[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Pages 25686-25688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11001]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2011-0418; FRL-9302-4]
Human Studies Review Board (HSRB); Notification of a Public
Teleconference
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The U. S. Environmental Protection Agency (EPA) Office of the
Science Advisor (OSA) announces a public teleconference of the HSRB to
discuss its draft report from the April 13-14, 2011 HSRB meeting, and
consider a draft letter from an HSRB workgroup on providing research
participants with individualized study results measuring the amount of
antimicrobial cleaning products on participants' skin and the amount
they breathe in while mopping floors.
DATES: The teleconference will be held on Tuesday, May 24, 2011 from
approximately 1 p.m. to approximately 3 p.m. Eastern Time.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0418, by one of the following methods:
Internet: http://www.regulations.gov: Follow the Web site
instructions for submitting comments.
E-mail: [email protected].
Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),
ORD Docket, Mail Code 28221T, 1200 Pennsylvania Ave., 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 West Building,
located at 1301 Constitution Avenue, NW., Washington, DC 20460. The
hours of operation are 8:30 a.m. to 4:30 p.m.
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Eastern Time, Monday through Friday, excluding Federal holidays. Please
call (202) 566-1744 or e-mail the ORD Docket at [email protected] for
instructions. Updates to Public Reading Room access are available
online at http://www.epa.gov/epahome/dockets.htm.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0418. EPA'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 comments includes information claimed to be
Confidential Business Information (CBI) 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 e-mail. 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 e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail 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, EPA recommends that you include your name
and other contact information in the body of your comments and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, 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 members of the public who wish to
receive further information should contact Jim Downing at telephone
number: (202) 564-2468; fax: (202) 564-2070; e-mail address:
[email protected], or Lu-Ann Kleibacker at telephone number: (202)
564-7189; fax: (202) 564-2070; e-mail address: [email protected]; mailing address: Environmental Protection Agency, Office
of the Science Advisor, 8105R, 1200 Pennsylvania Ave., 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 take place via telephone only.
Meeting access: For information on access or services for
individuals with disabilities, please contact Lu-Ann Kleibacker 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 action may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by EPA, or to
persons who are, or may be required to conduct testing of chemical
substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) or
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since
other 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 http://www.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 West Building,
located 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 e-mail the ORD Docket at [email protected] for instructions.
Updates to the Public Reading Room access are available on the Web site
(http://www.epa.gov/epahome/dockets.htm).
C. What should I consider as I prepare my comments for 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 you use
that support your views.
4. Provide specific examples to illustrate your concerns and
suggest alternatives.
5. To ensure proper receipt by 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 EPA, it is imperative that
you identify docket ID number EPA-HQ-ORD-2011-0418 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, May 17, 2011. 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 meeting. Each
individual or group wishing to make brief oral comments to the HSRB is
strongly advised to submit their request (preferably via e-mail) to Jim
Downing or Lu-Ann Kleibacker under FOR FURTHER INFORMATION CONTACT no
later than noon, Eastern Time, Tuesday, May 17, 2011, in order to be
included on the meeting agenda and to provide sufficient time for the
HSRB Chair and HSRB Designated Federal Official (DFO) to review the
meeting agenda to provide an appropriate public comment period. The
request should identify the name of
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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 written comments prior to the meeting.
For the HSRB 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
teleconference. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that
the Board 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, May 17, 2011. You should submit
your comments using the instructions in section I, under subsection C,
``What Should I Consider as I Prepare My Comments for 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 (FACA) 5 U.S.C. App.2 section
9. The HSRB provides advice, information, and recommendations to 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 EPA Science Advisor.
1. Topics for Discussion. The HSRB will be reviewing its draft
report from the April 13-14, 2011 HSRB meeting. The Board may also
discuss planning for future HSRB meetings. Background on the April 13-
14, 2011 HSRB meeting can be found at Federal Register Volume 76,
Number 59 (Monday, March 28, 2011), pages 17121-17123) and at the HSRB
Web site http://www.epa.gov/osa/hsrb/. The April 13-14, 2011 meeting
draft report is now available. You may obtain electronic copies of this
document and certain other related documents that might be available
electronically from the http://www.regulations.gov Web site and the
HSRB Internet home page at http://www.epa.gov/osa/hsrb. The HSRB will
also review and consider a draft letter providing participants with
individualized study results that was provided at a previous HSRB
meeting. The HSRB was asked to provide feedback on the letter that will
be sent to the participants from the Antimicrobial Exposure Assessment
Task Force II that measured the amount of antimicrobial cleaning
products on participants' skin and the amount they breathe in while
mopping floors.
For questions on document availability or if you do not have access
to the Internet, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
Dated: April 29, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-11001 Filed 5-4-11; 8:45 am]
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