[Federal Register Volume 70, Number 86 (Thursday, May 5, 2005)]
[Notices]
[Pages 23877-23881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program; Office of Chemical Nomination and 
Selection; Announcement of and Request for Public Comment on 
Toxicological Study Nominations to the National Toxicology Program

AGENCY: National Institute of Environmental Health Sciences, National 
Institutes of Health.

ACTION: Notice; request for comments.

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SUMMARY: The National Toxicology Program (NTP) continuously solicits 
and accepts nominations for toxicological studies to be undertaken by 
the program. Nominations of substances of potential human health 
concern are received from federal agencies, the public and other 
interested parties. These nominations are subject to several levels of 
review before selections for testing are made and toxicological studies 
are designed and implemented. This notice (1) provides brief background 
information and study recommendations regarding 15 nominations for NTP 
study (Table 1), (2) solicits public comment on the nominations and 
study recommendations, and (3) requests the submission of additional 
relevant information for consideration by the NTP in its continued 
evaluation of these nominations. An electronic copy of this 
announcement, Internet links to electronic versions of supporting 
documents for each nomination, and further information on the NTP and 
the NTP Study Nomination and Review Process can be accessed through the 
NTP Web site (http://ntp.niehs.nih.gov/; select ``Nominations to the 
Testing Program'').

DATES: Comments or information should be submitted by June 6, 2005.

ADDRESSES: Send comments or information to Dr. Scott A. Masten, Office 
of Chemical Nomination and Selection, NIEHS/NTP, 111 T.W. Alexander 
Drive, P.O. Box 12233, Research Triangle Park, North Carolina 27709; 
telephone: (919) 541-5710; FAX: (919) 541-3647; e-mail: 
[email protected]. Supporting documents for these nominations are 
available at the NTP Web site (http://ntp.niehs.nih.gov/ select 
``Nominations to the Testing Program'').

FOR FURTHER INFORMATION CONTACT: See contact information for Dr. Masten 
under ADDRESSES above.

SUPPLEMENTARY INFORMATION:

Background Information on NTP Study Nominations and the NTP Office of 
Chemical Nomination and Selection

    The NTP actively seeks to identify and select for study chemicals 
and other agents for which sufficient information is not available to 
adequately evaluate potential human health hazards. The NTP 
accomplishes this goal through a formal open nomination and selection 
process. Substances considered appropriate for study generally fall 
into two broad yet overlapping categories: (1) Substances judged to 
have high concern as possible public health hazards based on the extent 
of human exposure and/or suspicion of toxicity and (2) substances for 
which toxicological data gaps exist and additional studies would aid in 
assessing potential human health risks, e.g. by facilitating cross-
species extrapolation or evaluating dose-response relationships. 
Nominations are also solicited for studies that permit the testing of 
hypotheses to enhance the predictive ability of future NTP studies, 
address mechanisms of toxicity, or fill significant gaps in the 
knowledge of the toxicity of classes of chemical, biological, or 
physical substances.
    Study nominations may entail the evaluation of a variety of health-
related effects including, but not limited to, reproductive and 
developmental toxicity, genetic toxicity, immunotoxicity, 
neurotoxicity, metabolism and disposition, and carcinogenicity in 
appropriate experimental models. In reviewing and selecting nominations 
for study, the NTP also considers legislative mandates that require 
responsible private sector commercial organizations to evaluate their 
products for health and environmental effects. The possible human 
health consequences of anticipated or known human exposure, however, 
remain the over-riding factor in the NTP's decision to study a 
particular substance.
    Nominations undergo a multi-step, formal process of review. During 
the entire nomination review and selection process, the NTP works 
actively with regulatory agencies, its advisors, and interested parties 
to supplement information about nominated substances and ensure that 
regulatory and public health needs are addressed. The nomination review 
and selection process is accomplished through the participation of 
representatives from the National Institute of Environmental Health 
Sciences (NIEHS), other federal agencies represented on the Interagency 
Committee for Chemical Evaluation and Coordination (ICCEC), the NTP 
Board of Scientific Counselors--an external scientific advisory body, 
the NTP Executive Committee--the NTP federal interagency policy body, 
and the public. Study recommendations are initially developed and 
refined by the nominator, NTP staff, and the ICCEC. Individual study 
recommendations for the nominations listed in Table 1 may be further 
refined as the formal review

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process continues. The nomination review and selection process is 
described in further detail on the NTP Web site (http://ntp.niehs.nih.gov/; select ``Nominations to the Testing Program'').
    The NTP Office of Chemical Nomination and Selection (OCNS) manages 
the solicitation, receipt, and review of NTP toxicology study 
nominations. The OCNS conducts an initial review of each study 
nomination received to determine whether the substance or issue has 
been adequately studied or has been previously considered by the NTP. 
For nominations not eliminated from consideration or deferred at this 
stage, the OCNS initiates a formal review process, as described above. 
The OCNS also ensures adequate background information is available to 
support the review for each nomination. For further information on the 
OCNS visit the NTP Web site (http://ntp.niehs.nih.gov select 
``Nominations to the Testing Program'') or contact Dr. Masten (see 
ADDRESSES above).

Request for Comments and Additional Information

    The NTP invites interested parties to submit written comments or 
supplementary information on the nominated substances and study 
recommendations that appear in Table 1. The NTP welcomes toxicology and 
carcinogenesis study information from completed, ongoing, or 
anticipated studies, as well as information on current U.S. production 
levels, use or consumption patterns, human exposure, environmental 
occurrence, or public health concerns for any of the nominated 
substances. The NTP is interested in identifying appropriate, novel, 
animal and non-animal experimental models for mechanistic-based 
research, including genetically modified rodents and higher-throughput 
in vitro test methods, and as such, solicits comments regarding the use 
of specific in vivo and in vitro experimental approaches to address 
questions relevant to the nominated substances and issues under 
consideration. The NTP will not respond to submitted comments; however, 
all information received will be become part of the official record 
that the NTP considers in its ongoing review of these nominations. 
Persons submitting comments should include their name, affiliation, 
mailing address, phone, fax, e-mail address, and sponsoring 
organization (if any) with the submission. Written submissions will be 
made publicly available electronically on the NTP Web site as they are 
received (http://ntp.niehs.nih.gov/ select ``Nominations to the Testing 
Program'').

    Dated: April 22, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
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[FR Doc. 05-8959 Filed 5-4-05; 8:45 am]
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