View Information Collection Request (ICR) Package
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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:
202301-0910-014
Status:
Active
Previous ICR Reference No:
201911-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CBER
Title:
Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
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 without change
Conclusion Date:
02/27/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/24/2023
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2026
36 Months From Approved
02/28/2023
Responses
15,176
0
49,328
Time Burden (Hours)
29,579
0
94,592
Cost Burden (Dollars)
0
0
4,256,663
Abstract:
This information collection supports agency regulations regarding the reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product deviations. Respondents to the collection are manufacturers of these products. The information collection supports the agency's mission to protect the public health by safeguarding against the transmission and spread of communicable disease.
Authorizing Statute(s):
US Code:
21 USC 351
Name of Law: Adulterated Drugs and Devices
PL:
Pub.L. 78 - 410 351
Name of Law: Public Health Service Act; Biological Products
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:
87 FR 36512
06/17/2022
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 1074
01/06/2023
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
Form FDA 3486A; Web-based Addendum
FDA 3486A
Biological Product Deviation Report; web-based Addendum
HCT/P deviations
FDA 3486
Biological Product Deviation Report
Reporting of Biological Product Deviations by Licensed Manufacturer
FDA 3486
Biological Product Deviation Report
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services
FDA 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
15,176
49,328
0
0
-34,152
0
Annual Time Burden (Hours)
29,579
94,592
0
0
-65,013
0
Annual Cost Burden (Dollars)
0
4,256,663
0
0
-4,256,663
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:
Our estimated burden for the information collection reflects an overall decrease of 65,013 hours and 34,152 responses annually. We attribute this adjustment to a decrease in the number of reports we received since last evaluation of the information collection.
Annual Cost to Federal Government:
$285,460
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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?
No
Agency Contact:
Domini Bean 301 796-5733 domini.bean@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:
01/24/2023
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