Skip to Content

Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 This draft guidance does not represent and should not be construed to represent EPA policy viewpoint, or determination.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.

Start Further Info

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.Start Printed 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.

End Further Info End Preamble Start Supplemental Information

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.

Start Signature

Dated: July 15, 2011.

Paul T. Anastas,

EPA Science Advisor.

End Signature End Supplemental Information

[FR Doc. 2011-18569 Filed 7-21-11; 8:45 am]

BILLING CODE 6560-50-P