Information Collection

Annual Report - Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

IC 43606 under ICR 201207-0910-004 · OMB 0910-0594.

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Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
0594 GUIDANCE 6-29-12.pdf	Other-Guidance Document

Information Collection (IC) Details

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IC Title:

Annual Report - Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance Document			0594 GUIDANCE 6-29-12.pdf		Yes	Yes	Paper Only

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 4

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	4	4
Annual IC Time Burden (Hours)	20	20
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.