600.80(c)(2)

Adverse Experience Reporting for Licensed Biological Product; and General Records

OMB: 0910-0308

IC ID: 185787

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600.80(c)(2)
 
No Modified
 
Mandatory
 
21 CFR 600.80(c)(2)

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

Health Consumer Health and Safety

 

108 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 57,300 0 0 35,428 0 21,872
Annual IC Time Burden (Hours) 1,604,400 0 0 991,984 0 612,416
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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