Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

ICR 200908-0910-003

OMB: 0910-0594

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-07-16
ICR Details
0910-0594 200908-0910-003
Historical Active 200606-0910-002
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Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle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 09/15/2009
Retrieve Notice of Action (NOA) 08/10/2009
  Inventory as of this Action Requested Previously Approved
09/30/2012 36 Months From Approved 09/30/2009
4 0 4
20 0 20
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The draft guidance document serves as the special control to support the reclassification from class III to class II of the automated blood cell separator device operating on a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.

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

Not associated with rulemaking

  74 FR 9097 03/02/2009
74 FR 38196 07/31/2009
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

$248
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
08/10/2009


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