Initial registration

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

Documents and Forms

Document Name Document Type
0052 Screen Shots - eBER.pdf Other-eSystem screen shots
BER-Instructions-Electronic-Blood-Estab-Registration-Product-Listing-Form.pdf Instruction
CBER On-Line Login Page.docx Instruction

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

Information Collection Instruments:

Document Type	Instrument File	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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 176	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	176	24	152
Annual IC Time Burden (Hours)	176	24	152
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.