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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:
0910-0458
ICR Reference No:
201111-0910-002
Status:
Historical Active
Previous ICR Reference No:
201006-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
11/02/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/02/2011
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2014
01/31/2014
01/31/2014
Responses
46,950
0
46,950
Time Burden (Hours)
90,030
0
90,030
Cost Burden (Dollars)
0
0
0
Abstract:
FDA requires that all licensed manufacturers of biological products other than blood and blood products, all licensed manufacturers of human blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services report all biological product deviations in manufacturing for distributed products. It provides a more accurate surveillance of the nations blood supply, thereby enabling FDA to monitor actions taken in response to biological product deviations detected for all these establishments. This facilitates a rapid response by FDA where the public health may be at risk.
Authorizing Statute(s):
US Code:
42 USC 262
Name of Law: PHS Act
US Code:
21 USC 351
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
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
Biological Products: Reporting of Biolgical Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
3486, FDA 3486A, FDA 3486A
Biological Product Deviation Report
,
BPDR SUPPLEMENTAL INFORMATION
,
Recall Classification
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
3486
Biological Product Deviation Report
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
3486, FDA 3486A
Biological Product Deviation Report
,
BPDR SUPPLEMENTAL INFORMATION
Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
3486
Biological Product Deviation Report
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
46,950
46,950
0
0
0
0
Annual Time Burden (Hours)
90,030
90,030
0
0
0
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:
$812,526
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:
Eliazabeth Berbakos 3018271482
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:
11/02/2011
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