Initial registration

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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0052 can be found here:

Documents and Forms

Document Name Document Type
0052 Screen Shots - eBER.pdf Other-eSystem screen shots

Information Collection (IC) Details

IC Title:	Initial registration	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 607.37, 607.39 21 CFR 607.40 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 607.65

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 115	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	115	47	68
Annual IC Time Burden (Hours)	115	47	68
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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.