[Federal Register Volume 74, Number 100 (Wednesday, May 27, 2009)]
[Notices]
[Pages 25241-25244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12204]


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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 <a href="/cdn-cgi/l/email-protection#76181f131e051913131936181f131e0558181f1e58111900"><span class="__cf_email__" data-cfemail="3957505c514a565c5c567957505c514a17575051175e564f">[email protected]</span></a>. 
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: <a href="/cdn-cgi/l/email-protection#32415a535c57725c5b575a411c5c5b5a1c555d44"><span class="__cf_email__" data-cfemail="e5968d848b80a58b8c808d96cb8b8c8dcb828a93">[email protected]</span></a>. 
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: <a href="/cdn-cgi/l/email-protection#097a6168676c4967606c617a27676061276e667f"><span class="__cf_email__" data-cfemail="90e3f8f1fef5d0fef9f5f8e3befef9f8bef7ffe6">[email protected]</span></a>).

SUPPLEMENTARY INFORMATION:

Preliminary Agenda Topics and Availability of Meeting Materials

    <bullet> Update of NTP Activities.
    <bullet> Report of the Technical Reports Review Subcommittee 
Meeting held February 25, 2009.
    <bullet> 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.
    <bullet> Contract Concept Review: Investigative ADME Studies of 
Toxicants in NTP Animal Model Systems.
    <bullet> Contract Concept Review: Toxicology and Carcinogenicity 
Studies.
    <bullet> Contract Concept Review: Report on Carcinogens Support 
Contract.
    <bullet> 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
----------------------------------------------------------------------------------------------------------------
                                                                                            Preliminary study
         Substance [CAS No.]              Nomination source       Nomination rationale       recommendations
----------------------------------------------------------------------------------------------------------------
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.

[[Page 25243]]

 
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.
----------------------------------------------------------------------------------------------------------------
\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:
<bullet> 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.
<bullet> 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.

[[Page 25244]]

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


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