![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Human Studies Review Board; Notice of Public Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 27, 2006 (Volume 71, Number 187)]
[Notices]
[Page 56527-56528]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se06-89]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2006-0798; FRL-8223-8]
Human Studies Review Board; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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 human subjects research.
DATES: The public meeting will be held October 18-19, 2006, from 8:30
a.m. to approximately 5 p.m., eastern time on October 18, 2006, and
8:30 to approximately 2 eastern time on October 19, 2006.
Location: One Potomac Yard, 2777 Crystal Drive, Arlington, VA 22202.
Meeting Access: Seating at the meeting will be on a first-come
basis. Individuals requiring special accommodations at this meeting,
including wheelchair access and assistance for the hearing impaired,
should contact the Designated Federal Officer (DFO) at least 10
business days 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 information concerning
submission of relevant written or oral comments is provided in Unit
I.D. of this notice.
FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact Maria Szilagyi, Designated Federal
Officer (DFO), EPA, Office of the Science Advisor, (8105R),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 564-6809; fax: (202) 564
2070; e-mail addresses: szilagyi.maria@epa.gov. 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-2006-0798, by one of the following methods:
Internet: http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ORD.Docket@epa.gov.
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-
2006-0798. 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-
2006-0798. 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.
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
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.
[[Page 56528]]
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, 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. EPA's position paper(s), charge/questions to the HSRB, and the
meeting agenda are now available. 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 Internet Home Page 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.
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-2006-0798 in the subject line
on the first page of your request.
a. Oral comments. Requests to present oral comments will be
accepted up to October 10, 2006. 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
DFO listed under FOR FURTHER INFORMATION CONTACT no later than noon,
eastern time, October 10, 2006, in order to be included on the meeting
agenda and to provide sufficient time for the HSRB Chair and HSRB 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 5 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.
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 5 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, October 10, 2006. 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 DFO
listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the
length of written comments for consideration by the HSRB.
E. Background
EPA will be presenting for HSRB review the results of a completed
human toxicity study, evaluating the allergic contact dermatitis
response in individuals with known sensitivity to hexavalent chromium
to repeated exposure to a wood treatment solution containing hexavalent
chromium. In addition, the Board will be asked to review two revised
research protocols to evaluate the efficacy of new formulations of the
repellent, IR3535, against ticks and mosquitoes and to advise on a
draft guidance document explaining to the public how to submit proposed
and completed human research to EPA for review by the HSRB. Finally, at
the Board's request, EPA will present the statutory and regulatory
procedures that EPA and its federal advisory committees are required to
follow when handling materials claimed to be confidential business
information (CBI) under FIFRA or other laws. The HSRB intends to
discuss how it would like to operate in the event that EPA requests the
Board to review materials containing CBI.
Dated: September 22, 2006.
George Gray,
Science Advisor.
[FR Doc. E6-15832 Filed 9-26-06; 8:45 am]
BILLING CODE 6560-50-P