CGMP for Blood and Blood Components: Recordkeeping Requirements

Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"

OMB: 0910-0116

IC ID: 187286

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CGMP for Blood and Blood Components: Recordkeeping Requirements CBER
No Modified
21 CFR 630 21 CFR 606 21 CFR 640 21 CFR 610

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

Health Consumer Health and Safety


8,431 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 3,528,862 0 0 929,285 0 2,599,577
Annual IC Time Burden (Hours) 495,247 0 0 50,318 0 444,929
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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