[Federal Register: March 15, 2005 (Volume 70, Number 49)]
[Notices]
[Page 12707-12708]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr05-111]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP); Center for the Evaluation of
Risks to Human Reproduction (CERHR); Availability of the Expert Panel
Reports on Amphetamines and Methylphenidate; Request for Public
Comments
AGENCY: National Institute for Environmental Health Sciences (NIEHS);
National Institutes of Health (NIH).
ACTION: Announcement of report availability and request for comment.
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SUMMARY: The CERHR announces the availability of the final expert panel
reports on amphetamines and on methylphenidate on March 21, 2005, from
the CERHR Web site (http://cerhr.niehs.nih.gov) or in printed text from
the CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR
invites the submission of public comments on these expert panel reports
(see SUPPLEMENTARY INFORMATION below). The expert panel reports are
evaluations on the reproductive and developmental toxicities of
amphetamines and methylphenidate conducted by a 13-member expert panel
composed of scientists from the Federal government, universities, and
private companies. The CERHR previously solicited public comment on
draft versions of each expert panel report (Federal Register volume 69,
number 208, pages 62906-62907). Public deliberations by the panel took
place on January 10-12, 2005, at the Holiday Inn Old Town Select
Alexandria, Virginia to review and revise the draft expert panel
reports and reach conclusions regarding whether exposure to
amphetamines or methylphenidate is a hazard to human development or
reproduction. The expert panel also identified data gaps and research
needs. The final revisions on these reports have been reviewed for
accuracy of content and presentation by the amphetamines and
methylphenidate expert panel, NTP scientists, and CERHR personnel.
DATES: The final expert panel reports on amphetamines and
methylphenidate will be available for public comment on March 21, 2005.
Written public comments on these reports must be received by May 5,
2005.
ADDRESSES: Comments on the expert panel reports should be sent to Dr.
Michael D. Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-32,
Research Triangle Park, NC 27709 (mail), (919) 316-4511 (fax), or
shelby@niehs.nih.gov (e-mail). Courier address: CERHR, 79 T.W.
Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC
27709.
FOR FURTHER INFORMATION CONTACT: Dr. Michael D. Shelby, CERHR Director,
919-541-3455, shelby@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
The National Toxicology Program (NTP) Center for the Evaluation of
Risks to Human Reproduction (CERHR) convened an expert panel on January
10-12, 2005. The purpose of this meeting was to evaluate the scientific
evidence regarding the potential reproductive and/or developmental
toxicities associated with exposure to the central nervous system
stimulants, amphetamines and methylphenidate. Amphetamines evaluated
were d- and d, l-amphetamine and methamphetamine. Amphetamine is
indicated for the treatment of attention deficit hyperactivity disorder
(ADHD) and narcolepsy and methamphetamine is indicated for the
treatment of ADHD and for short-term treatment of obesity.
Methylphenidate 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. 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 effect of these
stimulants on child development.
Following receipt of public comments on the amphetamines and
methylphenidate final expert panel reports, CERHR staff will prepare
NTP-CERHR monographs for each of these compounds. NTP-CERHR monographs
are divided into four major sections: (1) The NTP Brief which provides
the NTP's interpretation of the potential for the chemical to cause
adverse reproductive and/or developmental effects in exposed humans,
(2) a roster of expert panel members, (3) the final expert panel
report, and (4) any public comments received on that report. The NTP
brief is based on the expert panel report, public comments on that
report, and any new information that became available after the expert
panel meeting.
Request for Comments
The CERHR invites written public comments on the amphetamines
expert panel report and the methylphenidate expert panel report. The
CERHR will post all comments received on the CERHR Web site and include
them as an appendix in the NTP-CERHR monographs for these chemicals.
All public comments will be considered by the NTP during preparation of
the NTP Brief described above under ``Background.''
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
[[Page 12708]]
and facsimile numbers, e-mail, and sponsoring organization, if any).
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 (see FOR FURTHER INFORMATION CONTACT
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. NTP-CERHR
monographs are available on the CERHR Web site or in hard copy or CD
from the CERHR.
Dated: March 7, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-5083 Filed 3-14-05; 8:45 am]
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