Agency Information Collection Activities; Proposals, Submissions, and Approvals

Federal Register: June 13, 2008 (Volume 73, Number 115)

Notices

Page 33811-33813

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr13jn08-51

ENVIRONMENTAL PROTECTION AGENCY

EPA-HQ-OPP-2008-0414; FRL-8366-3

Agency Information Collection Activities; Proposed Collection;

Comment Request; Submission of Protocols and Study Reports for

Environmental Research Involving Human Subjects; EPA ICR No. 2195.03,

OMB Control No. 2070-0169

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44

U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection

Request (ICR) to the Office of Management and Budget (OMB). This ICR, entitled: ``Submission of Protocols and Study Reports for Environmental

Research Involving Human Subjects'' and identified by EPA ICR No. 2195.03 and OMB Control No. 2070-0169, is scheduled to expire on

January 31, 2009. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection.

DATES: Comments must be received on or before August 12, 2008.

ADDRESSES: Submit your comments, identified by docket identification

(ID) number EPA-HQ-OPP-2008-0414, by one of the following methods:

Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.

Mail: Office of Pesticide Programs (OPP) Regulatory Public

Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460-0001.

Delivery: OPP Regulatory Public Docket (7502P),

Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South

Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The

Docket Facility telephone number is (703) 305-5805.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP- 2008-0414. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be

Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e- mail. The regulations.gov website is an ``anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e- mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the

Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the

``Submit'' button. Follow the instructions on the regulations.gov website to view the docket index or access available documents.

Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://

Page 33812

www.regulations.gov, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this

Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Hogue, Field and External

Affairs Division (7506P), Office of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 308-9072; fax number: (703) 305-5884; e- mail address: hogue.joe@epa.gov.

SUPPLEMENTARY INFORMATION:

1. What Information is EPA Particularly Interested in?

   Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits comments and information to enable it to: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility. 2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used. 3. Enhance the quality, utility, and clarity of the information to be collected. 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

2. What Should I Consider when I Prepare My Comments for EPA?

   You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible and provide specific examples. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the collection activity. 7. Make sure to submit your comments by the deadline identified under DATES. 8. To ensure proper receipt by EPA, be sure to identify the docket

   ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal

   Register citation.

3. What Information Collection Activity or ICR Does this Action Apply to?

   Affected entities: Entities potentially affected by this action are those that submit protocols and study reports for environmental research involving human subjects under the pesticide laws, typically registrants of pesticide products (NAICS 325320).

   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 currently scheduled to expire on January 31, 2009. 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 January 2006 final rule significantly strengthens and expands the protections for subjects of

   ``third-party'' human research (i.e., research that is not conducted or supported by EPA). 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 institutional review board (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 intentional dosing of human subjects when such research is submitted to EPA. Responses to this collection of information are mandatory.

   Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 32 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.

   The ICR provides a detailed explanation of this estimate, which is only briefly summarized here:

   Estimated total number of potential respondents: 62.

   Frequency of response: On occasion.

   Estimated total average number of responses for each respondent: 1.

   Estimated total annual burden hours: 1,404 hours.

   Estimated total annual costs: $84,674. This includes an estimated burden cost of $84,674 with no additional cost for capital investment or maintenance and operational costs.

4. Are There Changes in the Estimates from the Last Approval?

   There is no change in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB.

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5. What is the Next Step in the Process for this ICR?

   EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another

   Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under FOR

   FURTHER INFORMATION CONTACT.

   List of Subjects

   Environmental protection, Reporting and recordkeeping requirements.

   Dated: June 4, 2008.

   James B. Gulliford,

   Assistant Administrator, Office of Prevention, Pesticides and Toxic

   Substances.

   FR Doc. E8-13346 Filed 6-12-08; 8:45 am

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