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Protecting the Food Supply

March 2009

FDA Actions on the Bioterrorism Act of 2002

Overview of Prior Notice Final Rule and Draft CPG Implementing the Bioterrorism Act

(Final Rule, 73 FR 66294, November 7, 2008)
(Draft CPG October 2008)

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Table of Contents
  1. Overview of Prior Notice Final Rule and Draft CPG Implementing the Bioterrorism Act
  2. Agenda
  3. Background: FDA's Regulatory Development Timeline
  4. Background: FDA's Regulatory Development Timeline
  5. FDA'S Prior Notice: Definitions
  6. Port of Arrival vs. Port of Entry
  7. FDA Country of Production.(Originating Country)
  8. FDA Country of Production .vs. CBP Country of Origin
  9. FDA'S Prior Notice: Final Definitions (cont.)
  10. FDA'S Prior Notice: Final Definitions (cont.)
  11. Multiple facilities: Who is the PN manufacturer?
  12. What Food Imports are Subject to Prior Notice?
  13. What Definition of "Food" Applies?
  14. Examples of FDA-regulated Food Within Scope of the Rule
  15. Examples of FDA-regulated Food Within Scope of the Rule
  16. What is Excluded from the Prior Notice Food Definition
  17. What Kinds of Food Imports are Not Subject to Prior Notice?
  18. Who is Authorized to Provide Prior Notice?
  19. How Do I Submit Prior Notice?
  20. Submitting Prior Notice (cont.)
  21. FDA Industry Systems Screen Shot
  22. Submitting Prior Notice (cont.)
  23. How Far in Advance Can I submit Prior Notice?
  24. When Is My Prior Notice Due?
  25. When Is My Prior Notice Due? (cont.)
  26. What Information is Required in a Prior Notice?
  27. What Information is Required in a Prior Notice?
  1. What Information is Required in a Prior Notice?
  2. What Information is Required in a Prior Notice?
  3. What Information is Required in a Prior Notice?
  4. What Information is Required in a Prior Notice? (cont.)
  5. What Information is Required in a Prior Notice? (cont.)
  6. What Information is Required in a Prior Notice? (cont.)
  7. Requirements for Food Arriving by International Mail
  8. Requirements for Food Refused for Inadequate Prior Notice
  9. What Happens When FDA Accepts Your PN For Review?
  10. Prior Notice Confirmation Number Must Accompany . . .
  11. What if the Information Changes After I Submit a Prior Notice?
  12. What Happens to Food Without Adequate Prior Notice?
  13. What Happens to Food Without Adequate Prior Notice?
  14. What Happens to Food Without Adequate Prior Notice?
  15. Consequences of Failure to Submit Adequate Prior Notice
  16. Consequences of Failure to Register If Required
  17. Consequences of Failure to Register If Required (cont.)
  18. Prior Notice vs. 801(a) Admissibility
  19. Final Rule Highlights
  20. Final Rule Highlights: Time Frames
  21. Final Rule Highlights: Manufacturer
  22. Final Rule Highlights: Moved from CPG to Final Rule
  23. Draft CPG Highlights: Enforcement Discretion (ED)
  24. Draft CPG Highlights Revised Areas of ED
  25. Draft CPG Highlights: Removed or Moved to Final Rule
  26. Where Can I Find a Copy of the Final Rule?
  27. Questions?
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Hypertext updated by dav March 17, 2009