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View Information Collection (IC) List
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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:
2070-0169
ICR Reference No:
201207-2070-004
Status:
Historical Active
Previous ICR Reference No:
200812-2070-001
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
2195.04
Title:
Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects
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 with change
Conclusion Date:
08/12/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/20/2012
Terms of Clearance:
In accordance with 5 CFR 1320, this information collection request package has been approved for 3 years.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2016
36 Months From Approved
08/31/2013
Responses
17
0
54
Time Burden (Hours)
14,953
0
20,572
Cost Burden (Dollars)
0
0
0
Abstract:
The information collection activity consists of activity-driven reporting and recordkeeping requirements for those who intend to conduct research for submission to EPA under the pesticide laws. If such research involves intentional dosing of human subjects, these individuals (respondents) are required to submit study protocols to EPA and a cognizant local Human Subjects IRB before such research is initiated so that the scientific design and ethical standards that will be employed during the proposed study may be reviewed and approved. Also, respondents are required to submit information about the ethical conduct of completed research that involved human subjects when such research is submitted to EPA.
Authorizing Statute(s):
US Code:
21 USC 346a
Name of Law: Federal Food, Drug and Cosmetic Act (FFDCA)
US Code:
7 USC 136
Name of Law: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)
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:
76 FR 76399
12/07/2011
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 42723
07/20/2012
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
All Other Submitted Research with Human Subjects
Research Involving Intentional Exposure of Human Subjects
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
17
54
0
0
-37
0
Annual Time Burden (Hours)
14,953
20,572
0
0
-5,619
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 net decrease of 5,619 hours in the total annual estimated respondent burden; from 20,572 hours for the currently approved ICR to 14,953 hours for this renewal ICR. This change is due to a decrease in the anticipated number of responses per year. The anticipated number of responses per year is based on past submissions to the Agency, and from estimates obtained during the consultation process from entities that have submitted human subjects research since the implementation of the 2006 rule. However, based on the information provided in the consultation responses, it appears that the actual amount of time necessary to comply with the requirements for each response is higher than originally estimated. The estimated annual Agency burden has also decreased due to fewer anticipated responses per year.
Annual Cost to Federal Government:
$259,682
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:
Angela Hofmann
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:
07/20/2012
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