New registrations, including new labeler codes requests

Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

OMB: 0910-0045

IC ID: 183172

Information Collection (IC) Details

View Information Collection (IC)

New registrations, including new labeler codes requests
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR CFR Part 207  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA Form 2656 Registration of Drug Establishment (New registration, including new labeler codes for private label distributor) FDA-2656.doc No No Paper Only
Form FDA Form 2658 Registered Establishment FDA-2658.pdf No No Paper Only
Instruction 2658instruc..htm No No Paper Only
Instruction form2656.htm No No Paper Only
Form FDA Form 2657 Drug Product Listing (New Drug Listing) FDA-2657.pdf No No Paper Only
Other-guidance document Reg and list final guid 12-5-08 to OMB.doc No No Paper Only

Health Consumer Health and Safety

 

39 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 574 0 0 0 0 574
Annual IC Time Burden (Hours) 2,583 0 0 0 0 2,583
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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