National Toxicology Program (NTP), NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Notice of Availability of the NICEATM Pre-Screen Evaluation of a Cell Proliferation Assay To Detect Estrogenic Activity: Request for Comments and Nominations of Other In Vitro Endocrine Disruptor Test Methods, 60748-60749 [E6-17134]
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<![CDATA[
60748
Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices
December 14, 1998 (Volume 63, Number
239, page 68782)]. The 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. Expert panels conduct
scientific evaluations of agents selected
by the CERHR in public forums.
The CERHR invites the nomination of
agents 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.
Shelby (see FOR FURTHER INFORMATION
CONTACT above). The CERHR selects
chemicals 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: October 5, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E6–17137 Filed 10–13–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP),
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Notice of
Availability of the NICEATM Pre-Screen
Evaluation of a Cell Proliferation Assay
To Detect Estrogenic Activity: Request
for Comments and Nominations of
Other In Vitro Endocrine Disruptor Test
Methods
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH), HHS.
ACTION: Report availability and request
for comments and nominations.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: In January 2006, the
Interagency Coordinating Committee on
Alternative Methods (ICCVAM) received
VerDate Aug<31>2005
16:16 Oct 13, 2006
Jkt 211001
a test method nomination for the
validation of a cell-based estrogen
receptor (ER) transcriptional activation
(TA) test method from CertiChem, Inc.
CertiChem, Inc. submitted a background
review document (BRD) containing
information on historical development
of the test method, the rationale for the
test method, and supporting materials.
In accordance with the ICCVAM
nomination process, NICEATM
conducted a pre-screen evaluation of the
BRD to determine the extent that it
addressed ICCVAM prioritization
criteria, submission guidelines, and
recommendations for standardization
and validation of in vitro endocrine
disruptor test methods. NICEATM also
reviewed the performance of the test
method based on pre-validation data to
determine if it warranted consideration
for further validation. ICCVAM requests
public comments on the pre-screen
evaluation titled, ‘‘Pre-Screen
Evaluation of the CertiChem, Inc. In
Vitro Endocrine Disruptor Assay
(Robotic MCF–7 Cell Proliferation Assay
of Estrogenic Activity.)’’ The pre-screen
evaluation is available with supporting
documents at (https://
iccvam.niehs.nih.gov/methods/
endocrine.htm). ICCVAM also invites
public comments on whether this test
method should be considered for
additional validation studies. In
addition, ICCVAM again invites the
nomination of other in vitro ER and
androgen receptor (AR) binding and TA
test methods for which there are
standardized test method protocols, prevalidation data, and proposed validation
study designs.
DATES: Comments and nominations
should be received by November 30,
2006.
ADDRESSES: Correspondence should be
sent by mail, fax, or e-mail to Dr.
William S. Stokes, NICEATM Director,
NIEHS, P.O. Box 12233, MD EC–17,
Research Triangle Park, NC 27709,
(phone) 919–541–2384, (fax) 919–541–
0947, (e-mail) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
In May 2003, ICCVAM published the
report, ‘‘ICCVAM Evaluation of In Vitro
Test Methods for Detecting Potential
Endocrine Disruptors: Estrogen Receptor
and Androgen Receptor Binding and
Transcriptional Activation Assays (NIH
Publication No. 03–4503; available:
https://iccvam.niehs.nih.gov/methods/
endocrine.htm). The report recommends
minimum procedural standards that
should be incorporated in standardized
test method protocols and minimum
lists of chemicals that should be used
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
for validation studies. A request was
made for nominations of validation
studies for in vitro ER and AR binding
and TA test methods based on these
recommendations and for which there
are standardized test method protocols,
pre-validation data, and proposed
validation study designs (69 FR 21564).
ICCVAM subsequently received a
nomination from CertiChem, Inc. for the
validation of a cell-based ER TA method
that evaluates the estrogenic activity of
substances by measuring whether and to
what extent a substance induces cell
proliferation via ER-dependent
pathways. In support of this
nomination, ICCVAM received a BRD
containing information on the test
method’s historical development, its
rationale, its protocol, and other
supporting materials. In accordance
with the ICCVAM nomination process,
NICEATM conducted a pre-screen
evaluation of the BRD to determine the
extent that it addressed ICCVAM
prioritization criteria, submission
guidelines, and recommendations for
standardization and validation of in
vitro endocrine disruptor test methods.
NICEATM also reviewed the
performance of the proposed test
method based on pre-validation data to
determine if it warranted consideration
for further validation. The BRD was
reviewed for completeness and to
identify aspects or omissions that could
impede further review. The criteria
considered in evaluating information
provided in the BRD are:
• The extent to which the BRD
addresses ICCVAM prioritization
criteria.
• The extent to which the BRD
provides the information requested in
the ICCVAM Guidelines for the
Nomination and Submission of New,
Revised, and Alternative Test Methods
(NIH Pub. No. 03–4508, available at
https://iccvam.niehs.nih.gov).
• The extent to which the proposed
test method adheres to the
recommendations of the ICCVAM
Evaluation of In Vitro Test Methods for
Detecting Potential Endocrine
Disruptors (NIH Pub. No. 03–4503,
available at https://iccvam.niehs.nih.gov/
methods/endocrine.htm), especially
those regarding essential test method
components and recommended
validation substances.
• The extent to which the proposed
test method shows adequate
performance (reliability and accuracy)
during pre-validation to warrant
consideration for validation studies.
Based on the pre-screen evaluation,
ICCVAM made a draft recommendation
that this test method be considered as a
high priority for validation studies to
E:\FR\FM\16OCN1.SGM
16OCN1
Federal Register / Vol. 71, No. 199 / Monday, October 16, 2006 / Notices
evaluate its usefulness and limitations
for detecting substances with in vitro
estrogenic agonist and antagonist
activity, and that standardization of an
anti-estrogenic protocol be developed
prior to starting the main validation
effort. ICCVAM will finalize its
recommendations on the priority for
future validation of this test method
after considering comments received
from the public and the Scientific
Advisory Committee on Alternative
Toxicological Methods (SACATM) at
their November 30, 2006 meeting.
ICCVAM also takes this opportunity
to again invite the nomination of other
in vitro ER and AR binding and TA test
methods for which there are
standardized test method protocols, prevalidation data, and proposed validation
study designs (see also 69 FR 21564).
When submitting written comments
and nominations please refer to this
Federal Register notice and include
appropriate contact information (name,
affiliation, mailing address, phone, fax,
e-mail and sponsoring organization, if
applicable). All comments received by
the deadline listed above will be placed
on the ICCVAM/NICEATM Web site and
made available to ICCVAM. In addition,
there will be an opportunity for oral
public comments on the draft ICCVAM
pre-screen evaluation during a meeting
of the SACATM scheduled for
November 30, 2006. Details of the
SACATM meeting are published as a
separate Federal Register notice (see
https://ntp.niehs.nih.gov/go/frn for the
Federal Register notice citation).
jlentini on PROD1PC65 with NOTICES
Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that use or generate toxicological
information. ICCVAM conducts
technical evaluations of new, revised,
and alternative methods with regulatory
applicability and promotes the scientific
validation and regulatory acceptance of
toxicological test methods that more
accurately assess the safety and hazards
of chemicals and products and that
refine, reduce, or replace animal use.
The ICCVAM Authorization Act of 2000
(42 U.S.C. 285) established ICCVAM as
a permanent interagency committee of
the NIEHS under the NICEATM.
NICEATM administers the ICCVAM and
provides scientific and operational
support for ICCVAM-related activities.
NICEATM and ICCVAM work
collaboratively to evaluate new and
improved test methods applicable to the
needs of Federal agencies. Additional
information about ICCVAM and
VerDate Aug<31>2005
16:16 Oct 13, 2006
Jkt 211001
NICEATM can be found at the following
Web site: https://iccvam.niehs.nih.gov.
Dated: October 5, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E6–17134 Filed 10–13–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
New Agency Information Collection
Activity Under OMB Review: National
Explosives Detection Canine Team
Program (NEDCTP), Training Course
Feedback Forms
Transportation Security
Administration, DHS.
ACTION: Notice.
AGENCY:
This notice announces that
the Transportation Security
Administration (TSA) has forwarded the
new Information Collection Request
(ICR) abstracted below to the Office of
Management and Budget (OMB) for
review and approval under the
Paperwork Reduction Act. The ICR
describes the nature of the information
collection and its expected burden. TSA
published a Federal Register notice,
with a 60-day comment period soliciting
comments, of the following collection of
information on August 9, 2006, 71 FR
45573.
SUMMARY:
Send your comments by
November 15, 2006. A comment to OMB
is most effective if OMB receives it
within 30 days of publication.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to Nathan Lesser, Desk Officer,
Department of Homeland Security/TSA,
and sent via electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–6974.
FOR FURTHER INFORMATION CONTACT:
Katrina Kletzly, Attorney-Advisor,
Office of the Chief Counsel, TSA–2,
Transportation Security Administration,
601 South 12th Street, Arlington, VA
22202–4220; telephone (571) 227–1995;
facsimile (571) 227–1381.
SUPPLEMENTARY INFORMATION:
DATES:
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
60749
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
Title: National Explosives Detection
Canine Team Program (NEDCTP),
Training Course Feedback Forms.
Type of Request: New collection.
OMB Control Number: Not yet
assigned.
Form(s): Training Course Feedback
Forms.
Affected Public: Canine course
participants.
Abstract: The National Explosives
Detection Canine Team Program
(NEDCTP) is a component of TSA’s
Office of Law Enforcement/Federal Air
Marshal Service and is a cooperative
partnership with participating airports
and mass transit systems. TSA provides
and trains the canines, and provides indepth training for the handlers. TSA
also partially reimburses the
participating agency for costs associated
with the teams, such as salaries,
overtime, canine food, and veterinary
care. Following training, TSA requests
that handlers and supervisors complete
TSA’s Training Course Feedback Form.
TSA will use the feedback results to
continuously evaluate the quality of
training, improve the course curriculum
and course of instruction, as well as
obtain new ideas, best practices, and
insight on the overall canine training
program.
Number of Respondents: 150.
Estimated Annual Burden Hours: An
estimated 150 hours annually.
Issued in Arlington, Virginia, on October
10, 2006.
Lisa S. Dean,
Privacy Officer.
[FR Doc. E6–17132 Filed 10–13–06; 8:45 am]
BILLING CODE 9110–05–P
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 71, Number 199 (Monday, October 16, 2006)]
[Notices]
[Pages 60748-60749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17134]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP), NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Notice of
Availability of the NICEATM Pre-Screen Evaluation of a Cell
Proliferation Assay To Detect Estrogenic Activity: Request for Comments
and Nominations of Other In Vitro Endocrine Disruptor Test Methods
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH), HHS.
ACTION: Report availability and request for comments and nominations.
-----------------------------------------------------------------------
SUMMARY: In January 2006, the Interagency Coordinating Committee on
Alternative Methods (ICCVAM) received a test method nomination for the
validation of a cell-based estrogen receptor (ER) transcriptional
activation (TA) test method from CertiChem, Inc. CertiChem, Inc.
submitted a background review document (BRD) containing information on
historical development of the test method, the rationale for the test
method, and supporting materials. In accordance with the ICCVAM
nomination process, NICEATM conducted a pre-screen evaluation of the
BRD to determine the extent that it addressed ICCVAM prioritization
criteria, submission guidelines, and recommendations for
standardization and validation of in vitro endocrine disruptor test
methods. NICEATM also reviewed the performance of the test method based
on pre-validation data to determine if it warranted consideration for
further validation. ICCVAM requests public comments on the pre-screen
evaluation titled, ``Pre-Screen Evaluation of the CertiChem, Inc. In
Vitro Endocrine Disruptor Assay (Robotic MCF-7 Cell Proliferation Assay
of Estrogenic Activity.)'' The pre-screen evaluation is available with
supporting documents at (https://iccvam.niehs.nih.gov/methods/
endocrine.htm). ICCVAM also invites public comments on whether this
test method should be considered for additional validation studies. In
addition, ICCVAM again invites the nomination of other in vitro ER and
androgen receptor (AR) binding and TA test methods for which there are
standardized test method protocols, pre-validation data, and proposed
validation study designs.
DATES: Comments and nominations should be received by November 30,
2006.
ADDRESSES: Correspondence should be sent by mail, fax, or e-mail to Dr.
William S. Stokes, NICEATM Director, NIEHS, P.O. Box 12233, MD EC-17,
Research Triangle Park, NC 27709, (phone) 919-541-2384, (fax) 919-541-
0947, (e-mail) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
In May 2003, ICCVAM published the report, ``ICCVAM Evaluation of In
Vitro Test Methods for Detecting Potential Endocrine Disruptors:
Estrogen Receptor and Androgen Receptor Binding and Transcriptional
Activation Assays (NIH Publication No. 03-4503; available: https://
iccvam.niehs.nih.gov/methods/endocrine.htm). The report recommends
minimum procedural standards that should be incorporated in
standardized test method protocols and minimum lists of chemicals that
should be used for validation studies. A request was made for
nominations of validation studies for in vitro ER and AR binding and TA
test methods based on these recommendations and for which there are
standardized test method protocols, pre-validation data, and proposed
validation study designs (69 FR 21564). ICCVAM subsequently received a
nomination from CertiChem, Inc. for the validation of a cell-based ER
TA method that evaluates the estrogenic activity of substances by
measuring whether and to what extent a substance induces cell
proliferation via ER-dependent pathways. In support of this nomination,
ICCVAM received a BRD containing information on the test method's
historical development, its rationale, its protocol, and other
supporting materials. In accordance with the ICCVAM nomination process,
NICEATM conducted a pre-screen evaluation of the BRD to determine the
extent that it addressed ICCVAM prioritization criteria, submission
guidelines, and recommendations for standardization and validation of
in vitro endocrine disruptor test methods. NICEATM also reviewed the
performance of the proposed test method based on pre-validation data to
determine if it warranted consideration for further validation. The BRD
was reviewed for completeness and to identify aspects or omissions that
could impede further review. The criteria considered in evaluating
information provided in the BRD are:
The extent to which the BRD addresses ICCVAM
prioritization criteria.
The extent to which the BRD provides the information
requested in the ICCVAM Guidelines for the Nomination and Submission of
New, Revised, and Alternative Test Methods (NIH Pub. No. 03-4508,
available at https://iccvam.niehs.nih.gov).
The extent to which the proposed test method adheres to
the recommendations of the ICCVAM Evaluation of In Vitro Test Methods
for Detecting Potential Endocrine Disruptors (NIH Pub. No. 03-4503,
available at https://iccvam.niehs.nih.gov/methods/endocrine.htm),
especially those regarding essential test method components and
recommended validation substances.
The extent to which the proposed test method shows
adequate performance (reliability and accuracy) during pre-validation
to warrant consideration for validation studies.
Based on the pre-screen evaluation, ICCVAM made a draft
recommendation that this test method be considered as a high priority
for validation studies to
[[Page 60749]]
evaluate its usefulness and limitations for detecting substances with
in vitro estrogenic agonist and antagonist activity, and that
standardization of an anti-estrogenic protocol be developed prior to
starting the main validation effort. ICCVAM will finalize its
recommendations on the priority for future validation of this test
method after considering comments received from the public and the
Scientific Advisory Committee on Alternative Toxicological Methods
(SACATM) at their November 30, 2006 meeting.
ICCVAM also takes this opportunity to again invite the nomination
of other in vitro ER and AR binding and TA test methods for which there
are standardized test method protocols, pre-validation data, and
proposed validation study designs (see also 69 FR 21564).
When submitting written comments and nominations please refer to
this Federal Register notice and include appropriate contact
information (name, affiliation, mailing address, phone, fax, e-mail and
sponsoring organization, if applicable). All comments received by the
deadline listed above will be placed on the ICCVAM/NICEATM Web site and
made available to ICCVAM. In addition, there will be an opportunity for
oral public comments on the draft ICCVAM pre-screen evaluation during a
meeting of the SACATM scheduled for November 30, 2006. Details of the
SACATM meeting are published as a separate Federal Register notice (see
https://ntp.niehs.nih.gov/go/frn for the Federal Register notice
citation).
Background Information on ICCVAM and NICEATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that use or generate
toxicological information. ICCVAM conducts technical evaluations of
new, revised, and alternative methods with regulatory applicability and
promotes the scientific validation and regulatory acceptance of
toxicological test methods that more accurately assess the safety and
hazards of chemicals and products and that refine, reduce, or replace
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285)
established ICCVAM as a permanent interagency committee of the NIEHS
under the NICEATM. NICEATM administers the ICCVAM and provides
scientific and operational support for ICCVAM-related activities.
NICEATM and ICCVAM work collaboratively to evaluate new and improved
test methods applicable to the needs of Federal agencies. Additional
information about ICCVAM and NICEATM can be found at the following Web
site: https://iccvam.niehs.nih.gov.
Dated: October 5, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E6-17134 Filed 10-13-06; 8:45 am]
BILLING CODE 4140-01-P
