[Federal Register Volume 72, Number 37 (Monday, February 26, 2007)]
[Notices]
[Pages 8384-8385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Announcement of the Availability 
of the Hydroxyurea Expert Panel Report; Request for Public Comment

AGENCY: National Institute of Environmental Health Sciences; National 
Institutes of Health, HHS.

ACTION: Request for comment.

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SUMMARY: CERHR announces availability of the hydroxyurea expert panel 
report by March 5, 2007 on the CERHR Web site (http://cerhr.niehs.nih.gov) or in print from CERHR (see ``ADDRESSES'' below). 
This expert panel report is an evaluation of the reproductive and 
developmental toxicity of hydroxyurea conducted by a 13-member expert 
panel composed of scientists from the Federal Government, universities, 
and private organizations. CERHR invites the submission of public 
comments on this expert panel report.

DATES: The final hydroxyurea expert panel report will be available by 
March 5, 2007, and written public comments on this report should be 
received by April 18, 2007.

ADDRESSES: Public comments and any other correspondence 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 
[email protected] (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. 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 crises. CERHR selected 
hydroxyurea for expert panel evaluation because of (1) increasing use 
in the treatment of sickle cell disease in children and adults, (2)

[[Page 8385]]

knowledge that it inhibits DNA synthesis and is cytotoxic, and (3) 
published evidence of reproductive and developmental toxicity in 
rodents.
    The CERHR convened an expert panel on January 24-26, 2007, 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 also identified data gaps 
and research needs. Prior to the meeting, CERHR solicited public 
comment on the draft expert panel report (Federal Register Vol. 71, No. 
199 pp. 60746-60748).
    Following receipt of public comments on the hydroxyurea expert 
panel report, CERHR staff will prepare the NTP-CERHR monograph. NTP-
CERHR monographs are divided into four major sections: (1) The NTP 
Brief which provides the NTP's interpretation of the potential for the 
chemical to cause adverse reproductive and/or developmental effects in 
exposed humans, (2) a roster of expert panel members, (3) the final 
expert panel report, and (4) public comments received on that report. 
The NTP Brief is based on the expert panel report, public comments on 
that report, public and peer review comments on the draft NTP Brief, 
and any new information that became available after the expert panel 
meeting.

Request for Comments

    CERHR invites written public comments on the hydroxyurea expert 
panel report. Written comments should be sent to Dr. Michael Shelby at 
the address provided above. 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). All comments received will be posted 
on the CERHR website and will be included in the NTP-CERHR monograph on 
hydroxyurea. The NTP will consider all public comments during 
preparation of the NTP Brief.

Background Information on CERHR

    The NTP established CERHR in June 1998 [Federal Register, December 
14, 1998 (Vol. 63, No. 239, pp. 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. Expert panels conduct scientific 
evaluations of agents selected by CERHR in public forums.
    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 Web site (http://cerhr.niehs.nih.gov) or by 
contacting Dr. Shelby (see ADDRESSES above). 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 notice July 16, 2001 (Vol. 66, No. 
136, pp 37047-37048) and is available on the CERHR Web site under 
``About CERHR'' or in printed copy from CERHR.

    Dated: February 12, 2007.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E7-3151 Filed 2-23-07; 8:45 am]
BILLING CODE 4140-01-P