[Federal Register Volume 68, Number 216 (Friday, November 7, 2003)]
[Notices]
[Pages 63122-63123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; The National Toxicology Program 
(NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR), 
Announces Availability of Draft Expert Panel Report on Fluoxetine and 
Expert Panel Meeting on Fluoxetine; Requests Public Comment on the 
Draft Report

SUMMARY: The NTP CERHR announces--
    (1) Availability of sections 1-4 of the draft expert panel report 
on fluoxetine and solicits written public comments on the report by 
January 6, 2004.
    (2) The fluoxetine expert panel meeting on March 3-5, 2004 at the 
Holiday Inn Old Town Select, Alexandria, Virginia and invites the 
public to present oral comments at this meeting.
    Questions about the draft expert panel report, submission of public 
comments, and the expert panel meeting should be directed to Dr. 
Michael Shelby, CERHR Director (contact information below).

Draft Expert Panel Report On Fluoxetine Available

    The CERHR announces the availability of the draft expert panel 
report on fluoxetine hydrochloride (Prozac[reg]; SarafemTM, 
CAS RN 59333-67-4; fluoxetine, CAS RN 54910-89-3). Fluoxetine, 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) 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 Sarafem 
TM, 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.
    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 written at 
expert panel meeting)

    Sections 1-4 will be available to the public by the publication 
date of this notice and can be obtained electronically on the CERHR Web 
site (http://cerhr.niehs.nih.gov) or in hard copy by contacting Dr. 
Michael Shelby, Director CERHR [NIEHS, 79 T.W. Alexander Drive, 
Building 4401, room 103, P.O. Box 12233, MD EC-32, Research Triangle 
Park, NC 27709, telephone: (919) 541-3455; facsimile: (919) 316-4511; 
[email protected]].

Request for Written Comments on Draft Expert Panel Report

    The CERHR invites written public comments on sections 1-4 of the 
draft expert panel report on fluoxetine. Comments can be submitted in 
hard copy or electronic format and must be received by the CERHR by 
January 6, 2004. These comments will be distributed to the expert panel 
and CERHR staff for consideration in revising the draft report and in 
preparing for the expert panel meeting. They will be posted on the 
CERHR website prior to the expert panel meeting. These 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,

[[Page 63123]]

telephone and facsimile numbers, e-mail, and sponsoring organization, 
if any).

Expert Panel Meeting Planned

    The CERHR will hold an expert panel meeting March 3-5, 2004, at the 
Holiday Inn Old Town Select, 480 King Street, Alexandria, VA 22314 
(telephone: 703-549-6080, facsimile: 684-6508). The CERHR has asked the 
expert panel to review the scientific evidence regarding the potential 
reproductive and/or developmental toxicity associated with exposure to 
fluoxetine. The expert panel will review and revise the draft expert 
panel report and reach conclusions regarding whether exposure to 
fluoxetine is a hazard to human development or reproduction. The expert 
panel will also identify data gaps and research needs.
    This meeting is open to the public and attendance is limited only 
by the available meeting room space. The meeting will begin at 8:30 
a.m. each day. On March 3 and 4, it is anticipated that a lunch break 
will occur from noon-1 p.m. and that the meeting will adjourn 5-6 p.m. 
The meeting is expected to adjourn by noon on March 5; 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. Following the expert panel meeting and 
completion of the expert panel report, the CERHR will post the report 
on its website and solicit public comment through a Federal Register 
notice.

Preliminary Meeting Agenda

Meeting begins at 8:30 a.m. each day
Lunch break anticipated from noon-1 p.m.

March 3, 2004

Opening remarks
Oral public comments (7 minutes per speaker; one representative per 
group, see below)
Review of sections 1-4 of the draft expert panel report on fluoxetine
Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs

March 4, 2004

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs
Preparation of draft summaries and conclusion statements

March 5, 2004

Presentation, discussion of, and agreement on summaries and conclusions
Closing comments

Oral Public Comments Welcome at Expert Panel Meeting

    Time is set-aside on March 3, 2004, for the presentation of oral 
public comments at the expert panel meeting. To facilitate planning, 
those persons wishing to make oral public comments are asked to contact 
Dr. Shelby by February 25 (contact information provided above). 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, also send a 
copy of the statement or talking points to Dr. Shelby by February 25. 
This information 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 March 3, 2004 (7:30-8:30 a.m.). Those 
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.

Fluoxetine Expert Panel

    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 this 
review.

Expert Panel Members and Affiliation

Ronald Hines, Ph.D., Chair, Medical College of Wisconsin, Milwaukee, WI
Jane Adams, Ph.D., University of Massachusetts, Boston, MA
Germaine M. Buck, Ph.D., National Institute of Child Health and Human 
Development Rockville, MD
Willem Faber, Ph.D., WFT Consulting, LLC, Victor, NY
Joseph F. Holson, Ph.D., WIL Research Laboratories, Inc., Ashland, OH
Sandra W. Jacobson, Ph.D., Wayne State University School of Medicine, 
Detroit, MI
Martin Keszler, M.D., Georgetown University Hospital, Washington, DC
Robert Taylor Segraves, M.D., Ph.D., MetroHealth Medical Center, 
Cleveland, OH
Lynn T. Singer, Ph.D., Case Western Reserve University, Cleveland, OH
I. Glen Sipes, Ph.D., University of Arizona, Tucson, AZ
Kennth McMartin, Ph.D., Louisiana State University, Shreveport, LA
Paige L. Williams, Ph.D., Harvard School of Public Health, Boston, MA

Background Information on the CERHR

    The NTP established the NTP CERHR in June 1998 [Federal Register, 
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 Home page (http://cerhr.niehs.nih.gov) 
or by contacting Dr. Shelby (contact information provided above). The 
CERHR selects chemicals for evaluation based upon several factors 
including production volume, extent of human exposure, public concern, 
and published evidence of reproductive or developmental toxicity.
    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 (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 31, 2003.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 03-28042 Filed 11-6-03; 8:45 am]
BILLING CODE 4140-01-P