Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

ICR 200606-0910-002

OMB: 0910-0594

Federal Form Document

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ICR Details
0910-0594 200606-0910-002
Historical Active
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Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 09/19/2006
Retrieve Notice of Action (NOA) 06/13/2006
  Inventory as of this Action Requested Previously Approved
09/30/2009 36 Months From Approved
4 0 0
20 0 0
0 0 0

The draft guidance document serves as the special control to support the reclassification from class III to class II of the automated blood cell separator device operating on a centrifugal or filtration separation principle intended for the routine collection of blood and blood components.

None
None


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 0 0 4 0 0
Annual Time Burden (Hours) 20 0 0 20 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
06/13/2006


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