Registration of Food Facilities

13. An Overview of the Registration of Food Facilities Interim Final Rule
14. Bioterrorism Act of 2002 Section 305
15. Overview of Registration Requirements
16. Who Must Register?
17. Who Must Register? (cont.)
18. U.S. Agent
19. U.S. Agent (cont.)
20. What Food is Subject to FDA's Jurisdiction?
21. What Food is Subject to FDA's Jurisdiction (cont)?
22. Examples of FDA-regulated Food Within Scope of the Rule
23. Examples of FDA-regulated Food Within Scope of the Rule (cont.)
24. Registration Definitions
25. "Facility" Definition (cont.)
26. Definitions (cont.)
27. Definitions (cont.)
28. What Facilities Are Exempt?
29. What Facilities Are Exempt?
30. Definitions (cont.)
31. Definitions (cont.)
32. Definitions (cont.)
33. Definitions (cont.)
34. Definitions (cont.)
35. Farm Definition (cont.)
36. Allowable Farm Activities (If facility otherwise meets the farm definition)
37. Additional Exemption for Some Foreign Facilities
38. Foreign Facilities - Register or Exempt?
39. "Mixed-Type" Facilities
40. "Mixed-Type" Facilities (cont)
41. Two Types of Information: Mandatory and Optional
42. What Information is Required?
43. What Information Is Required? (cont)
44. What Information Is Required? (cont)
45. What Information is Optional?
46. What Information is Optional?
47. What Information is Optional?
48. How to Register
49. How to Register
50. How to Register (cont.)
51. Costs and Frequency of Registration
52. What if Changes Occur?
53. Cancellation of Registration
54. Cancellation of Registration (cont)
55. Where to Register, Update or Cancel a Registration
56. Screenshot of FDA Industry Systems Login Screen
57. Screenshot of FFRM Main Menu
58. Confidentiality of Registration Information
59. Registered Facilities
60. Food Registrations
61. What Are the Consequences of Failing to Register, if Required?
62. Consequences of Failure to Register If Required (cont)
63. Questions on the Registration Interim Final Rule ???
64. Intermission!

Prior Notice of Imported Food

65. An Overview of the Prior Notice of Imported Food Interim Final Rule
66. Bioterrorism Act of 2002 Section 307
67. Overview of Prior Notice Requirements
68. The Current Import Process
69. The Current Import Process
70. The Current Import Process
71. The Current Import Process
72. Prior Notice of Imported Food
73. The New Import Process (Prior Notice)
74. The New Import Process (Prior Notice)
75. Prior Notice vs. 801(a) Admissibility
76. Prior Notice vs. 801(a) Admissibility (cont.)
77. FDA'S Prior Notice: Definitions
78. Port of Arrival vs. Port of Entry
79. FDA Country of Production (Originating Country)
80. FDA Country of Production vs. CBP Country of Origin
81. FDA'S Prior Notice: Definitions
82. "Article of Food" vs. Shipment of Food*
83. What Food Imports are Subject to Prior Notice?
84. What Food Imports are Subject to Prior Notice (cont)?
85. What Definition of "Food" Applies?
86. Examples of FDA-regulated Food Within Scope of the Rule
87. Examples of FDA-regulated Food Within Scope of the Rule
88. What is Excluded from the Prior Notice Food Definition
89. What Kinds of Food Imports are Not Subject to Prior Notice?
90. What Kinds of Food Imports are Not Subject to Prior Notice?
91. Comparison of "Food" for Registration and Prior Notice
92. Who is Authorized to Provide Prior Notice?
93. How Do I Submit Prior Notice?
94. Submitting Prior Notice (cont.)
95. Prior Notice System Interface Screenshot
96. Submitting Prior Notice (cont.)
97. Submitting Prior Notice (cont.)
98. When Is My Prior Notice Due?
99. When Is My Prior Notice Due? (cont.)
100. What Information is Required in a Prior Notice?
101. What Information is Required in a Prior Notice?
102. What Information is Required in a Prior Notice?
103. What Information is Required in a Prior Notice?
104. What Information is Required in a Prior Notice? (cont.)
105. What Information is Required in a Prior Notice? (cont.)
106. What Information is Required in a Prior Notice? (cont.)
107. Requirements for Food Arriving by International Mail
108. Requirements for Food Refused for Inadequate Prior Notice
109. What Happens When FDA Accepts Your PN For Review?
110. Prior Notice Confirmation Number Must Accompany . . .
111. What if the Information Changes After I Submit a Prior Notice?
112. What Happens to Food Without Adequate Prior Notice?
113. What Happens to Food Without Adequate Prior Notice?
114. What Happens to Food Without Adequate Prior Notice?
115. Consequences of Failure to Submit Adequate Prior Notice
116. Consequences of Failure to Register If Required
117. Consequences of Failure to Register If Required (cont.)
118. FDA-CBP Joint Implementation Plan
119. Compliance Status
120. Prior Notice Submission By Source
121. ACS Submission By Source
122. Percent of Information Complete
123. Percent Complete by Mode of Transportation (ACS)
124. Percent Complete by Mode of Transportation (PNSI)

Additional Information

125. For Further Information . . .
126. Outreach Materials are Available on FDA's Website
127. Questions Regarding "Does The Rule Apply to My Activity?"
128. Questions Regarding Does A Rule Apply to What I Do?
129. Technical Assistance Questions
130. Thank You