[Federal Register Volume 73, Number 192 (Thursday, October 2, 2008)]
[Notices]
[Pages 57358-57360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23181]


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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 (NTP BSC). The NTP 
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 NTP BSC meeting will be held on November 20-21, 2008. The 
deadline for submission of written comments is November 6, 2008, and 
for pre-registration to attend the meeting, including registering to 
present oral comments, is November 13, 2008. 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#e58b8c808d968a80808aa58b8c808d96cb8b8c8dcb828a93"><span class="__cf_email__" data-cfemail="86e8efe3eef5e9e3e3e9c6e8efe3eef5a8e8efeea8e1e9f0">[email protected]</span></a>. 
Requests should be made at least 7 days in advance of the event.

ADDRESSES: The NTP 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 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: 
<a href="/cdn-cgi/l/email-protection#89fae1e8e7ecc9e7e0ece1faa7e7e0e1a7eee6ff"><span class="__cf_email__" data-cfemail="0c7f646d62694c626569647f22626564226b637a">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#b8cbd0d9d6ddf8d6d1ddd0cb96d6d1d096dfd7ce"><span class="__cf_email__" data-cfemail="f3809b929d96b39d9a969b80dd9d9a9bdd949c85">[email protected]</span></a>).

SUPPLEMENTARY INFORMATION: 

Preliminary Agenda Topics and Availability of Meeting Materials

November 20-21, 2008

    <bullet> Update of NTP activities
    <bullet> NTP testing program: nominations and proposed research 
projects on bisphenol AF, dimethylamine borane, ethylene glycol 2-
ethylhexyl ether, hydroxyurea, L-beta-methylaminoalanine, and triclosan
    <bullet> BSC working group report on criteria for evaluating 
outcomes in immunotoxicology studies
    <bullet> BSC working group report on criteria for evaluating 
outcomes in reproductive toxicology studies
    <bullet> BSC working group report on criteria for evaluating 
outcomes in developmental toxicology studies
    <bullet> Toxicology of DNA-based therapies
    <bullet> Concept review: production of mold materials
    <bullet> Sources of variability in NTP toxicogenomic studies
    <bullet> Update on the High Throughput Screening Initiative

    The preliminary agenda, roster of NTP BSC members and ad hoc 
reviewers, draft NTP research concepts, public comments, and any 
additional information, when available, will be posted on the NTP BSC 
meeting Web site (http://ntp.niehs.nih.gov/go/165) or may be requested 
in hardcopy from the Executive Secretary for the NTP BSC (see ADDRESSES 
above). 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.

[[Page 57359]]

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 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 (http://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 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 NTP 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 NTP BSC meeting is November 6, 
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\
----------------------------------------------------------------------------------------------------------------
Bisphenol AF [1478-61-1].............  NIEHS..................  Moderate production and  --Comprehensive
                                                                 use in polymer           toxicological
                                                                 synthesis; short-term    characterization.
                                                                 studies suggest
                                                                 potential for
                                                                 endocrine disruption
                                                                 and adverse
                                                                 reproductive effects;
                                                                 lack of adequate
                                                                 toxicity data.
Dimethylamine borane [74-94-2].......  National Institute for   Possible contact         --Dermal absorption
                                        Occupational Safety      sensitizer and           studies.
                                        and Health.              systemic toxicant but   --Skin sensitization
                                                                 insufficient evidence    studies.
                                                                 as determined by the    --Subchronic dermal
                                                                 NIOSH Dermal Subject     toxicity studies with
                                                                 Matter Expert            neurotoxicity and
                                                                 Workgroup.               behavioral
                                                                                          assessments.
Ethylene glycol 2-ethylhexyl ether     NIEHS..................  High production volume;  --Reproductive and
 [1559-35-9].                                                    potential worker         developmental toxicity
                                                                 exposures; suspicion     studies.
                                                                 of toxicity based on
                                                                 chemical structure;
                                                                 lack of adequate
                                                                 toxicity data.
Hydroxyurea [127-07-1]...............  NIEHS and Private        Long-term safety         No experimental animal
                                        Individual.              concern when used as     toxicity studies at
                                                                 therapy for sickle       this time; human
                                                                 cell anemia; NTP         studies currently
                                                                 Center for the           being considered by
                                                                 Evaluation of Risks to   the NIH and other
                                                                 Human Reproduction       federal agencies may
                                                                 (CERHR) Expert Panel     address outstanding
                                                                 identified a critical    safety concerns.
                                                                 data need for multi-
                                                                 generational
                                                                 experimental animal
                                                                 studies to assess the
                                                                 long-term effects of
                                                                 prenatal and postnatal
                                                                 exposures on postnatal
                                                                 development including
                                                                 developmental
                                                                 neurotoxicity,
                                                                 reproductive function,
                                                                 and carcinogenicity.
L-beta-Methylaminoalanine [15920-93-   NIEHS..................  Natural product          --Absorption,
 1].                                                             produced by              distribution,
                                                                 cyanobacteria with       metabolism, and
                                                                 localized and            elimination studies.
                                                                 potentially widespread  --Neurotoxicity
                                                                 environmental            studies.
                                                                 occurrence; suspected   --Biomolecular
                                                                 risk factor for          screening studies.
                                                                 neurological
                                                                 disease(s); lack of
                                                                 adequate toxicity data.

[[Page 57360]]

 
Triclosan [3380-34-5]................  Private Individual and   Widespread use in        --Carcinogenicity
                                        U.S. Food and Drug       consumer products;       studies via dermal
                                        Administration.          frequent and long-term   administration.
                                                                 exposure for all age    --Phototoxicity
                                                                 groups; lack of          studies.
                                                                 adequate toxicity data  --Reproductive toxicity
                                                                 for dermal exposures.    studies.
----------------------------------------------------------------------------------------------------------------
\1\ National Institute of Environmental Health Sciences (NIEHS).
\2\ The term ``comprehensive toxicological characterization'' in this table refers 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 biomolecular
  screening, in vitro mechanistic, in vitro and in vivo genotoxicity, absorption, disposition, metabolism, and
  elimination, short-term repeat dose (2-4 weeks) in vivo studies, 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 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 NTP BSC meeting page (http://ntp.niehs.nih.gov/go/165) 
by October 9, 2008.

Attendance and Registration

    The meeting is scheduled for November 20-21, 2008, beginning at 
8:30 a.m. on each day and continuing to 5 p.m. on November 20 and on 
November 21 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 (http://ntp.niehs.nih.gov/go/165) by November 13, 2008, 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 November 6, 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. Persons wishing to 
present oral comments are encouraged to pre-register on the NTP meeting 
Web site. 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 November 13, 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: September 23, 2008.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
 [FR Doc. E8-23181 Filed 10-1-08; 8:45 am]
BILLING CODE 4140-01-P


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