Human Studies Review Board; Notification of a Public Meeting, 30135-30137 [2014-12172]
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Federal Register / Vol. 79, No. 101 / Tuesday, May 27, 2014 / Notices
spanning from Manchester-By-The-Sea
to Marshfield, a corridor in Vineyard
Sound, and a corridor in Nantucket
Sound. The state wide NDA will
seamlessly integrate the 20 smaller
NDAs that have been designated in
Massachusetts since 1991. The
boundaries for this statewide NDA
encompass all Commonwealth of
Massachusetts coastal waters: from
mean low water along the coast of
Massachusetts, seaward to the statefederal boundary, north to the border
with New Hampshire, and south to the
border with Rhode Island: https://
www.mass.gov/eea/agencies/czm/
program-areas/coastal-water-quality/
ndas/.
Massachusetts has certified that there
are a total of 132 pumpout facilities in
coastal Massachusetts: https://
www.mass.gov/eea/agencies/czm/
program-areas/coastal-water-quality/
clean-boating/pumpout-list.html.
Based on the examination of the
petition and its supporting
documentation, and information from
site visits conducted by EPA New
England staff, EPA has determined that
adequate facilities for the safe and
sanitary removal and treatment of
sewage from all vessels are reasonably
available for the area covered under this
determination. This determination is
made pursuant to Section 312 (f) (3) of
Public Law 92–500, as amended by
Public Laws 95–217 and 100–4.
Dated: May 14, 2014.
H. Curtis Spalding,
Regional Administrator, New England Region.
[FR Doc. 2014–12170 Filed 5–23–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–ORD–2014–0411; FRL 9911–45–
OA]
Human Studies Review Board;
Notification of a Public Meeting
U. S. Environmental Protection
Agency.
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 ethical and
scientific reviews of EPA research with
human subjects.
DATES: This public meeting will be held
on June 11, 2014, from approximately
10:30 a.m. to approximately 4:00 p.m.
Eastern Time. Comments may be
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SUMMARY:
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submitted on or before noon (Eastern
Time) on Friday, June 4, 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–2014–0411, 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: 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
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30135
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.
Web cast: 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
experts on community engagement. The
Agency has not attempted to describe all
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Federal Register / Vol. 79, No. 101 / Tuesday, May 27, 2014 / Notices
the specific entities that may have
interest in human subjects research. If
you have any questions regarding this
notice, 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, in the 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 May 2014. In addition, the
Agency may provide additional
background documents as the materials
become available. You may obtain
electronic copies of these documents,
and other related documents that are
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:
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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–
2014–0411 in the subject line on the
first page of your request.
1. Oral comments. Requests to present
oral comments will be accepted up to
Friday, June 6, 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, Friday, June 6,
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 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 Board to have the best
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opportunity to review and consider your
comments as it deliberates on its report,
you should submit your comments by
June 4, 2014. 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 their
discussion during the meeting. 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 June 11, 2014, EPA’s Human
Studies Review Board will consider
scientific and ethical issues surrounding
these topics:
a. Published report by Gardner et al
(1988) of an intentional exposure
human study measuring the effects of
low dose oral iodide supplementation
on thyroid function
b. Published report by Paul et al
(1988) of an intentional exposure
human study measuring the effects of
small increases of dietary iodine on
thyroid function
c. Published report by Lemar et al
(1995) of an intentional exposure
human study measuring the effects of
chronic tetraglycine hydroperiodide
water purification tablet use on thyroid
function
d. Discussion of a 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
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Federal Register / Vol. 79, No. 101 / Tuesday, May 27, 2014 / Notices
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: May 15, 2014.
Robert Kavlock,
Interim Agency Science Advisor.
[FR Doc. 2014–12172 Filed 5–23–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9911–39–OA]
Notification of a Public Teleconference
of the Clean Air Scientific Advisory
Committee Augmented Sulfur Oxides
Primary NAAQS Review Panel
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
The Environmental Protection
Agency (EPA) Science Advisory Board
(SAB) Staff Office announces a public
teleconference of the Clean Air
Scientific Advisory Committee (CASAC)
Augmented Sulfur Oxides Primary
National Ambient Air Quality Standards
(NAAQS) Review Panel to discuss its
draft review of EPA’s Integrated Review
Plan for the Primary National Ambient
Air Quality Standard for Sulfur Dioxide
(External Review Draft).
DATES: The CASAC will hold a
teleconference on Wednesday, June 11,
2014, from 1:00 p.m. to 4:00 p.m.
(Eastern Time).
ADDRESSES: The CASAC public
teleconference will take place via
telephone only.
FOR FURTHER INFORMATION CONTACT: Any
member of the public who wants further
information concerning the CASAC’s
public teleconference may contact Dr.
Diana Wong, Designated Federal Officer
(DFO) via telephone at (202) 564–2049
or email at wong.diana-M@epa.gov.
General information concerning the
CASAC can be found on the EPA Web
site at https://www.epa.gov/casac.
SUPPLEMENTARY INFORMATION: The
CASAC was established pursuant to the
Clean Air Act (CAA) Amendments of
1977, codified at 42 U.S.C. 7409D(d)(2),
to review air quality criteria and
NAAQS and recommend any new
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SUMMARY:
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NAAQS and revisions of existing
criteria and NAAQS as may be
appropriate. The CASAC shall also
provide advice, information, and
recommendations to the Administrator
on the scientific and technical aspects of
issues related to the criteria for air
quality standards, research related to air
quality, sources of air pollution, and of
adverse effects which may result from
various strategies to attain and maintain
air quality standards. The CASAC is a
Federal Advisory Committee chartered
under the Federal Advisory Committee
Act (FACA), 5 U.S.C., App. 2. Section
109(d)(1) of the CAA requires that the
Agency periodically review and revise,
as appropriate, the air quality criteria
and the NAAQS for the six ‘‘criteria’’ air
pollutants, including oxides of sulfur.
EPA is currently reviewing the primary
(health-based) NAAQS for sulfur
dioxide (SO2), as an indicator for health
effects caused by the presence of oxides
of sulfur in the ambient air and has
requested CASAC advice.
For purposes of the review of the
sulfur oxides air quality criteria for
health and the primary NAAQS for
sulfur dioxide, the CASAC Augmented
Sulfur Oxides Review Panel was formed
following a request for public
nominations of experts (78 FR 43880—
43881, July 22, 2013), and held a public
teleconference on April 22, 2014 (as
noticed in 79 FR 16325–16326) to peer
review EPA’s Integrated Review Plan for
the Primary National Ambient Air
Quality Standard for Sulfur Dioxide
(External Review Draft- March 2014).
Information about this review activity
may be found on the CASAC Web site
at https://yosemite.epa.gov/sab/sab
product.nsf/fedrgstr_activites/SO_2%20
Primary%20NAAQS%20Review?Open
Document.
Pursuant to FACA and EPA policy,
notice is hereby given that the CASAC
Augmented Sulfur Oxides Primary
NAAQS Review Panel will hold a
public teleconference to discuss
CASAC’s draft review of this EPA
document. The CASAC Augmented
Sulfur Oxides Review Panel will
comply with the provisions of FACA
and all appropriate SAB Staff Office
procedural policies.
Technical Contacts: Any technical
questions concerning the Integrated
Review Plan for the Primary National
Ambient Air Quality Standard for Sulfur
Dioxide (External Review Draft—March
2014) should be directed to Dr. Michael
Stewart (stewart.michael@epa.gov).
Availability of Meeting Materials:
Prior to the teleconference, the CASAC
draft report, agenda and other materials
will be accessible through the calendar
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30137
link on the blue navigation bar at https://
www.epa.gov/casac/.
Procedures for Providing Public Input:
Public comment for consideration by
EPA’s federal advisory committees and
panels has a different purpose from
public comment provided to EPA
program offices. Therefore, the process
for submitting comments to a federal
advisory committee is different from the
process used to submit comments to an
EPA program office.
Federal advisory committees and
panels, including scientific advisory
committees, provide independent
advice to EPA. Members of the public
can submit relevant comments for a
federal advisory committee to consider
as it develops advice for EPA. Interested
members of the public may submit
relevant written or oral information on
the topic of this advisory activity, and/
or the group conducting the activity, for
the CASAC to consider during the
advisory process. Input from the public
to the CASAC will have the most impact
if it provides specific scientific or
technical information or analysis for
CASAC panels to consider or if it relates
to the clarity or accuracy of the
technical information. Members of the
public wishing to provide comment
should contact the DFO directly. Oral
Statements: In general, individuals or
groups requesting an oral presentation
on a public teleconference will be
limited to three minutes. Each person
making an oral statement should
consider providing written comments as
well as their oral statement so that the
points presented orally can be expanded
upon in writing. Interested parties
should contact Dr. Diana Wong, DFO, in
writing (preferably via email) at the
contact information noted above by June
4, 2014 to be placed on the list of public
speakers. Written Statements: Written
statements should be supplied to Dr.
Diana Wong, DFO, via email at the
contact information noted above by June
4, 2014 so that the information may be
made available to the Panel members for
their consideration. Written statements
should be supplied in one of the
following electronic formats: Adobe
Acrobat PDF, MS Word, MS
PowerPoint, or Rich Text files in IBM–
PC/Windows 98/2000/XP format. It is
the SAB Staff Office general policy to
post written comments on the Web page
for advisory meetings or
teleconferences. Submitters are
requested to provide an unsigned
version of each document because the
SAB Staff Office does not publish
documents with signatures on its Web
sites. Members of the public should be
aware that their personal contact
information, if included in any written
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Agencies
[Federal Register Volume 79, Number 101 (Tuesday, May 27, 2014)]
[Notices]
[Pages 30135-30137]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12172]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2014-0411; FRL 9911-45-OA]
Human Studies Review Board; Notification of a Public Meeting
AGENCY: U. S. Environmental Protection Agency.
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 ethical and scientific reviews of EPA
research with human subjects.
DATES: This public meeting will be held on June 11, 2014, from
approximately 10:30 a.m. to approximately 4:00 p.m. Eastern Time.
Comments may be submitted on or before noon (Eastern Time) on Friday,
June 4, 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-2014-0411, 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: 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.
Web cast: 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 experts on
community engagement. The Agency has not attempted to describe all
[[Page 30136]]
the specific entities that may have interest in human subjects
research. If you have any questions regarding this notice, 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, in the 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 May 2014. In
addition, the Agency may provide additional background documents as the
materials become available. You may obtain electronic copies of these
documents, and other related documents that are 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-2014-0411 in the subject
line on the first page of your request.
1. Oral comments. Requests to present oral comments will be
accepted up to Friday, June 6, 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, Friday, June 6, 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 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 Board to have the best opportunity to review and
consider your comments as it deliberates on its report, you should
submit your comments by June 4, 2014. 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 their discussion during the meeting.
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 June 11, 2014, EPA's
Human Studies Review Board will consider scientific and ethical issues
surrounding these topics:
a. Published report by Gardner et al (1988) of an intentional
exposure human study measuring the effects of low dose oral iodide
supplementation on thyroid function
b. Published report by Paul et al (1988) of an intentional exposure
human study measuring the effects of small increases of dietary iodine
on thyroid function
c. Published report by Lemar et al (1995) of an intentional
exposure human study measuring the effects of chronic tetraglycine
hydroperiodide water purification tablet use on thyroid function
d. Discussion of a 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
[[Page 30137]]
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: May 15, 2014.
Robert Kavlock,
Interim Agency Science Advisor.
[FR Doc. 2014-12172 Filed 5-23-14; 8:45 am]
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