Human Studies Review Board; Notice of Public Meeting, 14101-14103 [E7-5492]
Download as PDF
cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices
and (2) a summary of the above in a
biographical sketch (‘‘biosketch’’) of no
more than one page.
The qualifications of nominees
received in reply to this notice will be
assessed in terms of the specific
expertise sought for the HSRB. Qualified
nominees who agree to be considered
further will be included in a smaller
subset (known as the ‘‘Short List’’). This
Short List consisting of nominee’s name
and biosketch will be posted for public
comment on the OSA Web site https://
www.epa.gov/osa/index.htm. The public
will be requested to provide relevant
information or other documentation on
nominees that OSA should consider in
evaluating the candidates. Public
comments will be accepted for 14
calendar days on the Short List. Board
members will be selected from the Short
List. Short List candidates not selected
for HSRB membership may be
considered for future HSRB membership
as vacancies become available or as
HSRB consultants for future HSRB
meetings. The Agency estimates posting
the names of Short List candidates
sometime in late May. However, please
be advised that this is an approximate
time frame and the date could change.
Thus, if you have any questions
concerning posting of Short List
candidates on the OSA Web site, please
consult the person listed under FOR
FURTHER INFORMATION CONTACT.
For the HSRB, a balanced panel is
characterized by inclusion of members
who possess the necessary domains of
knowledge, the relevant technical
perspectives, and the collective breadth
of experience to adequately address the
Agency’s charge. Interested candidates
who are employees of a federal
department or agency (other than EPA)
or are members of another federal
advisory committee are eligible to serve
on the HSRB, and their nominations are
welcome. Other factors that will be
considered include: Availability to
participate in the Board’s scheduled
meetings, absence of any conflicts of
interest and absence of an appearance of
a lack of impartiality, independence
with respect to the matters under
review, and public comments in
response to the Short List. Though
financial conflicts of interest or the
appearance of a lack of impartiality, lack
of independence, or bias may lead to
nonselection, the absence of such
concerns does not ensure that a
candidate will be selected to serve on
the HSRB. Numerous qualified
candidates are likely to be identified.
Selection decisions will involve careful
weighing a number of factors including,
but not limited to, the candidates’ areas
of expertise and professional
VerDate Aug<31>2005
15:30 Mar 23, 2007
Jkt 211001
qualifications, and responses to the
Short List in achieving an overall
balance of different perspectives on the
Board.
People who are hired to serve on the
Board are subject to the provisions of 5
CFR part 2634, Executive Branch
Financial Disclosure, as supplemented
by the EPA in 5 CFR part 6401. In
anticipation of this requirement, each
nominee will be asked to submit a
Confidential Financial Disclosure Form
for Special Government Employees
Serving on Federal Advisory
Committees at the U.S. Environmental
Protection Agency (EPA Form 3110–48
[5–02]). This form seeks information
regarding the candidate’s financial
interests, the candidate’s employment,
stocks, and bonds, and where
applicable, sources of research support.
However, this form is confidential and
will not be disclosed to the public. The
EPA will evaluate the candidate’s
financial disclosure form to assess
whether there are financial conflicts of
interest, appearance of a lack of
impartiality, or any prior involvement
with the development of the documents
under consideration, including previous
scientific peer review, before the
candidate is considered further for
service on the HSRB.
Candidates selected from the Short
List will be appointed to the HSRB.
HSRB members are to perform several
activities including reviewing extensive
background materials between meetings
of the Board, preparing draft responses
to Agency charge questions, attending
Board meetings, participating in the
discussion and deliberations at these
meetings, drafting assigned sections of
meeting reports, and reviewing and
helping to finalize Board reports.
Nominations should be submitted by
one of the methods listed under
ADDRESSEES.
The Agency will consider all
nominations for HSRB membership that
are received on or before April 25, 2007.
However, final selection of members is
a discretionary function of the Agency
and will be announced on the OSA Web
site https://www.epa.gov/osa/index.htm
soon after comments are received on the
Short List.
Dated: March 19, 2007.
George M. Gray,
Science Advisor.
[FR Doc. E7–5484 Filed 3–23–07; 8:45 am]
BILLING CODE 6560–50–P
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
14101
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2007–0216; FRL–8291–4]
Human Studies Review Board; Notice
of Public Meeting
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.
DATES: The public meeting will be held
on April 18, 2007 from 10 a.m. to
approximately 5:30 p.m., Eastern Time
and April 19–20, 2007 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–2007–0216, 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),
E:\FR\FM\26MRN1.SGM
26MRN1
14102
Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices
cprice-sewell on PROD1PC66 with NOTICES
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–
0216. 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
VerDate Aug<31>2005
15:30 Mar 23, 2007
Jkt 211001
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/.
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 a.m. to 4:30 a.m. Eastern
Standard 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 late March
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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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–
0216 in the subject line on the first page
of your request.
a. Oral comments. Requests to present
oral comments will be accepted up to
April 11, 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
Standard Time, April 11, 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
E:\FR\FM\26MRN1.SGM
26MRN1
Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices
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
Standard Time, April 11, 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.
cprice-sewell on PROD1PC66 with NOTICES
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.
At the April 2007 meeting of the
HSRB, EPA will present for HSRB
review:
• The results of two completed insect
repellent efficacy studies on an aerosol
formulation of the active ingredient
IR3535, studies which the Agency
intends to rely in making registration
VerDate Aug<31>2005
15:30 Mar 23, 2007
Jkt 211001
decisions. Protocols for this research
were reviewed by the Board at its June
and October 2006 meetings.
• A proposal for a new field study of
the effectiveness of products containing
oil of lemon eucalyptus in repelling
mosquitoes.
• Completed studies of human skin
irritation and skin sensitization on two
pending pesticide products whose use
would involve extensive dermal
exposure. These studies were conducted
before the effective date of EPA’s human
studies rules (April 7, 2006).
• EPA’s assessment of the need for
new research on the exposure received
by occupational handlers who mix,
load, or apply agricultural or
antimicrobial pesticides.
• An EPA ‘‘draft framework’’
concerning best practices for recruiting
and enrolling subjects in studies of
occupational exposure.
In addition, at the Board’s request,
EPA will present its interpretation and
application of the standard in 40 CFR
26.1705: ‘‘EPA shall not rely on data
from any research initiated after April 7,
2006, unless EPA has adequate
information to determine that the
research was conducted in substantial
compliance with [EPA’s human studies
rules].’’ 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: March 19, 2007.
George M. Gray,
Science Advisor.
[FR Doc. E7–5492 Filed 3–23–07; 8:45 am]
BILLING CODE 6560–50–P
COUNCIL ON ENVIRONMENTAL
QUALITY
The National Environmental Policy
Act—Collaboration Handbook
Council On Environmental
Quality.
ACTION: Notice and request for
comments.
AGENCY:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
14103
SUMMARY: The Council on
Environmental Quality (CEQ) used an
interagency work group to develop a
handbook to help NEPA practitioners
improve the effectiveness of their NEPA
processes through collaboration. The
handbook focuses on collaboration in
the context of the NEPA process,
outlines general principles, presents
useful steps, and provides information
on methods of collaboration. CEQ
invites comments on the proposed
handbook, ‘‘Collaboration in NEPA—A
Handbook for NEPA Practitioners,’’ that
is available from CEQ directly or at
https://www.NEPA.gov in the Current
Developments section.
DATES: Written comments should be
submitted on or before May 4, 2007.
ADDRESSES: Copies of the proposed
handbook can be requested from CEQ.
Electronic comments on the proposed
handbook and requests for a copy of the
proposed handbook can be sent to
horst_greczmiel@ceq.eop.gov with the
subject line reading ‘‘NEPA
Modernization (Collaboration).’’ Fax
written comments and requests to (202)
456–0753 with the subject line reading
‘‘NEPA Modernization (Collaboration).’’
Electronic or facsimile comments or
requests are preferred because Federal
offices experience intermittent mail
delays caused by security screening.
Written comments and requests may
also be submitted to ‘‘NEPA
Modernization (Collaboration), Attn:
Associate Director for NEPA Oversight,
722 Jackson Place, NW., Washington,
DC 20503.’’
FOR FURTHER INFORMATION CONTACT:
Horst Greczmiel, 202–395–5750.
SUPPLEMENTARY INFORMATION: The
Council on Environmental Quality
(CEQ) established a National
Environmental Policy Act (NEPA) Task
Force and is now implementing
recommendations designed to
modernize the implementation of NEPA
and make the NEPA process more
effective and efficient. Additional
information is available on the task
force Web site at https://ceq.eh.doe.gov/
ntf.
The proposed handbook,
‘‘Collaboration in NEPA—A Handbook
for NEPA Practitioners,’’ was developed
to assist those responsible for
conducting National Environmental
Policy Act (NEPA) analyses in
expanding the effective use of
collaboration as part of the NEPA
process. Collaboration is defined for
purposes of the handbook as seeking
agreements at one or more stages of the
NEPA process by cultivating shared
vision, trust, and communication. The
main goal of the handbook is to
E:\FR\FM\26MRN1.SGM
26MRN1
Agencies
[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14101-14103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5492]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2007-0216; FRL-8291-4]
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 on April 18, 2007 from 10 a.m.
to approximately 5:30 p.m., Eastern Time and April 19-20, 2007 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-2007-0216, 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),
[[Page 14102]]
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-
2007-0216. 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.
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 a.m. to 4:30 a.m. Eastern Standard 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 late March 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-2007-0216 in the subject line
on the first page of your request.
a. Oral comments. Requests to present oral comments will be
accepted up to April 11, 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 Standard Time, April 11, 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
[[Page 14103]]
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 Standard Time, April 11, 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.
At the April 2007 meeting of the HSRB, EPA will present for HSRB
review:
The results of two completed insect repellent efficacy
studies on an aerosol formulation of the active ingredient IR3535,
studies which the Agency intends to rely in making registration
decisions. Protocols for this research were reviewed by the Board at
its June and October 2006 meetings.
A proposal for a new field study of the effectiveness of
products containing oil of lemon eucalyptus in repelling mosquitoes.
Completed studies of human skin irritation and skin
sensitization on two pending pesticide products whose use would involve
extensive dermal exposure. These studies were conducted before the
effective date of EPA's human studies rules (April 7, 2006).
EPA's assessment of the need for new research on the
exposure received by occupational handlers who mix, load, or apply
agricultural or antimicrobial pesticides.
An EPA ``draft framework'' concerning best practices for
recruiting and enrolling subjects in studies of occupational exposure.
In addition, at the Board's request, EPA will present its
interpretation and application of the standard in 40 CFR 26.1705: ``EPA
shall not rely on data from any research initiated after April 7, 2006,
unless EPA has adequate information to determine that the research was
conducted in substantial compliance with [EPA's human studies rules].''
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: March 19, 2007.
George M. Gray,
Science Advisor.
[FR Doc. E7-5492 Filed 3-23-07; 8:45 am]
BILLING CODE 6560-50-P