Human Studies Review Board (HSRB); Notification of a Public Meeting, 17121-17123 [2011-7198]
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Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices
On March 15, 2011, Federal Energy
Regulatory Commission staff (Staff) held
a technical conference to obtain further
information to aid the Commission in
considering issues related to the
ownership of and priority access rights
to new participant-funded transmission
projects.
In particular, Staff sought to explore
issues related to priority rights to use
transmission infrastructure developed
under various new business models in
two specific contexts: independent and/
or merchant transmission, and generator
lead lines. In both contexts, participants
were encouraged to identify and discuss
the appropriate balance between the
Commission’s requirements for open
access and the needs of project
developers. Participants were also
encouraged to propose and discuss
specific regulatory alternatives that are
consistent with the Commission’s open
access policies and its statutory
responsibility to ensure that rates,
terms, and conditions of service are just
and reasonable and not unduly
discriminatory or preferential.
Persons wishing to comment on these
issues should submit written comments
to the Commission no later than April
21, 2011.
Dated: March 18, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011–7149 Filed 3–25–11; 8:45 am]
BILLING CODE 6717–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9286–7; Docket ID No. EPA–HQ–ORD–
2011–0050]
Draft Integrated Science Assessment
for Ozone and Related Photochemical
Oxidants
Environmental Protection
Agency (EPA).
ACTION: Notice of extension of public
comment.
AGENCY:
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Dated: March 22, 2011.
Darrell A. Winner,
Acting Director, National Center for
Environmental Assessment.
[FR Doc. 2011–7219 Filed 3–25–11; 8:45 am]
BILLING CODE 6560–50–P
EPA is announcing an
extension of the public comment period
for the first external review draft of a
document titled, ‘‘First External Review
Draft Integrated Science Assessment for
Ozone and Related Photochemical
Oxidants’’ (EPA/600/R–10/076A). The
original Federal Register notice
announcing the public comment period
was published on February 28, 2011
(76 FR 10893). This assessment
document was developed by the
National Center for Environmental
Assessment (NCEA) within EPA’s Office
of Research and Development as part of
SUMMARY:
the review of the national ambient air
quality standards (NAAQS) for ozone.
DATES: The public comment period
began on February 28, 2011, and ends
May 5, 2011. Comments must be
received by EPA by May 5, 2011.
ADDRESSES: The ‘‘First External Review
Draft Integrated Science Assessment for
Ozone and Related Photochemical
Oxidants’’ will be available primarily via
the Web page under the Recent
Additions and Publications menus at
https://www.epa.gov/ncea. A limited
number of CD–ROM or paper copies
will be available. Contact Ms. Debbie
Wales by phone (919–541–4731),
facsimile (919–541–5078), or e-mail
(wales.deborah@epa.gov) to request
either of these, and please provide your
name, your mailing address, and the
document title, ‘‘First External Review
Draft Integrated Science Assessment for
Ozone and Related Photochemical
Oxidants’’ (EPA/600/R–10/076A) to
facilitate processing of your request.
FOR FURTHER INFORMATION CONTACT: For
technical information, contact Dr. James
Brown, NCEA; telephone: 919–541–
0765; facsimile: 919–541–1818; or
e-mail: Brown.James@epa.gov.
Comments may be submitted
electronically via https://
www.regulations.gov, by mail, by
facsimile, or by hand delivery/courier.
Please follow the detailed instructions
provided in the SUPPLEMENTARY
INFORMATION section of Federal Register
Notice (76 FR 10893).
For information on submitting
comments to the docket, please contact
the Office of Environmental Information
Docket; telephone: 202–566–1752;
facsimile: 202–566–1753; or e-mail:
ORD.Docket@epa.gov.
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2011–0124; FRL–9287–1]
Human Studies Review Board (HSRB);
Notification of a Public Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The U.S. Environmental
Protection Agency (EPA) Office of the
Science Advisor (OSA) announces a
public meeting of the HSRB to advise
the Agency on EPA’s scientific and
SUMMARY:
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ethical reviews of research with human
subjects.
DATES: This public meeting will be held
on April 13–14, 2011, from
approximately 8:30 a.m. to
approximately 5 p.m. Eastern Time.
ADDRESSES: Submit your written
comments, identified by Docket ID No.
EPA–HQ–ORD–2011–0124, 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 Avenue 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 Avenue NW.,
Washington, DC 20460. The hours of
operation are 8:30 a.m. to 4:30 p.m.
Eastern Time, 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–2011–
0124. 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
the disclosure of which 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.
FOR FURTHER INFORMATION CONTACT: Any
member of the public who wishes to
receive further information should
contact Jim Downing at telephone
number: (202) 564–2468; fax: (202) 564–
2070; e-mail address:
downing.jim@epa.gov, or Lu-Ann
Kleibacker at telephone number: (202)
564–7189; fax: 202–564–2070; e-mail
address: kleibacker.lu-ann@epa.gov;
mailing address: Environmental
Protection Agency, Office of the Science
Advisor (8105R), 1200 Pennsylvania
Avenue NW., Washington, DC 20460.
General information concerning the EPA
HSRB can be found on the EPA Web site
at https://www.epa.gov/osa/hsrb/.
SUPPLEMENTARY INFORMATION:
Location: Holiday Inn National
Airport, 2650 Jefferson Davis Highway,
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 persons listed under FOR
FURTHER INFORMATION CONTACT at least
ten 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 section I. ‘‘Public Meeting,’’
under subsection D. ‘‘How May I
Participate in this Meeting?’’ of this
notice.
Emcdonald on DSK2BSOYB1PROD with NOTICES
I. Public Meeting
A. Does this action apply to me?
This action is directed to the public
in general. This action may, however, be
of particular interest to persons who
conduct or assess human studies,
especially studies on substances
regulated by EPA, 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 Jim
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Downing or Lu-Ann Kleibacker 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/.
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 Avenue NW.,
Washington, DC 20460. The hours of
operation are 8:30 a.m. to 4:30 p.m.
Eastern Time, 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). EPA’s position paper(s),
charge/questions to the HSRB, and the
meeting agenda will be available by the
end of March 2011. 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
EPA HSRB Web site at https://
www.epa.gov/osa/hsrb/. For questions
on document availability, or if you do
not have access to the Internet, consult
either Jim Downing or Lu-Ann
Kleibacker 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:
1. Explain your views as clearly as
possible.
2. Describe any assumptions that you
used.
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3. Provide copies of any technical
information and/or data that you used to
support your views.
4. Provide specific examples to
illustrate your concerns and suggest
alternatives.
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.
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–2011–
0124 in the subject line on the first page
of your request.
1. Oral comments. Requests to present
oral comments will be accepted up to
Wednesday, April 6, 2011. 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 Jim
Downing or Lu-Ann Kleibacker, under
FOR FURTHER INFORMATION CONTACT, no
later than noon, Eastern Time,
Wednesday, April 6, 2011, in order to be
included on the meeting agenda and to
provide sufficient time for the HSRB
Chair and HSRB Designated Federal
Official (DFO) to review the meeting
agenda to provide an appropriate public
comment period. The request should
identify the name of the individual
making the presentation and the
organization (if any) the individual will
represent. Oral comments before the
HSRB are generally limited to five
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
the time limitations by having
numerous individuals sign up
separately to speak on their behalf. If
additional time is available, further
public comments may be possible.
2. Written comments. Submit your
written comments prior to the meeting.
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 this meeting. If you submit
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Emcdonald on DSK2BSOYB1PROD with NOTICES
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, Wednesday, April 6, 2011. You
should submit your comments using the
instructions in section I., under
subsection C., ‘‘What Should I Consider
as I Prepare My Comments for EPA?’’ In
addition, the Agency also requests that
persons submitting comments directly
to the docket also provide a copy of
their comments to Jim Downing or LuAnn Kleibacker listed under FOR
FURTHER INFORMATION CONTACT. There is
no limit on the length of written
comments for consideration by the
HSRB.
E. Background
The HSRB is a Federal advisory
committee operating in accordance with
the Federal Advisory Committee Act
(FACA) 5 U.S.C. App.2 § 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: (1)
Research proposals and protocols; (2)
reports of completed research with
human subjects; and (3) 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.
1. Topics for discussion. At its
meeting on April 13 and 14, 2011, EPA’s
Human Studies Review Board will
consider scientific and ethical issues
surrounding these topics:
a. The report of a completed scenario
monograph and study reports from the
Agricultural Handler Exposure Task
Force (AHETF) measuring the dermal
and inhalation exposure of professional
agricultural workers applying liquid
spray pesticides to tree or trellis crops
using open cab airblast equipment.
b. The report of a completed scenario
monograph and study report from the
Antimicrobial Exposure Assessment
Task Force II (AEATF) in which the
dermal and inhalation exposure of
professional janitorial workers was
monitored as they applied a liquid
antimicrobial product to indoor surfaces
using a trigger spray bottle and wipes or
ready-to-use wipes.
c. A published report by Gulson et al
(2010) of an intentional exposure
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human study measuring dermal
absorption of zinc oxides contained in
sunscreen.
d. A reevaluation of an intentional
human dosing study with chlorpyrifos
(Kisicki) previously reviewed by the
HSRB; pertinent new information from
the sponsor has been made available.
2. 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: March 23, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011–7198 Filed 3–25–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL- 9287–2]
Science Advisory Board Staff Office;
Notification of a Public Meeting of the
Advisory Council on Clean Air
Compliance Analysis Augmented for
Review of the Report to Congress on
Black Carbon
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA or Agency) Science
Advisory Board (SAB) Staff Office
announces a public face-to-face meeting
of the Black Carbon Review Panel.
DATES: The meeting will be held on
April 18, 2011 from 9 a.m. to 5 p.m. and
April 19, 2011 from 8:30 a.m. to 2:30
p.m. (Eastern Time).
ADDRESSES: The Panel meeting will be
held at the Omni Shoreham, 2500
Calvert Street NW., Washington, DC
20008.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Members of the public who wish to
obtain further information regarding this
meeting must contact Ms. Stephanie
Sanzone, Designated Federal Officer
(DFO). Ms. Sanzone may be contacted at
the EPA Science Advisory Board
(1400R), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue,
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17123
NW., Washington, DC 20460; or by
telephone/voice mail at (202) 564–2067;
fax at (202) 565–2098; or e-mail at
sanzone.stephanie@epa.gov. General
information concerning the Council can
be found at the EPA Council Web site
at https://www.epa.gov/
advisorycouncilcaa. Any inquiry
regarding EPA’s Draft Report to
Congress on Black Carbon should be
directed to Erika Sasser, EPA Office of
Air Quality Planning and Standards
(OAQPS), at sasser.erika@epa.gov or
(919) 541–3889.
SUPPLEMENTARY INFORMATION:
Background: The Advisory Council
on Clean Air Compliance Analysis
(Council) was established pursuant to
Section 812 of the Clean Air Act (CAA)
Amendments of 1990 (codified as 42
U.S.C. 7612) to provide independent
advice to the Administrator on technical
and economic aspects of analyses and
reports EPA prepares on the impacts of
the CAA on the public health, economy,
and environment of the United States.
The Council is a Federal Advisory
Committee chartered under the Federal
Advisory Committee Act (FACA), 5
U.S.C., App. 2. Pursuant to FACA and
EPA policy, notice is hereby given that
the Council augmented with additional
experts (hereafter referred to as the
Black Carbon Review Panel) will hold a
public meeting to review EPA’s Draft
Report to Congress on Black Carbon.
The Panel will comply with the
provisions of FACA and all appropriate
SAB Staff Office procedural policies.
The October 2009 Interior
Appropriations bill (Pub. L. 111–88)
requires the EPA, in consultation with
other Federal agencies, to prepare a
comprehensive report to Congress on
the climate effects of black carbon.
Black carbon, or soot, results from
incomplete combustion of organic
matter such as fossil fuels and biomass.
The report to Congress will evaluate and
synthesize available information on
sources of black carbon, impacts of
black carbon on global and regional
climate, and the potential utility and
cost-effectiveness of mitigation options
for reducing climate and public health
impacts of black carbon.
EPA’s Office of Air Quality Planning
and Standards (OAQPS) requested that
the Council review the draft Report to
Congress on Black Carbon to evaluate
the report’s scientific rigor,
completeness, and technical accuracy.
To conduct this review, the Council was
augmented with additional experts in
climate modeling and black carbon
emissions, impacts, and control
strategies. Information about formation
of the Black Carbon Review Panel can
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Agencies
[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17121-17123]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7198]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2011-0124; FRL-9287-1]
Human Studies Review Board (HSRB); Notification of a Public
Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Environmental Protection Agency (EPA) Office of the
Science Advisor (OSA) announces a public meeting of the HSRB to advise
the Agency on EPA's scientific and ethical reviews of research with
human subjects.
DATES: This public meeting will be held on April 13-14, 2011, from
approximately 8:30 a.m. to approximately 5 p.m. Eastern Time.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0124, 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 Avenue 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 Avenue NW., Washington, DC 20460. The
hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, 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-
2011-0124. 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 the
disclosure of which 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 17122]]
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to
receive further information should contact Jim Downing at telephone
number: (202) 564-2468; fax: (202) 564-2070; e-mail address:
downing.jim@epa.gov, or Lu-Ann Kleibacker at telephone number: (202)
564-7189; fax: 202-564-2070; e-mail address: kleibacker.lu-ann@epa.gov;
mailing address: Environmental Protection Agency, Office of the Science
Advisor (8105R), 1200 Pennsylvania Avenue NW., Washington, DC 20460.
General information concerning the EPA HSRB can be found on the EPA Web
site at https://www.epa.gov/osa/hsrb/.
SUPPLEMENTARY INFORMATION:
Location: Holiday Inn National Airport, 2650 Jefferson Davis
Highway, 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
persons listed under FOR FURTHER INFORMATION CONTACT at least ten
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 section
I. ``Public Meeting,'' under subsection D. ``How May I Participate in
this Meeting?'' of this notice.
I. Public Meeting
A. Does this action apply to me?
This action is directed to the public in general. This action may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by EPA, 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 Jim Downing or Lu-Ann Kleibacker 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/.
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 Avenue NW., Washington, DC
20460. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time,
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). EPA's position
paper(s), charge/questions to the HSRB, and the meeting agenda will be
available by the end of March 2011. 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 EPA HSRB Web site at https://www.epa.gov/osa/hsrb/. For questions on document availability, or if
you do not have access to the Internet, consult either Jim Downing or
Lu-Ann Kleibacker 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:
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 that you
used to support your views.
4. Provide specific examples to illustrate your concerns and
suggest alternatives.
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.
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-2011-0124 in the subject line
on the first page of your request.
1. Oral comments. Requests to present oral comments will be
accepted up to Wednesday, April 6, 2011. 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 Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER
INFORMATION CONTACT, no later than noon, Eastern Time, Wednesday, April
6, 2011, in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB Designated Federal Official
(DFO) to review the meeting agenda to provide an appropriate public
comment period. The request should identify the name of the individual
making the presentation and the organization (if any) the individual
will represent. Oral comments before the HSRB are generally limited to
five 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 the time limitations by
having numerous individuals sign up separately to speak on their
behalf. If additional time is available, further public comments may be
possible.
2. Written comments. Submit your written comments prior to the
meeting. 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 this meeting. If you submit
[[Page 17123]]
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, Wednesday, April 6, 2011. You should submit your comments using
the instructions in section I., under subsection C., ``What Should I
Consider as I Prepare My Comments for EPA?'' In addition, the Agency
also requests that persons submitting comments directly to the docket
also provide a copy of their comments to Jim Downing or Lu-Ann
Kleibacker listed under FOR FURTHER INFORMATION CONTACT. There is no
limit on the length of written comments for consideration by the HSRB.
E. Background
The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act (FACA) 5 U.S.C. App.2 Sec. 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: (1) Research proposals and protocols; (2) reports
of completed research with human subjects; and (3) 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.
1. Topics for discussion. At its meeting on April 13 and 14, 2011,
EPA's Human Studies Review Board will consider scientific and ethical
issues surrounding these topics:
a. The report of a completed scenario monograph and study reports
from the Agricultural Handler Exposure Task Force (AHETF) measuring the
dermal and inhalation exposure of professional agricultural workers
applying liquid spray pesticides to tree or trellis crops using open
cab airblast equipment.
b. The report of a completed scenario monograph and study report
from the Antimicrobial Exposure Assessment Task Force II (AEATF) in
which the dermal and inhalation exposure of professional janitorial
workers was monitored as they applied a liquid antimicrobial product to
indoor surfaces using a trigger spray bottle and wipes or ready-to-use
wipes.
c. A published report by Gulson et al (2010) of an intentional
exposure human study measuring dermal absorption of zinc oxides
contained in sunscreen.
d. A reevaluation of an intentional human dosing study with
chlorpyrifos (Kisicki) previously reviewed by the HSRB; pertinent new
information from the sponsor has been made available.
2. 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: March 23, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-7198 Filed 3-25-11; 8:45 am]
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