[Federal Register Volume 77, Number 50 (Wednesday, March 14, 2012)]
[Notices]
[Pages 15099-15101]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6202]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2012-0175; FRL-9647-2]
Human Studies Review Board; Notification of a Public Webinar/
Teleconference
AGENCY: U. S. Environmental Protection Agency.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The EPA Office of the Science Advisor announces a public
Webinar/teleconference of the HSRB to discuss its draft report from the
HSRB meeting held January 26, 2012.
DATES: The Webinar/teleconference will be held on Wednesday, March 28,
2012,
[[Page 15100]]
from approximately 2 p.m. to approximately 4 p.m. Eastern Time.
Comments may be submitted on or before Wednesday, March 21, 2012.
ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2012-0175, by one of the following methods:
Internet: http://www.regulations.gov: Follow the Web site
instructions for submitting comments.
Email: ORD.Docket@epa.gov.
Mail: Environmental Protection Agency, 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 West Building,
located at 1301 Constitution Avenue NW., Washington, DC 20460. The
Reading Room's 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
online at http://www.epa.gov/epahome/dockets.htm.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2012-0175. 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 the 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 comments
and with any disk or CD-ROM 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 members of the public who wish to
receive further information about this Webinar/Teleconference should
contact Jim Downing at telephone number (202) 564-2468; fax (202) 564-
2070; email address downing.jim@epa.gov or Lu-Ann Kleibacker on
telephone number (202) 564-7189; fax: (202) 564-2070; email address
kleibacker.lu-ann@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 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 the Internet and
telephone only. Access information can be found on the HSRB Web site:
http://www.epa.gov/osa/hsrb/ or by contacting the persons listed under
the FOR FURTHER INFORMATION CONTACT section of this Notice.
Meeting access: For detailed 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 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. Since other
entities may also be interested, the EPA 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?
You may use http://www.regulations.gov, or you may access this
Federal Register document via the EPA's Internet site 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
at 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; its
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
regarding the Public Reading Room access are available at http://www.epa.gov/epahome/dockets.htm.
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 used
that 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.
[[Page 15101]]
D. How may I participate in this meeting?
You may participate by providing comments in this meeting by
following the instructions in this section. To ensure proper receipt of
your comments by the EPA, it is imperative that you identify Docket ID
No. EPA-HQ-ORD-2012-0175 in the subject line on the first page of your
request.
1. Oral comments. Requests to present oral comments will be
accepted up to and including Wednesday, March 21, 2012. 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 email) to Jim Downing or Lu-Ann Kleibacker under FOR
FURTHER INFORMATION CONTACT no later than noon, Eastern Time,
Wednesday, March 21, 2012, 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. Please 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, Wednesday, March 21, 2012.
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 EPA 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 Section 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
the 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 January 26, 2012, HSRB meeting. The HSRB may also
discuss planning for future HSRB meetings. Background on the January
26, 2012 HSRB meeting can be found at the HSRB Web site: http://www.epa.gov/osa/hsrb. The January 26, 2012 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 regulations.gov and the HSRB Web site at http://www.epa.gov/osa/hsrb. For questions on document availability or if you do not have
Internet access, consult the persons listed under FOR FURTHER
INFORMATION.
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 HSRB final meeting report will be found at
http://www.epa.gov/osa/hsrb or from the persons listed under FOR
FURTHER INFORMATION CONTACT.
Dated: March 7, 2012.
Lek Kadeli,
Acting Assistant Administrator.
[FR Doc. 2012-6202 Filed 3-13-12; 8:45 am]
BILLING CODE 6560-50-P