[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17102-17103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP); Liaison and Scientific Review 
Office (LSRO); Announcement of National Toxicology Program (NTP) 
Workshop on ``Animal Models for the NTP Rodent Cancer Bioassay: Strains 
& Stocks--Should We Switch?''

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH).

ACTION: Meeting Announcement.

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SUMMARY: Over the past year, the National Toxicology Program (NTP) has 
developed and refined a vision for toxicology in the 21st century 
(``NTP Vision'') and a roadmap for implementing this vision (``NTP 
Roadmap'') that will strategically position the program at the 
forefront for providing scientific data and the interpretation of those 
data for public health decision-making (see SUPPLEMENTARY INFORMATION 
for additional detail). As part of the NTP Roadmap, the program will 
convene a series of public workshops to review aspects of the existing 
testing program. The first workshop is scheduled for June 16-17, 2005, 
at the NIEHS in Research Triangle Park, NC and will focus on evaluating 
stocks and strains currently used in the NTP rodent cancer bioassay in 
order to improve the ability of the bioassay to identify substances 
that may pose a carcinogenic hazard for humans. In particular, the goal 
of this workshop is to seek scientific input as to whether the NTP 
should continue to use both the F344 rat and B6C3F1 mouse models, use 
other strains, and/or use multiple strains as previously suggested 
(Festing, 1995). Future workshops will address other study design 
issues such as diet, length of study, and age at exposure. The NTP 
invites public comments on the appropriateness of the F344N and B6C3F1 
models currently used and the submission of historical control data for 
rodent models that the NTP might consider at the workshop. The program 
will include plenary sessions as well as three breakout group meetings 
for in-depth discussions of rat models, mouse models, and the multiple 
strain approach. Following the meeting, the NTP will prepare a workshop 
report and present its proposed testing strategy to the NTP Board of 
Scientific Counselors for their consideration and input.
    Attendance at the meeting is limited only by the space available. 
Members of the public may register to attend the workshop on a first-
come, first-served basis per the procedures outlined below. A copy of 
the agenda and any additional information on the workshop, including 
participants and background materials, will be posted on the NTP Web 
site when available (http://ntp.niehs.nih.gov select ``Meetings and 
Workshops'')

DATES: The workshop will be held June 16-17, 2005. The meeting will 
begin at 8:30 a.m. each day and end at 5 p.m. on June 16 and 
approximately 12 p.m. on June 17.
    Comments: Written comments and historical control data should be 
received by May 19, 2005, to enable review by NIEHS/NTP staff and 
workshop panelists prior to the meeting (see FOR FURTHER INFORMATION 
CONTACT below). The deadline for registration to present oral comments 
at the meeting is June 9, 2005.
    Registration: Individuals who plan to attend are strongly 
encouraged to register by June 9, 2005, in order to ensure access to 
the NIEHS campus (see FOR FURTHER INFORMATION CONTACT below). Persons 
needing special assistance, such as sign language

[[Page 17103]]

interpretation or other reasonable accommodation, in order to attend 
are asked to notify the NTP at least 7 business days in advance of the 
meeting.

ADDRESSES: The meeting will be held in the Rodbell Auditorium, Rall 
Building at the National Institute of Environmental Health Sciences, 
111 T.W. Alexander Drive, Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: Public comments, data submission and 
any other correspondence should be submitted to Dr. Angela King-Herbert 
(NIEHS, P.O. Box 12233, MD B3-06, Research Triangle Park, NC 27709; 
telephone: 919-541-3464, fax 919-541-7666; or e-mail: 
[email protected]).

SUPPLEMENTARY INFORMATION:

Background on the NTP Vision and Roadmap to Achieve the Vision

    The NTP was established in 1978 to coordinate toxicological testing 
programs within the Department of Health and Human Services, develop 
and validate improved testing methods, develop approaches and generate 
data to strengthen scientific knowledge about potentially hazardous 
substances and communicate with stakeholders. In its more than 25 years 
of existence, NTP has become a world leader in providing scientific 
information that improves our nation's ability to evaluate potential 
human health effects from chemical and physical exposures. The NTP 
maintains a number of complex, interrelated research and testing 
programs that provide unique and critical information needed by health 
regulatory and research agencies to protect public health.
    The last decade of the 20th century and the turn of the 21st 
century have produced dramatic technological advances in molecular 
biology and computer science. The NTP is ready to evaluate its key 
activities and, in a focused and concerted effort, determine how best 
to incorporate these new scientific technologies into its research and 
testing strategies and broaden scientific knowledge on the linkage 
between mechanism and disease. In August 2003, the NTP defined its 
vision for the 21st century and undertook a yearlong process to refine 
that vision and develop a roadmap for its implementation. The NTP 
Vision is to support the evolution of toxicology from a predominately 
observational science at the level of disease-specific models to a 
predominately predictive science focused upon a broad inclusion of 
target-specific, mechanism-based, biological observations. The NTP 
roadmap for implementation of the vision will strategically position 
the program at the forefront for providing scientific data and the 
interpretation of those data for public health decision-making. The NTP 
Roadmap was developed with input from numerous groups including its 
federal partners, its advisory committees, and the public. In carrying 
out the NTP Roadmap, the program plans to formally review the designs 
of NTP assays to determine whether protocol changes are needed. 
Additional information about the NTP Vision and Roadmap is available on 
its Web site (http://ntp.niehs.nih.gov/ntp select ``NTP Vision and 
Roadmap'').
    The NTP periodically conducts reviews of animal models used in the 
NTP cancer bioassay including recent evaluations on the use of fish and 
transgenic mouse models as alternative approaches (Board of Scientific 
Counselors, 2004; NTP Board of Scientific Counselors Technical Reports 
Review Subcommittee, 2003; Scientific Advisory Committee on Alternative 
Toxicological Methods, 2004). However, the last formal review of the 
NTP rodent bioassay occurred in August 1984 (Report of the Ad Hoc Panel 
on Chemical Carcinogenesis Testing and Evaluation of the NTP Board of 
Scientific Counselors, August 17, 1984). Although the NTP has expanded 
the breadth of its evaluation of individual agents and the number of 
endpoints critically assessed in the bioassay, the rodent cancer 
bioassay study design has been minimally modified over the past 30 
years. For this reason, the program intends to convene a series of 
workshops to evaluate the rodent cancer bioassay, beginning with choice 
of species and strain. Future workshops will address other study design 
issues, such as diet, study length, and age at exposure. The ultimate 
goal of any change to the NTP cancer bioassay is to improve the 
identification of carcinogenic potential (i.e., hazard identification) 
and/or improve our ability to predict cancer in humans.

Request for Comments

    Public input at this meeting is invited and time is set aside for 
the presentation of public comments on any agenda topic. Each 
organization is allowed one time slot per agenda topic. At least 7 
minutes will be allotted to each speaker, and if time permits, may be 
extended to 10 minutes. Registration for oral comments will also be 
available on-site, although time allowed for presentation by on-site 
registrants may be less then that for pre-registered speakers and will 
be determined by the number of persons who register at the meeting. 
Written statements can supplement and may expand the oral presentation. 
If registering on-site and reading from written text, please bring 40 
copies of the statement for distribution and to supplement the record. 
Written comments received in response to this notice will be posted on 
the NTP Web site (http://ntp.niehs.nih.gov select ``Meetings and 
Workshops'').
    Persons submitting written comments should include their name, 
affiliation, mailing address, phone, fax, e-mail, and sponsoring 
organization (if any) with the document. Individuals wishing to submit 
historical control data are encouraged to contact Dr. Angela King-
Herbert prior to submission (see FOR FURTHER INFORMATION CONTACT 
above).

References

    Festing, MF. (1995). Use of a multistrain assay could improve the 
NTP carcinogenesis bioassay. Environ Health Perspect. 1995 
Jan;103(1):44-52. Available: http://ehp.niehs.nih.gov/.
    Meeting Minutes of the NTP Board of Scientific Counselors (BSC)--
June 29, 2004. Available: http://ntp-server.niehs.nih.gov/ntpweb/index.cfm?objectid=720164F2-BDB7-CEBA-F5C6A2E21851F0C4.
    Meeting Minutes of the NTP Board of Scientific Counselors Technical 
Reports Review Subcommittee (TRR Subcommittee)--May 22, 2003. 
Available: http://ntp-server.niehs.nih.gov/ntpweb/index.cfm?objectid=9404F3B3-F1F6-975E-70F0DB8B0FDF8F86.
    Meeting Minutes of the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM)--March 10-11, 2004. Available: http://ntp-server.niehs.nih.gov/ntpweb/index.cfm?objectid=AF6CC417-F1F6-975E-75B5F3FF7DF1CDDC.

    Dated: March 22, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-6605 Filed 4-1-05; 8:45 am]
BILLING CODE 4140-01-P