[Federal Register Volume 63, Number 9 (Wednesday, January 14, 1998)]
[Notices]
[Pages 2255-2256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-901]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program; Board of Scientific Counselors'
Meeting
Pursuant to Public Law 92-463, notice is hereby given of a meeting
of the National Toxicology Program (NTP) Board of Scientific
Counselors, U.S. Public Health Service, in the Conference Center,
Building 101, South Campus, National Institute of Environmental Health
Sciences (NIEHS), 111 Alexander Drive, Reserve Triangle Park, North
Carolina, on February 5 and 6, 1998.
Agenda
The meeting will be open to the public from 8:45 a.m. to 4:00 p.m.
on February 5, and from 8:45 a.m. to adjournment on February 6, with
attendance limited only by space available. The primary agenda topic on
February 5 will be a comprehensive evaluation of the strategies for use
of transgenic mouse models in bioassays for carcinogenesis. Included
will be an introduction, history and rationale for using transgenic
animals to identify carcinogens, sharing of results from three mouse
models--p53def, Tg.AC, and rasH2--, NTP strategies for
evaluating models, utility of transgenic model results for risk
assessment, and regulatory agency perspectives. There are four issues
that the Board will be asked to advise the NTP on, being: (1) Is the
NTP approach to evaluation and validation of transgenic models for use
in cancer bioassays sufficient and appropriate?;?; (2) How can existing
models be best utilized? What are their limitations?; (3) What new
models are needed, i.e., should the NTP seek to develop organ-specific
tumor models; and (4) Are the scientific needs of regulatory agencies
being adequately addressed? Background materials pertaining to the
evaluation of transgenic models will be available on request from the
Executive Secretary after January 12, 1998.
Among several agenda topics on February 6 will be a discussion of
and opportunity for public comment on chemicals nominated for NTP
studies that were reviewed by the NTP Interagency Committee for
Chemical Evaluation and Coordination on August 15, 1997, and December
11, 1997. The Committee recommended nine chemicals and four mixtures
for toxicological studies, recommended four chemicals be deferred for
additional information, and recommended six chemicals not be studied.
The chemicals/classes with CAS Nos. in parentheses are--Recommended for
Study: (1) 2-Acetylpyridine (1122-62-9); (2) Asphalt Fumes (8052-42-4);
(3) 2-Chloropyridine (109-09-1); (4) Comfrey (72698-57-8) with
Symphytine (22571-95-5); (5) Glycoluril (496-46-8); (6) Goldenseal (--)
containing Berberine (2086-83-1) and Hydrastine (118-08-1); (7) Luminol
(o--Aminophthalic Hydrazide) (521-31-3); (8) 4-Methoxy-N-methyl-1,8--
naphthalimide (3271-05-4); (9) Myristicin (607-91-0); (10) 7-(2H-
Naphthol[1,2-d] triazol-2-yl)-3-phenylcoumarin; (11) Orthanilic Acid
(88-21-1); (12) Phenothiazine (92-84-2); and (13) Saw Palmetto
containing -Sitosterol (83-46-5). The chemicals for which No
Study is Recommended are: (1) trans-1,4-Dichloro-2-butene; (2)
Dicyclopentadiene (77-73-6); (3) C.I. Direct Black 80 (8003-69-8); (4)
Ethyl Cyanoacrylate (7085-85-0); (5) Isoamyl Acetate; and (6) 2,4,6-
Tribromophenol. Chemicals Deferred for Additional Information are: (1)
3-Amino-5-mercapto-1,2,4-triazole (16691-43-3); (2) Diethylamine (109-
89-7); (3) Isopropylamine (75-31-0); and (4) Triethylamine (121-44-8).
[[Page 2256]]
Also, on February 6 will be reports of recent meetings of the
Report on Carcinogens and Technical Reports Review Subcommittees. The
Board will review concept proposals on (1) genetic susceptibility of
the pregastrulation embryo to environmental exposures, (2) molecular
detection of aneuploidy in rodent germ cells, and (3) pathology support
for the National Toxicology Program.
Public Input Encouraged
In order to facilitate planning for the meeting, persons wanting to
make a formal presentation during the public comment period must notify
the Executive Secretary, Dr. Larry G. Hart, P.O. Box 12233, Research
Triangle Park, NC 27709 (telephone 919/541-3971; FAX 919/541-0295; or
email at hart@niehs.nih.gov) by no later than February 2, 1997, and, if
possible, provide a written copy in advance of the meeting. Written
statements should supplement and may expand on the oral presentation,
or may be submitted in lieu of an oral presentation, and should be
received by February 2 so copies can be made for distribution to
Subcommittee members, staff, and the public. Oral presentations should
be limited to no more than five minutes.
The Executive Secretary will furnish agenda and a roster of Board
members and ad hoc expert reviewers prior to the meeting. Summary
minutes subsequent to the meeting will be available upon request.
Dated: January 7, 1998.
Samuel H. Wilson,
Deputy Director, National Toxicology Program.
[FR Doc. 98-901 Filed 1-13-98; 8:45 am]
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