[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57383-57385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22745]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2013-0626; FRL-9900-98-ORD]
Human Studies Review Board; Notification of a Public Meeting
AGENCY: U.S. Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The EPA Office of the Science Advisor announces a public
meeting of the Human Studies Review Board to advise the Agency on the
EPA scientific and ethical reviews of research with human subjects.
DATES: This public meeting will be held on October 1, 2013, from
approximately 12:30 p.m. to approximately 5:30 p.m. Eastern Time.
Comments may be submitted on or before noon (Eastern Time) on Thursday,
September 24, 2013.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2013-0626, 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: Direct your comments to Docket ID No. EPA-HQ-ORD-
2013-0626. 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
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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] or Lu-Ann Kleibacker on telephone number (202) 564-
7189; 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/osa/hsrb/.
SUPPLEMENTARY INFORMATION:
Location: The meeting will be held at the EPA Conference Center--S-
4380, One Potomac Yard (South Building), 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
persons listed under FOR FURTHER INFORMATION CONTACT at least ten
business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.
Procedures for providing public input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Section
I, ``Public Meeting'' under subsection D. ``How May I Participate in
this Meeting?'' of this notice.
I. Public Meeting
A. Does this action apply to me?
This action is directed to the public in general. This 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. 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 or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION
CONTACT.
B. How can I access electronic copies of this document and other
related information?
In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at 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, 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 the last week of September 2013. 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 http://www.epa.gov/osa/hsrb/. For questions on document availability, or if
you do not have access to the Internet, consult either Jim Downing or
Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT.
C. What should I consider as I prepare my comments for 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-2013-0626 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, September 24, 2013. To the extent that time
permits, interested persons who have not pre-registered may be
permitted by the Chair of the HSRB to present oral comments at the
meeting. Each individual or group wishing to make brief oral comments
to the HSRB is strongly advised to submit their request (preferably via
email) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER
INFORMATION CONTACT no later than noon, Eastern Time, Tuesday,
September 24, 2013, 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
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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, September 24, 2013. 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 or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION
CONTACT. There is no limit on the length of written comments for
consideration by the HSRB.
E. Background
The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act 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. Topic for discussion. At its meeting on October 1, 2013, EPA's
Human Studies Review Board will consider scientific and ethical issues
surrounding this topic:
A new scenario design and associated protocol from the
Antimicrobial Exposure Assessment Task Force II (AEATF-II)
describing proposed research to monitor the dermal and inhalation
exposure during manual pouring of solid formulation antimicrobial
products. EPA requests the advice of the HSRB concerning whether, if
it is revised as suggested in EPA's review and if it is performed as
described, this research is likely to generate scientifically
reliable data, useful for assessing the exposure of those who pour
solid formulation antimicrobial pesticide products, and to meet the
applicable requirements of 40 CFR part 26, subparts K and L.
In addition, the EPA will present general information about
EPA's Repellency Awareness Program and discuss possible implications
of this program for the HSRB.
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.
Dated: September 9, 2013.
Glenn Paulson,
Science Advisor.
[FR Doc. 2013-22745 Filed 9-17-13; 8:45 am]
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