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⚠️ Notice: This information collection may be referencing outdated material.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
Form 2830 Initial registration Form and Instruction
2830 Blood Establishment Registration and Product Listing FORM FDA 2830 1-21-15.pdf Form and 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 607.20, 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

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 68	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Previously Approved
Annual Number of Responses for this IC	68	68
Annual IC Time Burden (Hours)	68	68
Annual IC Cost Burden (Dollars)	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.