[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Pages 78861-78863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30408]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2014-0882; FRL-9920-92-ORD]
Human Studies Review Board; Notification of a Public Meeting
AGENCY: Environmental Protection Agency.
ACTION: Notice.
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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 January 14, 2015, from
approximately 10:00 a.m. to approximately 5:00 p.m. Eastern Time.
Comments may be submitted on or before noon (Eastern Time) on
Wednesday, January 7, 2015.
ADDRESSES: The meeting will be conducted entirely on the Internet using
Adobe Connect. Registration is required to attend this meeting. Please
visit the HSRB Web site: http://www.epa.gov/hsrb to register.
Comments: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2014-0882, by one of the following methods:
Internet: http://www.regulations.gov: Follow the online
instructions for submitting comments.
Email: [email protected].
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 [email protected] for instructions. Updates to Public
Reading Room access are available on the Web site http://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 http://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 http://www.regulations.gov or email. The http://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 http://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:
[email protected]; 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 http://www.epa.gov/hsrb.
SUPPLEMENTARY INFORMATION:
Meeting access: Access to this Internet meeting is open to all at
the information provided above.
Procedures for providing public input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Section
I, ``Public Meeting'' under subsection D. ``How May I Participate in
this Meeting?'' of this notice.
I. Public Meeting
A. Does this action apply to me?
This action is directed to the public in general. This 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 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.
[[Page 78862]]
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 http://www.epa.gov/fedrgstr/.
Docket: All documents in the docket are listed in the http://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 http://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 [email protected] for instructions. Updates
to Public Reading Room access are available on the Web site (http://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 early January 2015. 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 http://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-2014-0882 in the subject
line on the first page of your request.
1. Oral comments. Requests to present oral comments during the
conference call will be accepted up to Noon Eastern Time on Wednesday,
January 7, 2015. 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 during the call. 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, listed
under FOR FURTHER INFORMATION CONTACT no later than noon, Eastern Time,
Wednesday, January 7, 2015, 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 on or before noon (Eastern Time) on Wednesday,
January 7, 2015. 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 Wednesday, January 14,
2015, EPA's Human Studies Review Board will consider scientific and
ethical issues surrounding three topics:
a. A published report: Repeated Nitrogen Dioxide Exposures and
Eosinophilic Airway Inflammation in Asthmatics: A Randomized Crossover
Study
b. A published report: Tissue response of gastric mucosa after
ingestion of fluoride
c. A published report: The Effect of Flouride and Calcium on Spinal
Bone Mineral Content: A Controlled, Prospective (three year) Study
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 http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition,
information regarding the Board's final meeting report, will be found
at http://www.epa.gov/osa/hsrb/ or from the person listed under FOR
FURTHER INFORMATION CONTACT.
[[Page 78863]]
Dated: December 16, 2014.
Robert Kavlock,
Interim Agency Science Advisor.
[FR Doc. 2014-30408 Filed 12-30-14; 8:45 am]
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