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Notice

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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Summary

The NTP CERHR announces:

(1) The availability of sections 1-4 of the draft expert panel reports for amphetamines and methylphenidate on November 15, 2004. Written public comments on the draft report must be received by December 29, 2004.

(2) The expert panel meeting for amphetamines and methylphenidate will be held on January 10-12, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia. The public is invited to present oral comments at this meeting.

Questions and public comments should be directed to Dr. Michael Shelby, CERHR Director (contact information below).

Draft Expert Panel Reports on Amphetamines and Methylphenidate Available

The CERHR announces the availability of the draft expert panel reports on amphetamines and methylphenidate on November 15, 2004 on the CERHR Web site (http://cerhr.niehs.nih.gov) or in printed text from the CERHR (contact information below). Amphetamines and methamphetamine are central nervous system stimulants. Amphetamine is indicated for the treatment of narcolepsy and attention deficit hyperactivity disorder (ADHD), and methamphetamine is indicated for the treatment of ADHD and for short-term treatment of obesity. These chemicals are available for pharmaceutical use as various salts and enantiomer preparations. The most common proprietary amphetamine preparation is Adderall®, a mixture of d- and l-amphetamine salts in a 3:1 ratio. d-Methamphetamine is used in pharmaceutical preparations in the United States and is also manufactured and used as an illicit drug. Methylphenidate (CAS RN 298-59-9) is a central nervous system stimulant approved by the Food and Drug Administration for the treatment of ADHD and narcolepsy in persons six years and older. d, l-Methylphenidate is marketed under the names Ritalin®, Metadate®, Methylin®, and Concerta®. The d-enantiomer is marketed under the name FocalinTM. The CERHR selected amphetamines and methylphenidate for expert panel evaluation because of widespread usage in children, availability of developmental studies in children and experimental animals, and public concern about the effects of these stimulants on child 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)

Sections 1-4 will be available to the public by the November 15th in PDF format on the CERHR Web site (http://cerhr.niehs.nih.gov) or in hard copy or as a PDF file on compact disk by contacting Dr. Michael Shelby, Director CERHR [NIEHS, 79 T.W. Alexander Drive, Building 4401, Room 103, PO 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 reports on amphetamines and methylphenidate. Comments can be submitted in hard copy or electronic format and must be received by the CERHR on or before December 29, 2004. Any comments received by this date 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 reports and in preparing for the expert panel meeting. Written 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 January 10-12, 2005, at the Holiday Inn Old Town Select 480 King Street, Alexandria, VA 22314 (telephone: 703-549-6080, facsimile: 703-684-6508). The expert panel will review the scientific evidence regarding Start Printed Page 62907the potential reproductive and/or developmental toxicity associated with exposure to amphetamines and methylphenidate. The expert panel will review and revise the draft expert panel report and reach conclusions regarding whether exposure to amphetamines and/or methylphenidate 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 January 10 and 11, it is anticipated that a lunch break will occur from noon-1 p.m. and the meeting will adjourn 5-6 p.m. The meeting is expected to adjourn by noon on January 12; 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 web site and solicit public comment on it through a Federal Register notice.

Preliminary Meeting Agenda

Meeting begins at 8:30 am each day

Lunch break anticipated from noon-1 p.m.

January 10, 2005

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 reports on amphetamines and methylphenidate

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs

January 11, 2005

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs

Preparation of draft summaries and conclusion statements

January 12, 2005

Presentation, discussion of, and agreement on summaries and conclusions

Closing comments

Oral Public Comments Welcome at Expert Panel Meeting

Time is set-aside on January 10, 2005, 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 January 5 (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, email and sponsoring organization (if any). If possible, also send a copy of the statement or talking points to Dr. Shelby by January 5. 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 10, 2005 from 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.

Amphetamines and Methylphenidate 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

Mari S. Golub, Ph.D., Chair, University of California, Davis, CA

Lucio G. Costa, Ph.D., University of Washington, Seattle, WA

Kevin M. Crofton, Ph.D., U.S. Environmental Protection Agency Research, Triangle Park, NC

Deborah A. Frank, M.D., Boston Medical Center, Boston, MA

Peter A. Fried, Ph.D., Carleton University, Ottawa, Ontario, Canada

Beth C. Gladen, Ph.D., National Institute of Environmental Health Sciences Research, Triangle Park, NC

Rogene F. Henderson, Ph.D., Lovelace Respiratory Research Institute, Albuquerque, NM

Erica L. Liebelt, M.D., University of Alabama School of Medicine, Birmingham, AL

Shari I. Lusskin, M.D., New York University School of Medicine, New York, NY

M. Sue (Pahl) Marty, Ph.D., The Dow Chemical Company, Midland, MI

Andrew S. Rowland, Ph.D., University of New Mexico, Albuquerque, NM

John Vincent Scialli, M.D., Consultant & Private Practice, Phoenix, AZ

Mary Vore, Ph.D., University of Kentucky, Lexington, KY

Background Information About 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 web site under “About CERHR” or in printed copy from the CERHR.

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Dated: October 18, 2004.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

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[FR Doc. 04-24088 Filed 10-27-04; 8:45 am]

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