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Protecting the Food Supply

October 2003

FDA Actions on New Bioterrorism Legislation

Overview of Prior Notice Interim Final Rule Implementing the Bioterrorism Act

(Interim Final Rule, 68 FR 58974, October 10, 2003)

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Table of Contents
  1. Overview of Prior Notice 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. Background: FDA's Regulatory Development Timeline
  6. Background: FDA's Regulatory Development Timeline
  7. Regulatory Development Timeline (cont.)
  8. What Is An Interim Final Rule (IFR)?
  9. FDA'S Prior Notice: Definitions
  10. Port of Arrival vs. Port of Entry
  11. FDA Country of Production (Originating Country)
  12. FDA Country of Production vs. CBP Country of Origin
  13. FDA'S Prior Notice: Final Definitions (cont.)
  14. "Article of Food" vs. Shipment of Food*
  15. What Food Imports are Subject to Prior Notice?
  16. What Food Imports are Subject to Prior Notice (cont)?
  17. What Definition of "Food" Applies?
  18. Examples of FDA-regulated Food Within Scope of the Rule
  19. Examples of FDA-regulated Food Within Scope of the Rule
  20. What is Excluded from the Prior Notice Food Definition
  21. What Kinds of Food Imports are Not Subject to Prior Notice?
  22. Who is Authorized to Provide Prior Notice?
  23. How Do I Submit Prior Notice?
  24. Submitting Prior Notice (cont.)
  25. www.acces.fda.gov Page Screen Shot
  26. Submitting Prior Notice (cont.)
  1. Submitting Prior Notice (cont.)
  2. When Is My Prior Notice Due?
  3. When Is My Prior Notice Due? (cont.)
  4. What Information is Required in a Prior Notice?
  5. What Information is Required in a Prior Notice?
  6. What Information is Required in a Prior Notice?
  7. What Information is Required in a Prior Notice?
  8. What Information is Required in a Prior Notice? (cont.)
  9. What Information is Required in a Prior Notice? (cont.)
  10. What Information is Required in a Prior Notice? (cont.)
  11. Requirements for Food Arriving by International Mail
  12. Requirements for Food Refused for Inadequate Prior Notice
  13. What Happens When FDA Accepts Your PN For Review?
  14. Prior Notice Confirmation Number Must Accompany . . .
  15. What if the Information Changes After I Submit a Prior Notice?
  16. What Happens to Food Without Adequate Prior Notice?
  17. What Happens to Food Without Adequate Prior Notice?
  18. What Happens to Food Without Adequate Prior Notice?
  19. Consequences of Failure to Submit Adequate Prior Notice
  20. Consequences of Failure to Register If Required
  21. Consequences of Failure to Register If Required (cont.)
  22. Prior Notice vs. 801(a) Admissibility
  23. How Do I Get a Copy of the Interim Final Rule?
  24. How To Comment.(Deadline December 24, 2003)
  25. For Further Information . . .
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Food Safety and Terrorism
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Hypertext updated by dav/las January 22, 2004