[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54821-54823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25587]


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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, HHS.

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 December 9-10, 2009. The 
deadline for submission of written comments is November 25, 2009, and 
for pre-registration to attend the meeting, including registering to 
present oral comments, is December 2, 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 [email protected]. 
Requests should be made at least 7 business 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, K2-03, Research Triangle Park, NC 27709; telephone: 
919-541-4253; fax: 919-541-0295; e-mail: [email protected]. Courier 
address: NIEHS, 530 Davis Drive, Room K2138, Morrisville, NC 27560.

FOR FURTHER INFORMATION CONTACT: Dr. Barbara Shane (telephone: 919-541-
4253 or e-mail: [email protected]).

SUPPLEMENTARY INFORMATION:

Preliminary Agenda Topics and Availability of Meeting Materials

     Report of the NTP Director.
     NTP Update.
     NTP Testing Program: Nominations and proposed research 
projects on Butterbur, Evening primrose oil, Hydroquinone, Silica 
flour, and Valerian extracts and oil.
     Review of the NTP Host Susceptibility Program.
     NTP's Use of Contracts in the Testing Program.
     Concept Contract Review for Chemistry Services to the NTP.
     Concept Contract Review for NTP Reproductive and 
Developmental Toxicology and Perinatal Carcinogenicity Studies.
     NTP Evaluation Process.
     Update from the Center for the Evaluation of Risks to 
Human Reproduction.
     NTP's Dietary Supplements and Herbal Medicines Initiative.
    The preliminary agenda, roster of BSC members and ad hoc reviewers, 
background materials for agenda topics, 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). Updates to the agenda will also be posted to this site. 
Following the meeting, summary minutes will be prepared and made 
available on the BSC 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 NTP Federal 
interagency review committee for NTP study nominations, 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

[[Page 54822]]

for submission of written comments to be considered at the BSC meeting 
is November 25, 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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Butterbur (Petasites hybridus)         National Institute of    Use as a dietary         Comprehensive
 extract [90082-63-6].                  Environmental Health     supplement; lack of      toxicological
                                        Sciences\1\.             toxicological data;      characterization.
                                                                 suspicion of toxicity
                                                                 based on
                                                                 pharmacological
                                                                 activity of
                                                                 constituents;
                                                                 potential presence of
                                                                 toxic pyrrolizidine
                                                                 alkaloids.
Evening primrose oil (Oenothera        NIEHS..................  Use as a dietary         --Initial toxicological
 biennis L.) extract [90028-66-3].                               supplement,              characterization.
                                                                 particularly for        --Immunotoxicity
                                                                 immune conditions;       studies.
                                                                 lack of adequate        --Reproductive toxicity
                                                                 toxicological data.      studies.
Hydroquinone [123-31-9]..............  U.S. Food and Drug       Use in drugs and         --Dermal toxicity and
                                        Administration.          cosmetics; evidence of   carcinogenicity
                                                                 carcinogenicity from     studies.
                                                                 oral exposures in       --Reproductive toxicity
                                                                 prior NTP studies;       studies.
                                                                 insufficient
                                                                 toxicological data for
                                                                 regulatory hazard
                                                                 determination.
Silica flour [14808-60-7]............  Private Individual.....  Use in industrial and    --Initial toxicological
                                                                 consumer products;       characterization via
                                                                 inhalation exposures     oral and dermal routes
                                                                 associated with          of administration.
                                                                 autoimmune disease;     --Immunotoxicity
                                                                 lack of toxicity data    studies.
                                                                 for oral and dermal
                                                                 exposures;
                                                                 insufficient data to
                                                                 evaluate dose-response
                                                                 for renal and
                                                                 autoimmune effects by
                                                                 any route of exposure.
Valerian (Valeriana officinalis L.)    NIEHS..................  Use as a dietary         Comprehensive
 root extract [8057-49-6]; Valerian                              supplement; lack of      toxicological
 oil [8008-88-6].                                                toxicological data;      characterization.
                                                                 concern for adverse
                                                                 developmental and
                                                                 reproductive effects.
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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 and the preliminary study recommendations. A research 
concept may also encompass larger public health issues or topics in 
toxicology that could be appropriately addressed 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 October 26, 2009.

Attendance and Registration

    The meeting is scheduled for December 9-10, 2009, beginning at 8:30 
a.m. on each day and continuing to approximately 5 p.m. on December 9 
and on December 10 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 December 2, 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 November 25, 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. Registration for oral comments will also be available on-site, 
although time

[[Page 54823]]

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 December 2, 2009, to enable review by the 
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 BSC and 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 NTP. 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: October 16, 2009.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. E9-25587 Filed 10-22-09; 8:45 am]
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