Human Studies Review Board; Notice of Public Meeting, 31323-31325 [E7-10859]
Download as PDF
Federal Register / Vol. 72, No. 108 / Wednesday, June 6, 2007 / Notices
or e-mail. The 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 www.regulations.gov, your email 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.
Docket: All documents in the docket
are listed in the 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
www.regulations.gov or in hard copy at
the ORD Docket, EPA/DC, EPA West,
Room 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.
Dated: May 30, 2007.
Jeffery Morris,
Acting Director, Office of Science Policy.
[FR Doc. E7–10888 Filed 6–5–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2007–0403; FRL–8322–7]
Human Studies Review Board; Notice
of Public Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: The U.S. Environmental
Protection Agency’s (EPA or Agency)
Office of the Science Advisor (OSA)
VerDate Aug<31>2005
16:59 Jun 05, 2007
Jkt 211001
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
from June 27–June 29, 2007
approximately 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.
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 Paul
Lewis, EPA, Office of the Science
Advisor, (8105R), 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. General
information concerning the EPA HSRB
can be found on the EPA Web site at
https://www.epa.gov/osa/hsrb/.
ADDRESSES: Submit your written
comments, identified by Docket ID No.
EPA–HQ–ORD–2007–0403, by one of
the following methods:
Internet: https://www.regulations.gov:
Follow the on-line instructions for
submitting comments.
E-mail: ORD.Docket@epa.gov.
Mail: Environmental Protection
Agency, EPA Docket Center (EPA/DC),
ORD Docket, Mailcode: 28221T, 1200
Pennsylvania Ave., NW., Washington,
DC 20460.
Hand 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 e-mail the
ORD Docket at ord.docket@epa.gov for
instructions. Updates to Public Reading
PO 00000
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31323
Room access are available on the Web
site (https://www.epa.gov/epahome/
dockets.htm).
Instructions: Direct your comments to
Docket ID No. EPA–HQ–ORD–2007–
0403. 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
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, especially 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.
E:\FR\FM\06JNN1.SGM
06JNN1
31324
Federal Register / Vol. 72, No. 108 / Wednesday, June 6, 2007 / 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/.
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, 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 AM to 4:30 PM EST, Monday
through Friday, excluding Federal
holidays. Please call (202) 566–1744 or
email the ORD Docket at
ord.docket@epa.gov for instructions.
Updates to Public Reading Room access
are available on the Web site (https://
www.epa.gov/epahome/dockets.htm).
EPA’s position paper(s), charge/
questions to the HSRB, and the meeting
agenda will be available by early June
2007. 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/. For questions
on document availability or if you do
not have access to the Internet, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
jlentini on PROD1PC65 with NOTICES
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.
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16:59 Jun 05, 2007
Jkt 211001
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–2007–
0403 in the subject line on the first page
of your request.
a. Oral comments. Requests to present
oral comments will be accepted up to
June 20, 2007. 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 email) to the person
listed under FOR FURTHER INFORMATION
CONTACT no later than noon, Eastern
Time, June 20, 2007 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 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
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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, June 20, 2007. 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. Topics for Discussion. 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 June 27–29, 2007 meeting of the
Human Studies Review Board will
address scientific and ethical issues
surrounding:
• A research proposal from CarrollLoye Biological Research to evaluate the
efficacy of two conditionally registered
products containing picaridin in
repelling mosquitoes in the field.
• A research proposal from Insect
Control & Research, Inc. to evaluate the
efficacy of two unregistered products
containing picaridin in repelling
mosquitoes in the field.
• A completed study measuring the
effects on human subjects of acute
inhalation exposure to acrolein.
Acrolein is an active ingredient used in
biocides in agricultural and industrial
water supply systems and is currently
undergoing reregistration.
• Three completed clinical studies of
the efficacy and side effects of 4aminopyridine when used as a
therapeutic agent to treat neurological
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06JNN1
Federal Register / Vol. 72, No. 108 / Wednesday, June 6, 2007 / Notices
symptoms in patients with either spinal
cord injury or multiple sclerosis. 4aminopyridine is an active ingredient
used in bird repellents that is currently
undergoing reregistration.
• Extensive background materials
concerning research to quantify the
level of exposure received by people
who mix, load, and apply pesticides.
These materials, which were prepared
by the Agricultural Handlers Exposure
Task Force and by the Antimicrobial
Exposure Assessment Task Force,
generally explain the scope of the
research programs being proposed by
the Task Forces and describe the general
scientific framework for conducting the
research. In addition, each Task Force
has provided Standard Operating
Procedures which will guide the
conduct of the studies.
The Board may also be reviewing
draft HSRB reports for subsequent Board
approval. Finally, the Board may also
discuss planning for future HSRB
meetings.
b. 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 https://
www.epa.gov/osa/hsrb/ and https://
www.regulations.gov. In addition,
information concerning a Board meeting
report, if applicable, can be found at
https://www.epa.gov/osa/hsrb/ or from
the person listed under FOR FURTHER
INFORMATION CONTACT.
Dated: May 31, 2007.
Kevin Teichman,
Acting EPA Science Advisor.
[FR Doc. E7–10859 Filed 6–5–07; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2006–1004; FRL–8113–5]
Pesticides; Draft Guidance for
Pesticide Registrants on Antimicrobial
Pesticide Products With AnthraxRelated Claims
Environmental Protection
Agency (EPA).
ACTION: Notice of availability.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: The Agency is announcing
the availability of, and seeking public
comment on, a draft Pesticide
Registration Notice entitled, ‘‘Guidance
for Antimicrobial Pesticide Products
With Anthrax-Related Claims.’’ PR
notices are issued by the Office of
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16:59 Jun 05, 2007
Jkt 211001
Pesticide Programs (OPP) to inform
pesticide registrants and other
interested persons about important
policies, procedures, and registration
related decisions. This particular notice
would, once final, provide guidance to
prospective applicants of antimicrobial
products that make labeling claims to
inactivate Bacillus anthracis (anthrax)
spores (hereafter referred to as ‘‘anthraxrelated products’’).
DATES: Comments must be received on
or before September 4, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2006–1004, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2006–
1004. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line 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 regulations.gov or email. The Federal regulations.gov
website 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 regulations.gov, your email address will be automatically
captured and included as part of the
comment that is placed in the docket
and made available on the Internet. If
you submit an electronic comment, EPA
recommends that you include your
name and other contact information. If
PO 00000
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Fmt 4703
Sfmt 4703
31325
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.
Docket: All documents in the docket
are listed in the docket 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,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Bldg.), 2777
S. Crystal Dr., Arlington, VA. The hours
of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT: Jeff
Kempter, Antimicrobials Division,
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5448; fax number: (703) 308–
6467; e-mail address:
kempter.carlton@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me
This action is directed to the public
in general. Although this action may be
of particular interest to those persons
who are required to register pesticides
and federal, state, and local government
agencies and private institutions or
organizations who are interested in biodecontamination chemicals. 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 information in this notice,
consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
E:\FR\FM\06JNN1.SGM
06JNN1
Agencies
[Federal Register Volume 72, Number 108 (Wednesday, June 6, 2007)]
[Notices]
[Pages 31323-31325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10859]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2007-0403; FRL-8322-7]
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 from June 27-June 29, 2007
approximately 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.
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 Paul Lewis, EPA, Office of the
Science Advisor, (8105R), 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.
General information concerning the EPA HSRB can be found on the EPA Web
site at https://www.epa.gov/osa/hsrb/.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2007-0403, by one of the following methods:
Internet: https://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ORD.Docket@epa.gov.
Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),
ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington,
DC 20460.
Hand 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 e-mail the ORD Docket at ord.docket@epa.gov for
instructions. Updates to Public Reading Room access are available on
the Web site (https://www.epa.gov/epahome/dockets.htm).
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0403. 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
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,
especially 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 31324]]
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/.
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, 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 AM to 4:30 PM EST, Monday through Friday,
excluding Federal holidays. Please call (202) 566-1744 or email the ORD
Docket at ord.docket@epa.gov for instructions. Updates to Public
Reading Room access are available on the Web site (https://www.epa.gov/
epahome/dockets.htm).
EPA's position paper(s), charge/questions to the HSRB, and the
meeting agenda will be available by early June 2007. 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/. 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-2007-0403 in the subject line
on the first page of your request.
a. Oral comments. Requests to present oral comments will be
accepted up to June 20, 2007. 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 email) to the
person listed under FOR FURTHER INFORMATION CONTACT no later than noon,
Eastern Time, June 20, 2007 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 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 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, June 20, 2007. 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. Topics for Discussion. 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 June 27-29, 2007 meeting of the Human Studies Review Board will
address scientific and ethical issues surrounding:
A research proposal from Carroll-Loye Biological Research
to evaluate the efficacy of two conditionally registered products
containing picaridin in repelling mosquitoes in the field.
A research proposal from Insect Control & Research, Inc.
to evaluate the efficacy of two unregistered products containing
picaridin in repelling mosquitoes in the field.
A completed study measuring the effects on human subjects
of acute inhalation exposure to acrolein. Acrolein is an active
ingredient used in biocides in agricultural and industrial water supply
systems and is currently undergoing reregistration.
Three completed clinical studies of the efficacy and side
effects of 4-aminopyridine when used as a therapeutic agent to treat
neurological
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symptoms in patients with either spinal cord injury or multiple
sclerosis. 4-aminopyridine is an active ingredient used in bird
repellents that is currently undergoing reregistration.
Extensive background materials concerning research to
quantify the level of exposure received by people who mix, load, and
apply pesticides. These materials, which were prepared by the
Agricultural Handlers Exposure Task Force and by the Antimicrobial
Exposure Assessment Task Force, generally explain the scope of the
research programs being proposed by the Task Forces and describe the
general scientific framework for conducting the research. In addition,
each Task Force has provided Standard Operating Procedures which will
guide the conduct of the studies.
The Board may also be reviewing draft HSRB reports for subsequent
Board approval. Finally, the Board may also discuss planning for future
HSRB meetings.
b. 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 https://
www.epa.gov/osa/hsrb/ and https://www.regulations.gov. In addition,
information concerning a Board meeting report, if applicable, can be
found at https://www.epa.gov/osa/hsrb/ or from the person listed under
FOR FURTHER INFORMATION CONTACT.
Dated: May 31, 2007.
Kevin Teichman,
Acting EPA Science Advisor.
[FR Doc. E7-10859 Filed 6-5-07; 8:45 am]
BILLING CODE 6560-50-P