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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Annual updates of registration information
Modified
9735
43808
0
Form
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Form
FDA Form 2658
Registered Establishment
Instruction
Instruction
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
Other-guidance document
June and December updates of all drug listing information
Modified
18799
84596
0
Form
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Form
FDA Form 2658
Registered Establishment
Instruction
Instruction
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
Other-guidance document
New drug listings
Modified
10295
46328
0
Form
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Form
FDA Form 2658
Registered Establishment
Instruction
Instruction
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
Other-guidance document
New listings for private label distributor
Modified
1469
6611
0
Form
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Form
FDA Form 2658
Registered Establishment
Instruction
Instruction
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
Other-guidance document
New registrations, including new labeler codes requests
Modified
574
2583
0
Form
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Form
FDA Form 2658
Registered Establishment
Instruction
Instruction
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
Other-guidance document
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Modified
1000
40000
0
Form
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Form
FDA Form 2658
Registered Establishment
Instruction
Instruction
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
Other-guidance document
SOP maintenance
Modified
3295
3295
0
Form
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Form
FDA Form 2658
Registered Establishment
Instruction
Instruction
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
Other-guidance document
Waiver requests
Modified
1
1
0
Form
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
Form
FDA Form 2658
Registered Establishment
Instruction
Instruction
Form
FDA Form 2657
Drug Product Listing (New Drug Listing)
Other-guidance document
Total burden requested under this ICR:
45168
227222
0
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