Human Studies Review Board; Notice of Public Meeting and Proposed Candidates for Membership to the Board, 12194-12196 [E6-3339]
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12194
Federal Register / Vol. 71, No. 46 / Thursday, March 9, 2006 / Notices
Dated: March 2, 2006.
Richard Reding,
Designated Federal Officer.
[FR Doc. E6–3343 Filed 3–8–06; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8043–6]
National Advisory Council for
Environmental Policy and Technology
Environmental Protection
Agency (EPA).
ACTION: Notice of meeting.
AGENCY:
Under the Federal Advisory
Committee Act, Public Law 92463, EPA
gives notice of a public teleconference
of the National Advisory Council for
Environmental Policy and Technology
(NACEPT). NACEPT provides advice to
the EPA Administrator on a broad range
of environmental policy, technology,
and management issues. The Council is
a panel of experts who represent diverse
interests from academia, industry, nongovernmental organizations, and local,
state, and tribal governments. The
purpose of this teleconference is twofold: To discuss and approve
recommendations from the NACEPT
Environmental Technology
Subcommittee and to discuss and
approve comments on the Draft 2006–
2011 EPA Strategic Plan Architecture
from a subset of the Council. A copy of
the agenda for the meeting will be
posted at https://www.epa.gov/ocem/
nacept/cal-nacept.htm.
DATES: NACEPT will hold a public
teleconference on Wednesday, March
22, 2006 from 10:30 a.m.–12:30 p.m.
Eastern Time.
ADDRESSES: The meeting will be held in
the U.S. EPA Office of Cooperative
Environmental Management at 655 15th
Street, NW., Suite 800, Washington, DC
20005.
FOR FURTHER INFORMATION CONTACT:
Sonia Altieri, Designated Federal
Officer, altieri.sonia@epa.gov, (202)
233–0061, U.S. EPA, Office of
Cooperative Environmental
Management (1601E), 1200
Pennsylvania Avenue NW., Washington,
DC 20460.
SUPPLEMENTARY INFORMATION: Requests
to make oral comments or to provide
written comments to the Council should
be sent to Sonia Altieri, Designated
Federal Officer, at the contact
information above by March 17, 2006.
The public is welcome to attend all
portions of the meeting, but seating is
limited and is allocated on a first-come,
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SUMMARY:
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first-serve basis. Members of the public
wishing to gain access to the conference
room on the day of the meeting must
contact Sonia Altieri at (202) 233–0061
or altieri.sonia@epa.gov by Tuesday,
March 21, 2006.
Meeting Access: For information on
access or services for individuals with
disabilities, please contact Sonia Altieri
at (202) 233–0061 or
altieri.sonia@epa.gov. To request
accommodation of a disability, please
contact Sonia Altieri, preferably at least
10 days prior to the meeting, to give
EPA as much time as possible to process
your request.
Dated: February 28, 2006.
Sonia Altieri,
Designated Federal Officer.
[FR Doc. E6–3342 Filed 3–8–06; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2006–0187; FRL–8042–6]
Human Studies Review Board; Notice
of Public Meeting and Proposed
Candidates for Membership to the
Board
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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. In addition, OSA is soliciting
public comment on its proposed list of
candidates for membership to the HSRB.
DATES: The public meeting will be held
April 4–6, 2006 from 8:30 a.m. to
approximately 5 p.m., eastern time.
Location: Holiday Inn Rosslyn at Key
Bridge, 1900 North Fort Myer Drive,
Arlington, VA 22209. The telephone
number for the Holiday Inn Rosslyn at
Key Bridge is 703–807–2000.
Requests to Present Oral Comments
and Special Accommodations: To
submit requests for special
accommodation arrangements or
requests to present oral comments,
notify the DFO listed under FOR
FURTHER INFORMATION CONTACT. To
ensure proper receipt by EPA, your
request must identify docket ID number
EPA–HQ–ORD–2006–0187 in the
subject line on the first page of your
response. Additional information
concerning the submission of requests
to present oral comments and
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submission of written comments is
provided in Unit I.E.
FOR FURTHER INFORMATION CONTACT: Any
member of the public who wishes
further information should contact Paul
I. Lewis, Designated Federal Official
(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 addresses:
lewis.paul@epa.gov.
ADDRESSES: Submit your written
comments, identified by Docket ID No.
EPA–HQ–ORD–2006–018, by one of the
following methods: https://
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–
0187. 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–
0187. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
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 https://
www.regulations.gov or e-mail. The
https://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 https://
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
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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.
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.
hsrobinson on PROD1PC70 with NOTICES
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 https://
www.epa.gov/fedrgstr/. A frequently
updated electronic version of the Code
of Federal Regulations (CFR) is available
at https://www.gpoaccess.gov/ecfr/.
Docket: All documents in the docket
are listed in the https://
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 https://
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, charge/
questions to the HSRB, HSRB
composition and the meeting agenda
will be available by mid March 2006. In
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13:58 Mar 08, 2006
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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 https://www.epa.gov/osa/hsrb/.
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 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
unit. To ensure proper receipt by EPA,
it is imperative that you identify docket
ID number EPA–HQ–ORD–2006–0187
in the subject line on the first page of
your request.
1. Oral comments. Oral comments
presented at the meetings should not be
repetitive of previously submitted oral
or written comments. Although requests
to present oral comments are accepted
until the date of the meeting (unless
otherwise stated), to the extent that time
permits, interested persons 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
DFO listed under FOR FURTHER
INFORMATION CONTACT no later than
noon, eastern time, March 29, 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
approximately 5 minutes unless prior
arrangements have been made. In
addition, each speaker should bring 30
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12195
copies of his or her comments and
presentation slides for distribution to
the HSRB at the meeting.
2. Written comments. Although
written comments will be accepted until
the date of the meeting (unless
otherwise stated), the Agency strongly
encourages that written comments be
submitted, using the instructions in
Unit 1.C. no later than noon, eastern
time, March 29, 2006 to provide the
HSRB the time necessary to consider
and review the written comments. It is
requested that persons submitting
comments directly to the docket also
notify the DFO listed under FOR
FURTHER INFORMATION CONTACT. There is
no limit on the extent of written
comments for consideration by the
HSRB.
3. Seating at the meeting. 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.
F. Background
At the inaugural meeting of the HSRB,
EPA will provide a broad overview of
the Agency’s approach to the
assessment of the potential risk to
human health from the use of pesticides
and how EPA uses data from human
studies in such risk assessments. The
Agency will then present to the HSRB
its scientific and ethics reviews of
approximately two dozen completed
human studies concerning the following
pesticide active ingredients: aldicarb,
amitraz, azinphos-methyl, dichlorovos
(DDVP), ethephon, methomyl, oxamyl,
and sodium cyanide. The studies being
reviewed 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 ethical or
scientific reasons. The Agency will ask
the HSRB to advise the Agency on a
range of scientific issues and on how the
studies should be assessed against the
provisions in sections 26.1701–26.1704
of EPA’s final human studies rule.
II. Proposed Candidates for
Membership to the Board
On January 3, 2006, the EPA, OSA
announced a request for nominations of
qualified individuals to serve on the
HSRB (Federal Register 71 116). Per the
Federal Register notice, the OSA
requested nominees who are nationally-
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Federal Register / Vol. 71, No. 46 / Thursday, March 9, 2006 / Notices
recognized experts in one or more of the
following disciplines:
(a) Biostatistics. Expertise in
statistical design and analysis of human
subjects research studies.
(b) Human toxicology. Expertise in
pharmacokinetic and toxicokinetic
studies, clinical trials, and toxicology of
cholinesterase inhibitors and other
classes of environmental substances.
(c) Bioethics. Expertise in the ethics of
research on human subjects; research
ethics.
(d) Human health risk assessment.
EPA carefully considered the
qualifications of nominees who agreed
to be further considered and has
identified candidates from whom EPA
expects to select members to serve on
the HSRB. EPA now invites comments
from members of the public for relevant
information or other documentation that
the OSA should consider in the
selection of HSRB members. The names
of the candidates, together with a short
biographical description of their
qualifications, appear on the Agency’s
Web site at https://www.epa.gov/osa/
hsrb/. Please e-mail your comments no
later than noon, eastern time, March 14,
2006, listed under FOR FURTHER
INFORMATION CONTACT.
Any information furnished by the
public in response to this Web site
posting will be combined with
information already provided by the
candidates, and gathered independently
by the OSA. Prior to final selection of
HSRB members, the combined
information will be reviewed and
evaluated for any possible financial
conflict of interest or a possible
appearance of a lack of impartiality. The
information will also be used to ensure
appropriate balance and breadth of
expertise needed to address the charge
to the Board. The EPA Science Advisor
will make the final decision concerning
who will serve on the HSRB.
Dated: March 2, 2006.
George Gray,
EPA Science Advisor.
[FR Doc. E6–3339 Filed 3–8–06; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
hsrobinson on PROD1PC70 with NOTICES
[FRL–8043–7]
National and Governmental Advisory
Committees to the U.S. Representative
to the Commission for Environmental
Cooperation
Environmental Protection
Agency (EPA).
ACTION: Notice of meeting.
AGENCY:
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SUMMARY: Under the Federal Advisory
Committee Act, Public Law 92463, EPA
gives notice of a meeting of the National
Advisory Committee (NAC) and
Governmental Advisory Committee
(GAC) to the U.S. Representative to the
North American Commission for
Environmental Cooperation (CEC). The
National and Governmental Advisory
Committees advise the EPA
Administrator in his capacity as the U.S.
Representative to the CEC Council. The
Committees are authorized under
Articles 17 and 18 of the North
American Agreement on Environmental
Cooperation (NAAEC), North American
Free Trade Agreement Implementation
Act, Public Law 103–182, and as
directed by Executive Order 12915,
entitled ‘‘Federal Implementation of the
North American Agreement on
Environmental Cooperation.’’ The NAC
is composed of 12 members
representing academia, environmental
non-governmental organizations, and
private industry. The GAC consists of 12
members representing state, local, and
tribal governments. The Committees are
responsible for providing advice to the
U.S. Representative on a wide range of
strategic, scientific, technological,
regulatory, and economic issues related
to implementation and further
elaboration of the NAAEC. The purpose
of the meeting is to continue the
Committee’s consideration of
environment and trade issues in the
CEC context. A copy of the agenda for
the meeting will be posted at https://
www.epa.gov/ocem/nacgac-page.htm.
DATES: The National and Governmental
Advisory Committees will hold a two
day open meeting on Thursday, April 6,
from 9 a.m. to 5:30 p.m. and Friday,
April 7, from 8:30 a.m. to 2:30 p.m.
ADDRESSES: The meeting will be held at
the Hotel Washington, 515 15th St. NW.,
Washington, DC 20004. The meeting is
open to the public, with limited seating
on a first-come, first-served basis.
FOR FURTHER INFORMATION CONTACT:
Oscar Carrillo, Designated Federal
Officer, carrillo.oscar@epa.gov, (202)
233–0072, U.S. EPA, Office of
Cooperative Environmental
Management (1601E), 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460.
SUPPLEMENTARY INFORMATION: Requests
to make oral comments or provide
written comments to the Committees
should be sent to Oscar Carrillo,
Designated Federal Officer, at the
contact information above.
Meeting Access: For information on
access or services for individuals with
disabilities, please contact Oscar
Carrillo at (202) 233–0072 or
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carrillo.oscar@epa.gov. To request
accommodation of a disability, please
contact Oscar Carrillo, preferably at
least 10 days prior to the meeting, to
give EPA as much time as possible to
process your request.
Dated: March 1, 2006.
Oscar Carrillo,
Designated Federal Officer.
[FR Doc. E6–3341 Filed 3–8–06; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8043–2]
Proposed CERCLA Agreement for
Recovery of Response Costs,
Intermountain Waste Oil Refinery NPL
Site, Bountiful, Davis County, UT
U.S. Environmental Protection
Agency.
ACTION: Notice and request for public
comment.
AGENCY:
SUMMARY: In accordance with the
requirements of section 122(h)(1) of the
Comprehensive Environmental
Response, Compensation, and Liability
Act, as amended (‘‘CERCLA’’), 42 U.S.C.
9622(h)(1), notice is hereby given of a
proposed administrative settlement
under section 122(h) of CERCLA, 42
U.S.C. 9622(h), between EPA and
Intermountain Oil Company (‘‘Settling
Party’’) regarding the Intermountain Oil
Company facility (the ‘‘Facility’’) at the
Intermountain Waste Oil Refinery NPL
Site (‘‘Site’’). The property which is the
subject of this proposed settlement is a
parcel of land approximately two acres
in size and is located at approximately
995 South and 500 West in Bountiful,
Davis County, Utah. The settlement,
embodied in the proposed Agreement
for Recovery of Response Costs
(‘‘Agreement’’), is intended to resolve
the Settling Party’s liability at the Site
for all response costs incurred and paid,
or to be incurred and paid, by EPA in
connection with the work performed at
the Site as provided for in the
Agreement and is based on the Settling
Party’s inability to pay for a significant
portion of the response costs incurred
by EPA at the Site.
Intermountain Oil Company is the
owner of a parcel of land which has
been impacted by business operations at
the Intermountain Oil Company Facility
and is included within the defined
boundaries of the Site. The proposed
Agreement will resolve Settling Party’s
liability under section 107(a)(1) of
CERCLA, 42 U.S.C. 9607(a)(1). Under
the terms of the proposed Agreement,
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Agencies
[Federal Register Volume 71, Number 46 (Thursday, March 9, 2006)]
[Notices]
[Pages 12194-12196]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3339]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2006-0187; FRL-8042-6]
Human Studies Review Board; Notice of Public Meeting and Proposed
Candidates for Membership to the Board
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. In addition,
OSA is soliciting public comment on its proposed list of candidates for
membership to the HSRB.
DATES: The public meeting will be held April 4-6, 2006 from 8:30 a.m.
to approximately 5 p.m., eastern time.
Location: Holiday Inn Rosslyn at Key Bridge, 1900 North Fort Myer
Drive, Arlington, VA 22209. The telephone number for the Holiday Inn
Rosslyn at Key Bridge is 703-807-2000.
Requests to Present Oral Comments and Special Accommodations: To
submit requests for special accommodation arrangements or requests to
present oral comments, notify the DFO listed under FOR FURTHER
INFORMATION CONTACT. To ensure proper receipt by EPA, your request must
identify docket ID number EPA-HQ-ORD-2006-0187 in the subject line on
the first page of your response. Additional information concerning the
submission of requests to present oral comments and submission of
written comments is provided in Unit I.E.
FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes
further information should contact Paul I. Lewis, Designated Federal
Official (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 addresses: lewis.paul@epa.gov.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2006-018, by one of the following methods: https://
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-2006-0187. 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-
2006-0187. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
https://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 https://
www.regulations.gov or e-mail. The https://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 https://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
[[Page 12195]]
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.
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 https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of the Code of Federal
Regulations (CFR) is available at https://www.gpoaccess.gov/ecfr/.
Docket: All documents in the docket are listed in the https://
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 https://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, charge/questions to the HSRB, HSRB
composition and the meeting agenda will be available by mid March 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 https://www.epa.gov/osa/hsrb/.
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 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 unit. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-ORD-2006-0187 in the subject line
on the first page of your request.
1. Oral comments. Oral comments presented at the meetings should
not be repetitive of previously submitted oral or written comments.
Although requests to present oral comments are accepted until the date
of the meeting (unless otherwise stated), to the extent that time
permits, interested persons 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 DFO listed under FOR
FURTHER INFORMATION CONTACT no later than noon, eastern time, March 29,
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
approximately 5 minutes unless prior arrangements have been made. In
addition, each speaker should bring 30 copies of his or her comments
and presentation slides for distribution to the HSRB at the meeting.
2. Written comments. Although written comments will be accepted
until the date of the meeting (unless otherwise stated), the Agency
strongly encourages that written comments be submitted, using the
instructions in Unit 1.C. no later than noon, eastern time, March 29,
2006 to provide the HSRB the time necessary to consider and review the
written comments. It is requested that persons submitting comments
directly to the docket also notify the DFO listed under FOR FURTHER
INFORMATION CONTACT. There is no limit on the extent of written
comments for consideration by the HSRB.
3. Seating at the meeting. 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.
F. Background
At the inaugural meeting of the HSRB, EPA will provide a broad
overview of the Agency's approach to the assessment of the potential
risk to human health from the use of pesticides and how EPA uses data
from human studies in such risk assessments. The Agency will then
present to the HSRB its scientific and ethics reviews of approximately
two dozen completed human studies concerning the following pesticide
active ingredients: aldicarb, amitraz, azinphos-methyl, dichlorovos
(DDVP), ethephon, methomyl, oxamyl, and sodium cyanide. The studies
being reviewed 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 ethical or scientific reasons. The Agency will ask the HSRB to
advise the Agency on a range of scientific issues and on how the
studies should be assessed against the provisions in sections 26.1701-
26.1704 of EPA's final human studies rule.
II. Proposed Candidates for Membership to the Board
On January 3, 2006, the EPA, OSA announced a request for
nominations of qualified individuals to serve on the HSRB (Federal
Register 71 116). Per the Federal Register notice, the OSA requested
nominees who are nationally-
[[Page 12196]]
recognized experts in one or more of the following disciplines:
(a) Biostatistics. Expertise in statistical design and analysis of
human subjects research studies.
(b) Human toxicology. Expertise in pharmacokinetic and
toxicokinetic studies, clinical trials, and toxicology of
cholinesterase inhibitors and other classes of environmental
substances.
(c) Bioethics. Expertise in the ethics of research on human
subjects; research ethics.
(d) Human health risk assessment.
EPA carefully considered the qualifications of nominees who agreed
to be further considered and has identified candidates from whom EPA
expects to select members to serve on the HSRB. EPA now invites
comments from members of the public for relevant information or other
documentation that the OSA should consider in the selection of HSRB
members. The names of the candidates, together with a short
biographical description of their qualifications, appear on the
Agency's Web site at https://www.epa.gov/osa/hsrb/. Please e-mail your
comments no later than noon, eastern time, March 14, 2006, listed under
FOR FURTHER INFORMATION CONTACT.
Any information furnished by the public in response to this Web
site posting will be combined with information already provided by the
candidates, and gathered independently by the OSA. Prior to final
selection of HSRB members, the combined information will be reviewed
and evaluated for any possible financial conflict of interest or a
possible appearance of a lack of impartiality. The information will
also be used to ensure appropriate balance and breadth of expertise
needed to address the charge to the Board. The EPA Science Advisor will
make the final decision concerning who will serve on the HSRB.
Dated: March 2, 2006.
George Gray,
EPA Science Advisor.
[FR Doc. E6-3339 Filed 3-8-06; 8:45 am]
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