National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors, 20289-20291 [E8-7831]
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Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Notices
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[FR Doc. E8–8062 Filed 4–14–08; 8:45 am]
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Office of Liaison, Policy and Review;
Meeting of the NTP Board of Scientific
Counselors
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health.
ACTION: Meeting announcement and
request for comments.
AGENCY:
SUMMARY: Pursuant to Public Law 92–
463, notice is hereby given of a meeting
of the NTP Board of Scientific
Counselors (NTP BSC). The NTP BSC is
composed of scientists from the public
and private sectors and provides
primary scientific oversight to the NTP
Director and evaluates the scientific
merit of the NTP’s intramural and
collaborative programs.
DATES: The NTP BSC meeting will be
held on June 11–12, 2008. The deadline
for submission of written comments is
PO 00000
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20289
May 23, 2008, and for pre-registering to
attend the meeting, including providing
notice of intent to present oral
comments, is June 4, 2008. Persons
needing interpreting services in order to
attend should contact 301–402–8180
(voice) or 301–435–1908 (TTY). For
other accommodations, 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 NTP BSC meeting will
be held at the Radisson Hotel Research
Triangle Park, 150 Park 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 NTP BSC,
NTP Office of Liaison, Policy and
Review, NIEHS, P.O. Box 12233, MD
A3–01, Research Triangle Park, NC
27709; telephone: 919–541–4253; fax:
919–541–0295; or e-mail:
shane@niehs.nih.gov. Courier address:
NIEHS, 111 T.W. Alexander Drive,
Room A322, Research Triangle Park, NC
27709.
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
June 11–12, 2008
• Update of NTP activities.
• Center for the Evaluation of Risks to
Human Reproduction: Peer review of
the draft NTP Brief on Bisphenol A.
• Criteria for evaluating outcomes in
reproductive, developmental, and
immunotoxicology studies.
• Report on the NTP BSC Technical
Reports Review Subcommittee meeting
held February 27–28, 2008.
• NTP studies of DNA-based
therapies.
• NTP testing program: Proposed
research projects on
dimorpholinodiethyl ether, 2ethylhexyl-p-methoxycinnamate, furan,
melamine and cyanuric acid, 4,7,10trioxatridecane-1,13-diamine, and
tetravalent and pentavalent vanadium
compounds.
• Update on the High Throughput
Screening Initiative.
• Update on the Host Susceptibility
Program.
The preliminary agenda, roster of NTP
BSC members and ad hoc reviewers,
proposed NTP research projects, public
comments, and any additional
information, when available, will be
posted on the NTP BSC meeting Web
site (https://ntp.niehs.nih.gov/go/165) or
E:\FR\FM\15APN1.SGM
15APN1
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Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Notices
may be requested in hardcopy from the
Executive Secretary for the NTP BSC
(see ADDRESSES above). Following the
meeting, summary minutes will be
prepared and made available on the
NTP meeting Web site.
Peer Review of the Draft NTP Brief on
Bisphenol A
The NTP Center for the Evaluation of
Risks to Human Reproduction (CERHR)
conducts scientifically based
assessments of the potential for
chemicals to adversely affect human
reproduction and development. CERHR
follows a multi-step process for its
evaluations (66 FR 37047). Currently,
CERHR is conducting an evaluation of
bisphenol A (CAS RN: 80–5–07), a high
production volume chemical used
primarily in the production of
polycarbonate plastics and epoxy resins.
Polycarbonate plastics have many
applications including food and drink
packaging, compact discs, and medical
devices, while epoxy resins are used as
lacquers to coat metal products such as
food cans, bottle tops, and water supply
pipes. CERHR selected bisphenol A for
evaluation because of its (1) High
production volume, (2) widespread
human exposure, (3) evidence of
reproductive toxicity in laboratory
animals, and (4) public concern.
As part of its evaluation process,
CERHR has prepared the draft NTP Brief
on bisphenol A that contains the NTP’s
conclusions and scientific support on
whether or not exposure to this
chemical presents a concern for human
reproduction or the development of
children. The draft brief is based on the
CERHR Expert Panel Report on
Bisphenol A released November 30,
2007, public comments on that report
(the report and comments are available
at https://cerhr.niehs.nih.gov/chemicals/
bisphenol/pubcomm-bisphenol.html),
and new studies related to the toxicity
or biological activity of bisphenol A
published since the February 2007 cutoff date for literature for the expert
panel’s deliberations.
The draft brief will undergo peer
review at the NTP BSC meeting. The
NTP invites written public comments
on the draft NTP Brief on Bisphenol A
and/or presentation of oral comments at
the NTP BSC meeting (see ‘‘Request for
Comments’’ below). The draft brief will
be available on the CERHR Web site
(https://cerhr.niehs.nih.gov/chemicals/
bisphenol/bisphenol.html) and the NTP
BSC meeting Web site (https://
ntp.niehs.nih.gov/go/165) on April 15,
2008.
NTP Testing Program: 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 doseresponse 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 NTP 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 (https://
ntp.niehs.nih.gov; select ‘‘Nominations
to the Testing Program’’).
Table 1 lists new nominations to be
reviewed at the NTP BSC meeting.
Background documents for each
nomination are available on the NTP
Web site at https://ntp.niehs.nih.gov/go/
nom. The NTP invites interested parties
to submit written comments, provide
supplementary information, and/or
present oral comments at the NTP BSC
meeting on the nominated substances
and preliminary study
recommendations that appear in Table 1
(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 mechanisticbased 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 NTP BSC meeting
is May 23, 2008 (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
Nominated by 1
Nomination rationale
Preliminary study
recommendations 2
Dimorpholinodiethyl ether [6425–
39–4].
NCI ................................................
NCI ................................................
High production volume; potential
worker exposures; lack of adequate toxicological data; suspicion of toxicity based on
structure.
High production volume; widespread consumer exposure as
a common sunscreen active ingredient; reported estrogenic
and reproductive effects.
—Initial toxicological characterization.
—Studies to assess the potential
for nitrosation.
2-Ethylhexyl p-methoxycinnamate
[5466–77–3].
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Substance
[CAS No.]
4,7,10-Trioxatridecane-1,13diamine [4246–51–9].
NCI ................................................
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High production volume; potential
worker exposures; lack of adequate toxicological data; acutely
toxic.
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—Comprehensive
toxicological
characterization including carcinogenicity and developmental
toxicity studies.
—Characterization
of
photodecomposition products.
—Biomolecular screening studies.
—Genotoxicity studies.
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Federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Notices
TABLE 1.—TESTING RECOMMENDATIONS FOR SUBSTANCES NOMINATED TO THE NTP FOR TOXICOLOGICAL STUDIES—
Continued
Substance
[CAS No.]
Nominated by 1
Nomination rationale
Preliminary study
recommendations 2
Vanadium, tetravalent and pentavalent forms.
NIEHS, U.S. Environmental Protection Agency.
Widespread occurrence as drinking water contaminant and use
as a dietary supplement; EPA
Drinking Water Contaminant
Candidate List research need;
pentavalent form is carcinogenic via the inhalation route;
inadequate data to assess risk
of oral exposures.
—Comprehensive
toxicological
characterization.
—Chronic toxicity and carcinogenicity studies via oral route of
administration.
—Multi-generation
reproductive
and
developmental
toxicity
studies.
1 National
Institute of Environmental Health Sciences (NIEHS); National Cancer Institute (NCI).
terms ‘‘initial toxicological characterization’’ 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 for each 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).
2 The
To facilitate review of proposed
research projects by the NTP 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 appropriately
addressed through studies on the
nominated agent. Draft research
concepts for the new nominations listed
in Table 1 will be available on the NTP
BSC meeting page (https://
ntp.niehs.nih.gov/go/165) by May 7,
2008.
In addition to review of the new
nominations in Table 1, the NTP BSC
will review proposed research projects
for (1) furan [CAS RN: 110–00–9]; and
(2) melamine [CAS RN: 108–78–1] and
cyanuric acid [CAS RN: 108–80–5].
Draft research concepts for these
proposed projects will be available on
the NTP BSC meeting page (https://
ntp.niehs.nih.gov/go/165) by May 7,
2008.
jlentini on PROD1PC65 with NOTICES
Attendance and Registration
The meeting is scheduled for June 11–
12, 2008, beginning at 8:30 a.m. on each
day and continuing to 5 p.m. on June 1
and on June 12 until adjournment. The
meeting is open to the public with
attendance limited only by the space
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17:31 Apr 14, 2008
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available. Individuals who plan to
attend are encouraged to register online
at the NTP BSC meeting Web site
(https://ntp.niehs.nih.gov/go/165) by
June 4, 2008, to facilitate planning for
the meeting. The NTP is making plans
to videocast the meeting through the
Internet at https://www.niehs.nih.gov/
news/video/live.
(see ADDRESSES above) by June 4, 2008,
to enable review by the NTP BSC prior
to 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 to the NTP BSC and NIEHS/
NTP staff and to supplement the record.
Request for Comments
Background Information on the NTP
Board of Scientific Counselors
The NTP 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.
Specifically, the NTP 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. NTP BSC
meetings are held annually or
biannually.
Written comments submitted in
response to this notice should be
received by May 23, 2008. Comments
will be posted on the NTP 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 NTP 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 NTP BSC chair.
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 preregistered 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 NTP BSC
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Dated: April 4, 2008.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E8–7831 Filed 4–11–08; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 73, Number 73 (Tuesday, April 15, 2008)]
[Notices]
[Pages 20289-20291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7831]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: Pursuant to Public Law 92-463, notice is hereby given of a
meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP
BSC is composed of scientists from the public and private sectors and
provides primary scientific oversight to the NTP Director and evaluates
the scientific merit of the NTP's intramural and collaborative
programs.
DATES: The NTP BSC meeting will be held on June 11-12, 2008. The
deadline for submission of written comments is May 23, 2008, and for
pre-registering to attend the meeting, including providing notice of
intent to present oral comments, is June 4, 2008. Persons needing
interpreting services in order to attend should contact 301-402-8180
(voice) or 301-435-1908 (TTY). For other accommodations, 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 NTP BSC meeting will be held at the Radisson Hotel
Research Triangle Park, 150 Park 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 NTP BSC, NTP Office of Liaison, Policy and Review,
NIEHS, P.O. Box 12233, MD A3-01, Research Triangle Park, NC 27709;
telephone: 919-541-4253; fax: 919-541-0295; or e-mail:
shane@niehs.nih.gov. Courier address: NIEHS, 111 T.W. Alexander Drive,
Room A322, Research Triangle Park, NC 27709.
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
June 11-12, 2008
Update of NTP activities.
Center for the Evaluation of Risks to Human Reproduction:
Peer review of the draft NTP Brief on Bisphenol A.
Criteria for evaluating outcomes in reproductive,
developmental, and immunotoxicology studies.
Report on the NTP BSC Technical Reports Review
Subcommittee meeting held February 27-28, 2008.
NTP studies of DNA-based therapies.
NTP testing program: Proposed research projects on
dimorpholinodiethyl ether, 2-ethylhexyl-p-methoxycinnamate, furan,
melamine and cyanuric acid, 4,7,10-trioxatridecane-1,13-diamine, and
tetravalent and pentavalent vanadium compounds.
Update on the High Throughput Screening Initiative.
Update on the Host Susceptibility Program.
The preliminary agenda, roster of NTP BSC members and ad hoc
reviewers, proposed NTP research projects, public comments, and any
additional information, when available, will be posted on the NTP BSC
meeting Web site (https://ntp.niehs.nih.gov/go/165) or
[[Page 20290]]
may be requested in hardcopy from the Executive Secretary for the NTP
BSC (see ADDRESSES above). Following the meeting, summary minutes will
be prepared and made available on the NTP meeting Web site.
Peer Review of the Draft NTP Brief on Bisphenol A
The NTP Center for the Evaluation of Risks to Human Reproduction
(CERHR) conducts scientifically based assessments of the potential for
chemicals to adversely affect human reproduction and development. CERHR
follows a multi-step process for its evaluations (66 FR 37047).
Currently, CERHR is conducting an evaluation of bisphenol A (CAS RN:
80-5-07), a high production volume chemical used primarily in the
production of polycarbonate plastics and epoxy resins. Polycarbonate
plastics have many applications including food and drink packaging,
compact discs, and medical devices, while epoxy resins are used as
lacquers to coat metal products such as food cans, bottle tops, and
water supply pipes. CERHR selected bisphenol A for evaluation because
of its (1) High production volume, (2) widespread human exposure, (3)
evidence of reproductive toxicity in laboratory animals, and (4) public
concern.
As part of its evaluation process, CERHR has prepared the draft NTP
Brief on bisphenol A that contains the NTP's conclusions and scientific
support on whether or not exposure to this chemical presents a concern
for human reproduction or the development of children. The draft brief
is based on the CERHR Expert Panel Report on Bisphenol A released
November 30, 2007, public comments on that report (the report and
comments are available at https://cerhr.niehs.nih.gov/chemicals/
bisphenol/pubcomm-bisphenol.html), and new studies related to the
toxicity or biological activity of bisphenol A published since the
February 2007 cut-off date for literature for the expert panel's
deliberations.
The draft brief will undergo peer review at the NTP BSC meeting.
The NTP invites written public comments on the draft NTP Brief on
Bisphenol A and/or presentation of oral comments at the NTP BSC meeting
(see ``Request for Comments'' below). The draft brief will be available
on the CERHR Web site (https://cerhr.niehs.nih.gov/chemicals/bisphenol/
bisphenol.html) and the NTP BSC meeting Web site (https://
ntp.niehs.nih.gov/go/165) on April 15, 2008.
NTP Testing Program: 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 NTP 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 (https://ntp.niehs.nih.gov; select
``Nominations to the Testing Program'').
Table 1 lists new nominations to be reviewed at the NTP BSC
meeting. Background documents for each nomination are available on the
NTP Web site at https://ntp.niehs.nih.gov/go/nom. The NTP invites
interested parties to submit written comments, provide supplementary
information, and/or present oral comments at the NTP BSC meeting on the
nominated substances and preliminary study recommendations that appear
in Table 1 (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 NTP
BSC meeting is May 23, 2008 (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.] Nominated by \1\ Nomination rationale recommendations \2\
----------------------------------------------------------------------------------------------------------------
Dimorpholinodiethyl ether [6425-39-4] NCI.................... High production volume; --Initial toxicological
potential worker characterization.
exposures; lack of --Studies to assess the
adequate toxicological potential for
data; suspicion of nitrosation.
toxicity based on
structure.
2-Ethylhexyl p-methoxycinnamate [5466- NCI.................... High production volume; --Comprehensive
77-3]. widespread consumer toxicological
exposure as a common characterization
sunscreen active including
ingredient; reported carcinogenicity and
estrogenic and developmental toxicity
reproductive effects. studies.
--Characterization of
photodecomposition
products.
4,7,10-Trioxatridecane-1,13-diamine NCI.................... High production volume; --Biomolecular
[4246-51-9]. potential worker screening studies.
exposures; lack of --Genotoxicity studies.
adequate toxicological
data; acutely toxic.
[[Page 20291]]
Vanadium, tetravalent and pentavalent NIEHS, U.S. Widespread occurrence --Comprehensive
forms. Environmental as drinking water toxicological
Protection Agency. contaminant and use as characterization.
a dietary supplement; --Chronic toxicity and
EPA Drinking Water carcinogenicity
Contaminant Candidate studies via oral route
List research need; of administration.
pentavalent form is --Multi-generation
carcinogenic via the reproductive and
inhalation route; developmental toxicity
inadequate data to studies.
assess risk of oral
exposures.
----------------------------------------------------------------------------------------------------------------
\1\ National Institute of Environmental Health Sciences (NIEHS); National Cancer Institute (NCI).
\2\ The terms ``initial toxicological characterization'' 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 for each 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 NTP 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 appropriately
addressed through studies on the nominated agent. Draft research
concepts for the new nominations listed in Table 1 will be available on
the NTP BSC meeting page (https://ntp.niehs.nih.gov/go/165) by May 7,
2008.
In addition to review of the new nominations in Table 1, the NTP
BSC will review proposed research projects for (1) furan [CAS RN: 110-
00-9]; and (2) melamine [CAS RN: 108-78-1] and cyanuric acid [CAS RN:
108-80-5]. Draft research concepts for these proposed projects will be
available on the NTP BSC meeting page (https://ntp.niehs.nih.gov/go/165)
by May 7, 2008.
Attendance and Registration
The meeting is scheduled for June 11-12, 2008, beginning at 8:30
a.m. on each day and continuing to 5 p.m. on June 1 and on June 12
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 NTP BSC meeting Web site (https://
ntp.niehs.nih.gov/go/165) by June 4, 2008, to facilitate planning for
the meeting. The NTP is making plans to videocast the meeting through
the Internet at https://www.niehs.nih.gov/news/video/live.
Request for Comments
Written comments submitted in response to this notice should be
received by May 23, 2008. Comments will be posted on the NTP 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 NTP 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 NTP BSC chair. 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
NTP BSC (see ADDRESSES above) by June 4, 2008, to enable review by the
NTP BSC prior to 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
to the NTP BSC and NIEHS/NTP staff and to supplement the record.
Background Information on the NTP Board of Scientific Counselors
The NTP 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. Specifically, the NTP
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. NTP BSC meetings are held annually or biannually.
Dated: April 4, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E8-7831 Filed 4-11-08; 8:45 am]
BILLING CODE 4140-01-P
