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:
2080-0082
ICR Reference No:
201601-2080-001
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
EPA/ORD
Agency Tracking No:
2530.01
Title:
Recordkeeping for Institutional Dual Use Research of Concern (iDURC) Policy Compliance
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
02/29/2016
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/03/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/04/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2016
6 Months From Approved
Responses
24
0
0
Time Burden (Hours)
72
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The White House Office of Science and Technology Policy issued the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (iDURC Policy) in September 2014. It became effective, September 24, 2015 (79 Federal Register 57589). All federal departments and agencies are required to implement this Policy. Institutions subject to the iDURC Policy are those that receive funding from a USG entity for research that involves a certain set of agents or toxins, or that receive funding from a non-USG entity for the same research and also receive funding from a USG entity for life sciences research. The iDURC Policy requires that institutions subject to the Policy train individuals within their institution that are conducting research involving any of the agents or toxins identified in the Policy. Additionally, institutions are to maintain records of that training. EPA is submitting an emergency information collection request for these recordkeeping requirements.
Emergency Justfication:
EPA is requesting emergency clearance of this ICR under 5 CFR 1320.13(a)(2)(i) because the iDURC policy’s effective date has passed, but without PRA approval the recordkeeping provisions cannot yet be implemented. Standard processing of this ICR would further delay full implementation of the policy, which seeks to mitigate the risk of public harm from life sciences research being misapplied.
Authorizing Statute(s):
None
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
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 5749
02/03/2016
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
Federally-owned, Contractor-run Labs
Private Sector
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
24
0
0
24
0
0
Annual Time Burden (Hours)
72
0
0
72
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
There is no currently approved burden as this is a new information collection request.
Annual Cost to Federal Government:
$17,422
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:
Brendan Doyle 202 564-4584 doyle.brendan@epa.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:
02/04/2016
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