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, 12707-12708 [05-5083]

Download as PDF Federal Register / Vol. 70, No. 49 / Tuesday, March 15, 2005 / Notices Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Mark P. Rubert, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1775, rubertm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, E coli Gene Regulation. Date: April 7, 2005. Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Alexander D. Politis, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD 20892, 301–435– 1150, politisa@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel, Innovations in Biomedical Computational Science and Technology. Date: April 13, 2005. Time: 10 a.m. to 1 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Christopher Sempos, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3146, MSC 7770, Bethesda, MD 20892, 301–451– 1329, semposch@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: March 8, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–5080 Filed 3–14–05; 8:45 am] BILLING CODE 4140–01–M 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 National Institute for Environmental Health Sciences AGENCY: VerDate jul<14>2003 15:31 Mar 14, 2005 Jkt 205001 (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 (https:// 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) PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 12707 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 E:\FR\FM\15MRN1.SGM 15MRN1 12708 Federal Register / Vol. 70, No. 49 / Tuesday, March 15, 2005 / Notices 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 (https://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] BILLING CODE 4140–01–P Territory of American Samoa (FEMA– 1582-DR), dated February 18, 2005, and related determinations. EFFECTIVE DATE: March 3, 2005. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646–2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the Territory of American Samoa is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of February 18, 2005: Manu’a Islands for Individual Assistance and Categories C through G under the Public Assistance program (already designated for debris removal (Category A) and emergency protective measures (Category B), including direct Federal assistance under the Public Assistance program.) The Territory of American Samoa for Crisis Counseling under the Individual Assistance program (already designated for debris removal (Category A) and emergency protective measures (Category B), including direct Federal assistance under the Public Assistance program.) (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households ProgramOther Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) Michael D. Brown, Under Secretary, Emergency Preparedness and Response, Department of Homeland Security. [FR Doc. 05–5050 Filed 3–14–05; 8:45 am] BILLING CODE 9110–10–P DEPARTMENT OF HOMELAND SECURITY DEPARTMENT OF HOMELAND SECURITY [FEMA–1582–DR] Federal Emergency Management Agency American Samoa; Amendment No. 2 to Notice of a Major Disaster Declaration [FEMA–1578–DR] Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security. ACTION: Notice. Kentucky; Amendment No. 1 to Notice of a Major Disaster Declaration AGENCY: SUMMARY: This notice amends the notice of a major disaster declaration for the 15:31 Mar 14, 2005 Jkt 205001 Marshall County for Public Assistance. Marshall County for emergency protective measures (Category B) under the Public Assistance program for a period of 48 hours. Lyon County for emergency protective measures (Category B) under the Public Assistance program for a period of 48 hours (already designated for Public Assistance). (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individual and Household Housing; 97.049, Individual and Household Disaster Housing Operations; 97.050 Individual and Household ProgramOther Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) Michael D. Brown, Under Secretary, Emergency Preparedness and Response, Department of Homeland Security. [FR Doc. 05–5051 Filed 3–14–05; 8:45 am] BILLING CODE 9110–10–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Federal Emergency Management Agency VerDate jul<14>2003 SUMMARY: This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA– 1578–DR), dated February 8, 2005, and related determinations. EFFECTIVE DATE: March 7, 2005. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646–2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of February 8, 2005: Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security. ACTION: Notice. AGENCY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Proposed Low-Effect Habitat Conservation Plan for Southern California Edison Etiwanda-Miraloma Transmission Line Reconductor Project, Riverside and San Bernardino Counties, CA Fish and Wildlife Service, Interior. ACTION: Notice of availability; receipt of application. AGENCY: SUMMARY: Southern California Edison (applicant) has applied to the U.S. Fish and Wildlife Service (Service) for a 5year incidental take permit for two E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 (https://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 (https://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]
BILLING CODE 4140-01-P

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