[Federal Register: October 28, 2004 (Volume 69, Number 208)]
[Notices]
[Page 62906-62907]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc04-74]
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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;
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
[[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]
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