National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Evaluation of In Vitro Estrogen Receptor Transcriptional Activation and In Vitro Cell Proliferation Assays for Endocrine Disruptor Chemical Screening: Request for Nominations for an Independent Expert Peer Review Panel and Submission of Relevant In Vitro and In Vivo Data, 62317-62319 [E9-28278]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 227 / Friday, November 27, 2009 / Notices
62317
FEDERAL MEDICAL ASSISTANCE PERCENTAGES AND ENHANCED FEDERAL MEDICAL ASSISTANCE PERCENTAGES,
EFFECTIVE OCTOBER 1, 2010–SEPTEMBER 30, 2011—Continued
[Fiscal year 2011]
Federal medical
assistance
percentages
State
New Mexico .............................................................................................................................................
New York .................................................................................................................................................
North Carolina ..........................................................................................................................................
North Dakota ............................................................................................................................................
Northern Mariana Islands * ......................................................................................................................
Ohio .........................................................................................................................................................
Oklahoma .................................................................................................................................................
Oregon .....................................................................................................................................................
Pennsylvania ............................................................................................................................................
Puerto Rico * ............................................................................................................................................
Rhode Island ............................................................................................................................................
South Carolina .........................................................................................................................................
South Dakota ...........................................................................................................................................
Tennessee ...............................................................................................................................................
Texas .......................................................................................................................................................
Utah .........................................................................................................................................................
Vermont ...................................................................................................................................................
Virgin Islands * .........................................................................................................................................
Virginia .....................................................................................................................................................
Washington ..............................................................................................................................................
West Virginia ............................................................................................................................................
Wisconsin .................................................................................................................................................
Wyoming ..................................................................................................................................................
69.78
50.00
64.71
60.35
50.00
63.69
64.94
62.85
55.64
50.00
52.97
70.04
61.25
65.85
60.56
71.13
58.71
50.00
50.00
50.00
73.24
60.16
50.00
Enhanced federal
medical assistance
percentages
78.85
65.00
75.30
72.25
65.00
74.58
75.46
74.00
68.95
65.00
67.08
79.03
72.88
76.10
72.39
79.79
71.10
65.00
65.00
65.00
81.27
72.11
65.00
* For purposes of section 1118 of the Social Security Act, the percentage used under titles I, X, XIV, and XVI will be 75.00 per centum.
** The values for the District of Columbia in the table were set for the State plan under titles XIX and XXI and for capitation payments and DSH
allotments under those titles. For other purposes, the percentage for DC is 50.00 per centum, unless otherwise specified by law.
[FR Doc. E9–28438 Filed 11–25–09; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Evaluation of In
Vitro Estrogen Receptor
Transcriptional Activation and In Vitro
Cell Proliferation Assays for Endocrine
Disruptor Chemical Screening:
Request for Nominations for an
Independent Expert Peer Review Panel
and Submission of Relevant In Vitro
and In Vivo Data
sroberts on DSKD5P82C1PROD with NOTICES
AGENCY: National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
ACTION: Request nominations for an
independent expert panel and
submission of relevant data.
SUMMARY: NICEATM, in collaboration
with the Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM), is
planning to convene an independent
scientific peer review panel (hereafter,
Panel) to assess the validation status of
an in vitro stably-transfected estrogen
VerDate Nov<24>2008
18:08 Nov 25, 2009
Jkt 220001
receptor (ER) transcriptional activation
(TA) Assay (LUMI–CELL® ER assay) and
an in vitro cell proliferation assay
(CertiChem MCF–7 Cell Proliferation
assay) for their usefulness and
limitations in determining whether and
to what extent chemicals can interact
with estrogen receptors in vitro.
Validated assays that can detect the
interaction of chemicals with specific
hormone receptors including the ER are
included in the U.S. Environmental
Protection Agency (EPA) Endocrine
Disruptor Screening Program (EDSP)
(https://www.epa.gov/endo/pubs/
assayvalidation/status.htm). The two
assays that will undergo peer review are
currently undergoing validation studies
to determine their usefulness and
limitations for the EDSP. Any other
existing data from these two assays are
requested to ensure that all available
relevant data are considered by the
Panel. Data from other existing in vitro
and in vivo assays for the 78 reference
substances used for the validation
studies (available at https://
iccvam.niehs.nih.gov/docs/endo_docs/
EDAddendFinal.pdf) are requested for
use in characterizing the expected in
vitro and in vivo activity of these 78
reference substances. At this time
NICEATM requests:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
• Nominations of expert scientists for
consideration as potential Panel
members.
• Submission of existing data from
the LUMI–CELL® ER and the CertiChem
MCF–7 Cell Proliferation assays.
• Submission of data from in vivo or
other in vitro assessments for the 78
reference substances recommended by
ICCVAM for the validation of in vitro ER
and AR binding and TA test methods
(available at https://
iccvam.niehs.nih.gov/docs/endo_docs/
EDAddendFinal.pdf).
DATES: Submit nominations and data by
January 11, 2010. Data submitted after
this date will be considered in the
evaluation, where feasible.
ADDRESSES: Submit nominations and
data electronically by e-mail to
niceatm@niehs.nih.gov, or via the
NICEATM–ICCVAM Web site at https://
iccvam.niehs.nih.gov/contact/
FR_pubcomment.htm. Nominations and
data may also be sent by mail or fax to
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, (e-mail).
Courier address: NIEHS, NICEATM, 530
Davis Drive, Room 2034, Morrisville,
NC 27560.
E:\FR\FM\27NON1.SGM
27NON1
62318
Federal Register / Vol. 74, No. 227 / Friday, November 27, 2009 / Notices
FOR FURTHER INFORMATION CONTACT: Dr.
William S. Stokes, (telephone) 919–541–
2384, (fax) 919–541–0947 and (e-mail)
niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
sroberts on DSKD5P82C1PROD with NOTICES
Background
In April 2000, the EPA requested that
ICCVAM evaluate the validation status
of in vitro ER and AR binding and TA
assays for potential use in the proposed
EPA EDSP. ICCVAM and NICEATM
compiled available relevant data for 137
existing assays and compiled data were
submitted to an independent expert
panel for review. This panel concluded
that there were no adequately validated
in vitro ER- or AR-based test methods
(the panel’s report is available on the
NICEATM–ICCVAM Web site at https://
iccvam.niehs.nih.gov/methods/
endocrine/end_EPrpt.htm). Based on
these conclusions and
recommendations, along with comments
from the public, ICCVAM recommended
minimum procedural standards and a
list of 78 reference substances that
should be used to standardize and
validate in vitro ER and AR binding and
TA test method protocols. These
recommendations were made publicly
available in the report: ICCVAM
Evaluation of the In Vitro Methods for
Detecting Potential Endocrine
Disruptors: Estrogen Receptor and
Androgen Receptor Binding and
Transcriptional Activation Assays
(available at: https://
iccvam.niehs.nih.gov/methods/
endocrine/end_TMER.htm). The list of
78 reference substances was
subsequently modified because of cost
and availability considerations and
published in a separate Addendum
(available at: https://
iccvam.niehs.nih.gov/docs/endo_docs/
EDAddendFinal.pdf).
Two in vitro assays to detect ER
agonists and antagonists were
subsequently nominated to ICCVAM for
validation studies in response to an
ICCVAM request (69 FR 21564): The
LUMI–CELL® ER assay developed by
Xenobiotic Detection Systems, Inc.
(XDS) and the CertiChem MCF–7 Cell
Proliferation assay developed by
CertiChem, Inc. (CertiChem). Based on
preliminary results provided for these
test methods and comments from the
public and the Scientific Advisory
Committee on Alternative Toxicological
Methods (SACATM; 69 FR 21564 and
71 FR 60748, respectively), ICCVAM
and its Endocrine Disruptor Working
Group recommended a high priority for
validation studies for the LUMI–CELL®
ER and CertiChem MCF–7 Cell
Proliferation assays.
VerDate Nov<24>2008
18:08 Nov 25, 2009
Jkt 220001
An international interlaboratory
validation study of the LUMI–CELL® ER
assay is currently nearing completion.
The study includes three laboratories
sponsored by NICEATM, the European
Centre for the Validation of Alternative
Methods, and the Japanese Center for
the Validation of Alternative Methods.
An intralaboratory validation study of
the MCF–7 Cell Proliferation assay has
been completed by CertiChem in
conjunction with NICEATM, and an
interlaboratory study is planned.
NICEATM will prepare draft
background review documents (BRDs)
following completion of the validation
studies that will provide comprehensive
summaries of available data, analyses of
test method accuracy and reliability,
and related information characterizing
the current validation status of each of
the assays. The draft BRDs will form the
basis for draft ICCVAM test method
recommendations on usefulness and
limitations, standardized test method
protocols, future studies, and
performance standards that will
subsequently be provided to the Panel
and made available to the public. The
Panel will meet in public session to
review the validation status of the
LUMI–CELL® ER, MCF–7 Cell
Proliferation assays, and any of the
other assays for which there are
adequate data available. The Panel will
comment on the extent to which the
BRD supports draft ICCVAM test
method recommendations. The Panel
may also consider the results for other
assays with incomplete validation
databases to determine their current
validation status and to identify data
gaps that need to be addressed in order
to further characterize their usefulness
and limitations for the EDSP. Meeting
information, including dates, locations,
and public availability of the BRDs will
be announced in future Federal Register
notices and will also be posted on the
ICCVAM/NICEATM Web site (https://
iccvam.niehs.nih.gov/methods/
endocrine/end_eval.htm).
Request for Nominations of Scientific
Experts
NICEATM requests nominations of
scientists with relevant knowledge and
experience to serve on the Panel. Areas
of relevant expertise include, but are not
limited to, biostatistics, cellular biology,
endocrinology, molecular genetics,
regulatory toxicology, reproductive
toxicology, and test method validation.
Each nomination should include the
nominee’s name, affiliation, contact
information (i.e., mailing address, email
address, telephone, and fax numbers),
curriculum vitae, and a brief summary
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
of relevant experience and
qualifications.
Request for Data
NICEATM invites the submission of
relevant in vitro and in vivo data and
information for reference substances on
the list of 78 substances recommended
by ICCVAM for standardizing and
validating in vitro ER and AR binding
and TA test methods (available at
https://iccvam.niehs.nih.gov/docs/
endo_docs/EDAddendFinal.pdf) or
other substances for which data exists
from the two in vitro test methods
described in this notice. Relevant in
vivo data may include, but are not
limited to: Multi-generational
reproductive and developmental
toxicity studies, uterotrophic bioassays,
and short term assays assessing changes
in phenotypic parameters such as
anogenital distance, time of vaginal
opening, nipple retention, and preputial
separation delays in males.
Although data can be accepted at any
time, data received by January 11, 2010
will ensure consideration during the
ICCVAM evaluation process. Relevant
data received after this date will be
considered during the ICCVAM
evaluation process where feasible. All
information submitted in response to
this notice will be made publicly
available and may be incorporated into
future NICEATM and ICCVAM reports
and publications as appropriate.
When submitting data, please
reference this Federal Register notice
and provide appropriate contact
information (name, affiliation, mailing
address, phone, fax, e-mail, and
sponsoring organization, as applicable).
NICEATM prefers that data be
submitted as copies of pages from study
notebooks and/or study reports, if
available. Laboratory data and analyses
available in electronic format may also
be submitted. Each submission for a
substance should preferably include the
following information, as appropriate:
• Common and trade name
• Chemical Abstracts Service Registry
Number (CASRN)
• Commercial source
• In vivo or in vitro test protocol used
• Individual animal or in vitro
responses at each observation time (i.e.,
laboratory data)
• The extent to which the data were
collected in accordance with national/
international Good Laboratory Practice
guidelines
• Date and testing organization
• Physical and chemical properties
(e.g., molecular weight, pH, water
solubility, etc.)
E:\FR\FM\27NON1.SGM
27NON1
Federal Register / Vol. 74, No. 227 / Friday, November 27, 2009 / Notices
Background Information on ICCVAM,
NICEATM, and SACATM
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, 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
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: https://
iccvam.niehs.nih.gov.
SACATM was established January 9,
2002 and is composed of scientists from
the public and private sectors (67 FR
11358). SACATM provides advice to the
Director of the NIEHS, ICCVAM, and
NICEATM regarding the statutorily
mandated duties of ICCVAM and
activities of NICEATM. Additional
information about SACATM, including
the charter, roster, and records of past
meetings, can be found at https://
ntp.niehs.nih.gov/go/167.
Dated: November 16, 2009.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. E9–28278 Filed 11–25–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sroberts on DSKD5P82C1PROD with NOTICES
Office of the Secretary
Screening Framework Guidance for
Synthetic Double-Stranded DNA
Providers
AGENCY: Department of Health and
Human Services, Office of the Secretary.
ACTION:
Notice.
Authority: Public Health Service Act, 42
U.S.C. 241, Section 301; HSPD–10.
VerDate Nov<24>2008
18:08 Nov 25, 2009
Jkt 220001
SUMMARY: To reduce the risk that
individuals with ill intent may exploit
the commercial application of nucleic
acid synthesis technology to access
genetic material derived from or
encoding Select Agents or Toxins, the
U.S. Government has developed
recommendations for a framework for
synthetic nucleic acid screening. This
document is intended to provide
guidance to producers of synthetic
genomic products regarding the
screening of orders so that these orders
are filled in compliance with current
U.S. regulations and to encourage best
practices in addressing potential
biosecurity concerns. Following this
guidance is voluntary, though many
specific recommendations serve to
remind providers of their obligations
under existing regulations. The target
audience for this guidance is the gene
and genome synthesis industry, because
the technical hurdles for de novo
synthesis of Select Agents and Toxins
from double-stranded DNA are much
lower than for de novo synthesis of
these agents from single-stranded
oligonucleotides. This guidance
proposes a screening framework for
commercial providers of synthetic
double-stranded DNA 200 base pairs
(bps) or greater in length to address
concerns associated with the potential
for misuse of their products. The
framework includes customer screening
and sequence screening, follow-up
screening as necessary, and consultation
with U.S. Government contacts, as
needed.
This guidance is submitted for public
consideration and comment for a period
of 60 days. The Office of the Assistant
Secretary of Preparedness and Response
(ASPR) within the Department of Health
and Human Services (HHS) is
submitting this document for public
consideration as the lead agency in a
broad interagency process to draft the
guidance.
DATES: The public is encouraged to
submit written comments on this
proposed action. Comments may be
submitted to HHS/ASPR in electronic or
paper form at the HHS/ASPR e-mail
address, mailing address, and fax
number shown below under the heading
FOR FURTHER INFORMATION CONTACT. All
comments should be submitted by
January 26, 2010. All written comments
received in response to this notice will
be available for review by request.
FOR FURTHER INFORMATION CONTACT:
Jessica Tucker, Ph.D., Office of
Medicine, Science, and Public Health,
Office of the Assistant Secretary for
Preparedness and Response, U.S.
Department of Health and Human
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
62319
Services, 330 C Street, SW., Room
5008B, Washington, DC 20201; phone:
202–260–0632; fax: 202–205–8494;
e-mail address:
asprfrcorrespondence@hhs.gov.
SUPPLEMENTARY INFORMATION:
Screening Framework Guidance for
Synthetic Double-Stranded DNA
Providers
I. Summary
Synthetic biology, the developing
interdisciplinary field that focuses on
both the design and fabrication of novel
biological components and systems as
well as the re-design and fabrication of
existing biological systems, is poised to
become the next significant
transforming technology for the life
sciences and beyond. Synthetic biology
is not constrained by the requirement of
using existing genetic material. Thus,
technologies that permit the directed
synthesis of polynucleotides have great
potential to be used to generate
organisms, both currently existing and
novel, including pathogens that could
threaten public health, agriculture,
plants, animals, the environment, or
material. To reduce the risk that
individuals with ill intent may exploit
the commercial application of nucleic
acid synthesis technology to access
genetic material derived from or
encoding Select Agents or Toxins, the
U.S. Government has developed
recommendations for a framework for
synthetic nucleic acid screening. This
document is intended to provide
guidance to producers of synthetic
genomic products regarding the
screening of orders so that these orders
are filled in compliance with current
U.S. regulations and to encourage best
practices in addressing potential
biosecurity concerns.
Following this guidance is voluntary,
though many specific recommendations
serve to remind providers of their
obligations under existing regulations.
The target audience for this guidance is
the gene and genome synthesis industry,
because the technical hurdles for de
novo synthesis of Select Agents and
Toxins from double-stranded DNA are
much lower than for de novo synthesis
of these agents from single-stranded
oligonucleotides. This guidance
proposes a screening framework for
commercial providers of synthetic
double-stranded DNA 200 base pairs
(bps) or greater in length to address
concerns associated with the potential
for misuse of their products. The
framework includes customer screening
and sequence screening, follow-up
screening as necessary, and consultation
with U.S. Government contacts, as
E:\FR\FM\27NON1.SGM
27NON1
]]>Agencies
[Federal Register Volume 74, Number 227 (Friday, November 27, 2009)]
[Notices]
[Pages 62317-62319]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28278]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Evaluation
of In Vitro Estrogen Receptor Transcriptional Activation and In Vitro
Cell Proliferation Assays for Endocrine Disruptor Chemical Screening:
Request for Nominations for an Independent Expert Peer Review Panel and
Submission of Relevant In Vitro and In Vivo Data
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Request nominations for an independent expert panel and
submission of relevant data.
-----------------------------------------------------------------------
SUMMARY: NICEATM, in collaboration with the Interagency Coordinating
Committee on the Validation of Alternative Methods (ICCVAM), is
planning to convene an independent scientific peer review panel
(hereafter, Panel) to assess the validation status of an in vitro
stably-transfected estrogen receptor (ER) transcriptional activation
(TA) Assay (LUMI-CELL[supreg] ER assay) and an in vitro cell
proliferation assay (CertiChem MCF-7 Cell Proliferation assay) for
their usefulness and limitations in determining whether and to what
extent chemicals can interact with estrogen receptors in vitro.
Validated assays that can detect the interaction of chemicals with
specific hormone receptors including the ER are included in the U.S.
Environmental Protection Agency (EPA) Endocrine Disruptor Screening
Program (EDSP) (https://www.epa.gov/endo/pubs/assayvalidation/status.htm). The two assays that will undergo peer review are currently
undergoing validation studies to determine their usefulness and
limitations for the EDSP. Any other existing data from these two assays
are requested to ensure that all available relevant data are considered
by the Panel. Data from other existing in vitro and in vivo assays for
the 78 reference substances used for the validation studies (available
at https://iccvam.niehs.nih.gov/docs/endo_docs/EDAddendFinal.pdf) are
requested for use in characterizing the expected in vitro and in vivo
activity of these 78 reference substances. At this time NICEATM
requests:
Nominations of expert scientists for consideration as
potential Panel members.
Submission of existing data from the LUMI-CELL[supreg] ER
and the CertiChem MCF-7 Cell Proliferation assays.
Submission of data from in vivo or other in vitro
assessments for the 78 reference substances recommended by ICCVAM for
the validation of in vitro ER and AR binding and TA test methods
(available at https://iccvam.niehs.nih.gov/docs/endo_docs/EDAddendFinal.pdf).
DATES: Submit nominations and data by January 11, 2010. Data submitted
after this date will be considered in the evaluation, where feasible.
ADDRESSES: Submit nominations and data electronically by e-mail to
niceatm@niehs.nih.gov, or via the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm. Nominations and data
may also be sent by mail or fax to 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, (e-mail).
Courier address: NIEHS, NICEATM, 530 Davis Drive, Room 2034,
Morrisville, NC 27560.
[[Page 62318]]
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, (telephone)
919-541-2384, (fax) 919-541-0947 and (e-mail) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
In April 2000, the EPA requested that ICCVAM evaluate the
validation status of in vitro ER and AR binding and TA assays for
potential use in the proposed EPA EDSP. ICCVAM and NICEATM compiled
available relevant data for 137 existing assays and compiled data were
submitted to an independent expert panel for review. This panel
concluded that there were no adequately validated in vitro ER- or AR-
based test methods (the panel's report is available on the NICEATM-
ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/endocrine/end_EPrpt.htm). Based on these conclusions and recommendations, along with
comments from the public, ICCVAM recommended minimum procedural
standards and a list of 78 reference substances that should be used to
standardize and validate in vitro ER and AR binding and TA test method
protocols. These recommendations were made publicly available in the
report: ICCVAM Evaluation of the In Vitro Methods for Detecting
Potential Endocrine Disruptors: Estrogen Receptor and Androgen Receptor
Binding and Transcriptional Activation Assays (available at: https://iccvam.niehs.nih.gov/methods/endocrine/end_TMER.htm). The list of 78
reference substances was subsequently modified because of cost and
availability considerations and published in a separate Addendum
(available at: https://iccvam.niehs.nih.gov/docs/endo_docs/EDAddendFinal.pdf).
Two in vitro assays to detect ER agonists and antagonists were
subsequently nominated to ICCVAM for validation studies in response to
an ICCVAM request (69 FR 21564): The LUMI-CELL[supreg] ER assay
developed by Xenobiotic Detection Systems, Inc. (XDS) and the CertiChem
MCF-7 Cell Proliferation assay developed by CertiChem, Inc.
(CertiChem). Based on preliminary results provided for these test
methods and comments from the public and the Scientific Advisory
Committee on Alternative Toxicological Methods (SACATM; 69 FR 21564 and
71 FR 60748, respectively), ICCVAM and its Endocrine Disruptor Working
Group recommended a high priority for validation studies for the LUMI-
CELL[supreg] ER and CertiChem MCF-7 Cell Proliferation assays.
An international interlaboratory validation study of the LUMI-
CELL[supreg] ER assay is currently nearing completion. The study
includes three laboratories sponsored by NICEATM, the European Centre
for the Validation of Alternative Methods, and the Japanese Center for
the Validation of Alternative Methods. An intralaboratory validation
study of the MCF-7 Cell Proliferation assay has been completed by
CertiChem in conjunction with NICEATM, and an interlaboratory study is
planned.
NICEATM will prepare draft background review documents (BRDs)
following completion of the validation studies that will provide
comprehensive summaries of available data, analyses of test method
accuracy and reliability, and related information characterizing the
current validation status of each of the assays. The draft BRDs will
form the basis for draft ICCVAM test method recommendations on
usefulness and limitations, standardized test method protocols, future
studies, and performance standards that will subsequently be provided
to the Panel and made available to the public. The Panel will meet in
public session to review the validation status of the LUMI-CELL[supreg]
ER, MCF-7 Cell Proliferation assays, and any of the other assays for
which there are adequate data available. The Panel will comment on the
extent to which the BRD supports draft ICCVAM test method
recommendations. The Panel may also consider the results for other
assays with incomplete validation databases to determine their current
validation status and to identify data gaps that need to be addressed
in order to further characterize their usefulness and limitations for
the EDSP. Meeting information, including dates, locations, and public
availability of the BRDs will be announced in future Federal Register
notices and will also be posted on the ICCVAM/NICEATM Web site (https://iccvam.niehs.nih.gov/methods/endocrine/end_eval.htm).
Request for Nominations of Scientific Experts
NICEATM requests nominations of scientists with relevant knowledge
and experience to serve on the Panel. Areas of relevant expertise
include, but are not limited to, biostatistics, cellular biology,
endocrinology, molecular genetics, regulatory toxicology, reproductive
toxicology, and test method validation. Each nomination should include
the nominee's name, affiliation, contact information (i.e., mailing
address, email address, telephone, and fax numbers), curriculum vitae,
and a brief summary of relevant experience and qualifications.
Request for Data
NICEATM invites the submission of relevant in vitro and in vivo
data and information for reference substances on the list of 78
substances recommended by ICCVAM for standardizing and validating in
vitro ER and AR binding and TA test methods (available at https://iccvam.niehs.nih.gov/docs/endo_docs/EDAddendFinal.pdf) or other
substances for which data exists from the two in vitro test methods
described in this notice. Relevant in vivo data may include, but are
not limited to: Multi-generational reproductive and developmental
toxicity studies, uterotrophic bioassays, and short term assays
assessing changes in phenotypic parameters such as anogenital distance,
time of vaginal opening, nipple retention, and preputial separation
delays in males.
Although data can be accepted at any time, data received by January
11, 2010 will ensure consideration during the ICCVAM evaluation
process. Relevant data received after this date will be considered
during the ICCVAM evaluation process where feasible. All information
submitted in response to this notice will be made publicly available
and may be incorporated into future NICEATM and ICCVAM reports and
publications as appropriate.
When submitting data, please reference this Federal Register notice
and provide appropriate contact information (name, affiliation, mailing
address, phone, fax, e-mail, and sponsoring organization, as
applicable).
NICEATM prefers that data be submitted as copies of pages from
study notebooks and/or study reports, if available. Laboratory data and
analyses available in electronic format may also be submitted. Each
submission for a substance should preferably include the following
information, as appropriate:
Common and trade name
Chemical Abstracts Service Registry Number (CASRN)
Commercial source
In vivo or in vitro test protocol used
Individual animal or in vitro responses at each
observation time (i.e., laboratory data)
The extent to which the data were collected in accordance
with national/international Good Laboratory Practice guidelines
Date and testing organization
Physical and chemical properties (e.g., molecular weight,
pH, water solubility, etc.)
[[Page 62319]]
Background Information on ICCVAM, NICEATM, and SACATM
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, 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 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:
https://iccvam.niehs.nih.gov.
SACATM was established January 9, 2002 and is composed of
scientists from the public and private sectors (67 FR 11358). SACATM
provides advice to the Director of the NIEHS, ICCVAM, and NICEATM
regarding the statutorily mandated duties of ICCVAM and activities of
NICEATM. Additional information about SACATM, including the charter,
roster, and records of past meetings, can be found at https://ntp.niehs.nih.gov/go/167.
Dated: November 16, 2009.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. E9-28278 Filed 11-25-09; 8:45 am]
BILLING CODE 4140-01-P
