[Federal Register Volume 71, Number 199 (Monday, October 16, 2006)]
[Notices]
[Pages 60746-60748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17137]


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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.

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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 [email protected] 
(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, [email protected].

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,

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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]
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