National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): 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, 25867-25869 [2010-10958]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Notices
jlentini on DSKJ8SOYB1PROD with NOTICES
Background
ICCVAM originally recommended the
LLNA as a valid stand-alone alternative
method to existing ACD test methods in
1999 (NIH publication No. 99–4494;
available at https://iccvam.niehs.nih.gov/
docs/immunotox_docs/llna/
llnarep.pdf). ICCVAM recommended
that the LLNA could be used as a
substitute for the existing guinea pig
based test methods for most testing
situations, which would reduce the
number of animals required and avoid
pain and distress. The Environmental
Protection Agency (EPA), the Food and
Drug Administration (FDA), and the
Consumer Product Safety Commission
(CPSC) subsequently accepted the
method as a valid substitute. The
Organization for Economic Co-operation
and Development (OECD) adopted the
LLNA as international OECD Test
Guideline 429 and the International
Standards Organization (ISO) adopted
the LLNA as ISO Test 10993–10.
The updated LLNA test method
protocol uses 20% fewer animals than
the original LLNA protocol
recommended by ICCVAM in 1999, and
provides improved guidance on dose
selection and other procedures to
improve assay accuracy and
reproducibility. The rLLNA procedure
can further reduce the number of
animals required by 40% compared to
the updated LLNA protocol multi-dose
procedure. ICCVAM recommends that
the rLLNA test method should be
routinely considered before conducting
the traditional multi-dose LLNA, and
should be used as the initial test for
ACD where determined appropriate.
ICCVAM evaluation and complete
recommendations for the updated LLNA
test method protocol and the rLLNA
procedure are provided in 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 No. 09–6439, available at
https://iccvam.niehs.nih.gov/methods/
immunotox/LLNA–LD/TMER.htm).
ICCVAM also recommends that the
LLNA test method performance
standards can be used to efficiently
evaluate the validity of modified test
methods that are mechanistically and
functionally similar to the traditional
LLNA. The LLNA test method
performance standards are provided in
the ICCVAM report, Recommended
Performance Standards: Murine Local
Lymph Node Assay (NIH Publication
No. 09–7357, available at https://
VerDate Mar<15>2010
17:18 May 07, 2010
Jkt 220001
iccvam.niehs.nih.gov/methods/
immunotox/PerfStds/llna-ps.htm).
ICCVAM evaluated the updated
versions of the LLNA in response to a
2007 nomination from the CPSC
(https://iccvam.niehs.nih.gov/methods/
immunotox/llnadocs/
CPSC_LLNA_nom.pdf). The nomination
also requested that ICCVAM evaluate
the validation status of (1) new versions
of the LLNA test method protocol that
do not require the use of radioactive
materials; (2) use of the LLNA to test
mixtures, aqueous solutions, metals,
and other substances; and (3) use of the
LLNA to determine ACD potency
categories for hazard classification and
labeling purposes. ICCVAM
recommendations on these new versions
and applications are undergoing
finalization and will be forwarded to
Federal agencies in 2010.
Agency Reponses to ICCVAM
Recommendations
In September 2009, ICCVAM
forwarded final test method
recommendations for the rLLNA, the
updated LLNA test method protocol,
and LLNA performance standards to
U.S. Federal agencies for consideration,
in accordance with the ICCVAM
Authorization Act of 2000 (42 U.S.C.
285l–3(e)(4)) (74 FR 50212). The
ICCVAM Authorization Act requires
member agencies to review ICCVAM
test method recommendations and
notify ICCVAM in writing of their
findings no later than 180 days after
receipt of recommendations. The Act
also requires ICCVAM to make ICCVAM
recommendations and agency responses
available to the public. Agency
responses are to include identification
of relevant test methods for which the
ICCVAM test method recommendations
may be added or substituted, and
indicate any revisions or planned
revisions to existing guidelines,
guidances, or regulations to be made in
response to these recommendations.
Background Information on ICCVAM
and NICEATM
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
25867
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).
Dated: April 30, 2010.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2010–10954 Filed 5–7–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP)
Interagency Center for the Evaluation
of Alternative Toxicological Methods
(NICEATM): 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: National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH), Department of Health and Human
Services.
ACTION: Announcement of a workshop.
SUMMARY: The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM) and
NICEATM announce an upcoming
‘‘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 workshop
will bring together an international
group of scientific experts from
government, industry, and academia to
review the current state of the science,
availability, and future need for
alternative methods that can reduce,
refine, and replace the use of animals
for human and veterinary vaccine postlicensing potency and safety testing.
Plenary and breakout sessions will
address current U.S. and international
regulatory requirements, currently
available alternatives, and future
research, development, and validation
activities needed to further advance the
use of alternative methods for vaccine
post-licensing potency and safety
testing. This workshop is free and open
E:\FR\FM\10MYN1.SGM
10MYN1
25868
Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Notices
jlentini on DSKJ8SOYB1PROD with NOTICES
to the public with attendance limited
only by the space available. Abstracts
for scientific posters for display at the
workshop are also invited (see
SUPPLEMENTARY INFORMATION).
DATES: The workshop will be held on
September 14–16, 2010. Sessions will
begin at 8:30 a.m. and end at
approximately 5 p.m. on all days. The
deadline for submission of poster
abstracts is July 29, 2010. Individuals
who plan to attend are asked to register
in advance (by August 30, 2010) with
NICEATM.
ADDRESSES: The workshop will be held
at the William H. Natcher Conference
Center, 45 Center Drive, NIH Campus,
Bethesda, MD 20892. Persons needing
special assistance, such as sign language
interpretation or other reasonable
accommodation in order to attend,
should contact 919–541–2475 voice,
919–541–4644 TTY (text telephone),
through the Federal TTY Relay System
at 800–877–8339, or e-mail to
niehsoeeo@niehs.nih.gov. Requests
should be made at least 14 days in
advance of the event.
FOR FURTHER INFORMATION CONTACT:
Correspondence should be sent by mail,
fax, or e-mail 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, (e-mail)
niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
Vaccines represent a vital and costeffective tool in the prevention of
infectious diseases in humans and
animals. Regulatory authorities require
post-licensing potency and safety testing
of human and veterinary vaccines to
ensure their effectiveness and minimize
potential adverse health effects. Because
some of these tests require large
numbers of laboratory animals that may
experience unrelieved pain and distress,
the development and validation of
alternative methods that can reduce,
refine, and replace the use of animals
for vaccine potency and safety testing is
one of ICCVAM’s four highest priorities.
The workshop goals are to (1) review the
state of the science of alternative
methods that are currently available
and/or accepted for use that can reduce,
refine (less 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
VerDate Mar<15>2010
17:18 May 07, 2010
Jkt 220001
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.
Preliminary Workshop Agenda
Day 1 Tuesday, September 14, 2010
• Welcome and Introduction of
Workshop Goals and Objectives
• Overview of Public Health Needs
and Regulatory Requirements for
Vaccine Safety and Potency Testing
• Replacement Methods for Vaccine
Potency Testing: Current State of the
Science
• Breakout Groups: Non-animal
Replacement Methods for Vaccine
Potency Testing
• Human Vaccines
• Veterinary Vaccines
Day 2 Wednesday, September 15, 2010
• Refinement Alternatives: Using
Serological Methods to Avoid Challenge
Testing
• Refinement Alternatives: Using
Earlier Humane Endpoints to Avoid or
Minimize Animal Pain and Distress in
Vaccine Potency Challenge Testing
• Reduction Alternatives: Strategies
to Further Reduce Animal Numbers for
Vaccine Potency Testing
• Breakout Groups: Refinement and
Reduction of Animal Use for Vaccine
Potency Testing
• Human Vaccines
• Veterinary Vaccines
Day 3 Thursday, September 16, 2010
• Vaccine Post-licensing Safety
Testing: Reduction, Refinement and
Replacement Methods and Strategies
• Breakout Groups: Post-license
Vaccine Safety Testing: Alternative
Strategies for the Replacement,
Refinement, and Reduction of Animals
• Human Vaccines
• Veterinary Vaccines
• Closing Comments
Registration
Registration information, tentative
agenda, and additional meeting
information are available on the
workshop Web site (https://
iccvam.niehs.nih.gov/meetings/
BiologicsWksp-2010/
BiologicsWksp.htm) and upon request
from NICEATM (see FOR FURTHER
INFORMATION CONTACT).
Call for Abstracts
ICCVAM and NICEATM invite the
submission of abstracts for scientific
posters to be displayed during this
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
workshop. Posters should address
current research, development,
validation, and/or regulatory acceptance
of alternative methods that may reduce,
refine, and/or replace the use of animals
in vaccine potency or vaccine postlicensing safety testing. The body of the
abstract must be limited to 400 words or
fewer. Key references relevant to the
abstract may be included after the
abstract body. However, the length of
the abstract and references should not
exceed one page. All submissions
should be at least 12-point font and all
margins for the document should be no
less than one inch. Title information
should include names of all authors and
associated institutions. The name and
contact information (i.e., address, phone
number, fax number, e-mail address) for
the corresponding or senior author
should be provided at the end of the
abstract.
A statement indicating whether
animals or humans were used in studies
described in the poster must accompany
all abstracts. All abstracts that involve
studies using animals or animal tissues
should be accompanied by a statement
by the senior author certifying that all
animal use was carried out in
accordance with applicable laws,
regulations, and guidelines, and that the
studies were approved by the
appropriate Institutional Animal Care
and Use Committee or equivalent. A
statement that all human studies were
conducted in accordance with
applicable laws, regulations, and
guidelines, and that the studies were
approved by the appropriate
Institutional Review Board or equivalent
must accompany any abstracts that
involve studies using humans.
Abstracts must be submitted by e-mail
to niceatm@niehs.nih.gov. The deadline
for abstract submission is close of
business on July 29, 2010. ICCVAM and
NICEATM will review the submitted
abstracts. The corresponding author will
be notified of the abstract’s acceptance
approximately five weeks prior to the
workshop. Guidelines for poster
presentations will be sent to
corresponding authors along with the
notification of acceptance.
Background Information on ICCVAM
and NICEATM
ICCVAM is an interagency committee
composed of representatives from 15
U.S. Federal regulatory and research
agencies that require, 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
E:\FR\FM\10MYN1.SGM
10MYN1
Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Notices
that more accurately assess the safety
and health hazards of chemicals and
products and that refine (less pain and
distress), reduce, or replace animal use.
The ICCVAM Authorization Act of 2000
(42 U.S.C. 2851–2, 2851–5 [2000]),
available at https://iccvam.niehs.nih.gov/
about/PL106545.htm) 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 coordinates international
validation studies. 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, guidelines for nomination of
test methods for validation studies, and
guidelines for submission of test
methods for ICCVAM evaluation are
available at https://iccvam.niehs.nih.gov.
Dated: April 30, 2010.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2010–10958 Filed 5–7–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0233]
The National Institutes of Health and
the Food and Drug Administration
Joint Leadership Council:
Stakeholders Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
ACTION: Notice of public meeting;
request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting, in conjunction with the
National Institutes of Health (NIH), to
solicit comments from interested
persons on how the agencies can more
effectively collaborate to advance the
translation of biomedical research
discoveries into approved diagnostics
and therapies as well as promote
science to enhance the evaluation tools
used for regulatory review. A newly
formed NIH–FDA Joint Leadership
Council will help ensure that regulatory
considerations form an increasing
component of biomedical research
planning, and that the latest science is
integrated into the regulatory review
process.
VerDate Mar<15>2010
17:18 May 07, 2010
Jkt 220001
DATES: The public meeting will be held
on June 2, 2010, from 8:30 a.m. to 12:30
p.m. Persons interested in attending the
meeting must register by Wednesday,
May 26, 2010, at 5 p.m. e.s.t. (see
section III of this document). Submit
written or electronic comments by
Wednesday, May 26, 2010, at 5 p.m.
e.s.t.
ADDRESSES: The public meeting will be
held at FDA, 10903 New Hampshire
Ave., Bldg. 31, rm. 1503C, Silver Spring,
MD 20993–0002.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments
to https://www.regulations.gov. All
comments should be identified with the
docket number found in brackets at the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Rakesh Raghuwanshi, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4283, Silver Spring,
MD 20993–0002, 301–796–4769, FAX:
301–847–8617, e-mail:
rakesh.raghuwanshi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
With the dramatic breakthroughs
occurring in biomedical research
discovery, new public health challenges
on the rise, an ever-changing economic
landscape resulting from globalization,
and the prospect for fundamental
changes to healthcare delivery in the
United States, there is a pressing need
for greater collaboration between FDA
and NIH. Both NIH and FDA have the
goals of translating science discoveries
into medical products and therapies,
and both NIH and FDA have important
roles and contributions to make towards
these efforts. To address these important
areas of common interest, NIH and FDA
announced a new partnership effort that
includes, among other initiatives, the
regulatory science program and the
NIH–FDA Joint Leadership Council.
The NIH–FDA Joint Leadership
Council provides a forum for the
leadership of both agencies to: (1) Work
together on strategic planning at a high
level; (2) stimulate an enhanced culture
of collaboration between the agencies at
all levels; and (3) further coordinate and
target efforts to promote promising new
therapies using the latest technological
advances, such as stem cell biology,
biomarkers, and computational
sciences. NIH and FDA plan to work
jointly to address the gap between
biomedical research discoveries and
new medical products. They can create
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
25869
new programs to support development
of innovative therapies and promote
personalized medicine, utilizing new
clinical trial design strategies and
regulatory review processes
incorporating the use of genetic or other
biomarkers and information
technologies. These activities will also
support postmarketing and/or other
population-based surveys for safety
assessments. Overall, there are many
new avenues for NIH and FDA to
explore such that we can deliver safer
and more effective treatments faster.
II. Scope of the Meeting
FDA and NIH are interested in
receiving comments from the public on
the regulatory considerations that
should be an integral part of the
biomedical research program
development and scientific tools or
approaches that would enhance the
ability to evaluate new medical
products. The comments should focus
on ways in which NIH and FDA can
partner to promote interdisciplinary
biomedical research through scientific
exchange and new programs designed to
advance innovation and development of
new therapies incorporating many of the
latest basic research discoveries.
Suggestions about the ways FDA and
NIH can work together to promote an
integrated biomedical research agenda
including regulatory review approaches
and/or processes on areas of common
interest and mission are being sought.
Some areas for which we are
specifically interested in input are the
following:
1. What steps should be taken to
enhance the translation of biomedical
research discoveries into new and
approved preventatives, diagnostics,
therapies, or devices for clinical use?
2. What are the priority scientific
issues that currently need to be
addressed (e.g., clinical trial design,
endpoint selection and qualification,
bioinformatics needs) in order to inform
regulatory assessments and analyses of
new products?
3. How could we enhance the
exchange of scientific information
across all sectors in order to better
identify and prioritize scientific areas
for emphasis in regulatory research?
4. What mechanisms for the support
of regulatory science research would be
most effective and efficient in
addressing pressing priority areas in the
translational pipeline?
III. Registration To Attend and/or To
Participate in the Meeting
If you wish to attend the public
meeting, you must register by e-mailing
Rakesh Raghuwanshi
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 75, Number 89 (Monday, May 10, 2010)]
[Notices]
[Pages 25867-25869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10958]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP) Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM):
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: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH), Department of Health and Human
Services.
ACTION: Announcement of a workshop.
-----------------------------------------------------------------------
SUMMARY: The Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) and NICEATM announce an upcoming
``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 workshop will bring
together an international group of scientific experts from government,
industry, and academia to review the current state of the science,
availability, and future need for alternative methods that can reduce,
refine, and replace the use of animals for human and veterinary vaccine
post-licensing potency and safety testing. Plenary and breakout
sessions will address current U.S. and international regulatory
requirements, currently available alternatives, and future research,
development, and validation activities needed to further advance the
use of alternative methods for vaccine post-licensing potency and
safety testing. This workshop is free and open
[[Page 25868]]
to the public with attendance limited only by the space available.
Abstracts for scientific posters for display at the workshop are also
invited (see SUPPLEMENTARY INFORMATION).
DATES: The workshop will be held on September 14-16, 2010. Sessions
will begin at 8:30 a.m. and end at approximately 5 p.m. on all days.
The deadline for submission of poster abstracts is July 29, 2010.
Individuals who plan to attend are asked to register in advance (by
August 30, 2010) with NICEATM.
ADDRESSES: The workshop will be held at the William H. Natcher
Conference Center, 45 Center Drive, NIH Campus, Bethesda, MD 20892.
Persons needing special assistance, such as sign language
interpretation or other reasonable accommodation in order to attend,
should contact 919-541-2475 voice, 919-541-4644 TTY (text telephone),
through the Federal TTY Relay System at 800-877-8339, or e-mail to
niehsoeeo@niehs.nih.gov. Requests should be made at least 14 days in
advance of the event.
FOR FURTHER INFORMATION CONTACT: Correspondence should be sent by mail,
fax, or e-mail 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, (e-mail) niceatm@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
Vaccines represent a vital and cost-effective tool in the
prevention of infectious diseases in humans and animals. Regulatory
authorities require post-licensing potency and safety testing of human
and veterinary vaccines to ensure their effectiveness and minimize
potential adverse health effects. Because some of these tests require
large numbers of laboratory animals that may experience unrelieved pain
and distress, the development and validation of alternative methods
that can reduce, refine, and replace the use of animals for vaccine
potency and safety testing is one of ICCVAM's four highest priorities.
The workshop goals are to (1) review the state of the science of
alternative methods that are currently available and/or accepted for
use that can reduce, refine (less 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.
Preliminary Workshop Agenda
Day 1 Tuesday, September 14, 2010
Welcome and Introduction of Workshop Goals and Objectives
Overview of Public Health Needs and Regulatory
Requirements for Vaccine Safety and Potency Testing
Replacement Methods for Vaccine Potency Testing: Current
State of the Science
Breakout Groups: Non-animal Replacement Methods for
Vaccine Potency Testing
Human Vaccines
Veterinary Vaccines
Day 2 Wednesday, September 15, 2010
Refinement Alternatives: Using Serological Methods to
Avoid Challenge Testing
Refinement Alternatives: Using Earlier Humane Endpoints to
Avoid or Minimize Animal Pain and Distress in Vaccine Potency Challenge
Testing
Reduction Alternatives: Strategies to Further Reduce
Animal Numbers for Vaccine Potency Testing
Breakout Groups: Refinement and Reduction of Animal Use
for Vaccine Potency Testing
Human Vaccines
Veterinary Vaccines
Day 3 Thursday, September 16, 2010
Vaccine Post-licensing Safety Testing: Reduction,
Refinement and Replacement Methods and Strategies
Breakout Groups: Post-license Vaccine Safety Testing:
Alternative Strategies for the Replacement, Refinement, and Reduction
of Animals
Human Vaccines
Veterinary Vaccines
Closing Comments
Registration
Registration information, tentative agenda, and additional meeting
information are available on the workshop Web site (https://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp.htm) and
upon request from NICEATM (see FOR FURTHER INFORMATION CONTACT).
Call for Abstracts
ICCVAM and NICEATM invite the submission of abstracts for
scientific posters to be displayed during this workshop. Posters should
address current research, development, validation, and/or regulatory
acceptance of alternative methods that may reduce, refine, and/or
replace the use of animals in vaccine potency or vaccine post-licensing
safety testing. The body of the abstract must be limited to 400 words
or fewer. Key references relevant to the abstract may be included after
the abstract body. However, the length of the abstract and references
should not exceed one page. All submissions should be at least 12-point
font and all margins for the document should be no less than one inch.
Title information should include names of all authors and associated
institutions. The name and contact information (i.e., address, phone
number, fax number, e-mail address) for the corresponding or senior
author should be provided at the end of the abstract.
A statement indicating whether animals or humans were used in
studies described in the poster must accompany all abstracts. All
abstracts that involve studies using animals or animal tissues should
be accompanied by a statement by the senior author certifying that all
animal use was carried out in accordance with applicable laws,
regulations, and guidelines, and that the studies were approved by the
appropriate Institutional Animal Care and Use Committee or equivalent.
A statement that all human studies were conducted in accordance with
applicable laws, regulations, and guidelines, and that the studies were
approved by the appropriate Institutional Review Board or equivalent
must accompany any abstracts that involve studies using humans.
Abstracts must be submitted by e-mail to niceatm@niehs.nih.gov. The
deadline for abstract submission is close of business on July 29, 2010.
ICCVAM and NICEATM will review the submitted abstracts. The
corresponding author will be notified of the abstract's acceptance
approximately five weeks prior to the workshop. Guidelines for poster
presentations will be sent to corresponding authors along with the
notification of acceptance.
Background Information on ICCVAM and NICEATM
ICCVAM is an interagency committee composed of representatives from
15 U.S. Federal regulatory and research agencies that require, 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
[[Page 25869]]
that more accurately assess the safety and health hazards of chemicals
and products and that refine (less pain and distress), reduce, or
replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C.
2851-2, 2851-5 [2000]), available at https://iccvam.niehs.nih.gov/about/PL106545.htm) 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
coordinates international validation studies. 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, guidelines for nomination of test methods for validation
studies, and guidelines for submission of test methods for ICCVAM
evaluation are available at https://iccvam.niehs.nih.gov.
Dated: April 30, 2010.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2010-10958 Filed 5-7-10; 8:45 am]
BILLING CODE 4140-01-P
