Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components

ICR 200510-0910-006

OMB: 0910-0116

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0116 200510-0910-006
Historical Active 200210-0910-003
HHS/FDA
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components
Extension without change of a currently approved collection   No
Regular
Approved without change 12/13/2005
Retrieve Notice of Action (NOA) 10/26/2005
  Inventory as of this Action Requested Previously Approved
12/31/2008 12/31/2008 12/31/2005
530,829 0 42,435
564,678 0 335,346
0 0 0

The recordkeeping requirements serve preventative and remedial purposes, and ensure that industry has needed information to perform the #lookback# procedures. The reporting requirements inform FDA or any deviations that occur and that may require immediate corrective action. The disclosure requirements identify the blood and blood components and their important properties, that they meet the CGMP requirements, and facilitate their source tracing. Consignee notification ensures that the prior collections of products are appropriately quarantined.

None
None


No

1
IC Title Form No. Form Name
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components

  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 530,829 42,435 0 0 488,394 0
Annual Time Burden (Hours) 564,678 335,346 0 0 229,332 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
10/26/2005


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