Availability of the Report on the International Workshop on Alternative Methods To Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions, 2064-2065 [2012-563]
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Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
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[FR Doc. 2012–498 Filed 1–12–12; 8:45 am]
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15:46 Jan 12, 2012
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Board of Governors of the Federal Reserve
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Robert deV. Frierson,
Deputy Secretary of the Board.
Board of Governors of the Federal Reserve
System, January 9, 2012.
Robert deV. Frierson,
Deputy Secretary of the Board.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2012–500 Filed 1–12–12; 8:45 am]
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FEDERAL RESERVE SYSTEM
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[FR Doc. 2012–501 Filed 1–12–12; 8:45 am]
BILLING CODE 6210–01–P
Availability of the Report on the
International Workshop on Alternative
Methods To Reduce, Refine, and
Replace the Use of Animals in Vaccine
Potency and Safety Testing: State of
the Science and Future Directions
Division of the National
Toxicology Program (DNTP), National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH).
ACTION: Availability of workshop report.
AGENCY:
The NTP Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM)
announces availability of the report on
the ‘‘International Workshop on
Alternative Methods To Reduce, Refine,
and Replace the Use of Animals in
Vaccine Potency and Safety Testing:
State of the Science and Future
Directions.’’ The report was published
as an issue of the journal Procedia in
Vaccinology, and is available on the
journal’s Web site at https://
www.sciencedirect.com/science/journal/
1877282X. A limited number of CDs and
printed copies of the report are available
from NICEATM (see ADDRESSES).
ADDRESSES: Requests for copies of the
report should be sent by mail, fax, or
email to Dr. William S. Stokes,
NICEATM Director, NIEHS, P.O. Box
12233, MD K2–16, Research Triangle
Park, NC, 27709, (phone) (919) 541–
2384, (fax) (919) 541–0947, (email)
niceatm@niehs.nih.gov.
SUMMARY:
Dr.
William S. Stokes: (telephone) (919)
541–2384, (fax) (919) 541–0947, or
(email) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background
Regulatory authorities require postlicensing potency and safety testing of
human and veterinary vaccines to
ensure their effectiveness and minimize
potential adverse health effects.
However, such testing requires large
numbers of animals and accounts for the
majority of animals reported to the
USDA with unrelieved pain and
distress. Accordingly, identification and
promotion of alternative methods that
E:\FR\FM\13JAN1.SGM
13JAN1
Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
can reduce, refine, or replace the use of
animals for vaccine potency and safety
testing is one of the four highest
priorities of the Interagency
Coordinating Committee on the
Validation of Alternative Methods
(ICCVAM), an interagency committee of
the Federal government administered by
NICEATM.
To address this priority, NICEATM
and ICCVAM, along with international
partners organized an ‘‘International
Workshop on Alternative Methods To
Reduce, Refine, and Replace the Use of
Animals in Vaccine Potency and Safety
Testing: State of the Science and Future
Directions,’’ which took place on
September 14–16, 2010 at NIH in
Bethesda, Maryland. The report of the
workshop is now available.
Workshop Goals and Outcomes
The goals of the workshop were to (1)
review the state of the science of
alternative methods currently available
and/or accepted for use that can reduce,
refine (enhance animal well-being and
lessen or avoid pain and distress), and
replace animal use in vaccine potency
and safety testing, and discuss ways to
promote their implementation; (2)
identify knowledge and data gaps that
should be addressed to develop
alternative methods that can further
reduce, refine, and/or replace the use of
animals in vaccine potency and safety
testing; and (3) identify and prioritize
research, development, and validation
efforts needed to address these
knowledge and data gaps in order to
advance alternative methods for vaccine
potency and safety testing while
ensuring the protection of human and
animal health.
The workshop report is comprised of
27 papers that summarize the plenary
session presentations and the
conclusions and recommendations
developed by the workshop participants
during six breakout group sessions. The
report recommends vaccines that should
have the highest priority for future
reduction, refinement, and replacement
efforts. Other key recommendations
include:
• Procedures such as earlier humane
endpoints should be developed and
implemented immediately to reduce or
avoid the pain and distress experienced
by animals for vaccines that still require
live-agent challenge testing. Until nonanimal tests are available, development
of serological assays should also be
considered as a way to avoid challenge
testing.
• Specific non-animal approaches
that have successfully replaced animals
for some vaccine potency testing should
be developed for vaccines currently
VerDate Mar<15>2010
15:46 Jan 12, 2012
Jkt 226001
requiring animals through
identification, purification, and
characterization of vaccine protective
antigens.
• International harmonization and
cooperation efforts and closer
collaborations between human and
veterinary vaccine researchers should be
enhanced in order to support more
rapid progress towards reduction,
refinement, and replacement of animal
use for vaccine testing.
The workshop was organized by
NICEATM and ICCVAM in partnership
with the European Centre for the
Validation of Alternative Methods, the
Japanese Center for the Validation of
Alternative Methods, and Health
Canada. The workshop was cosponsored by the Society of Toxicology.
Background Information on NICEATM
and ICCVAM
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. The ICCVAM
Authorization Act of 2000 (42 U.S.C.
285l-3) established ICCVAM as a
permanent interagency committee of the
NIEHS under NICEATM. ICCVAM
conducts technical evaluations of new,
revised, and alternative 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, or replace animal use.
NICEATM administers ICCVAM,
provides scientific and operational
support for ICCVAM technical
evaluations and 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).
Dated: January 6, 2012.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2012–563 Filed 1–12–12; 8:45 am]
BILLING CODE 4140–01–P
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2065
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Prevention (CDC) publishes a list of
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Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
EEOICPA Dose Reconstruction
Interviews and Forms (0920–0530,
Expiration 03/30/2012)—Extension—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
On October 30, 2000, the Energy
Employees Occupational Illness
Compensation Program Act of 2000
(42 U.S.C. 7384–7385) was enacted.
This Act established a federal
compensation program for employees of
the Department of Energy (DOE) and
certain of its contractors, subcontractors
and vendors, who have suffered cancers
and other designated illnesses as a
result of exposures sustained in the
production and testing of nuclear
weapons.
Executive Order 13179, issued on
December 7, 2000, delegated authorities
assigned to ‘‘the President’’ under the
Act to the Departments of Labor, Health
and Human Services, Energy and
Justice. The Department of Health and
Human Services (DHHS) was delegated
the responsibility of establishing
methods for estimating radiation doses
received by eligible claimants with
cancer applying for compensation.
NIOSH is applying the following
methods to estimate the radiation doses
of individuals applying for
compensation.
In performance of its dose
reconstruction responsibilities, under
the Act, NIOSH is providing voluntary
interview opportunities to claimants (or
their survivors) individually and
providing them with the opportunity to
E:\FR\FM\13JAN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2064-2065]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-563]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Availability of the Report on the International Workshop on
Alternative Methods To Reduce, Refine, and Replace the Use of Animals
in Vaccine Potency and Safety Testing: State of the Science and Future
Directions
AGENCY: Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS), National Institutes
of Health (NIH).
ACTION: Availability of workshop report.
-----------------------------------------------------------------------
SUMMARY: The NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM) announces availability of the report on
the ``International Workshop on Alternative Methods To Reduce, Refine,
and Replace the Use of Animals in Vaccine Potency and Safety Testing:
State of the Science and Future Directions.'' The report was published
as an issue of the journal Procedia in Vaccinology, and is available on
the journal's Web site at https://www.sciencedirect.com/science/journal/1877282X. A limited number of CDs and printed copies of the report are
available from NICEATM (see ADDRESSES).
ADDRESSES: Requests for copies of the report should be sent by mail,
fax, or email to Dr. William S. Stokes, NICEATM Director, NIEHS, P.O.
Box 12233, MD K2-16, Research Triangle Park, NC, 27709, (phone) (919)
541-2384, (fax) (919) 541-0947, (email) niceatm@niehs.nih.gov.
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes: (telephone)
(919) 541-2384, (fax) (919) 541-0947, or (email) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
Regulatory authorities require post-licensing potency and safety
testing of human and veterinary vaccines to ensure their effectiveness
and minimize potential adverse health effects. However, such testing
requires large numbers of animals and accounts for the majority of
animals reported to the USDA with unrelieved pain and distress.
Accordingly, identification and promotion of alternative methods that
[[Page 2065]]
can reduce, refine, or replace the use of animals for vaccine potency
and safety testing is one of the four highest priorities of the
Interagency Coordinating Committee on the Validation of Alternative
Methods (ICCVAM), an interagency committee of the Federal government
administered by NICEATM.
To address this priority, NICEATM and ICCVAM, along with
international partners organized an ``International Workshop on
Alternative Methods To Reduce, Refine, and Replace the Use of Animals
in Vaccine Potency and Safety Testing: State of the Science and Future
Directions,'' which took place on September 14-16, 2010 at NIH in
Bethesda, Maryland. The report of the workshop is now available.
Workshop Goals and Outcomes
The goals of the workshop were to (1) review the state of the
science of alternative methods currently available and/or accepted for
use that can reduce, refine (enhance animal well-being and lessen or
avoid pain and distress), and replace animal use in vaccine potency and
safety testing, and discuss ways to promote their implementation; (2)
identify knowledge and data gaps that should be addressed to develop
alternative methods that can further reduce, refine, and/or replace the
use of animals in vaccine potency and safety testing; and (3) identify
and prioritize research, development, and validation efforts needed to
address these knowledge and data gaps in order to advance alternative
methods for vaccine potency and safety testing while ensuring the
protection of human and animal health.
The workshop report is comprised of 27 papers that summarize the
plenary session presentations and the conclusions and recommendations
developed by the workshop participants during six breakout group
sessions. The report recommends vaccines that should have the highest
priority for future reduction, refinement, and replacement efforts.
Other key recommendations include:
Procedures such as earlier humane endpoints should be
developed and implemented immediately to reduce or avoid the pain and
distress experienced by animals for vaccines that still require live-
agent challenge testing. Until non-animal tests are available,
development of serological assays should also be considered as a way to
avoid challenge testing.
Specific non-animal approaches that have successfully
replaced animals for some vaccine potency testing should be developed
for vaccines currently requiring animals through identification,
purification, and characterization of vaccine protective antigens.
International harmonization and cooperation efforts and
closer collaborations between human and veterinary vaccine researchers
should be enhanced in order to support more rapid progress towards
reduction, refinement, and replacement of animal use for vaccine
testing.
The workshop was organized by NICEATM and ICCVAM in partnership
with the European Centre for the Validation of Alternative Methods, the
Japanese Center for the Validation of Alternative Methods, and Health
Canada. The workshop was co-sponsored by the Society of Toxicology.
Background Information on NICEATM and ICCVAM
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.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) established
ICCVAM as a permanent interagency committee of the NIEHS under NICEATM.
ICCVAM conducts technical evaluations of new, revised, and alternative
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, or replace
animal use.
NICEATM administers ICCVAM, provides scientific and operational
support for ICCVAM technical evaluations and 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).
Dated: January 6, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-563 Filed 1-12-12; 8:45 am]
BILLING CODE 4140-01-P
