Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

Forms and Documents

Document	Type	Status	Availability
0594 GUIDANCE FOR INDUSTRY SUPPORTING STATEMENT 7-6-12 FINAL.doc	Supporting Statement A	Uploaded 2012-07-06	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
43606	Annual Report - Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle	Other-Guidance Document	Modified

ICR Details

OMB Control No: 0910-0594	ICR Reference No: 201207-0910-004
Status: Historical Active	Previous ICR Reference No: 200908-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/15/2012
	Date Received in OIRA: 07/17/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	36 Months From Approved	09/30/2012
Responses	4	0	4
Time Burden (Hours)	20	0	20
Cost Burden (Dollars)	0	0	0

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Abstract: The special control draft guidance document serves to support the reclassification from class III to class II of the automated blood cell separator device that operates by either centrifugal or filtration separation principles intended for the routine collection of blood and blood components (21 CFR 864.9245).

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Authorizing Statute(s): PL: Pub.L. 101 - 629 104 Name of Law: Safe Medical Devices Act of 1990
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 8879	02/15/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 41410	07/13/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
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

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	4	4	0	0	0	0
Annual Time Burden (Hours)	20	20	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $272

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/17/2012

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