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

Forms and Documents

Document Name	Status
2195.05_ss_Attachment I_Data and Methodology Used.docx Supplementary Document	2016-08-22
2195.05_ss_Attachment H_Consultation Responses.pdf Supplementary Document	2016-08-22
2195.05_ss_Attachment G_Display Related to OMB Control Number.pdf Supplementary Document	2016-08-22
2195.05_ss_Attachment F_Estimated Wage Rates_May 2014.pdf Supplementary Document	2016-08-22
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
2195.05_ss_Attachment E_Estimated Wage Rates_May 2014.pdf Supplementary Document	2016-08-22
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
2195ss05.docx Supporting Statement A	2016-08-22

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: 201608-2070-001
Status: Active	Previous ICR Reference No: 201207-2070-004
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2195.05
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 without change	Conclusion Date: 04/04/2019
	Date Received in OIRA: 08/30/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	36 Months From Approved	04/30/2019
Responses	17	0	17
Time Burden (Hours)	10,242	0	14,953
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:
	80 FR 80360	12/24/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 59224	08/29/2016
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	17	0	0	0	0
Annual Time Burden (Hours)	10,242	14,953	0	0	-4,711	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 4,711 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This decrease is due to a reduction in the preparation of protocols and studies. This change is an adjustment.

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Annual Cost to Federal Government: $338,854

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: 08/30/2016

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