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Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services - 606.171

IC 178970 under ICR 201701-0910-007 · OMB 0910-0458.

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Document Type
Form and Instruction
Form and Instruction
Information Collection (IC) Details

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Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services - 606.171
 
No Modified
 
Mandatory
 
21 CFR 606.171

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 3486 Biological Product Deviation Report FORM FDA-3486 12-5-13.pdf Yes Yes Fillable Printable

Health Consumer Health and Safety

 

1,738 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 45,774 0 0 -9,180 0 54,954
Annual IC Time Burden (Hours) 91,548 0 0 -18,360 0 109,908
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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