Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects

Forms and Documents

Document Name	Status
ATTACHMENT H_2195-04_A List of Related Regulations in 40 CFR 9-1_Display Related to OMB Control Number.pdf Supplementary Document	2012-05-29
ATTACHMENT G_2195-04_Wage Rates for Pesiticide Registrants.pdf Supplementary Document	2012-05-29
Attachment F_2195-04_Memo - Assumptions and Methodology for Burden Hour Calculations.pdf Supplementary Document	2012-05-29
ATTACHMENT D_2195-04_Applicable Sections of FFDCA 408.pdf Supplementary Document	2012-05-29
ATTACHMENT C_2195-04_Applicable Sections of FIFRA 3_4_and_25.pdf Supplementary Document	2012-05-29
Attachment E_2195-04_Record of Consultations Questionnaire and Responses.pdf Supplementary Document	2012-05-29
Attachment B_2195-04_Appropriations Act, 2006, Pub. Law No. 109-54.pdf Supplementary Document	2012-05-29
Attachment A_Final Rule_2195-04_Protections for Subjects in Human Research_Feb 6 2006.pdf Supplementary Document	2012-05-29
2195ss04_revised_2013-07-31.docx Supporting Statement A	2013-08-02

IC Document Collections

IC ID	Document Title	Status
25015	Research Involving Intentional Exposure of Human Subjects	Modified
187530	All Other Submitted Research with Human Subjects	Modified

ICR Details

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
	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

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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.

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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

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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:
	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

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

IC Title	Form No.	Form Name
Research Involving Intentional Exposure of Human Subjects
All Other Submitted Research with Human Subjects

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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	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.

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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

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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: 07/20/2012

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