Initial listing (including NDC) information

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

OMB: 0910-0045

IC ID: 183173

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

View Information Collection (IC)

Initial listing (including NDC) information CDER
 
No Unchanged
 
Mandatory
 
21 CFR 207 21 CFR 207.33 21 CFR 207.41, 207.45, 207.49 21 CFR 207.53, 207.54, 207.55

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

1,713 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 12,470 0 0 0 0 12,470
Annual IC Time Burden (Hours) 18,705 0 0 0 0 18,705
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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