Component, Drug, Product Container, Closure, and Labeling Records

Current Good Manufacturing Practices for Finished Pharmaceuticals

OMB: 0910-0139

IC ID: 215475

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Information Collection (IC) Details

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Component, Drug, Product Container, Closure, and Labeling Records CDER
 
No New
 
Mandatory
 
21 CFR 211.184

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

Health Public Health Monitoring

 

4,360 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 13,080 0 0 13,080 0 0
Annual IC Time Burden (Hours) 6,540 0 0 6,540 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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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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