Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment, 48950-48952 [05-16597]

Download as PDF 48950 Federal Register / Vol. 70, No. 161 / Monday, August 22, 2005 / Notices In October 1988, we held the Fourth Conference on Air Quality Modeling. Its purpose was to advise the public on new modeling techniques and to solicit comments to guide our consideration of any rulemaking needed to further revise the Guideline. We held the Fifth Conference on Air Quality Modeling in March 1991, which served as a public hearing for the proposed revisions to the Guideline. In August 1995, we held the sixth conference as a forum to update our available modeling tools with stateof-the-science techniques for airing these issues and for the public to offer new ideas. The last conference held was the Seventh Conference on Air Quality Modeling in June 28 and 29, 2000, which served as a public hearing for the proposed changes to the recommended air quality models in Appendix W. Several presentations were made, including the development of an enhanced Gaussian dispersion model with boundary layer parameterization (AERMOD 1); the development of the CALPUFF modeling system by Earth Tech, Inc. through the Interagency Workgroup on Air Quality Modeling (IWAQM 2); the development and testing of ISC-PRIME by the Electric Power Research Institute’s building downwash program; and on revisions to the Emissions and Dispersion Modeling System (EDMS) by the Federal Aviation Administration. In addition, several presentations on models for consideration as ‘‘alternative models’’ were made and a panel of experts discussed meteorological data assimilation for the next generation of dispersion models. The proceedings are found in Docket No. A–99–05. Public Participation The Eighth Conference on Air Quality Modeling will be open to the public; no admission fee is charged and there is no formal registration. The conference will begin the first morning with introductory remarks by the presiding EPA official. The following topics will be presented: I. AERMOD implementation issues; II. CALPUFF implementation issues; III. Assimilated meteorological data for air dispersion models; 1 AMS/EPA Regulatory MODel; AERMOD is being developed by AERMIC: AMS/EPA Regulatory Model Improvement Committee. 2 IWAQM was formed in 1991 to provide a focus for development of technically sound regional air quality models for regulatory assessments of pollutant source impacts on federal Class I areas. IWAQM is an interagency collaboration that includes efforts by EPA, U.S. Forest Service, National Park Service, and Fish and Wildlife Service. VerDate jul<14>2003 16:09 Aug 19, 2005 Jkt 205001 IV. New approach for updating (revising) models; V. Alternative approaches for selection of approved dispersion models; and, VI. Other presentations by the public. Those wishing to speak at the conference, whether to volunteer a presentation on a special topic or to offer general comment on any of the modeling techniques scheduled for presentation, should contact us at the address given in the FURTHER INFORMATION section (note the cutoff date). Such persons should identify the organization (if any) on whose behalf they are speaking and the length of presentation. If a presentation of general comments is projected to be longer than 10 minutes, the presenter should also state why a longer period is needed. Persons failing to submit a written notice but desiring to speak at the conference should notify the presiding officer immediately before the conference and they will be scheduled on a time-available basis. The conference will be conducted informally and chaired by an EPA official. There will be no sworn testimony or cross examination. A verbatim transcript of the conference proceedings will be produced and placed in the docket. Speakers should bring extra copies of their presentation for inclusion in the docket and for the convenience of the reporter. Speakers will be permitted to enter into the record any additional written comments that are not presented orally. Additional written statements or comments should be sent to the OAR Regulatory Docket (see ADDRESSES section). A transcript of the proceedings and a copy of all written comments will be maintained in Docket OAR–2005–0157 which will remain open until October 24, 2005 for the purpose of receiving additional comments. Dated: August 17, 2005. Mary E. Henigin, Acting Director, Office of Air Quality Planning and Standards, Office of Air and Radiation. [FR Doc. 05–16682 Filed 8–19–05; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–7957–2; E–Docket ID No. ORD–2005– 0022] Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment AGENCY: Environmental Protection Agency. PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 Notice of extension of public comment period. ACTION: SUMMARY: The U.S. Environmental Protection Agency (EPA) is extending the public comment period on the external review draft document titled, ‘‘Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment’’ (EPA/600/R–05/ 043A), by 45 days. On July 28, 2005, EPA published a Federal Register notice (70 FR 43692) announcing: (1) The public availability of the draft document; (2) the beginning of a 30-day public comment period; and (3) an anticipated external peer-review workshop. EPA is extending the public comment period to October 14, 2005, in response to requests for extension of the comment period. EPA intends to make comments received by the end of the extended public comment period (October 14, 2005) available to Versar, Inc., an EPA contractor for external scientific peer review, for the external peer review panelists prior to the anticipated workshop. The U.S. EPA will consider all comments received by October 14, 2005, in preparing a final report. EPA still expects Versar, Inc., to convene a panel of experts and organize and conduct an external peer-review workshop. This workshop will be announced in a separate Federal Register notice, once EPA is notified by Versar, Inc., of the date and location for the workshop. The public comment period and the external peer-review workshop are separate processes that will provide opportunities for all interested parties to comment on the document. In preparing a final report, EPA will consider any public comments that EPA receives in accordance with this notice. DATES: The 45-day extension of the public comment period begins August 30, 2005, and ends October 14, 2005. Technical comments should be in writing and must be received by EPA by close of business October 14, 2005. ADDRESSES: The draft document and EPA’s peer-review charge are available primarily via the Internet on the National Center for Environmental Assessment’s home page under the Recent Additions and Publications menus at http://www.epa.gov/ncea. A limited number of paper copies are available from the Technical Information Staff, National Center for Environmental Assessment; telephone: (202) 564–3261; facsimile: (202) 565– 0050. If you are requesting a paper copy, please provide your name, mailing address, and the document title, E:\FR\FM\22AUN1.SGM 22AUN1 Federal Register / Vol. 70, No. 161 / Monday, August 22, 2005 / Notices ‘‘Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment’’ (EPA/600/R–05/ 043A). Comments may be submitted electronically via EPA’s E–Docket, by mail, by facsimile, or by hand delivery/ courier. Please follow the detailed instructions as provided in the SUPPLEMENTARY INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: For information on the public comment period, contact the OEI Docket; telephone: (202) 566–1752; facsimile: (202) 566–1753; or e-mail: ORD.Docket@epa.gov. If you have questions about the document, please contact the Technical Information Staff, National Center for Environmental Assessment, U.S. Environmental Protection Agency, Washington, DC 20460; telephone: (202) 564–3261; facsimile: (202) 565–0050; or e-mail: NCEADC.Comment@epa.gov. SUPPLEMENTARY INFORMATION: I. Information About the Document Physiologically-based pharmacokinetic (PBPK) models represent an important class of dosimetry models that are useful for predicting internal dose at target organs for risk assessment applications. Doseresponse relationships that appear unclear or confusing at the administered dose level can become more understandable when expressed on the basis of internal dose of the chemical. To predict internal dose level, PBPK models use pharmacokinetic data to construct mathematical representations of biological processes associated with the absorption, distribution, metabolism, and elimination of compounds. With the appropriate data, these models can be used to extrapolate across species and exposure scenarios, and address various sources of uncertainty in risk assessments. This external review draft document addresses the following questions: (1) Why do risk assessors need PBPK models; (2) How can these models be used in risk assessments; and (3) What are the characteristics of acceptable PBPK models for use in risk assessment? II. How To Submit Technical Comments to EPA’s E-Docket EPA has established an official public docket for information pertaining to ‘‘Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment’’ (EPA/600/R–05/ 043A), Docket ID No. ORD–2005–0022. VerDate jul<14>2003 16:09 Aug 19, 2005 Jkt 205001 The official public docket is the collection of materials available for public viewing and includes the documents specifically referenced in this action, any public comments received, and other information related to this action, but excludes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the Headquarters EPA Docket Center, (EPA/DC) EPA West Building, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OEI Docket is (202) 566–1752; facsimile: 202–566–1753; or e-mail: ORD.Docket@epa.gov. An electronic version of the public docket is available through EPA’s electronic public docket and comment system, E-Docket. You may use EDocket at http://www.epa.gov/edocket/ to submit or view public comments, to access the index of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select ‘‘search,’’ then key in the appropriate docket identification number. Certain types of information will not be placed in E-Docket. Information claimed as CBI and other information for which disclosure is restricted by statute will not be available for public viewing in the official public docket or in E-Docket. EPA’s policy is that copyrighted material will not be placed in EPA’s electronic public docket but will be referenced there and will be available as printed material in the official public docket. If you intend to submit comments to EPA, please note that it is EPA policy to make public comments available for public viewing as received at the EPA Docket Center or in E-Docket. This policy applies to information submitted electronically or in paper form, except where restricted by copyright, CBI, or statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA’s electronic public docket. The entire printed comment, including the copyrighted material, will be available in the official public docket. Public comments submitted on computer disks that are mailed or PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 48951 delivered to the EPA Docket Center will be transferred to E-Docket. Public comments that are mailed or delivered to the EPA Docket Center will be scanned and placed in E-Docket. Where practical, physical objects will be photographed, and the photograph will be placed in E-Docket with a brief description written by the docket staff. You may submit comments electronically, by mail, by facsimile, or by hand delivery/courier. To ensure proper receipt by EPA, include the appropriate docket identification number with your submission. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked ‘‘late,’’ and may only be considered if time permits. If you submit comments electronically, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any submitted disk or CD–ROM, and in any cover letter accompanying the disk or CD–ROM. This ensures that you can be identified as the person submitting the comment and allows EPA to contact you in case the Agency cannot read your submission due to technical difficulties or needs further information on the substance of your comment. EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in E-Docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, it may delay or preclude consideration of your comment. Electronic submission of comments to E–Docket is EPA’s preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments. To access EPA’s electronic public docket from the EPA Internet Home Page, select ‘‘Information Sources,’’ ‘‘Dockets,’’ and ‘‘EPA Dockets.’’ Once in the system, select ‘‘search,’’ and then key in Docket ID No. ORD–2005–0022. The system is an ‘‘anonymous access’’ system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment. Comments may be sent by electronic mail (e-mail) to ORD.Docket@epa.gov, Attention Docket ID No. ORD–2005– 0022. In contrast to EPA’s electronic public docket, EPA’s e-mail system is E:\FR\FM\22AUN1.SGM 22AUN1 48952 Federal Register / Vol. 70, No. 161 / Monday, August 22, 2005 / Notices not an ‘‘anonymous access’’ system. If you send an e-mail comment directly to the docket without going through EPA’s E-Docket, EPA’s e-mail system automatically captures your e-mail address, and it becomes part of the information in the official public docket and in E-Docket. You may submit comments on a disk or CD–ROM that you mail to the OEI Docket mailing address. Files will be accepted in WordPerfect, Word, or PDF format. Avoid the use of special characters and any form of encryption. If you provide comments in writing, please submit one unbound original with pages numbered consecutively, and three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies. Dated: August 16, 2005. George Alapas, Acting Director, National Center for Environmental Assessment. [FR Doc. 05–16597 Filed 8–19–05; 8:45 am] BILLING CODE 6560–50–U ENVIRONMENTAL PROTECTION AGENCY [OEI–2005–0010; FRL–7956–7] Office of Environmental Information; Announcement of Availability and Comment Period for Institutional Controls Draft Data Standard AGENCY: Environmental Protection Agency. ACTION: Notice of data availability & request for comment. SUMMARY: Notice of availability for a 45 day review and comment period is hereby given for the Draft Institutional Controls Data Standard. The Draft Institutional Control (IC) Data Standard provides a structure for defining the elements required for describing IC information. It provides information about the implementation, monitoring, enforcement, and termination of instruments (via the IC Event) as well as the objectives they meet, associated locations, affiliates and their roles/responsibilities relevant to the IC, cleanup actions (via the IC Event), technologies, and the documentation related to each of the aforementioned subsets of data. States and U.S. EPA completed a technical review of this standard in the Fall of 2004. Comments must be submitted on or before October 5, 2005. DATES: VerDate jul<14>2003 16:09 Aug 19, 2005 Jkt 205001 FOR FURTHER INFORMATION CONTACT: Dawn Banks-Waller; Environmental Protection Agency; 1200 Pennsylvania Avenue, MC 2822T; Washington, DC 20460; Phone: (202) 566 0625; Fax: (202) 566 1624; e-mail: BanksWaller.Dawn@epa.gov. SUPPLEMENTARY INFORMATION: This standard was developed by the Environmental Data Standards Council (EDSC). The EDSC is a partnership of among EPA, States, and Tribes which promotes the efficient sharing of environmental information through the cooperative development of data standards. The standards are intended for use in environmental data exchanges among States, tribal entities and the U.S. EPA. They are not meant to dictate or to limit data an agency chooses to collect for its own internal purposes. Adoption of a data standard should not be interpreted to mean that revisions to databases or information systems are required. What the adoption does mean is that formats for sharing data with Exchange Network (EN) partners will change because the Exchange Network has adopted Shared Schema Components (SSCs) based on the data standards. The SSCs are available on the Exchange Network Web site at http://www.exchangenetwork.net. The draft data standards documents can be found on EDSC’s Web site at http://www.envdatastandards.net/ and are available through the Docket system as indicated below. I. General Information A. How Can I Get Copies of These Documents and Other Related Information? 1. Docket. EPA has established an official public docket for this action under Docket ID No. OEI–2005–0010. The official public docket is the collection of materials that is available for public viewing at the OEI Docket in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OEI Docket is (202) 566–1752. 2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http://www.epa.gov/fedrgstr/. An electronic version of the public docket is available through EPA’s electronic public docket and comment system, EPA Dockets. You may use EPA PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 Dockets at http://www.epa.gov/edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. Once in the system, select ‘‘search,’’ then key in the appropriate docket identification number. Dated: August 10, 2005. Oscar Morales, Director, Collection Strategies Division. [FR Doc. 05–16595 Filed 8–19–05; 8:45 am] BILLING CODE 6560–50–U FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than September 15, 2005. E:\FR\FM\22AUN1.SGM 22AUN1

Agencies

[Federal Register Volume 70, Number 161 (Monday, August 22, 2005)]
[Notices]
[Pages 48950-48952]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16597]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-7957-2; E-Docket ID No. ORD-2005-0022]


Approaches for the Application of Physiologically-Based 
Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment

AGENCY: Environmental Protection Agency.

ACTION: Notice of extension of public comment period.

-----------------------------------------------------------------------

SUMMARY: The U.S. Environmental Protection Agency (EPA) is extending 
the public comment period on the external review draft document titled, 
``Approaches for the Application of Physiologically-Based 
Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment'' 
(EPA/600/R-05/043A), by 45 days. On July 28, 2005, EPA published a 
Federal Register notice (70 FR 43692) announcing: (1) The public 
availability of the draft document; (2) the beginning of a 30-day 
public comment period; and (3) an anticipated external peer-review 
workshop. EPA is extending the public comment period to October 14, 
2005, in response to requests for extension of the comment period. EPA 
intends to make comments received by the end of the extended public 
comment period (October 14, 2005) available to Versar, Inc., an EPA 
contractor for external scientific peer review, for the external peer 
review panelists prior to the anticipated workshop. The U.S. EPA will 
consider all comments received by October 14, 2005, in preparing a 
final report.
    EPA still expects Versar, Inc., to convene a panel of experts and 
organize and conduct an external peer-review workshop. This workshop 
will be announced in a separate Federal Register notice, once EPA is 
notified by Versar, Inc., of the date and location for the workshop. 
The public comment period and the external peer-review workshop are 
separate processes that will provide opportunities for all interested 
parties to comment on the document. In preparing a final report, EPA 
will consider any public comments that EPA receives in accordance with 
this notice.

DATES: The 45-day extension of the public comment period begins August 
30, 2005, and ends October 14, 2005. Technical comments should be in 
writing and must be received by EPA by close of business October 14, 
2005.

ADDRESSES: The draft document and EPA's peer-review charge are 
available primarily via the Internet on the National Center for 
Environmental Assessment's home page under the Recent Additions and 
Publications menus at http://www.epa.gov/ncea. A limited number of 
paper copies are available from the Technical Information Staff, 
National Center for Environmental Assessment; telephone: (202) 564-
3261; facsimile: (202) 565-0050. If you are requesting a paper copy, 
please provide your name, mailing address, and the document title,

[[Page 48951]]

``Approaches for the Application of Physiologically-Based 
Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment'' 
(EPA/600/R-05/043A).
    Comments may be submitted electronically via EPA's E-Docket, by 
mail, by facsimile, or by hand delivery/courier. Please follow the 
detailed instructions as provided in the SUPPLEMENTARY INFORMATION 
section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment 
period, contact the OEI Docket; telephone: (202) 566-1752; facsimile: 
(202) 566-1753; or e-mail: ORD.Docket@epa.gov.
    If you have questions about the document, please contact the 
Technical Information Staff, National Center for Environmental 
Assessment, U.S. Environmental Protection Agency, Washington, DC 20460; 
telephone: (202) 564-3261; facsimile: (202) 565-0050; or e-mail: 
NCEADC.Comment@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Information About the Document

    Physiologically-based pharmacokinetic (PBPK) models represent an 
important class of dosimetry models that are useful for predicting 
internal dose at target organs for risk assessment applications. Dose-
response relationships that appear unclear or confusing at the 
administered dose level can become more understandable when expressed 
on the basis of internal dose of the chemical. To predict internal dose 
level, PBPK models use pharmacokinetic data to construct mathematical 
representations of biological processes associated with the absorption, 
distribution, metabolism, and elimination of compounds. With the 
appropriate data, these models can be used to extrapolate across 
species and exposure scenarios, and address various sources of 
uncertainty in risk assessments. This external review draft document 
addresses the following questions: (1) Why do risk assessors need PBPK 
models; (2) How can these models be used in risk assessments; and (3) 
What are the characteristics of acceptable PBPK models for use in risk 
assessment?

II. How To Submit Technical Comments to EPA's E-Docket

    EPA has established an official public docket for information 
pertaining to ``Approaches for the Application of Physiologically-Based 
Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment'' 
(EPA/600/R-05/043A), Docket ID No. ORD-2005-0022. The official public 
docket is the collection of materials available for public viewing and 
includes the documents specifically referenced in this action, any 
public comments received, and other information related to this action, 
but excludes Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. The official 
public docket is available for public viewing at the Office of 
Environmental Information (OEI) Docket in the Headquarters EPA Docket 
Center, (EPA/DC) EPA West Building, Room B102, 1301 Constitution Ave., 
NW., Washington, DC. The EPA Docket Center Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752; facsimile: 202-566-1753; or e-mail: ORD.Docket@epa.gov.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, E-Docket. You may 
use E-Docket at http://www.epa.gov/edocket/ to submit or view public 
comments, to access the index of the contents of the official public 
docket, and to access those documents in the public docket that are 
available electronically. Once in the system, select ``search,'' then 
key in the appropriate docket identification number.
    Certain types of information will not be placed in E-Docket. 
Information claimed as CBI and other information for which disclosure 
is restricted by statute will not be available for public viewing in 
the official public docket or in E-Docket. EPA's policy is that 
copyrighted material will not be placed in EPA's electronic public 
docket but will be referenced there and will be available as printed 
material in the official public docket.
    If you intend to submit comments to EPA, please note that it is EPA 
policy to make public comments available for public viewing as received 
at the EPA Docket Center or in E-Docket. This policy applies to 
information submitted electronically or in paper form, except where 
restricted by copyright, CBI, or statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the official public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the EPA Docket Center will be transferred to E-Docket. 
Public comments that are mailed or delivered to the EPA Docket Center 
will be scanned and placed in E-Docket. Where practical, physical 
objects will be photographed, and the photograph will be placed in E-
Docket with a brief description written by the docket staff.
    You may submit comments electronically, by mail, by facsimile, or 
by hand delivery/courier. To ensure proper receipt by EPA, include the 
appropriate docket identification number with your submission. Please 
ensure that your comments are submitted within the specified comment 
period. Comments received after the closing date will be marked 
``late,'' and may only be considered if time permits.
    If you submit comments electronically, EPA recommends that you 
include your name, mailing address, and an e-mail address or other 
contact information in the body of your comment. Also include this 
contact information on the outside of any submitted disk or CD-ROM, and 
in any cover letter accompanying the disk or CD-ROM. This ensures that 
you can be identified as the person submitting the comment and allows 
EPA to contact you in case the Agency cannot read your submission due 
to technical difficulties or needs further information on the substance 
of your comment. EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket and 
made available in E-Docket. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, it may 
delay or preclude consideration of your comment.
    Electronic submission of comments to E-Docket is EPA's preferred 
method for receiving comments. Go directly to EPA Dockets at http://
www.epa.gov/edocket, and follow the online instructions for submitting 
comments. To access EPA's electronic public docket from the EPA 
Internet Home Page, select ``Information Sources,'' ``Dockets,'' and 
``EPA Dockets.'' Once in the system, select ``search,'' and then key in 
Docket ID No. ORD-2005-0022. The system is an ``anonymous access'' 
system, which means EPA will not know your identity, e-mail address, or 
other contact information unless you provide it in the body of your 
comment.
    Comments may be sent by electronic mail (e-mail) to 
ORD.Docket@epa.gov, Attention Docket ID No. ORD-2005-0022. In contrast 
to EPA's electronic public docket, EPA's e-mail system is

[[Page 48952]]

not an ``anonymous access'' system. If you send an e-mail comment 
directly to the docket without going through EPA's E-Docket, EPA's e-
mail system automatically captures your e-mail address, and it becomes 
part of the information in the official public docket and in E-Docket.
    You may submit comments on a disk or CD-ROM that you mail to the 
OEI Docket mailing address. Files will be accepted in WordPerfect, 
Word, or PDF format. Avoid the use of special characters and any form 
of encryption.
    If you provide comments in writing, please submit one unbound 
original with pages numbered consecutively, and three copies of the 
comments. For attachments, provide an index, number pages consecutively 
with the comments, and submit an unbound original and three copies.

    Dated: August 16, 2005.
George Alapas,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 05-16597 Filed 8-19-05; 8:45 am]
BILLING CODE 6560-50-U