a Copy of the Interim Final Rule?
  25. How To Comment(Deadline December 24, 2003)
  26. For Further Information . . .
  27. Whom Do I Call?
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Hypertext updated by dvd/dav/las January 22, 2004