Waiver requests

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⚠️ Notice: This information collection may be referencing outdated material.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 Form FDA 2830 Waiver requests Form and Instruction
Form FDA 2830 Blood Establishment Registration and Product Listing Form FDA 2830.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Waiver requests	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 607.22, 607.22(b)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form FDA 2830	Blood Establishment Registration and Product Listing	Form FDA 2830.pdf		No		Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 25	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	Previously Approved
Annual Number of Responses for this IC	25	25
Annual IC Time Burden (Hours)	25	25
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.