National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft Expert Panel Report on Hydroxyurea and Request for Public Comment on the Draft Report; Announcement of the Hydroxyurea Expert Panel Meeting, 60746-60748 [E6-17137]
Download as PDF
<![CDATA[
jlentini on PROD1PC65 with NOTICES
60746
Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3211,
MSC 7808, Bethesda, MD 20892. (301) 435–
0903. saadisoh@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Health of
the Population SBIR Study Section Panel.
Date: November 2–3, 2006.
Time: 8:30 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Karin F. Helmers, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166,
MSC 7770, Bethesda, MD 20892. (301) 435–
1017. helmersk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: Non-HIV Anti-Infective
Therapeutics.
Date: November 2, 2006.
Time: 9 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Watergate, 2650 Virginia
Avenue, NW., Washington, DC 20037.
Contact Person: Rossana Berti, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3191,
MSC 7846, Bethesda, MD 20892. 301–402–
6411. bertiros@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, RIBT
Member Conflicts.
Date: November 2, 2006.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: George M. Barnas, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2180,
MSC 7817, Bethesda, MD 20892. 301–435–
0696. barnasg@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Neural
Control of Cardiovascular Function.
Date: November 2, 2006.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Anshumali Chaudhari,
PhD, Scientific Review Administrator, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4124,
MSC 7802 Bethesda, MD 20892. (301) 435–
1210. chaudhaa@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Technology
Development.
Date: November 2, 2006.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Aug<31>2005
16:16 Oct 13, 2006
Jkt 211001
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Sally Ann Amero, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7849, Bethesda, MD 20892. 301–435–
1159. ameros@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, GENHAT
Collaborative.
Date: November 2, 2006.
Time: 12:30 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Churchill Hotel, 1914
Connecticut Ave., NW., Washington, DC
20009.
Contact Person: Russell T. Dowell, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4128,
MSC 7814, Bethesda, MD 20892. 301–435–
1850. dowellr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Endocrinology, Metabolism, Nutrition and
Reproductive Special Emphasis Panel SBIR.
Date: November 3, 2006.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Krish Krishnan, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892. 301–435–
1041. krishnak@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Research on
Ethical Issues in Human Studies.
Date: November 3, 2006.
Time: 9 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Watergate, 2650 Virginia
Avenue, NW., Washington, DC 20037.
Contact Person: Stephen H. Krosnick, MD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3028A,
MSC 7770, Bethesda, MD 20892. 301–435–
1712. krosnics@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Globin Gene
Regulation.
Date: November 3, 2006.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Robert T. Su, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4134,
MSC 7802, Bethesda, MD 20892. 301–435–
1195. sur@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Metal Ions
and Kinases.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Date: November 3, 2006.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn Georgetown, 2101
Wisconsin Ave., NW., Washington, DC
20007.
Contact Person: Alessandra M. Bini, PhD,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5142,
MSC 7840, Bethesda, MD 20892. 301–435–
1024. binia@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 5, 2006.
Linda Payne,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–8698 Filed 10–13–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP);
Center for the Evaluation of Risks to
Human Reproduction (CERHR);
Availability of the Draft Expert Panel
Report on Hydroxyurea and Request
for Public Comment on the Draft
Report; Announcement of the
Hydroxyurea Expert Panel Meeting
National Institute for
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH), HHS.
ACTION: Announcement of a meeting and
request for public comment.
AGENCY:
SUMMARY: The CERHR announces the
availability of the draft expert panel
report for hydroxyurea on November 1,
2006, from the CERHR Web site
(https://cerhr.niehs.nih.gov) or in printed
text from the CERHR (see FOR FURTHER
INFORMATION CONTACT below). The
CERHR invites the submission of public
comments on sections 1–4 of the draft
expert panel report (see SUPPLEMENTARY
INFORMATION below). The expert panel
will meet on January 24–26, 2007, at the
Radisson Hotel Old Town in
Alexandria, VA, to review and revise
the draft expert panel report and reach
conclusions regarding whether exposure
to hydroxyurea is a hazard to human
development or reproduction. The
expert panel will also identify data gaps
and research needs. CERHR expert
panel meetings are open to the public
with time scheduled for oral public
comment. Attendance is limited only by
E:\FR\FM\16OCN1.SGM
16OCN1
Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices
jlentini on PROD1PC65 with NOTICES
the available meeting room space.
Following the expert panel meeting and
completion of the expert panel report,
the CERHR will post the final report on
its Web site and solicit public comment
on it through a Federal Register notice.
DATES: The expert panel meeting for
hydroxyurea will be held on January
24–26, 2007. Sections 1–4 of the draft
expert panel report will be available for
public comment on November 1, 2006.
Written public comments on the draft
report must be received by December
15, 2006. Time is set-aside at the expert
panel meeting on January 24, 2007 for
oral public comments. Individuals
wishing to make oral public comments
are asked to contact Dr. Michael D.
Shelby, CERHR Director, by January 17,
2007, and if possible, send a copy of the
statement or talking points at that time.
Persons needing special assistance in
order to attend are asked to contact Dr.
Shelby at least 7 business days prior to
the meeting.
ADDRESSES: The expert panel meeting
on hydroxyurea will be held at the
Radisson Hotel Old Town 901 N. Fairfax
Street Alexandria, VA 22314–1501
(telephone: 703–683–6000, facsimile:
703–683–7597). Comments on the draft
expert panel report should be sent to Dr.
Michael D. Shelby, CERHR Director,
NIEHS, P.O. Box 12233, MD EC–32,
Research Triangle Park, NC 27709
(mail), (919) 316–4511 (fax), or
shelby@niehs.nih.gov (e-mail). Courier
address: CERHR, 79 T.W. Alexander
Drive, Building 4401, Room 103,
Research Triangle Park, NC 27709.
FOR FURTHER INFORMATION CONTACT: Dr.
Michael D. Shelby, CERHR Director,
919–541–3455, shelby@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
Hydroxyurea (CAS RN: 127–07–1) is
used in the treatment of cancer, sickle
cell disease, and thalassemia. It is the
only treatment for sickle cell disease
used in children aside from blood
transfusion. Hydroxyurea may be used
in the treatment of children and adults
with sickle cell disease for an extended
period of time or for repeated cycles of
therapy. Treatment with hydroxyurea
may be associated with cytotoxic and
myelosuppressive effects and
hydroxyurea is mutagenic. Hydroxyurea
is FDA-approved for reducing the
frequency of painful crises and the need
for blood transfusions in adults with
sickle cell anemia who experience
recurrent moderate to severe painful
crises. CERHR selected this chemical for
evaluation because of (1) increasing use
in the treatment of sickle cell disease in
children and adults, (2) knowledge that
VerDate Aug<31>2005
16:16 Oct 13, 2006
Jkt 211001
it inhibits DNA synthesis and is
cytotoxic, and (3) published evidence of
reproductive and developmental
toxicity in rodents.
At the expert panel meeting, the
expert panel will review and revise the
draft expert panel report and reach
conclusions regarding whether exposure
to hydroxyurea is a hazard to human
reproduction or development. Each
draft expert panel report has the
following sections:
1.0 Chemistry, Use, and Human
Exposure.
2.0 General Toxicological and
Biological Effects.
3.0 Developmental Toxicity Data.
4.0 Reproductive Toxicity Data.
5.0 Summary, Conclusions, and
Critical Data Needs (to be prepared at
expert panel meeting).
Request for Comments
The CERHR invites written public
comments on sections 1–4 of the draft
expert panel report on hydroxyurea.
Any comments received will be posted
on the CERHR Web site prior to the
meeting and distributed to the expert
panel and CERHR staff for their
consideration in revising the draft report
and preparing for the expert panel
meeting. Persons submitting written
comments are asked to include their
name and contact information
(affiliation, mailing address, telephone
and facsimile numbers, e-mail, and
sponsoring organization, if any) and
send them to Dr. Shelby (see ADDRESSES
above) for receipt by December 15, 2006.
Time is set-aside on January 24, 2007,
for the presentation of oral public
comments at the expert panel meeting.
Seven minutes will be available for each
speaker (one speaker per organization).
When registering to comment orally,
please provide your name, affiliation,
mailing address, telephone and
facsimile numbers, e-mail and
sponsoring organization (if any). If
possible, send a copy of the statement
or talking points to Dr. Shelby by
January 17. This statement will be
provided to the expert panel to assist
them in identifying issues for discussion
and will be noted in the meeting record.
Registration for presentation of oral
comments will also be available at the
meeting on January 24, 2007, from 7:30–
8:30 a.m. Persons registering at the
meeting are asked to bring 20 copies of
their statement or talking points for
distribution to the expert panel and for
the record.
Preliminary Agenda
The meeting begins each day at 8:30
a.m. On January 24 and 25, it is
anticipated that a lunch break will occur
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
60747
from noon-1 p.m. and the meeting will
adjourn at 5–6 p.m. The meeting is
expected to adjourn by noon on January
26; however, adjournment may occur
earlier or later depending upon the time
needed by the expert panel to complete
its work. Anticipated agenda topics for
each day are listed below.
January 24, 2007
• Opening remarks.
• Oral public comments (7 minutes
per speaker; one representative per
group).
• Review of sections 1–4 of the draft
expert panel report on hydroxyurea.
• Discussion of Section 5.0 Summary,
Conclusions, and Critical Data Needs.
January 25, 2007
• Discussion of Section 5.0 Summary,
Conclusions, and Critical Data Needs.
• Preparation of draft summaries and
conclusion statements.
January 26, 2007
• Presentation, discussion of, and
agreement on summaries, conclusions,
and data needs.
• Closing comments.
Expert Panel Roster
The CERHR expert panel is composed
of independent scientists selected for
their scientific expertise in reproductive
and/or developmental toxicology and
other areas of science relevant for these
evaluations.
Erica Liebelt, M.D. (Chair), University of
Alabama, Birmingham, AL.
Sophie Balk, M.D., Albert Einstein
College of Medicine, New York, NY.
Will Faber, PhD, Consultant, Victor, NY.
Jeffrey Fisher, PhD, University of
Georgia, Athens, GA.
Claude Hughes, Jr., M.D., PhD,
Quintiles, Inc., Research Triangle
Park, NC.
Sophie Lanzkron, M.D., Johns Hopkins
University, Baltimore, MD.
Kerry Lewis, M.D., Howard University,
Washington, DC.
Harihara Mehendale, PhD, University of
Louisiana, Monroe, LA.
Marvin Meistrich, PhD, University of
Texas, Houston, TX.
John Rogers, PhD, U.S. Environmental
Protection Agency, Research Triangle
Park, NC.
Aziza Shad, M.D., Georgetown
University, Washington, DC.
Richard Skalko, PhD, East Tennessee
State University, Johnson City, TN.
Edward Stanek III, PhD, University of
Massachusetts, Amherst, MA.
Background Information on the CERHR
The NTP established the NTP CERHR
in June 1998 [Federal Register,
E:\FR\FM\16OCN1.SGM
16OCN1
60748
Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices
December 14, 1998 (Volume 63, Number
239, page 68782)]. The CERHR is a
publicly accessible resource for
information about adverse reproductive
and/or developmental health effects
associated with exposure to
environmental and/or occupational
exposures. Expert panels conduct
scientific evaluations of agents selected
by the CERHR in public forums.
The CERHR invites the nomination of
agents for review or scientists for its
expert registry. Information about
CERHR and the nomination process can
be obtained from its homepage (https://
cerhr.niehs.nih.gov) or by contacting Dr.
Shelby (see FOR FURTHER INFORMATION
CONTACT above). The CERHR selects
chemicals for evaluation based upon
several factors including production
volume, potential for human exposure
from use and occurrence in the
environment, extent of public concern,
and extent of data from reproductive
and developmental toxicity studies.
CERHR follows a formal, multi-step
process for review and evaluation of
selected chemicals. The formal
evaluation process was published in the
Federal Register on July 16, 2001
(Volume 66, Number 136, pages 37047–
37048) and is available on the CERHR
Web site under ‘‘About CERHR’’ or in
printed copy from the CERHR.
Dated: October 5, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E6–17137 Filed 10–13–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP),
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Notice of
Availability of the NICEATM Pre-Screen
Evaluation of a Cell Proliferation Assay
To Detect Estrogenic Activity: Request
for Comments and Nominations of
Other In Vitro Endocrine Disruptor Test
Methods
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH), HHS.
ACTION: Report availability and request
for comments and nominations.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: In January 2006, the
Interagency Coordinating Committee on
Alternative Methods (ICCVAM) received
VerDate Aug<31>2005
16:16 Oct 13, 2006
Jkt 211001
a test method nomination for the
validation of a cell-based estrogen
receptor (ER) transcriptional activation
(TA) test method from CertiChem, Inc.
CertiChem, Inc. submitted a background
review document (BRD) containing
information on historical development
of the test method, the rationale for the
test method, and supporting materials.
In accordance with the ICCVAM
nomination process, NICEATM
conducted a pre-screen evaluation of the
BRD to determine the extent that it
addressed ICCVAM prioritization
criteria, submission guidelines, and
recommendations for standardization
and validation of in vitro endocrine
disruptor test methods. NICEATM also
reviewed the performance of the test
method based on pre-validation data to
determine if it warranted consideration
for further validation. ICCVAM requests
public comments on the pre-screen
evaluation titled, ‘‘Pre-Screen
Evaluation of the CertiChem, Inc. In
Vitro Endocrine Disruptor Assay
(Robotic MCF–7 Cell Proliferation Assay
of Estrogenic Activity.)’’ The pre-screen
evaluation is available with supporting
documents at (https://
iccvam.niehs.nih.gov/methods/
endocrine.htm). ICCVAM also invites
public comments on whether this test
method should be considered for
additional validation studies. In
addition, ICCVAM again invites the
nomination of other in vitro ER and
androgen receptor (AR) binding and TA
test methods for which there are
standardized test method protocols, prevalidation data, and proposed validation
study designs.
DATES: Comments and nominations
should be received by November 30,
2006.
ADDRESSES: Correspondence should be
sent by mail, fax, or e-mail to Dr.
William S. Stokes, NICEATM Director,
NIEHS, P.O. Box 12233, MD EC–17,
Research Triangle Park, NC 27709,
(phone) 919–541–2384, (fax) 919–541–
0947, (e-mail) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
In May 2003, ICCVAM published the
report, ‘‘ICCVAM Evaluation of In Vitro
Test Methods for Detecting Potential
Endocrine Disruptors: Estrogen Receptor
and Androgen Receptor Binding and
Transcriptional Activation Assays (NIH
Publication No. 03–4503; available:
https://iccvam.niehs.nih.gov/methods/
endocrine.htm). The report recommends
minimum procedural standards that
should be incorporated in standardized
test method protocols and minimum
lists of chemicals that should be used
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
for validation studies. A request was
made for nominations of validation
studies for in vitro ER and AR binding
and TA test methods based on these
recommendations and for which there
are standardized test method protocols,
pre-validation data, and proposed
validation study designs (69 FR 21564).
ICCVAM subsequently received a
nomination from CertiChem, Inc. for the
validation of a cell-based ER TA method
that evaluates the estrogenic activity of
substances by measuring whether and to
what extent a substance induces cell
proliferation via ER-dependent
pathways. In support of this
nomination, ICCVAM received a BRD
containing information on the test
method’s historical development, its
rationale, its protocol, and other
supporting materials. In accordance
with the ICCVAM nomination process,
NICEATM conducted a pre-screen
evaluation of the BRD to determine the
extent that it addressed ICCVAM
prioritization criteria, submission
guidelines, and recommendations for
standardization and validation of in
vitro endocrine disruptor test methods.
NICEATM also reviewed the
performance of the proposed test
method based on pre-validation data to
determine if it warranted consideration
for further validation. The BRD was
reviewed for completeness and to
identify aspects or omissions that could
impede further review. The criteria
considered in evaluating information
provided in the BRD are:
• The extent to which the BRD
addresses ICCVAM prioritization
criteria.
• The extent to which the BRD
provides the information requested in
the ICCVAM Guidelines for the
Nomination and Submission of New,
Revised, and Alternative Test Methods
(NIH Pub. No. 03–4508, available at
https://iccvam.niehs.nih.gov).
• The extent to which the proposed
test method adheres to the
recommendations of the ICCVAM
Evaluation of In Vitro Test Methods for
Detecting Potential Endocrine
Disruptors (NIH Pub. No. 03–4503,
available at https://iccvam.niehs.nih.gov/
methods/endocrine.htm), especially
those regarding essential test method
components and recommended
validation substances.
• The extent to which the proposed
test method shows adequate
performance (reliability and accuracy)
during pre-validation to warrant
consideration for validation studies.
Based on the pre-screen evaluation,
ICCVAM made a draft recommendation
that this test method be considered as a
high priority for validation studies to
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 71, Number 199 (Monday, October 16, 2006)]
[Notices]
[Pages 60746-60748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17137]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP); Center for the Evaluation of
Risks to Human Reproduction (CERHR); Availability of the Draft Expert
Panel Report on Hydroxyurea and Request for Public Comment on the Draft
Report; Announcement of the Hydroxyurea Expert Panel Meeting
AGENCY: National Institute for Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH), HHS.
ACTION: Announcement of a meeting and request for public comment.
-----------------------------------------------------------------------
SUMMARY: The CERHR announces the availability of the draft expert panel
report for hydroxyurea on November 1, 2006, from the CERHR Web site
(https://cerhr.niehs.nih.gov) or in printed text from the CERHR (see FOR
FURTHER INFORMATION CONTACT below). The CERHR invites the submission of
public comments on sections 1-4 of the draft expert panel report (see
SUPPLEMENTARY INFORMATION below). The expert panel will meet on January
24-26, 2007, at the Radisson Hotel Old Town in Alexandria, VA, to
review and revise the draft expert panel report and reach conclusions
regarding whether exposure to hydroxyurea is a hazard to human
development or reproduction. The expert panel will also identify data
gaps and research needs. CERHR expert panel meetings are open to the
public with time scheduled for oral public comment. Attendance is
limited only by
[[Page 60747]]
the available meeting room space. Following the expert panel meeting
and completion of the expert panel report, the CERHR will post the
final report on its Web site and solicit public comment on it through a
Federal Register notice.
DATES: The expert panel meeting for hydroxyurea will be held on January
24-26, 2007. Sections 1-4 of the draft expert panel report will be
available for public comment on November 1, 2006. Written public
comments on the draft report must be received by December 15, 2006.
Time is set-aside at the expert panel meeting on January 24, 2007 for
oral public comments. Individuals wishing to make oral public comments
are asked to contact Dr. Michael D. Shelby, CERHR Director, by January
17, 2007, and if possible, send a copy of the statement or talking
points at that time. Persons needing special assistance in order to
attend are asked to contact Dr. Shelby at least 7 business days prior
to the meeting.
ADDRESSES: The expert panel meeting on hydroxyurea will be held at the
Radisson Hotel Old Town 901 N. Fairfax Street Alexandria, VA 22314-1501
(telephone: 703-683-6000, facsimile: 703-683-7597). Comments on the
draft expert panel report should be sent to Dr. Michael D. Shelby,
CERHR Director, NIEHS, P.O. Box 12233, MD EC-32, Research Triangle
Park, NC 27709 (mail), (919) 316-4511 (fax), or shelby@niehs.nih.gov
(e-mail). Courier address: CERHR, 79 T.W. Alexander Drive, Building
4401, Room 103, Research Triangle Park, NC 27709.
FOR FURTHER INFORMATION CONTACT: Dr. Michael D. Shelby, CERHR Director,
919-541-3455, shelby@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
Hydroxyurea (CAS RN: 127-07-1) is used in the treatment of cancer,
sickle cell disease, and thalassemia. It is the only treatment for
sickle cell disease used in children aside from blood transfusion.
Hydroxyurea may be used in the treatment of children and adults with
sickle cell disease for an extended period of time or for repeated
cycles of therapy. Treatment with hydroxyurea may be associated with
cytotoxic and myelosuppressive effects and hydroxyurea is mutagenic.
Hydroxyurea is FDA-approved for reducing the frequency of painful
crises and the need for blood transfusions in adults with sickle cell
anemia who experience recurrent moderate to severe painful crises.
CERHR selected this chemical for evaluation because of (1) increasing
use in the treatment of sickle cell disease in children and adults, (2)
knowledge that it inhibits DNA synthesis and is cytotoxic, and (3)
published evidence of reproductive and developmental toxicity in
rodents.
At the expert panel meeting, the expert panel will review and
revise the draft expert panel report and reach conclusions regarding
whether exposure to hydroxyurea is a hazard to human reproduction or
development. Each draft expert panel report has the following sections:
1.0 Chemistry, Use, and Human Exposure.
2.0 General Toxicological and Biological Effects.
3.0 Developmental Toxicity Data.
4.0 Reproductive Toxicity Data.
5.0 Summary, Conclusions, and Critical Data Needs (to be prepared
at expert panel meeting).
Request for Comments
The CERHR invites written public comments on sections 1-4 of the
draft expert panel report on hydroxyurea. Any comments received will be
posted on the CERHR Web site prior to the meeting and distributed to
the expert panel and CERHR staff for their consideration in revising
the draft report and preparing for the expert panel meeting. Persons
submitting written comments are asked to include their name and contact
information (affiliation, mailing address, telephone and facsimile
numbers, e-mail, and sponsoring organization, if any) and send them to
Dr. Shelby (see ADDRESSES above) for receipt by December 15, 2006.
Time is set-aside on January 24, 2007, for the presentation of oral
public comments at the expert panel meeting. Seven minutes will be
available for each speaker (one speaker per organization). When
registering to comment orally, please provide your name, affiliation,
mailing address, telephone and facsimile numbers, e-mail and sponsoring
organization (if any). If possible, send a copy of the statement or
talking points to Dr. Shelby by January 17. This statement will be
provided to the expert panel to assist them in identifying issues for
discussion and will be noted in the meeting record. Registration for
presentation of oral comments will also be available at the meeting on
January 24, 2007, from 7:30-8:30 a.m. Persons registering at the
meeting are asked to bring 20 copies of their statement or talking
points for distribution to the expert panel and for the record.
Preliminary Agenda
The meeting begins each day at 8:30 a.m. On January 24 and 25, it
is anticipated that a lunch break will occur from noon-1 p.m. and the
meeting will adjourn at 5-6 p.m. The meeting is expected to adjourn by
noon on January 26; however, adjournment may occur earlier or later
depending upon the time needed by the expert panel to complete its
work. Anticipated agenda topics for each day are listed below.
January 24, 2007
Opening remarks.
Oral public comments (7 minutes per speaker; one
representative per group).
Review of sections 1-4 of the draft expert panel report on
hydroxyurea.
Discussion of Section 5.0 Summary, Conclusions, and
Critical Data Needs.
January 25, 2007
Discussion of Section 5.0 Summary, Conclusions, and
Critical Data Needs.
Preparation of draft summaries and conclusion statements.
January 26, 2007
Presentation, discussion of, and agreement on summaries,
conclusions, and data needs.
Closing comments.
Expert Panel Roster
The CERHR expert panel is composed of independent scientists
selected for their scientific expertise in reproductive and/or
developmental toxicology and other areas of science relevant for these
evaluations.
Erica Liebelt, M.D. (Chair), University of Alabama, Birmingham, AL.
Sophie Balk, M.D., Albert Einstein College of Medicine, New York, NY.
Will Faber, PhD, Consultant, Victor, NY.
Jeffrey Fisher, PhD, University of Georgia, Athens, GA.
Claude Hughes, Jr., M.D., PhD, Quintiles, Inc., Research Triangle Park,
NC.
Sophie Lanzkron, M.D., Johns Hopkins University, Baltimore, MD.
Kerry Lewis, M.D., Howard University, Washington, DC.
Harihara Mehendale, PhD, University of Louisiana, Monroe, LA.
Marvin Meistrich, PhD, University of Texas, Houston, TX.
John Rogers, PhD, U.S. Environmental Protection Agency, Research
Triangle Park, NC.
Aziza Shad, M.D., Georgetown University, Washington, DC.
Richard Skalko, PhD, East Tennessee State University, Johnson City, TN.
Edward Stanek III, PhD, University of Massachusetts, Amherst, MA.
Background Information on the CERHR
The NTP established the NTP CERHR in June 1998 [Federal Register,
[[Page 60748]]
December 14, 1998 (Volume 63, Number 239, page 68782)]. The CERHR is a
publicly accessible resource for information about adverse reproductive
and/or developmental health effects associated with exposure to
environmental and/or occupational exposures. Expert panels conduct
scientific evaluations of agents selected by the CERHR in public
forums.
The CERHR invites the nomination of agents for review or scientists
for its expert registry. Information about CERHR and the nomination
process can be obtained from its homepage (https://cerhr.niehs.nih.gov)
or by contacting Dr. Shelby (see FOR FURTHER INFORMATION CONTACT
above). The CERHR selects chemicals for evaluation based upon several
factors including production volume, potential for human exposure from
use and occurrence in the environment, extent of public concern, and
extent of data from reproductive and developmental toxicity studies.
CERHR follows a formal, multi-step process for review and
evaluation of selected chemicals. The formal evaluation process was
published in the Federal Register on July 16, 2001 (Volume 66, Number
136, pages 37047-37048) and is available on the CERHR Web site under
``About CERHR'' or in printed copy from the CERHR.
Dated: October 5, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E6-17137 Filed 10-13-06; 8:45 am]
BILLING CODE 4140-01-P
