[Federal Register: October 16, 2006 (Volume 71, Number 199)]
[Notices]
[Page 60746-60748]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc06-64]
-----------------------------------------------------------------------
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
(http://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 (http://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