[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Pages 12413-12415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4583]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2008-0033; FRL-8539-8]
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 review of human subjects research.
DATES: The public meeting will be held from April 9-April 10, 2008 from
8:30 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.
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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 Unit
I.D. of this notice.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2008-0033, by any of the following methods:
Internet: http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected].
USPS Mail: Environmental Protection Agency, EPA Docket Center (EPA/
DC), ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
Hand or Courier 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. The
hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Standard Time
(EST), Monday through Friday, excluding Federal holidays. Please call
(202) 566-1744 or email 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-
2008-0033. 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 through
http://www.regulations.gov or e-mail that you consider to be CBI or
otherwise protected from disclosure. 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.
FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact Lu-Ann Kleibacker, EPA, Office of
the Science Advisor, (8105R), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202)
564-7189; 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/.
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 particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by EPA and to
persons who may sponsor or conduct research with human subjects with
the intention to submit it to EPA for consideration under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) or section 408
under the Federal Food, Drug, and Cosmetic Act (FFDCA). 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?
You may access this Federal Register document electronically either
through http://www.regulations.gov or through the EPA Web site 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 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. 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. The hours of operation are 8:30 a.m. 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 mid March 2008. 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 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:
a. Explain your views as clearly as possible.
b. Describe any assumptions that you used.
c. Provide copies of any technical information and/or data you used
that support your views.
d. Provide specific examples to illustrate your concerns and
suggest alternatives.
e. 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-2008-0033 in the subject line
on the first page of your request.
a. Oral comments. Requests to present oral comments will be
accepted up to April 1, 2008. To the extent that time
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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
email) to the person listed under FOR FURTHER INFORMATION CONTACT no
later than noon, Eastern time, April 1, 2008 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 multiple individuals sign up
separately to speak on their behalf. Each speaker should bring 25
copies of his or her comments and presentation slides for distribution
to the HSRB at the meeting. At the discretion of the Board Chair and
DFO, public commenters, if present during the Board's discussion, may
be asked to provide clarification of their comments to assist the Board
in their discussion.
b. 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, April 1, 2008. You should submit your
comments using the instructions in Unit I.C. of 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
A. 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.
B. Topics for Discussion
The EPA will present for HSRB review scientific and ethical issues
surrounding:
An update on revisions to the EPA document, ``Scientific
and Ethical Approaches for Observational Exposure Studies,'' which the
HSRB previously reviewed and commented on at the October 24-26, 2007
HSRB meeting.
Two closely related product-specific reports from a single
completed field study by Carroll-Loye Biological Research of the
mosquito repellent efficacy of two registered pesticide products
containing Deet.
A research proposal from Insect Control & Research, Inc.
to evaluate the laboratory efficacy in repelling stable flies of a
registered pesticide product containing picaridin.
Two research proposals from the Antimicrobial Exposure
Assessment Task Force II (AEATF) to monitor exposures of subjects who
apply an antimicrobial pesticide by wiping and by mopping. The AEATF
proposals will consist of multiple documents including a ``Governing
Document'' describing the larger research initiative of which these two
studies are a part, a set of ``Standard Operating Procedures'' for the
execution of the studies, a ``Scenario Justification'' describing the
AEATF's rationale for key elements of each study design, and protocols
for the mop study and for the wipe study.
In addition, the Agency will report to the Board on how it has
resolved issues relating to the design of sampling strategies for
handler research programs proposed by the Agricultural Handlers
Exposure Task Force and the Antimicrobials Exposure Assessment Task
Force II. Finally, the HSRB may also discuss planning for future HSRB
meetings.
C. 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.
Dated: February 14, 2008.
George Gray,
Science Advisor.
[FR Doc. E8-4583 Filed 3-6-08; 8:45 am]
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