June and December review and updates (or certifications) of listing (including NDC) information

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

OMB: 0910-0045

IC ID: 183175

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Other-Agency Guidance
Information Collection (IC) Details

View Information Collection (IC)

June and December review and updates (or certifications) of listing (including NDC) information CDER
 
No Unchanged
 
Mandatory
 
21 CFR 207.35, 207.57 21 CFR 207

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance Reg and Listing 2009 Guidance.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

5,300 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 106,000 0 0 0 0 106,000
Annual IC Time Burden (Hours) 79,500 0 0 0 0 79,500
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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