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

ICR 200811-0910-006

OMB: 0910-0116

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2009-02-06
Supplementary Document
2009-02-06
Supporting Statement A
2008-11-17
ICR Details
0910-0116 200811-0910-006
Historical Active 200510-0910-006
HHS/FDA
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components
Revision of a currently approved collection   No
Regular
Approved with change 02/10/2009
Retrieve Notice of Action (NOA) 11/20/2008
This ICR is approved consistent with FDA memo of 1/23/09 and on the understanding that 1)0910-0460 has already been discontinued and 2) that the burden changes are largely the result of a technical error in the number of responses entered into the system in 2005. FDA also agrees to discontinue 0910-0610 within 2 months of this approval.
  Inventory as of this Action Requested Previously Approved
02/29/2012 36 Months From Approved 02/28/2009
3,011,033 0 530,829
426,913 0 564,678
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.

US Code: 42 USC 351 Name of Law: PHS Act
   US Code: 21 USC 321 Name of Law: FFDCA
  
None

Not associated with rulemaking

  73 FR 35694 06/24/2008
73 FR 66901 11/12/2008
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 3,011,033 530,829 0 0 2,480,204 0
Annual Time Burden (Hours) 426,913 564,678 0 0 -137,765 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$2,109,298
No
No
Uncollected
Uncollected
Uncollected
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.
11/20/2008


© 2024 OMB.report | Privacy Policy