Donor Exceptions

Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - Final Rule

OMB: 0910-0795

IC ID: 183141

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Donor Exceptions CBER
 
No Modified
 
Mandatory
 
21 CFR 630.20(c)

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

Health Consumer Health and Safety

 

1,945 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 1,945 84,656 -82,711 0 0 0
Annual IC Time Burden (Hours) 1,945 677,248 -675,303 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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