Initial registration

Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices

OMB: 0910-0052

IC ID: 5706

Documents and Forms
Information Collection (IC) Details

View Information Collection (IC)

Initial registration CDER
 
No Modified
 
Mandatory
 
21 CFR 607.20, 607.21, 607.22 21 CFR 607.25, 607.26 21 CFR 607 21 CFR 607.30, 607.31, 607.35 21 CFR 607.37, 607.39 21 CFR 607.40 21 CFR 607.65

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 2830 Blood Establishment Registration and Product Listing FORM FDA 2830 1-21-15.pdf Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

68 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 68 0 0 0 0 68
Annual IC Time Burden (Hours) 68 0 0 0 0 68
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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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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