Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and "Lookback" Requirements

ICR 200210-0910-003

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 200210-0910-003
Historical Active 200009-0910-012
HHS/FDA
Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and "Lookback" Requirements
Extension without change of a currently approved collection   No
Regular
Approved without change 11/27/2002
Retrieve Notice of Action (NOA) 10/10/2002
Approved consistent with clarification in FDA memo of 11-25-02.
  Inventory as of this Action Requested Previously Approved
12/31/2005 12/31/2005 11/30/2003
42,435 0 397
335,346 0 332,403
0 0 0

The information collection requirements in the CGMP regulations and lookback requirements provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirement serve preventative and remedial purposes. The disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP..........

None
None


No

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

  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 42,435 397 0 0 42,038 0
Annual Time Burden (Hours) 335,346 332,403 0 0 2,943 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.
10/10/2002


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