National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report: The Reduced Murine Local Lymph Node Assay, an Alternative Test Method Using Fewer Animals To Assess the Allergic Contact Dermatitis Potential of Chemicals and Products; Availability of ICCVAM Recommended Murine Local Lymph Node Assay Performance Standards; Notice of Transmittal to Federal Agencies of ICCVAM Test Method Recommendations for the Reduced Murine Local Lymph Node Assay, Updated Murine Local Lymph Node Assay Test Method Protocol, and Murine Local Lymph Node Assay Test Method Performance Standards, 50212-50213 [E9-23534]
Download as PDF
<![CDATA[
50212
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: September 24, 2009.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. E9–23460 Filed 9–29–09; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
NTP Interagency Center for the
Evaluation of Alternative Toxicological
Methods (NICEATM); Availability of the
Interagency Coordinating Committee
on the Validation of Alternative
Methods (ICCVAM) Test Method
Evaluation Report: The Reduced
Murine Local Lymph Node Assay, an
Alternative Test Method Using Fewer
Animals To Assess the Allergic
Contact Dermatitis Potential of
Chemicals and Products; Availability
of ICCVAM Recommended Murine
Local Lymph Node Assay Performance
Standards; Notice of Transmittal to
Federal Agencies of ICCVAM Test
Method Recommendations for the
Reduced Murine Local Lymph Node
Assay, Updated Murine Local Lymph
Node Assay Test Method Protocol, and
Murine Local Lymph Node Assay Test
Method Performance Standards
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
AGENCY: National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH)
ACTION: Availability of ICCVAM Test
Method Evaluation Report (TMER) and
Recommended Test Method
Performance Standards; Notice of
Transmittal.
SUMMARY: NICEATM announces
availability of the ICCVAM Test Method
Evaluation Report: The Reduced Murine
Local Lymph Node Assay: An
Alternative Test Method Using Fewer
Animals to Assess the Allergic Contact
Dermatitis Potential of Chemicals and
Products (NIH Publication 09–6439).
The TMER provides ICCVAM’s
evaluation and recommendations for the
reduced Murine Local Lymph Node
Assay (rLLNA) test method as a
reduction alternative that uses fewer
animals compared to the traditional
Murine Local Lymph Node Assay
(LLNA) for assessing the potential of test
substances to cause allergic contact
dermatitis (ACD). The report includes
ICCVAM’s recommendations on (a) the
usefulness and limitations of the
VerDate Nov<24>2008
14:56 Sep 29, 2009
Jkt 217001
rLLNA, (b) an updated ICCVAM LLNA
test method protocol, which includes
the procedures for conducting the
rLLNA, (c) future studies to further
characterize the usefulness and
limitations of the rLLNA, and (d) rLLNA
test method performance standards. The
TMER includes the report of an
international independent scientific
peer review panel (hereafter, Panel) and
the final rLLNA background review
document (BRD). The BRD provides the
data and analyses used to evaluate the
current validation status of the rLLNA
test method for assessing the ACD
potential of chemicals and products.
ICCVAM concluded that the scientific
validity of the rLLNA has been
adequately evaluated and that the
performance of the rLLNA, when
conducted in accordance with the
ICCVAM-recommended LLNA test
method protocol, is sufficient to
distinguish between skin sensitizers and
non-sensitizers. ICCVAM also
concluded that the rLLNA would reduce
animal use by 40% for each test
compared to the traditional, multi-dose
LLNA. Accordingly, ICCVAM
recommends that the rLLNA test
method should be routinely considered
before conducting the traditional, multidose LLNA, and used where appropriate
as the initial test to determine the
potential of chemicals and products to
produce ACD. For testing situations that
require dose-response information,
rLLNA-positive substances will need to
be tested with the traditional multi-dose
LLNA. This testing should be done
using the updated ICCVAMrecommended test method protocol,
which reduces animal use by 20%
compared to the original ICCVAMrecommended test method protocol by
decreasing the minimum number of
animals per dose group from five to
four.
NICEATM also announces availability
of the ICCVAM Recommended
Performance Standards: Murine Local
Lymph Node Assay (NIH Publication
09–7357). The ICCVAM recommends
that LLNA test method performance
standards can be used to efficiently
evaluate the validity of modified
versions of the LLNA that are
mechanistically and functionally similar
to the traditional LLNA. The traditional
LLNA test method is the reference test
method used as the basis for
establishing the LLNA performance
standards. The performance standards
specify the essential test method
components that must be included in a
modified LLNA in order to use the
performance standards to evaluate the
validity of the modified test method.
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Fmt 4703
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The performance standards also specify
a minimum list of reference substances
to evaluate the accuracy and reliability
of the modified test method, and the
accuracy and reliability values that must
be achieved in order for the modified
test method to be considered equal to or
better than the traditional LLNA.
Electronic copies of the ICCVAM
rLLNA TMER and the report on
ICCVAM-recommended LLNA
performance standards are available
from the NICEATM–ICCVAM Web site
at https://iccvam.niehs.nih.gov or by
contacting NICEATM (see FOR FURTHER
INFORMATION CONTACT). The two reports
have been forwarded to U.S. Federal
agencies for regulatory and other
acceptance considerations, where
applicable. Responses will be posted on
the NICEATM–ICCVAM website as they
are received.
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, (e-mail)
niceatm@niehs.nih.gov. Courier address:
NICEATM, NIEHS, Room 2034, 530
Davis Drive, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
The U.S. Consumer Product Safety
Commission (CPSC) nominated several
new versions and applications of the
LLNA to ICCVAM in 2007 for
evaluation of their scientific validity
(https://iccvam.niehs.nih.gov/methods/
immunotox/llnadocs/
CPSC_LLNA_nom.pdf). The nomination
requested that ICCVAM assess the
validation status of: (1) the LLNA limit
dose procedure (i.e., the rLLNA); (2)
three modified LLNA test method
protocols that do not require the use of
radioactive materials; (3) the use of the
LLNA to test mixtures, aqueous
solutions, and metals (applicability
domain for the LLNA); and (4) the use
of the LLNA to determine ACD potency
categories for hazard classification.
NICEATM published a Federal Register
notice (72 FR 27815) requesting public
comments on the appropriateness and
relative priority of the CPSC-nominated
LLNA activities, the development of test
method performance standards for the
LLNA, the nomination of scientists to
serve on the Panel, and the submission
of data from LLNA testing that related
to the CPSC-nominated LLNA activities,
as well as corresponding data from
human and other animal studies. After
considering public comments and
comments from the Scientific Advisory
Committee on Alternative Toxicological
E:\FR\FM\30SEN1.SGM
30SEN1
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices
Methods (SACATM), ICCVAM
unanimously endorsed the nomination
with a high priority. ICCVAM and
NICEATM began evaluation activities
and also initiated development of
proposed test method performance
standards for the LLNA since these had
not previously been developed (https://
iccvam.niehs.nih.gov/methods/
immunotox/immunotox.htm).
NICEATM and ICCVAM compiled a
comprehensive draft BRD on the rLLNA
test method and a draft test method
performance standards document for the
LLNA and released them for public
comment in January 2008 (73 FR 1360).
NICEATM and ICCVAM convened the
Panel at a meeting on March 4–6, 2008,
to review the draft BRDs and evaluate
the validation status of the proposed test
methods and applications. The Panel
also reviewed the extent that the
information contained in the draft BRDs
supported draft ICCVAM test method
recommendations for test method uses
and limitations, updated standardized
test method protocols, and proposed
future studies. The Panel reviewed the
draft ICCVAM LLNA test method
performance standards for their
adequacy for assessing the accuracy and
reliability of test method protocols that
are based on similar scientific principles
and that measure the same biological
effect as the traditional LLNA. The
Panel considered public comments
made at the meeting as well as public
comments submitted in advance of the
meeting, before concluding their
deliberations. The Panel’s report was
made available in May 2008 (73 FR
29136) for public comment. The draft
ICCVAM BRDs, draft ICCVAM test
method recommendations, draft
ICCVAM LLNA test method
performance standards, the Panel’s
report, and all public comments were
made available to the SACATM for
comment on June 18–19, 2008 (73 FR
25754).
ICCVAM considered the Panel’s
report, all public comments, and
SACATM comments in finalizing its
recommendations for the rLLNA, the
updated LLNA test method protocol,
and LLNA test method performance
standards. ICCVAM has forwarded its
test method recommendations to U.S.
Federal agencies for consideration, in
accordance with the ICCVAM
Authorization Act of 2000 (42 U.S.C.
285l–3(e)(4)). Agency responses to the
ICCVAM test method recommendations
will be made available on the
NICEATM–ICCVAM Web site as they
are received.
VerDate Nov<24>2008
14:56 Sep 29, 2009
Jkt 217001
Background Information on ICCVAM,
NICEATM, and SACATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that use, generate, or disseminate
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 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 U.S.
Federal agencies. Additional
information about ICCVAM and
NICEATM can be found on their Web
site (https://www.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 statutorilymandated 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: September 22, 2009.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. E9–23534 Filed 9–29–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Renewal of Charter for the Secretary’s
Advisory Committee on National
Health Promotion and Disease
Prevention Objectives for 2020
AGENCY: Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science,
Office of Disease Prevention and Health
Promotion.
ACTION: Notice.
SUMMARY: As stipulated by the Federal
Advisory Committee Act, as amended (5
U.S.C. Appendix 2), the U.S.
Department of Health and Human
Services is hereby announcing that the
PO 00000
Frm 00052
Fmt 4703
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50213
charter for the Secretary’s Advisory
Committee on National Health
Promotion and Disease Prevention
Objectives for 2020 (Healthy People
2020 Advisory Committee; HPAC) has
been renewed.
FOR FURTHER INFORMATION CONTACT:
Emmeline Ochiai, Executive Secretary,
Secretary’s Advisory Committee on
National Health Promotion and Disease
Prevention Objectives for 2020,
Department of Health and Human
Services, Office of Public Health and
Science, Office of Disease Prevention
and Health Promotion, 1101 Wootton
Parkway, Room LL–100, Rockville, MD
20852; Telephone: (240) 453–8259; Fax
(240) 453–8281. Additional information
is available on the Internet at https://
www.healthypeople.gov.
SUPPLEMENTARY INFORMATION: Every ten
years, through the Healthy People
initiative, the U.S. Department of Health
and Human Services (HHS) leverages
scientific insights and lessons from the
past decade, along with the new
knowledge of current data, trends, and
innovations to develop the next
iteration of the national health
promotion and disease prevention
objectives. Healthy People provides
science-based, ten-year national
objectives for promoting health and
preventing disease. Since 1980, Healthy
People has set and monitored national
health objectives to meet a broad range
of health needs, encourage
collaborations across sectors, guide
individuals toward making informed
health decisions, and measure the
impact of our prevention and health
promotion activities. Healthy People
2020 will reflect assessment of major
risks to health and wellness, changing
public health priorities, and emerging
technologies related to our nation’s
health preparedness and prevention.
The Committee will continue to
provide advice and consultation to the
Secretary of Health and Human Services
for developing and implementing the
next iteration of the national health
promotion and disease prevention goals
and objectives and provide
recommendations for initiatives to occur
during the implementation phase of the
goals and objectives. HHS will use the
recommendations to form the
development of the national health
promotion and disease prevention
objectives for 2020 and the process for
implementing the objectives. The intent
is to develop and launch objectives
designed to improve the health status
and reduce health risks for Americans
by the year 2020. Renewal of the HPAC
charter provides authorization for the
Committee to operate until September 4,
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 74, Number 188 (Wednesday, September 30, 2009)]
[Notices]
[Pages 50212-50213]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23534]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Availability
of the Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) Test Method Evaluation Report: The Reduced
Murine Local Lymph Node Assay, an Alternative Test Method Using Fewer
Animals To Assess the Allergic Contact Dermatitis Potential of
Chemicals and Products; Availability of ICCVAM Recommended Murine Local
Lymph Node Assay Performance Standards; Notice of Transmittal to
Federal Agencies of ICCVAM Test Method Recommendations for the Reduced
Murine Local Lymph Node Assay, Updated Murine Local Lymph Node Assay
Test Method Protocol, and Murine Local Lymph Node Assay Test Method
Performance Standards
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH)
ACTION: Availability of ICCVAM Test Method Evaluation Report (TMER) and
Recommended Test Method Performance Standards; Notice of Transmittal.
-----------------------------------------------------------------------
SUMMARY: NICEATM announces availability of the ICCVAM Test Method
Evaluation Report: The Reduced Murine Local Lymph Node Assay: An
Alternative Test Method Using Fewer Animals to Assess the Allergic
Contact Dermatitis Potential of Chemicals and Products (NIH Publication
09-6439). The TMER provides ICCVAM's evaluation and recommendations for
the reduced Murine Local Lymph Node Assay (rLLNA) test method as a
reduction alternative that uses fewer animals compared to the
traditional Murine Local Lymph Node Assay (LLNA) for assessing the
potential of test substances to cause allergic contact dermatitis
(ACD). The report includes ICCVAM's recommendations on (a) the
usefulness and limitations of the rLLNA, (b) an updated ICCVAM LLNA
test method protocol, which includes the procedures for conducting the
rLLNA, (c) future studies to further characterize the usefulness and
limitations of the rLLNA, and (d) rLLNA test method performance
standards. The TMER includes the report of an international independent
scientific peer review panel (hereafter, Panel) and the final rLLNA
background review document (BRD). The BRD provides the data and
analyses used to evaluate the current validation status of the rLLNA
test method for assessing the ACD potential of chemicals and products.
ICCVAM concluded that the scientific validity of the rLLNA has been
adequately evaluated and that the performance of the rLLNA, when
conducted in accordance with the ICCVAM-recommended LLNA test method
protocol, is sufficient to distinguish between skin sensitizers and
non-sensitizers. ICCVAM also concluded that the rLLNA would reduce
animal use by 40% for each test compared to the traditional, multi-dose
LLNA. Accordingly, ICCVAM recommends that the rLLNA test method should
be routinely considered before conducting the traditional, multi-dose
LLNA, and used where appropriate as the initial test to determine the
potential of chemicals and products to produce ACD. For testing
situations that require dose-response information, rLLNA-positive
substances will need to be tested with the traditional multi-dose LLNA.
This testing should be done using the updated ICCVAM-recommended test
method protocol, which reduces animal use by 20% compared to the
original ICCVAM-recommended test method protocol by decreasing the
minimum number of animals per dose group from five to four.
NICEATM also announces availability of the ICCVAM Recommended
Performance Standards: Murine Local Lymph Node Assay (NIH Publication
09-7357). The ICCVAM recommends that LLNA test method performance
standards can be used to efficiently evaluate the validity of modified
versions of the LLNA that are mechanistically and functionally similar
to the traditional LLNA. The traditional LLNA test method is the
reference test method used as the basis for establishing the LLNA
performance standards. The performance standards specify the essential
test method components that must be included in a modified LLNA in
order to use the performance standards to evaluate the validity of the
modified test method. The performance standards also specify a minimum
list of reference substances to evaluate the accuracy and reliability
of the modified test method, and the accuracy and reliability values
that must be achieved in order for the modified test method to be
considered equal to or better than the traditional LLNA.
Electronic copies of the ICCVAM rLLNA TMER and the report on
ICCVAM-recommended LLNA performance standards are available from the
NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov or by contacting
NICEATM (see FOR FURTHER INFORMATION CONTACT). The two reports have
been forwarded to U.S. Federal agencies for regulatory and other
acceptance considerations, where applicable. Responses will be posted
on the NICEATM-ICCVAM website as they are received.
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, (e-mail)
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530
Davis Drive, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
The U.S. Consumer Product Safety Commission (CPSC) nominated
several new versions and applications of the LLNA to ICCVAM in 2007 for
evaluation of their scientific validity (https://iccvam.niehs.nih.gov/methods/immunotox/llnadocs/CPSC_LLNA_nom.pdf). The nomination
requested that ICCVAM assess the validation status of: (1) the LLNA
limit dose procedure (i.e., the rLLNA); (2) three modified LLNA test
method protocols that do not require the use of radioactive materials;
(3) the use of the LLNA to test mixtures, aqueous solutions, and metals
(applicability domain for the LLNA); and (4) the use of the LLNA to
determine ACD potency categories for hazard classification. NICEATM
published a Federal Register notice (72 FR 27815) requesting public
comments on the appropriateness and relative priority of the CPSC-
nominated LLNA activities, the development of test method performance
standards for the LLNA, the nomination of scientists to serve on the
Panel, and the submission of data from LLNA testing that related to the
CPSC-nominated LLNA activities, as well as corresponding data from
human and other animal studies. After considering public comments and
comments from the Scientific Advisory Committee on Alternative
Toxicological
[[Page 50213]]
Methods (SACATM), ICCVAM unanimously endorsed the nomination with a
high priority. ICCVAM and NICEATM began evaluation activities and also
initiated development of proposed test method performance standards for
the LLNA since these had not previously been developed (https://iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm). NICEATM and
ICCVAM compiled a comprehensive draft BRD on the rLLNA test method and
a draft test method performance standards document for the LLNA and
released them for public comment in January 2008 (73 FR 1360).
NICEATM and ICCVAM convened the Panel at a meeting on March 4-6,
2008, to review the draft BRDs and evaluate the validation status of
the proposed test methods and applications. The Panel also reviewed the
extent that the information contained in the draft BRDs supported draft
ICCVAM test method recommendations for test method uses and
limitations, updated standardized test method protocols, and proposed
future studies. The Panel reviewed the draft ICCVAM LLNA test method
performance standards for their adequacy for assessing the accuracy and
reliability of test method protocols that are based on similar
scientific principles and that measure the same biological effect as
the traditional LLNA. The Panel considered public comments made at the
meeting as well as public comments submitted in advance of the meeting,
before concluding their deliberations. The Panel's report was made
available in May 2008 (73 FR 29136) for public comment. The draft
ICCVAM BRDs, draft ICCVAM test method recommendations, draft ICCVAM
LLNA test method performance standards, the Panel's report, and all
public comments were made available to the SACATM for comment on June
18-19, 2008 (73 FR 25754).
ICCVAM considered the Panel's report, all public comments, and
SACATM comments in finalizing its recommendations for the rLLNA, the
updated LLNA test method protocol, and LLNA test method performance
standards. ICCVAM has forwarded its test method recommendations to U.S.
Federal agencies for consideration, in accordance with the ICCVAM
Authorization Act of 2000 (42 U.S.C. 285l-3(e)(4)). Agency responses to
the ICCVAM test method recommendations will be made available on the
NICEATM-ICCVAM Web site as they are received.
Background Information on ICCVAM, NICEATM, and SACATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that use, generate, or
disseminate 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
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 U.S. Federal agencies. Additional
information about ICCVAM and NICEATM can be found on their Web site
(https://www.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: September 22, 2009.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. E9-23534 Filed 9-29-09; 8:45 am]
BILLING CODE 4140-01-P
