[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]
BILLING CODE 4140-01-P