Index of Presentation Slides

1. Overview of Registration and Prior Notice Proposed Regulations Implementing the Bioterrorism Act
2. Purpose of Briefing
3. FDA Regulatory Development: Lead Personnel
4. Background: FDA's Regulatory Development Timeline
5. Background: FDA's Regulatory Development Timeline
6. Regulatory Development Timeline (cont.)
7. Proposed Registration Requirements 68 FR 5378 (Feb. 3, 2003)
8. Who Must Register?
9. Who Must Register? (cont.)
10. What Food is Subject to FDA's Jurisdiction?
11. Examples of FDA-Regulated Food (cont.)
12. Proposed Definitions
13. Proposed Definitions (cont.)
14. Proposed Definitions (cont.)
15. What Facilities Does The Proposed Rule Exempt?
16. What Facilities Does FDA Not Regulate?
17. Proposed Definitions (cont.)
18. Proposed Definitions (cont.)
19. Proposed Definitions (cont.)
20. Proposed Definitions (cont.)
21. Proposed Farm Definition (cont.)
22. Additional Exemption for Some Foreign Facilities
23. Foreign Facilities-Register or Exempt?
24. "Mixed-Type" Facilities
25. "Mixed-Type" Facilities (cont.)
26. "Mixed-Type" Farm (cont.)
27. Proposal: What Information Is Required?
28. What Information Is Required? (cont.)
29. What Information Is Required? (cont.)
30. Optional Information* (* Mandatory registration fields still required)
31. Proposed Rule: How to Register

32. Proposed Rule: How to Register (cont.)
33. What if Changes Occur?
34. What If A Facility Is Not Registered?
35. Next Steps
36. Proposed Requirements for Prior Notice Regulation 68 FR 5428 (Feb. 3, 2003)
37. Sec. 307: Prior Notice of Imported Food Shipments
38. Prior Notice Implementation
39. FDA'S Prior Notice: Proposed Definitions
40. Port of Entry and Crossing Location
41. FDA'S Prior Notice: Proposed Definitions (cont.)
42. Originating Country vs. Country of Origin
43. "Article of Food" vs. Shipment of Food*
44. Proposal - Who is Authorized to Provide Prior Notice?
45. What Food is Subject to the Proposed Requirements?
46. What Food is Not Subject to Proposed Prior Notice Requirements?
47. Proposal: When Is My Prior Notice Due?
48. How do I Submit Prior Notice, Amendments & Updates?
49. Submitting Prior Notice, Amendments & Updates (cont.)
50. Proposal: What Information is Required in a Prior Notice?
51. What Information is Required in a Prior Notice? (cont.)
52. What Information is Required in a Prior Notice? (cont.)
53. What Information is Required in a Prior Notice? (cont.)
54. What Information is Required in a Prior Notice? (cont.)
55. What if the Information Changes After I Submit a Prior Notice?
56. What if the Information Changes After I Submit a Prior Notice (cont.)?
57. Sec. 307: Prior Notice of Imported Food Shipments
58. Next Steps
59. How Do I Get a Copy of the Proposed Rule(s)?
60. How To Comment (Deadline April 4, 2003)
61. For Further Information . . .