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1. EXPLAIN THE CIRCUMSTANCES THAT MAKE THE COLLECTION 

OF INFORMATION NECESSARY. IDENTIFY ANY LEGAL OR 

ADMINISTRATIVE REQUIREMENTS THAT NECESSITATE THE 

COLLECTION. 

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 required to maintain records of their training. EPA is submitting an

information collection request for these recordkeeping requirements.

2. INDICATE HOW, BY WHOM, AND FOR WHAT PURPOSE THE 

INFORMATION IS TO BE USED. EXCEPT FOR A NEW COLLECTION, 

INDICATE THE ACTUAL USE THE AGENCY HAS MADE OF THE 

INFORMATION RECEIVED FROM THE CURRENT COLLECTION.

The iDURC Policy requires that individuals conducting research involving a certain set of agents 

or toxins must be trained, and records of their training must be maintained. Institutions are to 

provide training and maintain their training records. EPA may choose to collect the records, if 

appropriate. EPA expects that private industry and the federal government, in the form of 

government-owned/contractor-operated laboratories, will be affected by this information 

collection. The information may be used to ensure EPA is in compliance with the Policy, and 

that institutions receiving EPA funding are in compliance as well.

3. DESCRIBE WHETHER, AND TO WHAT EXTENT, THE COLLECTION OF 

INFORMATION INVOLVES THE USE OF AUTOMATED, ELECTRONIC, 

MECHANICAL, OR OTHER TECHNOLOGICAL COLLECTION 

TECHNIQUES OR OTHER FORMS OF INFORMATION TECHNOLOGY, 

E.G. PERMITTING ELECTRONIC SUBMISSION OF RESPONSES, AND 

THE BASIS FOR THE DECISION FOR ADOPTING THIS MEANS OF 

COLLECTION. ALSO DESCRIBE ANY CONSIDERATION OF USING 

INFORMATION TECHNOLOGY TO REDUCE BURDEN. 

EPA may request records be transmitted electronically to the Agency by the institution. 

Institutions may provide training and maintain records as best fits their organization.
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4. DESCRIBE EFFORTS TO IDENTIFY DUPLICATION. SHOW 

SPECIFICALLY WHY ANY SIMILAR INFORMATION ALREADY 

AVAILABLE CANNOT BE USED OR MODIFIED FOR USE FOR THE 

PURPOSE(S) DESCRIBED IN ITEM 2 ABOVE.

There is no duplication as there are no other sources available to collect this information. EPA 

will only require the institutions it directly funds for research involving any of the agents or 

toxins listed in the iDURC Policy, or those referred to EPA by the National Institutes of Health

(NIH) to maintain training records. EPA expects that the amount referred by NIH will be de 

minimis.

5. IF THE COLLECTION OF INFORMATION IMPACTS SMALL 

BUSINESSES OR OTHER SMALL ENTITIES, DESCRIBE THE 

METHODS USED TO MINIMIZE BURDEN.

This collection of information is not reasonably expected to impact small businesses or other 

small entities. 

6. DESCRIBE THE CONSEQUENCE TO FEDERAL PROGRAM OR 

POLICY ACTIVITIES IF THE COLLECTION IS NOT CONDUCTED OR 

IS CONDUCTED LESS FREQUENTLY, AS WELL AS ANY TECHNICAL 

OR LEGAL OBSTACLES TO REDUCING BURDEN.

The aim of the iDURC Policy is to ensure the benefits of certain types of research are conducted 

and communicated responsibly, while minimizing the risks that the results of such research are 

used in a manner that results in harm. If the collection is not conducted, EPA cannot guarantee

that institutions are complying with and supporting the goal of the iDURC Policy. 

7. EXPLAIN ANY SPECIAL CIRCUMSTANCES THAT WOULD CAUSE 

AN INFORMATION COLLECTION TO BE CONDUCTED IN A 

MANNER: 

- REQUIRING RESPONDENTS TO REPORT 

INFORMATION TO THE AGENCY MORE OFTEN THAN 

QUARTERLY; 

- REQUIRING RESPONDENTS TO PREPARE A WRITTEN 

RESPONSE TO A COLLECTION OF INFORMATION IN 

FEWER THAN 30 DAYS AFTER RECEIPT OF IT;

- REQUIRING RESPONDENTS TO SUBMIT MORE THAN 

AN ORIGINAL AND TWO COPIES OF ANY DOCUMENT; 

- REQUIRING RESPONDENTS TO RETAIN RECORDS, 

OTHER THAN HEALTH, MEDICAL, GOVERNMENT 
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CONTRACT, GRANT-IN-AID, OR TAX RECORDS FOR 

MORE THAN 3 YEARS; 

- IN CONNECTION WITH A STATISTICAL SURVEY, THAT 

IS NOT DESIGNED TO PRODUCE VALID AND 

RELIABLE RESULTS THAT CAN BE GENERALIZED TO 

THE UNIVERSE OF STUDY;

- REQUIRING THE USE OF A STATISTICAL DATA 

CLASSIFICATION THAT HAS NOT BEEN REVIEWED 

AND APPROVED BY OMB;

- THAT INCLUDES A PLEDGE OF CONFIDENTIALITY 

THAT IS NOT SUPPORTED BY AUTHORITY 

ESTABLISHED IN STATUE OR REGULATION, THAT IS 

NOT SUPPORTED BY DISCLOSURE AND DATA 

SECURITY POLICIES THAT ARE CONSISTENT WITH 

THE PLEDGE, OR WHICH UNNECESSARILY IMPEDES 

SHARING OF DATA WITH OTHER AGENCIES FOR 

COMPATIBLE CONFIDENTIAL USE; OR

- REQUIRING RESPONDENTS TO SUBMIT 

PROPRIETARY TRADE SECRET, OR OTHER 

CONFIDENTIAL INFORMATION UNLESS THE AGENCY 

CAN DEMONSTRATE THAT IT HAS INSTITUTED 

PROCEDURES TO PROTECT THE INFORMATION'S 

CONFIDENTIALITY TO THE EXTENT PERMITTED BY 

LAW. 

The iDURC Policy requires that training records be maintained for the term of the research grant 

or contract, plus 3 years after its completion. EPA may ask institutions to comply with this 

section of the Policy and retain such records for more than the 3 years that is stated in the 

question above (requiring respondents to retain records, other than health, medical, government 

contract, grant-in-aid, or tax records for more than 3 years). There are no other special 

circumstances. The collection of information is conducted in a manner consistent with the 

guidelines in 5 CFR 1320.6.

8. IF APPLICABLE, IDENTIFY THE DATE AND PAGE NUMBER 

OF PUBLICATION IN THE FEDERAL REGISTER OF THE AGENCY'S 

NOTICE, REQUIRED BY 5 CFR 1320.8(d), SOLICITING COMMENTS 

ON THE INFORMATION COLLECTION PRIOR TO SUBMISSION TO 

OMB. SUMMARIZE PUBLIC COMMENTS RECEIVED IN RESPONSE 

TO THAT NOTICE AND DESCRIBE ACTIONS TAKEN BY THE 

AGENCY IN RESPONSE TO THESE COMMENTS. SPECIFICALLY 

ADDRESS COMMENTS RECEIVED ON COST AND HOUR BURDEN. 
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As this is being submitted for initial review, public comment is being requested concurrent with 

OMB review. EPA will follow standard public notice and comment procedures in the process of 

renewing this ICR. No comments were received regarding the Emergency ICR currently in 

place.

DESCRIBE EFFORTS TO CONSULT WITH PERSONS OUTSIDE THE 

AGENCY TO OBTAIN THEIR VIEWS ON THE AVAILABILITY OF 

DATA, FREQUENCY OF COLLECTION, THE CLARITY OF 

INSTRUCTIONS AND RECORDKEEPING, DISCLOSURE, OR 

REPORTING FORMAT (IF ANY), AND ON THE DATA ELEMENTS TO 

BE RECORDED, DISCLOSED, OR REPORTED. 

CONSULTATION WITH REPRESENTATIVES OF THOSE FROM 

WHOM INFORMATION IS TO BE OBTAINED OR THOSE WHO MUST 

COMPILE RECORDS SHOULD OCCUR AT LEAST ONCE EVERY 3 

YEARS -- EVEN IF THE COLLECTION OF INFORMATION ACTIVITY 

IS THE SAME AS IN PRIOR PERIODS. THERE MAY BE 

CIRCUMSTANCES THAT MAY PRECLUDE CONSULTATION IN A 

SPECIFIC SITUATION. THESE CIRCUMSTANCES SHOULD BE 

EXPLAINED. 

Efforts to consult respondents or parties interested in this collection are being considered. 

9. EXPLAIN ANY DECISION TO PROVIDE ANY PAYMENT OR GIFT TO 

RESPONDENTS, OTHER THAN REMUNERATION OF 

CONTRACTORS OR GRANTEES. 

No payments or gifts are to be provided to respondents.

10. DESCRIBE ANY ASSURANCE OF CONFIDENTIALITY PROVIDED TO 

RESPONDENTS AND THE BASIS FOR THE ASSURANCE IN STATUTE, 

REGULATION, OR AGENCY POLICY.

EPA does not expect any issues of confidentiality to be relevant to this information collection.

11. PROVIDE ADDITIONAL JUSTIFICATION FOR ANY QUESTIONS OF A 

SENSITIVE NATURE, SUCH AS SEXUAL BEHAVIOR AND 

ATTITUDES, RELIGIOUS BELIEFS, AND OTHER MATTERS THAT 

ARE COMMONLY CONSIDERED PRIVATE. THIS JUSTIFICATION 

SHOULD INCLUDE THE REASONS WHY THE AGENCY CONSIDERS 

THE QUESTIONS NECESSARY, THE SPECIFIC USES TO BE MADE 

OF THE INFORMATION, THE EXPLANATION TO BE GIVEN TO 

PERSONS FROM WHOM THE INFORMATION IS REQUESTED, AND 

ANY STEPS TO BE TAKEN TO OBTAIN THEIR CONSENT. 
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Questions of a sensitive nature are not being posed in this information collection.

12. PROVIDE ESTIMATES OF THE HOUR BURDEN OF THE COLLECTION 

OF INFORMATION. 

THE STATEMENT SHOULD:

- INDICATE THE NUMBER OF RESPONDENTS, 

FREQUENCY OF RESPONSE, ANNUAL HOUR BURDEN, AND 

AN EXPLANATION OF HOW THE BURDEN WAS ESTIMATED. 

UNLESS DIRECTED TO DO SO, AGENCIES SHOULD NOT 

CONDUCT SPECIAL SURVEYS TO OBTAIN INFORMATION ON 

WHICH TO BASE HOUR BURDEN ESTIMATES. 

CONSULTATION WITH A SAMPLE (FEWER THAN 10) OF 

POTENTIAL RESPONDENTS IS DESIRABLE. IF THE HOUR 

BURDEN ON RESPONDENTS IS EXPECTED TO VARY WIDELY 

BECAUSE OF DIFFERENCE IN ACTIVITY, SIZE, OR 

COMPLEXITY, SHOW THE RANGE OF ESTIMATED HOUR 

BURDEN, AND EXPLAIN THE REASONS FOR THE VARIANCE. 

GENERALLY, ESTIMATES SHOULD NOT INCLUDE BURDEN 

HOURS FOR CUSTOMARY AND USUAL BUSINESS 

PRACTICES. 

- IF THIS REQUEST FOR APPROVAL COVERS 

MORE THAN ONE FORM, PROVIDE SEPARATE HOUR 

BURDEN ESTIMATES FOR EACH FORM AND AGGREGATE 

THE HOUR BURDENS. 

EPA currently has funded an average of 2-3 research projects each year involving any of the 

agents or toxins identified in the iDURC Policy over the past three years. EPA anticipates 

funding such projects at the same or lower rate in the coming years, whether through acquisition 

or assistance agreements. EPA estimates that such projects will be conducted by either private 

industry or the federal government in the form of government-owned/contractor-operated labs. 

EPA consulted with a small sample of project officers to estimate burden on respondents. The 

total number of annual respondents is estimated to be 12-24, with about 6-8 respondents per 

research project. The training records, while not necessarily collected by EPA, are expected to be 

completed while or after the research agreement is finalized, and no more frequently than 

annually. The total annual hour burden, based on consultations and estimates of how long the 

training and recordkeeping will take, is 36-64, or about 3 hours per individual respondent. This 

burden was estimated by estimating that training will take 2 hours per individual and that 

retaining records of such training will take up to an hour per individual. EPA estimates that onethird of respondents will be from government-owned/contractor-operated labs, and two-thirds 

from private industry.
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- Provide estimates of annualized cost to respondents for the hour burdens for 

collections of information, identifying and using appropriate wage rate 

categories.

Based on the 3-hour estimate for 12-24 respondents, and at an average wage rate of $40-$60, the 

annualized cost to respondents is estimated to range from $1,440 to $4,320. The hourly wage rate 

was estimated based on consultation with project officers at EPA and Bureau of Labor Statistics 

data on appropriate disciplines and specialties, including Life Scientists and Environmental 

Engineers, among others.

13. PROVIDE AN ESTIMATE OF THE TOTAL ANNUAL COST BURDEN 

TO RESPONDENTS OR RECORDKEEPERS RESULTING FROM THE 

COLLECTION OF INFORMATION. (DO NOT INCLUDE THE COST 

OF ANY HOUR BURDEN SHOWN IN ITEMS 12 AND 14). 

- THE COST ESTIMATE SHOULD BE SPLIT INTO TWO 

COMPONENTS: (a) A TOTAL CAPITAL AND START-UP COST 

COMPONENT (ANNUALIZED OVER ITS EXPECTED USEFUL 

LIFE); AND (b) A TOTAL OPERATION AND MAINTENANCE 

AND PURCHASE OF SERVICES COMPONENT. THE 

ESTIMATES SHOULD TAKE INTO ACCOUNT COSTS 

ASSOCIATED WITH GENERATING, MAINTAINING, AND 

DISCLOSING OR PROVIDING THE INFORMATION. INCLUDE 

DESCRIPTIONS OF METHODS USED TO ESTIMATE MAJOR 

COST FACTORS INCLUDING SYSTEM AND TECHNOLOGY 

ACQUISITION, EXPECTED USEFUL LIFE OF CAPITAL 

EQUIPMENT, THE DISCOUNT RATE(S), AND THE TIME 

PERIOD OVER WHICH COSTS WILL BE INCURRED. CAPITAL 

AND START-UP COSTS INCLUDE, AMONG OTHER ITEMS, 

PREPARATIONS FOR COLLECTING INFORMATION SUCH AS 

PURCHASING COMPUTERS AND SOFTWARE; MONITORING, 

SAMPLING, DRILLING AND TESTING EQUIPMENT; AND 

RECORD STORAGE FACILITIES. 

- IF COST ESTIMATES ARE EXPECTED TO VARY WIDELY, 

AGENCIES SHOULD PRESENT RANGES OF COST BURDENS 

AND EXPLAIN THE REASONS FOR THE VARIANCE. THE 

COST OF PURCHASING OR CONTRACTING OUT 

INFORMATION COLLECTION SERVICES SHOULD BE A PART 

OF THIS COST BURDEN ESTIMATE. IN DEVELOPING COST 

BURDEN ESTIMATES, AGENCIES MAY CONSULT WITH A 

SAMPLE OF RESPONDENTS (FEWER THAN 10), UTILIZE THE 

60-DAY PRE-OMB SUBMISSION PUBLIC COMMENT PROCESS 

AND USE EXISTING ECONOMIC OR REGULATORY IMPACT 

ANALYSIS ASSOCIATED WITH THE RULEMAKING 

CONTAINING THE INFORMATION COLLECTION, AS 
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APPROPRIATE. 

- GENERALLY, ESTIMATES SHOULD NOT INCLUDE 

PURCHASES OF EQUIPMENT OR SERVICES, OR PORTIONS 

THEREOF, MADE: (1) PRIOR TO OCTOBER 1, 1995, (2) TO 

ACHIEVE REGULATORY COMPLIANCE WITH 

REQUIREMENTS NOT ASSOCIATED WITH THE 

INFORMATION COLLECTION, (3) FOR REASONS OTHER 

THAN TO PROVIDE INFORMATION OR KEEPING RECORDS 

FOR THE GOVERNMENT, OR (4) AS PART OF CUSTOMARY 

AND USUAL BUSINESS OR PRIVATE PRACTICES. 

There are no capital, start-up, or ongoing operation or maintenance costs associated with this 

information collection.

14. PROVIDE ESTIMATES OF ANNUALIZED COST TO THE FEDERAL 

GOVERNMENT. ALSO, PROVIDE A DESCRIPTION OF THE METHOD 

USED TO ESTIMATE COST, WHICH SHOULD INCLUDE 

QUANTIFICATION OF HOURS, OPERATION EXPENSES (SUCH AS 

EQUIPMENT, OVERHEAD, PRINTING, AND SUPPORT STAFF), AND 

ANY OTHER EXPENSE THAT WOULD NOT HAVE BEEN INCURRED 

WITHOUT THIS COLLECTION OF INFORMATION. AGENCIES ALSO 

MAY AGGREGATE COST ESTIMATES FROM ITEMS 12, 13, AND 14 

IN A SINGLE TABLE. 

The Agency anticipates incurring some costs associated with this information collection. The 

costs are associated with employee labor and materials for analyzing, evaluating, summarizing, 

and/or reporting on the training records. The costs are summarized below.

The Agency estimates that 0.1 FTE of a GS-14 Employee will be required for potential audits 

and reviewing training records. The annual salary for a GS-14, Step 1 in Washington, DC is 

$108,887. Including the standard overhead factor of 60%, the Agency estimates an annualized 

cost of $17,422. 

15. EXPLAIN THE REASON FOR ANY PROGRAM CHANGES OR 

ADJUSTMENTS IN BURDEN ESTIMATES FROM THE PREVIOUS 

APPROVED ICR. 

There are no changes to the burden estimates from the previously approved Information 

Collection Request.
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Information 

Collection

Reason Previous 

Burden

New Burden Difference Type of 

Change

Recordkeeping 

for iDURC 

Training

ICR

Renewal

0 64 64 PC

PC = Program Change

A = Adjustment

16. FOR COLLECTIONS OF INFORMATION WHOSE RESULTS WILL BE 

PUBLISHED, OUTLINE PLANS FOR TABULATION, AND 

PUBLICATION. ADDRESS ANY COMPLEX ANALYTICAL 

TECHNIQUES THAT WILL BE USED. PROVIDE THE TIME 

SCHEDULE FOR THE ENTIRE PROJECT, INCLUDING BEGINNING 

AND ENDING DATES OF THE COLLECTION OF INFORMATION, 

COMPLETION OF REPORT, PUBLICATION DATES, AND OTHER 

ACTIONS. 

The Agency does not intend to publish any information resulting from this information 

collection.

17. IF SEEKING APPROVAL TO NOT DISPLAY THE EXPIRATION DATE 

FOR OMB APPROVAL OF THE INFORMATION COLLECTION, 

EXPLAIN THE REASONS THAT DISPLAY WOULD BE 

INAPPROPRIATE. 

The Agency plans to display the expiration date for OMB approval of the information collection 

on all applicable instruments.

18. EXPLAIN EACH EXCEPTION TO THE CERTIFICATION STATEMENT 

IDENTIFIED IN ITEM 19, "CERTIFICATION FOR PAPERWORK 

REDUCTION ACT SUBMISSIONS," IN ROCIS. 

The Agency is able to certify compliance with all provisions under Item 19 of OMB Form 83-I.