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

Forms and Documents

Document Name	Status
2530ss02.docx Supporting Statement A	2016-09-22

IC Document Collections

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

ICR Details

OMB Control No: 2080-0082	ICR Reference No: 201609-2080-001
Status: Historical Active	Previous ICR Reference No: 201601-2080-001
Agency/Subagency: EPA/ORD	Agency Tracking No: 2530.02
Title: Recordkeeping for Institutional Dual Use Research of Concern (iDURC) Policy Compliance
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: 01/17/2017
	Date Received in OIRA: 09/28/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	01/31/2017
Responses	24	0	24
Time Burden (Hours)	72	0	72
Cost Burden (Dollars)	0	0	0

---

Abstract: To comply with the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (Policy) (www.phe.gov/s3/dualuse/Pages/default.aspx), EPA must ensure that the institutions that are subject to the Policy train their laboratory personnel and maintain records of that training. This training is specific to "dual use research of concern," and should include information on how to properly identify DURC and appropriate methods for ensuring research that is determined to be DURC is conducted and communicated responsibly.

---

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
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 33530	05/26/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 66658	09/28/2016
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
Private Sector
Federally-owned, Contractor-run Labs

---

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	24	0	0	0	0
Annual Time Burden (Hours)	72	72	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: $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

---

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: 09/28/2016

---