National Toxicology Program

[Federal Register: November 7, 2003 (Volume 68, Number 216]
[Notices]
[Pages 63122 - 63123]

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®; Sarafem™, 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™, 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® 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 website (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; shelby@niehs.nih.gov].

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, 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 - 1:00 p.m. and that the meeting will adjourn 5 - 6:00 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 - 1:00 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

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 homepage (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 website under "About CERHR" or in printed copy from the CERHR.

Dated: October 31, 2003

Samuel H. Wilson,
Deputy Director, National Institute Environmental Health Sciences

[Billing Code 4140-01-P]