[Federal Register Volume 68, Number 73 (Wednesday, April 16, 2003)]
[Notices]
[Pages 18666-18667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program (NTP) Board of Scientific Counselors 
Technical Reports Review Subcommittee Meeting; Review of Draft NTP 
Technical Reports

    Pursuant to Pub. L. 92-463, notice is hereby given of the next 
meeting of the NTP Board of Scientific Counselors Technical Reports 
Review Subcommittee on May 22, 2003 in the Rodbell Auditorium, Rall 
Building, South Campus, National Institute of Environmental Health 
Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, 
North Carolina. The meeting will begin at 8:30 a.m.

Agenda

    The primary agenda topic is the peer review of six draft NTP 
Technical Reports of rodent toxicology and carcinogenesis studies 
conducted by the NTP. The reports are listed in the table below in the 
tentative order of their review. There will be a brief presentation 
describing the p53 (+/-) and the p16 (+/-) haploinsufficient transgenic 
mouse models for short-term cancer bioassays prior to the reviews of 
the aspartame and acesulfame potassium reports.
    The agenda and roster of Subcommittee members will be available 
prior to the meeting on the NTP Web homepage at http://ntp-server.niehs.nih.gov and upon request to the NTP Executive Secretary, 
Dr. Mary S. Wolfe, PO Box 12233, 111 T.W. Alexander Dr., MD A3-01, 
Research Triangle Park, NC 27709, T: 919-541-0530; F: 919-541-0295; e-
mail: [email protected]. Following the meeting, summary minutes will 
be available on the NTP Web site and in hard copy upon request to the 
Executive Secretary. Plans are underway for making this meeting 
available for viewing on the Internet (http://www.niehs.nih.gov/external/video.htm).
    The NTP Board of Scientific Counselors Technical Reports Review 
Subcommittee meeting is open to the public. Attendance at this meeting 
is limited only by the space available. Individuals who plan to attend 
are asked to register with the NTP Executive Secretary (see contact 
information above). The names of those registered will be given to the 
NIEHS Security Office in order to gain access to the campus. Persons 
attending who have not pre-registered may be asked to provide pertinent 
information about the meeting, i.e., title or host of meeting before 
gaining access to the campus. All visitors (whether or not you are pre-
registered) will need to be prepared to show 2 forms of identification 
(ID) (e.g., driver's license, government ID). Persons needing special 
assistance, such as sign language interpretation or other reasonable 
accommodation in order to attend, are asked to notify the NTP Executive 
Secretary at least seven business days in advance of the meeting (see 
contact information above).

Draft Reports Available for Public Review and Comment

    Approximately one month prior to the meeting, the draft reports 
will be available for public review, free of charge, through ehpOnline 
(http://ehp.niehs.nih.gov). Printed copies of the draft NTP Technical 
Reports can be obtained, as available, from Central Data Management 
(CDM), NIEHS, PO Box 12233, MD EC-03, Research Triangle Park, NC 27709, 
T: 919-541-3419, F: 919-541-3687, e-mail: [email protected].
    Comments on any of the NTP Technical Reports are welcome. Time will 
be provided at the meeting for oral public comment on the reports. 
Persons requesting time for an oral presentation on a particular report 
are asked to notify the Executive Secretary (contact information given 
above) by May 14, 2003 and provide their contact information (name, 
affiliation, mailing address, phone, fax, e-mail), and supporting 
organization (if any). Persons registering to make comments are asked 
to provide a written copy of their statement to the Executive Secretary 
on or before May 14, 2003, to enable review by the Subcommittee and NTP 
staff prior to the meeting. These statements can supplement or expand 
an oral presentation. Each speaker will be allotted at least 7 minutes 
and, if time permits, up 10 minutes for presentation of oral comments. 
Each organization is allowed one time slot per report being reviewed. 
Registration for making public comments will also be available on-site. 
If registering on-site to speak and reading comments from printed text, 
the speaker is asked to provide 25 copies of the statement. These 
copies will be distributed to the Subcommittee and NTP staff and will 
supplement the record.
    Written comments without an oral presentation at the meeting are 
also welcome. Comments should include contact information for the 
submitter (name, affiliation, mailing address, phone, fax, and e-mail) 
and supporting organization (if any). Written comments should be 
received by the Executive Secretary on or before May 14, 2003, to 
enable distribution to the Subcommittee and NTP staff for their review 
and consideration prior to the meeting.

Request for Additional Information

    The NTP would welcome receiving toxicology and carcinogenesis 
information from completed, ongoing or planned studies as well as 
current production data, human exposure information, and use patterns 
for any of the chemicals listed in this announcement. Please send this 
information to CDM at the address given above. CDM will forward the 
information to the appropriate NTP staff scientist.

NTP Technical and Toxicity Report Series

    The NTP conducts toxicology and carcinogenesis studies of agents of 
public health concern. Any scientist, organization, or member of the 
public may nominate a chemical for NTP testing. Details about the 
nomination process are available on the NTP Web site (http://ntp-server.niehs.nih.gov, select How to Nominate Substances). The results 
of short-term rodent toxicology studies are published in the NTP 
Toxicity Report series. Longer-term studies, generally, rodent 
carcinogenicity studies, are published in the NTP Technical Report 
series. Shorter-term carcinogenicity studies will appear in a new 
Technical Report Series being unveiled at the upcoming meeting. The 
studies of aspartame and acesulfame potassium will be the first two 
studies reported in the new series. Study abstracts for all reports are 
available at the NTP Web site under NTP Study Information. PDF files of 
completed reports are available free-of-charge from ehpOnline under 
Publications and hard copies of published reports can be obtained 
through subscription to ehpOnline (http://ehp.niehs.nih.gov/ contact 
information: T: 919-653-2595 or 866-541-3841, e-mail: 
[email protected]).

NTP Board of Scientific Counselors

    The NTP Board of Scientific Counselors (``the Board'') is a 
technical advisory body composed of scientists from the public and 
private sectors who provide primary scientific oversight and

[[Page 18667]]

peer review to the NTP. Specifically, the Board advises the NTP on 
matters of scientific program content, both present and future, and 
conducts periodic review of the program for the purpose of determining 
and advising on the scientific merit of its activities and overall 
scientific quality. The Technical Reports Review Subcommittee of the 
Board provides scientific peer review of the findings and conclusions 
of NTP Technical Reports. The Report on Carcinogens Subcommittee of the 
Board provides scientific peer review of nominations to the Report on 
Carcinogens, a Congressionally mandated listing of agents known or 
reasonably anticipated to be human carcinogens.
    The Board's members are selected from recognized authorities 
knowledgeable in fields such as toxicology, pharmacology, pathology, 
biochemistry, epidemiology, risk assessment, carcinogenesis, 
mutagenesis, molecular biology, behavioral toxicology, neurotoxicology, 
immunotoxicology, reproductive toxicology or teratology, and 
biostatistics. The NTP strives for equitable geographic distribution 
and for minority and female representation on the Board.

    Dated: April 8, 2003.
Kenneth Olden,
Director, National Toxicology Program.

 National Toxicology Program (NTP) Technical Reports Tentatively Scheduled for Review by the NTP Board of Scientific Counselors Technical Reports Review
                   Subcommittee on May 22, 2003 at the National Institute of Environmental Health Sciences, Research Triangle Park, NC
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                                                                                                                                                  Review
            Chemical CAS number                  Report number                       Primary uses                    Route and exposure levels    order
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Propylene Glycol Mono-t-butyl Ether 57018-  TR 515                  Solvent......................................  Two-year study by inhalation        1
 52-7.                                                                                                              0, 75, 300, or 1,200 ppm in
                                                                                                                    air to F344/N rats and
                                                                                                                    B6C3F1 mice.
2-Methylimidazole 693-98-1................  TR 516                  Chemical and pharmaceutical intermediate.....  Two-year study by feed 0,           2
                                                                                                                    300, 1,000, or 3,000 ppm to
                                                                                                                    male F344/N rats 0, 1,000,
                                                                                                                    2,500 or 5,000 ppm to
                                                                                                                    female F344/N rats 0, 625,
                                                                                                                    1,250, or 2,500 ppm to male
                                                                                                                    and female B6C3F1 mice.
Triethanolamine 102-71-6..................  TR 518                  Large variety of industrial and manufacturing  Two-year dermal study 0,            3
                                                                     applications.                                  200, 630, or 2,000 mg/kg to
                                                                                                                    male B6C3F1 mice and 0,
                                                                                                                    100, 300, or 1,000 mg/kg to
                                                                                                                    female B6C3F1 mice.
Stoddard Solvent IIC 64742-88-7...........  TR 519                  Paint and dry cleaning solvent...............  Two-year study by inhalation        4
                                                                                                                    0, 550, 1,100, or 2,200 mg/
                                                                                                                    cubic meter in air to F344/
                                                                                                                    N rats and B6C3F1 mice.
Aspartame 22839-47-0......................  NEW 01                  Artificial sweetener.........................  Nine-month study by feed 0,         5
                                                                                                                    3,125, 6,250, 12,500,
                                                                                                                    25,000, or 50,000 ppm to
                                                                                                                    p53 (+/-) haploinsufficient
                                                                                                                    mice.
Acesulfame Potassium 55589-62-3...........  NEW 02                  Artificial sweetener.........................  Nine-month study by feed 0,         6
                                                                                                                    0.3%, 1%, or 3% to p53 (+/-
                                                                                                                    ) haploinsufficient mice.
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[FR Doc. 03-9283 Filed 4-15-03; 8:45 am]
BILLING CODE 4140-01-P