Independent Scientific Peer Review Panel Meeting on an In Vitro, 4113-4115 [2011-1329]
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Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Notices
B. Annual Reporting Burden
Public reporting burden for this
collection of information is estimated to
average 2 hours per request for
commercial financing and 2 hours per
request for performance-based
financing, including the time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing the collection
of information.
The annual reporting burden for
commercial financing is estimated as
follows:
Respondents: 1,000.
Responses per Respondent: 5.
Total Responses: 5,000.
Hours per Response: 2.
Total Burden Hours: 10,000.
The annual reporting burden for
performance-based financing is
estimated as follows:
Respondents: 500.
Responses per Respondent: 12.
Total Responses: 6,000.
Hours per Response: 2.
Total Burden Hours: 12,000.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCA), 1275
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telephone (202) 501–4755. Please cite
OMB Control No. 9000–0138, Contract
Financing, in all correspondence.
Dated: January 13, 2011.
Millisa Gary,
Acting Director, Office of Governmentwide
Acquisition Policy.
blog.citizen.apps.gov/
GSA_PSC_Manual/. Comments on the
draft PSC Manual must be posted at
https://blog.citizen.apps.gov/
GSA_PSC_Manual, ‘‘Comments’’ section,
between February 8, 2011 and March 9,
2011.
FOR FURTHER INFORMATION CONTACT: Ms.
Pat Brooks at pat.brooks@gsa.gov.
SUPPLEMENTARY INFORMATION:
The Products and Services Code (PSC)
Manual provides codes to describe
products, services, and research and
development purchased by the
government. The codes are one of the
data elements reported in the Federal
Procurement Data System (FPDS). GSA,
which maintains the PSC Manual, is in
the process of updating the manual. The
changes will include updating the
descriptions, adding or deleting codes
as necessary, and adding
environmental/sustainability attributes
required for reporting to the Office of
Management and Budget.
A draft of the proposed PSC Manual
will be posted in a GSA blog
application, https://
blog.citizen.apps.gov/
GSA_PSC_Manual/ on February 8, 2011.
There will be a ‘‘Comment’’ section in
the blog. A thirty (30) day comment
period will be available.
Dated: January 18, 2011.
Rodney Lantier,
Assistant Deputy Associate Administrator,
Office of Acquisition Policy, Office of
Governmentwide Policy.
[FR Doc. 2011–1291 Filed 1–21–11; 8:45 am]
BILLING CODE 6820–34–P
[FR Doc. 2011–1290 Filed 1–21–11; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
GENERAL SERVICES
ADMINISTRATION
[Docket No. 2011–0006; Sequence 2]
Federal Procurement Data System
Product Service Code Manual Update
Office of Governmentwide
Policy, General Services Administration
(GSA).
ACTION: Notice.
AGENCY:
This notice announces that
the Products and Services Code (PSC)
Manual, which provides codes to
describe products, services, and
research and development purchased by
the government, is in the process of
being updated; GSA, which maintains
the PSC Manual, is in the process of
updating the manual.
DATES: Effective date: January 24, 2011.
Comment date: A draft of the PSC
Manual will be posted at https://
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SUMMARY:
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Independent Scientific Peer Review
Panel Meeting on an In Vitro Estrogen
Receptor Transcriptional Activation
Test Method for Endocrine Disruptor
Chemical Screening; National
Toxicology Program (NTP); NTP
Interagency Center for the Evaluation
of Alternative Toxicological Methods
(NICEATM); Announcement of an
Independent Scientific Peer Review
Panel Meeting on an In Vitro Estrogen
Receptor Transcriptional Activation
Test Method for Endocrine Disruptor
Chemical Screening; Availability of
Draft Background Review Document
(BRD); Request for Comments
National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH), HHS.
ACTION: Meeting announcement and
request for comments.
AGENCY:
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NICEATM, in collaboration
with the Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM),
announces a public meeting of an
independent scientific peer review
panel (Panel) to evaluate the validation
status of LUMI–CELL® ER (BG1Luc ER
TA), an in vitro transcriptional
activation (TA) assay used to identify
chemicals that can interact with human
estrogen receptors (ERs). Validated
assays that can detect the interaction of
chemicals with specific hormone
receptors, including ERs, have been
accepted and included in the U.S.
Environmental Protection Agency (EPA)
Endocrine Disruptor Screening Program
(EDSP) (https://www.epa.gov/endo/pubs/
assayvalidation/status.htm).
Consequently, the BG1Luc ER TA may
be applicable for addressing the ER TA
component of the EPA EDSP Tier 1
screening battery.
At this meeting, the Panel will review
the draft BRD for the BG1Luc ER TA
and evaluate the extent to which
established validation and acceptance
criteria have been appropriately
addressed. The Panel also will be asked
to comment on the extent to which the
information included in the BRD
supports ICCVAM’s draft test method
recommendations.
NICEATM invites public comments
on the draft BRD and draft ICCVAM test
method recommendations. These
documents are available on the
NICEATM–ICCVAM Web site at:
https://iccvam.niehs.nih.gov/methods/
endocrine/PeerPanel11.htm.
DATES: The meeting will be held on
March 29–30, 2011, from 8:30 a.m. to
5 p.m. each day. In order to facilitate
planning for this meeting, persons
wishing to attend are asked to register
by March 15, 2011, via the NICEATM–
ICCVAM Web site (https://
iccvam.niehs.nih.gov/contact/reg-formEDpanel.htm). Comments should be
sent by March 10, 2011.
ADDRESSES: The meeting will be held at
the National Institutes of Health (NIH),
William H. Natcher Conference Center,
45 Center Drive, Bethesda, MD 20892.
Persons needing special assistance in
order to attend, such as sign language
interpretation or other reasonable
accommodation, should contact 301–
402–8180 (voice) or 301–435–1908 TTY
(text telephone) at least seven business
days before the event.
FOR FURTHER INFORMATION CONTACT: Dr.
Warren Casey, Deputy Director,
NICEATM, NIEHS, P.O. Box 12233,
Mail Stop: K2–16, Research Triangle
Park, NC 27709, (telephone) 919–541–
2384, (fax) 919–541–0947, (e-mail)
SUMMARY:
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Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Notices
niceatm@niehs.nih.gov. Courier address:
NICEATM, NIEHS, 530 Davis Drive,
Room 2035, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
mstockstill on DSKH9S0YB1PROD with NOTICES
Background
In January 2004, Xenobiotics
Detection Systems, Inc. (XDS, Durham,
NC) nominated their LUMI–CELL® TA
(BG1Luc ER TA) Test Method for an
interlaboratory validation study to be
coordinated by NICEATM. This method
uses BG–1 cells, a human ovarian
carcinoma cell line that was stably
transfected with an estrogen-responsive
luciferase reporter gene, to measure
whether and to what extent a substance
induces or inhibits TA activity via ER
mediated pathways. Included in the
nomination package were test results
from XDS for 56 of the 78 ICCVAM
Reference Substances for agonist
activity and 16 of the 78 ICCVAM
Reference Substances for antagonist
activity. These studies were funded
primarily by a Small Business
Innovation Research (SBIR) grant
(SBIR43ES010533–01) from the NIEHS.
In accordance with the ICCVAM
nomination process, NICEATM
conducted a pre-screen evaluation of the
nomination package to determine the
extent to which it addressed the
ICCVAM prioritization criteria and
adherence to the ICCVAM
recommendations for the
standardization and validation of in
vitro endocrine disruptor test methods.
Based on this evaluation, ICCVAM
recommended a high priority for
validation studies for the BG1Luc ER
TA test method. The NIEHS
subsequently agreed to support the
validation study in light of its
participation as one of the three NTP
agencies, whose mission includes the
development and validation of
improved testing methods.
The international interlaboratory
validation study of the BG1Luc ER TA
test method has been completed. The
study included three laboratories
sponsored by NICEATM, the European
Centre for the Validation of Alternative
Methods, and the Japanese Center for
the Validation of Alternative Methods.
NICEATM and ICCVAM have
prepared a draft BRD that provides
comprehensive summaries of data,
analyses of test method accuracy and
reliability, and related information
characterizing the current validation
status of the test method. The draft BRD
forms the basis for ICCVAM test method
recommendations on usefulness and
limitations, standardized test method
protocols, future studies, and
performance standards.
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Peer Review Panel Meeting
This meeting will take place March
29–30, 2011, at the National Institutes of
Health (NIH) William H. Natcher
Conference Center, 45 Center Drive,
Bethesda, MD 20892. It will begin at
8:30 a.m. and is scheduled to conclude
each day at approximately 5 p.m. The
meeting is open to the public at no
charge, with attendance limited only by
the space available. The Panel will
consider the draft ICCVAM BRD,
recommendations, and performance
standards for the test method and
evaluate the extent to which the draft
ICCVAM test method recommendations
are supported by the information
provided in the draft BRD.
Additional information about the
meeting, including a roster of the Panel
members and the draft agenda, will be
posted on the NICEATM–ICCVAM Web
site at https://iccvam.niehs.nih.gov/
methods/endocrine/PeerPanel11.htm
two weeks before the meeting. This
information will also be available after
that date by contacting NICEATM (see
FOR FURTHER INFORMATION CONTACT).
Attendance and Registration
In order to facilitate planning for this
meeting, persons wishing to attend are
asked to register by March 15, 2011, via
the NICEATM–ICCVAM Web site at
https://iccvam.niehs.nih.gov/contact/regform-EDpanel.htm.
Availability of the Documents
The draft BRD and draft ICCVAM test
method recommendations will be
posted no later than February 1, 2011 on
the NICEATM–ICCVAM Web site
(https://iccvam.niehs.nih.gov/methods/
endocrine/PeerPanel11.htm) or may be
obtained by contacting NICEATM (see
FOR FURTHER INFORMATION CONTACT).
Request for Public Comments
NICEATM invites the submission of
written comments on the draft BRD,
draft ICCVAM test method
recommendations, and draft
performance standards by March 10,
2011. NICEATM prefers that comments
be submitted electronically via the
NICEATM–ICCVAM Web site (https://
iccvam.niehs.nih.gov/contact/
FR_pubcomment.htm) or via e-mail to
niceatm@niehs.nih.gov. Written
comments may also be sent by mail, fax,
or e-mail to Dr. Casey (see FOR FURTHER
INFORMATION CONTACT). When submitting
written comments, 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). NICEATM will post all
comments on the NICEATM–ICCVAM
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Web site (https://iccvam.niehs.nih.gov)
identified by the individual’s name and
affiliation or sponsoring organization (if
applicable). NICEATM will provide
these comments to the Panel and
ICCVAM agency representatives and
make them available to the public at the
meeting.
Opportunity will be provided for
members of the public to present oral
comments at designated times during
the peer review. Up to seven minutes
will be allotted per speaker. If you wish
to present oral statements at the meeting
(one speaker per organization), contact
NICEATM (see FOR FURTHER
INFORMATION CONTACT) by March 2, 2011.
Please provide a written copy of your
comments with contact information
(name, affiliation, mailing address,
phone, fax, e-mail, and sponsoring
organization, if applicable) when
registering to make oral comments. If it
is not possible to provide a copy of your
statement in advance, please bring 40
copies to the meeting for distribution to
the Panel and to supplement the record.
Written statements can supplement and
expand the oral presentation. Please
provide NICEATM with copies of any
supplementary written statement using
the guidelines outlined above.
Summary minutes and the Panel’s
final report will be available following
the meeting on the NICEATM–ICCVAM
Web site (https://iccvam.niehs.nih.gov).
ICCVAM will consider the Panel’s
conclusions and recommendations and
any public comments received in
finalizing their test method
recommendations for the test method.
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 and
safety testing information. ICCVAM
conducts technical evaluations of new,
revised, and alternative methods with
regulatory applicability and promotes
the scientific validation and regulatory
acceptance of toxicological and safetytesting methods that more accurately
assess the safety and hazards of
chemicals and products and that reduce,
refine (decrease or eliminate pain and
distress), and replace animal use. The
ICCVAM Authorization Act of 2000 (42
U.S.C. 285l-3, available at https://
iccvam.niehs.nih.gov/docs/about_docs/
PL106545.pdf) established ICCVAM as a
permanent interagency committee of the
NIEHS under NICEATM. NICEATM
administers ICCVAM and provides
scientific and operational support for
ICCVAM-related activities. NICEATM
and ICCVAM work collaboratively to
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Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Notices
evaluate new and improved test
methods applicable to the needs of
Federal agencies. Additional
information about ICCVAM and
NICEATM is available on the
NICEATM–ICCVAM Web site at https://
iccvam.niehs.nih.gov.
Dated: January 13, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–1329 Filed 1–21–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Meeting of the Task Force on
Community Preventive Services
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)
announces the next meeting of the Task
Force on Community Preventive
Services (Task Force). The Task Force—
an independent, nonfederal body of
nationally known leaders in public
health practice, policy, and research
who are appointed by the CDC
Director—was convened in 1996 by the
Department of Health and Human
Services (HHS) to assess the
effectiveness of community,
environmental, population, and
healthcare system interventions in
public health and health promotion.
During this meeting the Task Force will
consider the findings of systematic
reviews and issue recommendations and
findings to help inform decision making
about policy, practice, and research in a
wide range of U.S. settings. The Task
Force’s recommendations, along with
the systematic reviews of the scientific
evidence on which they are based, are
compiled in the Guide to Community
Preventive Services (Community Guide).
DATES: The meeting will be held on
Wednesday, February, 16, 2011 from
8:30 a.m. to 5:30 p.m. EST and
Thursday, February 17, 2011 from 8:30
a.m. to 1 p.m. EST.
ADDRESSES: Atlanta Marriott Century
Center, 2000 Century Blvd., NE.,
Atlanta, GA.
FOR FURTHER INFORMATION CONTACT: Sara
Dodge, Division of Community
Preventive Services, Epidemiology and
Analysis Program Office, Office of
Surveillance, Epidemiology, and
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SUMMARY:
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Laboratory Services, Centers for Disease
Control and Prevention, 1600 Clifton
Road, Atlanta, Georgia 30333, phone:
(404) 498–0554, e-mail:
communityguide@cdc.gov.
Purpose:
The purpose of the meeting is for the
Task Force to consider the findings of
reviews and issue recommendations and
findings to help inform decision making
about policy, practice, and research in a
wide range of U.S. settings.
Matters To Be Discussed:
Effectiveness of small media clientoriented screening interventions to
decrease breast, cervical and colorectal
cancers; privatization of alcohol retail
sales; school dismissal policy to reduce
influenza transmission; client or family
incentives to reduce vaccine
preventable diseases; clinic based
education when used alone to reduce
vaccine preventable diseases; and
extended school hours to promote
health equity. New reviews on
cardiovascular disease and skin cancer
will also be discussed.
Meeting Accessibility: This meeting is
open to the public, limited only by
space available.
SUPPLEMENTARY INFORMATION:
Dated: January 7, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–1302 Filed 1–21–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH–156]
Request for the Technical Review of
the Draft Current Intelligence Bulletin
(CIB): Derivation of Immediately
Dangerous to Life and Health (IDLH)
Values
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of public comment
period.
AGENCY:
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC) is
conducting a public review of the draft,
Current Intelligence Bulletin (CIB):
Derivation of Immediately Dangerous to
Life and Health (IDLH) Values. NIOSH
SUMMARY:
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4115
is requesting technical review of the
draft CIB. The draft document and
instructions for submitting comments
can be found at https://www.cdc.gov/
niosh/docket/review/docket156/
default.html.
Public Comment Period: Comments
must be received by March 15, 2011.
A public meeting to be convened
either in Cincinnati, Ohio or via
Teleweb may be scheduled at a date and
time to be announced later if
determined to be necessary. This public
meeting will be announced via a
subsequent notice.
ADDRESSES: Written comments,
identified by docket number NIOSH–
156, may be submitted by any of the
following ways:
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 4676
Columbia Parkway, Cincinnati, OH
45226.
• Facsimile: (513) 533–8285.
• E-mail: nioshdocket@cdc.gov.
All information received in response
to this notice will be available for public
examination and copying at the NIOSH
Docket Office, 4676 Columbia Parkway,
Room 111, Cincinnati, Ohio 45226. A
complete electronic docket containing
all comments submitted will be
available on the NIOSH Web page at
https://www.cdc.gov/niosh/docket, and
comments will be available in writing
by request. NIOSH includes all
comments received without change in
the docket, including any personal
information provided. All electronic
comments should be formatted as
Microsoft Word. Please make reference
to docket number NIOSH 156.
FOR FURTHER INFORMATION CONTACT: G.
Scott Dotson, NIOSH, Robert A. Taft
Laboratories, MS–C32, 4676 Columbia
Parkway, Cincinnati, OH 45226,
telephone (513) 533–8540.
SUPPLEMENTARY INFORMATION: In 1974,
the National Institute for Occupational
Safety and Health (NIOSH) and the
Occupational Safety and Health
Administration (OSHA) jointly initiated
the development of occupational health
standards consistent with Section 6(b)
of the Occupational Safety and Health
Act of 1970 for substances with thenexisting OSHA permissible exposure
limits (PELs). This joint effort was
called the Standards Completion
Program (SCP). As part of the respirator
selection process for each draft
technical standard, Immediately
Dangerous to Life and Health (IDLH)
values were determined for each
chemical. The purpose of deriving an
IDLH value was to provide guidance on
respirator selection and to establish a
maximum exposure concentration in
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Agencies
[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4113-4115]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1329]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Independent Scientific Peer Review Panel Meeting on an In Vitro
Estrogen Receptor Transcriptional Activation Test Method for Endocrine
Disruptor Chemical Screening; National Toxicology Program (NTP); NTP
Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM); Announcement of an Independent Scientific Peer
Review Panel Meeting on an In Vitro Estrogen Receptor Transcriptional
Activation Test Method for Endocrine Disruptor Chemical Screening;
Availability of Draft Background Review Document (BRD); Request for
Comments
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH), HHS.
ACTION: Meeting announcement and request for comments.
-----------------------------------------------------------------------
SUMMARY: NICEATM, in collaboration with the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM), announces
a public meeting of an independent scientific peer review panel (Panel)
to evaluate the validation status of LUMI-CELL[supreg] ER (BG1Luc ER
TA), an in vitro transcriptional activation (TA) assay used to identify
chemicals that can interact with human estrogen receptors (ERs).
Validated assays that can detect the interaction of chemicals with
specific hormone receptors, including ERs, have been accepted and
included in the U.S. Environmental Protection Agency (EPA) Endocrine
Disruptor Screening Program (EDSP) (https://www.epa.gov/endo/pubs/assayvalidation/status.htm). Consequently, the BG1Luc ER TA may be
applicable for addressing the ER TA component of the EPA EDSP Tier 1
screening battery.
At this meeting, the Panel will review the draft BRD for the BG1Luc
ER TA and evaluate the extent to which established validation and
acceptance criteria have been appropriately addressed. The Panel also
will be asked to comment on the extent to which the information
included in the BRD supports ICCVAM's draft test method
recommendations.
NICEATM invites public comments on the draft BRD and draft ICCVAM
test method recommendations. These documents are available on the
NICEATM-ICCVAM Web site at: https://iccvam.niehs.nih.gov/methods/endocrine/PeerPanel11.htm.
DATES: The meeting will be held on March 29-30, 2011, from 8:30 a.m. to
5 p.m. each day. In order to facilitate planning for this meeting,
persons wishing to attend are asked to register by March 15, 2011, via
the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov/contact/reg-form-EDpanel.htm). Comments should be sent by March 10, 2011.
ADDRESSES: The meeting will be held at the National Institutes of
Health (NIH), William H. Natcher Conference Center, 45 Center Drive,
Bethesda, MD 20892. Persons needing special assistance in order to
attend, such as sign language interpretation or other reasonable
accommodation, should contact 301-402-8180 (voice) or 301-435-1908 TTY
(text telephone) at least seven business days before the event.
FOR FURTHER INFORMATION CONTACT: Dr. Warren Casey, Deputy Director,
NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research Triangle
Park, NC 27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail)
[[Page 4114]]
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, 530 Davis
Drive, Room 2035, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
In January 2004, Xenobiotics Detection Systems, Inc. (XDS, Durham,
NC) nominated their LUMI-CELL[supreg] TA (BG1Luc ER TA) Test Method for
an interlaboratory validation study to be coordinated by NICEATM. This
method uses BG-1 cells, a human ovarian carcinoma cell line that was
stably transfected with an estrogen-responsive luciferase reporter
gene, to measure whether and to what extent a substance induces or
inhibits TA activity via ER mediated pathways. Included in the
nomination package were test results from XDS for 56 of the 78 ICCVAM
Reference Substances for agonist activity and 16 of the 78 ICCVAM
Reference Substances for antagonist activity. These studies were funded
primarily by a Small Business Innovation Research (SBIR) grant
(SBIR43ES010533-01) from the NIEHS.
In accordance with the ICCVAM nomination process, NICEATM conducted
a pre-screen evaluation of the nomination package to determine the
extent to which it addressed the ICCVAM prioritization criteria and
adherence to the ICCVAM recommendations for the standardization and
validation of in vitro endocrine disruptor test methods. Based on this
evaluation, ICCVAM recommended a high priority for validation studies
for the BG1Luc ER TA test method. The NIEHS subsequently agreed to
support the validation study in light of its participation as one of
the three NTP agencies, whose mission includes the development and
validation of improved testing methods.
The international interlaboratory validation study of the BG1Luc ER
TA test method has been completed. The study included three
laboratories sponsored by NICEATM, the European Centre for the
Validation of Alternative Methods, and the Japanese Center for the
Validation of Alternative Methods.
NICEATM and ICCVAM have prepared a draft BRD that provides
comprehensive summaries of data, analyses of test method accuracy and
reliability, and related information characterizing the current
validation status of the test method. The draft BRD forms the basis for
ICCVAM test method recommendations on usefulness and limitations,
standardized test method protocols, future studies, and performance
standards.
Peer Review Panel Meeting
This meeting will take place March 29-30, 2011, at the National
Institutes of Health (NIH) William H. Natcher Conference Center, 45
Center Drive, Bethesda, MD 20892. It will begin at 8:30 a.m. and is
scheduled to conclude each day at approximately 5 p.m. The meeting is
open to the public at no charge, with attendance limited only by the
space available. The Panel will consider the draft ICCVAM BRD,
recommendations, and performance standards for the test method and
evaluate the extent to which the draft ICCVAM test method
recommendations are supported by the information provided in the draft
BRD.
Additional information about the meeting, including a roster of the
Panel members and the draft agenda, will be posted on the NICEATM-
ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/endocrine/PeerPanel11.htm two weeks before the meeting. This information will
also be available after that date by contacting NICEATM (see FOR
FURTHER INFORMATION CONTACT).
Attendance and Registration
In order to facilitate planning for this meeting, persons wishing
to attend are asked to register by March 15, 2011, via the NICEATM-
ICCVAM Web site at https://iccvam.niehs.nih.gov/contact/reg-form-EDpanel.htm.
Availability of the Documents
The draft BRD and draft ICCVAM test method recommendations will be
posted no later than February 1, 2011 on the NICEATM-ICCVAM Web site
(https://iccvam.niehs.nih.gov/methods/endocrine/PeerPanel11.htm) or may
be obtained by contacting NICEATM (see FOR FURTHER INFORMATION
CONTACT).
Request for Public Comments
NICEATM invites the submission of written comments on the draft
BRD, draft ICCVAM test method recommendations, and draft performance
standards by March 10, 2011. NICEATM prefers that comments be submitted
electronically via the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm) or via e-mail to
niceatm@niehs.nih.gov. Written comments may also be sent by mail, fax,
or e-mail to Dr. Casey (see FOR FURTHER INFORMATION CONTACT). When
submitting written comments, 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). NICEATM will post all comments on the NICEATM-ICCVAM Web
site (https://iccvam.niehs.nih.gov) identified by the individual's name
and affiliation or sponsoring organization (if applicable). NICEATM
will provide these comments to the Panel and ICCVAM agency
representatives and make them available to the public at the meeting.
Opportunity will be provided for members of the public to present
oral comments at designated times during the peer review. Up to seven
minutes will be allotted per speaker. If you wish to present oral
statements at the meeting (one speaker per organization), contact
NICEATM (see FOR FURTHER INFORMATION CONTACT) by March 2, 2011. Please
provide a written copy of your comments with contact information (name,
affiliation, mailing address, phone, fax, e-mail, and sponsoring
organization, if applicable) when registering to make oral comments. If
it is not possible to provide a copy of your statement in advance,
please bring 40 copies to the meeting for distribution to the Panel and
to supplement the record. Written statements can supplement and expand
the oral presentation. Please provide NICEATM with copies of any
supplementary written statement using the guidelines outlined above.
Summary minutes and the Panel's final report will be available
following the meeting on the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov). ICCVAM will consider the Panel's conclusions and
recommendations and any public comments received in finalizing their
test method recommendations for the test method.
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 and safety testing information. ICCVAM conducts technical
evaluations of new, revised, and alternative methods with regulatory
applicability and promotes the scientific validation and regulatory
acceptance of toxicological and safety-testing methods that more
accurately assess the safety and hazards of chemicals and products and
that reduce, refine (decrease or eliminate pain and distress), and
replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C.
285l-3, available at https://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) established ICCVAM as a permanent interagency committee
of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides
scientific and operational support for ICCVAM-related activities.
NICEATM and ICCVAM work collaboratively to
[[Page 4115]]
evaluate new and improved test methods applicable to the needs of
Federal agencies. Additional information about ICCVAM and NICEATM is
available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov.
Dated: January 13, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-1329 Filed 1-21-11; 8:45 am]
BILLING CODE 4140-01-P