
[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]                         

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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.

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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:

I. 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.

II. 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.

III. 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.

IV. 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.

[[Page 33813]]

V. 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]

BILLING CODE 6560-50-S
