National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health, HHS.
Meeting announcement and request for comments.
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.
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 firstname.lastname@example.org. Requests should be made at least 7 business days in advance of the event.
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@example.com. Courier address: NIEHS, 530 Davis Drive, Room K2138, Morrisville, NC 27560.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Dr. Barbara Shane (telephone: 919-541-4253 or e-mail: firstname.lastname@example.org).End Further Info End Preamble Start Supplemental 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 Start Printed Page 54822for 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.
|Substance [CAS No.]||Nomination source||Nomination rationale||Preliminary study recommendations|
|Butterbur (Petasites hybridus) extract [90082-63-6]||National Institute of Environmental Health Sciences1||Use as a dietary supplement; lack of toxicological data; suspicion of toxicity based on pharmacological activity of constituents; potential presence of toxic pyrrolizidine alkaloids||Comprehensive toxicological characterization.|
|Evening primrose oil (Oenothera biennis L.) extract [90028-66-3]||NIEHS||Use as a dietary supplement, particularly for immune conditions; lack of adequate toxicological data||—Initial toxicological characterization. —Immunotoxicity studies. —Reproductive toxicity studies.|
|Hydroquinone [123-31-9]||U.S. Food and Drug Administration||Use in drugs and cosmetics; evidence of carcinogenicity from oral exposures in prior NTP studies; insufficient toxicological data for regulatory hazard determination||—Dermal toxicity and carcinogenicity studies. —Reproductive toxicity studies.|
|Silica flour [14808-60-7]||Private Individual||Use in industrial and consumer products; inhalation exposures associated with autoimmune disease; lack of toxicity data for oral and dermal exposures; insufficient data to evaluate dose-response for renal and autoimmune effects by any route of exposure||—Initial toxicological characterization via oral and dermal routes of administration. —Immunotoxicity studies.|
|Valerian (Valeriana officinalis L.) root extract [8057-49-6]; Valerian oil [8008-88-6]||NIEHS||Use as a dietary supplement; lack of toxicological data; concern for adverse developmental and reproductive effects||Comprehensive toxicological characterization.|
|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 Start Printed Page 54823allowed 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.Start Signature
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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