Federal Register, Volume 63 Issue 9 (Wednesday, January 14, 1998)

[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--p53^def, 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 [email protected]) 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]
BILLING CODE 4140-01-M