Human Studies Review Board; Notification of a Public Meeting, 15332-15334 [2014-05908]
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15332
Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices
13045, entitled ‘‘Protection of Children
from Environmental Health Risks and
Safety Risks’’ (62 FR 19885, April 23,
1997) and Executive Order 13211
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001). In addition,
this action also does not require any
special considerations under Executive
Order 12898 entitled ‘‘Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
F. National Technology Transfer and
Advancement Act
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act (15
U.S.C. 272 note).
VI. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq. does not apply
because this action is not a rule as that
term is defined in 5 U.S.C. 804(3).
List of Subjects
Environmental protection,
Administrative practice and procedure,
Business and industry, Chemicals,
Reporting and recordkeeping
requirements.
Dated: March 12, 2014.
James Jones,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2014–06050 Filed 3–18–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2014–0189; FRL–9908–30–
ORD]
Human Studies Review Board;
Notification of a Public Meeting
U.S. Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) Office of the Science
Advisor announces a public meeting of
the Human Studies Review Board to
advise the Agency on the EPA ethical
and scientific reviews of research with
human subjects.
DATES: This public meeting will be held
on April 8–9, 2014, from approximately
9:30 p.m. to approximately 5:30 p.m.
Eastern Time. Comments may be
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SUMMARY:
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submitted on or before noon (Eastern
Time) on Tuesday, April 1, 2014.
ADDRESSES: The meeting will be held at
the Environmental Protection Agency,
Conference Center, Lobby Level, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA 22202.
Comments: Submit your written
comments, identified by Docket ID No.
EPA–HQ–ORD–2014–0189, by one of
the following methods:
Internet: https://www.regulations.gov:
Follow the online instructions for
submitting comments.
Email: ORD.Docket@epa.gov.
Mail: The EPA Docket Center EPA/
DC, ORD Docket, Mail code: 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 WJC West, 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 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.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–ORD–2014–
0189. The Agency’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 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 email. 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 email comment directly
to the EPA without going through https://
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, the EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
electronic storage media you submit. If
the EPA cannot read your comment due
to technical difficulties and cannot
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contact you for clarification, the 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; email address:
downing.jim@epa.gov; mailing address
Environmental Protection Agency,
Office of the Science Advisor, Mail code
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/hsrb.
SUPPLEMENTARY INFORMATION:
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.
Webcast: This meeting may be
webcast. Please refer to the HSRB Web
site, https://www.epa.gov/hsrb/ for
information on how to access the
webcast. Please note that the webcast is
a supplementary public process
provided only for convenience. If
difficulties arise resulting in webcasting
outages, the meeting will continue as
planned.
I. Public Meeting
A. Does this action apply to me?
This action is directed to the public
in general. This Notice may, however,
be of particular interest to persons who
conduct or assess human studies,
especially studies on substances
regulated by the EPA, or to persons who
are, or may be required to conduct
testing of chemical substances under the
Federal Food, Drug, and Cosmetic Act
or the Federal Insecticide, Fungicide,
and Rodenticide Act. This notice might
also be of special interest to participants
of studies involving human subjects, or
representatives of study participants or
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Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices
experts on community engagement.
Since many 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 listed under FOR FURTHER
INFORMATION CONTACT.
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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 WJC West, 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 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).
The Agency’s position paper(s), charge/
questions to the HSRB, and the meeting
agenda will be available by the last
week of March 2014. 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/hsrb/. For questions on
document availability, or if you do not
have access to the Internet, consult Jim
Downing listed under FOR FURTHER
INFORMATION CONTACT.
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C. What should I consider as I prepare
my comments for the 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 the
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 the
EPA, it is imperative that you identify
Docket ID number EPA–HQ–ORD–
2014–0189 in the subject line on the
first page of your request.
1. Oral comments. Requests to present
oral comments will be accepted up to
Tuesday, April 1, 2014. 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, under FOR FURTHER
INFORMATION CONTACT no later than
noon, Eastern Time, Tuesday, April 1,
2014, in order to be included on the
meeting agenda and to provide
sufficient time for the HSRB Chair and
HSRB Designated Federal Official 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 focused on the ethical and
scientific issues of the topics being
considered by the Board, we do not
intend to permit organizations to
expand the time limitations by having
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15333
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 Board 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
comments after this date, those
comments will be provided to the Board
members, but you should recognize that
the HSRB 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, Tuesday, April 1, 2014. You
should submit your comments using the
instructions in Section I., under
subsection C., ‘‘What Should I Consider
as I Prepare My Comments for the
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 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 5
U.S.C. App.2 § 9. The HSRB provides
advice, information, and
recommendations to the 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 the Agency’s
Science Advisor.
1. Topics for discussion. At its
meeting on April 8–9, 2014, EPA’s
Human Studies Review Board will
consider ethical and scientific issues
surrounding the following topics:
a. AEATF–II Protocol: A Study for
Measurement of Potential Dermal and
Inhalation Exposure During Manual
Pouring of Two Solid Formulations
Containing an Antimicrobial
b. AEATF–II Protocol: A Study for
Measurement of Potential Dermal and
Inhalation Exposure During
Application of Latex Paint Containing
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an Antimicrobial Pesticide Product
Using a Brush and Roller for Indoor
Surface Painting
c. AEATF Protocol: Determination of
Removal Efficiency of 1,2Benzisothiazol-3(2H)-one (BIT) from
Hand Surfaces Using an Isopropyl
Alcohol/Water Wipe and Wash
Procedure
d. Laboratory Evaluation of Bite
Protection from Repellent
Impregnated Clothing for the United
States Military
e. Background presentation on the
Repellency Awareness Graphic and
possible implications for the HSRB
f. Report from the HSRB Work Group of
the Return of Individual Research
Results
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 regarding the Board’s final
meeting report, will be found at https://
www.epa.gov/osa/hsrb/ or from the
person listed under FOR FURTHER
INFORMATION CONTACT.
Dated: March 10, 2014.
Glenn Paulson,
Science Advisor.
section 104(k)(3) grants are not eligible
to apply for these funds. EPA will
consider awarding supplemental
funding only to RLF grantees who have
demonstrated an ability to deliver
programmatic results by making at least
one loan or subgrant. The award of these
funds is based on the criteria described
at CERCLA 104(k)(4)(A)(ii).
The Agency is now accepting requests
for supplemental funding from RLF
grantees. Requests for funding must be
submitted to the appropriate EPA
Regional Brownfields Coordinator
(listed below) by April 18, 2014.
Funding requests for hazardous
substances and/or petroleum funding
will be accepted. Specific information
on submitting a request for RLF
supplemental funding is described
below and additional information may
be obtained by contacting the EPA
Regional Brownfields Coordinator.
DATES: This action is effective March 19,
2014.
ADDRESSES: A request for supplemental
funding must be in the form of a letter
addressed to the appropriate Regional
Brownfields Coordinator (see listing
below) with a copy to Megan Quinn,
Quinn.Megan@epa.gov.
FOR FURTHER INFORMATION CONTACT:
Megan Quinn, U.S. EPA, (202) 566–2773
or the appropriate Brownfields Regional
Coordinator.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2014–05908 Filed 3–18–14; 8:45 am]
Background
BILLING CODE 6560–50–P
The Small Business Liability Relief
and Brownfields Revitalization Act
added section 104(k) to CERCLA to
authorize federal financial assistance for
brownfields revitalization, including
grants for assessment, cleanup and job
training. Section 104(k) includes a
provision for EPA to, among other
things, award grants to eligible entities
to capitalize Revolving Loan Funds and
to provide loans and subgrants for
brownfields cleanup. Section
104(k)(4)(A)(ii) authorizes EPA to make
additional grant funds available to RLF
grantees for any year after the year for
which the initial grant is made
(noncompetitive RLF supplemental
funding) taking into consideration:
(I) the number of sites and number of
communities that are addressed by the
revolving loan fund;
(II) the demand for funding by eligible
entities that have not previously
received a grant under this subsection;
(III) the demonstrated ability of the
eligible entity to use the revolving loan
fund to enhance remediation and
provide funds on a continuing basis;
and
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9908–32–OSWER]
FY2014 Supplemental Funding for
Brownfields Revolving Loan Fund
(RLF) Grantees
Environmental Protection
Agency (EPA).
ACTION: Notice of the availability of
funds.
AGENCY:
The Environmental Protection
Agency’s (EPA) Office of Brownfields
and Land Revitalization (OBLR) plans to
make available approximately $6
million to provide supplemental funds
to Revolving Loan Fund capitalization
grants previously awarded
competitively under section 104(k)(3) of
the Comprehensive Environmental
Response, Compensation and Liability
Act (CERCLA). Brownfields Cleanup
Revolving Loan Fund (BCRLF) pilots
awarded under section 104(d)(1) of
CERCLA that have not transitioned to
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(IV) such other similar factors as the
[Agency] considers appropriate to carry
out this subsection.
Eligibility
In order to be considered for
supplemental funding, grantees must
demonstrate that they have expended
existing funds and that they have a clear
plan for quickly expending requested
additional funds. Grantees must
demonstrate that they have made at
least one loan or subgrant prior to
applying for this supplemental funding
and have significantly depleted existing
available funds. For FY2014, EPA
defines ‘‘significantly depleted funds’’
as any grant where $400,000 or less
remains uncommitted. Additionally, the
RLF recipient must have demonstrated
a need for supplemental funding based
on, among other factors, the number of
sites that will be addressed;
demonstrated the ability to make loans
and subgrants for cleanups that can be
started and completed expeditiously
(i.e., ‘‘shovel-ready’’ projects) and will
lead to redevelopment; demonstrated
the existence of additional leveraged
funds to complete the project in a timely
manner and move quickly from cleanup
to redevelopment, including the use of
tax incentives such as new market tax
credits, direct funding or other
resources to advance the project to
completion; demonstrated the ability to
administer and revolve the
capitalization funding in the RLF grant;
demonstrated an ability to use the RLF
grant to address funding gaps for
cleanup; and demonstrated that they
have provided a community benefit
from past and potential loan(s) and/or
subgrant(s). Special consideration may
be given to those communities affected
by plant closures or other economic
disruptions. Special consideration may
also be given to those grantees that can
demonstrate projects that have a clear
prospect of aiding the in-sourcing of
manufacturing capacity and keeping
and/or adding jobs, or otherwise
creating jobs, in the affected area. EPA
encourages innovative approaches to
maximizing revolving and leveraging
with other funds, including use of
grants funds as a loan loss guarantee,
combining with other government or
private sector lending resources.
Applicants for supplemental funding
must contact the appropriate Regional
Brownfields Coordinator below to
obtain information on the format for
supplemental funding applications for
their region. When requesting
supplemental funding, applicants must
specify whether they are seeking
funding for sites contaminated by
hazardous substances or petroleum.
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Agencies
[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Notices]
[Pages 15332-15334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05908]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2014-0189; FRL-9908-30-ORD]
Human Studies Review Board; Notification of a Public Meeting
AGENCY: U.S. Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) Office of the
Science Advisor announces a public meeting of the Human Studies Review
Board to advise the Agency on the EPA ethical and scientific reviews of
research with human subjects.
DATES: This public meeting will be held on April 8-9, 2014, from
approximately 9:30 p.m. to approximately 5:30 p.m. Eastern Time.
Comments may be submitted on or before noon (Eastern Time) on Tuesday,
April 1, 2014.
ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
Comments: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2014-0189, by one of the following methods:
Internet: https://www.regulations.gov: Follow the online
instructions for submitting comments.
Email: ORD.Docket@epa.gov.
Mail: The EPA Docket Center EPA/DC, ORD Docket, Mail code: 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 WJC West, 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 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.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2014-0189. The Agency'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 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 email. 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 email comment directly to the EPA without
going through https://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, the EPA recommends that you include your
name and other contact information in the body of your comment and with
any electronic storage media you submit. If the EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, the 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; email address:
downing.jim@epa.gov; mailing address Environmental Protection Agency,
Office of the Science Advisor, Mail code 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/hsrb.
SUPPLEMENTARY INFORMATION:
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.
Webcast: This meeting may be webcast. Please refer to the HSRB Web
site, https://www.epa.gov/hsrb/ for information on how to access the
webcast. Please note that the webcast is a supplementary public process
provided only for convenience. If difficulties arise resulting in
webcasting outages, the meeting will continue as planned.
I. Public Meeting
A. Does this action apply to me?
This action is directed to the public in general. This Notice may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by the EPA,
or to persons who are, or may be required to conduct testing of
chemical substances under the Federal Food, Drug, and Cosmetic Act or
the Federal Insecticide, Fungicide, and Rodenticide Act. This notice
might also be of special interest to participants of studies involving
human subjects, or representatives of study participants or
[[Page 15333]]
experts on community engagement. Since many 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 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 WJC West, 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 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). The Agency's position paper(s),
charge/questions to the HSRB, and the meeting agenda will be available
by the last week of March 2014. 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/hsrb/. For questions on document availability, or if you do
not have access to the Internet, consult Jim Downing listed under FOR
FURTHER INFORMATION CONTACT.
C. What should I consider as I prepare my comments for the 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 the 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 the EPA, it is imperative
that you identify Docket ID number EPA-HQ-ORD-2014-0189 in the subject
line on the first page of your request.
1. Oral comments. Requests to present oral comments will be
accepted up to Tuesday, April 1, 2014. 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, under FOR FURTHER INFORMATION CONTACT no later than noon,
Eastern Time, Tuesday, April 1, 2014, in order to be included on the
meeting agenda and to provide sufficient time for the HSRB Chair and
HSRB Designated Federal Official 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 focused on the ethical and
scientific issues of the topics being considered by the Board, we do
not intend 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 Board 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 comments after this date, those comments
will be provided to the Board members, but you should recognize that
the HSRB 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, Tuesday, April 1, 2014. You should
submit your comments using the instructions in Section I., under
subsection C., ``What Should I Consider as I Prepare My Comments for
the 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 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 5 U.S.C. App.2 Sec. 9. The
HSRB provides advice, information, and recommendations to the 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 the Agency's Science Advisor.
1. Topics for discussion. At its meeting on April 8-9, 2014, EPA's
Human Studies Review Board will consider ethical and scientific issues
surrounding the following topics:
a. AEATF-II Protocol: A Study for Measurement of Potential Dermal and
Inhalation Exposure During Manual Pouring of Two Solid Formulations
Containing an Antimicrobial
b. AEATF-II Protocol: A Study for Measurement of Potential Dermal and
Inhalation Exposure During Application of Latex Paint Containing
[[Page 15334]]
an Antimicrobial Pesticide Product Using a Brush and Roller for Indoor
Surface Painting
c. AEATF Protocol: Determination of Removal Efficiency of 1,2-
Benzisothiazol-3(2H)-one (BIT) from Hand Surfaces Using an Isopropyl
Alcohol/Water Wipe and Wash Procedure
d. Laboratory Evaluation of Bite Protection from Repellent Impregnated
Clothing for the United States Military
e. Background presentation on the Repellency Awareness Graphic and
possible implications for the HSRB
f. Report from the HSRB Work Group of the Return of Individual Research
Results
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 regarding the Board's final meeting report, will be found
at https://www.epa.gov/osa/hsrb/ or from the person listed under FOR
FURTHER INFORMATION CONTACT.
Dated: March 10, 2014.
Glenn Paulson,
Science Advisor.
[FR Doc. 2014-05908 Filed 3-18-14; 8:45 am]
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