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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: April 17, 2006 (Volume 71, Number 73)]
[Notices]
[Page 19725-19727]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ap06-61]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2006-0316; FRL-8158-8]
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 reviews of human subjects research.
DATES: The public meeting will be held May 2-4, 2006 from 8:30 a.m. to
approximately 5 p.m., eastern time (However, the third day may not be
needed).
Location: Holiday Inn Hotel & Suites, Alexandria-Historic District,
625 First Street, Alexandria, VA 22314. The telephone number for the
Holiday Inn Hotel & Suites, Alexandria-Historic District is (703) 548-6300.
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 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.E. of this notice.
FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact Paul I. Lewis, Designated Federal
Officer (DFO), EPA, Office of the Science Advisor, (8105),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 564-8381; fax: (202) 564-
2070; e-mail address: lewis.paul@epa.gov.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2006-0316, by one of the following methods:
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), Room B102, EPA West
Building, 1301 Constitution Avenue, NW., Washington, DC 20460,
Attention Docket ID No. EPA-HQ-ORD-2006-0316. 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-
2006-0316. 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
[[Page 19726]]
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.
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/.
A frequently updated electronic version of the Code of Federal Regulations
(CFR) is available at http://www.gpoaccess.gov/ecfr/
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, EPA West Room B102, 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 will be available by mid to late April 2006. 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 May 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 used
that support your views.
4. Provide specific examples to illustrate your concerns.
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.
E. 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-2006-0316 in the subject line
on the first page of your request.
1. Oral comments. Requests to present oral comments will be
accepted up to April 26, 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, April 26, 2006, in order to be included on the meeting
agenda. 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, 35 mm projector, chalkboard). 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
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 being 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 5 business days prior to the beginning of
the meeting. If you submit comments after the 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 26, 2006. You should submit your
comments using the instructions in Unit 1.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.
F. Background
The HSRB will meet to consider and review EPA's scientific and
ethics analyses of six completed human toxicity studies concerning
three different compounds, including: Hexavalent chromium, a
constituent of a wood preservative; and the following pesticide active
ingredients--carbofuran and methyl isothiocyanate (MITC). The studies
being considered at this meeting will include both studies on which the
Agency proposes to rely in actions under the pesticide laws and studies
that the Agency has decided not to use in its risk assessments, either
for scientific reasons or because they do not meet the standards in
EPA's final human studies rule, 40 CFR part 26. The Agency will ask the
HSRB to advise the Agency on a range of scientific and ethics issues
and on how the studies should be assessed against the provisions in 40
CFR 26.1701-26.1704 of EPA's final human studies rule. In addition, the
Board may be reviewing draft HSRB reports for subsequent Board approval.
[[Page 19727]]
Dated: April 11, 2006.
William H. Farland,
Acting EPA Science Advisor.
[FR Doc. 06-3635 Filed 4-14-06; 8:45 am]
BILLING CODE 6960-50-M