Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

ICR 201207-0910-004

OMB: 0910-0594

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-07-06
ICR Details
0910-0594 201207-0910-004
Historical Active 200908-0910-003
HHS/FDA
Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Extension without change of a currently approved collection   No
Regular
Approved without change 08/15/2012
Retrieve Notice of Action (NOA) 07/17/2012
  Inventory as of this Action Requested Previously Approved
08/31/2015 36 Months From Approved 09/30/2012
4 0 4
20 0 20
0 0 0

The special control draft guidance document serves to support the reclassification from class III to class II of the automated blood cell separator device that operates by either centrifugal or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).

PL: Pub.L. 101 - 629 104 Name of Law: Safe Medical Devices Act of 1990
  
None

Not associated with rulemaking

  77 FR 8879 02/15/2012
77 FR 41410 07/13/2012
No

  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
No
No

$272
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/17/2012


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