[Federal Register: October 14, 2005 (Volume 70, Number 198)]
[Notices]
[Page 60076-60077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc05-40]
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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.
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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 http://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: http://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 http://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]
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