
[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76399-76401]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31023]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9327-3]


Agency Information Collection Activities; Proposed Renewal of 
Several Currently Approved Collections; Comment Request

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 requests to renew several currently approved Information 
Collection Request (ICR) to the Office of Management and Budget (OMB). 
The ICRs are specifically identified in this document by their 
corresponding titles, EPA ICR numbers, OMB Control numbers, and related 
docket identification (ID) numbers. Before submitting these ICRs to OMB 
for review and approval, EPA is soliciting comments on specific aspects 
of the information collection activities.

DATES: Comments must be received on or before February 6, 2012.

ADDRESSES: Submit your comments, identified by the docket ID number for 
the corresponding ICR as identified in this document, 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 Facility'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 the docket ID number for the 
corresponding ICR as identified in this document. 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 email. The regulations.gov Web site 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 email comment directly to EPA without 
going through regulations.gov, your email 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 http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is

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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://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: For questions regarding EPA Docket ID 
Number EPA-HQ-OPP-2011-0704: Lily G. Negash, Field and External Affairs 
Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 347-8515; fax number: (703) 305-5884; 
email address: negash.lily@epa.gov.
    For questions regarding EPA Docket ID Number EPA-HQ-OPP-2011-0902: 
Ryne Yarger, Field and External Affairs Division (7506P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 605-1193; 
fax number: (703) 305-5884; email address: yarger.ryne@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 do I need to know about PRA?

    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information subject to PRA approval 
unless it displays a currently valid OMB control number. The OMB 
control numbers for EPA's regulations in title 40 of the Code of 
Federal Regulations (CFR), after appearing in the preamble of the final 
rule, are further displayed either by publication in the Federal 
Register or by other appropriate means, such as on the related 
collection instruments or form, if applicable. The display of OMB 
control numbers for certain EPA regulations is consolidated in a list 
at 40 CFR 9.1.
    Under PRA, 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.

IV. Which ICRs are being renewed?

    EPA is planning to submit a number of currently approved ICRs to 
OMB for review and approval under PRA. In addition to specifically 
identifying the ICRs by title and corresponding ICR, OMB and docket ID 
numbers, this unit provides a brief summary of the information 
collection activity and the Agency's estimated burden. The Supporting 
Statement for each ICR, a copy of which is available in the 
corresponding docket, provides a more detailed explanation.

A. Docket ID Number EPA-HQ-OPP-2011-0704

    Title: Submission of Protocols and Study Reports for Environmental 
Research Involving Human Subjects.
    ICR number: EPA ICR No. 2195.04.
    OMB control number: OMB Control No. 2070-0169.
    ICR status: The approval for this ICR is scheduled to expire on 
August 31, 2012.
    Affected entities: Entities potentially affected by this ICR 
include anyone who submits protocols and study reports for 
environmental research involving human subjects under FIFRA and/or 
FFDCA. Although EPA has only received such third-party research (i.e., 
research that is not conducted or supported by EPA) in conjunction with 
FIFRA from pesticide registrants, it is conceivable that other entities 
could submit such information in the future. Principal respondents to 
this ICR are employers of physical, engineering, and life scientists in 
the fields of research and development.
    Abstract: The Environmental Protection Agency (EPA or the Agency) 
is responsible for the regulation of pesticides under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal 
Food, Drug, and Cosmetic Act (FFDCA). 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. 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.
    In addition to other protections, if such research involves 
intentional

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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.
    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. The information 
requirements identified in the final rule do not duplicate other 
federal agency information collections.
    The ICR, a copy of which is available in the docket, provides a 
detailed explanation of this estimate, which is only briefly summarized 
here:
    Estimated total number of potential respondents: 54.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 20,572 hours.
    Estimated total annual costs: $1,712,833. This includes an 
estimated burden cost of $1,712,833 and no additional cost for non-
burden hour paperwork costs, e.g., investment or maintenance and 
operational costs.
    Changes in the estimates from the last approval: The renewal of 
this ICR will not result in a change in the number of hours in the 
total estimated respondent burden identified in the currently approved 
ICR.

B. Docket ID Number EPA-HQ-OPP-2011-0902

    Title: Consumer Research through Focus Groups to Develop Improved 
Labeling for Pesticide Products.
    ICR number: EPA ICR No. 2367.02.
    OMB control number: OMB Control No. 2070-0175.
    ICR status: The approval for this ICR is scheduled to expire on 
August 31, 2012.
    Affected entities: Entities potentially affected by this ICR are 
members of the general public who volunteer to participate in a focus 
group.
    Abstract: EPA intends to renew a voluntary information collection 
for consumer research involving the use of focus groups to test various 
versions of pesticide product labels and other informational materials 
intended for the general public. The purpose of this research is to 
identify the consumer's understanding of the information on a pesticide 
product label to assure that the consumer can effectively use this 
information to select the pesticide product most likely to meet their 
needs and can readily understand label instructions regarding the safe 
use, handling, and disposal of the product. The collected information 
will be used to inform the Agency on the need for and nature of 
potential revisions to EPA guidance and regulations regarding pesticide 
product labels and to create other user-friendly consumer information 
materials.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 2 
hours per response. The ICR, a copy of which is available in the 
docket, provides a detailed explanation of this estimate, which is only 
briefly summarized here:
    Estimated total number of potential respondents: 300.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 200 hours.
    Estimated total annual costs: $6,014. There are no capital 
expenditures or operational and maintenance costs associated with this 
collection activity.
    Changes in the estimates from the last approval: The renewal of 
this ICR will result in an overall decrease of 181.34 hours in the 
total estimated respondent burden identified in the currently approved 
ICR. This decrease reflects EPA's actual costs of conducting a series 
of 10 focus groups in 2010. This change is an adjustment.

V. What is the next step in the process for these ICRs?

    EPA will consider the comments received and amend the individual 
ICRs as appropriate. The final ICR packages 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 these ICRs to OMB and the opportunity for 
the public to submit additional comments for OMB consideration. If you 
have any questions about any of these ICRs or the approval process in 
general, please contact the person listed under FOR FURTHER INFORMATION 
CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: November 21, 2011.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2011-31023 Filed 12-6-11; 8:45 a.m.]
BILLING CODE 6560-50-P


