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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:
201201-0910-001
Status:
Historical Active
Previous ICR Reference No:
200811-0910-006
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:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
04/09/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/03/2012
Terms of Clearance:
OMB notes compliance with the prior terms of clearance.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2015
36 Months From Approved
04/30/2012
Responses
3,206,393
0
3,011,033
Time Burden (Hours)
506,637
0
426,913
Cost Burden (Dollars)
0
0
0
Abstract:
The information collection requirements in the CGMP, donor testing, donor notification, and "lookback" regulations 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 requirements 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 requirements have been met, and facilitate the tracing back of a product to its original source. The reporting requirements inform FDA of any deviations that occur and that may require immediate corrective action.
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:
76 FR 45262
07/28/2011
30-day Notice:
Federal Register Citation:
Citation Date:
76 FR 79692
12/22/2011
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Recordkeeping burden: SOPs and maintenance of records
Reporting burden: adverse reactions and testing
Third party disclosure: adverse reactions, test requirements, labeling, "lookback" requirements, donor notification
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
3,206,393
3,011,033
0
0
195,360
0
Annual Time Burden (Hours)
506,637
426,913
0
0
79,724
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:
The current increase to 506,637 burden hours (an increase of 79,724 hours) is attributed to an increase in the number of total annual records under ยง 606.160, which was due to an increase in the number of donations for both Whole Blood and Source Plasma.
Annual Cost to Federal Government:
$1,901,868
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 [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
Common Form ICR:
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:
(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:
01/03/2012
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