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? 
• 28. What Information is Required in a Prior Notice? 
• 29. What Information is Required in a Prior Notice? 
• 30. What Information is Required in a Prior Notice? 
• 31. What Information is Required in a Prior Notice? (cont.) 
• 32. What Information is Required in a Prior Notice? (cont.) 
• 33. What Information is Required in a Prior Notice? (cont.) 
• 34. Requirements for Food Arriving by International Mail 
• 35. Requirements for Food Refused for Inadequate Prior Notice 
• 36. What Happens When FDA Accepts Your PN For Review? 
• 37. Prior Notice Confirmation Number Must Accompany . . . 
• 38. What if the Information Changes After I Submit a Prior Notice? 
• 39. What Happens to Food Without Adequate Prior Notice? 
• 40. What Happens to Food Without Adequate Prior Notice? 
• 41. What Happens to Food Without Adequate Prior Notice? 
• 42. Consequences of Failure to Submit Adequate Prior Notice 
• 43. Consequences of Failure to Register If Required 
• 44. Consequences of Failure to Register If Required (cont.) 
• 45. Prior Notice vs. 801(a) Admissibility 
• 46. Final Rule Highlights 
• 47. Final Rule Highlights: Time Frames 
• 48. Final Rule Highlights: Manufacturer 
• 49. Final Rule Highlights: Moved from CPG to Final Rule 
• 50. Draft CPG Highlights: Enforcement Discretion (ED) 
• 51. Draft CPG Highlights: Revised Areas of ED 
• 52. Draft CPG Highlights: Removed or Moved to Final Rule 
• 53. Where Can I Find a Copy of the Final Rule? 
• 54. Questions?