[Federal Register: May 27, 2009 (Volume 74, Number 100)]
[Notices]
[Page 25241-25244]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my09-38]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); Office of Liaison, Policy and
Review Meeting of the NTP Board of Scientific Counselors
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health.
ACTION: Meeting announcement and request for comments.
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SUMMARY: Pursuant to Public Law 92-463, notice is hereby given of a
meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a
federally chartered, external advisory group composed of scientists
from the public and private sectors that provides primary scientific
oversight to the NTP Director and evaluates the scientific merit of the
NTP's intramural and collaborative programs.
DATES: The BSC meeting will be held on July 23-24, 2009. The deadline
for submission of written comments is July 9, 2009, and for pre-
registration to attend the meeting, including registering
[[Page 25242]]
to present oral comments, is July 16, 2009. Persons needing
interpreting services in order to attend should contact 301-402-8180
(voice) or 301-435-1908 (TTY). For other accommodations while on the
NIEHS campus, contact 919-541-2475 or e-mail niehsoeeo@niehs.nih.gov.
Requests should be made at least 7 days in advance of the event.
ADDRESSES: The BSC meeting will be held in the Rodbell Auditorium, Rall
Building, at the NIEHS, 111 T.W. Alexander Drive, Research Triangle
Park, NC 27709. Public comments on all agenda topics and any other
correspondence should be submitted to Dr. Barbara Shane, Executive
Secretary for the BSC, NTP Office of Liaison, Policy and Review, NIEHS,
P.O. Box 12233, MD K2-03, Research Triangle Park, NC 27709; telephone:
919-541-4253; fax: 919-541-0295; or e-mail: shane@niehs.nih.gov.
Courier address: NIEHS, 530 Davis Drive, Room K 2138, Research Triangle
Park, NC 27713.
FOR FURTHER INFORMATION CONTACT: Dr. Barbara Shane (telephone: 919-541-
4253 or e-mail: shane@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Preliminary Agenda Topics and Availability of Meeting Materials
Update of NTP Activities.
Report of the Technical Reports Review Subcommittee
Meeting held February 25, 2009.
NTP Testing Program: Nominations and Proposed Research
Projects on alkylanilines, p-chlorobenzotrifluoride, deoxynivalenol,
Dong quai, indium tin oxide, and tris(4-chlorophenyl)methane and
tris(4-chlorophenyl)methanol.
Contract Concept Review: Investigative ADME Studies of
Toxicants in NTP Animal Model Systems.
Contract Concept Review: Toxicology and Carcinogenicity
Studies.
Contract Concept Review: Report on Carcinogens Support
Contract.
Interagency Agreements with Food and Drug Administration/
National Center for Toxicological Research and Centers for Disease
Control and Prevention/National Institute for Occupational Safety and
Health.
The preliminary agenda, roster of BSC members, draft NTP research
concepts, public comments, and any additional information, when
available, will be posted on the BSC meeting Web site (http://
ntp.niehs.nih.gov/go/165) or may be requested in hardcopy from the
Executive Secretary for the BSC (see ADDRESSES above). Any updates to
the agenda will also be posted to this site. Following the meeting,
summary minutes will be prepared and made available on the NTP meeting
Web site.
NTP Testing Program: Nominations and Proposed Research Projects
The NTP actively seeks to identify and select for study chemicals
and other substances 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 subject to a multi-step, formal process of review
before selections for testing are made and toxicological studies are
designed and implemented. The nomination review and selection process
is accomplished through the participation of representatives from the
NIEHS, other federal agencies represented on the Interagency Committee
for Chemical Evaluation and Coordination (ICCEC), the BSC, the NTP
Executive Committee--the NTP federal interagency policy body, and the
public. 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'').
Table 1 lists new nominations to be reviewed at the BSC meeting.
Background documents for each nomination are available on the NTP Web
site http://ntp.niehs.nih.gov/go/nom. The NTP invites interested
parties to submit written comments, provide supplementary information,
or present oral comments at the BSC meeting on the nominated substances
and preliminary study recommendations (see ``Request for Comments''
below). The NTP welcomes toxicology 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
animal and non-animal experimental models for mechanistic-based
research, including genetically modified rodents and high-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. Although the deadline for submission of written comments
to be considered at the BSC meeting is July 9, 2009 (see ``Request for
Comments'' below), the NTP welcomes comments or additional information
on these study nominations at any time.
Table 1--Testing Recommendations for Substances Nominated to the NTP for Toxicological Studies
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Preliminary study
Substance [CAS No.] Nomination source Nomination rationale recommendations
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Alkylanilines........................ National Institute of Potential for human Initial toxicological
2-Ethylaniline [578-54-1]........... Environmental Health exposure from a characterization.
3-Ethylaniline [587-02-0]........... Sciences\1\. variety of industrial
3,5-Dimethylaniline [108-69-0]...... and ambient sources;
suspicion of toxicity
based on chemical
structure;
insufficient data to
characterize toxicity
of this aniline
subclass.
p-Chlorobenzotrifluoride [98-56-6]... Kowa American Corp..... High production volume; Comprehensive
increasing industrial toxicological
and potential consumer characterization
use; lack of workplace including
exposure standards; developmental and
lack of chronic reproductive toxicity
toxicity data. and chronic toxicity/
carcinogenicity
studies.
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Deoxynivalenol [51481-10-8].......... NIEHS.................. Widespread Comprehensive
environmental toxicological
occurrence and characterization
potential for human including reproductive
exposure through toxicity and chronic
consumption of toxicity/
contaminated foods; carcinogenicity
demonstrated studies.
toxicological
activity; lack of
definitive
carcinogenicity and
reproductive toxicity
studies.
Dong quai (Angelica sinensis root Private Individual..... Widespread use as a Comprehensive
[308068-61-3] and extract [299184-76- dietary supplement; toxicological
2]). suspicion of toxicity characterization
based on estrogenic including photo-
activity and chemical toxicity studies.
structure; lack of
adequate toxicity data.
Indium tin oxide [50926-11-9]........ NIEHS.................. Increasing production Comprehensive
and use; documented toxicological
pulmonary effects in characterization.
exposed workers;
suspicion of toxicity
based on chemical
structure; lack of
adequate toxicity data.
Tris(4-chlorophenyl)methane [27575-78- NIEHS.................. Widespread occurrence Initial toxicological
6] and Tris(4-chlorophenyl)methanol and persistence in the characterization.
[3010-80-8]. environment; suspicion
of toxicity based on
anti-androgenic
activity; lack of
adequate toxicity data.
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\1\ National Institute of Environmental Health Sciences (NIEHS)
\2\ The terms ``initial'' and ``comprehensive toxicological characterization'' in this table refer to the
approximate scope of a research program to address toxicological data needs. The types of toxicological
studies that would be considered by NTP staff during the conceptualization and design of a research program
are:
Initial toxicological characterization: biomolecular screening, in vitro mechanistic, in vitro and in
vivo genotoxicity, absorption, disposition, metabolism, and elimination, and short-term repeat dose (2-4
weeks) in vivo studies.
Comprehensive toxicological characterization: all of the aforementioned plus subchronic toxicity (13-26
weeks), chronic toxicity (1-2 years), carcinogenicity in conventional or genetically modified rodent models,
organ systems toxicity (immunotoxicity, reproductive and developmental toxicity, neurotoxicity), in vivo
mechanistic, toxicokinetics, and other special studies as appropriate (e.g., chemistry, toxicogenomics,
phototoxicity).
To facilitate review of proposed research projects by the BSC and
the public, NTP staff developed a draft research concept document for
each nomination recommended for study. A research concept is a brief
document outlining the nomination or study rationale, and the
significance, study approach, and expected outcome of a proposed
research program tailored for each nomination. The purpose of these
research concepts is to outline the general elements of a program of
study that would address the specific issues that prompted the
nomination, but also encompass studies that may address larger public
health issues or topics in toxicology that could be addressed
appropriately through studies on the nominated substance(s). Draft
research concepts for the new nominations listed in Table 1 will be
available on the BSC meeting page (http://ntp.niehs.nih.gov/go/165) by
June 8, 2009.
Attendance and Registration
The meeting is scheduled for July 23-24, 2009, beginning at 8:30
a.m. on each day and continuing to 5 p.m. on July 23 and on July 24
until adjournment. The meeting is open to the public with attendance
limited only by the space available. Individuals who plan to attend are
encouraged to register online at the BSC meeting Web site (http://
ntp.niehs.nih.gov/go/165) by July 16, 2009, to facilitate planning for
the meeting. The NTP is making plans to videocast the meeting through
the Internet at http://www.niehs.nih.gov/news/video/live.
Request for Comments
Written comments submitted in response to this notice should be
received by July 9, 2009. Comments will be posted on the BSC meeting
Web site and persons submitting them will be identified by their name
and affiliation and/or sponsoring organization, if applicable. Persons
submitting written comments should include their name, affiliation (if
applicable), phone, e-mail, and sponsoring organization (if any) with
the document.
Time will be allotted during the meeting for the public to present
oral comments to the BSC on the agenda topics. 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 at the discretion of the BSC chair. Persons wishing to present
oral comments are encouraged to pre-register on the NTP meeting Web
site by July 16. Registration for oral comments will also be available
on-site, although time allowed for presentation by on-site registrants
may be less than that for pre-registered speakers and will be
determined by the number of persons who register at the meeting.
Persons registering to make oral comments are asked, if possible,
to send a copy of their statement to the Executive Secretary for the
BSC (see ADDRESSES above) by July 16, 2009. 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 to the BSC and NIEHS/NTP staff and to supplement the
record.
Background Information on the NTP Board of Scientific Counselors
The BSC is a technical advisory body comprised of scientists from
the public and private sectors that provides primary scientific
oversight to the overall program and its centers.
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Specifically, the BSC 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 their overall scientific quality. Its
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. Members serve
overlapping terms of up to four years. BSC meetings are held annually
or biannually.
Dated: May 15, 2009.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. E9-12204 Filed 5-26-09; 8:45 am]
BILLING CODE 4140-01-P