National Toxicology Program (NTP); Office of Liaison, Policy and Review Meeting of the NTP Board of Scientific Counselors, 21003-21005 [2010-9252]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Notices]
[Pages 21003-21005]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9252]


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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 June 21-22, 2010. The deadline 
for submission of written comments is June 7, 2010, and for pre-
registration to attend the meeting, including registering to present 
oral comments, is June 14, 2010. 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 niehsoeeo@niehs.nih.gov. 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. Lori White, Designated 
Federal Officer for the BSC, NTP Office of Liaison, Policy and Review, 
NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709; 
telephone: 919-541-9834; fax: 919-541-0295; whiteld@niehs.nih.gov. 
Courier address: NIEHS, 530 Davis Drive, Room K2136, Morrisville, NC 
27560.

FOR FURTHER INFORMATION CONTACT: Dr. Lori D. White (telephone: 919-541-
9834 or whiteld@niehs.nih.gov).

SUPPLEMENTARY INFORMATION:

Preliminary Agenda Topics and Availability of Meeting Materials

     Report of the NIEHS/NTP Director.
     Report of the NTP Associate Director.
     Center for the Evaluation of Risks to Human Reproduction 
(CERHR) Proposed Evaluation Concept: Cancer Chemotherapy During 
Pregnancy.
     Peer Review of Draft Substance Profiles for the 12th 
Report on Carcinogens (RoC): glass wool fibers, cobalt-tungsten 
carbide: powders and hard metals, and formaldehyde.
     NTP Testing Program Nomination and Proposed Research 
Project: Hydroxyurea.
    The preliminary agenda, roster of BSC members, background 
materials, public comments, and any additional information, when 
available, will be posted on the BSC meeting Web site (https://ntp.niehs.nih.gov/go/165) or may be requested in hardcopy from the 
Designated Federal Officer for the BSC (see ADDRESSES above). Updates 
to the preliminary agenda will also be posted to this site. The draft 
substance profiles will be available by close of business, April 21, 
2010, on the NTP BSC meeting Web site. The draft research concepts for 
the CERHR evaluation and the NTP Testing Program nomination will be 
available on the BSC meeting page (https://ntp.niehs.nih.gov/go/165) by 
May 10, 2010.
    Following the meeting, summary minutes will be prepared and made 
available on the BSC meeting Web site.

Attendance and Registration

    The meeting is scheduled for June 21-22, 2010, beginning at 8:30 
a.m. (Eastern Daylight Time) and continuing to approximately 5:30 p.m. 
on June 21 and until adjournment on June 22. This 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 (https://ntp.niehs.nih.gov/go/165) by June 14, 
2010, to facilitate planning for the meeting. Registered attendees are 
encouraged to access the meeting website to stay abreast of the most 
current information regarding 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 June 7, 2010. 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. In addition to in-person 
oral comments at the meeting at the NIEHS, public comments can be 
presented by teleconference line. There will be 50 lines for this call; 
availability will be on a first-come, first-served basis. The available 
lines will be open from 8 a.m. until 5:30 p.m. on June 21, and 8 a.m. 
until adjournment on June 22, although public comments will be received 
only during the formal public comment periods, which will be indicated 
on the preliminary agenda. 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 and indicate whether they 
will present comments in-person or via the teleconference line. The 
access number for the teleconference line will be provided to 
registrants by email prior to the meeting. Registration for oral

[[Page 21004]]

comments will also be available on June 21 and June 22, although time 
allowed for presentation by these 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 to send a copy 
of their statement to the Designated Federal Officer for the BSC (see 
ADDRESSES above) by June 14, 2010, 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. Registered speakers using 
PowerPoint slides with their oral comments should send them to the 
Designated Federal Officer (see ADDRESSES) by June 14, 2010.

Background Information on CERHR

    The NTP established CERHR in 1998 [63 FR 68782]. CERHR is a 
publicly accessible resource for information about adverse reproductive 
and/or developmental health effects associated with exposure to 
environmental and/or occupational exposures. CERHR follows a formal 
process for the evaluation of selected substances that includes 
opportunities for public input. CERHR invites the nomination of 
substances for review or scientists for its expert registry. 
Information about CERHR and the nomination process can be obtained from 
its homepage (https://cerhr.niehs.nih.gov) or by contacting Dr. Kristina 
Thayer (919-541-5021 or thayer@niehs.nih.gov). CERHR selects substances 
for evaluation based upon several factors including production volume, 
potential for human exposure from use and occurrence in the 
environment, extent of public concern, and extent of data from 
reproductive and developmental toxicity studies. Expert panels conduct 
scientific evaluations of substances selected by CERHR in public 
forums. Following these evaluations, CERHR prepares the NTP-CERHR 
monograph on the substance evaluated. The monograph is transmitted to 
appropriate Federal and State agencies and made available to the 
public.

Background Information on the Report on Carcinogens

    The RoC is a public information document prepared for the U.S. 
Congress by the NTP in response to Section 301(b)(4) of the Public 
Health Service Act, as amended. The intent of the document is to 
provide a listing of agents, substances, mixtures, or exposure 
circumstances that are either known or reasonably anticipated to cause 
cancer in humans and to which a significant number of people in the 
United States are exposed. The NTP is following a multi-step scientific 
review process with multiple opportunities for public input for 
preparation of the 12th RoC (https://ntp.niehs.nih.gov/go/29353) that 
was announced in the Federal Register on April 16, 2007 (72 FR 18999). 
On several occasions, the NTP has published notices announcing 
candidate substances under consideration for review for the 12th RoC 
(69 FR 28940, 69 FR 62276, 70 FR 60548, 72 FR 26394). Publication of 
the RoC is intended to occur every two years (42 U.S.C. 301(b)(4)); 
however, in 2007, the NTP initiated a revised and extended review 
process for the 12th RoC (72 FR 18999). Although the NTP initially 
planned to review a larger set of candidate substances, in light of the 
time and resources required to carry out the review process, the NTP 
has now defined the set of eight candidate substances for the 12th RoC. 
The three draft substance profiles being peer-reviewed at this BSC 
meeting are the second and last set of candidate substances that the 
NTP intends to review for the 12th RoC. The draft substance profiles 
for the first set of five candidate substances for the 12th RoC were 
peer reviewed by the BSC at a meeting on February 24, 2009 (https://ntp.niehs.nih.gov/go/9741). Information about the review of candidate 
substances for the 12th RoC, including public comments and background 
documents, is available on the RoC Web site (https://ntp.niehs.nih.gov/go/10091) or from the RoC Center Director, Dr. Ruth Lunn (919-316-4637 
or lunn@niehs.nih.gov). The remaining candidate substances initially 
identified for possible review for the 12th RoC may be considered for 
the 13th RoC.

Background Information on 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 (https://ntp.niehs.nih.gov/, select 
``Nominations to the Testing Program'').
    Background documents for each nomination are available on the NTP 
Web site https://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 June 7, 2010 (see ``Request for 
Comments'' above), the NTP welcomes comments or additional information 
on these study nominations at any time.
    To facilitate review of the proposed research project by the BSC 
and the public, NTP staff developed a draft research concept document 
for the nomination recommended for study. A research concept is a brief 
document

[[Page 21005]]

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 a research concept 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 concept will be available on the BSC meeting page 
(https://ntp.niehs.nih.gov/go/165) by May 10, 2010.

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. The 
BSC usually meets biannually.

    Dated: April 13, 2010.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2010-9252 Filed 4-21-10; 8:45 am]
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