[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Notices]
[Pages 75707-75709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29483]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0414; FRL-8751-2]
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
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
[[Page 75708]]
announces 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.
DATES: Additional comments may be submitted on or before January 12,
2009.
ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2008-0414, to (1) EPA online using www.regulations.gov (our preferred
method), by e-mail to opp.ncic@epa.gov, 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.
FOR FURTHER INFORMATION CONTACT: 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: hogue.joe@epa.gov.
SUPPLEMENTARY INFORMATION: 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
www.regulations.gov, 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
www.regulations.gov, 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 www.regulations.gov 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 www.regulations.gov.
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
[[Page 75709]]
implemented, 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.
Dated: December 8, 2008.
John Moses,
Acting Director, Collection Strategies Division.
[FR Doc. E8-29483 Filed 12-11-08; 8:45 am]
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