[Federal Register Volume 70, Number 49 (Tuesday, March 15, 2005)]
[Notices]
[Pages 12707-12708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5083]


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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 
[email protected] (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, [email protected].

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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