National Toxicology Program; Hormonally-Induced Reproductive Tumors: Relevance of Rodent Bioassays Workshop, 74835-74836 [E5-7414]
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Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Notices
meeting are asked to bring 20 copies of
their statement or talking points for
distribution to the expert panel and for
the record.
Preliminary Agenda
The meeting begins each day at 8:30
a.m. . On March 15 and 16, it is
anticipated that a lunch break will occur
from noon-1 p.m. and the meeting will
adjourn at 5–6 p.m. The meeting is
anticipated to adjourn by noon on
March 17; however, adjournment may
occur earlier or later depending upon
the time needed by the expert panel to
complete its work. Anticipated agenda
topics for each day are listed below.
March 15, 2006
• Opening remarks
• Oral public comments (7 minutes per
speaker; one representative per group)
• Review of sections 1–4 of the draft
expert panel reports on genistein and
soy formula
• Discussion of Section 5.0 Summary,
Conclusions, and Critical Data Needs
March 16, 2006
• Discussion of Section 5.0 Summary,
Conclusions, and Critical Data Needs
• Preparation of draft summaries and
conclusion statements
March 17, 2006
• Presentation, discussion of, and
agreement on summaries,
conclusions, and data needs
• Closing comments
Expert Panel Roster
The CERHR expert panel is composed
of independent scientists selected for
their scientific expertise in reproductive
and/or developmental toxicology or
other areas of science relevant for these
evaluations.
Karl K. Rozman, Ph.D., D.A.B.T.
(Chair)—University of Kansas Medical
Center, Kansas City, KS
Jatinger Bhatia, M.B.B.S.—Medical
College of Georgia, Augusta, GA
Antonia M. Calafat, Ph.D.—National
Center for Environmental Health,
Centers for Disease Control and
Prevention, Atlanta, GA
Christina Chambers, Ph.D., M.P.H.—
University of California San Diego
Medical Center, San Diego, CA
Martine Culty, Ph.D.—Georgetown
University Medical Center,
Washington, DC
Ruth Ann Etzel, Ph.D.—Alaska Native
Medical Center, Anchorage, AK
Jody Anne Flaws, Ph.D.—University of
Maryland School of Medicine,
Baltimore, MD
Deborah K. Hansen, Ph.D.—National
Center for Toxicological Research,
Jefferson, Arkansas
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19:37 Dec 15, 2005
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Patricia B. Hoyer, Ph.D.—University of
Arizona, Tucson, AZ
Elizabeth Hutt Jeffery, Ph.D.—
University of Illinois, Urbana, IL
James S. Kesner, Ph.D.—National
Institute for Occupational Safety and
Health, Cincinnati, OH
M. Sue Marty, Ph.D.—The Dow
Chemical Company, Midland, MI
John A. Thomas, Ph.D.—University of
Texas, San Antonio, TX
David M. Umbach, Ph.D.—National
Institute of Environmental Health
Sciences, Research Triangle Park, NC
Background Information on the CERHR
The NTP established CERHR in June
1998 [Federal Register, December 14,
1998 (Volume 63, Number 239, page
68782)]. CERHR is a publicly accessible
resource for information about adverse
reproductive and/or developmental
health effects associated with
environmental and/or occupational
exposures. Expert panels conduct
scientific evaluations of environmental
chemicals, drugs, physical agents, or
mixtures (collectively referred to as
‘‘substances’’) selected by the CERHR in
public forums.
The CERHR invites the nomination of
substances for expert panel evaluation
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.
Shelby (see ADDRESSES above). 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.
CERHR follows a formal, multi-step
process for review and evaluation of
selected chemicals. The formal
evaluation process was published in the
Federal Register on July 16, 2001
(Volume 66, Number 136, pages 37047–
37048) and is available on the CERHR
Web site under ‘‘About CERHR’’ or in
printed copy from the CERHR.
Dated: December 5, 2005.
David A. Schwartz,
Director, National Institute of Environmental
Health Sciences and the National Toxicology
Program.
[FR Doc. E5–7412 Filed 12–15–05; 8:45 am]
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74835
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program;
Hormonally-Induced Reproductive
Tumors: Relevance of Rodent
Bioassays Workshop
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
AGENCY:
ACTION:
Workshop announcement.
SUMMARY: For more than a quarter
century, the National Toxicology
Program (NTP) testing program has
provided extensive and useful scientific
information for predicting human health
hazards and protecting public health.
The NTP periodically conducts reviews
of animal models used in its bioassays
to critically analyze their predictive
power and determine whether the
protocols for these studies should be
altered. As part of this effort, the NTP
is convening a workshop titled
‘‘Hormonally-Induced Reproductive
Tumors: Relevance of Rodent
Bioassays.’’ The 21⁄2 day workshop will
be held on May 22–24, 2006, at the
Marriott Raleigh Crabtree Valley, 4500
Marriott Drive, Raleigh, NC 27612.
The workshop’s overall goal is to
determine the adequacy and relevance
to human disease outcome of rodent
models for four types of hormonallyinduced reproductive tumors (ovary,
mammary gland, prostate, and testis).
Other topics for discussion include
proposed modes of action (for each
tumor type and for hormonal tumors in
general), dose response for tumor
induction, predictiveness of rodent preneoplastic events for humans, the
importance of the inclusion of an in
utero exposure in the etiology of
specific tumors, and the concept of
‘‘additivity to background’’ when
normal hormones are present with
homeostatic control mechanisms. The
program will include plenary sessions
as well as four breakout group sessions
for in-depth discussions.
This meeting is open to the public
with time set aside for public
comments. Attendance is limited by the
space available to approximately 100
public attendees. Individuals may
register to attend the workshop on a
first-come, first-served basis per the
procedures outlined below. A copy of
the agenda and any additional
information about the workshop,
including background materials, public
comments, and invited participants,
will be posted on the NTP Web site
when available (see NTP Web site
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74836
Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Notices
https://ntp.niehs.nih.gov select
‘‘Meetings and Workshops’’).
DATES: The workshop will be held on
May 22–24, 2006. The workshop will
begin each day at 8:30 a.m. and end at
approximately 5 p.m. on May 22–23 and
approximately 12 p.m. on May 24.
Comments: Written comments should
be received by May 12, 2006, to allow
time for adequate review before the
meeting (see FOR FURTHER INFORMATION
CONTACT below). Individuals wishing to
make oral public comments are asked to
contact Dr. Paul Foster (see FOR FURTHER
INFORMATION CONTACT below) by March
12, 2006, and if possible, also to send a
copy of the statement or talking points
at that time.
Registration: Individuals who plan to
attend are encouraged to register online
at the NTP Web site https://
ntp.niehs.nih.gov/ select ‘‘Meetings and
Workshops’’ as soon as possible because
seating is limited to approximately 100
public attendees. Persons needing
special assistance, such as sign language
interpretation or other reasonable
accommodation in order to attend,
should contact 919–541–2475 voice,
919–541–4644 TTY (text telephone),
through the Federal TTY Relay System
at 800–877–8339, or by e-mail to
niehsoeeo@niehs.nih.gov. Requests
should be made at least 7 days in
advance of the event.
ADDRESSES: The workshop will be held
at the Marriott Raleigh Crabtree Valley,
4500 Marriott Drive, Raleigh, North
Carolina 27612.
FOR FURTHER INFORMATION CONTACT:
Correspondence should be submitted to
Dr. Paul Foster (NIEHS, P. O. Box
12233, MD EC–34, Research Triangle
Park, NC, 27709; telephone: 919–541–
2513, fax: 919–541–4255; or e-mail:
foster2@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Background
The workshop will include plenary
sessions as well as four simultaneous
breakout group sessions for in-depth
discussion of the topics mentioned
above. Each breakout group will address
the following topics for a specific tumor
type (ovary, mammary gland, prostate,
or testis), relevance to human disease
outcome of rodent models, proposed
modes of action, dose response for
tumor induction, predictiveness of
rodent pre-neoplastic events for
humans, the importance of the inclusion
of an in utero exposure in the etiology
of specific tumors, and the concept of
‘‘additivity to background’’ when
normal hormones are present with
homeostatic control mechanisms. The
VerDate Aug<31>2005
19:37 Dec 15, 2005
Jkt 208001
NTP will prepare a workshop report
following the meeting.
Request for Comments
Public input at this meeting is invited
and time is set aside for the presentation
of public comments during the plenary
session on May 22, 2006. Each
organization is allowed one speaker
during the public comment period. At
least 7 minutes will be allotted to each
speaker, and if time permits, may be
extended to 10 minutes. Registration for
oral comments will also be available onsite, 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.
Written statements can supplement
and may expand the oral presentation.
If registering on-site and reading from
written text, please bring 50 copies of
the statement for distribution and to
supplement the record. Written
comments received in response to this
notice will be posted on the NTP Web
site (https://ntp.niehs.nih.gov select
‘‘Meetings and Workshops’’). Persons
submitting written comments should
include their name, affiliation, mailing
address, phone, fax, e-mail, and
sponsoring organization (if any) with
the document.
Dated: December 5, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences.
[FR Doc. E5–7414 Filed 12–15–05; 8:45 am]
BILLING CODE 4140–01–P
Transportation Security Policy, TSA–9,
Transportation Security Administration,
601 South 12th Street, Arlington, VA
22202–4220.
FOR FURTHER INFORMATION CONTACT:
Katrina Wawer at the above address or
by telephone (571) 227–1995 or
facsimile (571) 227–2594.
SUPPLEMENTARY INFORMATION:
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995, (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information,
unless it displays a valid OMB control
number. Therefore, in preparation for
OMB review and approval of the
following information collection, TSA is
soliciting comments to—
(1) Evaluate whether the proposed
information requirement is necessary for
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Information Collection Requirement
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
Intent To Request Renewal From OMB
of One Current Public Collection of
Information: Security Programs for
Indirect Air Carriers
Transportation Security
Administration (TSA), DHS.
ACTION: Notice.
AGENCY:
SUMMARY: TSA invites public comment
on one currently approved information
collection requirement abstracted below
that we will submit to the Office of
Management and Budget (OMB) for
renewal in compliance with the
Paperwork Reduction Act.
DATES: Send your comments by
February 14, 2006.
ADDRESSES: Katrina Wawer, Information
Collection Specialist, Office of
PO 00000
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1652–0004; Security Programs for
Indirect Air Carriers, 49 CFR part 1548.
This rule prescribes aviation security
rules governing each person (including
air freight forwarder and any
cooperative shippers’ association)
engaged, or who intends to be engaged,
indirectly in the air transportation of
package cargo that is intended for
carriage aboard a passenger-carrying air
carrier aircraft inside the United States.
TSA requires that such carriers maintain
records of their security programs and
make those documents available for
inspection upon request by any TSA
Inspector. The current estimated annual
burden is 1,306 hours.
Issued in Arlington, Virginia, on December
8, 2005.
Lisa S. Dean,
Privacy Officer.
[FR Doc. E5–7406 Filed 12–15–05; 8:45 am]
BILLING CODE 4910–62–P
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]]>Agencies
[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Notices]
[Pages 74835-74836]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7414]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program; Hormonally-Induced Reproductive
Tumors: Relevance of Rodent Bioassays Workshop
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Workshop announcement.
-----------------------------------------------------------------------
SUMMARY: For more than a quarter century, the National Toxicology
Program (NTP) testing program has provided extensive and useful
scientific information for predicting human health hazards and
protecting public health. The NTP periodically conducts reviews of
animal models used in its bioassays to critically analyze their
predictive power and determine whether the protocols for these studies
should be altered. As part of this effort, the NTP is convening a
workshop titled ``Hormonally-Induced Reproductive Tumors: Relevance of
Rodent Bioassays.'' The 2\1/2\ day workshop will be held on May 22-24,
2006, at the Marriott Raleigh Crabtree Valley, 4500 Marriott Drive,
Raleigh, NC 27612.
The workshop's overall goal is to determine the adequacy and
relevance to human disease outcome of rodent models for four types of
hormonally-induced reproductive tumors (ovary, mammary gland, prostate,
and testis). Other topics for discussion include proposed modes of
action (for each tumor type and for hormonal tumors in general), dose
response for tumor induction, predictiveness of rodent pre-neoplastic
events for humans, the importance of the inclusion of an in utero
exposure in the etiology of specific tumors, and the concept of
``additivity to background'' when normal hormones are present with
homeostatic control mechanisms. The program will include plenary
sessions as well as four breakout group sessions for in-depth
discussions.
This meeting is open to the public with time set aside for public
comments. Attendance is limited by the space available to approximately
100 public attendees. Individuals may register to attend the workshop
on a first-come, first-served basis per the procedures outlined below.
A copy of the agenda and any additional information about the workshop,
including background materials, public comments, and invited
participants, will be posted on the NTP Web site when available (see
NTP Web site
[[Page 74836]]
https://ntp.niehs.nih.gov select ``Meetings and Workshops'').
DATES: The workshop will be held on May 22-24, 2006. The workshop will
begin each day at 8:30 a.m. and end at approximately 5 p.m. on May 22-
23 and approximately 12 p.m. on May 24.
Comments: Written comments should be received by May 12, 2006, to
allow time for adequate review before the meeting (see FOR FURTHER
INFORMATION CONTACT below). Individuals wishing to make oral public
comments are asked to contact Dr. Paul Foster (see FOR FURTHER
INFORMATION CONTACT below) by March 12, 2006, and if possible, also to
send a copy of the statement or talking points at that time.
Registration: Individuals who plan to attend are encouraged to
register online at the NTP Web site https://ntp.niehs.nih.gov/ select
``Meetings and Workshops'' as soon as possible because seating is
limited to approximately 100 public attendees. Persons needing special
assistance, such as sign language interpretation or other reasonable
accommodation in order to attend, should contact 919-541-2475 voice,
919-541-4644 TTY (text telephone), through the Federal TTY Relay System
at 800-877-8339, or by e-mail to niehsoeeo@niehs.nih.gov. Requests
should be made at least 7 days in advance of the event.
ADDRESSES: The workshop will be held at the Marriott Raleigh Crabtree
Valley, 4500 Marriott Drive, Raleigh, North Carolina 27612.
FOR FURTHER INFORMATION CONTACT: Correspondence should be submitted to
Dr. Paul Foster (NIEHS, P. O. Box 12233, MD EC-34, Research Triangle
Park, NC, 27709; telephone: 919-541-2513, fax: 919-541-4255; or e-mail:
foster2@niehs.nih.gov).
SUPPLEMENTARY INFORMATION:
Background
The workshop will include plenary sessions as well as four
simultaneous breakout group sessions for in-depth discussion of the
topics mentioned above. Each breakout group will address the following
topics for a specific tumor type (ovary, mammary gland, prostate, or
testis), relevance to human disease outcome of rodent models, proposed
modes of action, dose response for tumor induction, predictiveness of
rodent pre-neoplastic events for humans, the importance of the
inclusion of an in utero exposure in the etiology of specific tumors,
and the concept of ``additivity to background'' when normal hormones
are present with homeostatic control mechanisms. The NTP will prepare a
workshop report following the meeting.
Request for Comments
Public input at this meeting is invited and time is set aside for
the presentation of public comments during the plenary session on May
22, 2006. Each organization is allowed one speaker during the public
comment period. At least 7 minutes will be allotted to each speaker,
and if time permits, may be extended to 10 minutes. 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.
Written statements can supplement and may expand the oral
presentation. If registering on-site and reading from written text,
please bring 50 copies of the statement for distribution and to
supplement the record. Written comments received in response to this
notice will be posted on the NTP Web site (https://ntp.niehs.nih.gov
select ``Meetings and Workshops''). Persons submitting written comments
should include their name, affiliation, mailing address, phone, fax, e-
mail, and sponsoring organization (if any) with the document.
Dated: December 5, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. E5-7414 Filed 12-15-05; 8:45 am]
BILLING CODE 4140-01-P
