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Presentation: Overview of Bioterrorism Act's Establishment and Maintenance of Records Final Rule (May 2005)
FDA Actions Bioterrorism Act of 2002 Legislation
(Final Rule, 69 FR 71561, December 9, 2004)
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Index of Presentation Slides
- 1. Overview of Bioterrorism Act's Establishment and Maintenance of Records Final Rule
- 2. Regulatory Development of Rule
- 3. Final Rule: Overview of Some Significant Definitions
- 4. Definitions (cont.)
- 5. Definitions (cont.)
- 6. Examples of FDA-Regulated Food
- 7. Examples of FDA-Regulated Food
- 8. Examples of FDA-Regulated Food
- 9. What Foods Does FDA Not Regulate?
- 10. Definitions (cont.)
- 11. Definitions (cont.)
- 12. Definitions (cont.)
- 13. Definitions (cont.)
- 14. Definitions (cont.)
- 15. Definitions (cont.)
- 16. Definitions (cont.)
- 17. Definitions (cont.)
- 18. Who is subject to this subpart?
- 19.Who is excluded from all of the regulations in this subpart?
- 20. Who is excluded from all of the regulations in this subpart?
- 21. Who is excluded from all of the regulations in this subpart?
- 22. Who is subject only to the record access and prohibited act provisions?
- 23. Who is subject only to the record access and prohibited act provisions?
- 24.Who is subject only to the record access and prohibited act provisions?
- 25. Substance, Activity, Coverage Chart
- 26. Substance, Activity, Coverage Chart (cont'd)
- 27. Partial Exclusions
- 28. Partial Exclusions
- 29. Establishment and Maintenance of Records by Non-Transporters
- 30. Establishment and Maintenance of Records by Transporters (Various Transportation Companies)
- 31. Transporters - One Company With Multiple Modes of Transportation
- 32. Records Non-transporters Have To Establish And Maintain to Identify the Immediate Previous Source (IPS)
- 33. Records Non-transporters Have To Establish And Maintain to Identify the IPS
- 34. Records Non-transporters Have To Establish And Maintain to Identify the IPS
- 35. Records Non-transporters Have To Establish And Maintain to Identify the Immediate Subsequent Recipient (ISR)
- 36. Records Non-transporters Have To Establish And Maintain to Identify the ISR
- 37. Records Non-transporters Have To Establish And Maintain to Identify the ISR
- 38. Non-transporters' Records .Regarding the ISR
- 39. Example 1: Common Storage Silo for An Ingredient (e.g., Flour)
- 40. Example 2: Dedicated Storage Silos for Each Ingredient Source
- 41. Requirements for Transporters to Establish and Maintain Records
- 42. Requirements for Transporters to Establish and Maintain Records
- 43. Various Transportation Companies
- 44. One Transportation Company with Multiple Modes of Transportation
- 45. Requirements for Transporters to Establish and Maintain Records (cont.)
- 46. Requirements for Transporters to Establish and Maintain Records (cont.)
- 47. Agreements Between Non-Transporters and Transporters Must Contain:
- 48. Requirements for Agreements (cont.)
- 49. Requirements for Agreements (cont.)
- 50. Record Retention Periods
- 51. What are the record retention requirements?
- 52. Consequences: New Prohibited Acts
- 53. Consequences: New Prohibited Acts (cont.)
- 54. What are the compliance dates?
- 55. Calculating FTE's for compliance date purposes:
- 56. Do other recordkeeping requirements in statutes and regulations still apply?
- 57. Can Existing Records Satisfy the Requirements of this Subpart?
- 58. What are the record availability requirements?
- 59. What are the record availability requirements (cont)?
- 60. What records are excluded from BT Act records access?
- 61. FDA Draft Records Access Guidance: FDA Procedures
- 62. FDA Draft Records Access Guidance: FDA Procedures
- 63. FDA Draft Records Access Guidance: FDA Procedures
- 64. FDA Draft Records Access Guidance: FDA Procedures
- 65. FDA Draft Records Access Guidance: How Will FDA Make a Request?
- 66. FDA Draft Records Access Guidance:
- 67. FDA Draft Records Access Guidance:
- 68. For Further Information . . .
- 69. Examples of Outreach Materials Available On FDA's Website
- 70. Questions?
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