Postmarketing Safety Reporting for Combination Biological Products

Biological Products; General records and postmarket adverse experience reporting

OMB: 0910-0308

IC ID: 259220

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Postmarketing Safety Reporting for Combination Biological Products
 
No Modified
 
Mandatory
 
21 CFR 4; subpart B 21 CFR 4.101-4.105  (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

Health Consumer Health and Safety

 

11 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 198 0 0 0 0 198
Annual IC Time Burden (Hours) 69 0 0 -20 0 89
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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