[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Notices]
[Pages 15332-15334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05908]
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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.
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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 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: 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-
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 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: 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, http://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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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 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 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 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-2014-0189 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
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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 1,2-
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 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: March 10, 2014.
Glenn Paulson,
Science Advisor.
[FR Doc. 2014-05908 Filed 3-18-14; 8:45 am]
BILLING CODE 6560-50-P