Recordkeeping for Institutional Dual Use Research of Concern (iDURC) Policy Compliance

Forms and Documents

Document Name	Status
2530ss01.docx Supporting Statement A	2016-01-28

IC Document Collections

IC ID	Document Title	Status
219895	Federally-owned, Contractor-run Labs Other-DURC Policy	New
219893	Private Sector Other-DURC Policy	New

ICR Details

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
	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

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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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Private Sector
Federally-owned, Contractor-run Labs

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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.

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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

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Common Form ICR:  No

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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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