Adverse Experience Reporting for Licensed Biological Product; and General Records

Adverse Experience Reporting for Licensed Biological Product; and General Records

OMB: 0910-0308

IC ID: 185791

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Adverse Experience Reporting for Licensed Biological Product; and General Records
 
No New
 
Mandatory
 
21 CFR 600.12(b)(2)

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

Health Consumer Health and Safety

 

303 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 1,842 0 1,842 0 0 0
Annual IC Time Burden (Hours) 44,208 0 44,208 0 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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