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Notice

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

Document Details

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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AGENCY:

National Institute for Environmental Health Sciences (NIEHS); National Institutes of Health (NIH).

ACTION:

Announcement of report availability and request for comment.

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.

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FOR FURTHER INFORMATION CONTACT:

Dr. Michael D. Shelby, CERHR Director, 919-541-3455, shelby@niehs.nih.gov.

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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 Start Printed Page 12708and 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.

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Dated: March 7, 2005.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

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[FR Doc. 05-5083 Filed 3-14-05; 8:45 am]

BILLING CODE 4140-01-P