[Federal Register Volume 69, Number 83 (Thursday, April 29, 2004)]
[Notices]
[Pages 23517-23518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9736]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program (NTP); National Institute of
Environmental Health Sciences; The NTP Center for the Evaluation of
Risks to Human Reproduction (CERHR) Expert Panel Report on the
Developmental and Reproductive Toxicity of Fluoxetine: Notice of
Availability and Request for Public Comments
SUMMARY: Notice is hereby given of the availability on April 19, 2004,
of the Expert Panel Report on the Developmental and Reproductive
Toxicity of Fluoxetine. This report includes the summaries and
conclusions of the expert panel's evaluation of the scientific data for
potential reproductive and/or developmental hazards associated with
exposure to fluoxetine. The CERHR held this expert panel meeting March
3-5, 2004. CERHR is seeking public comment on this report and
additional information about recent, relevant toxicology or human
exposure studies.
Availability of Reports
This expert panel report will be available by April 19, 2004 on the
CERHR Web site (http://cerhr.niehs.nih.gov) and in printed copy or
compact disc by contacting the CERHR [P.O. Box 12233, MD EC-32,
Research Triangle Park, NC 27709; telephone: (919) 541-3455; fax: (919)
316-4511; or e-mail: [email protected]].
Request for Public Comments
The CERHR invites public comments on this expert panel report and
input regarding any recent, relevant toxicology or human exposure
studies. The CERHR requests that all comments and other information be
submitted to the CERHR at the address above by June 17, 2004.
All public comments received by the date above will be reviewed and
included in the final NTP-CERHR monograph on fluoxetine to be prepared
by NTP staff. The NTP-CERHR monograph will include the NTP brief,
expert panel report, and all public comments received on the report.
The brief will provide the NTP's interpretation of the potential for
adverse reproductive and/or developmental effects to humans from
exposure to fluoxetine. The NTP-CERHR monograph will be sent to
appropriate federal agencies and will be available to the public and
the scientific community on the CERHR web site, in hardcopy, or on
compact disk.
Background
Fluoxetine hydrochloride (Prozac[reg]; SarafemTM), an
antidepressant, is a widely prescribed drug in the United States. The
CERHR selected fluoxetine for evaluation because of (1) sufficient
reproductive and developmental studies, (2) sufficient human exposure
information, (3) changing prescription patterns, and (4) public concern
about potential reproductive and/or developmental hazards associated
with exposure. Fluoxetine hydrochloride, under the name
SarafemTM), is prescribed to treat premenstrual dysphoric
disorder (PMDD), potentially increasing the number of exposures for
women of childbearing age. Furthermore, the Food and Drug
Administration recently approved Prozac[reg]; for use in 7-17 year-olds
thereby increasing exposures of children.
A 12-member expert panel composed of scientists from the federal
government, universities, and private companies conducted an evaluation
of the reproductive and developmental toxicities of fluoxetine
hydrochloride (Federal Register Vol. 68, No. 216, pages 63122--63123,
November 2003). Public deliberations by the panel took place March 3-5,
2004, at the Holiday Inn Old Town Select in Alexandria, Virginia.
Following the March meeting, the draft expert panel report was revised
to incorporate the panel's conclusions and subsequently reviewed by
Fluoxetine Expert Panel, NTP scientists, and CERHR personnel.
Additional Information About CERHR
The NTP and the NIEHS established the NTP CERHR in June 1998
(Federal Register Vol. 63, No. 239, page 68782, December 1998). The
purpose of the CERHR is to provide scientifically based, uniform
assessments of the potential for adverse effects on reproduction and
development caused
[[Page 23518]]
by agents to which humans may be exposed. Further information on the
CERHR's chemical review process, including how to nominate chemicals
for evaluation and scientists for the expert registry, can be obtained
from its Web site (http://cerhr.niehs.nih.gov) or by contacting the
CERHR directly (see address above). The CERHR also serves as a resource
for information on various environmental exposures and their potential
to affect pregnancy and child development. The web site has information
about common concerns related to fertility, pregnancy and the health of
unborn children and links to other resources for information about
public health.
Dated: April 21, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-9736 Filed 4-28-04; 8:45 am]
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