Annual Report

Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0594 can be found here:

Documents and Forms

Document Name Document Type
0594 SCGD Blood Separator.pdf Other-Special Controls Guidance Docu

Information Collection (IC) Details

IC Title:	Annual Report	Agency IC Tracking Number:	CBER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 864.9245 21 CFR 803

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Special Controls Guidance Document			0594 SCGD Blood Separator.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: 3	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 50 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3	-1	4
Annual IC Time Burden (Hours)	15	-5	20
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.