[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32461-32463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13684]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2010-0381; FRL-9159-9]
Human Studies Review Board; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency)
Office of the Science Advisor (OSA) announces a public meeting of the
Human Studies Review Board (HSRB) to advise the Agency on EPA's
scientific and ethical reviews of research with human subjects.
DATES: The public meeting will be held on June 23, 2010, from
approximately 10 a.m. to approximately 5:30 p.m., Eastern Time.
Location: Environmental Protection Agency, Conference Center--Lobby
Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive,
Arlington, VA 22202.
Meeting Access: Seating at the meeting will be on a first-come
basis. To request accommodation of a disability, please contact the
person listed under FOR FURTHER INFORMATION CONTACT at least 10
business days prior to the meeting, to allow EPA as much time as
possible to process your request.
Procedures for Providing Public Input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in section
I., under subsection D., SUPPLEMENTARY INFORMATION of this notice.
FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact Jim Downing, EPA, Office of the
Science Advisor, (8105R), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-2468; fax: (202) 564-2070; e-mail addresses: [email protected].
General information concerning the EPA HSRB can be found on the EPA Web
site at http://www.epa.gov/osa/hsrb/.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2010-0381, by one of the following methods:
Internet: http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),
ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave, NW., Washington,
DC 20460.
Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building,
located at 1301 Constitution Ave., NW., Washington, DC 20460. The hours
of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through
Friday, excluding Federal holidays. Please call (202) 566-1744 or e-
mail the ORD Docket at [email protected] for instructions. Updates to
Public Reading Room access are available on the Web site (http://www.epa.gov/epahome/dockets.htm).
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2010-0381. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online 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 the
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.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 e-mail comment directly to EPA, without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public 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.
SUPPLEMENTARY INFORMATION:
I. Public Meeting
A. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of interest to persons who conduct or assess human studies,
especially studies on substances regulated by EPA, or to
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persons who are, or may be required to conduct testing of chemical
substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) or
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since
other entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I access electronic copies of this document and other
related information?
In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
Federal Register listings at http://www.epa.gov/fedrgstr/.
Docket: All documents in the docket are listed in the http://www.regulations.gov index. 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, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Public Reading Room. The EPA/DC Public Reading Room is located in
the EPA Headquarters Library, Room Number 3334 in the EPA West
Building, located at 1301 Constitution Ave., NW., Washington, DC 20460.
The hours of operation are 8:30 am to 4:30 p.m. EST, Monday through
Friday, excluding Federal holidays. Please call (202) 566-1744 or e-
mail the ORD Docket at [email protected] for instructions. Updates to
Public Reading Room access are available on the Web site (http://www.epa.gov/epahome/dockets.htm). EPA's position paper(s), charge/
questions to the HSRB, and the meeting agenda will be available by
early June 2010. In addition, the Agency may provide additional
background documents as the materials become available. You may obtain
electronic copies of these documents, and certain other related
documents that might be available electronically, from the
regulations.gov Web site and the EPA HSRB Web site at http://www.epa.gov/osa/hsrb/. For questions on document availability, or if
you do not have access to the Internet, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
C. What should I consider as 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.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data that you
used to support your views.
4. Provide specific examples to illustrate your concerns and
suggest alternatives.
5. 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.
D. How may I participate in this meeting?
You may participate in this meeting by following the instructions
in this section. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-ORD-2010-0381 in the subject line
on the first page of your request.
1. Oral comments. Requests to present oral comments will be
accepted up to June 16, 2010. To the extent that time permits,
interested persons who have not pre-registered may be permitted by the
Chair of the HSRB to present oral comments at the meeting. Each
individual or group wishing to make brief oral comments to the HSRB is
strongly advised to submit their request (preferably via e-mail) to the
person listed under FOR FURTHER INFORMATION CONTACT no later than noon,
Eastern Time, June 16, 2010, in order to be included on the meeting
agenda, and to provide sufficient time for the HSRB Chair and HSRB
Designated Federal Officer (DFO) to review the agenda to provide an
appropriate public comment period. The request should identify the name
of the individual making the presentation, the organization (if any)
the individual will represent, and any requirements for audiovisual
equipment (e.g., overhead projector, LCD projector, chalkboard). Oral
comments before the HSRB are limited to five minutes per individual or
organization. Please note that this limit applies to the cumulative
time used by all individuals appearing either as part of, or on behalf
of an organization. While it is our intent to hear a full range of oral
comments on the science and ethics issues under discussion, it is not
our intent to permit organizations to expand these time limitations by
having numerous individuals sign up separately to speak on their
behalf. If additional time is available, there may be flexibility in
time for public comments. Each speaker should bring 25 copies of his or
her comments and presentation slides for distribution to the HSRB at
the meeting.
2. Written comments. Although you may submit written comments at
any time, for the HSRB to have the best opportunity to review and
consider your comments as it deliberates on its report, you should
submit your comments at least five business days prior to the beginning
of the meeting. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that
the Board members may not have adequate time to consider those comments
prior to making a decision. Thus, if you plan to submit written
comments, the Agency strongly encourages you to submit such comments no
later than noon, Eastern Time, June 16, 2010. You should submit your
comments using the instructions in section I., under subsection C.,
``What should I consider as I prepare my comments for EPA?'' above in
this notice. In addition, the Agency also requests that person(s)
submitting comments directly to the docket also provide a copy of their
comments to the person listed under FOR FURTHER INFORMATION CONTACT.
There is no limit on the length of written comments for consideration
by the HSRB.
E. Background
1. Topics for discussion. The HSRB is a Federal advisory committee
operating in accordance with the Federal Advisory Committee Act (FACA)
5 U.S.C. App. 2 section 9. The HSRB provides advice, information, and
recommendations to EPA on issues related to scientific and ethical
aspects of human subjects research. The major objectives of the HSRB
are to provide advice and recommendations on: (1) Research proposals
and protocols; (2) reports of completed research with human subjects;
and (3) how to strengthen EPA's programs for protection of human
subjects of research. The HSRB reports to the EPA Administrator through
EPA's Science Advisor.
At its meeting on June 23, 2010, EPA's Human Studies Review Board
will consider scientific and ethical issues surrounding these topics:
(a) The unpublished report of the completed Carroll-Loye Biological
Research, Inc. study LNX-002: Field Repellency of Two Picaridin-Based
Personal Insect Repellents to Black Flies. The protocol for this study
was
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reviewed favorably by the HSRB at their meeting in June 2009. EPA seeks
the advice of the HSRB on the scientific soundness of this completed
study for use to estimate the duration of complete protection against
black flies provided by the tested repellents, and on whether available
information supports a determination that the study was conducted in
substantial compliance with subparts K and L of 40 CFR part 26.
(b) The unpublished report of the completed Carroll-Loye Biological
Research, Inc. study LNX-003: Laboratory Repellency of Two Picaridin-
Based Personal Insect Repellents to Two Species of Ticks. The protocol
for this study was reviewed favorably by the HSRB at their meeting in
October 2009. EPA seeks the advice of the HSRB on the scientific
soundness of this completed study for use to estimate the duration of
complete protection against ticks provided by the tested repellents,
and on whether available information supports a determination that the
study was conducted in substantial compliance with subparts K and L of
40 CFR Part 26.
(c) In addition, EPA will present to the HSRB update reports on two
topics of interest:
(1) The revised guideline for performance testing of topically
applied repellent products, for use by investigators and sponsors of
new studies
(2) The terms of a recent settlement of litigation related to EPA's
2006 rule for the protection of human subjects of research, in which
EPA has agreed to initiate rulemaking to amend the 2006 rule.
2. Meeting minutes and reports. Minutes of the meeting, summarizing
the matters discussed and recommendations, if any, made by the advisory
committee regarding such matters, will be released within 90 calendar
days of the meeting. Such minutes will be available at http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition,
information concerning a Board meeting report, if applicable, can be
found at http://www.epa.gov/osa/hsrb/ or from the person listed under
FOR FURTHER INFORMATION CONTACT.
Kevin Teichman,
EPA Science Advisor.
[FR Doc. 2010-13684 Filed 6-7-10; 8:45 am]
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