[Federal Register: March 17, 2008 (Volume 73, Number 52)]
[Notices]
[Page 14251]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr08-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Center for the Evaluation of
Risks to Human Reproduction (CERHR); Availability of the Draft NTP
Brief on Hydroxyurea; Request for Public Comments
AGENCY: National Institute of Environmental Health Sciences (NIEHS);
National Institutes of Health (NIH).
ACTION: Request for comments.
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SUMMARY: CERHR invites the submission of public comments on the draft
NTP Brief for Hydroxyurea. The draft NTP Brief is available from the
CERHR Web site (http://cerhr.niehs.nih.gov; see ``Hydroxyurea'' under
``CERHR Reports & Monographs'') or in hardcopy from CERHR (see
ADDRESSES below). Public comments will be considered during the peer
review and finalization of the NTP Brief.
DATES: Written comments on the draft NTP Brief for Hydroxyurea should
be received by May 1, 2008.
ADDRESSES: Public comments and any other correspondence should be
addressed to Dr. Michael D. Shelby, CERHR Director, NIEHS, P.O. Box
12233, MD EC-32, Research Triangle Park, NC 27709 (mail), (919) 541-
3455 (phone), (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.
SUPPLEMENTARY INFORMATION:
Background
Hydroxyurea 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 and, in severe
cases, bone marrow transplantation. 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
use in adults with sickle cell anemia to reduce the frequency of
moderate to severe painful crises and the need for blood transfusions.
CERHR selected hydroxyurea 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. On January 24-26, 2007, CERHR convened an expert panel to
conduct an evaluation of the potential reproductive and developmental
toxicities of hydroxyurea. The expert panel report was released for
public comment on February 26, 2007 (Federal Register Vol. 72, No. 37,
pp. 8384-8385). Following this public comment period, CERHR staff
prepared the draft NTP Brief for Hydroxyurea that provides in plain
language:
Background information on the substance(s).
Findings of the expert panel.
Discussion of any relevant data available after the expert
panel meeting.
NTP's conclusions on the potential for the substance to
cause adverse reproductive and/or developmental effects in exposed
humans.
Upon finalization, the NTP Brief for Hydroxyurea will be included
in the CERHR Monograph for Hydroxyurea. The draft NTP Brief for
Hydroxyurea and related background materials, including the hydroxyurea
expert panel report and previously received public comments, are
available on the CERHR Web site (http://cerhr.niehs.nih.gov; see
``Hydroxyurea'' under ``CERHR Reports & Monographs'').
Request for Comments
The NTP invites written public comments on the draft NTP Brief for
Hydroxyurea. Any comments received will be posted on the CERHR Web site
and considered during the peer review and finalization of the NTP Brief
for Hydroxyurea. 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 submit comments to Dr. Shelby (see ADDRESSES
above) for receipt by May 1, 2008.
Background Information on CERHR
The NTP established CERHR in June 1998 (Federal Register Vol. 63,
No. 239, p. 68782). 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.
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. Michael Shelby, CERHR Director (see ADDRESSES). 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. Expert panels conduct
scientific evaluations of agents selected by CERHR in public forums.
Following these evaluations, CERHR prepares the NTP-CERHR monograph on
the agent evaluated. The monograph is transmitted to appropriate
federal and state agencies and made available to the public.
Dated: March 6, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E8-5242 Filed 3-14-08; 8:45 am]
BILLING CODE 4140-01-P