[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 43999-44000]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18569]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2009-0694; FRL-9442-8]
Notice of Availability of the External Review Draft of the
Guidance for Applying Quantitative Data to Develop Data-Derived
Extrapolation Factors for Interspecies and Intraspecies Extrapolation;
Extension of Public Comment Period
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: On June 9, 2011 the U.S. Environmental Protection Agency (EPA)
announced the release of the External Review Draft of ``Guidance for
Applying Quantitative Data to Develop Data-Derived Extrapolation
Factors for Interspecies and Intraspecies Extrapolation'' for public
comment (76 FR 33752-33753). With this notice EPA is announcing an
extension of the comment period to August 9, 2011. EPA is releasing
this draft document solely for the purpose of seeking public comment
prior to external peer review. The document will undergo independent
peer review during an expert peer review meeting, which will be
convened, organized and conducted by an EPA contractor in 2011. The
date of the external peer review meeting will be announced in a
subsequent Federal Register notice. All comments received by the docket
closing date, August 9, 2011, will be shared with the external peer
review panel for their consideration. Comments received after the close
of the comment period may be considered by EPA when it finalizes the
document. This document has not been formally disseminated by EPA. This
draft guidance does not represent and should not be construed to
represent EPA policy viewpoint, or determination. Members of the public
may obtain the draft interim guidance from http://www.regulations.gov;
or www.epa.gov/raf/DDEF/index.htm or from Dr. Michael Broder via the
contact information below.
DATES: All comments received by the docket closing date, August 9,
2011, will be shared with the external peer review panel for their
consideration. Comments received beyond that time may be considered by
EPA when it finalizes the document.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2009-0694, by one of the following methods:
Internet: http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: ORD.Docket@epa.gov
Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),
ORD Docket, Mailcode 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
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 ord.docket@epa.gov 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-
2009-0694. 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 comment 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 by statute 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 comment 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: Dr. Michael W. Broder at telephone
number: (202) 564-3393; fax: (202) 564-2070; e-mail address:
broder.michael@epa.gov; mailing address: Environmental Protection
Agency, Office of the Science Advisor (8105R), 1200 Pennsylvania
Avenue, NW., Washington, DC 20460.
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 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 ord.docket@epa.gov for
instructions. Updates to Public Reading Room access are available on
the Web site (http://www.epa.gov/epahome/dockets.htm).
For questions on document availability, or if you do not have
access to the Internet, consult Dr. Michael Broder listed under FOR
FURTHER INFORMATION CONTACT.
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 that you
used to support your views.
4. Provide specific examples to illustrate your concerns and
suggest alternatives.
[[Page 44000]]
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.
SUPPLEMENTARY INFORMATION: This draft guidance document outlines
approaches for developing factors for inter- and intra-species
extrapolation based on data describing toxicokinetic and/or
toxicodynamic properties of particular agent(s). It was developed to
provide guidance for EPA staff in evaluating such data and/or
information and to provide information to the regulated community and
other interested parties about deriving and implementing extrapolation
factors derived from data instead of defaults.
Dated: July 15, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-18569 Filed 7-21-11; 8:45 am]
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