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Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects; EPA ICR No. 2195.03, OMB Control No. 2070-0169

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Environmental Protection Agency (EPA).




In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document Start Printed Page 75708announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.


Additional comments may be submitted on or before January 12, 2009.


Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2008-0414, to (1) EPA online using (our preferred method), by e-mail to, or by mail to: OPP Regulatory Public Docket (7502P), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

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Joseph Hogue, Field and External Affairs Division, Office of Pesticide Programs, (7506P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-308-9072; fax number: 703-305-5884; e-mail address:

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EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On June 13, 2008 (73 FR 33811), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received two comments during the comment period, which are addressed in the ICR. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2008-0414, which is available for online viewing at, or in person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

Use EPA's electronic docket and comment system at, to submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the docket that are available electronically. Once in the system, select “docket search,” then key in the docket ID number identified above. Please note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing at as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information (CBI), or other information whose public disclosure is restricted by statute. For further information about the electronic docket, go to

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

ICR numbers: EPA ICR No. 2195.03, OMB Control No. 2070-0169.

ICR Status: This ICR is scheduled to expire on January 31, 2009. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: In January 2006, EPA issued a final rule to amend the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) at 40 CFR part 26. EPA's final rule significantly strengthened and expanded the protections for subjects of “third-party” human research (i.e., research that is not conducted or supported by EPA). Affected entities are required to submit information to EPA and an institutional review board (IRB) prior to initiating, and to EPA upon the completion of, certain studies that involve human research participants. The information collection activity imposed by this final rule 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.

This renewal ICR estimates the third party response burden from complying with the January 2006 final rule. Information is typically submitted by registrants of pesticide products to support the registration of their products. Responses to this collection of information are mandatory. The authority for this information collection is provided under section 25 of FIFRA and 40 CFR part 26.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 598 hours per response for research involving intentional exposure of human subjects, and 12 hours per response for all other submitted research with human subjects. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Pesticide registrants.

Estimated Number of Responses: 54.

Frequency of Response: On occasion.

Estimated Total Annual Hour Burden: 20,572.

Estimated Total Annual Cost: $1,579,098, includes $0 annualized capital or O&M costs.

Changes in the Estimates: There is an increase of 19,168 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is an adjustment to the estimate, based on input received during the consultation process from entities that have submitted human subjects research since the implementation of the rule. The burden estimates in the previous (new) ICR were developed before the rule was Start Printed Page 75709implemented, and were based on EPA's predictions of how long it would take study sponsors to prepare submissions. Based on the information provided in the consultation responses, it appears that the actual amount of time necessary to comply with the paperwork and recordkeeping requirements is higher than originally estimated.

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Dated: December 8, 2008.

John Moses,

Acting Director, Collection Strategies Division.

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[FR Doc. E8-29483 Filed 12-11-08; 8:45 am]