Document ID: EPA-HQ-ORD-2009-0694-0006
Agency: epa
Document Type: Notice
Title: Availability of the External Review Draft; Extension of Public Comment Period: Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation
Posted Date: 2011-07-22T04:00Z

[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draft guidance does not represent and should not be construed to 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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