Availability of ICCVAM Evaluation Report and Recommendations on the Usefulness and Limitations of the LUMI-CELL® ER (BG1Luc ER TA) Test Method, An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals, 8258-8260 [2012-3437]
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Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices
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[FR Doc. 2012–3590 Filed 2–10–12; 4:15 pm]
BILLING CODE 6712–01–P
FEDERAL ELECTION COMMISSION
Sunshine Act Meeting Notice
AGENCY:
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DATE AND TIME:
Monday, February 13,
2012 at 2 p.m.
PLACE:
999 E Street NW., Washington,
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This Meeting Will Be Closed to
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STATUS:
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
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The notificants listed below have
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1. Moishe Gubin, Hillside, Illinois,
and Mark Orenstein, Chicago, Illinois;
to collectively acquire voting shares of
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Lauderdale, Florida, and thereby
indirectly acquire voting shares of
OptimumBank, Plantation, Florida.
Board of Governors of the Federal Reserve
System, February 9, 2012.
Jennifer J. Johnson,
Secretary of the Board.
mstockstill on DSK4VPTVN1PROD with NOTICES
PERSON TO CONTACT FOR INFORMATION:
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Shawn Woodhead Werth,
Secretary and Clerk of the Commission.
[FR Doc. 2012–3532 Filed 2–10–12; 4:15 pm]
BILLING CODE 6715–01–P
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Board of Governors of the Federal Reserve
System.
Dated: February 9, 2012.
Jennifer J. Johnson,
Secretary of the Board.
[FR Doc. 2012–3357 Filed 2–13–12; 8:45 am]
BILLING CODE; P
[FR Doc. 2012–3358 Filed 2–13–12; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FEDERAL RESERVE SYSTEM
Availability of ICCVAM Evaluation
Report and Recommendations on the
Usefulness and Limitations of the
LUMI–CELL® ER (BG1Luc ER TA) Test
Method, An In Vitro Assay for
Identifying Human Estrogen Receptor
Agonist and Antagonist Activity of
Chemicals
ITEMS TO BE DISCUSSED:
Investigatory records compiled for
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information which if written would be
contained in such records
Information the premature disclosure
of which would be likely to have a
considerable adverse effect on the
implementation of a proposed
Commission action.
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procedures or matters affecting a
particular employee.
*
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The notice also will be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing on the
question whether the proposal complies
with the standards of section 4 of the
BHC Act.
Unless otherwise noted, comments
regarding the applications must be
received at the Reserve Bank indicated
or the offices of the Board of Governors
not later than February 29, 2012.
A. Federal Reserve Bank of Atlanta
(Chapelle Davis, Assistant Vice
President) 1000 Peachtree Street NE.,
Atlanta, Georgia 30309:
1. Gateway Financial Holdings of
Florida, Inc., Daytona Beach, Florida; to
engage through its subsidiary, Gateway
Asset Holdings, Daytona Beach, Florida,
in making, acquiring, brokering, or
servicing loans, or other extensions of
credit, pursuant to section 225.28(b)(1),
and activities related to extending
credit, pursuant to section 225.28(b)(2).
2. CertusHoldings, Inc., Atlanta,
Georgia; through its newly formed
wholly owned subsidiary, Certus
Investment Advisors, LLC, Atlanta,
Georgia, to engage in investment
advisory activities, pursuant to section
225.28(b)(6)(i).
Notice of Proposals To Engage in or
To Acquire Companies Engaged in
Permissible Nonbanking Activities
The companies listed in this notice
have given notice under section 4 of the
Bank Holding Company Act (12 U.S.C.
1843) (BHC Act) and Regulation Y, (12
CFR part 225) to engage de novo, or to
acquire or control voting securities or
assets of a company, including the
companies listed below, that engages
either directly or through a subsidiary or
other company, in a nonbanking activity
that is listed in § 225.28 of Regulation Y
(12 CFR 225.28) or that the Board has
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Division of the National
Toxicology Program (DNTP), National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH), HHS.
ACTION: Availability of report and
recommendations; Notice of
Transmittal.
AGENCY:
The NTP Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM)
announces availability of an Interagency
Coordinating Committee on the
SUMMARY:
E:\FR\FM\14FEN1.SGM
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Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices
Validation of Alternative Methods
(ICCVAM) test method evaluation report
(TMER) that includes recommendations
on the usefulness and limitations of the
LUMI–CELL® estrogen receptor (ER)
transcriptional activation (TA) test
method (hereafter referred to as the
BG1Luc ER TA test method) to identify
human ER agonist and antagonist
activity of chemicals. The report also
provides (1) performance standards that
can be used to evaluate functionally and
mechanistically similar test methods, (2)
recommended test method protocols, (3)
a final background review document
(BRD) describing the current validation
status of this test method, and (4)
recommendations for future studies.
ICCVAM recommends that the
BG1Luc ER TA test method can be used
as a screening test to identify substances
with in vitro estrogen agonist and
antagonist activity. This use is based on
an evaluation of results from an
international validation study and
corresponding accuracy and reliability.
The report and recommendations
have been transmitted to Federal
agencies to review and respond to
ICCVAM in accordance with the
provisions of the ICCVAM
Authorization Act of 2000 (42 U.S.C.
285l–2).
FOR FURTHER INFORMATION CONTACT: Dr.
William S. Stokes, Director, NICEATM,
NIEHS, P.O. Box 12233, Mail Stop: K2–
16, Research Triangle Park, NC, 27709,
(telephone) 919–541–2384, (fax) 919–
541–0947, (email)
niceatm@niehs.nih.gov. Courier address:
NICEATM, NIEHS, Room 2034, 530
Davis Drive, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
Background
In January 2004, Xenobiotic Detection
Systems, Inc. (XDS, Durham, NC)
nominated the BG1Luc ER TA test
method for an interlaboratory validation
study. ICCVAM and the Scientific
Advisory Committee on Alternative
Toxicological Methods (SACATM)
recommended a high priority for the
nominated study, based on the lack of
adequately validated test methods and
the regulatory and public health need
for such test methods. NICEATM
subsequently led and coordinated an
international validation study with its
counterparts in Japan (Japanese Center
for the Validation of Alternative
Methods) and Europe (European Centre
for the Validation of Alternative
Methods) in laboratories sponsored by
each validation organization. ICCVAM
also proposed the development of
BG1Luc ER TA test method performance
standards. ICCVAM assigned the
VerDate Mar<15>2010
21:57 Feb 13, 2012
Jkt 226001
activities a high priority after
considering comments from the public
and endorsement from SACATM.
ICCVAM established an interagency
Endocrine Disruptor Working Group
(EDWG) composed of scientists from the
15 Federal agencies represented on
ICCVAM to work with NICEATM to
carry out the relevant evaluation
activities. Following completion of the
validation study, NICEATM, ICCVAM,
and the EDWG prepared a draft BRD
and draft test method recommendations.
NICEATM released the ICCVAM draft
documents to the public for comment
and convened an international
independent scientific peer review
panel (hereafter referred to as the Panel)
in public session on March 29–30, 2011,
to provide their conclusions on the draft
BRD and draft ICCVAM test method
recommendations (76 FR 4113).
Stakeholders from the public were
provided opportunities to comment
throughout the review process,
including the opportunity for oral
comments at the Panel meeting. The
Panel considered these comments, as
well as public comments submitted
prior to the meeting, before concluding
its deliberations. The Panel report was
published and made available to the
public for review and comment (76 FR
28781). The draft test method
recommendations, the draft BRD, the
draft Panel report, and all public
comments were made available to
SACATM, which provided comments at
its public meeting on June 16–17, 2011
(76 FR 23323).
ICCVAM considered the peer review
panel report and all public and
SACATM comments in preparing the
ICCVAM final test method
recommendations. Detailed ICCVAM
recommendations are provided in the
ICCVAM TMER, The LUMI–CELL® ER
(BG1Luc ER TA) Test Method: An In
Vitro Assay for Identifying Human
Estrogen Receptor Agonist and
Antagonist Activity of Chemicals (NIH
Publication No. 11–7850, available at
https://iccvam.niehs.nih.gov/methods/
endocrine/ERTA–TMER.htm). ICCVAM
recommends that the BG1Luc ER TA
test method can be used as a screening
test to identify substances with in vitro
estrogen agonist activity. This use is
based on an evaluation of available
validation study data and corresponding
accuracy and reliability. ICCVAM
recommends that the accuracy of this
assay is at least equivalent to the current
ER TA assay included in regulatory
testing guidance. The ICCVAM TMER
also includes the updated ICCVAMrecommended BG1Luc ER TA test
method protocol, performance standards
that are applicable to functionally and
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Fmt 4703
Sfmt 4703
8259
mechanistically similar test methods,
the final BRD, relevant endocrine
disruptor testing regulations and testing
guidelines, applicable Federal Register
notices, the Panel report, public
comments, and SACATM meeting
minutes.
Background Information on ICCVAM,
NICEATM, and SACATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, generate, or
disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing 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), or replace animal
use. The ICCVAM Authorization Act of
2000 (42 U.S.C. 285l–3) established
ICCVAM as a permanent interagency
committee of the NIEHS under
NICEATM. NICEATM administers
ICCVAM, provides scientific and
operational support for ICCVAM-related
activities, and conducts independent
validation studies to assess the
usefulness and limitations of new,
revised, and alternative test methods
and strategies. NICEATM and ICCVAM
welcome the public nomination of new,
revised, and alternative test methods
and strategies applicable to the needs of
Federal agencies. Additional
information about NICEATM and
ICCVAM can be found on the
NICEATM–ICCVAM Web site (https://
iccvam.niehs.nih.gov).
SACATM was established in response
to the ICCVAM Authorization Act
(Section 285l–3[d]) and is composed of
scientists from the public and private
sectors (67 FR 11358). SACATM advises
ICCVAM, NICEATM, and the Director of
the NIEHS and NTP regarding
statutorily mandated duties of ICCVAM
and activities of NICEATM. SACATM
provides advice on priorities and
activities related to the development,
validation, scientific review, regulatory
acceptance, implementation, and
national and international
harmonization of new, revised, and
alternative toxicological test methods.
Additional information about SACATM,
including the charter, roster, and
records of past meetings, can be found
at https://ntp.niehs.nih.gov/go/167.
E:\FR\FM\14FEN1.SGM
14FEN1
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Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
References
EPA. 2009. Endocrine Disruptor Screening
Program Test Guidelines. OPPTS 890.1300:
Estrogen Receptor Transcriptional Activation
(Human Cell Line (HeLa-9903)). Washington,
DC: U.S. Environmental Protection Agency.
Available: https://www.regulations.gov/
#!documentDetail;D=EPA-HQ-OPPT-20090576-0006.
ICCVAM. 2011. ICCVAM Test Method
Evaluation Report: The LUMI–CELL® ER
(BG1Luc ER TA) Test Method: An In Vitro
Assay for Identifying Human Estrogen
Receptor Agonist and Antagonist Activity of
Chemicals. Research Triangle Park, NC:
National Institute of Environmental Health
Sciences. Available: https://
iccvam.niehs.nih.gov/methods/endocrine/
ERTA-TMER.htm.
ICCVAM. 2006. Addendum to ICCVAM
Evaluation of In Vitro Test Methods for
Detecting Potential Endocrine Disruptors.
Research Triangle Park, NC: National
Institute of Environmental Health Sciences.
Available: https://iccvam.niehs.nih.gov/docs/
endo_docs/EDAddendFinal.pdf.
ICCVAM. 2003a. 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. Research Triangle
Park, NC: National Institute of Environmental
Health Sciences. Available: https://
iccvam.niehs.nih.gov/methods/endocrine/
end_TMER.htm.
ICCVAM. 2002a. Background Review
Document. Current Status of Test Methods
for Detecting Endocrine Disruptors: In Vitro
Estrogen Receptor Transcriptional Activation
Assays. NIH Publication No. 03–4505.
Research Triangle Park, NC: National
Institute of Environmental Health Sciences.
Available: https://iccvam.niehs.nih.gov/
methods/endocrine/end_bckgnd.htm#ERTA.
ICCVAM. 2002b. Background Review
Document. Current Status of Test Methods
for Detecting Endocrine Disruptors: In Vitro
Androgen Receptor Binding Assays. NIH
Publication No. 03–4506. Research Triangle
Park, NC: National Institute of Environmental
Health Sciences. Available: https://
iccvam.niehs.nih.gov/methods/endocrine/
end_bckgnd.htm#ARBnd.
ICCVAM. 2002c. Background Review
Document: Current Status of Test Methods
for Detecting Endocrine Disruptors: In Vitro
Estrogen Receptor Binding Assays. NIH
Publication No. 03–4504. Research Triangle
Park, NC: National Institute of Environmental
Health Sciences. Available: https://
iccvam.niehs.nih.gov/methods/endocrine/
end_bckgnd.htm#ERBnd.
ICCVAM. 2002d. Background Review
Document. Current Status of Test Methods
for Detecting Endocrine Disruptors: In Vitro
Androgen Receptor Transcriptional
Activation Assays. NIH Publication No. 03–
4507. Research Triangle Park, NC: National
Institute of Environmental Health Sciences.
Available: https://iccvam.niehs.nih.gov/
methods/endocrine/end_bckgnd.htm#ARTA.
ICCVAM. 2002e. Expert Panel Evaluation
of the Validation Status of In Vitro Test
Methods for Detecting Endocrine Disruptors:
Estrogen Receptor and Androgen Receptor
VerDate Mar<15>2010
21:57 Feb 13, 2012
Jkt 226001
Binding and Transcriptional Activation
Assays. Expert Panel Final Report. Research
Triangle Park, NC: National Institute of
Environmental Health Sciences. Available:
https://iccvam.niehs.nih.gov/methods/
endocrine/end_EPrpt.htm.
OECD. 2009. Test No 455: The Stably
Transfected Human Estrogen Receptor-alpha
Transcriptional Activation Assay for
Detection of Estrogenic Agonist-Activity of
Chemicals. In: OECD Guidelines for the
Testing of Chemicals, Section 4: Health
Effects. Paris: OECD Publishing. Available:
https://www.oecd-ilibrary.org/environment/
oecd-guidelines-for-the-testing-of-chemicalssection-4-health-effects_20745788.
Rogers JM, Denison MS. 2000.
Recombinant cell bioassays for endocrine
disruptors: Development of a stably
transfected human ovarian cell line for the
detection of estrogenic and anti-estrogenic
chemicals. In Vitro Mol Toxicol 13(1):67–82.
Dated: February 7, 2012.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2012–3437 Filed 2–13–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10421]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Correction
In notice document 2012–2821
appearing on pages 6123–6124 in the
issue of February 7, 2012, make the
following correction:
On page 6124, in the first column, in
the last line, ‘‘April 9, 2012’’ should
read ‘‘April 3, 2012’’.
[FR Doc. C1–2012–2821 Filed 2–13–12; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0110]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Reporting: Manufacturer, Importer,
User Facility, and Distributor Reporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
SUMMARY:
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Sfmt 4703
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed extension of
an existing collection of information,
and to allow 60 days for public
comment in response to the notice. This
notice solicits comments on medical
device reporting (MDR); manufacturer,
importer, user facility, and distributor
reporting.
DATES: Submit either electronic or
written comments on the collection of
information by April 16, 2012.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
E:\FR\FM\14FEN1.SGM
14FEN1
]]>Agencies
[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Notices]
[Pages 8258-8260]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3437]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Availability of ICCVAM Evaluation Report and Recommendations on
the Usefulness and Limitations of the LUMI-CELL[supreg] ER (BG1Luc ER
TA) Test Method, An In Vitro Assay for Identifying Human Estrogen
Receptor Agonist and Antagonist Activity of Chemicals
AGENCY: Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS), National Institutes
of Health (NIH), HHS.
ACTION: Availability of report and recommendations; Notice of
Transmittal.
-----------------------------------------------------------------------
SUMMARY: The NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM) announces availability of an
Interagency Coordinating Committee on the
[[Page 8259]]
Validation of Alternative Methods (ICCVAM) test method evaluation
report (TMER) that includes recommendations on the usefulness and
limitations of the LUMI-CELL[supreg] estrogen receptor (ER)
transcriptional activation (TA) test method (hereafter referred to as
the BG1Luc ER TA test method) to identify human ER agonist and
antagonist activity of chemicals. The report also provides (1)
performance standards that can be used to evaluate functionally and
mechanistically similar test methods, (2) recommended test method
protocols, (3) a final background review document (BRD) describing the
current validation status of this test method, and (4) recommendations
for future studies.
ICCVAM recommends that the BG1Luc ER TA test method can be used as
a screening test to identify substances with in vitro estrogen agonist
and antagonist activity. This use is based on an evaluation of results
from an international validation study and corresponding accuracy and
reliability.
The report and recommendations have been transmitted to Federal
agencies to review and respond to ICCVAM in accordance with the
provisions of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-2).
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director,
NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research Triangle
Park, NC, 27709, (telephone) 919-541-2384, (fax) 919-541-0947, (email)
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530
Davis Drive, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
In January 2004, Xenobiotic Detection Systems, Inc. (XDS, Durham,
NC) nominated the BG1Luc ER TA test method for an interlaboratory
validation study. ICCVAM and the Scientific Advisory Committee on
Alternative Toxicological Methods (SACATM) recommended a high priority
for the nominated study, based on the lack of adequately validated test
methods and the regulatory and public health need for such test
methods. NICEATM subsequently led and coordinated an international
validation study with its counterparts in Japan (Japanese Center for
the Validation of Alternative Methods) and Europe (European Centre for
the Validation of Alternative Methods) in laboratories sponsored by
each validation organization. ICCVAM also proposed the development of
BG1Luc ER TA test method performance standards. ICCVAM assigned the
activities a high priority after considering comments from the public
and endorsement from SACATM.
ICCVAM established an interagency Endocrine Disruptor Working Group
(EDWG) composed of scientists from the 15 Federal agencies represented
on ICCVAM to work with NICEATM to carry out the relevant evaluation
activities. Following completion of the validation study, NICEATM,
ICCVAM, and the EDWG prepared a draft BRD and draft test method
recommendations. NICEATM released the ICCVAM draft documents to the
public for comment and convened an international independent scientific
peer review panel (hereafter referred to as the Panel) in public
session on March 29-30, 2011, to provide their conclusions on the draft
BRD and draft ICCVAM test method recommendations (76 FR 4113).
Stakeholders from the public were provided opportunities to comment
throughout the review process, including the opportunity for oral
comments at the Panel meeting. The Panel considered these comments, as
well as public comments submitted prior to the meeting, before
concluding its deliberations. The Panel report was published and made
available to the public for review and comment (76 FR 28781). The draft
test method recommendations, the draft BRD, the draft Panel report, and
all public comments were made available to SACATM, which provided
comments at its public meeting on June 16-17, 2011 (76 FR 23323).
ICCVAM considered the peer review panel report and all public and
SACATM comments in preparing the ICCVAM final test method
recommendations. Detailed ICCVAM recommendations are provided in the
ICCVAM TMER, The LUMI-CELL[supreg] ER (BG1Luc ER TA) Test Method: An In
Vitro Assay for Identifying Human Estrogen Receptor Agonist and
Antagonist Activity of Chemicals (NIH Publication No. 11-7850,
available at https://iccvam.niehs.nih.gov/methods/endocrine/ERTA-TMER.htm). ICCVAM recommends that the BG1Luc ER TA test method can be
used as a screening test to identify substances with in vitro estrogen
agonist activity. This use is based on an evaluation of available
validation study data and corresponding accuracy and reliability.
ICCVAM recommends that the accuracy of this assay is at least
equivalent to the current ER TA assay included in regulatory testing
guidance. The ICCVAM TMER also includes the updated ICCVAM-recommended
BG1Luc ER TA test method protocol, performance standards that are
applicable to functionally and mechanistically similar test methods,
the final BRD, relevant endocrine disruptor testing regulations and
testing guidelines, applicable Federal Register notices, the Panel
report, public comments, and SACATM meeting minutes.
Background Information on ICCVAM, NICEATM, and SACATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that require, use,
generate, or disseminate toxicological and safety testing information.
ICCVAM conducts technical evaluations of new, revised, and alternative
safety testing 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), or replace animal use. The ICCVAM
Authorization Act of 2000 (42 U.S.C. 285l-3) established ICCVAM as a
permanent interagency committee of the NIEHS under NICEATM. NICEATM
administers ICCVAM, provides scientific and operational support for
ICCVAM-related activities, and conducts independent validation studies
to assess the usefulness and limitations of new, revised, and
alternative test methods and strategies. NICEATM and ICCVAM welcome the
public nomination of new, revised, and alternative test methods and
strategies applicable to the needs of Federal agencies. Additional
information about NICEATM and ICCVAM can be found on the NICEATM-ICCVAM
Web site (https://iccvam.niehs.nih.gov).
SACATM was established in response to the ICCVAM Authorization Act
(Section 285l-3[d]) and is composed of scientists from the public and
private sectors (67 FR 11358). SACATM advises ICCVAM, NICEATM, and the
Director of the NIEHS and NTP regarding statutorily mandated duties of
ICCVAM and activities of NICEATM. SACATM provides advice on priorities
and activities related to the development, validation, scientific
review, regulatory acceptance, implementation, and national and
international harmonization of new, revised, and alternative
toxicological test methods. Additional information about SACATM,
including the charter, roster, and records of past meetings, can be
found at https://ntp.niehs.nih.gov/go/167.
[[Page 8260]]
References
EPA. 2009. Endocrine Disruptor Screening Program Test
Guidelines. OPPTS 890.1300: Estrogen Receptor Transcriptional
Activation (Human Cell Line (HeLa-9903)). Washington, DC: U.S.
Environmental Protection Agency. Available: https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0576-0006.
ICCVAM. 2011. ICCVAM Test Method Evaluation Report: The LUMI-
CELL[reg] ER (BG1Luc ER TA) Test Method: An In Vitro Assay for
Identifying Human Estrogen Receptor Agonist and Antagonist Activity
of Chemicals. Research Triangle Park, NC: National Institute of
Environmental Health Sciences. Available: https://iccvam.niehs.nih.gov/methods/endocrine/ERTA-TMER.htm.
ICCVAM. 2006. Addendum to ICCVAM Evaluation of In Vitro Test
Methods for Detecting Potential Endocrine Disruptors. Research
Triangle Park, NC: National Institute of Environmental Health
Sciences. Available: https://iccvam.niehs.nih.gov/docs/endo_docs/EDAddendFinal.pdf.
ICCVAM. 2003a. 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. Research Triangle Park, NC: National
Institute of Environmental Health Sciences. Available: https://iccvam.niehs.nih.gov/methods/endocrine/end_TMER.htm.
ICCVAM. 2002a. Background Review Document. Current Status of
Test Methods for Detecting Endocrine Disruptors: In Vitro Estrogen
Receptor Transcriptional Activation Assays. NIH Publication No. 03-
4505. Research Triangle Park, NC: National Institute of
Environmental Health Sciences. Available: https://iccvam.niehs.nih.gov/methods/endocrine/end_bckgnd.htm#ERTA.
ICCVAM. 2002b. Background Review Document. Current Status of
Test Methods for Detecting Endocrine Disruptors: In Vitro Androgen
Receptor Binding Assays. NIH Publication No. 03-4506. Research
Triangle Park, NC: National Institute of Environmental Health
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ICCVAM. 2002c. Background Review Document: Current Status of
Test Methods for Detecting Endocrine Disruptors: In Vitro Estrogen
Receptor Binding Assays. NIH Publication No. 03-4504. Research
Triangle Park, NC: National Institute of Environmental Health
Sciences. Available: https://iccvam.niehs.nih.gov/methods/endocrine/end_bckgnd.htm#ERBnd.
ICCVAM. 2002d. Background Review Document. Current Status of
Test Methods for Detecting Endocrine Disruptors: In Vitro Androgen
Receptor Transcriptional Activation Assays. NIH Publication No. 03-
4507. Research Triangle Park, NC: National Institute of
Environmental Health Sciences. Available: https://iccvam.niehs.nih.gov/methods/endocrine/end_bckgnd.htm#ARTA.
ICCVAM. 2002e. Expert Panel Evaluation of the Validation Status
of In Vitro Test Methods for Detecting Endocrine Disruptors:
Estrogen Receptor and Androgen Receptor Binding and Transcriptional
Activation Assays. Expert Panel Final Report. Research Triangle
Park, NC: National Institute of Environmental Health Sciences.
Available: https://iccvam.niehs.nih.gov/methods/endocrine/end_EPrpt.htm.
OECD. 2009. Test No 455: The Stably Transfected Human Estrogen
Receptor-alpha Transcriptional Activation Assay for Detection of
Estrogenic Agonist-Activity of Chemicals. In: OECD Guidelines for
the Testing of Chemicals, Section 4: Health Effects. Paris: OECD
Publishing. Available: https://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-4-health-effects_20745788.
Rogers JM, Denison MS. 2000. Recombinant cell bioassays for
endocrine disruptors: Development of a stably transfected human
ovarian cell line for the detection of estrogenic and anti-
estrogenic chemicals. In Vitro Mol Toxicol 13(1):67-82.
Dated: February 7, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-3437 Filed 2-13-12; 8:45 am]
BILLING CODE 4140-01-P
