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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