-
Food
-
Presentation: Overview of Prior Notice Final Rule and Draft CPG Implementing the Bioterrorism Act
March 8, 2009
-
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?
-
-
-

