Notice of a Scientific Peer-Review Meeting to Review the Draft Document: Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (EPA/600/R-05/043A), 60076-60077 [05-20600]

Download as PDF 60076 Federal Register / Vol. 70, No. 198 / Friday, October 14, 2005 / Notices Construction and Operation of the North Link Light Rail Extension, from Downtown Seattle and Northgate, Updated Information on Refined Design Concepts, Funding, Right-ofWay and US Army COE Section 404 Permits, King County, WA, Comment Period Ends: 11/30/2005, Contact: John Witmer 206–220–7954 EIS No. 20050428, Draft EIS, FRC, CA, Long Beach Liquefied Natural Gas (LNG) Import Project, Construction and Operation of a LNG Receiving Terminal and Associated Facilities, US Army COE 10 and 404 Permits, Long Beach, CA, Comment Period Ends: 12/08/2005, Contact: Thomas Russo 1–866–208–3372 Amended Notices EIS No. 20050328, Draft EIS, FHW, LA, US 90 Corridor, Proposed Interstate Highway 49 (I49 ) South Improvement from Raceland to the Davis Pond Diversion Canal, Section of Independent Utility 1 (SIU 1), Lafourche and St. Charles Parishes, LA, Comment Period Ends: 12/31/ 2005, Contact: William C. Farr 225– 757–7615 Revision of FR Notice Published 08/12/2005; Comment Period Extended from 9/30/2005 to 12/31/2005. Dated: October 11, 2005. Ken Mittelholtz, Environmental Protection Specialist, Office of Federal Activities. [FR Doc. 05–20619 Filed 10–13–05; 8:45 am] BILLING CODE 6560–50–U ENVIRONMENTAL PROTECTION AGENCY [E–Docket ID No. ORD–2005–0022; FRL– 7983–9] Notice of a Scientific Peer-Review Meeting to Review the Draft Document: Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment (EPA/600/R–05/043A) Environmental Protection Agency. ACTION: Notice of external peer-review panel meeting. AGENCY: SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing that Versar Inc., an EPA contractor for external scientific peer review, will convene a panel of experts and organize and conduct an independent external peer-review workshop to review the draft report, ‘‘Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and VerDate Aug<31>2005 13:54 Oct 13, 2005 Jkt 208001 Supporting Data in Risk Assessment’’ (EPA/600/R–05/043A), which was prepared by the National Center for Environmental Assessment (NCEA) within EPA’s Office of Research and Development. Versar, Inc. invites the public to register to attend this workshop as observers. In addition, Versar, Inc. invites the public to give oral and/or provide written comments at the workshop regarding the draft document under review. The draft document and EPA’s peer-review charge are available primarily via the Internet on NCEA’s home page under the Recent Additions and Publications menus at https://www.epa.gov/ncea. In preparing a final report, EPA will consider Versar, Inc.’s report of the comments and recommendations from the external peer-review workshop. In addition to the workshop announced today, EPA previously published a Federal Register notice (70 FR 43692) announcing a separate process for public comment on the draft document on July 28, 2005 and a second Federal Register notice (70 FR 48950) announcing a 45-day extension (closing October 14, 2005) of the public comment period. DATES: Versar, Inc. will hold the peerreview workshop from November 10, 2005, to November 11, 2005. On the first day, the meeting is scheduled to begin at 8:30 a.m. and end at 5 p.m., Eastern Daylight Time. The public may attend the peer-review workshop on November 10, 2005, as observers. In addition, members of the public in attendance at the workshop will be allowed to make brief (no longer than five minutes) oral statements at the commencement of the meeting. The second day of the workshop is scheduled from 8:30 a.m. to 12:30 p.m., Eastern Daylight Time. This second day will be not be open to the public and is meant to provide time for the peer-reviewers to begin drafting their comments on the draft report. ADDRESSES: The external peer-review panel meeting will be held at the Hyatt Arlington located at 1325 Wilson Boulevard, Arlington, VA, 22209. The EPA contractor, Versar, Inc., is organizing, convening, and conducting the peer-review panel meeting. To attend the meeting, register by November 4, by calling Ms. Amanda Jacob of Versar, Inc., 6850 Versar Center, Springfield, VA, 22151, at 703–750– 3000 ext. 260, or via e-mail at AJacob@versar.com, or by sending a facsimile to 703–642–6954. Interested parties may also register on-line at: https://epa.versar.com/pbpk. Space is limited, and reservations will be accepted on a first-come, first-served basis. At the time of your registration for PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 the meeting, please indicate if you intend to make an oral statement during the public comment period on the first day of the meeting. FOR FURTHER INFORMATION CONTACT: Questions regarding registration and logistics for the peer review meeting should be directed to Ms. Amanda Jacob, Versar, Inc., 6850 Versar Center, Springfield, VA, 22151; telephone: 703– 750–3000 ext. 260; facsimile: 703–642– 6954; e-mail: AJacob@versar.com. If you have questions about the document, please contact Technical Information Staff, NCEA, 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: On July 28, 2005, EPA published a Federal Register notice (70 FR 43692) that announced a 30-day public comment period through August 29, 2005, for EPA’s draft report, ‘‘Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment’’ (EPA/600/R–05/043A). EPA published a second notice in the Federal Register on August 22, 2005 (70 FR 48950) that extended the public comment period for 45 days from August 29, until October 14, 2005. On July 28, 2005, the draft document was made publicly available on NCEA’s Web site for review and comment. An electronic version of the public docket is available through EPA’s electronic public docket and comment system, E-Docket. To view comments, go to https://www.epa.gov/edocket/, select ‘‘search,’’ then key in the docket identification number, ORD–2005–0022. In the July 28, 2005, notice, EPA also announced that a subsequent Federal Register notice would announce the date and location of a workshop for independent external peer review of this draft document. Today’s notice provides information on that external peer-review workshop. The purpose of the draft document is to describe some approaches for the use of physiologically-based pharmacokinetic (PBPK) models in risk assessment. 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 E:\FR\FM\14OCN1.SGM 14OCN1 Federal Register / Vol. 70, No. 198 / Friday, October 14, 2005 / Notices 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 report 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? Dated: October 6, 2005. Peter Preuss, Director, National Center for Environmental Assessment. [FR Doc. 05–20600 Filed 10–13–05; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–7983–5] Science Advisory Board Staff Office; Notification of Advisory Meeting of the SAB All-Ages Lead Model (AALM) Review Panel Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: The Environmental Protection Agency (EPA or Agency) Science Advisory Board (SAB) Staff Office announces a public meeting of the SAB All-Ages Lead Model Review Panel (Panel) for the purpose of providing the Agency with advice and recommendations on the recentlydeveloped All-Ages Lead Model. DATES: The meeting will be held Thursday, October 27, 2005, from 9 a.m. to 5:30 p.m. (eastern time), and Friday, October 28, 2005, from 9 a.m. to 2 p.m. (eastern time). ADDRESSES: The meeting will take place at SAB Conference Center, 1025 F Street, NW., Suite 3700, Washington, DC 20004. FOR FURTHER INFORMATION CONTACT: Any member of the public who would like to submit written or brief oral comments (5 minutes or less), or wants further information concerning this meeting, may contact Mr. Fred Butterfield, Designated Federal Officer (DFO), EPA Science Advisory Board (1400F), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; via telephone/ voice mail: (202) 343–9994; fax: (202) 233–0643; or e-mail at: butterfield.fred@epa.gov. General information concerning the EPA Science VerDate Aug<31>2005 13:54 Oct 13, 2005 Jkt 208001 Advisory Board can be found on the EPA Web site at: https://www.epa.gov/ sab. SAB and the AALM Review Panel: The SAB was established by 42 U.S.C. 4365 to provide independent scientific and technical advice, consultation, and recommendations to the EPA Administrator on the technical basis for Agency positions and regulations. The SAB is a Federal advisory committee chartered under the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App. The Panel will provide advice through the chartered SAB, and will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. The SAB Staff Office recently established the SAB AALM Review Panel to provide the EPA Administrator, through the SAB, with advice and recommendations on the Agency’s AllAges Lead Model. The Panel will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Background: The SAB Staff Office has formed this Panel at the request of EPA’s Office of Research and Development (ORD), National Center for Environmental Assessment (NCEA), to provide advice and recommendations to the Agency on EPA’s recentlydeveloped All-Ages Lead Model (AALM). The AALM is designed to predict lead concentrations in body tissues and organs for a hypothetical individual, based on a simulated lifetime of lead exposure. Statistical methods can be used to extrapolate to a population of similarly-exposed individuals. The precursor to the AALM was the Integrated Exposure Uptake Biokinetic (IEUBK) Model for Lead in Children. The IEUBK Model underwent peer review by the SAB in 1991 and was subsequently revised in response to that review, leading to release of Version 0.99d of the IEUBK Model in March 1994. Since then, the IEUBK Model has been widely accepted and used in the risk assessment community as a tool for implementing the site-specific risk assessment process when the issue is childhood lead exposure. Based on further refinement of the IEUBK Model and its expansion for use with additional age groups beyond pediatric populations 6 years old or younger, the AALM has recently been developed to cover older childhood and adult lead exposure. The anticipated outcome will be reduced uncertainty in lead exposure assessments for children and adults. Any questions concerning either the AALM or the IEUBK Model for Lead in SUPPLEMENTARY INFORMATION: PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 60077 Children should be directed to Dr. Robert Elias, NCEA–RTP, at phone (919) 541–4167; or e-mail elias.robert@epa.gov. Availability of Meeting Materials: NCEA–RTP has posted the ‘‘All-Ages Lead Model (AALM) Version 1.05 (External Review Draft)’’ and related materials (including the Guidance Manual for the AALM Version 1.05) on the NCEA Web site at https:// cfpub.epa.gov/ncea/cfm/ recordisplay.cfm?deid=139314. Furthermore, the SAB Staff Office will post a copy of the final agenda and charge to the Panel for this advisory meeting on the SAB Web site at https://www.epa.gov/sab (under ‘‘Meeting Agendas’’) and https:// www.epa.gov/sab/panels/ ad_hoc_aalm_rev_panel.htm in advance of the Panel meeting. Procedures for Providing Public Comment: The SAB Staff Office accepts written public comments of any length, and will accommodate oral public comments whenever possible. The SAB Staff Office expects that public will not repeat previously-submitted oral or written statements. Oral Comments: Requests to provide oral comments must be in writing (e-mail, fax or mail) and received by Mr. Butterfield no later than October 20, 2005 to reserve time on the October 27, 2005 meeting agenda. Opportunities for oral comments will be limited to five minutes per speaker. Written Comments: Written comments should be received in the SAB Staff Office by October 21, 2005 so that the comments may be made available to the members of the members of the SAB AALM Review Panel for their consideration. Comments should be supplied to Mr. Butterfield at the contact information provided above, in the following formats: one hard copy with original signature, and one electronic copy via e-mail (acceptable file format: Adobe Acrobat PDF, WordPerfect, Word, or Rich Text files (in IBM–PC/Windows 98/2000/XP format)). Those providing written comments and who attend the meeting in person are also asked to bring 75 copies of their comments for public distribution. Meeting: Individuals requiring special accommodation at this meeting, including wheelchair access to the conference room, should contact Mr. Butterfield at the phone number or email address noted above no later than October 20, 2005 so that appropriate arrangements can be made. E:\FR\FM\14OCN1.SGM 14OCN1

Agencies

[Federal Register Volume 70, Number 198 (Friday, October 14, 2005)]
[Notices]
[Pages 60076-60077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20600]


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

ENVIRONMENTAL PROTECTION AGENCY

[E-Docket ID No. ORD-2005-0022; FRL-7983-9]


Notice of a Scientific Peer-Review Meeting to Review the Draft 
Document: Approaches for the Application of Physiologically-Based 
Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment 
(EPA/600/R-05/043A)

AGENCY: Environmental Protection Agency.

ACTION: Notice of external peer-review panel meeting.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing 
that Versar Inc., an EPA contractor for external scientific peer 
review, will convene a panel of experts and organize and conduct an 
independent external peer-review workshop to review the draft report, 
``Approaches for the Application of Physiologically-Based 
Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment'' 
(EPA/600/R-05/043A), which was prepared by the National Center for 
Environmental Assessment (NCEA) within EPA's Office of Research and 
Development. Versar, Inc. invites the public to register to attend this 
workshop as observers. In addition, Versar, Inc. invites the public to 
give oral and/or provide written comments at the workshop regarding the 
draft document under review. The draft document and EPA's peer-review 
charge are available primarily via the Internet on NCEA's home page 
under the Recent Additions and Publications menus at https://
www.epa.gov/ncea. In preparing a final report, EPA will consider 
Versar, Inc.'s report of the comments and recommendations from the 
external peer-review workshop. In addition to the workshop announced 
today, EPA previously published a Federal Register notice (70 FR 43692) 
announcing a separate process for public comment on the draft document 
on July 28, 2005 and a second Federal Register notice (70 FR 48950) 
announcing a 45-day extension (closing October 14, 2005) of the public 
comment period.

DATES: Versar, Inc. will hold the peer-review workshop from November 
10, 2005, to November 11, 2005. On the first day, the meeting is 
scheduled to begin at 8:30 a.m. and end at 5 p.m., Eastern Daylight 
Time. The public may attend the peer-review workshop on November 10, 
2005, as observers. In addition, members of the public in attendance at 
the workshop will be allowed to make brief (no longer than five 
minutes) oral statements at the commencement of the meeting. The second 
day of the workshop is scheduled from 8:30 a.m. to 12:30 p.m., Eastern 
Daylight Time. This second day will be not be open to the public and is 
meant to provide time for the peer-reviewers to begin drafting their 
comments on the draft report.

ADDRESSES: The external peer-review panel meeting will be held at the 
Hyatt Arlington located at 1325 Wilson Boulevard, Arlington, VA, 22209. 
The EPA contractor, Versar, Inc., is organizing, convening, and 
conducting the peer-review panel meeting. To attend the meeting, 
register by November 4, by calling Ms. Amanda Jacob of Versar, Inc., 
6850 Versar Center, Springfield, VA, 22151, at 703-750-3000 ext. 260, 
or via e-mail at AJacob@versar.com, or by sending a facsimile to 703-
642-6954. Interested parties may also register on-line at: https://
epa.versar.com/pbpk. Space is limited, and reservations will be 
accepted on a first-come, first-served basis. At the time of your 
registration for the meeting, please indicate if you intend to make an 
oral statement during the public comment period on the first day of the 
meeting.

FOR FURTHER INFORMATION CONTACT: Questions regarding registration and 
logistics for the peer review meeting should be directed to Ms. Amanda 
Jacob, Versar, Inc., 6850 Versar Center, Springfield, VA, 22151; 
telephone: 703-750-3000 ext. 260; facsimile: 703-642-6954; e-mail: 
AJacob@versar.com. If you have questions about the document, please 
contact Technical Information Staff, NCEA, 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: On July 28, 2005, EPA published a Federal 
Register notice (70 FR 43692) that announced a 30-day public comment 
period through August 29, 2005, for EPA's draft report, ``Approaches 
for the Application of Physiologically-Based Pharmacokinetic (PBPK) 
Models and Supporting Data in Risk Assessment'' (EPA/600/R-05/043A). 
EPA published a second notice in the Federal Register on August 22, 
2005 (70 FR 48950) that extended the public comment period for 45 days 
from August 29, until October 14, 2005. On July 28, 2005, the draft 
document was made publicly available on NCEA's Web site for review and 
comment. An electronic version of the public docket is available 
through EPA's electronic public docket and comment system, E-Docket. To 
view comments, go to https://www.epa.gov/edocket/, select ``search,'' 
then key in the docket identification number, ORD-2005-0022. In the 
July 28, 2005, notice, EPA also announced that a subsequent Federal 
Register notice would announce the date and location of a workshop for 
independent external peer review of this draft document. Today's notice 
provides information on that external peer-review workshop.
    The purpose of the draft document is to describe some approaches 
for the use of physiologically-based pharmacokinetic (PBPK) models in 
risk assessment. 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

[[Page 60077]]

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 report 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?

    Dated: October 6, 2005.
Peter Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. 05-20600 Filed 10-13-05; 8:45 am]
BILLING CODE 6560-50-P
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