[Federal Register Volume 69, Number 208 (Thursday, October 28, 2004)]
[Notices]
[Pages 62906-62907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24088]


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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 Reports on Amphetamines 
and Methylphenidate and Expert Panel Meeting; Requests Public Comments 
on the Draft Reports

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[reg], 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[reg], Metadate[reg], Methylin[reg], and Concerta[reg]. The d-
enantiomer is marketed under the name Focalin\TM\. 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; 
[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 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

[[Page 62907]]

the 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.

    Dated: October 18, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-24088 Filed 10-27-04; 8:45 am]
BILLING CODE 4140-01-P