Institutional Dual Use Research of Concern (iDURC) Policy Compliance (Renewal)

Forms and Documents

Document Name	Status
Form XX Federally-owned, Contractor-run Labs Form and Instruction	Modified
Form XX Private Sector Form and Instruction	Modified
2530ss03.docx Supporting Statement A	2020-01-24

IC Document Collections

IC ID	Document Title	Status
219895	Federally-owned, Contractor-run Labs Form and Instruction	Modified
219893	Private Sector Form and Instruction	Modified

ICR Details

OMB Control No: 2080-0082	ICR Reference No: 202001-2080-001
Status: Active	Previous ICR Reference No: 201609-2080-001
Agency/Subagency: EPA/ORD	Agency Tracking No: 2530.03
Title: Institutional Dual Use Research of Concern (iDURC) Policy Compliance (Renewal)
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: 02/28/2020
	Date Received in OIRA: 01/29/2020
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	36 Months From Approved	02/29/2020
Responses	40	0	24
Time Burden (Hours)	20	0	72
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. The purpose of the Policy is to identify Dual Use Research of Concern (DURC) and implement risk mitigation measures where applicable. DURC applies to life science research that provides knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. Institutions subject to the iDURC Policy are those within the United States that (1) receive funding from the U.S. Government to conduct or sponsor life sciences research and (2) conduct or sponsor reserach that involves one or more of the 15 agents or toxins identified in the iDURC Policy, even if the research is not supported by U.S. Government funding. Institutions outside of the United States that receive U.S. Government funding to conduct or sponsor research that involves one or more of the 15 agents or toxins identified in the iDURC Policy are also subject to the Policy. The iDURC Policy requires that institutions subject to the Policy provide education and training on DURC for individuals conducting life sciences research with one or more of the 15 agents or toxins identified in the iDURC Policy. It is also required that they maintain education and training records for the term of the research grant or contract. The policy states that records must be saved for three years after its completion, but no less than eight years, unless a shorter period is required by law or regulation.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 20352	05/09/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 5206	01/29/2020
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	XX	DURC Policy
Federally-owned, Contractor-run Labs	XX	DURC Policy

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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	40	24	0	0	16	0
Annual Time Burden (Hours)	20	72	0	0	-52	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: There is a decrease of 52 burden hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is a result of adjustments in estimates of time required for recordkeeping duties. The previous ICR was a first-time estimate of the number of hours it would take for individuals to complete training and maintain those records, based on similar training efforts that were in place at the time. The EPA-developed DURC training, as one example, requires about 20 minutes of an individuals time, with an additional 10 minutes for maintaining those records. Since then, in EPAs consultation with the private sector, the Agency learned that DURC training had been incorporated into ongoing and broader biosecurity and biosafety training and that the recordkeeping responsibilities covered in this ICR consume significantly less time than originally anticipated. Total burden hours have been adjusted accordingly.

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Annual Cost to Federal Government: $530

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? 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: 01/29/2020

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