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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0116
ICR Reference No:
200811-0910-006
Status:
Active
Previous ICR Reference No:
200510-0910-006
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components
Type of Information Collection:
Revision of a currently approved collection
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
02/10/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/20/2008
Terms of Clearance:
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
Expiration Date
02/29/2012
36 Months From Approved
02/28/2009
Responses
3,011,033
3,011,033
530,829
Time Burden (Hours)
426,913
426,913
564,678
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code: 42 USC 351 Name of Law: PHS Act
US Code: 21 USC 321 Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
73 FR 35694
06/24/2008
30-day Notice:
Federal Register Citation:
Citation Date:
73 FR 66901
11/12/2008
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components
Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$2,109,298
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [PPACA, P.L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Agency Contact:
Jonnalynn Capezzuto 3018274659
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
11/20/2008
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