[Federal Register Volume 74, Number 19 (Friday, January 30, 2009)]
[Notices]
[Pages 5653-5655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2037]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2009-0030; FRL-8769-9]
Human Studies Review Board (HSRB); Notice of a Public
Teleconference 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 review of human subjects research. The HSRB will
hold a Public teleconference to discuss two completed field studies by
Carroll-Loye Biological Research of mosquito repellent efficacy, and
spatial insect repellent technology.
DATES: The teleconference will be held on February 17, 2009, from 11:30
to approximately 4 p.m. (Eastern Time).
Location: The meeting will take place via telephone only.
Meeting Access: For information on access or services for
individuals with disabilities, please contact Lu-Ann Kleibacker prior
to the meeting using the information under FOR FURTHER INFORMATION
CONTACT, so that appropriate arrangements can be made.
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
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information concerning submission of relevant written or oral comments
is provided in section D. of this notice.
FOR FURTHER INFORMATION CONTACT: Members of the public who wish to
obtain the call-in number and access code to participate in the
telephone conference, or who wish further information may contact Lu-
Ann Kleibacker, EPA, Office of the Science Advisor (8105),
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; or via telephone/voice mail at (202) 564-7189 or
via e-mail at [email protected]. General information concerning
the EPA HSRB is 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-2009-0030, by one of the following methods:
http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
E-mail: [email protected].
Mail: ORD Docket, Environmental Protection Agency, Mailcode:
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand Delivery: EPA Docket Center (EPA/DC), Public Reading Room,
Infoterra Room (Room Number 3334), EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC 20460, Attention Docket ID No. EPA-ORD-
2009-0030. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays. Special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0030. 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 whose
disclosure 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.
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
on substances regulated by EPA or to 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 index under
the docket number. Even though it will be listed by title in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Copyright
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, Infoterra Room (Room Number 3334), 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the ORD Docket is (202) 566-
1752.
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 you use
that 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. For information on access to the teleconference,
please contact Lu-Ann Kleibacker prior to the meeting using the
information under FOR FURTHER INFORMATION CONTACT.
1. Oral Comments
Requests to present oral comments will be accepted up to February
9, 2009. 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 Lu-Ann Kleibacker listed under FOR
FURTHER INFORMATION CONTACT in order to be included on the meeting
agenda and to provide sufficient time for the HSRB Chair and HSRB DFO
to review the meeting agenda to provide an appropriate public comment
period. The request should identify the name of the individual making
the presentation and the organization (if any) the individual will
represent. Oral comments before the HSRB are limited to 5 minutes per
individual or organization. Please note that this includes 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 the time limitations by
having numerous individuals sign up separately to speak on their
behalf. If additional time is
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available, there may be flexibility in time for public comments.
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, EST,
February 9, 2009. To ensure proper receipt of all written material by
EPA, it is imperative that you identify docket ID number EPA-HQ-ORD-
2009-0030 in the subject line on the first page of your submission. In
addition, the Agency also requests that person(s) submitting comments
directly to the docket also provide a copy of their comments to Lu-Ann
Kleibacker listed under FOR FURTHER INFORMATION CONTACT. There is no
limit on the length of written comments for consideration by the HSRB.
E. Background
1. Human Studies Review Board
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: a. Research proposals and protocols; b. reports of
completed research with human subjects; and c. 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.
The EPA will present for HSRB review scientific and ethical issues
surrounding the reports from a completed field study of mosquito
repellent efficacy (SPC-001) and a completed laboratory study of tick
repellent efficacy (SPC-002) conducted by Carroll-Loye Biological
Research using multiple skin-applied repellent products containing
picaridin. In addition, the HSRB will consider and discuss general
information about ``spatial'' or ``area'' insect repellent products and
their testing, in preparation for expected future reviews of proposals
for field efficacy testing of spatial repellents. Insect repellent
testing reviewed by the Board in past meetings has concerned only skin-
applied repellents, which differ in important ways from spatial
repellents. Finally, the HSRB may also discuss planning for future HSRB
meetings.
2. Meeting Minutes and Reports
Minutes of the meeting, summarizing the matters discussed and
recommendations made, if any, 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.
Dated: January 26, 2009.
Kevin Teichman,
EPA Acting Science Advisor.
[FR Doc. E9-2037 Filed 1-29-09; 8:45 am]
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