Initial registration

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

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-eSystem screen shots 0052 Screen Shots - eBER.pdf Yes Yes Fillable Fileable
Instruction BER-Instructions-Electronic-Blood-Estab-Registration-Product-Listing-Form.pdf Yes Yes Fillable Fileable
Instruction CBER On-Line Login Page.docx Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

176 0
   
Private Sector Businesses or other for-profits
 
   99 %

  Requested 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 176 0 0 24 0 152
Annual IC Time Burden (Hours) 176 0 0 24 0 152
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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